1–8–01 Monday Vol. 66 No. 5 Jan. 8, 2001 Pages 1253–1560

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1 II Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001

The FEDERAL REGISTER is published daily, Monday through SUBSCRIPTIONS AND COPIES Friday, except official holidays, by the Office of the Federal Register, National Archives and Records Administration, PUBLIC Washington, DC 20408, under the Federal Register Act (44 U.S.C. Subscriptions: Ch. 15) and the regulations of the Administrative Committee of Paper or fiche 202–512–1800 the Federal Register (1 CFR Ch. I). The Superintendent of Assistance with public subscriptions 512–1806 Documents, U.S. Government Printing Office, Washington, DC 20402 is the exclusive distributor of the official edition. General online information 202–512–1530; 1–888–293–6498 Single copies/back copies: The Federal Register provides a uniform system for making available to the public regulations and legal notices issued by Paper or fiche 512–1800 Federal agencies. 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2 III

Contents Federal Register Vol. 66, No. 5

Monday, January 8, 2001

Agency for International Development Court Services and Offender Supervision Agency for the NOTICES District of Columbia Agency information collection activities: RULES Proposed collection; comment request, 1301 Organization and general functions, 1259–1262 Submission for OMB review; comment request, 1301 Defense Department Agriculture Department See Army Department See Forest Service See Defense Logistics Agency See Natural Resources Conservation Service See Navy Department PROPOSED RULES Privacy Act; implementation Army Department National Reconnaissance Office, 1280–1281 NOTICES NOTICES Privacy Act: Privacy Act: Systems of records, 1312–1319 National Reconnaissance Office; systems of records, 1311–1312 Bonneville Power Administration NOTICES Defense Logistics Agency Environmental statements; notice of intent: NOTICES Umatilla County, OR; Umatilla Generating Project, 1332– Privacy Act: 1333 Computer matching programs, 1319–1321 Education Department Broadcasting Board of Governors RULES NOTICES Postsecondary education: Agency information collection activities: Developing Hispanic-Serving Institutions Program, 1262– Proposed collection; comment request, 1303 1263 Special education and rehabilitative services: Centers for Disease Control and Prevention Assistance to States for Education of Children with NOTICES Disabilities Program, 1473–1478 Committees; establishment, renewal, termination, etc.: NOTICES Public Health Service Activities and Research at DOE Grants and cooperative agreements; availability, etc.: Sites Citizens Advisory Committee, 1362 International Research and Studies Program, 1329–1330 Meetings: National Institute on Disability and Rehabilitation Mine Safety and Health Research Advisory Committee, Research— 1362–1363 Disability and Rehabilitation Research Projects and Organization, functions, and authority delegations: Centers Program, 1479–1499 Management Analysis and Services Office, Program National center on accessible education-based Services Office, 1363–1364 information technology and the disability and business technical assistance centers, 1498–1506 Coast Guard Special education and rehabilitative services— RULES Recreational Program, 1441–1443 Drawbridge operations: Iowa and Illinois, 1262 Employment and Training Administration PROPOSED RULES RULES Drawbridge operations: Aliens: Connecticut, 1281–1283 Nonimmigrants on H-1B visas in specialty occupations Electrical engineering: and as fashion models, temporary employment; and Marine shipboard electrical cable standards; permanent employment, labor certification process incorporation by reference, 1283 Correction, 1375 Energy Department Commerce Department See Bonneville Power Administration See International Trade Administration See Federal Energy Regulatory Commission See National Oceanic and Atmospheric Administration NOTICES Environmental statements; availability, etc.: Commodity Futures Trading Commission Oak Ridge Y-12 Plant, TN; continued operations and RULES construction and operation of new facilities, 1330– Commodity Exchange Act: 1331 Commodity interest transactions; intermediaries; Patent licenses; non-exclusive, exclusive, or partially regulatory framework exclusive: Customer funds investment; correction, 1375 PhA Environmental Restoration Corp., 1331–1332

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Environmental Protection Agency Fish and Wildlife Service RULES PROPOSED RULES Air pollutants, hazardous; national emission standards: Endangered and threatened species: Off-site waste and recovery operations; technical Plant and animal taxa that are candidates or proposed for corrections, 1263–1268 listing, findings on recycled petitions, and Air programs: description of progress on listing actions; review, Stratospheric ozone protection— 1295–1300 Essential use allowances; allocation, 1461–1471 NOTICES Air quality planning purposes; designation of areas: Endangered and threatened species permit applications, Nevada, 1268–1270 1364–1365 NOTICES Grants and cooperative agreements; availability, etc.: Environmental Professional Intern Program, 1338–1342 Food and Drug Administration Meetings: RULES Science Advisory Board, 1342–1344 Administrative practice and procedure: Water quality criteria: Examination of administrative record and other advisory Ambient water quality criteria— committee records, 1257–1259 Human health protection; methylmercury, 1344–1359 PROPOSED RULES Administrative practice and procedure: Federal Aviation Administration Examination of administrative record and other advisory RULES committee records, 1275–1277 Airworthiness directives: Biological products: Pilatus Aircraft Ltd., 1255–1257 Human cellular and tissue-based products manufacturers; Raytheon, 1253–1255 current good tissue practice; inspection and PROPOSED RULES enforcement, 1507–1559 Airworthiness directives: Cessna, 1273–1275 SOCATA-Groupe AEROSPATIALE, 1271–1273 Forest Service NOTICES Environmental statements; notice of intent: Federal Communications Commission Coconino National Forest, AZ, 1301–1302 PROPOSED RULES Common carrier services: Earth station license applications; biennial regulatory General Services Administration review (2000 FY), 1283–1294 NOTICES Acquisition regulations: Federal Deposit Insurance Corporation Prior Federal Service Statement-Worksheet (SF 144A); NOTICES form cancellation, 1360 Agency information collection activities: Proposed collection; comment request, 1359 Health and Human Services Department See Centers for Disease Control and Prevention Federal Energy Regulatory Commission See Food and Drug Administration NOTICES See Health Care Financing Administration Electric rate and corporate regulation filings: See National Institutes of Health Commonwealth Edison Co. et al., 1333–1335 NOTICES Duke Electric Transmission et al., 1335–1338 Meetings: Complementary and Alternative Medicine Policy, White Federal Highway Administration House Commission, 1361 RULES Intelligent Transportation System architecture and standards, 1445–1454 Health Care Financing Administration NOTICES RULES Environmental statements; notice of intent: Group health plans; access, portability, and renewability Mercer and Middlesex Counties, NJ, 1369 requirements: Nondiscrimination in health coverage in group market, 1377–1420 Federal Reserve System PROPOSED RULES NOTICES Group health plans; access, portability, and renewability Banks and bank holding companies: requirements: Formations, acquisitions, and mergers, 1360 Bona fide wellness programs, 1420–1435 Meetings; Sunshine Act, 1360

Federal Transit Administration Interior Department NOTICES See Fish and Wildlife Service Reports and guidance documents; availability, etc.: See Land Management Bureau National Intelligent Transportation Systems Architecture See Minerals Management Service Policy on Transit Projects, 1454–1459 See Surface Mining Reclamation and Enforcement Office

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Internal Revenue Service National Institutes of Health RULES NOTICES Excise taxes: Agency information collection activities: Group health plans; access, portability, and renewability Submission for OMB review; comment request, 1364 requirements— Nondiscrimination in health coverage in group market, National Oceanic and Atmospheric Administration 1377–1420 RULES PROPOSED RULES Fishery conservation and management: Excise taxes: Alaska; fisheries of Exclusive Economic Zone— Group health plans; access, portability, and renewability Critical habitat closure pursuant to court order; closure requirements— removed; correction, 1375 Bona fide wellness programs, 1420–1435 Nondiscrimination in health coverage in group market; Natural Resources Conservation Service cross-reference, 1434–1437 NOTICES Nondiscrimination requirements for certain Field office technical guides; changes: grandfathered church plans; exception, 1436–1439 Iowa, 1302–1303

International Trade Administration Navy Department NOTICES NOTICES Antidumping: Privacy Act: Brake rotors from— Systems of records, 1321–1329 China, 1303–1309 Oil country tubular goods from— Pension and Welfare Benefits Administration Mexico, 1309–1310 RULES Stainless steel sheet and strip in coils from— Group health plans; access, portability, and renewability Italy, 1310 requirements: Applications, hearings, determinations, etc.: Nondiscrimination in health coverage in group market, University of— 1377–1420 Rochester, 1310 PROPOSED RULES Wisconsin-Madison, 1311 Group health plans; access, portability, and renewability Washington University School of Medicine, 1311 requirements: Bona fide wellness programs, 1420–1435 International Trade Commission Personnel Management Office NOTICES Meetings; Sunshine Act, 1367 NOTICES Agency information collection activities: Submission for OMB review; comment request, 1367– Labor Department 1368 See Employment and Training Administration See Pension and Welfare Benefits Administration Public Health Service See Centers for Disease Control and Prevention Land Management Bureau See Food and Drug Administration NOTICES See National Institutes of Health Agency information collection activities: Proposed collection; comment request; correction, 1375 Railroad Retirement Board Survey plat filings: NOTICES Alaska, 1365 Agency information collection activities: Submission for OMB review; comment request, 1368 Minerals Management Service PROPOSED RULES State Department Outer Continental Shelf; oil, gas, and sulphur operations: NOTICES Surety bonds for leases; requirements, 1277–1280 Art objects; importation for exhibition: NOTICES Van Gogh Portraits: Face to Face, 1368 Environmental statements; availability, etc.: Beaufort Sea, AK; British Petroleum Exploration, Inc.’s Surface Mining Reclamation and Enforcement Office Liberty development and production plan, 1365– NOTICES 1366 Agency information collection activities: Submission for OMB review; comment request, 1366– National Aeronautics and Space Administration 1367 NOTICES Meetings: Surface Transportation Board Advisory Council NOTICES Aero-Space Technology Advisory Committee, 1367 Railroad operation, acquisition, construction, etc.: CenTra, Inc., et al., 1371 National Highway Traffic Safety Administration Crown Enterprises, Inc., 1371–1372 NOTICES San Francisco Port Commission, 1372 Agency information collection activities: Railroad services abandonment: Proposed collection; comment request, 1369–1371 Mohall Railroad, Inc., 1372–1373

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Tennessee Valley Authority NOTICES Meetings: Separate Parts In This Issue Regional Resource Stewardship Council, 1368–1369 Part II Department of Health and Human Services, Health Care Thrift Supervision Office Financing Administration; Department of Labor, NOTICES Pension and Welfare Benefits Administration; Agency information collection activities: Department of Treasury, Internal Revenue Service, Proposed collection; comment request, 1373–1374 1377–1439

Part III Transportation Department Department of Education, 1441–1443 See Coast Guard See Federal Aviation Administration Part IV See Federal Highway Administration Department of Transportation, Federal Highway See Federal Transit Administration Administration and Federal Transit Administration, See National Highway Traffic Safety Administration 1445–1459 See Surface Transportation Board PROPOSED RULES Part V Privacy Act; implementation, 1294–1295 Environmental Protection Agency, 1461–1471

Part VI Treasury Department Department of Education, 1473–1478 See Internal Revenue Service See Thrift Supervision Office Part VII NOTICES Department of Education, 1479–1506 Agency information collection activities: Submission for OMB review; comment request, 1373 Part VIII Department of Health and Human Services, Food and Drug Administration, 1507–1559

Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

14 CFR 39 (2 documents) ....1253, 1255 Proposed Rules: 39 (2 documents) ....1271, 1273 17 CFR 1...... 1375 20 CFR 655...... 1375 21 CFR 14...... 1257 Proposed Rules: 14...... 1276 1271...... 1508 23 CFR 655...... 1446 940...... 1446 26 CFR 54...... 1378 Proposed Rules: 54 (3 documents) ...1421, 1435, 1435 28 CFR Ch. VIII...... 1259 29 CFR 2590...... 1378 Proposed Rules: 2590...... 1421 30 CFR Proposed Rules: 256...... 1277 32 CFR Proposed Rules: 326...... 1280 33 CFR 117...... 1262 Proposed Rules: 117...... 1281 34 CFR 300...... 1474 606...... 1262 40 CFR 63...... 1263 81...... 1268 82...... 1462 45 CFR 146...... 1378 Proposed Rules: 146...... 1421 46 CFR Proposed Rules: 110...... 1283 111...... 1283 47 CFR Proposed Rules: 23...... 1283 25...... 1283 49 CFR Proposed Rules: 10...... 1294 50 CFR 679...... 1375 Proposed Rules: 17...... 1295

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Rules and Regulations Federal Register Vol. 66, No. 5

Monday, January 8, 2001

This section of the FEDERAL REGISTER SUMMARY: This amendment adopts a 85, Wichita, Kansas 67201–0085; contains regulatory documents having general new airworthiness directive (AD) that telephone: (800) 429–5372 or (316) 676– applicability and legal effect, most of which applies to certain Raytheon Aircraft 3140. You may examine this are keyed to and codified in the Code of Company (Raytheon) Beech Models Federal Regulations, which is published under information at the Federal Aviation 50 titles pursuant to 44 U.S.C. 1510. A36, B36TC, and 58 airplanes. This AD Administration (FAA), Central Region, requires you to inspect for missing Office of the Regional Counsel, The Code of Federal Regulations is sold by rivets on the right hand side of the Attention: Rules Docket No. 99–CE–79– the Superintendent of Documents. Prices of fuselage and, if necessary, install rivets. AD, 901 Locust, Room 506, Kansas City, new books are listed in the first FEDERAL Raytheon has identified several REGISTER issue of each week. Missouri 64106; or at the Office of the instances of missing rivets on these Federal Register, 800 North Capitol airplanes. The actions specified by this Street, NW, suite 700, Washington, DC. AD are intended to install missing rivets DEPARTMENT OF TRANSPORTATION in the right hand fuselage panel FOR FURTHER INFORMATION CONTACT: T.N. Federal Aviation Administration assembly in the area above the right Baktha, Aerospace Engineer, FAA, wing and below the cabin door Wichita Aircraft Certification Office, 14 CFR Part 39 threshold. These rivets must be present 1801 Airport Road, Mid-Continent for the fuselage to carry the ultimate Airport, Wichita, Kansas 67209; [Docket No. 99±CE±79±AD; Amendment 39± load and prevent critical structural telephone: (316) 946–4155; facsimile: 12066; AD 2000±26±16] failure with loss of airplane control. (316) 946–4407. RIN 2120±AA64 DATES: This AD becomes effective on SUPPLEMENTARY INFORMATION: February 16, 2001. Airworthiness Directives; Raytheon The Director of the Federal Register Discussion Aircraft Company Beech Models A36, approved the incorporation by reference B36TC, and 58 Airplanes of certain publications listed in the What Events Have Caused This AD? regulations as of February 16, 2001. AGENCY: Federal Aviation Raytheon has identified several Administration, DOT. ADDRESSES: You may get the service instances of missing rivets on these information referenced in this AD from ACTION: Final rule. airplanes: Raytheon Aircraft Company, P.O. Box

Model Serial No.

Model A36 Bonanza ...... serials E±1 through E±3231; and E±3233. Model B36TC Bonanza ...... serials EA±1 through EA±635. Model 58 Baron ...... serials TH±1 through TH±1811; and TH±1813 through TH±1897.

Raytheon production and inspection 2000 (65 FR 57751). The NPRM proposed except for minor editorial personnel identified the missing rivets. proposed to require you to inspect for corrections. We determined that these The missing rivets are the result of a missing rivets on the right hand fuselage minor corrections: quality control problem. and if necessary, install rivets. —Will not change the meaning of the What Are the Consequences if the Was the Public Invited To Comment? AD; and Condition Is Not Corrected? —Will not add any additional burden Interested persons were afforded an upon the public than was already This condition results in the airplane opportunity to participate in the making proposed. being unable to carry the ultimate load of this amendment. No comments were with possible structural failure and loss received on the proposed rule or the Cost Impact of airplane control. FAA’s determination of the cost to the How Many Airplanes Does This AD public. Has FAA Taken Any Action to This impact? Point? The FAA’s Determination We estimate that this AD affects 3632 We issued a proposal to amend part What Is FAA’s Final Determination on airplanes in the U.S. registry. 39 of the Federal Aviation Regulations This Issue? (14 CFR part 39) to include an AD that What Is the Cost Impact of This AD on After careful review of all available would apply to certain Raytheon Beech Owners/Operators of the Affected information related to the subject Models A36, B36TC, and 58 airplanes. Airplanes? presented above, we have determined This proposal was published in the that air safety and the public interest We estimate the following costs to Federal Register as a notice of proposed require the adoption of the rule as accomplish the inspection: rulemaking (NPRM) on September 26,

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Labor cost Parts cost Total cost per airplane Total cost on U.S. operators

1 workhour × $60 per hour = $60 No parts required for the inspec- $60 per airplane ...... $60 × = $217,920. tion.

We estimate the following costs to accomplish the modification if necessary:

Laobor cost Parts cost Total cost per airplane

4 workouts × $60 per hour = $240 ...... $100 per airplane ...... $340 per airplane.

The manufacturer will allow warranty Executive Order 12866; (2) is not a the Federal Aviation Administration credit for labor and parts to the extent ‘‘significant rule’’ under DOT amends part 39 of the Federal Aviation noted in the service bulletin. Regulatory Policies and Procedures (44 Regulations (14 CFR part 39) as follows: FR 11034, February 26, 1979); and (3) Regulatory Impact will not have a significant economic PART 39ÐAIRWORTHINESS Does This AD Impact Various Entities? impact, positive or negative, on a DIRECTIVES substantial number of small entities The regulations adopted herein will under the criteria of the Regulatory 1. The authority citation for part 39 not have a substantial direct effect on Flexibility Act. A copy of the final continues to read as follows: the States, on the relationship between evaluation prepared for this action is Authority: 49 U.S.C. 106(g), 40113, 44701. the national government and the States, contained in the Rules Docket. A copy or on the distribution of power and of it may be obtained by contacting the § 39.13 [Amended] responsibilities among the various Rules Docket at the location provided levels of government. Therefore, it is under the caption ADDRESSES. 2. FAA amends § 39.13 by adding a determined that this final rule does not new AD to read as follows: have federalism implications under List of Subjects in 14 CFR Part 39 2000–26–16 Raytheon Aircraft Company: Executive Order 13132. Air transportation, Aircraft, Aviation Amendment 39–12066; Docket No. 99– safety, Incorporation by reference, Does This AD Involve a Significant Rule CE–79–AD. Safety. or Regulatory Action? (a) What airplanes are affected by this AD? Adoption of the Amendment For the reasons discussed above, I This AD affects the following airplanes, certify that this action (1) is not a Accordingly, under the authority certificated in any category: ‘‘significant regulatory action’’ under delegated to me by the Administrator,

Model Serial No.

Model A36 ...... E±1 through E±3231, and E±3233. Model B36TC ...... EA±1 through EA±635. Model 58 ...... TH±1 through TH±1811, and TH-1813 through TH±1897.

(b) Who must comply with this AD? to install missing rivets in the right hand prevent critical structural failure with loss of Anyone who wishes to operate any of the fuselage panel assembly in the area above the control of the airplane. above airplanes must comply with this AD. right wing and below the cabin door (d) What actions must I accomplish to (c) What problem does this AD address? threshold. These rivets must be present for address this problem? To address this The actions specified by this AD are intended the fuselage to carry the ultimate load and problem, you must do the following actions:

Actions Compliance times Procedures

(1) Inspect for up to 9 missing rivets between Inspect within the next 100 hours time-in-serv- Do this inspection in accordance with the AC- fuselage station (F.S.) 83.00 and F.S. 91.00 ice after February 16, 2001 (the effective COMPLISHMENT INSTRUCTIONS para- at water line (W.L.) 90.3. date of this AD). graph of Raytheon Mandatory Service Bul- letin SB 53±3341, Revision 1, Revised: May 2000, and the Bonanza Series Maintenance Manual or Baron Model 58 Series Mainte- nance Manual. (2) If you find rivets are missing, install these Before further flight after the inspection ...... Do these actions in accordance with the AC- rivets. COMPLISHMENT INSTRUCTIONS para- graph of Raytheon Mandatory Service Bul- letin SB 53±3341, Revision 1, Revised: May 2000, and the Bonanza Series Maintenance Manual or Baron Model 58 Series Mainte- nance Manual.

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(e) Can I comply with this AD in any other DEPARTMENT OF TRANSPORTATION FOR FURTHER INFORMATION CONTACT: way? You may use an alternative method of Roman T. Gabrys, Aerospace Engineer, compliance or adjust the compliance time if: Federal Aviation Administration FAA, Small Airplane Directorate, 901 (1) Your alternative method of compliance Locust, Room 301, Kansas City, provides an equivalent level of safety; and 14 CFR Part 39 Missouri 64106; telephone: (816) 329– (2) The Manager, Wichita Aircraft 4141; facsimile: (816) 329–4090. Certification Office (ACO), approves your [Docket No. 2000±CE±55±AD; Amendment SUPPLEMENTARY INFORMATION: alternative. Submit your request through an 39±12067; AD 2000±26±17] FAA Principal Maintenance Inspector, who Discussion may add comments and then send it to the RIN 2120±AA64 Manager, Wichita ACO. What Events Have Caused This AD? Airworthiness Directives; Pilatus The Federal Office for Civil Aviation Note: This AD applies to each airplane Aircraft Ltd. Models PC±12 and PC±12/ identified in paragraph (a) of this AD, (FOCA), which is the airworthiness 45 Airplanes regardless of whether it has been modified, authority for Switzerland, recently altered, or repaired in the area subject to the AGENCY: Federal Aviation notified the FAA that an unsafe requirements of this AD. For airplanes that Administration, DOT. condition may exist on certain Pilatus have been modified, altered, or repaired so Models PC–12 and PC–12/45 airplanes. ACTION: Final rule. that the performance of the requirements of The FOCA reports that the electrical this AD is affected, the owner/operator must SUMMARY: This amendment adopts a load of the left hand (LH) and right hand request approval for an alternative method of new airworthiness directive (AD) that (RH) windshields can become too high compliance in accordance with paragraph (e) applies to Pilatus Aircraft Ltd. (Pilatus) during flight at cruise altitudes when of this AD. The request should include an Models PC–12 and PC–12/45 airplanes the ‘‘LIGHT’’ mode is selected on the assessment of the effect of the modification, that are equipped with a certain windshield deicing system. The FOCA alteration, or repair on the unsafe condition windshield configuration. This AD references eight instances where addressed by this AD; and, if you have not requires you to incorporate pilot’s prolonged operation of the windshield eliminated the unsafe condition, specific operating handbook (POH) information deicing system in the ‘‘LIGHT’’ mode actions you propose to address it. that prohibits the operation of the caused this system to temporarily shut (f) Where can I get information about any windshield heating system in the down. already-approved alternative methods of ‘‘LIGHT’’ mode, and requires you to The airplanes involved in the above compliance? Contact T.N. Baktha, Aerospace modify the windshield deicing system instances were equipped with part Engineer, FAA, Wichita Aircraft Certification wiring and circuit breakers. You can number (P/N) 959.81.10.107 LH and P/ Office, 1801 Airport Road, Mid-Continent remove the POH information after N/ 959.81.10.108 RH windshields. Airport, Wichita, Kansas 67209; telephone: accomplishing the modification. This (316) 946–4155; facsimile: (316) 946–4407. What Are the Consequences if the AD is the result of mandatory (g) What if I need to fly the airplane to Condition Is Not Corrected? continuing airworthiness information another location to comply with this AD? The Operation of the existing design FAA can issue a special flight permit under (MCAI) issued by the airworthiness authority for Switzerland. The actions windshield deicing system in the sections 21.197 and 21.199 of the Federal ‘‘LIGHT’’ position can overload the Aviation Regulations (14 CFR 21.197 and specified by this AD are intended to prevent loss of electrical power to the electrical capacity of the wiring and 21.199) to operate your airplane to a location circuit breakers. This could result in where you can accomplish the requirements windshield deicing system due to operation in the ‘‘LIGHT’’ mode, which complete electrical power loss to the of this AD. windshield and icing of the windshield. (h) Are any service bulletins incorporated could result in icing of the windshield into this AD by reference? Actions required and loss of control of the airplane. Has FAA Taken Any Action to this by this AD must be done in accordance with DATES: This AD becomes effective on Point? Raytheon Mandatory Service Bulletin SB 53– February 24, 2001. We issued a proposal to amend part 3341, Revision 1, revised May 2000. The The Director of the Federal Register 39 of the Federal Aviation Regulations Director of the Federal Register approved this approved the incorporation by reference (14 CFR part 39) to include an AD that incorporation by reference under 5 U.S.C. of certain publications listed in the would apply to Pilatus Models PC–12 552(a) and 1 CFR part 51. You can get copies regulations as of February 24, 2001. and PC–12/45 airplanes that are from Raytheon Aircraft Company, P.O. Box ADDRESSES: You may get the service equipped with a certain windshield 85, Wichita, Kansas 67201–0085; telephone: information referenced in this AD from configuration. This proposal was (800) 429–5372 or (316) 676–3140. You can Pilatus Aircraft Ltd., Customer Liaison look at copies at the FAA, Central Region, published in the Federal Register as a Manager, CH–6371 Stans, Switzerland; Office of the Regional Counsel, 901 Locust, notice of proposed rulemaking (NPRM) telephone: +41 41 619 63 19; facsimile: Room 506, Kansas City, Missouri, or at the on October 2, 2000 (65 FR 58675). The Office of the Federal Register, 800 North +41 41 619 6224; or from Pilatus NPRM proposed to require you to Capitol Street, NW, suite 700, Washington, Business Aircraft Ltd., Product Support incorporate POH information that DC. Department, 11755 Airport Way, would prohibit the operation of the (i) When does this amendment become Broomfield, Colorado 80021; telephone: windshield heating system in the effective? This amendment becomes effective (303) 465–9099; facsimile: (303) 465– ‘‘LIGHT’’ mode, and would require you on February 16, 2001. 6040. You may examine this to modify the windshield deicing information at the Federal Aviation system wiring and circuit breakers. You Issued in Kansas City, Missouri, on Administration (FAA), Central Region, December 22, 2000. could remove the POH information after Office of the Regional Counsel, accomplishing the modification. Marvin R. Nuss, Attention: Rules Docket No. 2000–CE– Acting Manager, Small Airplane Directorate, 55–AD, 901 Locust, Room 506, Kansas Was the Public Invited To Comment? Aircraft Certification Service. City, Missouri 64106; or at the Office of Interested persons were afforded an [FR Doc. 01–183 Filed 1–5–01; 8:45 am] the Federal Register, 800 North Capitol opportunity to participate in the making BILLING CODE 4910±13±P Street, NW, suite 700, Washington, DC. of this amendment. No comments were

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Labor cost Parts cost Total cost per airplane Total cost on U.S. operators

18 workhours×$60 per hour $1,080 Pilatus will provide free-of-charge. $1,080 per airplane ...... $116,640.

Compliance Time of This AD responsibilities among the various PART 39ÐAIRWORTHINESS What Is the Compliance Time of This levels of government. Therefore, it is DIRECTIVES AD? determined that this final rule does not The compliance time of this AD is as have federalism implications under 1. The authority citation for part 39 follows: Executive Order 13132. continues to read as follows: —Incorporation of the POH temporary Does This AD Involve a Significant Rule Authority: 49 U.S.C. 106(g), 40113, 44701. revision: ‘‘Within the next 30 days or Regulatory Action? § 39.13 [Amended] after the effective date of this AD;’’ For the reasons discussed above, I and certify that this action (1) is not a 2. FAA amends § 39.13 by adding a —Modification: ‘‘Within the next 12 ‘‘significant regulatory action’’ under new AD to read as follows: months after the effective date of this Executive Order 12866; (2) is not a AD.’’ 2000–26–17 Pilatus Aircraft Ltd.: ‘‘significant rule’’ under DOT Amendment 39–12067; Docket No. Why Is the Compliance of This AD in Regulatory Policies and Procedures (44 2000–CE––55AD. Calendar Time Instead of Hours Time- FR 11034, February 26, 1979); and (3) (a) What airplanes are affected by this AD? in-Service (TIS)? will not have a significant economic This AD affects Models PC–12 and PC–12/45 Although loss of electrical power to impact, positive or negative, on a airplanes, manufacturer serial number (MSN) the windshield deicing system due to substantial number of small entities 101 through MSN 320, that are: operation in the ‘‘LIGHT’’ mode is under the criteria of the Regulatory (1) certificated in any category; and unsafe during flight, the condition is not Flexibility Act. A copy of the final (2) equipped with part number (P/N) a direct result of airplane operation. The evaluation prepared for this action is 959.81.10.107 LH and P/N 959.81.10.108 RH chance of this situation occurring is the contained in the Rules Docket. A copy windshields (PPG P/N NP172121–5 LH and same for an airplane with 10 hours time- of it may be obtained by contacting the NP172121–6 RH or FAA-approved equivalent Rules Docket at the location provided in-service (TIS) as it would be for an part numbers). under the caption ADDRESSES. airplane with 500 hours TIS. A calendar (b) Who must comply with this AD? time for compliance will assure that the List of Subjects in 14 CFR Part 39 Anyone who wishes to operate any of the above airplanes must comply with this AD. unsafe condition is addressed on all Air transportation, Aircraft, Aviation airplanes in a reasonable time period. (c) What problem does this AD address? safety, Incorporation by reference, The actions specified by this AD are intended Regulatory Impact Safety. to prevent loss of electrical power to the windshield deicing system due to operation Does This AD Impact Various Entities? Adoption of the Amendment in the ‘‘LIGHT’’ mode, which could result in The regulations adopted herein will Accordingly, under the authority icing of the windshield and loss of control of not have a substantial direct effect on delegated to me by the Administrator, the airplane. the States, on the relationship between the Federal Aviation Administration (d) What actions must I accomplish to the national government and the States, amends part 39 of the Federal Aviation address this problem? To address this or on the distribution of power and Regulations (14 CFR part 39) as follows: problem, you must accomplish the following:

Action Compliance Time Procedures

(1) Insert Temporary Revision No. 21 to PC±12 Within the next 30 days after February 24, Anyone who holds at least a private pilot cer- Pilot's Operating Handbook, Report No. 2001 (the effective date of this AD), unless tificate, as authorized by section 43.7 of the 01973±001, Section 2, Windshield Heater already accomplished.. Federal Aviation Regulations (14 CFR Operation 101±320, Issued: May 19, 2000.. 43.7), may incorporate the pilot's operating handbook (POH) revision required by this AD. You must make an entry into the air- craft records that shows compliance with this AD, in accordance with section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).

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Action Compliance Time Procedures

(2) Modify the windshield deicing system wires Within the next 12 months after February 24, In accordance with the modification proce- and circuit breakers. You may remove the 2001 (the effective date of this AD), unless dures in the Accomplishment Instructions POH temporary revision referenced in para- already accomplished.. section of Pilatus Service Bulletin No. 30± graph (d)(1) of this AD after accomplishing 006, dated May 22, 2000. this modification.. (3) Do not install, on any affected airplane, P/N As of February 24, 2001 (the effective date of Not applicable. 959.81.10.107 LH and P/N 959.81.10.108 this AD.). RH windshields (PPG P/N NP172121±5 LH and NP172121±6 RH or FAA-approved equivalent part numbers), without incor- porating the modification required in para- graph (d)(2) of this AD..

Note 1: Temporary Revision No. 21 to PC– Department, 11755 Airport Way, Broomfield, law. Elsewhere in this issue of the 12 Pilot’s Operating Handbook, Report No. Colorado 80021. You can look at copies at the Federal Register, FDA is publishing a 01973–001, Section 2, Windshield Heater FAA, Central Region, Office of the Regional companion proposed rule, under FDA’s Operation 101–320, Issued: May 19, 2000, Counsel, 901 Locust, Room 506, Kansas City, usual procedure for notice-and- eliminates the need for Temporary Revision Missouri, or at the Office of the Federal No. 14 in the POH. Register, 800 North Capitol Street, NW, suite comment rulemaking, to provide a (e) Can I comply with this AD in any other 700, Washington, DC. procedural framework to finalize the way? You may use an alternative method of (i) When does this amendment become rule in the event the agency receives any compliance or adjust the compliance time if: effective ? This amendment becomes effective significant adverse comments and (1) Your alternative method of compliance on February 24, 2001. withdraws this direct final rule. provides an equivalent level of safety; and Note 3: The subject of this AD is addressed DATES: This rule is effective May 23, (2) The Manager, Small Airplane in Swiss AD HB 2000–393, dated September 2001. Submit written comments by Directorate, approves your alternative. 6, 2000. March 26, 2001. If no timely significant Submit your request through an FAA Principal Maintenance Inspector, who may Issued in Kansas City, Missouri, on adverse comments are received, the add comments and then send it to the December 22, 2000. agency will publish a document in the Manager, Small Airplane Directorate. Marvin R. Nuss, Federal Register before April 23, 2001, Note 2: This AD applies to each airplane Acting Manager, Small Airplane Directorate, confirming the effective date of the identified in paragraph (a) of this AD, Aircraft Certification Service. direct final rule. The agency intends to regardless of whether it has been modified, [FR Doc. 01–184 Filed 1–5–01; 8:45 am] make the direct final rule effective 30 altered, or repaired in the area subject to the days after publication of the BILLING CODE 4910±13±U requirements of this AD. For airplanes that confirmation notice in the Federal have been modified, altered, or repaired so Register. If timely significant adverse that the performance of the requirements of comments are received, the agency will this AD is affected, the owner/operator must DEPARTMENT OF HEALTH AND publish a document of significant request approval for an alternative method of HUMAN SERVICES compliance in accordance with paragraph (e) adverse comments in the Federal of this AD. The request should include an Food and Drug Administration Register and withdraw this direct final assessment of the effect of the modification, rule before April 23, 2001. alteration, or repair on the unsafe condition 21 CFR Part 14 ADDRESSES: Submit written comments addressed by this AD; and, if you have not on the direct final rule to the Dockets eliminated the unsafe condition, specific [Docket No. 00N±1634] Management Branch (HFA–305), Food actions you propose to address it. Public Hearing Before a Public and Drug Administration, 5630 Fishers (f) Where can I get information about any Lane, rm. 1061, Rockville, MD 20852. already-approved alternative methods of Advisory Committee; Examination of compliance? Contact Roman T. Gabrys, Administrative Record and Other FOR FURTHER INFORMATION CONTACT: Aerospace Engineer, FAA, Small Airplane Advisory Committee Records Andrea C. Masciale, Center for Drug Directorate, 1201 Walnut, suite 900, Kansas Evaluation and Research (HFD–7), Food City, Missouri 64106; telephone: (816) 329– AGENCY: Food and Drug Administration, and Drug Administration, 5600 Fishers 4141; facsimile: (816) 329–4090. HHS. Lane, Rockville, MD 20857, 301–594– (g) What if I need to fly the airplane to ACTION: Direct final rule. 2041. another location to comply with this AD? The FAA can issue a special flight permit under SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: sections 21.197 and 21.199 of the Federal Administration (FDA) is amending its I. Discussion Aviation Regulations (14 CFR 21.197 and administrative regulations governing the 21.199) to operate your airplane to a location A. Background where you can accomplish the requirements public disclosure of written information of this AD. for consideration by an advisory Advisory committees provide (h) Are any service bulletins incorporated committee at an advisory committee independent advice and into this AD by reference? Actions required meeting. This action amends the recommendations to FDA on scientific by this AD must be done in accordance with regulations to state that the written and technical matters related to Pilatus Service Bulletin No. 30–006, dated information for consideration by an products regulated by the agency. To May 22, 2000. The Director of the Federal advisory committee at a committee assist committee members in preparing Register approved this incorporation by meeting is available for public to discuss the issues that will be raised reference under 5 U.S.C. 552(a) and 1 CFR part 51. You can get copies from Pilatus disclosure, whenever practicable, before at a committee meeting, the agency and, Aircraft Ltd., Customer Liaison Manager, or at the time of the meeting. FDA is in certain circumstances, affected CH–6371 Stans, Switzerland; or from Pilatus taking this action to reflect current FDA members of the regulated industry Business Aircraft Ltd., Product Support policy in conformance with applicable prepare written background materials

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Generally, (§ 20.61); (2) inter- or intra-agency public availability of these materials at advisory committee members are memoranda or letters (§ 20.62); and (3) the same time as the materials are provided these materials soon after they personnel, medical, and similar files, provided to an advisory committee, and are completed, often weeks before a the disclosure of which constitutes a because the advisory committee committee meeting. clearly unwarranted invasion of materials often need to be redacted FDA’s advisory committees are personal privacy (§ 20.63). before being made publicly available, established under the Federal Advisory If written materials contain some complying with § 14.75(a)(1) would Committee Act (5 U.S.C. app. 2) (the information that is disclosable and some require the agency to wait until the FACA). FDA’s procedures for the information that is not subject to materials are redacted before sending administration of advisory committees disclosure, the agency can make the the information to the advisory are set forth in part 14 (21 CFR part 14). materials available to the public after committees. This, in turn, would result Section 14.75(a)(1) states that, unless it deleting the nondisclosable information in less time for the committee members is otherwise exempt from disclosure, (§ 20.22). The process of reviewing the to review the materials prior to the written information for consideration by advisory committee materials, committee meeting. This delay would the committee at the meeting should be determining which information is be detrimental to the advisory available for public disclosure at the exempt from disclosure, and redacting committee process. Furthermore, same time it is made available to the the documents to remove the simultaneous availability of briefing committee. As described below, FDA nondisclosable information requires a materials to the advisory committee and finds this provision for simultaneous significant amount of time. For example, to the public is not required under the disclosure unnecessary and detrimental in the Federal Register of December 22, FACA. to the advisory committee process. 1999 (64 FR 71794), FDA announced the Therefore, the agency is amending Therefore, FDA is amending this availability of a draft guidance § 14.75(a)(1) to state that the written provision in its administrative document entitled ‘‘Disclosing information for consideration by an regulations. Information Provided to Advisory advisory committee at any meeting is Committees in Connection With Open available for public disclosure whenever B. Rationale for the Rule Advisory Committee Meetings Related practicable, before or at the time of the As interpreted by case law, the FACA to the Testing or Approval of New Drugs meeting. requires that, whenever practicable and and Convened by the Center for Drug II. Direct Final Rulemaking subject to any applicable exemption of Evaluation and Research, Beginning on the Freedom of Information Act (the January 1, 2000.’’ In the draft guidance FDA has determined that the subject FOIA) (5 U.S.C. 552), information document, the agency described a 4- of this rulemaking is suitable for a direct prepared for or provided to an advisory week process of reviewing and redacting final rule. This direct final rule revises committee be made publicly available an advisory committee package § 14.75(a)(1) to reflect current agency before or at the time of the advisory submitted by a sponsor of a new drug policy in conformance with applicable committee meeting at which the application and a 3-week process of law. The actions taken should be information is used and discussed (see, reviewing and redacting an advisory noncontroversial, and the agency does e.g., Food Chemical News v. Department committee package generated by the not anticipate receiving any significant of Health and Human Services, 980 F.2d Center for Drug Evaluation and adverse comment on this rule. 1468 (D.C. Cir. 1992)). Therefore, FDA’s Research. If FDA does not receive significant provision for disclosing information to Materials that are otherwise exempt adverse comment by March 26, 2001, the public at the same time the from disclosure under §§ 20.61, 20.62, the agency will publish a document in information is provided to the advisory and 20.63, however, may be disclosed to the Federal Register before April 23, committee (§ 14.75(a)(1)) goes beyond advisory committee members who are 2001, confirming the effective date of the requirements of the FACA. The special government employees for use the direct final rule. The agency intends agency is not obligated under the FACA in connection with their work on an to make the direct final rule effective 30 to provide the materials to the public at advisory committee (§ 20.84). Therefore, days after publication of the the same time they are provided to the the materials provided to advisory confirmation document in the Federal advisory committee. committee members need not go Register. A significant adverse comment Under § 14.75(b)(1), the public through the extensive and time- is one that explains why the rule would disclosure provision of § 14.75(a)(1) is consuming review and redaction be inappropriate, including challenges subject to FDA’s regulations in part 20 process. to the rule’s underlying premise or (21 CFR part 20). The regulations in part Advisory committees provide approach, or would be ineffective or 20 describe the agency’s policies and meaningful advice to FDA on technical unacceptable without a change. A procedures for disclosing information to and scientific matters related to the comment recommending a rule change the public under the FOIA. Information development and evaluation of FDA- in addition to this rule will not be that generally may be released to the regulated products. The value of the considered a significant adverse public, including information described advice provided by FDA advisory comment unless the comment states in § 14.75(a)(1), may not be released if committees depends, in large part, on why this rule would be ineffective it falls within one or more of the the ability of advisory committee without the additional change. If timely exemptions described in part 20. members to evaluate diverse, complex, significant adverse comments are Written materials provided to an and sometimes contentious scientific received, the agency will publish a advisory committee for consideration at issues during the course of a committee notice of significant adverse comment in a committee meeting often include meeting. It is crucial that the agency the Federal Register withdrawing this information that is not made publicly provide advisory committee members direct final rule before April 23, 2001. available because the information is background information as soon as Elsewhere in this issue of the Federal subject to one or more of the following practicable after the materials are Register, FDA is publishing a exemptions: (1) Trade secrets and generated so the members can companion proposed rule, identical to commercial or financial information adequately prepare for the meeting. the direct final rule, that provides a that is privileged or confidential Because § 14.75(a)(1) provides for the procedural framework within which the

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Therefore, Drug, and Cosmetic Act and under companion proposed rule will be under the Regulatory Flexibility Act, no authority delegated to the Commissioner treated as comments regarding the direct further analysis is required. of Food and Drugs, 21 CFR part 14 is final rule. Likewise, significant adverse Section 202(a) of the Unfunded amended to read as follows: comments submitted to the direct final Mandates Reform Act of 1995 (Public rule will be considered as comments to PART 14ÐPUBLIC HEARING BEFORE Law 104–4) requires that agencies A PUBLIC ADVISORY COMMITTEE the companion proposed rule and the prepare a written statement of agency will consider such comments in anticipated costs and benefits before 1. The authority citation for 21 CFR developing a final rule. FDA will not proposing any rule that may result in an part 14 is revised to read as follows: provide additional opportunity for expenditure by State, local, and tribal comment on the companion proposed Authority: 5 U.S.C. App. 2; 15 U.S.C. governments, in the aggregate, or by the 1451–1461; 21 U.S.C. 41–50, 141–149, 321– rule. private sector, of $100 million in any 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 If a significant adverse comment one year (adjusted annually for U.S.C. 201, 262, 263b, 264. applies to part of this rule and that part inflation). FDA is not required to may be severed from the remainder of prepare a statement of the costs and 2. Section 14.75 is amended by the rule, FDA may adopt as final those benefits of this rule because the rule is revising paragraph (a)(1) to read as parts of the rule that are not the subject not expected to result in any 1-year follows: of a significant adverse comment. A full expenditure that would exceed $100 description of FDA’s policy on direct § 14.75 Examination of administrative million adjusted for inflation. The record and other advisory committee final rule procedures may be found in current inflation-adjusted statutory records. a guidance document published in the threshold is $110 million. Federal Register of November 21, 1997 (a) * * * (62 FR 62466). V. Federalism (1) The written information for consideration by the committee at any III. Environmental Impact FDA has analyzed this final rule in meeting: Whenever practicable, before The agency has determined under 21 accordance with the principles set forth or at the time of the meeting. CFR 25.30(h) that this action is of a type in Executive Order 13132. FDA has * * * * * that does not individually or determined that the final rule does not contain policies that have substantial Dated: December 29, 2000. cumulatively have a significant effect on Margaret M. Dotzel, the human environment. Therefore, direct effects on the States, on the Associate Commissioner for Policy. neither an environmental assessment relationship between the National nor an environmental impact statement Government and the States, or on the [FR Doc. 01–389 Filed 1–5–01; 8:45 am] is required. distribution of power and BILLING CODE 4160±01±F responsibilities among the various IV. Analysis of Impacts levels of government. Accordingly, the FDA has examined the impacts of this agency has concluded that the final rule COURT SERVICES AND OFFENDER direct final rule under Executive Order does not contain policies that have SUPERVISION AGENCY FOR THE 12866, the Regulatory Flexibility Act (5 federalism implications as defined in DISTRICT OF COLUMBIA U.S.C. 601–612), and the Unfunded the order and, consequently, a Mandates Reform Act of 1995 (2 U.S.C. federalism summary impact statement is 28 CFR Chapter VIII 1501 et seq.). Executive Order 12866 not required. [CSOSA±0001] directs agencies to assess all costs and VI. Paperwork Reduction Act of 1995 benefits of available regulatory RIN 3225±ZA00 This direct final rule does not require alternatives and, when regulation is Organization and Functions necessary, to select regulatory information collections and, thus, is not approaches that maximize net benefits subject to review by the Office of AGENCY: Court Services and Offender (including potential economic, Management and Budget under the Supervision Agency for the District of environmental, public health and safety, Paperwork Reduction Act of 1995. Columbia. and other advantages; distributive VII. Request for Comments ACTION: Final rule. impacts; and equity). The agency believes that this rule is consistent with Interested persons may submit to the SUMMARY: The Court Services and the regulatory philosophy and Dockets Management Branch (address Offender Supervision Agency for the principles identified in Executive Order above) written comments regarding this District of Columbia (‘‘CSOSA’’) is 12866 and in the other two statutes. rule by March 26, 2001. Two copies of issuing regulations describing its This rule is not a significant regulatory any comments are to be submitted, organization and general functions. This action as defined by the Executive except that individuals may submit one description includes information on the order. copy. Comments are to be identified District of Columbia Pretrial Services Under the Regulatory Flexibility Act, with the docket number found in Agency (‘‘PSA’’), an independent entity if a rule has a significant impact on a brackets in the heading of this within CSOSA. CSOSA provides substantial number of small entities, an document. Received comments may be supervisory and treatment services to agency must analyze regulatory options seen in the Dockets Management Branch individuals on probation, parole and that would minimize any significant between 9 a.m. and 4 p.m., Monday supervised release for District of impact of the rule on small entities. The through Friday. Columbia Code violations. CSOSA also

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Therefore, in provides treatment services to social intervention programs that accordance with Executive Order 13132, defendants in the U.S. District Court decrease the likelihood of future the Director of CSOSA has determined and the United States Court of Appeals criminal behavior. that this rule does not have sufficient for the District of Columbia Circuit and CSOSA’s mission is to increase public federalism implications to warrant the to individuals on pretrial release for safety, prevent crime, reduce preparation of a Federalism Assessment. District of Columbia Code violations. recidivism, and support the fair EFFECTIVE DATE: January 8, 2001. administration of justice in close Regulatory Flexibility Act ADDRESSES: collaboration with the community. Law Office of General Counsel, The Director of CSOSA, in accordance CSOSA, Room 1253, 633 Indiana enforcement agencies, the courts, with the Regulatory Flexibility Act (5 Avenue, NW., Washington, DC 20004. corrections, and parole authorities each U.S.C. 605(b)), has reviewed this rule FOR FURTHER INFORMATION CONTACT: Roy play critical roles in addressing crime and ensuring public safety. CSOSA, and by approving it certifies that this Nanovic, Records Manager; telephone rule will not have a significant (202) 220–5359; e-mail together with PSA, coordinates closely economic impact upon a substantial [email protected]. with these entities to fulfill its role in the criminal justice process by number of small entities. This rule SUPPLEMENTARY INFORMATION: The Court providing supervisory and treatment pertains to agency management, and its Services and Offender Supervision services to individuals on pretrial economic impact is limited to the Agency for the District of Columbia release, probation, parole and agency’s appropriated funds. (‘‘CSOSA’’) was established within the supervised release, and by assisting Executive Branch of the Federal federal and local courts in determining Unfunded Mandates Reform Act of 1995 Government by the National Capital eligibility for release. Revitalization and Self-Government This rule will not result in the CSOSA’s regulations are being expenditure by State, local and tribal Improvement Act of 1997 codified in Chapter VIII of Title 28 of (‘‘Revitalization Act’’), Pub. L. 105–33, governments, in the aggregate, or by the the Code of Federal Regulations. Part private sector, of $100,000,000 or more 111 Stat. 251, 712 (D.C. Code 24–1232, 800 consists of a general statement of in any one year, and it will not 24–1233). On August 4, 2000, CSOSA organization and functions, including significantly or uniquely affect small was certified by the Attorney General as addresses for CSOSA’s and PSA’s an independent Federal agency. central and field offices, and addresses governments. Therefore, the Director of The Revitalization Act requires for submitting Freedom of Information CSOSA has determined that no actions CSOSA to provide supervision, through Act/Privacy Act requests, legal process, are necessary under the provisions of qualified supervision officers, to and tort claims. A more detailed the Unfunded Mandates Reform Act of offenders on probation, parole, and statement of organization and functions 1995. supervised release for violation of will appear in the ‘‘United States District of Columbia Code offenses. Small Business Regulatory Enforcement Government Manual.’’ Accordingly, CSOSA supervises all Fairness Act of 1996 offenders placed on probation by the Matters of Regulatory Procedure Superior Court of the District of This rule is not a major rule as Administrative Procedure Act Columbia, and all individuals on parole defined by section 804 of the Small pursuant to the District of Columbia Because this rule pertains to agency Business Regulatory Enforcement Code. CSOSA provides supervision to organization, CSOSA is issuing the rule Fairness Act of 1996. This rule will not offenders from other jurisdictions in as final without general notice of result in an annual effect on the accordance with the provisions of the proposed rulemaking and without any economy of $100,000,000 or more; a Interstate Parole and Probation delay in its effectiveness. Any interested major increase in costs or prices; or Compact. In accordance with its person, however, who wishes to submit significant adverse effects on supervisory functions and as authorized comments on the rule may do so by competition, employment, investment, by the Sex Offender Registration Act of writing or e-mailing the agency at the productivity, innovation, or on the 1999 (DC Law 13–137, D.C. Code 24– addresses given above in the ability of United States-based 1101 et seq.), CSOSA operates and ‘‘Addresses’’ and ‘‘For Further companies to compete with foreign- maintains the sex offender registry for Information Contact’’ captions. based companies in domestic and the District of Columbia. export markets. The DC Pretrial Services Agency Executive Order 12866 (‘‘PSA’’), an independent entity within This rule falls within a category of Plain Language Instructions CSOSA, assists the trial and appellate actions that the Office of Management levels of both the federal and local and Budget (OMB) has determined not We want to make CSOSA’s courts in determining eligibility for to constitute ‘‘significant regulatory documents easy to read and understand. pretrial release by providing verified actions’’ under section 3(f) of Executive If you have suggestions on how to background information and criminal Order 12866 and, accordingly, CSOSA improve the clarity of these regulations, histories on all arrestees and did not formally submit it to OMB for write, e-mail, or call CSOSA’s Records recommendations about available review. Manager (Roy Nanovic), at the address release options. PSA is further or telephone number given above in the Executive Order 13132 responsible for supervising defendants ‘‘Addresses’’ and ‘‘For Further released from custody during the This rule will not have substantial Information Contact’’ captions. pretrial period by monitoring direct effects on the States, on the

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List of Subjects in 28 CFR Part 800 on parole pursuant to the District of (4) Office of Community Justice Organization and Functions Columbia Code. CSOSA supervises Programs. (Government Agencies); Probation and offenders from other jurisdictions in (5) Special Criminal Justice Projects. (6) Office of Planning and Evaluation. Parole. accordance with the provisions of the Interstate Parole and Probation (7) Office of Professional Jasper Ormond, Compact. Responsibility. Interim Director. (2) CSOSA is also required to (8) Equal Employment Opportunity, determine uniform supervision and Diversity, and Special Programs. Accordingly, we amend Title 28 of the reporting practices, develop and operate (9) Office of Legislative, Code of Federal Regulations by adding intermediate sanctions programs for Intergovernmental, and Public Affairs. a new chapter VIII, consisting of Part sentenced offenders, and arrange for the (10) Information Technology Services. 800 to read as follows: supervision of District of Columbia (11) Office of Management and Chapter VIII—Court Services and Code offenders in jurisdictions outside Administration. Offender Supervision Agency for the the District of Columbia. (12) Office of Human Resources. (b) PSA. District of Columbia (3) In accordance with its supervisory (1) Office of the Director (including functions and as authorized by the Sex the Deputy Director). PART 800ÐORGANIZATION AND Offender Registration Act of 1999 (D.C. FUNCTIONS (2) Planning, Analysis and Evaluation. Law 13–137, D.C. Code 24–1101 et seq.), (3) Community Justice Programs. CSOSA operates and maintains the sex Sec. (4) Office of Operations (including 800.1 Statutory authorization. offender registry for the District of Information Technology and Forensic 800.2 Mission. Columbia. Toxicology and Drug Testing 800.3 Functions and responsibilities. (b) Pretrial Services. (1) The District of Laboratory). 800.4 Director. Columbia Pretrial Services Agency (5) Human Resources Management. 800.5 Agency components. (‘‘PSA’’) assists the trial and appellate (6) Finance and Administration. Appendix A. levels of both the federal and local Authority: 5 U.S.C. 301; Pub. L. 105–33, courts in determining eligibility for Appendix A to Part 800—Agency 111 Stat. 251, 712 (D.C. Code 24–1232, 24– pretrial release by providing verified Addresses 1233). background information and criminal I. Central Offices histories on all arrestees and Court Services and Offender Supervision § 800.1 Statutory authorization. recommendations about available The National Capital Revitalization Agency for the District of Columbia, 633 release options. Indiana Avenue, NW., Washington, DC and Self-Government Improvement Act (2) PSA is further responsible for 20004 of 1997 (‘‘Revitalization Act’’) supervising defendants released from CSOSA Community Supervision Services, established the Court Services and custody during the pretrial period by 300 Indiana Avenue, NW., Washington, DC Offender Supervision Agency for the monitoring compliance with conditions 20001 District of Columbia (‘‘CSOSA’’) within of release and by ensuring that they District of Columbia Pretrial Services the federal government as an appear for scheduled court hearings. Agency, 633 Indiana Avenue, NW., independent executive branch agency (3) PSA also provides defendants with Washington, DC 20004 and placed the District of Columbia the opportunity to participate in a II. Field Offices Pretrial Services Agency as an variety of social intervention programs independent entity within CSOSA. In Court Services and Offender Supervision that decrease the likelihood of future Agency for the District of Columbia/ addition, the District of Columbia Public criminal behavior. Community Supervision Services Defender Service, an independent District of Columbia agency, receives its § 800.4 Director. CSS Field Office, 409 E. Street, NW., (a) CSOSA is headed by a Director Washington, DC 20001 appropriated federal funds through a CSS Field Office, 401 New York Avenue, transfer from CSOSA. appointed by the President, by and with NE., Washington, DC 20002 the advice and consent of the Senate, for CSS Field Office, 1707 Kalorama Road, NW., § 800.2 Mission. a term of six years. Washington, DC 20009 CSOSA’s mission is to increase public (b) PSA is headed by a Director CSS Field Office, 1418 Good Hope Road, SE., safety, prevent crime, reduce appointed by the Chief Judge of the Washington, DC 20020 recidivism, and support the fair United States Court of Appeals for the CSS Field Office, 3850 S. Capitol Street, SE., administration of justice in close District of Columbia Circuit and the Washington, DC 20032 collaboration with the community. Chief Judge of the United States District CSS Field Office, 1230 Taylor Street, NW., Court for the District of Columbia in Washington, DC 20011 § 800.3 Functions and responsibilities. consultation with an Executive District of Columbia Pretrial Services Agency (a) Community Supervision Services. Committee. The Executive Committee Office of Operations Branch, 300 Indiana (1) The Revitalization Act requires includes the four chief judges of the Avenue, NW., Washington, DC 20001 CSOSA to provide supervision, through local and Federal trial and appellate Office of Operations Branch, 500 Indiana qualified supervision officers, to courts, the United States Attorney for Avenue, NW., Washington, DC 20001 offenders on probation, parole, and the District of Columbia, the Director of Office of Operations Branch, 333 supervised release for violation of the District of Columbia Public Defender Constitution Avenue, NW., Washington, District of Columbia Code offenses. The Service, and the Director of CSOSA. DC 20001 Agency carries out its responsibilities Office of Operations Branch, 601 Indiana on behalf of the court or agency having § 800.5 Agency components. Avenue, NW., Washington, DC 20004 jurisdiction over the person being (a) CSOSA. IV. FOIA/PA Requests (CSOSA and PSA) supervised. Accordingly, CSOSA (1) Office of the Director (including Office of the General Counsel (FOIA), Court supervises all offenders placed on the Deputy Director). Services and Offender Supervision Agency probation by the Superior Court of the (2) Office of the General Counsel. for the District of Columbia, 633 Indiana District of Columbia, and all individuals (3) Community Supervision Services. Avenue, NW., Washington, DC 20004

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IV. Service of Process (CSOSA and PSA, during work hours and Mr. Larry Moll, authorized in section 316 of Title III of except for PSA subpoenas) (309) 752–5244, after hours. The the HEA. Office of the General Counsel, Court Services drawbridge normally opens on signal. Under section 316, in general, an HSI and Offender Supervision Agency for the Dated: December 28, 2000 institution was an institution that District of Columbia, 633 Indiana Avenue, satisfied the statutory definition of an K.J. Eldridge, NW., Washington, DC 20004 ‘‘eligible institution’’ contained in Captain, U.S. Coast Guard, Acting V. Tort Claims (CSOSA and PSA) section 312 of the HEA, and had at least Commander, Eighth Coast Guard District. 25 percent of its enrollment consist of Office of the General Counsel, Court Services [FR Doc. 01–436 Filed 1–5–01; 8:45 am] and Offender Supervision Agency for the Hispanic students. An eligible BILLING CODE 4910±15±U District of Columbia, 633 Indiana Avenue, institution under section 312 of the HEA NW., Washington, DC 20004 basically satisfied four conditions. Two of the conditions related to accreditation [FR Doc. 01–395 Filed 1–5–01; 8:45 am] DEPARTMENT OF EDUCATION and licensure. The other two required BILLING CODE 3129±01±P the institution to have a high percentage 34 CFR Part 606 of low income students and low education and general (E&G) Developing Hispanic-Serving DEPARTMENT OF TRANSPORTATION expenditures. Institutions Program Under section 312, a branch campus Coast Guard AGENCY: Office of Postsecondary of an eligible institution also qualified Education, Department of Education. as an eligible institution if its main 33 CFR Part 117 ACTION: Final regulations. campus satisfied all four conditions and [CGD08±00±029] it, on its own, satisfied the last two. SUMMARY: When we published final Regulations that we promulgated to RIN 2115±AE47 regulations for the Developing Hispanic- implement these institutional eligibility requirements were codified in 34 CFR Drawbridge Operating Regulation; Serving Institutions (HSI) Program in 607.2(b) and (d). The regulations did not Mississippi River, Iowa and Illinois the Federal Register of December 15, 1999, it appears that one of the specifically address whether the main AGENCY: Coast Guard, DOT. regulatory provisions, dealing with the campus of a branch campus that applied ACTION: Temporary deviation. eligibility of branch campuses to receive for an HSI Program grant had to satisfy grants, could be viewed in a manner the Hispanic student enrollment SUMMARY: The Commander, Eighth that would result in an unintended requirement. However, it was the Coast Guard District, has authorized a change of policy. To rectify this Department’s policy that a main campus deviation from the regulation governing problem, we are revising that regulation did not have to qualify as an eligible the Burlington Railroad Drawbridge, to more clearly reflect our long standing HSI institution in terms of student Mile 403.1, Upper Mississippi River at policy that a branch campus is eligible enrollment if the branch campus is Burlington, Iowa. This deviation allows to apply for an HSI grant if the branch qualified. the drawbridge to remain closed-to- campus serves the appropriate number In the Higher Education Amendments navigation for 60 days from 12:01 a.m., of Hispanic students even if the main of 1998, Public Law 105–244, the December 31, 2000, until 12:01 a.m., campus does not. Congress moved the HSI Program into Title V of the HEA and reenacted, in March 1, 2001. The drawbridge will DATES: These regulations are effective that title, all the relevant provisions that open on signal if at least six (6) hours February 7, 2001. advance notice is given. governed that program while it was part FOR FURTHER INFORMATION CONTACT: of Title III of the HEA. To accommodate DATES: This temporary deviation is Sophia McArdle, U.S. Departmnet of that statutory change, we codified all effective from 12:01 a.m., December 31, Education, 1990 K Street, NW., Room the HSI Program requirements in a new 2000, until 12:01 a.m., March 1, 2001. 6061, Washington, DC 20006–8512. part, 34 CFR Part 606. The FOR FUTHER INFORMATION CONTACT: Roger Telephone: (202) 219–7078. If you use a recodification was technical in nature K. Wiebusch, Bridge Administrator, telecommunications device for the deaf and did not involve any change in Commander (obr), Eighth Coast Guard (TDD), you may call the Federal policy. Therefore, when we published District, 1222 Spruce Street, St. Louis, Information Relay Service (FIRS) at 1– Part 606 in the Federal Register on MO 63103–2832, (314) 539–3900, 800–877–8339. December 15, 1999, we waived extension 378. Individuals with disabilities may rulemaking. However, it has recently SUPPLEMENTARY INFORMATION: The obtain this document in an alternative come to our attention that one of the Burlington Railroad Drawbridge format (e.g., Braille, large print, recodified regulatory provisions has provides a vertical clearance of 21.5 feet audiotape, or computer diskette) on been read by some as though it, in fact, above normal pool in the closed to request to the contact person listed made a change in policy. That provision navigation position. Navigation on the under FOR FURTHER INFORMATION was § 606.2(b), relating to the eligibility waterway consists primarily of CONTACT. of a branch campus to qualify as an commercial tows and recreational SUPPLEMENTARY INFORMATION: eligible HSI institution. watercraft. This deviation has been As presently written, it could be coordinated with waterway users who Background viewed that in order for a branch do not object. The Higher Education Amendments campus to qualify as an eligible HSI This deviation allows the bridge to of 1992, Pub. Law 102–325, amended institution, it and its main campus must remain closed-to-navigation from 12:01 the Higher Education Act of 1965, as have an enrollment of at least 25 percent a.m., December 31, 2000, to 12:01 a.m., amended (HEA), by adding the Hispanic students. As described above, March 1, 2001, with openings provided Developing Hispanic Serving- however, such a reading would be upon receipt of six (6) hours advance Institutions (HSI) Program as an inconsistent with the Department’s notice. Advance notice may be given by authorized program under Title III, Part policy that the main campus does not calling Mr. Al Poole, (309) 345–6103 A of the HEA. The HSI Program was have to satisfy that requirement along

VerDate 112000 15:40 Jan 05, 2001 Jkt 190000 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\08JAR1.SGM pfrm02 PsN: 08JAR1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1263 with the branch campus. Therefore, we (Catalog of Federal Domestic Assistance new and existing major sources to are revising § 602.2(b) to more clearly Numbers: 84.031S, 84.031A, and 84.031B) control emissions of hazardous air reflect the Department’s long-standing List of Subjects in 34 CFR Part 606 pollutants (HAP) to the level reflecting policy. application of the maximum achievable Colleges and universities, Grant control technology. The technical Waiver of Proposed Rulemaking programs-education, Reporting and corrections and minor technical Under the Administrative Procedure recordkeeping requirements. amendments in this action will not Act (5 U.S.C. 553), the Department Dated: December 29, 2000. change the basic control requirements of generally offers interested parties the A. Lee Fritschler the rule or the level of health protection opportunity to comment on proposed Assistant Secretary, Office of Postsecondary it provides. regulations. However, these regulations Education. Section 553 of the Administrative merely clarify statutory changes and do For the reasons discussed in the Procedure Act, 5 U.S.C. 553(b)(B), not establish or effect substantive preamble, the Secretary amends Title 34 provides that, when an agency for good policy. Therefore, under 5 U.S.C. of the Code of Federal Regulations by cause finds that notice and public 553(b)(8), the Secretary has determined amending part 606 as follows: procedure are impracticable, that proposed regulations are unnecessary, or contrary to the public unnecessary and contrary to public PART 606ÐDEVELOPING HISPANIC- interest, the agency may issue a rule interest. SERVING INSTITUTIONS PROGRAM without providing notice and an Regulatory Flexibility Act Certification 1. The authority citation for part 606 opportunity for public comment. We The Secretary certifies that these continues to read as follows: have determined that there is good cause for making today’s rule final regulations would not have a significant Authority: 20 U.S.C. 1101 et seq., unless economic impact on a substantial otherwise noted. without prior proposal and opportunity number of small entities. for comment because the changes to the 2. Section 606.2 is amended by The small entities that would be rule are minor technical corrections, are revising paragraph (b) to read as follows: affected by these regulations are small noncontroversial in nature, and do not institutions of higher education (IHEs) § 606.2 What institutions are eligible to substantively change the requirements receiving Federal funds under this receive a grant under the Developing of the OSWRO rule. Thus, notice and program. However, the regulations Hispanic-Serving Institutions Program? public procedure are unnecessary. We would not have a significant economic * * * * * find that this constitutes good cause impact on the small IHEs affected (b) A branch campus of a Hispanic- under 5 U.S.C. 553(b)(B). because the regulations would not Serving institution is eligible to receive Section 553(d)(3) allows an agency, impose excessive regulatory burdens or a grant under this part if— upon finding good cause, to make a rule require unnecessary Federal (1) The institution as a whole meets effective immediately. Because today’s supervision. The regulations would the requirements of paragraphs (a)(3) changes do not substantively change the impose minimal requirements to ensure through (a)(6) of this section; and (2) requirements of the OSWRO rule, we the proper expenditure of program The branch campus satisfies the find good cause to make these funds. requirements of paragraphs (a)(1) amendments effectively immediately. through (a)(4) of this section. Paperwork Reduction Act of 1995 EFFECTIVE DATE: January 8, 2001. * * * * * These final regulations do not contain [FR Doc. 01–430 Filed 1–5–01; 8:45 am] ADDRESSES: Docket No. A–92–16 any information collection BILLING CODE 4000±01±U contains the supporting information for requirements. the original OSWRO NESHAP and this Electronic Access to this Document action. The docket is located at the U.S. ENVIRONMENTAL PROTECTION EPA in room M–1500, Waterside Mall You may view this document, as well AGENCY (ground floor), 401 M Street SW, as all other Department of Education Washington, DC 20460, and may be documents published in the Federal 40 CFR Part 63 inspected from 8:00 a.m. to 5:30 p.m., Register, in text or Adobe Portable Monday through Friday, excluding legal [AD±FRL±6928±2] Document Format (PDF) on the Internet holidays. A reasonable fee may be at either of the following sites: RIN 2060±AH96 charged for copying. http://ocfo.ed.gov/fedreg.htm FOR FURTHER INFORMATION CONTACT: Ms. http://www.ed.gov/news.html National Emission Standards for Hazardous Air Pollutants from Off-Site Elaine Manning, Waste and Chemical To use PDF, you must have Adobe Waste and Recovery Operations Processes Group, Emission Standards Acrobat Reader which is available free Division (MD–13), U.S. EPA, Research at either of the previous sites. If you AGENCY: Environmental Protection Triangle Park, NC, 27711, telephone have questions about using PDF, call the Agency (EPA). number (919) 541–5499, facsimile U.S. Government Printing Office (GPO), ACTION: Final rule; technical corrections number (919) 541–0246, electronic mail toll free, at 1–888–293–6498; or in the and amendments. address [email protected]. Washington, DC area at (202) 512–1530. Note: The official version of this document SUMMARY: Under the Clean Air Act SUPPLEMENTARY INFORMATION: Regulated is the document published in the Federal (CAA), the EPA promulgated the Entities. Entities potentially regulated Register. Free internet access to the official National Emission Standards for by this action include the following edition of the Federal Register and the Code Hazardous Air Pollutants (NESHAP) types of facilities if the facility receives of Federal Regulations is available on GPO from Off-Site Waste and Recovery ‘‘off-site material’’ as defined in the rule, Access at: Operations (OSWRO) on July 1, 1996 and the facility is determined to be a http://www.access.gpo.gov/nara/ with subsequent amendments on July major source of emissions of HAP as index.html 20, 1999. The promulgated rule requires defined in 40 CFR 63.2.

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Category Examples of regulated entities

Industry ...... Businesses that receive waste, used oil, or used solvent from off-site locations and manage this material in any of the following waste management or recovery operations: hazardous waste treatment, storage, and disposal facilities (TSDF); hazardous wastewater treatment operations exempted from air emission control requirements in 40 CFR parts 264 or 265; nonhazardous wastewater treatment facilities other than publicly owned treatment works; used solvent recovery operations; recovery operations that recycle or reprocess hazardous waste and are exempted from regulation as a TSDF in 40 CFR parts 264 or 265; and used oil re-refineries. Federal Government ...... Federal agency facilities that operate any of the waste management or recovery operations that meet the description of the entities listed under the ``Industry'' category in this table.

This table is not intended to be chemical products manufacturing (SIC NESHAP on July 1, 1996 (61 FR 34140). exhaustive, but rather provides a guide code 289x). The EPA is also aware of The OSWRO NESHAP establish for readers regarding entities likely to be off-site waste management or recovery standards to control HAP emissions regulated by this action. This table lists operations potentially subject to the rule from certain waste management and the types of entities that the EPA is now being located at a few facilities listed recovery operations that are not subject aware could potentially be regulated by under SIC codes for refuse systems, to Federal air standards under other this action. waste management, business services, subparts in 40 CFR part 61 or 63. A comprehensive list of Standard miscellaneous services, and Subpart DD specifies the rule’s Industrial Classification (SIC) codes nonclassifiable. Thus, the SIC code cannot be compiled for businesses applicability, standards for affected alone for a given facility does not sources, compliance requirements, and potentially regulated by this action due determine whether the facility is or is reporting and recordkeeping provisions. to the structure of the rule. The rule may not potentially subject to this rule. be applicable to any business that To determine whether your facility is In addition, subpart DD cross-references receives waste, used oil, or used solvent regulated by this action, you should other subparts in 40 CFR part 63 for the from an off-site location and then carefully examine the applicability specific air emissions control manages this material in one of the criteria in § 63.680 of the rule. If you requirements to be used for affected operations or processes specified in the have questions regarding the tanks, surface impoundments, rule. Thus, for many businesses subject applicability of this action to a containers, individual drain systems, to the rule, the regulated sources (i.e., particular entity, consult the person and oil-water and organic-water off-site waste management or recovery listed in the preceding FOR FURTHER separators. The cross-referenced operations) are only a small part of the INFORMATION CONTACT section of this subparts are Subpart OO, National overall manufacturing process or service document. World Wide Web (WWW). Emission Standards for Tanks, Level 1; conducted at the facility. In these cases, The text of today’s document will also Subpart PP, National Emission the SIC code indicates the primary be available on the WWW through the Standards for Containers; Subpart QQ, product produced or service provided at Technology Transfer Network (TTN). National Emission Standards for Surface the facility rather than the presence of Following signature, a copy of this Impoundments; Subpart RR, National an off-site waste management or action will be posted on the TTN’s Emission Standards for Individual Drain recovery operation at the site which is policy and guidance page for newly Systems; and Subpart VV, National operated to support the predominate proposed or promulgated rules http// Emission Standards for Oil-Water function of the facility. For example, www.epa.gov/ttn/oarpg. The TTN SIC code classifications likely to have Separators and Organic-Water provides information and technology Separators. Amendments were made to off-site waste management or recovery exchange in various areas of air the final rule on July 20, 1999. operations at some (but not all) facilities pollution control. If more information include, but are not limited to, regarding the TTN is needed, call the II. Summary of Corrections petroleum refineries (SIC code 2911), TTN HELP line at (919) 541–5384. industrial organic chemical Today’s changes are described in manufacturing (SIC code 286x), plastic I. Background Table 2 to this preamble for the materials and synthetics manufacturing The EPA, under 40 CFR part 63, convenience of the reader. (SIC code 282x), and miscellaneous subpart DD, promulgated the OSWRO

Table 2

Citation Change

§ 63.681 ...... Add definition ``Off-site material service'' to amendatory paragraph. § 63.684(b)(1)(ii)(A)&(B) ...... Add the letters ``A'' and ``B'' which were inadvertently left out of July 20, 1999 amendments. § 63.685(i) and (i)(4) ...... Add reference to (i)(4) in (i), intro paragraph, and add (i)(4), which was left out of July 1, 1996 final rule and the July 20, 1999 amendments. § 63.691(a) ...... In the July 20, 1999 amendments, § 63.683(b)(3) was eliminated and § 63.683(d) was added to take its place. The cite in § 63.691(a) referencing § 63.683 was not corrected in the July 1999 amendments to cite § 63.683(d). Today's action corrects this oversight. § 63.693(d)(3)(ii), (e)(3)(ii), (f)(3)(iii), The change to the rule removes the ±1 percent accuracy requirement and replaces it with reference to part and (g)(3)(ii). 60, appendix B, Performance Specification 8 or 9. The EPA received comments that the monitoring re- quirements in the rule were too vague, in that they did not define what type of monitoring device was ac- ceptable, nor did it establish procedures for determining the accuracy requirement (±1 percent) cited in the rule. The addition of part 60, appendix B, Performance Specification 8 or 9 to the rule will aid sources in choosing and certifying appropriate monitors, as well as establishing quality assurance proce- dures for maintaining, calibrating and auditing the monitors.

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Citation Change

§ 63.693 (d)(3), (d)(4)(i) and (iii) ..... This change adds another option to the carbon canister monitoring and replacement requirements con- sistent with those allowed under other related NESHAP and Resource Conservation and Recovery Act (RCRA) air rules. § 63.694(b)(2)(iii) ...... Correction to subscript of the ``QT'' term. § 63.694(1)(3)(ii)(A) ...... Correction to misprinted equation in July 1, 1996 final rule. Table 2. Applicability of Paragraphs § 63.10(b)(2)(xi) inadvertently left off table. The ``yes'' for this section was added. in Subpart A of Part 63ÐGeneral Provisions to Subpart DD. § 63.924(c)(2) ...... Change reference of § 63.692 to § 63.693. Section 63.692 is reserved. § 63.962(b)(3)(ii) ...... Corrected typographical error ``in accordance.'' § 63.965(b) ...... Corrected typographical error ``Standards.'' § 63.966 ...... Corrected typographical error ``Standards.'' § 63.1045 ...... Corrected typographical error ``Standards.''

III. Administrative Requirements agency does not use available and amendments do not impose an Under Executive Order 12866 (58 FR applicable voluntary consensus information collection burden under the 51735, October 4, 1993), this action is standards. provisions of the Paperwork Reduction These final rule amendments provide not a ‘‘significant regulatory action’’ and Act of 1995 (44 U.S.C. 3501 et seq.). The technical corrections and minor is therefore not subject to review by the EPA’s compliance with these statutes technical amendments to the Off-Site Office of Management and Budget and Executive Orders for the underlying Waste and Recovery Operations (OMB). Because the EPA has made a rule is discussed in the July 20, 1999 NESHAP (Subpart DD). These ‘‘good cause’’ finding that this action is amendments to the final OSWRO rule. amendments include two technical not subject to notice and comment The Congressional Review Act (5 standards: Performance Specification 8 requirements under the Administrative U.S.C. 801 et seq.), as added by the (PS–8), Performance Specification for Small Business Regulatory Enforcement Procedure Act or any other statute, it is Volatile Organic Compound Continuous not subject to the regulatory flexibility Fairness Act of 1996, generally provides Emission Monitoring Systems in that before a rule may take effect, the provisions of the Regulatory Flexibility Stationary Sources; and Performance Act (5 U.S.C. 601 et seq.), or to sections agency promulgating the rule must Specification 9 (PS–9), Performance submit a rule report, which includes a 202 and 205 of the Unfunded Mandates Specification for Gas Chromatograph Reform Act of 1995 (UMRA) (Public copy of the rule, to each House of the Continuous Emission Monitoring Congress and to the Comptroller General Law 104–4). In addition, this action Systems in Stationary Sources which of the United States. Section 808 allows does not significantly or uniquely affect are cited in § 63.693. the issuing agency to make a rule small governments or impose a Consistent with the NTTAA, the EPA significant intergovernmental mandate, conducted a search for EPA’s effective sooner than otherwise as described in sections 203 and 204 of Performance Specifications 8 and 9. No provided by the Congressional Review the UMRA. This action also does not candidate consensus standards were Act if the agency makes a good cause significantly or uniquely affect the identified for either performance finding that notice and public procedure communities of tribal governments, as specification applicable for these is impracticable, unnecessary or specified by Executive Order 13084 (63 amendments. Therefore, EPA is not contrary to the public interest. This FR 27655, May 10, 1998). This action proposing/adopting any voluntary determination must be supported by a does not have substantial direct effects consensus standards in this rulemaking. brief statement (5 U.S.C. 808(2)). As on the States, on the relationship Nevertheless, under § 63.8, sources are stated previously, the EPA has made between the national government and allowed to apply to EPA for permission such a good cause finding, including the the States, as specified in Executive to use alternative monitoring in lieu of reasons therefor, and established an Order 13132 (64 FR 43255, August 10, PS–8 and PS–9. effective date of January 8, 2001. The 1999). This action also is not subject to This technical correction action does EPA will submit a report containing this Executive Order 13045 (62 FR 19885, not involve special consideration of rule and other required information to April 23, 1997) because it is not environmental justice related issues as the U.S. Senate, the U.S. House of economically significant. required by Executive Order 12898 (59 Representatives, and the Comptroller Section 12(d) of the National FR 7629, February 16, 1994). In issuing General of the United States prior to Technology Transfer and Advancement these rule amendments, the EPA has publication of the rule in the Federal Act (NTTAA) of 1995 (Public Law No. taken the necessary steps to eliminate Register. This action is not a ‘‘major 104–113), directs EPA to use voluntary drafting errors and ambiguity, minimize rule’’ as defined by 5 U.S.C. 804(2). consensus standards in their regulatory potential litigation, and provide a clear List of Subjects in 40 CFR Part 63 and procurement activities unless to do legal standard for affected conduct, as so would be inconsistent with required by section 3 of Executive Order Environmental protection, Air applicable law or otherwise impractical. 12988 (61 FR 4729, February 7, 1996). pollution control, Off-site waste and Voluntary consensus standards are The EPA has complied with Executive recovery operations. technical standards (e.g., materials Order 12630 (53 FR 8859, March 15, Dated: December 27, 2000. specifications, test methods, sampling 1988) by examining the takings Carol M. Browner, procedures, business practices) implications of these rule amendments Administrator. developed or adopted by one or more in accordance with the ‘‘Attorney voluntary consensus bodies. The General’s Supplemental Guidelines for For the reasons set forth in the NTTAA directs EPA to provide the Evaluation of Risk and Avoidance of preamble, title 40, chapter I, part 63 of Congress, through annual reports to Unanticipated Takings’’ issued under the Code of Federal Regulations is OMB, with explanations when an the executive order. These rule amended as follows:

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PART 63Ð[AMENDED] § 63.691 Standards: Equipment leaks. (d)(4)(i) of this section, an owner or (a) The provisions of this section operator of a nonregenerable carbon 1. The authority citation for part 63 apply to the control of air emissions adsorption system may choose to continues to read as follows: from equipment leaks for which replace on a regular basis the carbon Authority: 42 U.S.C. 7401, et seq. § 63.683(d) references the use of this canister or the carbon in the control section for such air emissions control. device using the procedures in either Subpart DDÐNational Emission * * * * * paragraph (d)(4)(iii)(A) or (d)(4)(iii)(B) of Standards for Hazardous Air Pollutants 5. Section 63.693 is amended by: this section. For the purpose of from Off-Site Waste and Recovery a. Revising paragraphs (d)(3) complying with this paragraph Operations introductory text and (d)(3)(ii); (d)(4)(iii), a nonregenerable carbon b. Revising paragraph (d)(4)(i); adsorption system means a carbon 2. Section 63.684 is amended by c. Adding paragraph (d)(4)(iii) adsorption system that does not revising paragraph (b)(1)(ii) to read as d. Revising paragraph (e)(3)(ii); regenerate the carbon bed directly onsite follows: e. Revising paragraph (f)(3)(iii); and in the control device, such as a carbon f. Revising paragraph (g)(3)(ii). canister. The spent carbon removed § 63.684 Standards: Off-site material The revisions and addition read as treatment. from the nonregenerable carbon follows: adsorption system must be managed * * * * * according to the requirements in (b) * * * § 63.693 Standards: Closed-vent systems and control devices. paragraph (d)(4)(ii) of this section. (1) * * * * * * * * (A) Monitor the concentration level of (ii) In the case when off-site material (d) * * * the organic compounds in the exhaust streams entering the treatment process (3) The owner or operator must vent from the carbon adsorption system are a mixture of off-site material streams monitor the operation of the carbon on a regular schedule, and when carbon having an average VOHAP adsorption system in accordance with breakthrough is indicated, immediately concentration equal to or greater than the requirements of § 63.695(e) using replace either the existing carbon 500 ppmw at the point-of-delivery with one of the continuous monitoring canister with a new carbon canister or off-site material streams having average systems specified in paragraphs (d)(3)(i) replace the existing carbon in the VOHAP concentrations less than 500 through (iii) of this section. Monitoring control device with fresh carbon. ppmw at the point-of-delivery, then the the operation of a nonregenerable Measurement of the concentration level VOHAP concentration of the off-site carbon adsorption system (e.g., a carbon of the organic compounds in the material must be reduced to a level at canister) using a continuous monitoring exhaust vent stream must be made with the point-of-treatment that meets the system is not required when the carbon a detection instrument that is performance level specified in either canister or the carbon in the control appropriate for the composition of paragraph (b)(1)(ii)(A) or (B) of this device is replaced on a regular basis organic constituents in the vent stream section. according to the requirements in and is routinely calibrated to measure (A) Less than the VOHAP paragraph (d)(4)(iii) of this section. the organic concentration level expected concentration limit (CR) established for * * * * * to occur at breakthrough. The the treatment process using the (ii) A continuous monitoring system monitoring frequency must be daily or procedure specified in § 63.694(d); or to measure and record the daily average at an interval no greater than 20 percent (B) Less than the lowest VOHAP concentration level of organic of the time required to consume the concentration determined for each of compounds in the exhaust gas stream total carbon working capacity the off-site material streams entering the from the control device. The organic established as a requirement of treatment process as determined by the monitoring system must comply either paragraph (d)(2)(ii)(B) of this section, VOHAP concentration of the off-site with Performance Specification 8 or 9 in whichever is longer. material at the point-of-delivery. 40 CFR part 60, appendix B. The (B) Replace either the existing carbon * * * * * relative accuracy provision of canister with a new carbon canister or Performance Specification 8, Sections replace the existing carbon in the 3. Section 63.685 is amended by 2.4 and 3 need not be conducted. control device with fresh carbon at a revising paragraph (i) introductory text regular, predetermined time interval and adding paragraph (i)(4) to read as * * * * * (4) * * * that is less than the design carbon follows: (i) Following the initial startup of the replacement interval established as a § 63.685 Standards: Tanks. control device, all carbon in the control requirement of paragraph (d)(2)(ii)(B) of this section. * * * * * device shall be replaced with fresh carbon on a regular, predetermined time (e) * * * (i) The owner or operator who elects interval that is no longer than the (3) * * * to control air emissions by using an carbon service life established for the (ii) A continuous monitoring system enclosure vented through a closed-vent carbon adsorption system. The to measure and record the daily average system to an enclosed combustion provisions of this paragraph (d)(4)(i) do concentration level of organic control device shall meet the not apply to a nonregenerable carbon compounds in the exhaust gas stream requirements specified in paragraphs adsorption system (e.g., a carbon from the control device. The organic (i)(1) through (4) of this section. canister) for which the carbon canister monitoring system must comply either * * * * * or the carbon in the control device is with Performance Specification 8 or 9 in (4) The owner or operator shall replaced on a regular basis according to 40 CFR part 60, appendix B. The inspect and monitor the closed-vent the requirements in paragraph (d)(4)(iii) relative accuracy provision of system and control device as specified of this section. Performance Specification 8, Sections in § 63.693. * * * * * 2.4 and 3 need not be conducted. 4. Section 63.691 is amended by (iii) As an alternative to meeting the * * * * * revising paragraph (a) to read as follows: requirements in paragraphs (d)(3) and (f) * * *

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(3) * * * using the results for all samples (l) * * * (iii) For either type of vapor analyzed in accordance with paragraph (3) * * * incinerator, a continuous monitoring (b)(2)(ii) of this section and the (ii) * * * system to measure and record the daily following equation. An owner or average concentration of organic operator using a test method that (A) The following equations shall be compounds in the exhaust vent stream provides species-specific chemical used: from the control device. The organic concentrations may adjust the measured n monitoring system must comply either concentrations to the corresponding EKQ=××∑() CM × with Performance Specification 8 or 9 in i2 i ij ij concentration values which would be j=1 40 CFR part 60, appendix B. The obtained had the off-site material n relative accuracy provision of samples been analyzed using Method =×× × Performance Specification 8, Sections 305. To adjust these data, the measured EKQo2 o∑() CM oj oj 2.4 and 3 need not be conducted. concentration for each individual HAP j=1 * * * * * chemical species contained in the off- Where: (g) * * * site material is multiplied by the Cij, Coj = Concentration of sample component (3) * * * appropriate species-specific adjustment j of the gas stream at the inlet and outlet (ii) A continuous monitoring system factor (fm305) listed in Table 1 of this of the control device, respectively, dry to measure and record the daily average subpart. basis, parts per million by volume. concentration of organic compounds in Ei, Eo = Mass rate of TOC (minus methane the exhaust vent stream from the control 1 n and ethane) or total HAP at the inlet and =× × outlet of the control device, respectively, device. The organic monitoring system C ∑()QCii dry basis, kilogram per hour. must comply either with Performance QT i=1 Mij, Moj = Molecular weight of sample Specification 8 or 9 in 40 CFR part 60, Where: component j of the gas stream at the inlet appendix B. The relative accuracy C = Average VOHAP concentration of the off- and outlet of the control device, provision of Performance Specification site material at the point-of-delivery on respectively, gram/gram-mole. 8, Sections 2.4 and 3 need not be a mass-weighted basis, ppmw. Qi, Qo = Flow rate of gas stream at the inlet conducted. i = Individual sample ‘‘i’’ of the off-site and outlet of the control device, material. * * * * * respectively, dry standard cubic meter n = Total number of samples of the off-site per minute. 6. Section 63.694 is amended by ¥6 material collected (at least 4) for the K2 = Constant, 2.494×10 (parts per revising paragraphs (b)(2)(iii) and averaging period (not to exceed 1 year). million) ¥1 (gram-mole per standard (l)(3)(ii)(A) to read as follows: Qi = Mass quantity of off-site material stream cubic meter) (kilogram/gram) (minute/ represented by Ci, kg/hr. § 63.694 Testing methods and procedures. hour), where standard temperature QT = Total mass quantity of off-site material (gram-mole per standard cubic meter) is * * * * * during the averaging period, kg/hr. 20°C. (b) * * * Ci = Measured VOHAP concentration of * * * * * (2) * * * sample ‘‘i’’ as determined in accordance (iii) Calculations. The average with the requirements of § 63.694(a), 7. In Table 2 of Subpart DD, the entry VOHAP concentration (C) on a mass- ppmw. ‘‘63.10(b)(2)(x)’’ is revised to read as weighted basis shall be calculated by * * * * * follows:

TABLE 2 TO SUBPART DDÐAPPLICABILITY OF PARAGRAPHS IN SUBPART A OF THIS PART 63ÐGENERAL PROVISIONS TO SUBPART DD

Subpart A Applies to Subpart DD Explanation

******* 63.10(b)(2)(x)±(xi) ...... Yes.

*******

Subpart PPÐNational Emission Subpart RRÐNational Emission in accordance with the standards Standards for Containers Standards for Individual Drain Systems specified in § 63.693. * * * * * 9. Section 63.962 is amended by 8. Section 63.924 is amended by 10. Section 63.965 is amended by revising paragraph (b)(3)(ii)(A) to read revising paragraph (c)(2) to read as revising paragraph (b) to read as follows: as follows: follows: § 63.965 Recordkeeping requirements. § 63.962 Standards. § 63.924 StandardsÐContainer Level 3 * * * * * Controls. * * * * * (b) * * * (b) Owners and operators that use a * * * * * (3) * * * closed-vent system and a control device in accordance with the provisions of (c) * * * (ii) * * * (A) The junction box shall be vented § 63.962 shall prepare and maintain the (2) The closed-vent system and through a closed vent system to a records required for the closed-vent control device shall be designed and control device except as provided for in system and control device in accordance operated in accordance with the paragraph (b)(3)(ii)(B) of this section. with the requirements of § 63.693. requirements of § 63.693. The closed vent system and control 11. Section 63.966 is revised to read * * * * * device shall be designed and operated as follows:

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§ 63.966 Reporting requirements. EFFECTIVE DATE: This action is effective Comment 1: The District is concerned Owners and operators that use a on February 7, 2001. that after years of improving PM–10 closed-vent system and a control device ADDRESSES: You can inspect copies of ambient levels and public outreach in accordance with the provisions of the administrative record for this action efforts promoting their successes, the § 63.962 shall prepare and submit to the at EPA’s Region 9 office during normal proposed action will bring into question Administrator the reports required for business hours. U.S. Environmental the credibility of both the District and closed-vent systems and control devices Protection Agency, Region 9, Air EPA. Moreover, the District believes that in accordance with the requirements of Division, Planning Office (AIR–2), 75 the reclassification of the area to serious § 63.693. Hawthorne Street, San Francisco, nonattainment will require considerable California 94105. staff resources to be spent on plan Subpart VVÐNational Emission preparation and documentation Standards for Oil-Water Separators Electronic Availability requirements. and Organic-Water Separators This document is also available as an In addition, the District does not electronic file on EPA’s Region 9 Web believe that the serious classification 12. Section 63.1045 is amended by correctly defines the current PM–10 revising paragraph (b)(3)(ii) to read as Page at http://www.epa.gov/region09/ air. status of the RPA and that maintaining follows: the moderate classification, although it FOR FURTHER INFORMATION CONTACT: For may not be an option provided by the § 63.1045 StandardsÐPressurized monitoring data questions contact separator. Clean Air Act, would more correctly Manny Aquitania, U.S. EPA, Region 9, characterize the area. * * * * * Air Division, Technical Support Office (b) * * * Response 1: While the PM–10 (AIR–7), 75 Hawthorne Street, San ambient levels may have improved over (3) * * * Francisco, California 94105, (415) 744– (ii) At those times when purging of the years, the RPA was violating the 1299, [email protected]. For inerts from the separator is required, PM–10 standard on its CAA attainment other questions contact Doris Lo, U.S. and the purge stream is routed to a deadline of December 31, 1994 and is closed-vent system and control device Environmental Protection Agency, currently still in violation of the PM–10 designed and operated in accordance Region 9, Air Division, Planning Office standard. The basis for this conclusion with the applicable requirements of (AIR–2), 75 Hawthorne Street, San and the data supporting it are discussed § 63.693. Francisco, California 94105, (415) 744– in detail in the proposed rule. See 65 FR 1287, [email protected]. at 70327. [FR Doc. 01–365 Filed 1–5–01; 8:45 am] SUPPLEMENTARY INFORMATION: EPA has the responsibility under CAA BILLING CODE 6560±50±P sections 179(c) and 188(b)(2) to make I. Background findings of failure to attain for areas On November 22, 2000, EPA proposed which have not attained the NAAQS by ENVIRONMENTAL PROTECTION to find that the RPA, a moderate PM– the statutory deadline. Under section AGENCY 10 nonattainment area (40 CFR 81.329) 188(b)(2)(A), a moderate PM–10 40 CFR Part 81 did not attain either the 24-hour or nonattainment area is reclassified as annual PM–10 NAAQS by the required serious by operation of law if the [NV 032±FON; FRL±6927±7] attainment date of December 31, 1994 Administrator finds that the area has and, as a result, would be reclassified as failed to attain the NAAQS by the Clean Air Act Reclassification; a serious area. 65 FR 70326. The statutory attainment date. NevadaÐReno Planning Area; proposed finding and resulting EPA supports the District’s efforts to Particulate Matter of 10 Microns or reclassification is based on air quality improve the air quality in the Reno area Less (PM±10) data which revealed violations of the and understands that the District has AGENCY: Environmental Protection PM–10 NAAQS during 1992–1994. For already spent considerable resources in Agency (EPA). more background information see the developing measures that will satisfy ACTION: Final rule. November 22, 2000 proposal at 65 FR the requirements in CAA section 189(b) 70326. Today’s rulemaking provides for a serious PM–10 area. EPA SUMMARY: EPA is taking final action to EPA’s responses to public comments understands that the plan preparation find that the Reno (Washoe County) and finalizes EPA’s proposed action. and document requirements can be Planning Area (RPA) has not attained resource-intensive and difficult, but the annual and 24-hour PM–10 national II. Public Comments and EPA EPA is encouraged by the District’s ambient air quality standards (NAAQS) Responses ongoing efforts and believes that the by the Clean Air Act (CAA) mandated In response to the November 22, 2000 District’s past efforts (e.g., residential attainment date for moderate proposal, EPA received one comment wood burning and construction dust nonattainment areas, December 31, letter from the Washoe County District control measures) will also help address 1994. This finding is based on Health Department Air Quality the serious area planning requirements. monitored air quality data for the PM– Management Division (the District). In These ongoing and past efforts should 10 NAAQS during the years 1992–1994. general, the District believes that the air help the serious area plan preparation As a result of this failure to attain, the quality in the RPA has improved over and documentation requirements RPA will be reclassified under CAA the past decade and that a proceed with fewer resources and less section 188(b)(2) by operation of law as reclassification to serious is not difficulty. a serious nonattainment area on the indicative of the air quality Comment 2: The District stated that effective date of this rule. The State of improvement for the area; however, the the lawsuit and accompanying Nevada will be required to submit a District also recognizes that EPA arguments levied by the Sierra Club state implementation plan (SIP) revision proposed to reclassify the RPA pursuant present the perception that the air addressing the CAA provisions for to the Clean Air Act’s statutory quality in the RPA has continually been serious areas within 18 months of the requirements. Below are EPA’s at a level endangering public health. reclassification. responses to the District’s comments. The District believes this is a

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The SIP also must reiterates that the ambient air quality in monitors that collect air quality samples contain, among other things, a Washoe County has improved less than every day, a recorded demonstration that the implementation dramatically in the past ten years. exceedance will in effect be prorated, or of BACM will provide for attainment of Response 2: EPA agrees that the air adjusted, so that the number of expected the PM–10 NAAQS no later than quality in the Reno area has improved exceedances for that year will account December 31, 2001. CAA sections over the past 10 years. Unfortunately, for the days not sampled. 65 FR 70327. 189(b)(1)(A) and 188(e) authorize EPA the area is still in violation of the Once this adjustment is made, the to grant an extension of that deadline if NAAQS for PM–10 due to a violation number of violations in 1993 and 1999 certain conditions are met. EPA has recorded in 1999. See ‘‘Table of Sites would be greater than one in each of provided specific guidance on Violating PM–10 NAAQS in Reno those years. developing serious area PM–10 SIP Planning Area, 1997–1999’’ in the The operating agency can avoid the revisions in an addendum to the docket for the proposed rule. As stated adjustment process for incomplete data General Preamble to title I of the Clean in the response to comment 1, EPA by initiating and maintaining everyday Air Act. See 59 FR 41998 (August 16, supports the District in its efforts to sampling for four (4) calendar quarters. 1994). improve the air quality in the Reno area 40 CFR part 50, appendix K. However, and understands that the District has the continuous PM–10 data collected by IV. Summary of Final Action already spent considerable resources in the District using a Federal Equivalent As stated above, EPA is finalizing its developing measures that will satisfy Monitor (FEM) during the 1993 and proposed action to find that the RPA the CAA requirements for a serious PM– 1999 violation years cannot be failed to attain the PM–10 NAAQS by 10 area. considered because quality assurance the December 31, 1994 CAA deadline Comment 3: The District states that procedures prescribed in 40 CFR part for moderate areas and, as a result, the the RPA attained the annual standard 58, Appendix A and ‘‘Quality Assurance RPA will be reclassified as a serious for PM–10 in 1995. Handbook for Air Pollution PM–10 nonattainment area on the Response 3: As discussed in the Measurement Systems,’’ EPA, August effective date of this final rule. proposed rule at 65 FR 70327, 1998 were not followed. attainment for the PM–10 NAAQS is Comment 5: The District states that V. Administrative Requirements achieved when there are 3 consecutive the PM10 violation days in 1993 and Under Executive Order 12866 (58 FR years of clean data. In 1995, the highest 1999 were characterized by stagnant air 51735, October 4, 1993), this action is annual arithmetic mean for the RPA was conditions with low carbon monoxide not a ‘‘significant regulatory action’’ and 47 µg/m3 found at the Reno-Galetti Way levels. Thus, the District has determined therefore is not subject to review by the moniter (below the annual PM–10 that fugitive dust and residential wood Office of Management and Budget. NAAQS of 50 µg/m3). While the RPA combustion were not the cause, but that Under section 188(b)(2) of the CAA, did not violate the annual PM–10 re-entrained road dust from wintertime findings of failure to attain are based NAAQS in 1995 (i.e., had clean data), sanding/de-icing operations was the solely upon air quality considerations the RPA still had not attained the cause of the 24-hour PM–10 violations and the subsequent nonattainment area annual standard for PM–10 in 1995 due during 1993 and 1999. The District reclassification must occur by operation to the annual PM–10 levels in 1993 and recognizes the important effect of re- of law in light of those air quality 1994. The clean data pointed out by the entrained road dust on the area’s air conditions. These actions do not, in- District are encouraging to EPA, quality and is committed to enhancing and-of themselves, impose any new however, the violations recorded in its efforts to prevent and mitigate this requirements on any sectors of the 1999 make an attainment finding source. The District believes that economy. In addition, because the impossible at this time. Washoe County is currently meeting the statutory requirements are clearly Comment 4: The District states that NAAQS for PM–10 and, with the defined with respect to the differently the Truckee Meadows Basin did not additional work it plans, the area can classified areas, and because those experience any 24-hour PM–10 maintain attainment for PM–10. requirements are automatically triggered violations for 5 years (1994 through Response 5: EPA believes the District by classifications that, in turn, are 1998). The District states that the RPA has made a reasonable assessment of the triggered by air quality values, findings measured a violation of the 24-hour cause of the PM–10 violations in 1993 of failure to attain and reclassifications standard one day in 1993 and one day and 1999 and the Agency expects to see cannot be said to impose a materially six years later in 1999. The District measures to address this issue in its adverse impact on State, local, or tribal states that the measured 24-hour serious area PM–10 plan for the RPA. As governments or communities. violations were based on the national stated previously, based on air quality Accordingly, the Administrator every six-day monitoring schedule. For data, EPA does not agree that the RPA certifies that this action will not have a both 1993 and 1999, the District also is currently meeting the NAAQS for significant economic impact on a collected continuous PM–10 data that PM–10; however, EPA believes that the substantial number of small entities indicate the RPA did not violate the 24- District has a good understanding of the under the Regulatory Flexibility Act (5 hour standard during those years. The controls needed to attain and maintain U.S.C. 601 et seq.). District claims that if those continuous the PM–10 NAAQS. Similarly, because the finding of monitoring instruments were either failure to attain is a factual certified as a federal reference method III. SIP Requirements for Serious Areas determination based on air quality or if the data were subjected to federal PM–10 nonattainment areas considerations and the resulting quality assurance procedures by the reclassified as serious under section reclassification must occur by operation District, the Truckee Meadows Basin 188(b)(2) of the CAA are required to of law and, do not impose any federal

VerDate 112000 15:40 Jan 05, 2001 Jkt 190000 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\08JAR1.SGM pfrm02 PsN: 08JAR1 1270 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations intergovermental mandate, these actions steps to eliminate drafting errors and this action must be filed in the United do not contain any unfunded mandate ambiguity, minimize potential litigation, States Court of Appeals for the or significantly or uniquely affect small and provide a clear legal standard for appropriate circuit by March 9, 2001. governments, as described in the affected conduct. EPA has complied Filing a petition for reconsideration by Unfunded Mandates Reform Act of 1995 with Executive Order 12630 (53 FR the Administrator of this final rule does (Public Law 104–4). For the same 8859, March 15, 1988) by examining the not affect the finality of this rule for the reason, this action also does not takings implications of the rule in purposes of judicial review nor does it significantly or uniquely affect the accordance with the ‘‘Attorney extend the time within which a petition communities of Indian tribal General’s Supplemental Guidelines for for judicial review may be filed, and governments, as specified by Executive the Evaluation of Risk and Avoidance of shall not postpone the effectiveness of Order 13084 (63 FR 27655, May 10, Unanticipated Takings’’ issued under such rule or action. This action may not 1998). Also for the same reasons, this the executive order. This finding of be challenged later in proceedings to finding of failure to attain and resulting failure to attain does not impose an enforce its requirements. (See section reclassification will not have substantial information collection burden under the 307(b)(2).) provisions of the Paperwork Reduction direct effects on the States, on the List of Subject in 40 CFR Part 81 relationship between the national Act of 1995 (44 U.S.C. 3501 et seq.). government and the States, or on the The Congressional Review Act, 5 Environmental protection, Air distribution of power and U.S.C. 801 et seq., as added by the Small pollution control, Intergovernmental responsibilities among the various Business Regulatory Enforcement relations, Particulate matter. levels of government, as specified in Fairness Act of 1996, generally provides Dated: December 22, 2000. Executive Order 13132 (64 FR 43255, that before a rule may take effect, the John Wise, August 10, 1999). This action is also not agency promulgating the rule must Acting Regional Administrator, Region IX. subject to Executive Order 13045 (62 FR submit a rule report, which includes a Part 81, chapter I, title 40 of the Code 19885, April 23, 1997), because it is not copy of the rule, to each House of the of Federal Regulations is amended as economically significant. Finally, for the Congress and to the Comptroller General follows: same reason that this finding of failure of the United States. EPA will submit a to attain is a factual determination based report containing this rule and other PART 81Ð[AMENDED] on air quality considerations and the required information to the U.S. Senate, resulting reclassification must occur by the U.S. House of Representatives, and 1. The authority citation for part 81 operation of law, the requirements of the Comptroller General of the United continues to read as follows: section 12(d) of the National States prior to publication of the rule in Authority: 42 U.S.C. 7401 et seq. Technology Transfer and Advancement the Federal Register. A major rule 2. In § 81.329, the table for Nevada– Act of 1995 (15 U.S.C. 272 note) do not cannot take effect until 60 days after it PM–10 Nonattainment Areas is apply. is published in the Federal Register. amended by revising the entry for As required by section 3 of Executive This action is not a ‘‘major rule’’ as ‘‘Washoe County’’ to read as follows: Order 12988 (61 FR 4729, February 7, defined by 5 U.S.C. 804(2). 1996), in issuing this finding of failure Under section 307(b)(1) of the Clean § 81.329 Nevada. to attain, EPA has taken the necessary Air Act, petitions for judicial review of * * * * *

NEVADAÐPM±10

Designation Classification Designated area Date Type Date Type

Washoe County Reno Planning Area ...... 11/15/90 Nonattainment ...... 2/7/01 Serious Hydrographic area 87.

* * * * * [FR Doc. 01–467 Filed 1–5–01; 8:45 am] BILLING CODE 6560±50±U

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Proposed Rules Federal Register Vol. 66, No. 5

Monday, January 8, 2001

This section of the FEDERAL REGISTER Cedex, France; telephone: (33) any other suggestions you might have to contains notices to the public of the proposed (0)5.62.41.73.00; facsimile: (33) improve the clarity of FAA issuance of rules and regulations. The (0)5.62.41.76.54; or the Product Support communications that affect you. You purpose of these notices is to give interested Manager, SOCATA—Groupe can get more information about the persons an opportunity to participate in the AEROSPATIALE, North Perry Airport, Presidential memorandum and the plain rule making prior to the adoption of the final rules. 7501 Pembroke Road, Pembroke Pines, language initiative at http:// Florida 33023; telephone: (954) 894– www.plainlanguage.gov. 1160; facsimile: (954) 964–4191. This How Can I Be Sure FAA Receives My DEPARTMENT OF TRANSPORTATION information also may be examined at the Rules Docket at the address above. Comment? Federal Aviation Administration FOR FURTHER INFORMATION CONTACT: Karl If you want us to acknowledge the Schletzbaum, Aerospace Engineer, FAA, receipt of your comments, you must 14 CFR Part 39 Small Airplane Directorate, 901 Locust, include a self-addressed, stamped postcard. On the postcard, write [Docket No. 2000±CE±70±AD] Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4146; facsimile: ‘‘Comments to Docket No. 2000–CE–70– RIN 2120±AA64 (816) 329–4090. AD.’’ We will date stamp and mail the SUPPLEMENTARY INFORMATION: postcard back to you. Airworthiness Directives; SOCATAÐ Groupe AEROSPATIALE Model TBM Comments Invited Discussion 700 Airplanes How Do I Comment on the Proposed What Events Have Caused This AGENCY: Federal Aviation AD? Proposed AD? ´ ´ Administration, DOT. The FAA invites comments on this The Direction Geneale de l’Aviation ACTION: Notice of proposed rulemaking proposed rule. You may submit Civile (DGAC), which is the (NPRM). whatever written data, views, or airworthiness authority for France, arguments you choose. You need to recently notified FAA that an unsafe SUMMARY: This document proposes to include the rule’s docket number and condition may exist on certain Socata adopt a new airworthiness directive submit your comments in triplicate to Model TBM 700 airplanes equipped (AD) that would apply to certain the address specified under the caption with Option No. OPT 70–35–001 SOCATA—Groupe AEROSPATIALE ADDRESSES. The FAA will consider all (gaseous oxygen system). The DGAC (Socata) Model TBM 700 airplanes comments received on or before the communicates a report of oil entering equipped with Option No. OPT 70–35– closing date. We may amend the the gaseous oxygen system service 001 (gaseous oxygen system). The proposed rule in light of comments compartment on a Model TBM 700 proposed AD would require you to received. Factual information that airplane. In particular, oil was seeping incorporate a modification that relocates supports your ideas and suggestions is out of the engine oil pump breather. the oil breather vent location. The extremely helpful in evaluating the proposed AD is the result of mandatory effectiveness of the proposed AD action What Are the Consequences if the continuing airworthiness information and determining whether we need to Condition Is Not Corrected? (MCAI) issued by the airworthiness take additional rulemaking action. Such oil contamination could result authority for France. The actions in a fire or explosion. specified by the proposed AD are Are There Any Specific Portions of the intended to prevent oil from entering Proposed AD I Should Pay Attention to? Is There Service Information That the gaseous oxygen system service The FAA specifically invites Applies to This Subject? compartment. Such oil contamination comments on the overall regulatory, Socata has issued Service Bulletin No. could result in a fire or explosion. economic, environmental, and energy SB 70–085 71, dated October 2000. DATES: The Federal Aviation aspects of the proposed rule that might Administration (FAA) must receive any suggest a need to modify the rule. You What Are the Provisions of This Service comments on this proposed rule on or may examine all comments we receive Bulletin? before February 10, 2001. before and after the closing date of the The service bulletin includes ADDRESSES: Submit comments in rule in the Rules Docket. We will file a procedures for incorporating Technical triplicate to FAA, Central Region, Office report in the Rules Docket that Instruction No. OPT70 K076–71 of the Regional Counsel, Attention: summarizes each FAA contact with the (Modification No. MOD70–119–71) Rules Docket No. 2000–CE–70–AD, 901 public that concerns the substantive ‘‘OIL PUMP BREATHER’’. This Locust, Room 506, Kansas City, parts of the proposed AD. modification relocates the oil breather Missouri 64106. Comments may be We are re-examining the writing style vent location. inspected at this location between 8 we currently use in regulatory What Action Did DGAC Take? a.m. and 4 p.m., Monday through documents, in response to the Friday, holidays excepted. Presidential memorandum of June 1, The DGAC classified this service Service information that applies to the 1998. That memorandum requires bulletin as mandatory and issued proposed AD may be obtained from federal agencies to communicate more French AD Number 2000–439(A), dated SOCATA Groupe AEROSPATIALE, clearly with the public. We are November 15, 2000, in order to assure Customer Support, Aerodrome Tarbes- interested in your comments on whether the continued airworthiness of these Ossun-Lourdes, BP 930–F65009 Tarbes the style of this document is clearer, and airplanes in France.

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Was This in Accordance With the information, including the service No. OPT70 K076–71 (Modification No. Bilateral Airworthiness Agreement? information referenced above; and MOD70–119–71) ‘‘OIL PUMP This airplane model is manufactured determined that: BREATHER’’. in France and is type certificated for —The unsafe condition referenced in Cost Impact operation in the United States under the this document exists or could develop provisions of section 21.29 of the on other Socata Model TBM 700 How Many Airplanes Would the Federal Aviation Regulations (14 CFR airplanes of the same type design that Proposed AD Impact? 21.29) and the applicable bilateral are equipped with Option No. OPT airworthiness agreement. 70–35–001 (gaseous oxygen system); We estimate that 80 Model TBM 700 Pursuant to this bilateral —The actions specified in the airplanes are on the U.S. Registry. Of airworthiness agreement, DGAC has previously-referenced service these 80 airplanes, 4 have a gaseous kept FAA informed of the situation information should be accomplished oxygen system and would be affected by described above. on the affected airplanes; and the proposed AD. The FAA’s Determination and an —AD action should be taken in order to What Would Be the Cost Impact of the Explanation of the Provisions of the correct this unsafe condition. Proposed AD on Owners/Operators of Proposed AD What Would the Proposed AD Require? the Affected Airplanes? What Has FAA Decided? This proposed AD would require you We estimate the following costs to The FAA has examined the findings to relocate the oil breather vent location accomplish the proposed modification: of DGAC; reviewed all available by incorporating Technical Instruction

Total cost per Labor cost Parts cost airplane Total cost on U.S. operators

4 workhours × $60 = $240 ...... Socata will provide parts free of charge $240 $240 × 4 = $960.

Regulatory Impact on a substantial number of small entities Authority: 49 U.S.C. 106(g), 40113, 44701. under the criteria of the Regulatory Would This Proposed AD Impact § 39.13 [Amended] Flexibility Act. A copy of the draft Various Entities? regulatory evaluation prepared for this 2. FAA amends § 39.13 by adding a The regulations proposed herein action has been placed in the Rules new airworthiness directive (AD) to would not have a substantial direct Docket. A copy of it may be obtained by read as follows: effect on the States, on the relationship contacting the Rules Docket at the Socata—Groupe Aerospatiale: Docket No. between the national government and location provided under the caption 2000–CE–70–AD the States, or on the distribution of ADDRESSES. (a) What airplanes are affected by this AD? power and responsibilities among the List of Subjects in 14 CFR Part 39 This AD affects Model TBM 700 airplanes, various levels of government. Therefore, serial numbers 157, 158, 163, 167, and 168, Air transportation, Aircraft, Aviation it is determined that this proposed rule that are: would not have federalism implications safety, Safety. (1) equipped with Option No. OPT 70–35– under Executive Order 13132. The Proposed Amendment 001 (gaseous oxygen system); and (2) certificated in any category. Would This Proposed AD Involve a Accordingly, under the authority (b) Who must comply with this AD? Significant Rule or Regulatory Action? delegated to me by the Administrator, Anyone who wishes to operate any of the For the reasons discussed above, I the Federal Aviation Administration above airplanes must comply with this AD. certify that this proposed action (1) is proposes to amend part 39 of the (c) What problem does this AD address? not a ‘‘significant regulatory action’’ Federal Aviation Regulations (14 CFR The actions specified by this AD are intended under Executive Order 12866; (2) is not part 39) as follows: to prevent oil from entering the gaseous oxygen system service compartment. Such oil a ‘‘significant rule’’ under DOT PART 39ÐAIRWORTHINESS contamination could result in a fire or Regulatory Policies and Procedures (44 DIRECTIVES explosion. FR 11034, February 26, 1979); and (3) if (d) What actions must I accomplish to promulgated, will not have a significant 1. The authority citation for part 39 address this problem? To address this economic impact, positive or negative, continues to read as follows: problem, you must accomplish the following:

Actions Compliance Procedures

(1) Relocate the oil breather vent location by Within the next 100 hours time-in-service In accordance with Socata Service Bulletin incorporating Technical Instruction No. (TIS) after the effective date of this AD. No. SB 70±085 71, dated October 2000. OPT70 K076±71 (Modification No. MOD70± 119±71 ``OIL PUMP BREATHER''). (2) Do not incorporate, on any affected air- As of the effective date of this AD ...... Not applicable. plane, Option No. OPT 70±35±001 (gaseous oxygen system) without simultaneously incor- porating the modification required by para- graph (d)(1) of this AD.

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(e) Can I comply with this AD in any other DEPARTMENT OF TRANSPORTATION (316) 941–7550, facsimile: (316) 942– way? You may use an alternative method of 9008. You may look at this information compliance or adjust the compliance time if: Federal Aviation Administration at the Rules Docket at the address above. (1) Your alternative method of compliance FOR FURTHER INFORMATION CONTACT: Mr. provides an equivalent level of safety; and 14 CFR Part 39 Clyde Erwin, Aerospace Engineer, FAA, (2) The Manager, Small Airplane [Docket No. 2000±CE±26±AD] Wichita Aircraft Certification Office, Directorate, approves your alternative. 1801 Airport Road, Room 100, Mid- Submit your request through an FAA RIN 2120±AA64 Continent Airport, Wichita, Kansas Principal Maintenance Inspector, who may add comments and then send it to the Airworthiness Directives; Cessna 67209, telephone: (316) 946–4149; Manager, Small Airplane Directorate. Aircraft Company Models 172N, 172P, facsimile: (316) 946–4407. Note 1: This AD applies to each airplane R172K, 172RG, F172N, F172P, FR172J, SUPPLEMENTARY INFORMATION: and FR172K Airplanes identified in paragraph (a) of this AD, Comments Invited regardless of whether it has been modified, AGENCY: Federal Aviation How Do I Comment on This Proposed altered, or repaired in the area subject to the Administration, DOT. requirements of this AD. For airplanes that AD? ACTION: Notice of proposed rulemaking have been modified, altered, or repaired so (NPRM). We invite your comments on the that the performance of the requirements of proposed rule. You may send whatever this AD is affected, the owner/operator must SUMMARY: This document proposes to written data, views, or arguments you request approval for an alternative method of supersede Airworthiness Directive (AD) choose. You need to include the rule’s compliance in accordance with paragraph (e) 80–04–08, which currently requires docket number and send your of this AD. The request should include an inspecting (one-time) the fuel line and comments in triplicate to the address assessment of the effect of the modification, map light switch in the left hand mentioned under the caption alteration, or repair on the unsafe condition forward door post for chafing or arcing ADDRESSES. We will consider all addressed by this AD; and, if you have not and repairing any damage found on comments received by the closing date eliminated the unsafe condition, specific certain Cessna Aircraft Company mentioned above, before acting on the actions you propose to address it. (Cessna) Model 172N, R172K, F172N, proposed rule. We may change the (f) Where can I get information about any and FR172K airplanes. AD 80–04–08 proposals contained in this notice already-approved alternative methods of also required providing at least a 0.50- because of the comments received. compliance? Contact Karl Schletzbaum, inch clearance between the map light Aerospace Engineer, FAA, Small Airplane switch and the fuel line; and installing Are There Any Specific Portions of the Directorate, 901 Locust, Room 301, Kansas a switch cover (insulator) over the map Proposed AD I Should Pay Attention to? City, Missouri 64106; telephone: (816) 329– light switch. The FAA has determined The FAA specifically invites 4146; facsimile: (816) 329–4090. that chafing between the map light comments on the overall regulatory, (g) What if I need to fly the airplane to switch and the fuel line could continue economic, environmental, and energy another location to comply with this AD? The to develop over the life of the affected aspects of the proposed rule that might FAA can issue a special flight permit under airplanes. The proposed AD would call for a need to change the proposed sections 21.197 and 21.199 of the Federal extend the inspections and installation rule. You may examine all comments Aviation Regulations (14 CFR 21.197 and of the switch cover requirement to we receive. We will file a report in the 21.199) to operate your airplane to a location certain 172N, 172P, R172K, 172RG, where you can accomplish the requirements Rules Docket that summarizes each FAA F172N, F172P, FR172J, and FR172K contact with the public that concerns of this AD. series airplanes. The proposed AD (h) How do I get copies of the documents the substantive parts of this proposal. would also require replacement of the referenced in this AD? You may obtain copies The FAA is reexamining the writing fuel line, if damaged; and would make of the documents referenced in this AD from style we currently use in regulatory the switch cover inspection and SOCATA Groupe AEROSPATIALE, Customer documents, in response to the replacement repetitive. The actions Support, Aerodrome Tarbes-Ossun-Lourdes, Presidential memorandum of June 1, BP 930—F65009 Tarbes Cedex, France; or the specified by the proposed AD are 1998. That memorandum requires Product Support Manager, SOCATA— intended to detect and correct any federal agencies to communicate more Groupe AEROSPATIALE, North Perry chafing between the map light switch clearly with the public. We are Airport, 7501 Pembroke Road, Pembroke and the bordering fuel line, which could interested in your comments on the ease Pines, Florida 33023. You may examine these result in a fuel leak and an in-flight fire. of understanding this document, and documents at FAA, Central Region, Office of DATES: The Federal Aviation any other suggestions you might have to the Regional Counsel, 901 Locust, Room 506, Administration (FAA) must receive any improve the clarity of FAA Kansas City, Missouri 64106. comments on this proposed rule by communications that affect you. You Note 2: The subject of this AD is addressed February 12, 2001. can get more information about the in French AD 2000–439(A), dated November ADDRESSES: Send three copies of Presidential memorandum and the plain 15, 2000. comments to FAA, Central Region, language initiative at http:// Office of the Regional Counsel, www.faa.gov/language/. Issued in Kansas City, Missouri, on Attention: Rules Docket No. 2000–CE– December 29, 2000. How Can I Be Sure FAA Receives My 26–AD, 901 Locust, Room 506, Kansas Comment? David R. Showers, City, Missouri 64106. You may read Acting Manager, Small Airplane Directorate, comments at this location between 8 If you want to know that we received Aircraft Certification Service. a.m. and 4 p.m., Monday through your comments, you must include a [FR Doc. 01–306 Filed 1–5–01; 8:45 am] Friday, except holidays. self-addressed, stamped postcard. On BILLING CODE 4910±13±P You may get the service information the postcard, write ‘‘Comments Docket referenced in the proposed AD from the No. 2000–CE–26–AD.’’ We will date Cessna Aircraft Company, P.O. Box stamp and mail the postcard back to 7706, Wichita, Kansas 67277; telephone: you.

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Discussion What Are the Provisions of This Service What About the Cost of Repetitive Bulletin? Inspections? Has FAA Taken Any Action to This Point? The service bulletin includes The FAA has no way of determining procedures for: the number of repetitive inspections The FAA issued AD 80–04–08, —Inspecting for the existence and each owner/operator would incur over Amendment 39–3696, February 16, damage to the cover (insulator) for the the life of each of the affected airplanes, 1980, in order to preclude the doorpost map light switch; or how many covers (insulators) or fuel possibility of a fuel leak or an in-flight —Installing the cover (insulator) if not lines would need to be replaced, so the fire due to contact between a map light installed or found damaged; and cost impact is based on the initial switch and an adjacent fuel line of —Replacing the fuel line, if found inspection. certain Cessna Models 172N, R172K, damaged. F172N, and FR172K airplanes. AD 80– What Is the Difference Between the Cost 04–08 requires that you do the following The FAA’s Determination and an Impact of this Proposed AD and the on the affected airplanes: Explanation of the Provisions of the Cost Impact of AD 80–04–08? Proposed AD —Visually inspect the fuel line and map The cost impact of the proposed AD light switch located in the left hand What Has FAA Decided? is more than currently required by AD forward door post for chafing or After examining the circumstances 80–04–08. The differences between the arcing and replace damaged parts as and reviewing all available information proposed AD and AD 80–04–08 are the necessary. If not already existing, related to the incidents described above, additional airplane models that would provide at least a 0.50-inch clearance we have determined that: be affected and the repetitive between the map light switch and the —The unsafe condition referenced in inspections each affected airplane fuel line in accordance with this document exists or could develop owner/operator would incur over the procedures in FAA Advisory Circular on other Cessna models 172N, 172P, life of the airplane. 43.13–1A. R172K, 172RG, F172N, F172P, Regulatory Impact —Install a cover (insulator), Cessna Part FR172J, and FR172K airplanes of the Number 0511080–1, over the map same type designs; Would This Proposed AD Impact light switch in accordance with —The actions specified in the Relations Between Federal and State Cessna Single Engine Service previously referenced service Governments? Information Letter SE80–3 and information should be accomplished The regulations proposed would not Supplement #1 thereto, both dated on the affected airplanes; and have a substantial direct effect on the January 21, 1980. —AD action should be taken in order to States, on the between the national AD 80–04–08 was the result of correct this unsafe condition. government and the States, or on the instances of chafing between the map What Would This Proposed AD Require? distribution of power and light switch and the adjacent fuel line responsibilities among the various on the affected airplanes. When the This proposed AD would supersede levels of government. We have chafing caused an electrical short, AD–80–04–08 with a new AD that determined that this proposed rule insulation melted from the map light would require: would not have federalism implications wire and a hole was burned in the fuel —Repetitively inspecting for the under Executive Order 13132. line. existence and damage to the cover (insulator) for the doorpost map light Would This Proposed AD Involve a What Has Happened To Necessitate switch; Significant Rule or Regulatory Action? Further AD Action? —Installing a cover (insulator) if For the reasons discussed above, I Since issuance of AD 80–04–08, FAA missing or damaged; and certify that this action (1) is not a has received several reports of incidents —Replacing the fuel line, if damaged. ‘‘significant regulatory action’’ under of electrical shorts on Cessna Model Cost Impact Executive Order 12866; (2) is not a 172N airplanes. These electrical shorts ‘‘significant rule’’ under DOT have resulted because the mounting How Many Airplanes Would This Regulatory Policies and Procedures (44 screws may be elongated or broken out Proposed AD Impact? FR 11034, February 26, 1979); and (3) if on the affected airplanes or doorpost We estimate that the proposed AD put into effect, will not have a cover shapes have changed over time. would affect at least 7,750 airplanes. significant economic impact, positive or Switch covers may: What Would Be the Cost Impact of the negative, on a substantial number of —Deteriorate over time; Proposed Initial Inspection for the small entities under the criteria of the —Receive damage from service Affected Airplanes on the U.S. Register? Regulatory Flexibility Act. We have activities, placed a copy of the draft regulatory We estimate that it would take —Be left off after service activities; evaluation prepared for this action in approximately 1 workhour per airplane —Not be mounted properly; or the Rules Docket. You may get a copy to do the proposed initial inspection, at of it by contacting the Rules Docket at —Not be used in after-market interior an average labor rate of $60 an hour. installations. the location provided under the caption Based on the figures presented above, ADDRESSES. AD 80–04–08 applied to only certain the total cost impact of the proposed serial numbers and did not cover all of initial inspection on U.S. operators is List of Subjects in 14 CFR Part 39 the models that have map light switches estimated to be $465,000, or $60 per Air transportation, Aircraft, Aviation in the doorpost. airplane. If any parts are required, the safety, Safety. estimated cost per airplane for the cover Is There Service Information That (insulator) is $6.00. The cost for a The Proposed Amendment Applies to This Subject? replacement fuel line varies from $26.00 Therefore, under the authority Cessna issued Service Bulletin to $129.00, plus labor, depending on the delegated to me by the Administrator, SEB00–1, dated January 17, 2000. airplane model. the Federal Aviation Administration

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(FAA) proposes to amend part 39 of the Model Serial No. (b) Who must comply with this AD? Federal Aviation Regulations (14 CFR Anyone who wishes to operate any of the part 39) as follows: 172N ...... 17267585 through 17270049; above airplanes on the U.S. Register must 17270051 through 17274009; comply with this AD. PART 39ÐAIRWORTHINESS 17261445, 17261578, and (c) What problem does this AD address? DIRECTIVES 17270050. The actions specified by this AD are intended 172P ...... 17274010 through 17276654. to continue to detect and correct any chafing 1. The authority citation for part 39 172RG ..... 172RG0001 through between the map light switch and the continues to read as follows: 172RG1191; and 691. bordering fuel line, which could result in a Authority: 49 U.S.C. 106(g), 40113, 44701. F172N ...... F17201640 through F17202039. fuel leak or an in-flight fire. F172P ...... F17202040 through F17202254. (d) What must I do to address this § 39.13 [Amended] FR172J .... FR17200531 through 17200590. problem? To address this problem, unless 2. FAA amends § 39.13 by removing FR172K ... FR17200591 through 17200675. already done, you must do the following Airworthiness Directive (AD) 80–04–08, R172K ..... R1722000 through R1723454; actions: Amendment 39–3696, and by adding a and 680. new AD to read as follows: Cessna Aircraft Company: Docket No. 2000–CE–26–AD; Supersedes AD 80–04–08, Amendment 39–3696. (a) What airplanes are affected by this AD? The following Cessna model airplanes, certificated in any category:

Actions Compliance time Procedures

(1) Inspect the doorpost map light switch insu- Initially inspect within the next 100 hours time- Do this action following the ACCOMPLISH- lator (part number 0511080±1) to verify it is in-service (TIS) after the effective date of MENT INSTRUCTIONS section of Cessna installed and (if installed) not damaged. this AD or within the next 12 calendar Service Bulletin SEB00±1, dated January months after the effective date of this AD, 17, 2000. whichever occurs first. Repetitively inspect thereafter at intervals not to exceed 12 cal- endar months. (2) If a switch cover (insulator) is not installed Before further flight after the inspection where Do this action following the ACCOMPLISH- or is damaged in any way, install a new insu- any damage is found or the cover is found MENT INSTRUCTIONS section of Cessna lator (part number 0511080±1). missing. Service Bulletin SEB00±1, dated January 17, 2000, and the Cessna Manufacturer's Maintenance Manual. (3) If the fuel line is damaged in any way, in- Before further flight after the inspection where Do this action following the ACCOMPLISH- stall a new fuel line. The replacement fuel any damage is found. MENT INSTRUCTIONS section of Cessna line part number varies with aircraft model. Service Bulletin SEB00±1, dated January 17, 2000, and the Cessna Manufacturer's Maintenance Manual.

Note 1: The compliance times specified in alteration, or repair on the unsafe condition (i) Does this AD action affect any existing Cessna Service Bulletin SEB00–1, dated addressed by this AD; and, if you have not AD actions? This amendment supersedes AD January 17, 2000, are different from those eliminated the unsafe condition, specific 80–04–08, Amendment 39–3696. required by this AD. The compliance times actions you propose to address it. Issued in Kansas City, Missouri, on in this AD take precedence over those in the (f) Where can I get information about any service bulletin. December 27, 2000. already-approved alternative methods of (e) Can I comply with this AD in any other compliance? You can contact Mr. Clyde David R. Showers, way? You may use an alternative method of Erwin, Aerospace Engineer, FAA, Wichita Acting Manager, Small Airplane Directorate, compliance or adjust the compliance time if: Aircraft Certification Office, 1801 Airport Aircraft Certification Service. (1) Your alternative method of compliance Road, Room 100, Mid-Continent Airport, provides an equivalent level of safety; and [FR Doc. 01–343 Filed 1–5–01; 8:45 am] Wichita, Kansas 67209, telephone: (316) 946– (2) The Manager, Wichita Aircraft BILLING CODE 4910±13±P - Certification Office (ACO), approves your 4149; facsimile: (316) 946–4407. alternative. Send your request through an (g) What if I need to fly the airplane to FAA Principal Maintenance Inspector, who another location to comply with this AD? The may add comments and then send it to the FAA can issue a special flight permit under Manager, Wichita ACO. sections 21.197 and 21.199 of the Federal Note 2: This AD applies to each airplane Aviation Regulations (14 CFR 21.197 and identified in paragraph (a) of this AD, 21.199) to operate your airplane to a location regardless of whether it has been modified, where you can perform the requirements of altered, or repaired in the area subject to the this AD. requirements of this AD. For airplanes that (h) How do I get copies of the documents have been modified, altered, or repaired so referenced in this AD? You may get copies of that the performance of the requirements of the documents referenced in this AD from this AD is affected, the owner/operator must the Cessna Aircraft Company, P. O. Box 7706, request approval for an alternative method of Wichita, Kansas 67277; or you may read this compliance in accordance with paragraph (e) document at FAA, Central Region, Office of of this AD. The request should include an the Regional Counsel, 901 Locust, Room 506, assessment of the effect of the modification, Kansas City, Missouri 64106.

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DEPARTMENT OF HEALTH AND CFR part 14). Section 14.75(a)(1) states rule change in addition to this rule will HUMAN SERVICES that unless it is otherwise exempt from not be considered a significant adverse disclosure, written information for comment, unless the comment states Food and Drug Administration consideration by the committee at the why this rule would be ineffective meeting should be available for public without the additional change. 21 CFR Part 14 disclosure at the same time it is made III. Environmental Impact [Docket No. 00N±1634] available to the committee. FDA finds that this provision for simultaneous The agency has determined under 21 Public Hearing Before a Public disclosure is not required by the Federal CFR 25.30(h) that this action is of a type Advisory Committee; Examination of Advisory Committee Act (5 U.S.C. app. that does not individually or Administrative Record and Other 2) and that compliance with this cumulatively have a significant effect on Advisory Committee Records provision would be detrimental to the the human environment. Therefore, advisory committee process. Therefore, neither an environmental assessment AGENCY: Food and Drug Administration, the agency is proposing to amend nor an environmental impact statement HHS. § 14.75(a)(1) to state that the written is required. ACTION: Proposed rule. information for consideration by an IV. Analysis of Impacts advisory committee at any meeting is SUMMARY: The Food and Drug available for public disclosure, FDA has examined the impacts of this Administration (FDA) is proposing to whenever practicable, before or at the proposed rule under Executive Order amend its administrative regulations time of the meeting. 12866, the Regulatory Flexibility Act (5 governing the public disclosure of U.S.C. 601–612), and the Unfunded written information for consideration by II. Additional Information Mandates Reform Act of 1995 (2 U.S.C. an advisory committee at an advisory This proposed rule is a companion to 1501 et seq.). Executive Order 12866 committee meeting. This action would the direct final rule published in the directs agencies to assess all costs and amend the regulations to state that final rules section of this issue of the benefits of available regulatory written information for consideration by Federal Register. This companion alternatives and, when regulation is an advisory committee at a committee proposed rule and the direct final rule necessary, to select regulatory meeting is available for public are identical. This companion proposed approaches that maximize net benefits disclosure, whenever practicable, before rule will provide the procedural (including potential economic, or at the time of the meeting. FDA is framework to finalize the rule in the environmental, public health and safety, proposing this action to reflect current event the direct final rule receives and other advantages; distributive FDA policy in conformance with significant adverse comments and is impacts; and equity). The agency applicable law. This proposed rule is a withdrawn. The comment period for believes that this proposed rule is companion document to the direct final this companion proposed rule runs consistent with the regulatory rule published elsewhere in this issue of concurrently with the comment period philosophy and principles identified in the Federal Register. of the direct final rule. Any comments Executive Order 12866 and in the other DATES: Submit written comments on the received under the companion proposed two statutes. This proposed rule is not proposed rule by March 26, 2001. If rule will be treated as comments a significant regulatory action as defined FDA receives no significant adverse regarding the direct final rule. by the Executive order. comment on the amendment of these If no significant adverse comment is Under the Regulatory Flexibility Act, regulations within the specified received in response to the direct final if a rule has a significant impact on a comment period, the agency intends to rule, no further action will be taken substantial number of small entities, an publish a document confirming the related to this proposed rule. Instead, agency must analyze regulatory options effective date of the final rule in the FDA will publish a confirmation that would minimize any significant Federal Register within 30 days after document within 30 days after the impact of the rule on small entities. The the comment period in the direct final comment period ends, and FDA intends agency has considered the effect that rule ends. The direct final rule will be the direct final rule to become effective this proposed rule will have on small effective 30 days after publication of the 30 days after publication of the entities. Because the proposed rule will confirmation notice in the Federal confirmation document. If FDA receives amend only internal agency procedures, Register. significant adverse comments, the the agency certifies that the rule will not agency will withdraw the direct final have a significant economic impact on ADDRESSES: Submit written comments rule. FDA will proceed to respond to all a substantial number of small entities. to the Dockets Management Branch of the comments received regarding the Therefore, under the Regulatory (HFA–305), Food and Drug rule and, if appropriate, the rule will be Flexibility Act, no further analysis is Administration, 5630 Fishers Lane, rm. finalized under this companion required. 1061, Rockville, MD 20852. proposed rule using usual notice-and- Section 202(a) of the Unfunded FOR FURTHER INFORMATION CONTACT: comment procedures. Mandates Reform Act of 1995 (Public Andrea C. Masciale, Center for Drug For additional information, see the Law 104–4) requires that agencies Evaluation and Research (HFD–7), Food corresponding direct final rule prepare a written statement of and Drug Administration, 5600 Fishers published in the final rules section of anticipated costs and benefits before Lane, Rockville, MD 20857, 301–594– this issue of the Federal Register. FDA proposing any rule that may result in an 2041. will not provide additional opportunity expenditure by State, local, and tribal SUPPLEMENTARY INFORMATION: for comment. A significant adverse governments, in the aggregate, or by the comment is one that explains why the private sector, of $100 million in any I. Discussion rule would be inappropriate, including one year (adjusted annually for As described more fully in the related challenges to the rule’s underlying inflation). FDA is not required to direct final rule, FDA’s procedures for premise or approach, or would be prepare a statement of the costs and the administration of advisory ineffective or unacceptable without a benefits of this proposed rule because committees are set forth in part 14 (21 change. A comment recommending a the proposed rule is not expected to

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1277 result in any 1-year expenditure that PART 14ÐPUBLIC HEARING BEFORE Virginia 20170–4817; Attention: Rules would exceed $100 million adjusted for A PUBLIC ADVISORY COMMITTEE Processing Team (RPT). You may also inflation. The current inflation-adjusted send your comments by e-mail or e-mail 1. The authority citation for 21 CFR statutory threshold is $110 million. attachment. The RPT’s e-mail address is: part 14 is revised to read as follows: [email protected]. V. Federalism Authority: 5 U.S.C. App. 2; 15 U.S.C. FOR FURTHER INFORMATION CONTACT: John 1451–1461; 21 U.S.C. 41–50, 141–149, 321– FDA has analyzed this proposed rule Mirabella, Engineering and Operations 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 Division, (703) 787–1607. in accordance with the principles set U.S.C. 201, 262, 263b, 264. forth in Executive Order 13132. FDA SUPPLEMENTARY INFORMATION: OCS 2. Section 14.75 is amended by has determined that the proposed rule lessees must comply with regulations revising paragraph (a)(1) to read as does not contain policies that have governing operations, payments of rents follows: substantial direct effects on the States, and royalties, and end-of-lease on the relationship between the § 14.75 Examination of administrative obligations. To ensure that the lessee National Government and the States, or record and other advisory committee will be financially able to meet all on the distribution of power and records. requirements, including end-of-lease responsibilities among the various (a) * * * requirements, MMS requires the lessee levels of government. Accordingly, the (1) The written information for to post a bond. This rule would amend agency has concluded that the proposed consideration by the committee at any the provisions of 30 CFR 256.58 rule does not contain policies that have meeting: Whenever practicable, before concerning the cancellation of a bond. When the lessee has met all end-of- federalism implications as defined in or at the time of the meeting. lease obligations, MMS terminates the the order and, consequently, a * * * * * liability period of the bond. This federalism summary impact statement is Dated: December 29, 2000. amendment addresses situations when not required. Margaret M. Dotzel, the lessee appears to meet all end-of- VI. Paperwork Reduction Act of 1995 Associate Commissioner for Policy. lease requirements and we later [FR Doc. 01–390 Filed 1–5–01; 8:45 am] discover that obligations still exist. For FDA tentatively concludes that this BILLING CODE 4160±01±F example, an audit may reveal that the proposed rule contains no collections of lessee owes us additional royalty. As information. Therefore, clearance by the another example, a plugged well may Office of Management and Budget under DEPARTMENT OF THE INTERIOR start to leak. In either case, the lessee the Paperwork Reduction Act of 1995 is must correct the problem. not required. Minerals Management Service In the case of royalties, the liability would be discovered when the audit is VII. Request for Comments 30 CFR Part 256 conducted after the end of the surety’s Interested persons may submit to the RIN 1010±AC±68 liability period. By statute, any demand Dockets Management Branch (address for performance of a monetary above) written comments regarding this Revision of Requirements Governing obligation must be made within 7 years. proposal by March 26, 2001. This Surety Bonds for Outer Continental In the example of the leaking well, there is not a stipulated time period. Problems comment period runs concurrently with Shelf Leases. associated with plugged wells in the the comment period for the direct final AGENCY: Minerals Management Service OCS are rare; when they do occur, they rule; any comments received will be (MMS), Interior. are generally discovered within a few considered as comments regarding the ACTION: Proposed rule. years of the plugging activity. direct final rule. Two copies of any Should the lessee fail to perform a comments are to be submitted, except SUMMARY: The MMS is proposing to lease obligation, MMS turns to the that individuals may submit one copy. modify requirements governing surety surety for performance. This rule Comments are to be identified with the bonds for activities on the Outer addresses how long a bond will be held docket number found in brackets in the Continental Shelf (OCS). These changes before cancellation to assure availability heading of this document. Received will codify the terms and conditions to cover a problem that is discovered comments may be seen in the Dockets under which a surety will be relieved of after the liability period on a bond has Management Branch between 9 a.m. and responsibility when MMS terminates ended. The current regulation does not 4 p.m., Monday through Friday. In the the period of liability of a bond. set a limit on the period that MMS may event the direct final rule is withdrawn, Codifying these terms and conditions is continue to hold the bond company all comments received will be necessary to clarify the responsibilities responsible for a problem that occurs considered comments on this proposed of the lessee and the surety after the during the liability period. rule. lease expires. OCS wells rarely start to leak DATES: We will consider all comments following plugging operations. List of Subjects in 21 CFR Part 14 we receive by March 9, 2001. We will Therefore, we have difficulty predicting begin reviewing comments then and Administrative practice and when a leak might occur. This notice may not fully consider comments we procedure, Advisory committees, Color proposes a period of 7 years (plus such receive after March 9, 2001. additives, Drugs, Radiation protection. additional time taken for appeals or ADDRESSES: If you wish to comment, litigation) during which MMS may hold Therefore, under the Federal Food, you may submit your comments by any the bond for claims based upon Drug, and Cosmetic Act and under one of several methods. You may mail obligations that accrued during the authority delegated to the Commissioner or hand-carry comments (three copies) period of liability. During this period, of Food and Drugs, it is proposed that to the Department of the Interior; we will retain security or collateral 21 CFR part 14 be amended to read as Minerals Management Service; Mail pledged to MMS in lieu of a surety. The follows: Stop 4024; 381 Elden Street; Herndon, bond will be canceled after 7 years and

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 1278 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules any other forms of security will be Office of Management and Budget As discussed in the Regulatory returned. We believe that a 7-year (OMB) under Executive Order 12866. Planning and Review section, we expect period will provide adequate protection (1) This rule will not have an effect of this rule to have only minimal effects to the Government and will provide a $100 million or more on the economy. and, accordingly, we do not expect this measure of certainty to bond companies. It will not adversely affect in a material rule to have a significant effect on any The 7-year provision applies to all way the economy, productivity, company, large or small. Under current base bonds, unless we find that less competition, jobs, the environment, regulations, when a lessee meets all of security needs to be retained. The rule public health or safety, or State, local, the lease requirements, the period of would release supplemental bond or tribal governments or communities. liability ends. If MMS later discovers a providers, upon completion of the This rule, in many important ways, problem with the way the work was bonded work, from liability for follows aspects of current policy performed, we will hold the lessee obligations that accrued before included in the bond form. The rule will responsible. If the lessee is not able to acceptance of the reclamation work, also extend that policy to other forms of meet the obligation, we hold the bond unless we find that potential liability is security such as escrow accounts which company responsible. This regulation greater than the amount of the base are not currently used for base bonds. establishes a time period during which bond. We will normally release the Since this rule normally will not apply MMS will hold the bond before supplemental bond upon completion of to supplemental bonds without specific cancellation. The codification of a the bonded work because in most cases, action by the Regional Supervisor, the policy on bond cancellation is new. The we anticipate that the general bond will impact of this change is minimal. other change for current practice is that be sufficient to cover our estimate of (2) This rule will not create a serious MMS retains pledged securities for the potential residual liabilities. inconsistency or otherwise interfere same length of time we have been The proposal would not change the with an action taken or planned by waiting before canceling surety bonds. provision in 30 CFR 256.58(c) that another agency. Other agencies are not While this new provision is needed to allows MMS to reinstate your bond. affected by the bonds and other forms of ensure consistency of agency practice, That provision allows us to reinstate surety that protect the government’s the provision will not have a significant your bond as if no cancellation or interests. effect since companies currently do not release had occurred if: (3) This rule does not alter the use instruments other than surety bonds (1) You make a payment under the budgetary effects of entitlements, grants, to meet the basic bond requirement. lease and the payment is rescinded or user fees, or loan programs or the rights This rule will also affect companies must be repaid by the recipient because or obligations of their recipients. This that sell surety bonds or provide other you are insolvent, bankrupt, subject to rule will have no effect on the rights of types of security to OCS lessees. For reorganization, or placed in the recipients of entitlements, grants, those companies, this rule will provide receivership; or user fees, or loan programs. certainty with regard to residual (2) You represent to us that you have (4) This rule does not raise novel legal liabilities. Since the provisions in this discharged your obligations under the or policy issues. The rule more clearly rule are generally the same as current lease and your representation was conforms MMS practice to that of the practice, any effects on bonding materially false. private sector and provides certainty companies will be minor. Those minor with respect to the cancellation of effects will be reflected in costs charged Procedural Matters surety bonds and other lease security. to oil and gas lessees and will ultimately be borne by oil and gas lessees. These Public Comment Procedure: Our Regulatory Flexibility (RF) Act practice is to make comments, including effects are included in the estimates names and home addresses of The Department certifies that this rule addressing the oil and gas lessees. Your respondents, available for public review will not have a significant economic comments are important. The Small during regular business hours. effect on a substantial number of small Business and Agriculture Regulatory Individual respondents may request that entities under the RF Act (5 U.S.C. 601 Enforcement Ombudsman and 10 we withhold their home address from et seq.). Regional Fairness Boards were the rulemaking record, which we will This rule will affect lessees and established to receive comments from honor to the extent allowable by law. operators of leases on the OCS. This small business about Federal agency There may be circumstances in which includes about 130 different companies. enforcement actions. The Ombudsman we would withhold from the These companies are generally will annually evaluate the enforcement rulemaking record a respondent’s classified under the North American activities and rate each agency’s identity, to the extent allowable by law. Industry Classification System (NAICS) responsiveness to small business. If you If you wish us to withhold your name code 211111, Crude Petroleum and wish to comment on the enforcement and/or address, you must state this Natural Gas Extraction, which includes actions of MMS, call toll-free (888) 734– prominently at the beginning of your companies that extract crude petroleum 3247. and natural gas. For this NAICS code, a comment. However, we will not Paperwork Reduction Act (PRA) of small company is one with fewer than consider anonymous comments. We 1995 will make all submissions from 500 employees. Based on these criteria, organizations or businesses, and from we estimate that about 54 percent of the The information collection aspects of individuals identifying themselves as companies are considered small. This this rule remain unchanged. The representatives or officials of rule, therefore, affects a substantial proposed revisions contain no organizations or businesses, available number of small entities. additional information collection or for public inspection in their entirety. The companies that are considered recordkeeping requirements, and a small have an average of about 15 submission to OMB under the PRA is Regulatory Planning and Review offshore facilities. We estimate that not required. The OMB has approved (Executive Order 12866) these small companies have annual the information collection requirements This document is not a significant sales between $1 million and $380 in the current regulations and assigned rule and is not subject to review by the million. OMB control number 1010–0006, with a

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1279 current expiration date of March 31, (c) Does not have significant adverse § 256.58 Termination of the period of 2000. effects on competition, employment, liability and cancellation of a bond. investment, productivity, innovation, or This section defines the terms and Federalism (Executive Order 13132) the ability of U.S.-based enterprises to conditions under which MMS will With respect to Executive Order compete with foreign-based enterprises. terminate the period of liability of a 13132, the rule does not have We do not expect this rule to have a bond or cancel a bond. Terminating the Federalism implications. This rule does significant effect because, as discussed period of liability of a bond ends the not substantially and directly affect the earlier, this rule would, generally, period during which obligations relationship between the Federal and codify policies already in use. The continue to accrue but does not relieve State governments. The bonding substantive change for securities other the surety of the responsibility for program is between the Federal than surety bonds will not have a obligations that accrued during the Government and the lessees of Federal significant effect because the rule period of liability. Canceling a bond leases. The bond does not affect applies to the general bond requirement, relieves the surety of all liability. obligations between the lessee and any and surety bonds are used by almost all (a) When the surety under your bond State or local government. This rule MMS lessees to satisfy the base bond requests termination: does not impose costs on States or requirement. (1) The Regional Director will localities. State or local governments do terminate the period of liability under not provide bonds and do not need to Unfunded Mandate Reform Act your bond within 90 days after MMS comply with bonding requirements. (UMRA) of 1995 (Executive Order receives the request; and 12866) Takings (Executive Order 12630) (2) If you intend to continue This rule does not impose an operations, or have not completed With respect to Executive Order abandonment, you must provide a 12630, the proposed rule does not have unfunded mandate on State, local, or tribal governments or the private sector replacement bond of an equivalent significant Takings implications. A amount. Takings Implication Assessment is not of more than $100 million per year. The rule does not have a significant or (b) If, following the termination of the required. The proposed rulemaking is period of liability of a bond, you not a governmental action capable of unique effect on State, local, or tribal governments or the private sector. A provide a replacement bond according interfering with constitutionally to this paragraph, the Regional Director protected property rights. statement containing the information required by the UMRA (2 U.S.C. 1531 et will cancel your terminated bond and Civil Justice Reform (Executive Order seq.) is not required. This is because the the surety that provided your 12988) rule does not affect State, local, or tribal terminated bond will not retain any liability. The Regional Director will With respect to Executive Order governments, and the effect on the cancel your bond if: 12988, the Office of the Solicitor has private sector is small. (1) The surety issuing the new bond determined that this rule does not List of Subjects in 30 CFR Part 256 agrees to assume all outstanding unduly burden the judicial system and liabilities that accrued during the period meets the requirements of sections 3(a) Administrative practice and of liability that was terminated; and and 3(b)(2) of the Executive Order. procedure, Continental shelf, Government contracts, Oil and gas (2) The new bond is equal to or National Environmental Policy Act exploration, Public lands—mineral greater than the bond that is to be (NEPA) of 1969 resources, Reporting and recordkeeping canceled. This rule does not constitute a major requirements, Surety bonds. (c) If the period of liability is terminated for a bond but the bond is Federal action significantly affecting the Dated: December 20, 2000. quality of the human environment. A not replaced by a bond of an equivalent Sylvia V. Baca, detailed statement under the NEPA is amount, the surety that provided your not required. Assistant Secretary, Land and Minerals terminated bond will continue to be Management. responsible for accrued obligations until Small Business Regulatory Enforcement For the reasons stated in the the obligations are satisfied and for Fairness Act (SBREFA) preamble, the Minerals Management additional periods of time according to This rule is not a major rule under (5 Service (MMS) proposes to amend 30 paragraph (d) of this section. U.S.C. 804(2)) the SBREFA. This rule: CFR part 256 as follows: (d) At the time your lease expires or (a) Does not have an annual effect on 1. The authority citation for part 256 is terminated, the surety or sureties that the economy of $100 million or more. continues to read as follows: issued the bond(s) covering accrued (b) Will not cause a major increase in obligations will continue to be costs or prices for consumers, Authority: 43 U.S.C. 1331 et seq.; 42 U.S.C. responsible, and the Regional Director individual industries, Federal, State, or 6213. will retain other forms of security for local government agencies, or 2. Section 256.58 is revised to read as the period of time and under the terms geographic regions. follows: shown in the following table:

For the type of bond below The period of liability will end Your bond will be cancelled

(1) Base Bonds submitted under When the Regional Director deter- Seven years after the completion of all bonded obligations, or at the § 256.52(a), § 256.53(a), or (b). mines that you have met all of conclusion of any appeals or litigation related to your bonded obli- your obligations under the lease. gations, whichever is later. The Regional Director may: (i) determine that you need less than the full amount of the base bond to meet any possible future problems; and (ii) reduce the amount of your bond or return a portion of your secu- rity.

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For the type of bond below The period of liability will end Your bond will be cancelled

(2) Supplemental bonds submitted When the Regional Director deter- When you meet your bonded obligations, unless the Regional Direc- under § 256.53(d). mines that you have met all tor: your obligations covered by the supplemental bond. (i) determines that the future potential liability resulting from any un- detected problems is greater than the amount of the base bond; and (ii) notifies the provider of the bond that the Regional Director will wait up to 7 years before canceling all or a part of the bond (or longer period as necessary to complete any appeals or judicial liti- gation related to your bonded obligations).

(e) For all bonds, the Regional FOR FURTHER INFORMATION CONTACT: Ms. § 326.17 Exemptions. Director may reinstate your bond as if Barbara Freimann at (703) 808–5029. * * * * * no cancellation or release had occurred SUPPLEMENTARY INFORMATION: (e) QNRO–23 if: Executive Order 12866 (1) System name: Counterintelligence (1) A person makes a payment under Issue Files. the lease and the payment is rescinded It has been determined that this (2) Exemptions: (i) Investigatory or must be repaid by the recipient Privacy Act rule for the Department of material compiled for law enforcement because the person making the payment Defense does not constitute ‘‘significant purposes may be exempt pursuant to 5 is insolvent, bankrupt, subject to regulatory action’’. Analysis of the rule U.S.C. 552a(k)(2). However, if an reorganization, or placed in indicates that it does not have an annual individual is denied any right, privilege, receivership; or effect on the economy of $100 million or benefit for which he would otherwise (2) The responsible party represents to or more; does not create a serious be entitled by Federal law or for which MMS that it has discharged its inconsistency or otherwise interfere he would otherwise be eligible, as a obligations under the lease, and the with an action taken or planned by result of the maintenance of such representation was materially false another agency; does not materially alter information, the individual will be when the bond was canceled or the budgetary impact of entitlements, provided access to such information released. grants, user fees, or loan programs or the rights and obligations of recipients except to the extent that disclosure [FR Doc. 01–120 Filed 1–5–01; 8:45 am] thereof; does not raise novel legal or would reveal the identity of a BILLING CODE 4310±MR±P policy issues arising out of legal confidential source. mandates, the President’s priorities, or (ii) Investigatory material compiled the principles set forth in Executive solely for the purpose of determining Order 12866. suitability, eligibility, or qualifications DEPARTMENT OF DEFENSE for federal civilian employment, Regulatory Flexibility Act military service, federal contracts, or Office of the Secretary It has been determined that this access to classified information may be exempt pursuant to 5 U.S.C. 552a(k)(5), 32 CFR Part 326 Privacy Act rule for the Department of Defense does not have significant but only to the extent that such material National Reconnaissance Office economic impact on a substantial would reveal the identity of a Privacy Act Program number of small entities because it is confidential source. concerned only with the administration (iii) Therefore, portions of this system AGENCY: National Reconnaissance of Privacy Act systems of records within of records may be exempt pursuant to 5 Office, DOD. the Department of Defense. U.S.C. 552a(k)(2) and/or (k)(5) from the following subsections of 5 U.S.C. ACTION: Proposed rule. Paperwork Reduction Act 552a(c)(3), (d), (e)(1), (e)(4)(G), (H) and SUMMARY: The National Reconnaissance It has been determined that this (I), and (f). Office (NRO) is proposing to exempt one Privacy Act rule for the Department of (3) Authority: 5 U.S.C. 552a(k)(2) and Privacy Act systems of records. The Defense imposes no information (k)(5). system of records is QNRO–23, requirements beyond the Department of (4) Reasons: (i) From subsection (c)(3) Counterintelligence Issue Files. The Defense and that the information because to grant access to the exemptions are intended to increase the collected within the Department of accounting for each disclosure as value of the systems of records for law Defense is necessary and consistent required by the Privacy Act, including enforcement purposes, to comply with with 5 U.S.C. 552a, known as the the date, nature, and purpose of each prohibitions against the disclosure of Privacy Act, and 44 U.S.C. Chapter 35. disclosure and the identity of the certain kinds of information, and to List of Subjects in 32 CFR Part 326 recipient, could alert the subject to the protect the privacy of individuals Privacy. existence of the investigation or identified in the systems of records. prosecutable interest by NRO or other 1. The authority citation for 32 CFR DATES: Comments must be received by agencies. This could seriously part 326 continues to read as follows: March 9, 2001 to be considered by the compromise case preparation by agency. Authority: Pub. L. 93–579, 88 Stat 1896 (5 prematurely revealing its existence and ADDRESSES: National Reconnaissance U.S.C. 552a). nature; compromise or interfere with Office, Information Access and Release 2. Section 326.17 is proposed to be witnesses or make witnesses reluctant to Center, 14675 Lee Road, Chantilly, VA amended by adding paragraphs (e) as cooperate; and lead to suppression, 20151–1715. follows: alteration, or destruction of evidence.

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(ii) From subsections (d)(1) through effective law enforcement. Whenever FOR FURTHER INFORMATION CONTACT: Mr. (d)(4), and (f) because providing access possible, information of the above John McDonald, Project Officer, First to records of a civil or administrative nature will be deleted from the Coast Guard District, (617) 223–8364. investigation and the right to contest the requested documents and the balance SUPPLEMENTARY INFORMATION: contents of those records and force made available. The controlling changes to be made to the information principle behind this limited access is Request for Comments contained therein would seriously to allow disclosures except those We encourage you to participate in interfere with and thwart the orderly indicated above. The decisions to this rulemaking by submitting and unbiased conduct of the release information from these systems comments or related material. If you do investigation and impede case will be made on a case-by-case basis. so, please include your name and preparation. Providing access rights Dated: December 21, 2000. address, identify the docket number for normally afforded under the Privacy Act Patricia L. Toppings, this rulemaking (CGD01–00–228), would provide the subject with valuable indicate the specific section of this information that would allow Alternate OSD Federal Register Liaison Officer, Department of Defense. document to which each comment interference with or compromise of applies, and give the reason for each witnesses or render witnesses reluctant [FR Doc. 01–416 Filed 1–5–01; 8:45 am] BILLING CODE 5001±10±P comment. Please submit all comments to cooperate; lead to suppression, and related material in an unbound alteration, or destruction of evidence; format, no larger than 81⁄2 by 11 inches, enable individuals to conceal their suitable for copying. If you would like wrongdoing or mislead the course of the DEPARTMENT OF TRANSPORTATION to know if they reached us, please investigation; and result in the secreting enclose a stamped, self-addressed of or other disposition of assets that Coast Guard postcard or envelope. We will consider would make them difficult or all comments and material received impossible to reach in order to satisfy 33 CFR Part 117 during the comment period. We may any Government claim growing out of change this proposed rule in view of [CGD01±00±228] the investigation or proceeding. them. (iii) From subsection (e)(1) because it is not always possible to detect the RIN 2115±AE47 Public Meeting relevance or necessity of each piece of We do not now plan to hold a public information in the early stages of an Drawbridge Operation Regulations; meeting. But you may submit a request investigation. In some cases, it is only Mianus River, CT for a meeting by writing to the First after the information is evaluated in AGENCY: Coast Guard, DOT. Coast Guard District, Bridge Branch, at light of other evidence that its relevance ACTION: Notice of proposed rulemaking. the address under ADDRESSES and necessity will be clear. explaining why one would be beneficial. If we (iv) From subsections (e)(4)(G) and (H) SUMMARY: The Coast Guard proposes to because this system of records is determine that one would aid this change the drawbridge operating rulemaking, we will hold one at a time compiled for law enforcement purposes regulations for the Metro-North Bridge, and is exempt from the access and place announced by a later notice at mile 1.0, across the Mianus River at in the Federal Register. provisions of subsections (d) and (f). Greenwich, Connecticut. This proposed (v) From subsection (e)(4)(I) because rule would require the bridge to open on Background and Purpose to the extent that this provision is signal from 9 p.m. to 5 a.m., after an construed to require more detailed The Metro-North Bridge, mile 1.0, advance notice is given. The bridge across the Mianus River has a vertical disclosure than the broad, generic presently does not open for vessel traffic information currently published in the clearance of 20 feet at mean high water between 9 p.m. and 5 a.m., daily. This and 27 feet at mean low water in the system notice, an exemption from this action is expected to better meet the provision is necessary to protect the closed position. reasonable needs of navigation. confidentiality of sources of information The existing operating regulations in and to protect privacy and physical DATES: Comments must reach the Coast 33 CFR 117.209 require the bridge to safety of witnesses and informants. NRO Guard on or before March 9, 2001. open on signal from 5 a.m. to 9 p.m., will, nevertheless, continue to publish ADDRESSES: You may mail comments to immediately for commercial vessels and such a notice in broad generic terms as Commander (obr), First Coast Guard as soon as practicable, but no later than is its current practice. District, Bridge Branch, at 408 Atlantic 20 minutes after the signal to open is (vi) Consistent with the legislative Avenue, Boston, MA. 02110–3350, or given, for the passage of all other vessel purpose of the Privacy Act of 1974, the deliver them to the same address traffic. When a train scheduled to cross NRO will grant access to nonexempt between 7 a.m. and 3 p.m., Monday the bridge without stopping has passed material in the records being through Friday, except Federal holidays. the Greenwich or Riverside stations and maintained. Disclosure will be governed The telephone number is (617) 223– is in motion toward the bridge, the draw by NRO’s Privacy Regulation, but will 8364. The First Coast Guard District, shall open as soon as the train has be limited to the extent that the identity Bridge Branch, maintains the public crossed the bridge. From 9 p.m. to 5 of confidential sources will not be docket for this rulemaking. Comments a.m., the draw need not be opened for compromised; subjects of an and material received from the public, the passage of vessels. investigation of an actual or potential as well as documents indicated in this The Coast Guard received a request criminal violation will not be alerted to preamble as being available in the from a commercial vessel operator the investigation; the physical safety of docket, will become part of this docket requesting a change to the operating witnesses, informants and law and will be available for inspection or regulations for the Metro-North Bridge. enforcement personnel will not be copying at the First Coast Guard The commercial operator requested that endangered, the privacy of third parties District, Bridge Branch, 7 a.m. to 3 p.m., the bridge open for vessel traffic during will not be violated; and that the Monday through Friday, except, Federal the 9 p.m. to 5 a.m. time period when disclosure would not otherwise impede holidays. the bridge is normally closed.

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The Coast Guard published a The Coast Guard believes this rule Paperwork Reduction Act of 1995 (44 temporary 90 day deviation from the will better meet the reasonable needs of U.S.C. 3501–3520). drawbridge operation regulations on navigation based upon comments Federalism April 27, 2000, to provide immediate received and successful results of the relief to navigation and to obtain 90-day test deviation. We have analyzed this proposed rule comments from the public concerning under Executive Order 13132 and have this rule. The deviation was in effect Regulatory Evaluation determined that this rule does not have from June 7, 2000, through September 4, This proposed rule is not a implications for federalism under that 2000, during which time, the Metro- ‘‘significant regulatory action’’ under Order. North Bridge was required to open on section 3(f) of Executive Order 12866 Unfunded Mandates Reform Act signal, from 9 p.m. to 5 a.m., after a and does not require an assessment of four-hour advance notice was given. No potential costs and benefits under The Unfunded Mandates Reform Act comments were received during the 6(a)(3) of that Order. The Office of of 1995 (2 U.S.C. 1531–1538) governs the issuance of Federal regulations that comment period which ended on Management and Budget has not require unfunded mandates. An September 30, 2000. A late comment reviewed it under that Order. It is not unfunded mandate is a regulation that letter was received from the commercial significant under the regulatory policies requires a State, local, or tribal mariner that requested the rule change. and procedures of the Department of government or the private sector to The mariner indicated that his vessel Transportation (DOT) (44 FR 11040, incur direct costs without the Federal utilized the additional opening time Feb. 26, 1979). provided by the test deviation and made Government’s having first provided the We expect the economic impact of funds to pay those costs. This proposed about 40 transits after 9 p.m. during the this proposed rule to be so minimal that test period. The commercial mariner rule would not impose an unfunded a full Regulatory Evaluation, under mandate. will be adding an additional vessel to paragraph 10e of the regulatory policies his fleet next season which will also and procedures of DOT, is unnecessary. Taking of Private Property require bridge openings after 9 p.m., This conclusion is based on the fact that This proposed rule would not effect a daily. bridges are required to meet the The Coast Guard is responsible for the taking of private property or otherwise reasonable needs of navigation at all have taking implications under enforcement of the bridge laws and times and that this bridge will only need regulations which are intended to Executive Order 12630, Governmental to be crewed between the hours of 9 Actions and Interference with prevent any interference with the p.m. to 5 a.m., when there is a definite navigable waters of the United States Constitutionally Protected Property navigational need. Rights. whether by bridges, dams, dikes or other obstructions to navigation except by Small Entities Civil Justice Reform express permission of the United States. Under the Regulatory Flexibility Act This proposed rule meets applicable The decision as to whether a bridge (5 U.S.C. 601–612), we considered standards in sections 3(a) and 3(b)(2) of permit or a drawbridge operation whether this proposed rule would have Executive Order 12988, Civil Justice regulation will be issued or promulgated a significant economic impact on a Reform, to minimize litigation, is based upon the effect of the proposed substantial number of small entities. eliminate ambiguity, and reduce action on navigation to assure that the The term ‘‘small entities’’ comprises burden. action provides for the reasonable needs small businesses, not-for-profit of navigation after full consideration of Protection of Children organizations that are independently the effect of the proposed action on the owned and operated and are not We have analyzed this proposed rule human environment, including the dominant in their fields, and under Executive Order 13045, effect on rail and vehicular traffic. governmental jurisdictions with Protection of Children from The Coast Guard believes that in the Environmental Health Risks and Safety case of the Metro-North Bridge, that populations of less than 50,000. The Coast Guard certifies under Risks. This rule is not an economically changing the bridge operating significant rule and does not concern an section 5 U.S.C. 605(b), that this regulations to require openings between environmental risk to health or risk to proposed rule would not have a 9 p.m. and 5 a.m. is reasonable because safety that may disproportionately affect significant economic impact on a it provides for the needs of navigation, children. as demonstrated by the demand for substantial number of small entities. bridge openings during the test This conclusion is based upon the fact Environment deviation, and has no effect on rail that the bridge will now be available to We considered the environmental traffic over the bridge. open for all vessel traffic, both small impact of this proposed rule and entities and commercial operators, at all concluded that, under figure 2–1, Discussion of Proposal times. paragraph (32)(e), of Commandant The Coast Guard proposes to revise If you think that your business, Instruction M16475.1C, this proposed the operating regulations in 33 CFR organization, or governmental rule is categorically excluded from 117.209(b) for the Metro-North Bridge jurisdiction qualifies as a small entity further environmental documentation by requiring the bridge to open during and that this rule would have a because promulgation of drawbridge the 9 p.m. to 5 a.m. time period. significant economic impact on it, regulations have been found not to have The proposed rule would require the please submit a comment (see a significant effect on the environment. draw to open on signal from April 1 ADDRESSES) explaining why you think it A ‘‘Categorical Exclusion through October 31, from 9 p.m. to 5 qualifies and how and to what degree Determination’’ is available in the a.m., after at least a four-hour advance this rule would economically affect it. docket where indicated under notice is given and from November 1 Collection of Information ADDRESSES. through March 30, from 9 p.m. to 5 a.m., after at least a twenty-four hours This proposed rule would call for no List of Subjects in 33 CFR Part 117 advance notice is given. new collection of information under the Bridges.

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Regulations DATES: Comments and related material comments, please enclose a stamped, For the reasons set out in the must reach the Docket Management self-addressed postcard or envelope. preamble, the Coast Guard proposes to Facility on or before March 9, 2001. The Coast Guard will consider all amend 33 CFR part 117 as follows: ADDRESSES: To make sure your comments and materials received comments and related material are not during the comment period. PART 117ÐDRAWBRIDGE entered more than once in the docket, Background and Purpose OPERATION REGULATIONS please submit them by only one of the On February 8, 2000, a notice of following means: 1. The authority citation for part 117 (1) By mail to the Docket Management proposed rulemaking was published in continues to read as follows: Facility [USCG–2001–8602], U.S. the Federal Register (65 FR 6111). In Authority: 33 U.S.C. 499; 49 CFR 1.46; 33 Department of Transportation, room PL– this rulemaking the Coast Guard CFR 1.05–1(g); section 117.255 also issued 401, 400 Seventh Street SW., proposed to amend its electrical under the authority of Pub. Law 102–587, Washington, DC 20590–0001. engineering regulations for merchant 106 Stat. 5039. (2) By delivery to room PL–401 on the vessels by adding alternative cable 2. Section 117.209(b) is revised to Plaza level of the Nassif Building, 400 standards that were equivalent to the read as follows: Seventh Street SW., Washington, DC, existing standards. IEEE Std 45, 1998 between 9 a.m. and 5 p.m., Monday edition was not included in that § 117.209 Mianus River. through Friday, except Federal holidays. rulemaking as an alternative standard. * * * * * The telephone number is 202–366– In the comment process of that notice (b) The draw shall open on signal 9329. we received numerous requests from from April 1 through October 31, from (3) By fax to the Docket Management industry to recognize marine shipboard 9 p.m. to 5 a.m., after at least a four-hour Facility at 202–493–2251. electrical cable that is constructed to advance notice is given and from (4) Electronically through the Web IEEE Std. 45–1998 edition. We presently November 1 through March 30, from 9 Site for the Docket Management System recognize cable constructed to the IEEE p.m. to 5 a.m., after at least a twenty- at http://dms.dot.gov. Std. 45–1983 edition. The 1998 edition four-hour advance notice is given by The Docket Management Facility of IEEE Std. 45 changes the testing calling the number posted at the bridge. maintains the public docket for this requirements for marine shipboard Dated: December 6, 2000. notice. Comments and material received electrical cable, and it also requires third party verification. We recognize G.N. Naccara, from the public will become part of this docket and will be available for that there are types of cable found in Rear Admiral, U.S. Coast Guard, Commander, IEEE Std. 45–1998, that are not found in First Coast Guard District. inspection or copying at room PL–401 on the Plaza level of the Nassif Building, IEEE Std. 45–1983. [FR Doc. 01–435 Filed 1–5–01; 8:45 am] 400 Seventh Street SW., Washington, The Coast Guard seeks comments BILLING CODE 4910±15±U DC, between 9 a.m. and 5 p.m., Monday regarding the following three proposals: through Friday, except Federal holidays. 1. The Coast Guard should not recognize IEEE Std. 45–1998 edition. DEPARTMENT OF TRANSPORTATION You may also find this docket on the Internet at http://dms.dot.gov. 2. The Coast Guard should recognize Coast Guard FOR FURTHER INFORMATION CONTACT: For IEEE Std. 45–1998 edition and should questions on this notice, call Dolores remove the reference to the 1983 46 CFR Parts 110 and 111 Mercier, Project Manager, Office of edition. Design and Engineering Standards (G– 3. The Coast Guard should recognize [USCG±2001±8602] MSE), Coast Guard, telephone 202–267– IEEE Std. 45–1998 edition and should leave the reference to the 1983 edition. Marine Shipboard Electrical Cable 0658, fax 202–267–4816, e-mail [email protected]. For questions The Coast Guard encourages the Standards: Incorporation of IEEE public to submit comments on the above Standard 45, 1998 Edition on viewing or submitting material to the docket, call Dorothy Beard, Chief, three proposals. AGENCY: Coast Guard, DOT. Dockets, Department of Transportation, Dated: December 27, 2000. ACTION: Request for comments. phone 202–366–9329. Joseph J. Angelo, SUPPLEMENTARY INFORMATION: Director of Standards. SUMMARY: The Coast Guard is Request for Comments [FR Doc. 01–434 Filed 1–5–01; 8:45 am] considering requests to allow merchant BILLING CODE 4910±15±U vessels to use shipboard cable If you submit written comments, constructed to meet the requirements in please include your name and address, Clause 8 (Cable Construction), Clause 9 and identify the docket number for this FEDERAL COMMUNICATIONS (Cable Application), and Clause 10 rulemaking [USCG–2001–8602] and the COMMISSION (Cable Installation) of the Institute of reason for each comment. You may Electrical and Electronics Engineers submit your comments and material by 47 CFR Parts 23 and 25 (IEEE) Standard 45, Recommended mail, delivery, fax, or electronic means Practice for Electrical Installations on to the Docket Management Facility at [IB Docket No. 00±248, FCC 00±435] ADDRESSES; Shipboard-1998 edition. The 1998 the address under but 2000 Biennial Regulatory Review edition changes the testing requirements please submit your comments and for marine shipboard electrical cable material by only one means. Please AGENCY: Federal Communications from those in the 1983 edition. It also submit all comments and material in an Commission. 1 requires third party verification. The unbound format, no larger than 8 ⁄2 by ACTION: Notice of proposed rulemaking. Coast Guard requests comments 11 inches, suitable for copying and concerning which edition (the 1983 electronic filing to the Facility at the SUMMARY: In this document, the edition, the 1998 edition, or both) address under ADDRESSES. If you want Commission initiates a review of the should be incorporated by reference. acknowledgement of receipt of your procedures governing the processing of

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 1284 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules non-routine earth station license Street, SW., Washington, DC 20554, or revising the Commission’s power level applications. The Commission also via the Internet to [email protected], and to rules to provide for various types of proposes simplifying the application Edward C. Springer, OMB Desk Officer, VSAT multiple access methods; form for routine earth station licenses. Room 10236 NEOB, 725 17th Street, (4) Adopting a simplified license The Commission’s objectives are to NW., Washington, DC 20503 or via the application form for ‘‘routine’’ earth expedite the review of earth station Internet to stations; and application, so that earth station [email protected]. (5) Other miscellaneous rule operators can provide their services FOR FURTHER INFORMATION CONTACT: revisions. sooner. Steven Spaeth, Satellite and In addition, the Commission invites DATES: Comments are due on or before Radiocommunication Division, parties to propose revisions to part 23 of March 26, 2001. Reply comments are International Bureau, (202) 418–1539. its rules, governing International Fixed due on or before April 23, 2001. For additional information concerning Public Radiocommunication Services. Written comments by the public on the information collection(s) contained the proposed information collections are in this document, contact Judy Boley at Initial Regulatory Flexibility Analysis due March 26, 2001. Written comments 202–418–0214, or via the Internet at As required by the Regulatory must be submitted by the Office of [email protected]. Flexibility Act (RFA),1 the Commission Management and Budget (OMB) on the SUPPLEMENTARY INFORMATION: This is a has prepared this Initial Regulatory proposed information collection(s) on or summary of the Commission’s Notice of Flexibility Analysis (IRFA) of the before April 23, 2001. Proposed Rulemaking adopted possible significant economic impact on ADDRESSES: Comments may be filed December 11, 2000. The full text of this small entities by the policies and rules using the Commission’s Electronic Commission decision is available for proposed in this notice of proposed Comment Filing System (ECFS) or by inspection and copying during normal rulemaking. We request written public filing paper copies. See Electronic Filing business hours in the FCC Public comments on this IRFA. Commenters of Documents in Rulemaking Reference Room, 445 Twelfth Street, must identify their comments as Proceedings, 63 Fed. Reg. 24,121 (1998). SW., Room CY–A257, Washington, DC responses to the IRFA and must file the Comments filed through the ECFS can 20554. The complete text of this comments by the deadlines for be sent as an electronic file via the decision may also be purchased from comments on the notice of proposed Internet to . Generally, only one copy of International Transcription Service, Commission will send a copy of the an electronic submission must be filed. Suite 140, 2100 M Street, NW., notice of proposed rulemaking, If multiple docket or rulemaking Washington, DC 20037. including this IRFA, to the Chief numbers appear in the caption of this This NPRM contains proposed Counsel for Advocacy of the Small proceeding, however, commenters must information collection(s) subject to the Business Administration. See 5 U.S.C. transmit one electronic copy of the Paperwork Reduction Act of 1995 603(a). In addition, the Notice of comments to each docket or rulemaking (PRA). It has been submitted to the Proposed Rulemaking and IRFA (or number referenced in the caption. In Office of Management and Budget summaries thereof) will be published in completing the transmittal screen, (OMB) for review under the PRA. OMB, the Federal Register. commenters should include their full the general public, and other Federal name, Postal Service mailing address, agencies are invited to comment on the A. Need for, and Objectives of, the and the applicable docket or rulemaking proposed information collections Proposed Rules number. Parties may also submit an contained in this proceeding. The Telecommunications Act of 1996 electronic comment by Internet e-mail. requires the Commission in every even- To get filing instructions for e-mail Summary of Notice of Proposed Rulemaking numbered year beginning in 1998 to comments, commenters should send an review all regulations that apply to the e-mail to [email protected], and should The Commission has found several operations or activities of any provider include the following words in the body cases in which modifying or eliminating of telecommunications service and to of the message, ‘‘get form .’’ A sample form and stations, thereby expediting the is no longer necessary in the public directions will be sent in reply. provision of useful satellite services to interest due to meaningful economic Parties who choose to file by paper the public, without unreasonably competition. must file an original and four copies of increasing the risk of harmful each filing. If more than one docket or interference to existing earth station or Our objective is to repeal or modify rulemaking number appear in the space station operators, or terrestrial any rules in Part 25 that are no longer caption of this proceeding, commenters wireless operators in shared frequency necessary in the public interest, as must submit two additional copies for bands. In particular, we seek comment required by Section 11 of the each additional docket or rulemaking on the following rule revisions: Communications Act of 1934, as number. All filings must be sent to the (1) Codifying streamlined procedures amended. Commission’s Secretary, Magalie Roman for case-by-case examination of earth B. Legal Basis Salas, Office of the Secretary, Federal stations using ‘‘non-routine’’ antennas, Communications Commission, The non-routine power levels, or both; The proposed action is supported by Portals, 445 Twelfth Street, SW., Room (2) Relaxing some current Section 11 of the Communications Act TW–A325, Washington, DC 20554. requirements, such as increasing power of 1934, as amended, 47 U.S.C. 161. In addition to filing comments with and power density limits, and allowing the Secretary, a copy of any comments some temporary fixed earth stations to 1 See 5 U.S.C. 603. The RFA, see, 5 U.S.C. 601 et on the information collections begin operation sooner than is now seq., has been amended by the Contract With America Advancement Act of 1996, Public Law contained herein should be submitted to permitted; 104–121, 110 Stat. 847 (1996) (CWAAA). Title II of Judy Boley, Federal Communications (3) Streamlining the very small the CWAAA is the Small Business Regulatory Commission, Room 1–C804, 445 12th aperture terminal (VSAT) rules; and Enforcement Fairness Act of 1996 (SBREFA).

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C. Description and Estimate of the affected by the proposed rules, if operators serving 666,900 subscribers or Number of Small Entities to Which the adopted. less totals 1,450.15 We do not request Proposed Rules May Apply nor do we collect information 1. Cable Services The RFA directs agencies to provide concerning whether cable system The SBA has developed a definition a description of, and, where feasible, an operators are affiliated with entities of small entities for cable and other pay estimate of, the number of small entities whose gross annual revenues exceed television services, which includes all that may be affected by the proposed $250,000,000, and thus are unable at such companies generating $11 million rules, if adopted.2 The RFA generally this time to estimate with greater or less in revenue annually. This defines the term ‘‘small entity’’ as precision the number of cable system definition includes cable systems having the same meaning as the terms operators that would qualify as small operators, closed circuit television ‘‘small business,’’ ‘‘small organization,’’ cable operators under the definition in services, direct broadcast-satellite and ‘‘small governmental jurisdiction.’’ 3 the Communications Act. services, multipoint distribution In addition, the term ‘‘small business’’ systems, satellite master antenna 2. International Services has the same meaning as the term systems and subscription television ‘‘small business concern’’ under the The Commission has not developed a services. According to the Census Small Business Act.4 A small business definition of small entities applicable to Bureau data from 1992, there were 1,788 concern is one which: licensees in the international services. (1) Is independently owned and total cable and other pay television Therefore, the applicable definition of operated; services and 1,423 had less than $11 small entity is generally the definition (2) Is not dominant in its field of million in revenue. The Commission under the SBA rules applicable to operation; and has developed its own definition of a Communications Services, Not (3) Satisfies any additional criteria small cable system operator for the Elsewhere Classified (NEC).16 This established by the Small Business purposes of rate regulation. Under the definition provides that a small entity is Administration (SBA).5 A small Commission’s rules, a ‘‘small cable expressed as one with $11.0 million or organization is generally ‘‘any not-for- company,’’ is one serving fewer than less in annual receipts.17 According to profit enterprise which is independently 400,000 subscribers nationwide.11 the Census Bureau, there were a total of owned and operated and is not Based on our most recent information, 848 communications services providers, dominant in its field.’’ 6 Nationwide, as we estimate that there were 1,439 cable NEC, in operation in 1992, and a total of 1992, there were approximately operators that qualified as small cable of 775 had annual receipts of less than 12 275,801 small organizations.7 ‘‘Small system operators at the end of 1995. $9.999 million.18 The Census report governmental jurisdiction’’ generally Since then, some of those companies does not provide more precise data. means ‘‘governments of cities, counties, may have grown to serve over 400,000 a. Fixed Satellite Transmit/Receive towns, townships, villages, school subscribers, and others may have been Earth Stations. Currently there are over districts, or special districts, with a involved in transactions that caused 7500 authorized fixed satellite transmit/ population of less than 50,000.’’ 8 As of them to be combined with other cable receive earth stations authorized for use 1992, there were approximately 85,006 operators. Consequently, we estimate in bands shared with the terrestrial such jurisdictions in the United States.9 that there are fewer than 1,439 small fixed service. We do not request or This number includes 38,978 counties, entity cable system operators. collect annual revenue information, and The Communications Act also cities, and towns; of these, 37,566, or 96 thus are unable to estimate the number contains a definition of a small cable percent, have populations of fewer than of the earth stations that would system operator, which is ‘‘a cable 50,000.10 The Census Bureau estimates constitute a small business under the operator that, directly or through an that this ratio is approximately accurate SBA definition. affiliate, serves in the aggregate fewer for all governmental entities. Thus, of b. Mobile Satellite Earth Station than 1 percent of all subscribers in the the 85,006 governmental entities, we Feeder Links. There are two licensees United States and is not affiliated with estimate that 81,600 (91 percent) are operating in spectrum shared with any entity or entities whose gross small entities. Below, we further terrestrial fixed services. We do not annual revenues in the aggregate exceed request or collect annual revenue describe and estimate the number of $250,000,000.’’ 13 The Commission has information, and thus are unable to small entity licensees that may be determined that there are 66,690,000 estimate of the number of mobile subscribers in the United States. 2 5 U.S.C. 603(b)(3) satellite earth stations that would Therefore, we found that an operator 3 Id. 601(6). constitute a small business under the serving fewer than 666,900 subscribers 4 5 U.S.C. 601(3) (incorporating by reference the SBA definition. shall be deemed a small operator, if its definition of ‘‘small business concern’’ in 15 U.S.C. c. Space Stations (Geostationary). 632). Pursuant to the RFA, the statutory definition annual revenues, when combined with Commission records reveal that there of a small business applies ‘‘unless an agency, after the total annual revenues of all of its consultation with the Office of Advocacy of the are six space station licensees licensed affiliates, do not exceed $250 million in Small Business Administration and after in spectrum shared on a co-primary the aggregate.14 Based on available data, opportunity for public comment, establishes one or basis with the terrestrial fixed service in more definitions of such term which are we find that the number of cable appropriate to the activities of the agency and the C- and Ku-bands. We do not request publishes such definition(s) in the Federal 11 47 CFR 76.901(e). The Commission developed or collect annual revenue information, Register.’’ 5 U.S.C. 601(3). this definition based on its determination that a 5 Small Business Act, 15 U.S.C. 632 (1996). small cable system operator is one with annual 15 Paul Kagan Associates, Inc., Cable TV Investor, 6 5 U.S.C. 601(4). revenues of $100 million or less. Implementation of Feb. 29, 1996 (based on figures for Dec. 30, 1995). 7 1992 Economic Census, U.S. Bureau of the Sections of the 1992 Cable Act: Rate Regulation, 16 An exception is the Direct Broadcast Satellite Census, Table 6 (special tabulation of data under Sixth Report and Order and Eleventh Order on (DBS) Service, infra. contract to Office of Advocacy of the U.S. Small Reconsideration. 10 FCC Rcd 7393 (1995), 60 FR 17 13 CFR 120.121, SIC code 4899. Business Administration). 10534 (Feb. 27, 1995). 18 1992 Economic Census Industry and Enterprise 8 5 U.S.C. 601(5). 12 Paul Kagan Associates, Inc., Cable TV Investor, Receipts Size Report, Table 2D, SIC code 4899 (U.S. 9 U.S. Dept. of Commerce, Bureau of the Census, Feb. 29, 1996 (based on figures for Dec. 30, 1995). Bureau of the Census data under contract to the ‘‘1992 Census of Governments.’’ 13 47 U.S.C. 543(m)(2). Office of Advocacy of the U.S. Small Business 10 Id. 14 47 CFR 76.1403(b). Administration).

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Geostationary Space Station licensees present, there are over 13,500 common Paperwork Reduction Act: This NPRM licensed in spectrum shared on a co- carrier stations, and approximately contains proposed new and modified primary basis with the terrestrial fixed 18,000 private operational fixed stations information collections. The service in the C- and Ku-bands. We do and broadcast auxiliary radio stations in Commission, as part of its continuing not request or collect annual revenue the microwave services in spectrum that effort to reduce paperwork burdens, information, and thus are unable to is potentially affected by this invites the general public and the Office estimate of the number of non- rulemaking. Additionally, these stations of Management and Budget (OMB) to geostationary space stations that would represent the following distinct comment on the information constitute a small business under the licensees among the various radio collection(s) contained in this NPRM, as SBA definition. services: LMDS (121), DEMS (2), required by the Paperwork Reduction 3. Auxiliary, Special Broadcast and Common Carrier Fixed (PTP and LTTS) Act of 1995, Public Law 104–13. Public Other Program Distribution Services (1028), Private Operational Fixed PTP and agency comments are due at the (1511), and Fixed Broadcast Auxiliary same time as other comments on this This service involves a variety of (806).20 Inasmuch as the Commission NPRM; OMB notification of action is transmitters, generally used to relay has not yet defined a small business due April 23, 2001. Comments should broadcast programming to the public with respect to microwave services, we address: (a) whether the proposed (through translator and booster stations) will utilize the SBA’s definition collection of information is necessary or within the program distribution chain applicable to radiotelephone for the proper performance of the (from a remote news gathering unit back companies—i.e., an entity with no more functions of the Commission, including to the station). The Commission has not than 1,500 persons. 13 CFR 121.201, SIC whether the information shall have developed a definition of small entities CODE 4812. We estimate, for this practical utility; (b) the accuracy of the applicable to broadcast auxiliary purpose, that all of the Fixed Microwave Commission’s burden estimates; (c) licensees. Therefore, the applicable licensees (excluding broadcast auxiliary ways to enhance the quality, utility, and definition of small entity is the licensees) would qualify as small clarity of the information collected; and definition under the Small Business entities under the SBA definition for (d) ways to minimize the burden of the Administration (SBA) rules applicable radiotelephone companies. collection of information on the respondents, including the use of to radio broadcasting stations (SIC 4832) D. Description of Projected Reporting, and television broadcasting stations (SIC automated collection techniques or Recordkeeping, and Other Compliance other forms of information technology. 4833). These definitions provide that a Requirements small entity is one with either $5.0 OMB Control Number: 3060–0678. million or less in annual receipts for a None of the proposed rules in this Title: Part 25 of the Commission’s radio broadcasting station or $10.5 notice are expected to increase the Rules Governing the Licensing of, and million in annual receipts for a TV reporting, record keeping and other Spectrum Usage by, Satellite Network station. 13 C.F.R. 121.201, SIC CODES compliance requirements of any Earth Stations and Space Stations Form No.: FCC Form 312, FCC Form 4832 and 4833. There are currently telecommunications carrier. 312 EZ, FCC Form 312–R, FCC Form 3,237 FM translators and boosters, 4913 E. Steps Taken To Minimize Significant 19 312–M, FCC Form 312 Schedule S. TV translators. The FCC does not Economic Impact on Small Entities, and Type of Review: Revision of existing collect financial information on any Significant Alternatives Considered collection. broadcast facility and the Department of The RFA requires an agency to Respondents: Business or other for- Commerce does not collect financial describe any significant alternatives that profit entities. information on these auxiliary broadcast it has considered in reaching its Number of Respondents: 4,560. facilities. We believe, however, that proposed approach, which may include Estimated Time Per Response: 2 most, if not all, of these auxiliary the following four alternatives: (1) The hours. facilities could be classified as small establishment of differing compliance or Total Annual Burden: 9,120 hours. businesses by themselves. We also reporting requirements or timetables Total Annual Costs: $13,838,080. recognize that most translators and that take into account the resources Needs and Uses: The information boosters are owned by a parent station available to small entities; (2) the collection requirements accounted for in which, in some cases, would be covered clarification, consolidation, or this collection are necessary to by the revenue definition of small simplification of compliance or determine the technical, legal and business entity discussed above. These reporting requirements under the rule financial qualifications of applicants or stations would likely have annual for small entities; (3) the use of licensees to operate a station, transfer or revenues that exceed the SBA maximum performance, rather than design, assign a license, and to determine to be designated as a small business (as standards; and (4) an exemption from whether the authorization is in the noted, either $5 million for a radio coverage of the rule, or any part thereof, public interest, convenience and station or $10.5 million for a TV for small entities. necessity. Without such information, station). Furthermore, they do not meet This Notice solicits comment on the Commission could not determine the Small Business Act’s definition of a alternatives for more efficient whether to permit respondents to ‘‘small business concern’’ because they processing of non-routine earth station provide telecommunication services in the U.S. The Commission would 19 FCC News Release, Broadcast Station Totals as 20 Results of analysis by FCC ULS contractor in therefore be unable to fulfill its statutory of September 30, 1999, No. 71831 (Jan. 21, 1999). July 2000. and responsibilities in accordance with

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Amend § 25.115 by revising paragraphs (a) and (c) to read as follows: Pursuant to Sections 4(i), 7(a), 11, § 25.110 Filing of applications, fees, and 303(c), 303(f), 303(g), and 303(r) of the number of copies. § 25.115 Application for earth station Communications Act of 1934, as (a) Standard application forms authorizations. amended, 47 U.S.C. 154(i), 157(a), 161, applicable to this part may be obtained (a) Transmitting earth stations. 303(c), 303(f), 303(g), 303(r), that this from the Federal Communications Commission authorization must be Notice of Proposed Rulemaking is Commission, Forms Distribution Center, obtained for authority to operate a hereby Adopted. by calling 1–800–418–FORM (3676). transmitting earth station. Applications The Commission’s Consumer (b) Manually filed applications for shall be filed on FCC Form 312 and Information Bureau, Reference satellite radio station authorizations include the information specified in Information Center, Shall Send a copy governed by this part and requiring a fee § 25.130. of this Notice of Proposed Rulemaking, shall be mailed or hand-delivered to the * * * * * including the Initial Regulatory locations specified in Part 1, subpart G (c) Large Networks of Small Antennas Flexibility Analysis, to the Chief, of this chapter. The addresses for filing operating in the 12/14 GHz frequency Counsel for Advocacy of the Small and fee amounts for the applications are bands with U.S.-licensed or non-U.S.- Business Administration. also listed in the International and licensed satellites for domestic or Satellite services fee filing guide from Federal Communications Commission. international services. Applications to the Commission’s Forms Distribution Magalie Roman Salas, license small antenna network systems Center or by calling 1–800–418–FORM operating in the 12/14 GHz frequency Secretary. (3676). All other applications shall be band under blanket operating authority Proposed Rule Changes submitted to the Secretary, Federal shall be filed on FCC Form 312 and Communications Commission, 445 12th For the reasons discussed in the Schedule B, for each large (5 meters or Street, SW., Washington, DC 20554. preamble, the Federal Communications larger) hub station, and Schedule B for Commission seeks proposals for * * * * * each representative type of small revisions to part 23 and proposes to 5. Amend § 25.111 by revising antenna (less than 5 meters) operating amend part 25 of title 47 of the Code of paragraph (b) to read as follows: within the network. Federal Regulations as follows: § 25.111 Additional information. * * * * * 8. Revise § 25.117 to read as follows: PART 25ÐSATELLITE * * * * * COMMUNICATIONS (b) Applicants, permittees and § 25.117 Modification of station license. licensees of radio stations governed by (a) Except as provided for in § 25.118 1. The authority citation for part 25 this part shall provide the Commission (Modifications not requiring prior continues to read as follows: with all information it requires for the authorization), no modification of a Authority: 47 U.S.C. 701–744. Interprets or advance publication, coordination and radio station governed by this part applies Sections 4, 301, 302, 303, 307, 309, notification of frequency assignments which affects the parameters or terms and 332 of the Communications Act, as pursuant to the international radio and conditions of the station amended, 47 U.S.C. Sections 154, 301, 302, regulations. No protection from authorization shall be made except 303, 307, 309, 332, unless otherwise noted. interference caused by radio stations upon application to and grant of such 2. Amend § 25.103 by revising authorized by other Administrations is application by the Commission. paragraphs (b) and (c)(2) to read as guaranteed unless coordination (b) [Reserved] follows: procedures are timely completed or, (c) Applications for modification of with respect to individual earth station authorizations shall be § 25.103 Definitions. administrations, by successfully submitted on FCC Form 312, Main Form * * * * * completing coordination agreements. and Schedule B, except as set forth in (b) Authorized carrier. The term Any radio station authorization for paragraph (e) of this section. ‘‘authorized carrier’’ means a which coordination has not been (d) Applications for modifications of communications common carrier which completed may be subject to additional space station authorizations shall be is authorized by the Federal terms and conditions as required to filed in accordance with § 25.114, but Communications Commission under the effect coordination of the frequency only those items of information listed in Communications Act of 1934, as assignments with other § 25.114(c) that change need to be amended, to provide services by means Administrations. submitted, provided the applicant of communications satellites. 6. Amend § 25.113 by revising the certifies that the remaining information (c) * * * section heading and paragraph (a), and has not changed. (2) The corporation shall be deemed removing and reserving paragraph (b) to (e) Any application for modification to be a common carrier within the read as follows: of authorization to extend a required meaning of section 3(10) of the date of completion (e.g., begin Communications Act of 1934, as § 25.113 Station licenses and launch construction, complete construction, amended. authority. launch, bring into operation) shall be * * * * * (a) Construction permits are not filed on FCC Form 312M (Application 3. Amend § 25.109 by revising required for satellite earth stations. for Additional Time to Construct). The paragraph (c) to read as follows: Construction of such stations may application must include a verified commence prior to grant of a license at statement from the applicant: § 25.109 Cross-reference. the applicant’s own risk. Applicants (1) That states the additional time is * * * * * must comply with the provisions of 47 required due to unforeseeable

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 1288 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules circumstances beyond the applicant’s (VSAT hub earth stations and all remote units specified in its license into control, describes these circumstances terminals that are not part of a U.S.- operation by the time the licensee is with specificity, and justifies the precise licensed VSAT network are treated like renewed, subsequent modification extension period requested; or other earth stations for purposes of applications to add VSAT units will (2) That states there are unique and determining whether they can be require prior Commission authorization. overriding public interest concerns that modified without prior authorization.) 11. Amend § 25.130 by revising justify an extension, identifies these (b) Notification not required. An paragraph (a) to read as follows: interests and justifies a precise authorized earth station licensee may § 25.130 Filing requirements for extension period. add, change or replace transmitters or transmitting earth stations. (f) Applications for modification of antenna facilities without prior (a) Applications for a new or modified earth station authorizations shall be authorization, provided: submitted on FCC Form 312, Main Form transmitting earth station facility shall (1) The added, changed, or replaced be submitted on FCC Form 312, Main and Schedule B, whenever the resulting facilities conform to § 25.209; Form and Schedule B, accompanied by radiofrequency emissions that would be (2) The particulars of operations any required exhibits. In addition, the caused by the modification would cause remain unchanged; applicant shall submit the following the power density in a given area to (3) Frequency coordination is not information to be used as an exceed five percent of the required; and ‘‘informative’’ in the public notice radiofrequency exposure limits, such (4) The maximum power and power issued under § 25.151: that an environmental assessment density delivered into any antenna at (1) A detailed description of the statement would be required under the earth station site shall not exceed service to be provided, including § 1.1307(b)(3)(i) of this chapter. the values calculated by subtracting the frequency bands and satellites to be 9. Revise § 25.118 to read as follows: maximum antenna gain specified in the used. § 25.118 Modifications not requiring prior license from the maximum authorized (2) The diameter of the antenna. authorization. e.i.r.p. and e.i.r.p. density values. (3) Proposed power and power 10. Amend § 25.121 by revising (a) Notification required. Authorized density levels. paragraphs (a), (c), and (e) to read as (4) Identification of any random earth station operators may make the follows: access technique, if applicable, as listed following modifications to their licenses in § 25.134(a). without prior Commission § 25.121 License term and renewals. (5) Identification of any rule or rules authorization, provided that the (a) License term. Except as provided for which a waiver is requested. operators notify the Commission, using in paragraphs (b) and (c) of this section, 12. Amend § 25.131 by revising FCC Form 312 and Schedule B, within licenses for facilities governed by this paragraphs (a), (b), (h), (i), and (j) to read 30 days of the modification: part will be issued for a period of 10 as follows: (1) Licensees may make changes to years. their authorized earth stations without § 25.131 Filing requirements for receive- * * * * * obtaining prior Commission only earth stations. (c) Earth stations. For earth stations, authorization, provided that they have (a) Except as provided in paragraphs the license term will be specified in the complied with all applicable frequency (b) and (j) of this section, applications instrument of authorization. In no case coordination procedures in accordance for a license for a receive-only earth shall this term exceed 15 years. with § 25.251, and the modification station shall be submitted on FCC Form does not involve: * * * * * 312, Main Form and Schedule B, (i) An increase in EIRP or EIRP (e)(1) Renewal of licenses. accompanied by any required exhibits density (both main lobe and side lobe); Applications for renewals of earth and the information described in (ii) An increase in transmitted power; station licenses must be submitted on § § 25.130(a)(1) through 25.130(a)(5). (iii) A change in coordinates of more FCC Form 312R no earlier than 90 days, (b) Except as provided in paragraph (j) than 1 second in latitude or longitude and no later than 30 days, before the of this section, receive-only earth for stations operating in frequency expiration date of the license. stations in the fixed-satellite service that bands that are shared with terrestrial Applications for space station system operate with U.S.-licensed satellites systems; or replacement authorization for non- may be registered with the Commission (iv) A change in coordinates of 10 geostationary orbit satellites shall be in order to protect them from seconds or greater in latitude or filed no earlier than 90 days, and no interference from terrestrial microwave longitude for stations operating in later than 30 days, prior to the end of stations in bands shared co-equally with frequency bands that are not shared the seventh year of the existing license the fixed service in accordance with the with terrestrial systems. term. procedures of § § 25.203 and 25.251. (v) A change in operations from (2) In addition to the requirements of * * * * * private carrier to common carrier status. paragraph (e)(1) of this section, (h) Registration term. Registrations for (2) Equipment in an authorized earth applicants seeking renewal of a MET receive-only earth stations governed by station may be replaced without prior license must include as an attachment this section will be issued for a period authorization if the new equipment is to FCC Form 312R a statement of the of 15 years from the date on which the electrically identical to the existing number of MET units in its network application was filed. Applications for equipment. placed into operation. renewals of registrations must be (3) Authorized VSAT earth station (3) In addition to the requirements of submitted on FCC Form 312R operators may add VSAT remote paragraph (e)(1) of this section, (Application for Renewal of Radio terminals without prior authorization, applicants seeking renewal of a VSAT Station License in Specified Services) provided that they have complied with license must include as an attachment no earlier than 90 days and no later than all applicable frequency coordination to FCC Form 312R a statement of the 30 days before the expiration date of the procedures in accordance with § 25.251, number of VSAT units in its network registration. and such modifications do not require placed into operation. If a VSAT (i) Applications for modification of prior authorization under § 25.121(e)(3). licensee does not bring all the VSAT license or registration of receive-only

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1289 earth stations shall be made in the earth station must be completed and following requirements will be routinely conformance with § § 25.117 and the station must be brought into processed: 25.118. In addition, registrants are operation within 12 months from the (1) The maximum transmitter power required to notify the Commission when date of the license grant except as may spectral density of a digital modulated a receive-only earth station is no longer be determined by the Commission for carrier into any GSO FSS earth station operational or when it has not been any particular application. antenna shall not exceed—14.0— used to provide any service during any (2) Each license for mobile satellite 10log(N) dB(W/4 kHz). 6-month period. earth station terminals (METs) shall (i) For a VSAT network using (j) Receive-only earth stations specify as a condition therein the period frequency division multiple access operating with non-U.S. licensed space in which station operation must be (FDMA) or time division multiple stations shall file an FCC Form 312 commenced. The networks in which the access (TDMA) technique, N is equal to requesting a license or modification to METs will be operated must be brought one. operate such station. Receive-only earth into operation within 12 months from (ii) For a VSAT network using code stations used to receive INTELNET I the date of the license grant except as division multiple access (CDMA) service from INTELSAT space stations may be determined by the Commission technique, N is the likely maximum need not file for licenses. See for any particular application. number of co-frequency simultaneously Deregulation of Receive-Only Satellite (b)(1) Each license for a transmitting transmitting earth stations in the same Earth Stations Operating with the earth station included in this part shall satellite receiving beam. INTELSAT Global Communications also specify as a condition therein that Satellite System, Declaratory Ruling, upon the completion of construction, (iii) For a VSAT network using RM No. 4845, FCC 86–214 (released each licensee must file with the contention Aloha multiple access May 19, 1986) available through the Commission a certification containing technique, N is equal to two. International Reference Center, FCC, the following information: (iv) For a VSAT network using identified in § 0.453(m) of this chapter. (i) The name of the licensee; contention CDMA/Aloha multiple 13. Amend § 25.132 by revising (ii) File number of the application; access technique, N is twice the likely paragraph (a) and adding paragraph call sign of the antenna; maximum number of co-frequency (b)(3) to read as follows: (iii) Date of the license; simultaneously transmitting earth (iv) A certification that the facility as stations in the same satellite-receiving § 25.132 Verification of earth station beam without contention. antenna performance standards. authorized has been completed and that (2) The maximum GSO FSS satellite (a) All applications for transmitting each antenna facility has been tested EIRP spectral density of the digital earth stations must be accompanied by and is within 2 dB of the pattern modulated emission shall not exceed 6 a certificate pursuant to § 2.902 of the specified in § 25.209, § 25.135 (NVNG dB (W/4kHz) for all methods of chapter from the manufacturer of each MSS earth stations), or § 25.213 (1.6/2.4 modulation and accessing techniques. antenna that the results of a series of GHz Mobile-Satellite Service earth radiation pattern tests performed on stations). MET licenses shall specify as (3) The maximum hub earth station representative equipment in a condition that the licensee must file a EIRP shall not exceed 78.3 dBW for all representative configurations by the certification that it has begun to provide methods of multiple access techniques manufacturer demonstrates that the service; and supporting VSAT network equipment complies with the (v) The date on which the station identified in paragraph (a)(1) of this performance standards set forth in became operational; and section. § 25.209. The licensee must be prepared (vi) A statement that the station will (4) The maximum transmitter power to demonstrate the measurements to the remain operational during the license spectral density of an analog carrier into Commission on request. period unless the license is submitted any GSO FSS earth station antenna shall (b) * * * for cancellation. not exceed ¥8.0 dB(W/4kHz) and the (3) Applicants seeking authority to (2) For stations authorized under maximum GSO FSS satellite EIRP use an antenna that does not meet the § 25.115(c) (Large Networks of Small spectral density shall not exceed +13.0 standards set forth in § § 25.209(a) and Antennas operating in the 12/14 GHz dB(W/4kHz). (b), pursuant to the procedure set forth bands) and § 25.115(d) (User (b) Each applicant for digital and/or in § 25.220, are required to submit a Transceivers in the Mobile-Satellite analog VSAT network authorization copy of the manufacturer’s range test Service), and for mobile satellite earth proposing to use transmitted satellite plots of the antenna gain patterns station terminals (METs), a certificate carrier EIRP densities and/or maximum specified in paragraph (b)(1) of this must be filed when the network is put antenna input power in excess of those section. into operation. specified in paragraph (a) of this Section * * * * * * * * * * must comply with the procedures set 14. Amend § 25.133 by revising (e) An application for MET forth in § 25.220. paragraphs (a) and (b) and adding authorization shall be filed on FCC * * * * * paragraph (e) to read as follows: Form 312, Main Form and Schedule B. A MET licensee applying to renew its (d) An application for VSAT § 25.133 Period of construction; license must follow the procedures authorization shall be filed on FCC certification of commencement of provided in § 25.121(e)(2). Form 312, Main Form and Schedule B. operation. A VSAT licensee applying to renew its 15. Amend § 25.134 by revising license must follow the procedures (a)(1) Each license for an earth station paragraphs (a), (b), and (d) to read as provided in § 25.121(e)(3). governed by this part, except for mobile follows: satellite earth station terminals (METs), 16. Amend § 25.138 by adding the shall specify as a condition therein the § 25.134 Licensing provisions of very following sentence immediately period in which construction of small aperture terminal (VSAT) networks. succeeding the last sentence of facilities must be completed and station (a) All applications for VSAT service paragraphs (a)(1) and (a)(2) to read as operation commenced. Construction of in the 12/14 GHz band that meet the follows:

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§ 25.138 Blanket licensing provisions of section. If no comments or petitions are to provide a feeder link for the land GSO FSS earth stations in the 18.58±18.8 filed within 30 days of the public notice mobile-satellite service. (RR) GHz (space-to-Earth), 19.7±20.2 GHz (space- date, the authority granted will be (3) C-band. For purposes of this part, to-Earth), 28.35±28.6 GHz (Earth-to-space) considered a regular temporary fixed the C-band refers specifically to the and 29.5±30.0 GHz (Earth-to-space) bands. earth station authorization as of 30 days 3700–4200 MHz downlink and 5925– (a) * * * after the public notice date. If a 6425 MHz uplink frequency bands. (1) * * * N = two for Aloha systems. comment or petition is filed within 30 These paired bands are allocated to the N = 2 times the likely maximum number days of the public notice date, the Fixed-Satellite Service and are also of co-frequency simultaneously applicant must suspend operations referred to as the 4/6 GHz band(s). transmitting earth stations in the receive immediately pending resolution of the (4) Coordination distance. For the beam of the satellite for CDMA/Aloha issues raised in that comment or purposes of this part, the expression systems. petition. ‘‘coordination distance’’ means the (2) * * * N = two for Aloha systems. 20. Amend § 25.154 by revising distance from an earth station, within N = 2 times the likely maximum number paragraphs (c) and (d) and adding which there is a possibility of the use of of co-frequency simultaneously paragraph (e) to read as follows: a given transmitting frequency at this transmitting earth stations in the receive earth station causing harmful beam of the satellite for CDMA/Aloha § 25.154 Opposition to applications and interference to stations in the fixed or systems. other pleadings. mobile service, sharing the same band, * * * * * * * * * * or of the use of a given frequency for (c) Except for opposition to petitions reception at this earth station receiving § 25.141 [Removed] to deny an application filed pursuant to harmful interference from such stations 17. Remove § 25.141. § 25.220, oppositions to petitions to in the fixed or mobile service. deny an application or responses to (5) Earth station. A station located § 25.144 [Amended] comments and informal objections may either on the Earth’s surface or within 18. In § 25.144, remove and reserve be filed 10 days after the petition, the major portion of the Earth’s paragraph (a)(1). comment, or objection is filed and must atmosphere intended for 19. Amend § 25.151 by revising be in accordance with other applicable communication: paragraphs (c)(2) and (d), and adding provisions of §§ 1.41 through 1.52 of (i) With one or more space stations; or paragraph (e) to read as follows: this chapter. (ii) With one or more stations of the § 25.151 Public notice period. (d) Except for opposition to petitions same kind by means of one or more to deny an application filed pursuant to reflecting satellites or other objects in * * * * * § 25.220, reply comments by the party space. (c) * * * that filed the original petition may be (6) Electronic filing. The submission (2) For temporary authorization filed with respect to pleadings filed of applications, exhibits, pleadings, or pursuant to § 25.120. pursuant to paragraph (c) of this section other filings to the Commission in an * * * * * within 5 days after the time for filing electronic form using Internet or World (d) Except as specified in paragraph oppositions has expired unless the Wide Web on-line filing forms. (e) of this section, no application that Commission otherwise extends the (7) Equivalent diameter. When has appeared on public notice will be filing deadline and must be in circular aperture reflector antennas are granted until the expiration of a period accordance with other applicable employed, the size of the antenna is of thirty days following the issuance of provisions of §§ 1.41 through 1.52 of generally expressed as the diameter of the public notice listing the application, this chapter. the antenna’s main reflector. When non- or any major amendment thereto. Any (e) If petition to deny an application reflector or non-circular aperture comments or petitions must be filed pursuant to § 25.220 is filed, the antennas are employed, an equivalent delivered to the Commission by that applicant must file a statement with the diameter can be computed for the date in accordance with § 25.154. Commission explaining whether the antenna. The equivalent diameter is the (e)(1) Applicants seeking authority to applicant has resolved all outstanding diameter of a hypothetical circular operate a temporary fixed earth station coordination issues raised by the aperture antenna with the same aperture pursuant to § 25.277 may consider their petitioner, within 30 days of the date area as the actual antenna. For example, applications ‘‘provisionally granted,’’ the petition for deny is filed. This an elliptical aperture antenna with and may initiate operations upon the statement must be in accordance with major axis, a, and minor axis, b, will placement of the complete FCC Form the provisions of §§ 1.41 through 1.52 of have an equivalent diameter of [a × b]1¤2. 312 application on public notice, this chapter applicable to oppositions to A rectangular aperture antenna with provided that petitions to deny. length, l, and width, w, will have an (i) The temporary fixed earth station 21. Revise § 25.201 to read as follows: equivalent diameter of [(l × w)/π]1¤2. will operate only in the conventional (8) Fixed earth station. An earth Ku-band; § 25.201 Definitions. station intended to be used at a (ii) The temporary fixed earth (a) Definitions for terms in subpart C specified fixed point. station’s operations will be consistent of this part appear in paragraph (b) of (9) Fixed-Satellite Service. A with all routine-licensing requirements this section, and in § 2.1 of this chapter. radiocommunication service between for the conventional Ku-band; and (b)(1) Active satellite. An earth earth stations at given positions, when (iii) The temporary fixed earth satellite carrying a station intended to one or more satellites are used; the station’s operations will be limited to transmit or re-transmit given position may be a specified fixed satellites on the Permitted Space Station radiocommunication signals. point or any fixed point within List. (2) Base earth station. An earth station specified areas; in some cases this (2) Applications for authority granted in the fixed-satellite service or, in some service includes satellite-to-satellite pursuant to paragraph (e)(1) of this cases, in the land mobile-satellite links, which may also be operated in the section shall be placed on public notice service, located at a specified fixed inter-satellite service; the fixed-satellite pursuant to paragraph (a)(1) of this point or within a specified area on land service may also include feeder links of

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1291 other space radiocommunication may include satellite links between land (28) Satellite Digital Audio Radio services. (RR) earth stations at fixed locations. Service (‘‘DARS’’ or ‘‘SDARS’’). A (10) Full transponder. Radio (20) 1.6/2.4 GHz mobile-satellite radiocommunication service in which emissions or transmissions that occupy, service. A mobile-satellite service that audio programming is digitally or nearly occupy, the entire satellite operates in the 1610–1626.5 MHz and transmitted by one or more space transponder. C-band and Ku-band 2483.5–2500 MHz frequency bands, or stations directly to fixed, mobile, and/or satellite systems typically have in any portion thereof. portable stations, and which may transponder bandwidths on the order of (21) Passive satellite. An earth involve complementary SDARS 36 MHz or more. Single carrier full satellite intended to transmit radio repeaters, telemetry, tracking and transponder transmissions can include communication signals by reflection. control facilities. full motion analog video, thousands of (22) Permitted space station list. A list (29) Satellite system. A space system multiplexed voice channels, or high of satellites including all U.S.-licensed using one or more artificial earth date rates on the order of 50 Mb/s. satellites and those non-U.S.-licensed satellites. (11) Geostationary satellite. A satellites for which the Commission has (30) Spacecraft. A man-made vehicle geosynchronous satellite whose circular authorized U.S.-licensed earth stations which is intended to go beyond the and direct orbit lies in the plane of the to communicate with that satellite, and major portion of the Earth’s atmosphere. Earth’s equator and which thus remains the satellite operator has requested the (31) Space operation service. A fixed relative to the Earth; by extension, Commission to place its satellite on the radiocommunication service concerned a satellite which remains approximately Permitted Space Station List. exclusively with the operation of fixed relative to the Earth. (23) Power flux density. The amount spacecraft, in particular space tracking, (12) Inter-Satellite Service. A of power flow through a unit area space telemetry and space radiocommunication service providing within a unit bandwidth. The units of telecommand. These functions will links between artificial earth satellites. power flux density are those of power normally be provided within the service (13) Ku-band. In this rule part, the Ku- spectral density per unit area, namely in which the space station is operating. band refers specifically to the 11700– watts per hertz per square meter. These (32) Space radiocommunication. Any 12200 MHz downlink and 14000–14500 units are generally expressed in decibel radiocommunication involving the use MHz uplink frequency bands. These form as dB(W/Hz/m2), dB(W/m2) in a 4 of one or more space stations or the use paired bands are allocated to the Fixed- kHz band, or dB(W/m2) in a 1 MHz of one or more reflecting satellites or Satellite Service and are also referred to band. other objects in space. as the 12/14 GHz band(s). (24) Power spectral density. The (33) Space station. A station located (14) Land earth station. An earth amount of an emission’s transmitted on an object which is beyond, is station in the fixed-satellite service or, carrier power falling within the stated intended to go beyond, or has been in some cases, in the mobile-satellite reference bandwidth. The units of beyond, the major portion of the Earth’s service, located at a specified fixed power spectral density are watts per atmosphere. point or within a specified area on land hertz and are generally express in (34) Space system. Any group of to provide a feeder link for the mobile- decibel form as dB(W/Hz), dB(W/4kHz), cooperating earth stations and/or space satellite service. (RR) or dB(W/1MHz). stations employing space (15) Land mobile earth station. A (25) Protection areas. The geographic radiocommunication for specific mobile earth station in the land mobile- regions on the surface of the Earth purposes. satellite service capable of surface where United States Department of (35) Space telecommand. The use of movement within the geographical Defense (‘‘DoD’’) meteorological satellite radiocommunication for the limits of a country or continent. (RR) systems or National Oceanic and transmission of signals to a space station (16) Mobile earth station. An earth Atmospheric Administration (‘‘NOAA’’) to initiate, modify or terminate function station intended to be used while in meteorological satellite systems, or both of the equipment on a space object, motion or during halts at unspecified such systems, are receiving signals from including the space station. points. low earth orbiting satellites. (36) Space telemetering. The use of (17) Mobile-satellite service. A (26) Radiodetermination-satellite telemetering for the transmission from a radiocommunication service: service. A radiocommunication service space station of results of measurements (i) Between mobile earth stations and for the purpose of radiodetermination made in a spacecraft, including those one or more space stations, or between involving the use of one of more space relating to the functioning of the space stations used by this service; or stations. This service may also include spacecraft. (ii) Between mobile earth stations, by feeder links necessary for its own (37) Space tracking. Determination of means of one or more space stations. operation. (RR) the orbit, velocity or instantaneous This service may also include feeder (27) Routine processing or licensing. position of an object in space by means links necessary for its operation. (RR) A licensing process whereby of radiodetermination, excluding (18) Narrowband. Radio emissions or applications are processed in an primary radar, for the purpose of transmissions with narrow or limited expedited fashion. Such applications following the movement of the object. spectral bandwidths. Narrowband must be complete in all regards and (38) Temporary fixed earth station. satellite transmissions generally provide consistent with all Commission Rules An earth station operating in the Fixed a single channel or a very limited and must not raise any policy issues. Satellite Service at a fixed location for number of channels. Narrowband With respect to earth station licensing, less than 6 months. Temporary fixed satellite transmissions generally have an application is ‘‘routine’’ only if it earth stations are transportable facilities bandwidths of 40 kHz to 5 MHz. conforms to all antenna, power, that are moved to the point of operation (19) Non-Voice, Non-Geostationary coordination, radiation hazard, and before communicating. They are often mobile-satellite service. A mobile- FAA notification rules, and accesses used for emergency restoration of satellite service reserved for use by non- only ‘‘Permitted Space Station List’’ service and news gathering functions. geostationary satellites in the provision satellites in the C-band or Ku-band Temporary fixed earth stations do not of non-voice communications which frequency bands. operate while in motion.

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(39) Terrestrial radiocommunication. unacceptable levels of adjacent satellite § 25.212 Narrowband transmissions in the Any radiocommunication other than interference. In either case, the Fixed-Satellite Service. space radiocommunication or radio Commission will impose appropriate (c) * * * Antennas with an astronomy. terms and conditions in its equivalent diameter smaller than 1.2 (40) Terrestrial station. A station authorization of such facilities and meters in the 14 GHz band are subject effecting terrestrial operations. The applicant has the to the provisions of § 25.220 of this radiocommunication. burden of demonstrating that its chapter, which may include power (41) Wideband. See Full transponder. antenna not conforming to the standards reduction requirements. of paragraphs (a) and (b) of this section (d)(1) In the 6 GHz band, an earth § 25.202 [Amended] will not cause unacceptable station with an equivalent diameter of 22. In § 25.202, remove and reserve interference. This demonstration must 4.5 meters or greater may be routinely paragraph (a)(2). comply with the procedures set forth in licensed for transmission of SCPC 23. In § 25.204, revise paragraphs (a) § 25.220. services if the maximum power and (b) to read as follows: * * * * * densities into the antenna do not exceed +0.5 dBW/4 kHz for analog SCPC § 25.204 Power limits. 25. In § 25.211, revise paragraph (d) carriers with bandwidths up to 200 kHz, and add paragraphs (e), (f), and (g) to (a) In bands shared coequally with and do not exceed ¥2.7 dBW/4 kHz for read as follows: terrestrial radio communication narrow and/or wideband digital SCPC services, the equivalent isotropically § 25.211 Video transmissions in the Fixed- carriers. Antennas with an equivalent radiated power transmitted in any Satellite Services. diameter smaller than 1.2 meters in the direction towards the horizon by an 14 GHz band are subject to the earth station operating in frequency * * * * * (d) An earth station may be routinely provisions of § 25.220, which may bands between 1 and 15 GHz, shall not include power reduction requirements. exceed the following limits except as licensed for transmission to full transponder services provided: (2) In the 6 GHz band, an earth station provided for in paragraph (c) of this with an equivalent diameter antenna of section: (1) In the 6 GHz band, with an 4.5 meters or greater may be routinely +40 dBW in any 4 kHz band for θ < 0° antenna equivalent diameter 4.5 meters licensed for transmission of SCPC +40+3 θ dBW in any 4 kHz band for 0° or greater, the maximum power into the services if the maximum power spectral < θ ≤ 5° antenna does not exceed 26.5 dBW; or densities into the antenna do not exceed where θ is the angle of elevation of the (2) In the 14 GHz band, with an + 0.5 dB(W/4kHz) for analog SCPC horizon viewed from the center of antenna equivalent diameter 1.2 meters carriers with bandwidths up to 200 kHz radiation of the antenna of the earth or greater, the maximum power into the and do not exceed ¥2.7—10log(N) dB station and measured in degrees as antenna does not exceed 27 dBW. (W/4kHz) for narrow and/or wideband positive above the horizontal plane and (e) Antennas with an equivalent digital SCPC carriers. negative below it. diameter smaller than those specified in (i) For digital SCPC using frequency (b) In bands shared coequally with paragraph (d) of this section are subject division multiple access (FDMA) or terrestrial radio-communication to the provisions of § 25.220 of this time division multiple access (TDMA) services, the equivalent isotropically chapter, which may include power technique, N is equal to one. radiated power transmitted in any reduction requirements. These antennas (ii) For digital SCPC using code direction towards the horizon by an will not be routinely licensed for division multiple access (CDMA) earth station operating in frequency transmission of full transponder technique, N is the likely maximum bands above 15 GHz shall not exceed services. number of co-frequency simultaneously the following limits except as provided (f) Each applicant for authorization for transmitting earth stations in the same for in paragraph (c) of this section: video transmissions in the fixed-satellite satellite receiving beam. (iii) For digital SCPC using contention +64 dBW in any 1 MHz band for θ<0° service proposing to use transmitted +64+3 θ dBW in any 1 MHz band for satellite carrier EIRP densities, and/or Aloha multiple access technique, N is 0°<θ<5° maximum power into the antenna in equal to two. excess of those specified in § 25.211(d), (iv) For digital SCPC using contention θ where is as defined in paragraph (a) must comply with the procedures set CDMA/Aloha multiple access of this section. forth in § 25.220. technique, N is twice the likely * * * * * (g) The Commission has authority to maximum number of co-frequency 24. In § 25.209, revise paragraph (f) to apply the power level limits in this simultaneously transmitting earth read as follows: section to earth station applications for stations in the same satellite-receiving beam without contention. § 25.209 Antenna performance standards. authority to operate in any other FSS frequency band to the extent it deems (e) Each applicant for authorization * * * * * necessary to prevent unacceptable for narrowband transmissions in the (f) An earth station with an antenna interference into adjacent satellite fixed-satellite service proposing to use not conforming to the standards of systems, to the extent that power limits transmitted satellite carrier EIRP paragraphs (a) and (b) of this section have not been established elsewhere in densities, and/or maximum antenna will be authorized after February 15, this part. input power densities in excess of those 1985 upon finding by the Commission specified in paragraph (c) of this section 26. Section 25.212 is amended by: that unacceptable levels of interference for Ku-band service, or paragraph (d) of will not be caused under conditions of a. Adding the following sentence this section for C-band service, uniform 2° orbital spacing. An earth immediately succeeding the last respectively, must comply with the station antenna initially authorized on sentence of paragraph (c). procedures set forth in § 25.220. or before February 15, 1985 will be b. Revising paragraph (d). (f) The Commission has authority to authorized by the Commission to c. Adding paragraphs (e) and (f). apply the power level limits in this continue to operate as long as such The additions and revisions read as section to earth station applications for operations are found not to cause follows: authority to operate in any other FSS

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1293 frequency band to the extent it deems the applicant has provided the affidavits levels in § § 25.134, 25.211, 25.212, or necessary to prevent unacceptable listed in paragraph (d)(1) of this section the power density levels derived interference into adjacent satellite from the operator of that satellite(s). through the procedure set forth in systems, to the extent that power limits (3) The applicant will not be paragraph (c)(1) of this section, have not been established elsewhere in permitted to transmit to any satellite whichever is applicable, shall provide this part. unless the applicant has provided the the following affidavits as an exhibit to 27. Section 25.220 is added to read as affidavits listed in paragraph (e)(1) of its earth station application: follows: this section from the operator of that (i) A statement from the satellite satellite(s). operator acknowledging that the § 25.220 Non-conforming transmit/receive (d)(1) If an antenna proposed for use proposed operation of the subject non- earth station operations. by the applicant does not comply with conforming earth station with its (a)(1) This section applies to earth the performance standards contained in satellite(s) has the potential to create station applications in which: § 25.209(a) and (b), the applicant must interference to adjacent satellite (i) The proposed antenna does not submit the affidavits listed in networks that may be unacceptable. conform to the standards of § 25.209(a) paragraphs (d)(1)(i) through (d)(1)(iv) of (ii) A statement from the satellite and § 25.209(b), and/or this section to qualify for protection operator that it has coordinated the (ii) The proposed power density from receiving interference from other operation of the subject non-conforming levels are in excess of those specified in satellite systems. The applicant will be Earth Station accessing its satellite(s), § 25.134, § 25.211, or § 25.212, or those granted protection from receiving and its corresponding downlink power derived by the procedure set forth in interference only with respect to the density requirements (based on the paragraph (c)(1) of this section, satellite systems included in the information contained in the whichever is applicable. coordination agreements referred to in application) with all adjacent satellite (2) Paragraphs (b) through (e) and (g) the affidavit required by paragraph networks within 6° of orbital separation of this section apply to the earth station (d)(1)(ii) of this section, and only to the from its satellite(s), and the operations applications described in paragraph extent that protection from receiving will not violate any existing (a)(1) of this section, in which the interference is afforded by those coordination agreement for its applicant seeks transmit/receive coordination agreements. satellite(s) with other satellite systems. authority. (i) A statement from the satellite (iii) A statement from the satellite (3) Paragraphs (f) and (g) of this operator acknowledging that the operator that it will include the subject section applies to the earth station proposed operation of the subject non- non-conforming Earth Station power applications described in paragraph conforming earth station with its and power densities in all future (a)(1) of this section in which the satellite(s) has the potential to receive satellite network coordinations, and applicant seeks transmit-only or receive- interference from adjacent satellite (iv) A statement from the Earth station only authority. networks that may be unacceptable. applicant certifying that it will comply (4) The requirements for petitions to (ii) A statement from the satellite with all coordination agreements deny applications filed pursuant to this operator that it has coordinated the reached by the satellite operator(s). section are set forth in § 25.154. operation of the subject non-conforming (2) A license granted pursuant to (b) If an antenna proposed for use by earth station accessing its satellite(s), paragraph (e)(1) of this section will the applicant does not comply with the including its required downlink power include, as a condition on that license, antenna performance standards density based on the information that if no good faith agreement can be contained in § 25.209(a) and (b), the contained in the application, with all reached between the satellite operator applicant must provide, as an exhibit to adjacent satellite networks within 6° of and the operator of a future 2° its FCC Form 312 application, the orbital separation from its satellite(s), compliant satellite, the earth station antenna gain patterns specified in and the operations will not violate any operator shall reduce its power to those § 25.132(b). existing coordination agreement for its levels that would accommodate the 2° (c) If an antenna proposed for use by satellite(s) with other satellite systems. compliant satellite. the applicant does not comply with the (iii) A statement from the satellite (f)(1) If an earth station applicant performance standards contained in operator that it will include the subject requests transmit-only authority, and its § 25.209(a) and (b), the applicant must non-conforming earth station operations proposed antenna does not conform to meet the requirements of either in all future satellite network the standards of § 25.209(a) and (b), it paragraph (c)(1) or (c)(2) of this section coordinations, and must meet the requirements of to obtain protection from receiving (iv) A statement from the Earth station paragraphs (b) and (c) of this section. interference from adjacent satellite applicant certifying that it will comply (2) If an earth station applicant operators. The applicant must meet the with all coordination agreements requests transmit-only authority, and its requirements of either paragraph (c)(1) reached by the satellite operator(s). proposed proposed power density levels or (c)(3) of this section to obtain (2) A license granted pursuant to are in excess of those specified in authority to transmit. paragraph (d)(1) of this section will § § 25.134, 25.211, or 25.212, or those (1) The applicant must provide in its include, as a condition on that license, derived by the procedure set forth in Form 312, Schedule B, the power and that if no good faith agreement can be paragraph (c)(1) of this section, it must power density levels that result by reached between the satellite operator meet the requirements of paragraph (e) reducing the values stated in § § 25.134, and the operator of a future 2° of this section. 25.211, or 25.212, whichever is compliant satellite, the earth station (3) If an earth station applicant applicable, by the number of decibels operator shall accept the power density requests receive-only authority, and its that the non-compliant antenna fails to levels that would accommodate the 2° proposed antenna does not conform to meet the antenna performance standard compliant satellite. the standards of § 25.209(a) and (b), it of § 25.209(a) and (b), or (e)(1) An earth station applicant must meet the requirements of (2) The applicant will not receive proposing to use transmitted satellite paragraphs (b) and (d) of this section. protection from adjacent satellite carrier EIRP densities, and/or maximum (g) Applicants filing applications for interference from any satellite unless power into the antenna in excess of the earth stations pursuant to this section

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 1294 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules must provide the following information PART 25Ð[AMENDED] Parts (SUP) Program). Motor Carriage. for the Commission’s public notice: The recent establishment of DOT’s 30. Part 25 is amended by removing Federal Motor Carrier Safety (1) Detailed description of the service subpart H. to be provided, including frequency Administration has led to the bands and satellites to be used. [FR Doc. 01–88 Filed 1–5–01; 8:45 am] development of a management BILLING CODE 6712±01±P information system (Motor Carrier (2) The diameter of the antenna. Management Information System, DOT/ (3) Proposed power and power FMCSA 001) that will encompass, density levels. DEPARTMENT OF TRANSPORTATION among other things, safety (4) Identification of any random investigations of commercial motor access technique listed in § 25.134(a). Office of the Secretary carriers and of their drivers. In both (5) Identification of any rule or rules instances, investigations can result in for which a waiver is requested. 49 CFR Part 10 criminal prosecutions. To facilitate the cooperation of persons who have [Docket No. OST±96±1437; Notice 2000±1] 28. In § 25.274, revise paragraph (g) to information relevant to these read as follows: RIN 2105±AC57 investigations and who ask for § 25.274 Procedures to be followed in the confidentiality as a condition of their event of harmful interference. Privacy Act of 1974; Implementation providing that information, DOT * * * * * AGENCY: Office of the Secretary, proposes to exempt these systems from subsections (c)(3) (Accounting for (g) Where the earth station suspected Department of Transportation (DOT). Certain Disclosures), (d) (Access to of causing interference to the operations ACTION: Proposed rulemaking. Records), (e)(4)(G), (H), and (I) (Agency of another earth station cannot be Requirements), and (f) (Agency Rules) of identified or is identified as an earth SUMMARY: DOT proposes to exempt from the Privacy Act, 5 USC 552a. If we do station operating on a satellite system certain provisions of the Privacy Act the not exempt this system from these other than the one on which the earth record system designed to assist in provisions, persons who are subjects of station suffering undue interference is finding Suspected Unapproved Parts investigation will be able to learn that operating, it is the responsibility of a used in aviation, and a record system they are and who has provided representative of the earth station used to manage the flow of data about information about them, both of which suffering harmful interference to contact commercial motor carriers. An editorial correction is also proposed to some could well frustrate any investigation. the control center of other satellite Finally, in the Appendix, a reference systems. The operator of the earth existing language. Public comment is invited. to subsection (e)(4)(I) was inadvertently station suffering undue interference is omitted from, and section (g) was free to choose any representative to DATES: Comments are due February 20, inadvertently included in explanatory make this contact, including but not 2001. paragraph 2 at the end of, paragraph A. limited to the operator of the satellite ADDRESSES: Comments should be system on which the earth station is addressed to Documentary Services List of subjects in 49 CFR Part 10 operating. The operator of the earth Division, Attention: Docket Section, Privacy. station suffering undue interference is Room PL401, Docket No. OST–96–1437, Accordingly, DOT proposes to amend also free to contact the control center of Department of Transportation, SVC– the Appendix of Part 10 of 49 CFR as the other satellite systems directly. 124, Washington, DC 20590–0001. Any follows: 29. Amend § 25.277 by adding person wishing acknowledgment that 1. The authority citation for Part 10 paragraph (f) to read as follows: his/her comments have been received continues to read as follows: should include a self-addressed Authority: 5 USC 552a; 49 USC 322. § 25.277 Temporary fixed earth station stamped postcard. Comments received 2. Part II A. of the Appendix is operations. will be available for public inspection amended by adding new paragraphs 17 * * * * * and copying in the Documentary and 18, and by revising the first Services Division, Room PL401, (f) Filing requirements concerning sentence of explanatory paragraph 2 to Department of Transportation Building, applications for new temporary fixed read as follows: earth station facilities operating in 400 Seventh Street, SW., Washington, frequency bands shared co-equally with DC, from 9 AM to 5 PM ET Monday * * * * * Part II. Specific Exemptions. terrestrial fixed stations. through Friday except Federal holidays. A. The following systems of records are (1) When the initial location of the FOR FURTHER INFORMATION CONTACT: exempt from subsections (c)(3) (Accounting temporary fixed earth station’s Yvonne Coates, S–80, Office of the Chief of Certain Disclosures), (d) (Access to operation is known, the applicant shall Information Officer, Department of Records, (e)(4)(G), (H), (I) (Agency provide, as part of the Form 312 Transportation, Washington, DC 20590– Requirements) and (f) (Agency rules) of 5 0001; telephone: 202–366–6964; fax: USC 552a, to the extent that they contain application, a frequency coordination investigatory material for law enforcement report in accordance with § 25.203 for 202–366–7024; e-mail: purposes in accordance with 5 USC the initial station location. [email protected]. 552a(k)(2): (2) When the initial location of the SUPPLEMENTARY INFORMATION: Aviation. 17. Suspected Unapproved Parts (SUP) temporary fixed earth station’s To assist in the ongoing campaign of the Program, maintained by the Federal Aviation Administration (DOT/FAA 852). operation is not known at the time the Department’s Federal Aviation 18. Motor Carrier Management Information application is filed, the applicant shall Administration against defective and System (MCMIS), maintained by the Federal provide, as part of the Form 312 dangerous parts being used in aircraft, Motor Carrier Safety Administration (DOT/ application, a statement by the DOT is establishing a Privacy Act record FMCSA 001). applicant acknowledging its system in which evidence will be These exemptions are justified for the coordination responsibilities under gathered as investigations are conducted following reasons: § 25.277. (DOT/FAA 852 Suspected Unapproved * * * * *

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2. From subsections (d), (e)(4)(G), (H), and threats that we evaluated in order to the appropriate Regional Office(s) or (I), and (f), because granting an individual assign a listing priority number to each Nancy Gloman, Chief, Office of access to investigative records, and granting taxon. Conservation and Classification (703/ him/her access to investigative records with We request additional status 358–2171). that information, could interfere with the information that may be available for overall law enforcement process by revealing SUPPLEMENTARY INFORMATION: these candidates as well as information a pending sensitive investigation, possibly Recycled Petition Findings identify a confidential source, disclose on taxa that we should include as information that would constitute an candidates in future updates of this list. Background We will consider this information in unwarranted invasion of another individual’s The Endangered Species Act of 1973, preparing listing documents and future personal privacy, reveal a sensitive as amended (Act) (16 U.S.C. 1531 et investigative technique, or constitute a recycled petition findings. This seq.), provides two mechanisms for potential danger to the health or safety of law information will help us in monitoring enforcement personnel. * * * changes in the status of candidate taxa considering species for listing. First, the and in conserving these taxa. Act places on the Service the duty to Dated: December 28, 2000. identify and propose for listing those DATES: Eugene K. Taylor, Jr., We will accept comments on species which the Service finds require Deputy Chief Information Officer, U.S. these recycled petition findings at any listing under the standards of section Department of Transportation. time. 4(a)(1). We implement this duty through [FR Doc. 01–191 Filed 1–5–01; 8:45 am] ADDRESSES: Submit your comments the candidate assessment program. BILLING CODE 4910±62±M regarding a particular taxon to the Candidate taxa are those taxa for which Regional Director of the Region we have on file sufficient information identified as having the lead on biological vulnerability and threats DEPARTMENT OF THE INTERIOR responsibility for that taxon. You may to support issuance of a proposed rule submit comments of a more general to list, but issuance of the proposed rule Fish and Wildlife Service nature to the Chief, Office of is precluded by other higher priority Conservation and Classification, listing actions. Second, the Act allows 50 CFR Part 17 Division of Endangered Species, U.S. the public to petition us to add a species Fish and Wildlife Service, 4401 N. to the Threatened and Endangered Endangered and Threatened Wildlife Fairfax Drive, Room 420, Arlington, Species List. Under section 4(b)(3)(A), and Plants; Annual Notice of Findings Virginia 22203 (703/358–2171). Written when we receive such a petition, we on Recycled Petitions comments and materials received in must determine within 90 days, to the AGENCY: Fish and Wildlife Service, response to this notice will be available maximum extent practicable, whether Interior. for public inspection by appointment at the petition presents substantial ACTION: Notice of review. the appropriate Regional Office listed information that listing is warranted (a below. ‘‘90-day finding’’). If we make a positive SUMMARY: In this notice of review, we Information regarding the range, 90-day finding, under section 4(b)(3)(B) announce our recycled petition status, and habitat needs of and listing we must make one of three possible findings, as required in section priority assignment for a particular findings within 12 months of the receipt 4(b)(3)(C)(i) of the Endangered Species taxon is available for review at the of the petition (a ‘‘12-month finding’’). Act of 1972, as amended. When, in appropriate Regional Office listed below The first possible 12-month finding is response to a petition, we complete a or at the Division of Endangered that listing is not warranted, in which 12-month finding that listing a species Species, address listed above. case we need take no further action on is warranted but precluded, we must Region 1. California, Hawaii, Idaho, the petition. Second, we may find that make a new 12-month finding each year Nevada, Oregon, Washington, listing is warranted, in which case we until we publish a proposed rule or American Samoa, Guam, and the must promptly publish a proposed rule make a determination that listing is not Commonwealth of the Northern to list the species. Once we publish a warranted. These subsequent 12-month Mariana Islands. proposed rule for a species, section findings are referred to as recycled Regional Director (TE), U.S. Fish and 4(b)(5) and (6) govern further petition findings. Wildlife Service, Eastside Federal procedures, regardless of whether or not Information contained in this notice Complex, 911 N.E. 11th Avenue, we issued the proposal in response to a of review is based on our review of the Portland, Oregon 97232–4181 (503/ petition. Third, we may find that listing current status and threats to taxa that 231–6158). is ‘‘warranted but precluded.’’ Such a were the subjects of 27 outstanding Region 2. Arizona, New Mexico, finding means that immediate warranted but precluded findings. Oklahoma, and Texas. publication of a proposed rule to list the Based on our review, we find that 26 Regional Director (TE), U.S. Fish and species is precluded by higher priority species continue to warrant listing or Wildlife Service, 500 Gold Avenue listing proposals, and that we are changes in classification, but these S.W., Room 4012, P.O. Box 1306, making expeditious progress to add and activities are precluded by listing Albuquerque, New Mexico 87102 remove species from the Lists, as activities of higher priority as (505/248–6920). appropriate. determined by our listing priority Region 6. Colorado, Kansas, Montana, The standard for making a 12-month guidance. One species no longer Nebraska, North Dakota, South warranted but precluded finding on a warrants listing under the Endangered Dakota, Utah, and Wyoming. petition to list a species is identical to Species Act and, therefore, has been Regional Director (TE), U.S. Fish and our standard for making a species a removed from the candidate list. Wildlife Service, P.O. Box 25486, candidate for listing. Therefore, we add We announce the availability of Denver Federal Center, Denver, all petitioned species subject to such a listing priority assignment forms for Colorado 80225–0486 (303/236– finding to the candidate list. Pursuant to candidate taxa and listing priority 7400). our Petition Management Guidance, determinations for proposed taxa. These FOR FURTHER INFORMATION CONTACT: The made available on July 9, 1996 (61 FR documents describe the status and Endangered Species Coordinator(s) in 36075), we consider a petition to list a

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 1296 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules species already on the candidate list to January 6, 1989 (54 FR 554), and with in the ‘‘Category’’ column at the left side be a second petition and, therefore, minor corrections on August 10, 1989 of the table. We identify the taxa for redundant. We do not interpret the (54 FR 32833). We again published which we have made a continued petition provisions of the Act to require comprehensive animal notices on ‘‘warranted but precluded’’ finding on a us to make a duplicative finding; November 21, 1991 (56 FR 58804), recycled petition by the code ‘‘C’’ in the therefore, we will not make additional November 15, 1994 (59 FR 58982), and, category column. The ‘‘C’’ in this 90-day findings or initial 12-month as part of combined animal and plant column indicates taxa that are findings on petitions to list candidate notices, on February 28, 1996 (61 FR candidates for listing. We identify the species. Any petition regarding which 7596), and September 19, 1997 (62 FR one species removed from candidate we have made a warranted but 49398). On October 25, 1999 (64 FR status with the word ‘‘removed’’ in the precluded finding is subject to section 57534), we published our most recent category column. Candidates are taxa for 4(b)(3)(C)(i), which requires us to make combined candidate notice of review. which we have on file sufficient a new 12-month finding on the petition This notice is our recycled finding for information on biological vulnerability within 12-months of our determination the taxa that were the subjects of 27 and threats to support proposals to list that the petition action was warranted outstanding warranted but precluded them as endangered or threatened. but precluded. These required annual findings (21 findings for listing, 1 for Issuance of proposed rules for these taxa findings on warranted but precluded withdrawal, and 5 species for is precluded at present by other higher listing actions are referred to as recycled reclassification). We also provide notice priority listing actions. We anticipate petition findings. This notice constitutes of revised listing priority numbers and developing and publishing proposed publication of our recycled petition of removal of one species from rules for candidate taxa in the future. findings for all species on the candidate candidate status. We emphasize that we The column labeled ‘‘Priority’’ list that are currently the subject of an are not proposing these candidates for indicates the listing priority number for outstanding petition. This notice also listing by this notice, but we anticipate candidate taxa. We assign this number constitutes publication of recycled developing and publishing proposed based on the immediacy and magnitude petition findings for species subject to a listing rules for these taxa in the future. of threats as well as on taxonomic petition to reclassify an already-listed We encourage State agencies, other status. We published a complete species from threatened or endangered. Federal agencies, and other parties to description of our listing priority system give consideration to these taxa in in a September 21, 1983, Federal Previous Notices of Review environmental planning. We intend to Register notice (48 FR 43098). We have The Act directed the Secretary of the publish a new combined candidate revised the listing priority numbers for Smithsonian Institution to prepare a notice of review that contains all three species, identified by asterisks in report on endangered and threatened candidate species in March 2001. this column, as discussed below. plant taxa, which was published as The third column identifies the Findings on Recycled Petitions House Document No. 94–51. We Regional Office to which you should published a notice in the Federal Pursuant to section 4(b)(3)(C)(i), direct comments or questions (see Register on July 1, 1975 (40 FR 27823), when, in response to a petition, we find ADDRESSES section). We will consider in which we announced that we would that listing a species is warranted but all information provided in response to review more than 3,000 native plant precluded, we must make a new 12- this notice of review in deciding taxa named in the Smithsonian’s report month finding each year until we whether to propose taxa for listing and and other taxa added by the 1975 notice publish a proposed rule or make a when to undertake necessary listing for possible addition to the List of determination that listing is not actions. Comments received will Endangered and Threatened Plants. A warranted. These subsequent 12-month become part of the administrative record new comprehensive notice of review for findings are referred to as recycled for the taxa. native plants, that took into account the petition findings. Following the scientific name of each earlier Smithsonian report and other We reviewed the current status and taxon (fourth column) is the family accumulated information, superseded threats to the taxa that were the subjects designation (fifth column) and the the 1975 notice on December 15, 1980 of the 27 outstanding warranted but common name, if one exists (sixth (45 FR 82479). On November 28, 1983 precluded findings (22 finding for column). The seventh column provides (48 FR 53640), a supplemental plant listing and 5 species for the known historical range for the taxon, notice of review noted changes in the reclassification). As a result of this indicated by postal code abbreviations status of various taxa. We published review, we have made continued for States and U.S. territories (many taxa complete updates of the plant notice on warranted but precluded findings for 26 no longer occur in all of the areas September 27, 1985 (50 FR 39526), species (21 petitioned for listing and 5 listed). February 21, 1990 (55 FR 6184), for reclassification) and a not warranted September 30, 1993 (58 FR 51144), and, finding for 1 candidate. Below we Changes in Listing Priority as part of combined animal and plant provide additional information on status Washington ground squirrel notices, on February 28, 1996 (61 FR changes we have made as a result of our (Spermophilus washingtoni) 7596), September 19, 1997 (62 FR review conducted from October 25, Since the October 25, 1999, 49398), and October 25, 1999 (64 FR 1999, to date. See Table 1 for a summary publication of the Candidate Notice of 57534). of the candidate information. Listing Review we have received additional We published earlier comprehensive priority assignment form and listing information on the overall decline of the reviews for vertebrate animals in the priority determinations for proposed Washington ground squirrel throughout Federal Register on December 30, 1982 taxon are available by request (see its range and the increased magnitude (47 FR 58454), and on September 18, Addresses). These documents describe and permanence of threat that 1985 (50 FR 37958). We published an the status and threats that we evaluated agricultural conversion poses to its initial comprehensive review for in order to assign priority number to continued existence. Based on this invertebrate animals on May 22, 1984 each taxon. information we have changed the listing (49 FR 21664). We published a Taxa in Table 1 of this notice are priority number from 5 (a species with combined animal notice of review on assigned to two status categories, noted high magnitude, non-imminent threats)

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1297 to 2 (a species with high magnitude, the magnitude of these threats. In causing a reduction in prey availability. imminent threats). additional there is currently proposed Development of springs to provide Betts (1990, 1999) documented the development for areas which currently water for grazing has resulted in loss of curtailment in the range of the support the highest known surface water, reduced areas occupied Washington ground squirrel to three concentration of Washington ground during the winter by dormant spotted disjunct areas. His surveys on historic squirrels (Greene 1999), this proposed frogs, and result in loss of continuous and documented occurrences focused development increases the immediacy surface flows between foraging and on the perimeters of the range with the of the threats. Great Basin population of wintering sites. intent of evaluating reductions in the Columbia spotted frog (Rana There are large areas in the numbers of colonies and the size of the luteiventris), northeastern part of Nevada and current range. Although Betts’ surveys We have changed the listing priority southeastern Oregon where there has do not provide an exhaustive survey of number from 9 (a population with been little to no monitoring or surveying all potential squirrel locations or moderate magnitude, imminent threats) of occupied sites, and no actions have numbers of individuals, they do provide to 3 (a population with high magnitude, been taken yet to protect populations or a good estimate of the distribution and imminent, threats). This is based on a restore habitats in that region. Even in decline of Washington ground squirrels decrease in survival of newly hatched Idaho, where the status of populations in Oregon and Washington. Betts found and adult frogs and an increase in the are better known, neither the Bureau of that the species had disappeared from magnitude of the threats to the Great Land Management, on which some of 73.8 percent of the sites in Washington Basin population of the Columbia the known populations are found, nor and 76.9 percent of the sites in Oregon. spotted frogs from introduction of non- the State of Idaho have implemented In addition, Betts (1990) subjectively native fishes, grazing, and lack of conservation measures to control evaluated the vulnerability to extinction regulatory mechanisms. grazing within wetlands/riparian of each of the remaining known colonies Columbia spotted frogs in Idaho have habitats, stocking of non-native fish, or based on colony size, isolation, land shown significant declines in the last the development of springs in a manner ownership, and threat from human years through reductions in both newly consistent with Columbia spotted frog activity. hatched and adult survival. At the conservation. The lack of effective In 1990, Betts predicted that largest known site in Idaho, frog conservation actions, coupled with the approximately 29 percent of all colonies numbers have shown a significant recent declines, has resulted in an were highly vulnerable to extinction (19 decline, although eggs masses were increase in the magnitude and percent in Oregon, 35 percent in identified there was little or no survival immediacy of the threat since our last Washington); 31 percent were of these eggs to tadpoles or adult. One evaluation. moderately vulnerable (39 percent in other known population appears to be We also are correcting the historical Oregon, 25 percent in Washington); and extirpated due to the loss of beaver range for the Great basin population of 40 percent had low vulnerability (42 activity, with only one male frog the Columbia spotted frog. In the percent in Oregon, 39 percent in observed in 1999. Monitoring at another October 25, 1999, Federal Register it Washington). Since this prediction site that has been protected from grazing was erroneously published as U.S.A. follow up monitoring has shown that (although the spring and source of water (AK, CA, ID, MT, NV, OR, UT, WA, Betts’ predictions proved correct, and has been developed for off-site water WY), Canada. The correct historical many colonies classified as highly access by livestock), has had no range should read U.S.A. (NV, ID, OR); vulnerable were no longer present by documented recruitment in the last this has been changed in Table 1 of this 1999 (Betts 1999). three years (all frogs have been pit- notice. In addition to new information tagged at this site) and may disappear as Oregon spotted frog (Rana pretiosa) regarding population declines, recent the existing breeding females age. reports indicate that agricultural The introduction of non-native The listing priority number was conversion permanently eliminates salmonid and bass species for erroneously published as 6 in the 1999 Washington ground squirrel habitat and recreational fishing may have negatively CNOR. The listing priority number was use. Prior to this new information it was affected frog species throughout the changed from 6 (a subspecies with thought that areas could again be United States. The negative effects of moderate magnitude, imminent threats) recolonized. However, because the predation of this kind are difficult to to 2 (a full species, with high squirrel is so closely tied to deep, silty document, particularly in open stream magnitude, imminent threats) in the soils, specifically Warden soils on the systems. However, significant negative 1997 CNOR when the Oregon spotted Boeing Tract (Greene 1999), the tilling effects of predation on frog populations frog received full species recognition, and other mechanisms involved in in lake systems have been documented and should have been continued as 2 in conversion of shrub-steppe habitats to through research (Hayes and Jennings the 1999 CNOR. agricultural crop production not only 1986, Pilliod et al. 1996). The stocking Threats are considered imminent destroys the species’ food source, but it of non-native fishes is common because the remaining populations have also renders the soils necessary for throughout the waters of the Great experienced high mortality rates in burrowing unuseable and irretrievably Basin. Given the recent declines of frog recent years and the remaining modified. Washington ground squirrels populations and continued stocking of populations are isolated from each other are not found in tilled croplands non-native fishes, we believe the and face multiple threats. It has unique (Carlson et al. 1980; Betts 1990, 1999; magnitude of this threat has increased. egg-laying habits that make egg masses Quade 1994), nor have they been Grazing has also been identified as a susceptible to freezing and drought; two located in undeveloped areas between threat because it removes vegetative to three years of drought could irrigated crops (CH2M Hill 2000). As a cover and shrubs eliminating shelter eliminate a population. Communal egg result of these studies it is clear that necessary for frogs to avoid predators laying at traditional sites makes the once areas have been modified they are and UV-B radiation; in addition, cattle Oregon spotted frog especially no longer able to support Washington tramping on the banks and within the vulnerable to habitat loss. The best ground squirrels not only in the present water can cause changes in water documented population, at Conboy Lake but in the future as well, thus increasing temperature and water chemistry, National Wildlife Refuge, experienced a

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22.6 percent decline in egg mass counts we concluded in the initial 12-month protect the swift fox. Since then, 10 from 1998 to 1999. finding published June 16, 1995 (60 FR State wildlife agencies within the At the time of the original petition in 31663). Information gathered by the historic range of the swift fox have 1989 to list the spotted frog we used SFCT in Kansas and Colorado committed significant resources towards Thompson’s (1913) description of two demonstrates that the swift fox has been the conservation of the species with the subspecies, Rana pretiosa pretiosa and able to adapt to a mixed prairie- development of the CACS (Kahn et al. Rana pretiosa luteiventris, as our agricultural landscape. 1997). The primary objectives of the classification. However, this subspecific Adaptability to various habitat types CACS have largely been completed with classification was no longer recognized was further demonstrated in Wyoming the organization of the SFCT, the at the time of the initial warranted but where the swift fox was found to occupy acquisition of State and Federal precluded 12-month finding in 1993, sagebrush-grassland and sagebrush- funding, the generation of annual when we identified 5 distinct vertebrate greasewood habitat types with reports, and the determination of populations of the spotted frog. This topography ranging from flat to badland- current distribution of the swift fox. differentiation was based on geographic like terrain. Other habitat types used by Based on our reexamination of these and climatic separation, and supported swift fox included the sandhills of threats, and pursuant to our analysis of by genetic information. The confusing Nebraska and pinon-juniper habitat in the five factors under section 4(a)(1), we taxonomy resulting from reliance on Colorado and Oklahoma (Hoagland, find that the swift fox is not likely to morphological differences is being Swift Fox Conservation Team Chair, in become in danger of extinction clarified using recently developed litt. 2000). Historic and recent data throughout all or a significant portion of biochemical techniques for genetic indicate that the swift fox can be its range in the foreseeable future. analyses. Green (1986) used an analysis regionally adaptable in its food Therefore, we find that the petitioned of proteins to determine that Rana preferences and is not dependent upon action is not warranted and are pretiosa was a complex of at least 2 prairie dog communities to provide removing the swift fox from the species (Green 1986, Green et al. 1996). forage across most of its current range candidate list. Further protein and statistical analyses (Allen et al. 1995, Giddings 1997, Luce Findings on Reclassification From of 20 morphological measurements and Lindzey 1996, Roy 1998, Schmitt Threatened to Endangered provided additional information to help 2000). define the ranges of these 2 species As a result of new information, We have also previously made (Green et al. 1997), now known as the originally identified threats are no warranted but precluded findings for Oregon spotted frog and the Columbia longer applicable for the following petitions that sought to reclassify spotted frog. reasons: (1) The swift fox is more species status listed as threatened to abundant and widely distributed than endangered. Because these species are Finding on Candidate Removals previously thought, and (2) the species already listed, they are not candidates Swift Fox (Vulpes velox) is more flexible in its habitat for listing, and so are not included in requirements than originally believed. Table 1. However, this notice also In 1994, the Swift Fox Conservation The Service’s 1995 12-month Finding constitutes the recycled petition Team (SFCT) was formed by the 10 concluded that most remaining swift fox findings for these species. We find that States within the historic range of the populations occurred in marginally reclassification from threatened to swift fox, Canada, and several Federal viable populations in scattered, isolated endangered status is currently agencies, including the Service. This pockets of remnant short and mid-grass warranted but precluded for: team has drafted the Swift Fox prairie habitat. Moreover, we concluded (1) North Cascades Ecosystem grizzly Conservation Assessment and that most remaining grassland in the bear (Ursus arctos horribilis) population Conservation Strategy (CACS)(Kahn et western Great Plains consisted of a (Region 6); al. 1997), and produced five annual mixed cropland/grassland mosaic which (2) Cabinet-Yaak grizzly bear reports (Allen et al. 1995, Giddings did not favor swift fox use. However, populations (Region 6); 1997, Luce and Lindzey 1996, Roy 1998, extensive rangelands still exist as (3) Selkirk grizzly bear populations Schmitt 2000) which have provided predominately grassland environments (Region 6); additional information regarding the in the swift fox’s historic range and (4) spikedace (Meda fulgida) (Region distribution and abundance of the although some conversion to agriculture 2); and species. Swift fox distribution is more use is still occurring, it is at a much (5) loach minnow (Tiaroga cobitis) widespread than we originally lower rate than in previous years. (Region 2). concluded in our initial warranted but Additionally, recent studies indicate precluded 12-month finding in 1995. that the swift fox is more flexible than Progress in Revising the Lists The species occurs in 9 of the 10 States we previously determined in its habitat As described in section 4(b)(3)(B)(iii) within the historic range, and in requirements and can utilize areas with of the Act, in order for us to make a approximately 40 percent of its historic mixed land uses (Allen et al. 1995, ‘‘warranted but precluded’’ finding on a range. Evaluations conducted by the Giddings 1997, Luce and Lindzey 1996, petitioned action, we must be making SFCT have demonstrated nearly Roy 1998, Schmitt 2000). expeditious progress to add qualified continuous distribution of swift fox In the original finding we believe that taxa to the Lists of Endangered and populations from Wyoming south commercial trapping of furbearers Threatened Wildlife and Plants and to throughout eastern Colorado, western within the range of the swift fox may remove from the list taxa for which the Kansas, the Oklahoma Panhandle, have been a threat. However, available protections of the Act are no longer eastern New Mexico, and in two or three information suggests that this harvest necessary. counties in the extreme northern has not limited swift fox populations. We are making expeditions progress panhandle of Texas. Scattered We have also found no indication that in listing and delisting taxa during fiscal populations can also be found in parasites or diseases are significant year 2000 (October 1, 1999, to October Montana, South Dakota, and Nebraska. factors in the population dynamics of 1, 2000) as represented by our The swift fox also appears to be more wild foxes. In the 12-month finding, we publication in the Federal Register of general in its habitat requirements than cited a lack of regulatory mechanisms to emergency rules for 1 taxa, final listing

VerDate 112000 17:34 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 E:\FR\FM\08JAP1.SGM pfrm01 PsN: 08JAP1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1299 actions for 38 species, proposed listing (8) noting any mistakes, such as errors squirrels in North-Central Oregon. M.S. actions for 18 species, final delisting in the indicated historical ranges. Thesis, Oregon State University, Corvallis, actions for 1 species, proposed delisting OR. 59 pp. References Cited actions for 1 species, withdrawals of Hayes, M.P. and M.R. Jennings. 1986. Decline of ranid frog species in western North proposed rules for 1 species, final Allen, S.H., J.W. Hoagland, and E.D. Stukel. 1995. Report of the Swift Fox Conservation America: are bullfrogs responsible? J. designation of critical habitat for 5 Herpetology 20:490–509. species, proposed designation of critical Team. Betts, B.J. 1990. Geographic distribution and Kahn, R., L. Fox, P Horner, B. Giddings, and habitat for 17 species, 12-month petition habitat preferences of Washington ground C. Roy. 1997. Conservation assessment and finding for 7 species, and 90-day squirrels (Spermophilus washingtoni). conservation strategy for swift fox in the petition findings for 15 species. Northwestern Naturalist 71:27–37. United States. 54 pp. Betts, B.J. 1999. Current status of Washington Luce, B., and F. Lindzey. 1996. Annual Request for Information ground squirrels in Oregon and Report of the Swift Fox Conservation We request you submit any further Washington. Northwestern Naturalist Team. Pilliod, D., C.R, Peterson, P. Ritson. 1996. information on the taxa named in this 80:35–38. Carlson L., G. Geupel, J. Kjelmyr, J. Maciver, Impacts of introduced fish on spotted frog notice as soon as possible or whenever M. Morton, and N. Shishido. 1980. populations in high mountain lakes of it becomes available. Additionally, we Geographical range, habitat requirements, central Idaho. A summary of the invite any further comment or and a preliminary population study of conference on declining and sensitive information on any candidate taxa Spermophilus washingtoni. Final amphibians in the Rocky Mountains and mentioned in the October 25, 1999, Technical Report, National Science Pacific Northwest Idaho, Herpetological Candidate Notice or Review or found on Foundation Student-originated Studies Society and U.S. Fish and Wildlife Service, the Fish and Wildlife Service website. Program. 24 pp. Snake River Basin Office Report, Boise, We especially seek information: CH2M Hill. 2000. Washington ground Idaho. squirrel survey, April 12 and 13, 2000: Beef Quade, C. 1994. Status of Washington ground (1) indicating that we should remove Northwest, Boeing Boardman Tract, squirrels on the Boardman Naval Weapons a taxon from candidate or proposed Morrow County, Oregon. Field Report to Systems Training Facility: evaluation of status; Beef Northwest. 8 pp. monitoring methods, distribution, (2) indicating that we should add a Giddings, B. 1997. Swift Fox Conservation abundance, and seasonal activity patterns. taxon to the list of candidate taxa; Team Annual Report. Unpublished. Green, D. M. 1986. Systematics and evolution (3) recommending areas that we Roy, C. 1998. Swift Fox Conservation Team of western North American frogs allied to Annual Report. should designate as critical habitat for a Rana aurora and Rana boylii: Schmitt, G. 2000. Swift Fox Conservation taxon, or indicating that designation of electrophoretic evidence. Systematic Team Annual Report. critical habitat would not be prudent for Zoology 35:283–296. Thompson, H.B. 1913. Description of a new a taxon; Green, D. M., T.F. Sharbel, J. Kearsley, and subspecies of Rana pretiosa from Nevada. (4) documenting threats to any of the H. Kaiser. 1996. Postglacial range Proceedings of the Biological Society of fluctuation, genetic subdivision, and Washington 26:53–56. included taxa; speciation in the western North American (5) describing the immediacy or spotted frog complex, Rana pretiosa. Authority magnitude of threats facing candidate Evolution 50:374–390. taxa; Green, D. M., H. Kaiser, T.F. Sharbel, J. This notice of review is published (6) pointing out taxonomic or Kearsley, and K.R. McAllister. 1997. under the authority of the Endangered nomenclatural changes for any of the Cryptic species of spotted frogs, Rana Species Act (16 U.S.C. 1531 et seq.). pretiosa complex, in western North Dated: December 8, 2000. taxa; America. Copeia 1997:1–8. (7) suggesting appropriate common Greene, E. 1999. Abundance and habitat Jamie Rappaport Clark, names; or associations of Washington ground Director, Fish and Wildlife Service.

TABLE 1.ÐPETITIONED CANDIDATES (ANIMAL AND PLANT) [*denotes change in Listing Priority Number since October 25, 1999 review]

Status Lead Scientific name Family Common name Historic range Category Priority region

Mammals

C ...... 3 1 Emballonura Emballonuridae ...... Bat, sheath-tailed U.S.A. (AS, GU, MP semicaudata. (Aguijan, American (Aguijan)). Samoa population). C ...... *2 1 Spermophilus Sciuridae ...... Washington ground U.S.A. (OR, WA). washingtoni. squirrel. Removed N/A 6 Vulpes velox ...... Canidae ...... Fox, swift (U.S. popu- U.S.A. (CO, IA, KS, MN, lation). MT, ND, NE, NM, OK, SD, TX, WY), Can- ada.

Birds

C ...... 3 1 Oceanodroma castro .... Hydrobatidae ...... Storm-petrel, band- U.S.A. (HI). rumped (=Harcourt's) (Hawaii population). C ...... 8 2 Tympanuchus Phasianidae ...... Lesser prairie chicken ... U.S.A (CO, KS, NM, pallidicinctus. OK, TX).

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TABLE 1.ÐPETITIONED CANDIDATES (ANIMAL AND PLANT)ÐContinued [*denotes change in Listing Priority Number since October 25, 1999 review]

Status Lead Scientific name Family Common name Historic range Category Priority region

Reptiles

C ...... 5 2 Graptemys caglei ...... Emydidae ...... Turtle, Cagle's map ...... U.S.A. (TX.)

Amphibians

C ...... 5 1 Ambystoma Ambystomatidae ...... Salamander, California U.S.A. (CA). californiense. tiger. C ...... *3 1 Rana luteiventris (for- Ranidae ...... Columbia spotted frog U.S.A. (ID, NV, OR). merly incl. In R. (Great Basis popu- pretiosa). lation). C ...... *2 1 Rana pretoisa ...... Ranidae ...... Frog, Oregon spotted U.S.A. (CA, OR WA), (formerly spotted frog Canada. (W. Coast popu- lation)). C ...... 3 6 Bufo boreas boreas ...... Bufonidae ...... Toad, boreal (Southern U.S.A. (CO, MN, WY). Rocky Mtns. popu- lation).

Fish

C ...... 9 6 Thymallus arcticus ...... Salmonidae ...... Grayling, Arctic (Upper U.S.A. (MT, WY). Missouri R. fluvial population). C ...... 2 2 Gila intermedia ...... Cyprinidae ...... Chub, Gila ...... U.S.A. (AZ, MN), Mex- ico. C ...... 2 6 Macryhbopsis meeki ..... Cyprinidae ...... Chub, sicklefin ...... U.S.A. (AR, IA, IL, KS, KY, LA, MO, MS, MT, NE, ND, SD, TN). C ...... 2 6 Macryhbopsis gelida ..... Cyrpinidae ...... Chub, sturgeon ...... U.S.A. (AR, IA, IL, KS, KY, LA, MO, MS, MT, NE, ND, SD, TN, WY).

Snails

C ...... 8 2 Pyrgulopsis Hydrobiidae ...... Springsnail, Chupadera U.S.A. (NM). (=Fontelicella) chupaderae. C ...... 8 2 Pyrgulopsis Hydrobiidae ...... Springsnail, Gila ...... U.S.A. (NM). (=Fontelicella) gilae. C ...... 2 2 Tryonia kosteri ...... Hydrobiidae ...... Snail, Koster's tyronia ... U.S.A. (NM). C ...... 11 2 Pyrgulopsis Hydrobiidae ...... Springsnail, New Mexico U.S.A. (NM). (=Fontelicella) thermalis. C ...... 2 2 Assiminea pecos ...... Assununeidae ...... Pecos assiminea snail .. U.S.A. (NM, TX, and Mexico). C ...... 2 2 Pyrgulopsis Hydrobiidae ...... Roswell springsnail ...... U.S.A. (NM). (=Fontelicella) roswellensis.

Insects

C ...... 9 6 Cicindela limbata Cicindelidae ...... Coral Pink Sand Dunes U.S.A. (UT). albissima. tiger beetle.

Plants

C ...... 3 1 Chorizanthe parryi var. Polygonaceae ...... San Fernando Valley fernandina. Spineflower.

[FR Doc. 01–440 Filed 1–5–01; 8:45 am] BILLING CODE 4310±55±U

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Notices Federal Register Vol. 66, No. 5

Monday, January 8, 2001

This section of the FEDERAL REGISTER respond to the annual competition finances goods and related services contains documents other than rules or among applicants who apply on behalf under its Commodity Import Program proposed rules that are applicable to the of their sponsored overseas institutions, which are contracted for by public and public. Notices of hearings and investigations, independent reviewers and ASHA need private entities in the countries committee meetings, agency decisions and to assess the strength and capability of receiving the USAID assistance. Since rulings, delegations of authority, filing of petitions and applications and agency the U.S. organizations, the overseas USAID is not a party to these contracts, statements of organization and functions are institutions and the merits of their USAID needs some means to collect examples of documents appearing in this proposed projects. Easily accessible information directly from the suppliers section. historical records on past of the goods and related services and to accomplishments and performance by enable USAID to take an appropriate repeat USOs, would speed the grant action against them in the event they do AGENCY FOR INTERNATIONAL making process and provide not comply with the applicable DEVELOPMENT documented reasons for both successful regulations. USAID does this by security and unsuccessful applications. from the suppliers, as a condition for Notice of Public Information the disbursement of funds a certificate Annual Reporting Burden Collections Being Reviewed by the and agreement with USAID which U.S. Agency for International Respondents: 70. contains appropriate representations by Development; Comments Requested Total annual responses: 656. the suppliers. Total annual hours requested: 1,824 SUMMARY: U.S. Agency for International hours. Annual Reporting Burden Development (USAID) is making efforts Respondents: 400. to reduce the paperwork burden. USAID Dated: December 28, 2000. Total annual responses: 2,400. invites the general public and other Joanne Paskar, Total annual hours requested: 1,200 Federal agencies to take this Chief, Information and Records Division, hours. opportunity to comment on the Office of Administrative Services, Bureau for following proposed and/or continuing Management. Dated: December 28, 2000. information collections, as required by [FR Doc. 01–401 Filed 1–5–01; 8:45 am] Joanne Paskar, the Paperwork Reduction Act for 1995. BILLING CODE 6116±01±M Chief, Information and Records Division, Comments are requested concerning: (a) Office of Administrative Services, Bureau for Whether the proposed or continuing Management. AGENCY FOR INTERNATIONAL collections of information is necessary [FR Doc. 01–402 Filed 1–5–01; 8:45 am] DEVELOPMENT for the proper performance of the BILLING CODE 6116±01±M functions of the agency, including Notice of Public Information Collection whether the information shall have Requirements Submitted to OMB for practical utility; (b) the accuracy of the Review DEPARTMENT OF AGRICULTURE burden estimates; (c) ways to enhance the quality, utility, and clarity of the SUMMARY: U.S. Agency for International Forest Service information collected; and (d) ways to Development (USAID) has submitted minimize the burden of the collection of the following information collections to Buck Springs Range Analysis EIS; information on the respondents, OMB for review and clearance under the Southwestern Region, Arizona, including the use of automated Paperwork Reduction Act of 1995, Coconino County, Coconino National collection techniques or other forms of Public Law 104–13. Comments Forests information technology. regarding this information collection are AGENCY: Forest Service, USDA. best assured of having their full effect if DATES: Submit comments on or before ACTION: Notice of intent to prepare an March 9, 2001. received within 30 days of this notification. Comments should be environmental impact statement. FOR FURTHER INFORMATION CONTACT: addressed to: Desk Officer for USAID, Beverly Johnson, Bureau for SUMMARY: The Coconino National Forest Office of Information and Regulatory Management, Office of Administrative is planning to prepare an environmental Affairs, Office of Management and Services, Information and Records impact statement on a proposal to Budget (OMB), Washington DC 20503. Division, U.S. Agency for International manage livestock grazing use on the Copies of submission may be obtained Development, Room 2.07–106, RRB, Buck Springs Range Allotment during by calling (202) 712–1365. Washington, DC 20523, (202) 712–1365 the next 10 years. SUPPLEMENTARY INFORMATION: or via e-mail [email protected]. DATES: Comments in response to this OMB Number: OMB 0412–0012. SUPPLEMENTARY INFORMATION: Form Number: AID 282. Notice of Intent concerning the scope of OMB No: OMB 0412–0550. Title: Supplier’s Certificate Agreement the analysis should be received in Form No.: AID 1570–13 and 1570–14. with the U.S. Agency for International writing on or before February 7, 2001. Title: Narrative/Time-Line and Report Development Invoice-and-Contract ADDRESSES: Send written comments to on Commodities (Quarterly Reports). Abstract. USDA Forest Service, Coconino Type of Review: Renewal of Type of Submission: Renewal of National Forest, Blue Ridge Ranger Information Collection. Information Collection. Station, HC 31, Box 300, Happy Jack, Purpose: The purpose of this Purpose: The U.S. Agency for AZ 86024. Electronic mail may be sent information collection is to properly International Development (USAID) to [email protected].

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RESPONSIBLE OFFICIAL: The Forest those factors. Using the document to (see Council of Environmental Quality Supervisor of the Coconino National guide actions proposed for the Buck Regulations for implementing the Forest, Supervisor’s Office 2323 E. Springs Range Allotment, the Team procedural provisions of the National Greenlaw Lane, Flagstaff AZ 86004, will developed objectives and proposed Environmental Policy Act at 40 CFR decide what actions are most management practices for the allotment. 1503.3). appropriate for managing the Buck The resulting Proposed Action was In addition, Federal court decisions Springs Range Allotment. mailed to 209 individuals, organizations have established that reviewers of draft FOR FURTHER INFORMATION CONTACT: and cooperating resource agencies for environmental impact statements must Cathy Taylor, Interdisciplinary Team review and comment in April 1999. structure their participation in the Leader, Blue Ridge Ranger District, (520) From comments received, the Team environmental review of the proposal so 477–2255. developed statements to capture the that it is meaningful and alerts an SUPPLEMENTARY INFORMATION: The substantive issues and developed 6 agency to the reviewers’ position and proposal will issue a grazing permit for additional alternatives other than the contentions. Vermont Yankee Nuclear 634 cow/calf pairs and 8 horses. Annual proposed action. If you commented Power Corp v. NRDC, 435 US 519, 553 Operating Plan would adjust the during this scoping period, these (1978). Environmental objections that number of livestock allowed per year to comments are already incorporated into could have been raised at the draft stage resource conditions. The grazing the analysis. Some of these alternatives may be waived if not raised until after strategy would be a deferred rotation differ in grazing strategies, utilization completion of the final environmental system, with season of use running from levels, permitted numbers of livestock, impact statement. City of Angoon v. about May 15 to October 15. Fencing, pastures utilized, and improvements Hodel, 9th Circuit, (1986) and livestock trailing, water improvements, required, and are briefly described as Wisconsin Heritages, Inc. v. Harris, 490 cattleguards, and riders would be used follows: F. Supp. 1334, 1338 (E.D. Wis. 1980). • Proposed action as discussed above. to manage the distribution of livestock • No graze for a 10-year period. The reason for this is to ensure that and forage utilization, to avoid livestock • Continue current grazing substantive comments and objections grazing in some meadows and riparian management (no action). are made available to the Forest Service areas, and to increase livestock control • Continue deferred rotation and rely at a time when it can meaningfully in sensitive areas. Approximately 22 heavily on herding to affect distribution consider them in the final miles of fence would be constructed, to of livestock and to protect sensitive environmental impact statement. split three pastures, exclude six riparian and headwater meadow To assist the Forest Service in meadows, and protect two springs. habitats. identifying and considering issues and Dense thickets of small trees that • Continue deferred rotation and concerns on the proposed action, currently impede the gathering of emphasize the use of northern tier of comments on the draft environmental livestock would be precommercially pastures, with most southern pastures impact statement should be as specific thinned on 1500 acres to improve that include headwater meadows as possible. It is also helpful if livestock movement, increase the removed from the grazing land base. comments refer to specific pages or understory diversity, reduce the risk of • Implement a rest-rotation strategy, chapters of the draft statement. wildfire, and improve tree growth and where one-half of the allotment is Comments may also address the vigor. grazed each year. Distribution of adequacy of the draft environmental Preliminary issues include the effects livestock and use of sensitive drainages impact statement or the merits of the of grazing on the environment, are addressed primarily through range alternatives formulated and discussed in especially headwater meadows, and improvements. the statement. Reviewers may wish to • effects on species protected under the Implement a rest-rotation strategy refer to the Council on Environmental Endangered Species Act, specifically the on the northern tier of pastures. Quality Regulations for implementing Little Colorado spinedace and the Southern pastures with headwater the procedural provisions of the Mexican spotted owl. meadows are removed from the grazing National Environmental Policy Act at 40 The environmental analysis process land base. CFR 1503.3 in addressing these points. for the Buck Springs Range Allotment It is anticipated that environmental was initiated on June 25, 1998. An analysis and preparation of the draft and Dated: December 18, 2000. Interdisciplinary Team of Forest Service final environmental impact statements Jim Golden, resource specialists, and representatives will take about six months. The Draft Forest Supervisor. from the Arizona Game and Fish Environmental Impact Statement can be [FR Doc. 01–399 Filed 1–5–01; 8:45 am] Department, US Fish and Wildlife expected March of 2001 and the Final BILLING CODE 3410±11±M Service, Arizona Department of EIS in summer. The comment period on Environmental Quality, and the the draft environmental impact allotment permittee, developed a statement extends 45 days from the date DEPARTMENT OF AGRICULTURE guiding document for watershed the Environmental Protection Agency recovery before undertaking an analysis publishes the notice of availability in Natural Resources Conservation of the allotment. They described the the Federal Register. Service many factors affecting watershed The Forest Service believes, at this Notice of Proposed Changes to conditions within the allotment, early stage, it is important to give Section 4 of the Iowa State Technical including elk and livestock grazing, reviewers notice of several court rulings Guide recreation, transportation system, and related to public participation in the introduced aquatic species. In a environmental review process. To be the AGENCY: Natural Resources cooperative effort, the agencies making most helpful, comments on the draft Conservation Service (NRCS), U.S. up the team developed the East Clear environmental impact statement should Department of Agriculture. Creek Watershed Recovery Strategy for be as specific as possible and may the Little Colorado Spinedace and Other address the adequacy of the statement or ACTION: Notice of availability of Riparian Species to address many of the merits of the alternatives discussed proposed changes in the Iowa NRCS

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State Technical Guide for review and Radio Broadcasting to Cuba Act, dated, Officer for BBG, Mr. David Rostker, comment. October 4, 1983, to provide for the Office of Information and Regulatory broadcasting of accurate information to Affairs, Office of Management and SUMMARY: It has been determined by the the people of Cuba and for other Budget, New Executive Office Building, NRCS State Conservationist for Iowa purposes. This act was then amended by Docket Library, Room 10202, NEOB, that changes must be made in the NRCS Pub. Law 101–246, dated, February 16, Washington, DC 20503, Telephone (202) State Technical Guide specifically in 1990, which established the authority 395–3897. Section 4, Practice Standards and for TV Marti. Current Actions: The BBG is Specifications #590, Nutrient DATES: Comments are due on or before requesting reinstatement of this Management, to account for improved March 9, 2001. collection for a three-year period and technology. This practice can be used in approval for a revision to the burden systems that treat highly erodible land. FOR FURTHER INFORMATION CONTACT: The Agency Clearance Officer, Ms. Jeannette hours. DATES: Comments will be received on or Giovetti, BBG, M/AO, Room 1657A–1, Title: Interviews and Other Audience before February 7, 2001. 330 Independence Avenue, SW., Research for Radio and TV Marti. FOR FURTHER INFORMATION CONTACT: Washington, DC 20237, telephone (202) Abstract: Data from this information Leroy Brown, State Conservationist, 205–9692, e-mail address collection are used by BBG’s Office of Natural Resources Conservation Service, [email protected]; or OMB Desk Cuba Broadcasting (OCB) in fulfillment Federal Building, 210 Walnut Street, Officer for BBG, Mr. David Rostker, of its mandate to evaluate effectiveness 693 Federal Building, Des Moines, Iowa Office of Information and Regulatory of Radio and TV Marti operations by 50309; at 515/284–4260; fax 515/284– Affairs, Office of Management and estimating the audience size and 4394. Budget, New Executive Office Building, composition for broadcasts; and assess SUPPLEMENTARY INFORMATION: Section Docket Library, Room 10202, NEOB, signal reception, credibility and 343 of the Federal Agriculture Washington, DC 20503, Telephone (202) relevance of programming through this Improvement and Reform Act of 1996 395–3897. research. states that revisions made after Copies: Copies of the Request for Proposed Frequency of Responses: enactment of the law to NRCS State Clearance (OMB 83–I), supporting Number of Respondents—4880. technical guides used to carry out statement, and other documents that Recordkeeping Hours—.11. highly erodible land and wetland will be submitted to OMB for approval Total Annual Burden—560. provisions of the law shall be made may be obtained from the BBG Dated: January 2, 2001. available for public review and Clearance Officer. Dennis D. Sokol, comment. For the next 30 days the SUPPLEMENTARY INFORMATION: Public Director of Administration. NRCS will receive comments relative to reporting burden for this proposed [FR Doc. 01–450 Filed 1–5–01; 8:45 am] the proposed changes. Following that collection of information is estimated to BILLING CODE 8610±01±U period a determination will be made by average .11 hours per response (6.6 the NRCS regarding disposition of those minutes), including the time for comments and a final determination of reviewing instructions, searching DEPARTMENT OF COMMERCE change will be made. existing data sources, gathering and Dated: December 26, 2000. maintaining the data needed, and International Trade Administration completing and reviewing the collection Dennis Pate, [A±570±846] Assistant State Conservationist-Technology. of information. Responses are voluntary [FR Doc. 01–400 Filed 1–5–01; 8:45 am] and respondents will be required to Brake Rotors From the People's respond only one time. Comments are BILLING CODE 3410±16±M Republic of China: Preliminary Results requested on the proposed information and Partial Rescission of the Fourth collection concerning: New Shipper Review and Rescission of (a) Whether the proposed collection of BROADCASTING BOARD OF the Third Antidumping Duty information is necessary for the proper Administrative Review GOVERNORS performance of the agency, including AGENCY: Proposed Collection Reinstatement; whether the information has practical Import Administration, Comment Request utility; International Trade Administration, (b) The accuracy of the Agency’s Department of Commerce. SUMMARY: The Broadcasting Board of burden estimates; ACTION: Notice of preliminary results Governors (BBG), as part of its (c) Ways to enhance the quality, and partial rescission of fourth new continuing effort to reduce paperwork utility, and clarity of the information shipper review and rescission of third and respondent burden, invites the collected; and antidumping duty administrative general public and other Federal (d) Ways to minimize the burden of review. agencies to comment on an information the collection of information on the collection titled, ‘‘Interviews and Other respondents, including the use of SUMMARY: The Department of Commerce Audience Research for Radio and TV automated collection techniques or is currently conducting the fourth new Marti’’. This request for comment is other forms of information technology. shipper review and third administrative being made pursuant to the Paperwork Send comments regarding this burden review of the antidumping duty order Reduction Act of 1995 [Public Law 104– estimate or any other aspect of this on brake rotors from the People’s 13; 44 U.S.C. 3506(c)(2)(A)]. collection of information to the Agency Republic of China covering the period The information collection activity Clearance Officer, Ms. Jeannette April 1, 1999, through March 31, 2000. involved with this program is Giovetti, BBG, M/AO, Room 1657A–1, The fourth new shipper review covers conducted pursuant to the mandate 330 Independence Avenue, SW., two exporters. The Department of given to the BBG (formerly the United Washington, DC 20237, telephone (202) Commerce is preliminarily rescinding in States Information Agency) in 205–9692, e-mail address part the fourth new shipper review with accordance with Public Law 98–11, the [email protected]; or to the OMB Desk respect to one exporter. We have

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1304 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices preliminarily determined that sales have exporter/producer combinations that Department also initiated a new shipper not been made below normal value by received zero rates in the less-than-fair- review covering Hongfa and Luoyang on the other exporter. If these preliminary value (‘‘LTFV’’) investigation and thus May 26, 2000. See Brake Rotors from the results are adopted in our final results were excluded from the antidumping People’s Republic of China: Initiation of of the fourth new shipper review, we duty order only with respect to brake New Shipper Antidumping Duty Review, will instruct the U.S. Customs Service to rotors sold through the specified 65 FR 35322 (June 2, 2000). assess no antidumping duties on entries exporter/producer combinations.2 On June 5 and 6, 2000, we issued a of subject merchandise during the Also on April 28, 2000, the questionnaire to each PRC company period of review from the exporter that Department received timely requests listed in the brake rotor initiation cooperated in the review, for which the from Hongfa Machinery (Dalian) Co., notices. On June 28, 2000, the importer-specific assessment rates are Ltd. (‘‘Hongfa’’) and Luoyang Haoxiang Department provided the parties an zero or de minimis (i.e., less than 0.50 Brake Disc Factory (‘‘Luoyang’’) for a opportunity to submit publicly available percent), and to continue to assess new shipper review of this antidumping information for consideration in these duties on all entries of subject duty order in accordance with 19 CFR preliminary results. On June 29, 2000, merchandise made during the period of 351.214(c). In their requests for a new Hongfa and Luoyang requested an review by the other uncooperative shipper review and in accordance with extension of time until July 21, 2000, to exporter at the country-wide rate. 19 CFR 351.214(b)(2)(i) and (iii)(A), file their responses to the antidumping Furthermore, we will instruct the U.S. Hongfa and Luoyang each certified that duty questionnaire, which the Customs Service (‘‘the Customs it did not export the subject Department subsequently granted on Service’’) to require a cash deposit on all merchandise to the United States during July 7, 2000. future entries of the subject the period covered by the original LTFV Also on June 29, 2000, both merchandise from the uncooperative investigation, and that it is not affiliated respondents agreed to waive the time exporter at the country-wide rate. with any company which exported limits applicable to the new shipper The third administrative review subject merchandise to the United review and to permit the Department to covers three exporter/producer States during the period of conduct the new shipper review combinations (see ‘‘Background’’ investigation. Hongfa and Luoyang also concurrently with the administrative section of this notice for further certified that their export activities are review. Therefore, the Department discussion). The Department of not controlled by the central issued a Federal Register notice stating Commerce (‘‘the Department’’) is government of the People’s Republic of that it intended to conduct the new preliminarily rescinding the third China (‘‘PRC’’). Pursuant to 19 CFR shipper review concurrent with the administrative review because none of 351.214(b)(2)(iv), Hongfa and Luoyang administrative review (see Brake Rotors the respondents made shipments of the submitted documentation establishing from the People’s Republic of China: subject merchandise during the period the date on which the merchandise was Notice of Extension of Time Limits for of review (‘‘POR’’). Interested parties are first entered for consumption in the the Preliminary and Final Results of the invited to comment on these United States, the volume of that first Fourth New Shipper Antidumping Duty preliminary results. We will issue the shipment, and the date of the first sale Review, 65 FR 51294 (August 23, 2000)). final results no later than 120 days from to an unaffiliated customer in the On July 7, 2000, each of the exporters the date of publication of this notice. United States. which received zero rates in the LTFV EFFECTIVE DATE: January 8, 2001. On May 22, 2000, the excluded investigation stated that during the POR FOR FURTHER INFORMATION CONTACT: exporter/producer combinations it did not make U.S. sales of brake rotors Brian Smith or Brian Ledgerwood, submitted a letter in which they produced by companies other than Import Administration, International contended that the Department did not those included in its respective Trade Administration, U.S. Department have the basis for conducting an excluded exporter/producer of Commerce, 14th Street and administrative review of them because combination. On July 21, 2000, Hongfa Constitution Avenue, N.W., they were excluded from the and Luoyang submitted their Washington, DC 20230; telephone: (202) antidumping duty order on brake rotors questionnaire responses. On July 26, 482–1766 or (202) 482–3836, from the PRC. On May 26, 2000, the 2000, the petitioner requested an respectively. Department initiated an administrative extension of time until October 18, The Applicable Statute: Unless review covering the exporter/producer 2000, to submit publicly available otherwise indicated, all citations to the combinations which received zero rates information in this proceeding. On July Tariff Act of 1930, as amended (‘‘the in the LTFV investigation only with 31, 2000, the Department granted the Act’’), are references to the provisions respect to their U.S. sales of brake rotors petitioner’s request and extended the effective January 1, 1995, the effective produced by companies other than time limit for the submission of publicly date of the amendments made to the Act those included in the excluded available information by all parties. by the Uruguay Round Agreements Act. exporter/producer combinations noted On September 8, 2000, the petitioner In addition, unless otherwise indicated, above (see Initiation of Antidumping submitted a letter in which it requested all citations to the Department’s and Countervailing Duty Administrative that the Department conduct regulations are to 19 CFR Part 351 Reviews (65 FR 35320, June 2, 2000)). In verification of: (1) The responses (2000). accordance with 19 CFR 351.214(d), the submitted by the two respondents in the new shipper review; (2) the no- SUPPLEMENTARY INFORMATION: 2 The excluded exporters/producer combinations shipment claims made by the exporters Background are: (1) China National Automobile Industry Import named in the three exporter/producer & Export Corporation (‘‘CAIEC’’) or Shandong combinations excluded from the On April 28, 2000, the petitioner 1 Laizhou CAPCO Industry (‘‘Laizhou CAPCO’’)/ antidumping duty order; and (3) the requested an administrative review Laizhou CAPCO; (2) Shenyang Honbase Machinery Co., Ltd. (‘‘Shenyang Honbase’’) or Laizhou Luyuan Ministry of Foreign Trade and Economic pursuant to 19 CFR 351.213(b) for three Automobile Fittings Co., Ltd. (‘‘Laizhou Luyuan’’)/ Cooperation (‘‘MOFTEC’’) and National Shenyang Honbase or Laizhou Luyuan; and (3) 1 The petitioner is the Coalition for the China National Machinery and Equipment Import & Industrial and Commercial Preservation of American Brake Drum and Rotor Export (Xinjiang) Co., Ltd. (‘‘Xinjiang’’)/Zibo Botai Administration Bureau (‘‘NICAB’’). On Aftermarket Manufacturers. Manufacturing Co., Ltd. (‘‘Zibo’’). September 14, 2000, the Department

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1305 issued a decision memorandum which response from Hongfa, but did not the PRC government maintains de jure outlined the Department’s reasons for receive a response from Luoyang. On and de facto control over foreign-capital conducting a review of the exporter/ October 18, 2000, Luoyang’s counsel companies like Hongfa in the PRC. producer combinations receiving rates submitted a letter which stated that it Moreover, the petitioner renewed its of zero in the LTFV investigation with was withdrawing its notice of request that the Department conduct respect to shipments of merchandise appearance on behalf of Luoyang in the verification of MOFTEC and other PRC produced by manufacturers other than proceeding. Also on October 18, 2000, government entities based on the those in the respective excluded the petitioner submitted publicly contents of the PRC law it submitted. exporter/producer combinations (see available information for use in valuing On November 30, 2000, the September 14, 2000, Memorandum from the factors of production. On October Department issued its verification report the team to Louis Apple, Office 25, 2000, the respondents provided on Hongfa. Director). On September 15, 2000, the rebuttal publicly available information petitioner submitted comments on the and comments on the publicly available Scope of Reviews questionnaire responses submitted by information submitted by the petitioner. The products covered by these Hongfa and Luoyang. On September 25, On October 20, 2000, the Department reviews are brake rotors made of gray 2000, the Department issued provided a verification outline to cast iron, whether finished, supplemental questionnaires to Hongfa Hongfa. Also on October 20, 2000, the semifinished, or unfinished, ranging in and Luoyang. On September 29, 2000, Department issued a letter to Luoyang diameter from 8 to 16 inches (20.32 to Hongfa and Luoyang requested an which provided the firm with an 40.64 centimeters) and in weight from 8 extension of time until October 16, additional extension of time to submit to 45 pounds (3.63 to 20.41 kilograms). 2000, to file their responses to the its supplemental questionnaire The size parameters (weight and supplemental questionnaire, which the response. The Department also notified dimension) of the brake rotors limit Department subsequently granted on Luoyang that if it did not provide its their use to the following types of motor October 6, 2000. supplemental questionnaire response by vehicles: automobiles, all-terrain In order to substantiate the claims October 26, 2000, the Department would vehicles, vans and recreational vehicles made by the exporter/producer (1) conclude that Luoyang was no longer under ‘‘one ton and a half,’’ and light combinations excluded from the order participating in the proceeding; (2) trucks designated as ‘‘one ton and a that they did not ship merchandise from cancel plans to conduct verification of half.’’ producers other than those covered by Luoyang’s response; and (3) use the Finished brake rotors are those that their exclusion, on September 27, 2000, facts available with respect to Luoyang are ready for sale and installation the Department conducted a data query for the preliminary results. without any further operations. Semi- on brake rotor entries made during the On October 23, 2000, the petitioner finished rotors are those on which the POR from all exporters named in the submitted a letter objecting to the surface is not entirely smooth, and have excluded exporter/producer extension of time the Department had undergone some drilling. Unfinished combinations. As a result of the data granted to Luoyang for its supplemental rotors are those which have undergone query on September 28, 2000, the response. On October 24, 2000, the some grinding or turning. Department requested that the Customs Department placed on the record Service confirm the actual manufacturer correspondence obtained from the U.S. These brake rotors are for motor for specific entries associated with the Embassy in Beijing which indicated that vehicles, and do not contain in the excluded exporter/producer Luoyang did not intend to participate casting a logo of an original equipment combinations. further in the new shipper review (see manufacturer (‘‘OEM’’) which produces On October 4, 2000, in response to the October 24, 2000, Memorandum from vehicles sold in the United States (e.g., petitioner’s September 8, 2000, letter the case analyst to the file for further General Motors, Ford, Chrysler, Honda, requesting the verification of all details). Also on October 24, 2000, the Toyota, Volvo). Brake rotors covered in respondents in these reviews, the petitioner filed comments related to the these reviews are not certified by OEM Department informed the petitioner that Department’s verification of Hongfa. producers of vehicles sold in the United it (1) did intend to conduct verification On October 25, 2000, the Department States. The scope also includes of the responses submitted by Hongfa issued a memorandum stating that it composite brake rotors that are made of and Luoyang; (2) did not intend to preliminarily found no evidence that gray cast iron, which contain a steel conduct verification of the sales records shipments of merchandise subject to the plate, but otherwise meet the above of the exporters named in the three order were made by the three exporter/ criteria. Excluded from the scope of the exporter/producer combinations unless producer combinations during the POR. reviews are brake rotors made of gray the results of its Customs data query of From October 30 through November 2, cast iron, whether finished, U.S. entries of brake rotors during the 2000, the Department conducted semifinished, or unfinished, with a POR revealed that an excluded exporter verification of the information diameter less than 8 inches or greater shipped brake rotors produced by a firm submitted by Hongfa, in accordance than 16 inches (less than 20.32 other than the producer named in the with 19 CFR 351.307. centimeters or greater than 40.64 corresponding excluded exporter/ On November 15, 2000, the petitioner centimeters) and a weight less than 8 producer combination; and (3) did not submitted a copy of a PRC law (i.e., pounds or greater than 45 pounds (less intend to visit MOFTEC or NICAB ‘‘Rules for the Implementation of the than 3.63 kilograms or greater than because the information provided by the Law of the People’s Republic of China 20.41 kilograms). petitioner in its September 8, 2000, on Foreign-Capital Enterprises’’)(‘‘Rules Brake rotors are currently classifiable submission did not serve as a sufficient for Foreign-Capital Enterprises’’) and under subheading 8708.39.5010 of the basis for conducting such visits (see the claimed that the Department should Harmonized Tariff Schedule of the October 4, 2000, Letter from Louis resort to facts available with respect to United States (‘‘HTSUS’’). Although the Apple, Office Director, to Mr. Leslie A. Hongfa because Hongfa did not provide HTSUS subheading is provided for Glick for further details). a copy of this law in its entirety at convenience and customs purposes, the On October 16, 2000, the Department verification and because certain sections written description of the scope of these received a supplemental questionnaire of the law allegedly demonstrate that reviews is dispositive.

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Period of Reviews participation in this review, the Hongfa complied fully with the The period of review (‘‘POR’’) covers Department canceled verification of Department’s request for information in April 1, 1999, through March 31, 2000. Luoyang’s questionnaire response, this area. Thus, the petitioner’s claim is including its separate rate information. without merit. Verification Therefore, we consider Luoyang to be an With respect to the petitioner’s claim As provided in section 782(i)(2) of the uncooperative respondent and have that certain sections of the PRC Act, we verified information provided made the adverse inference that government document at issue indicate by Hongfa. We used standard Luoyang does not qualify for a separate de jure and de facto government control verification procedures, including on- rate. We, therefore, have treated of the export activities of wholly site inspection of the manufacturer’s Luoyang as part of the non-market foreign-owned companies such as facilities and examination of relevant economy (‘‘NME’’) entity. As part of the Hongfa, we note that the document in sales and financial records. Our NME entity, Luoyang is not entitled to question does not contain compelling verification results are outlined in the a rate as a new shipper, because the information which would lead us to verification report (see the November NME entity as a whole was subject to believe that the PRC government 30, 2000, Hongfa verification report for the LTFV investigation. For these exercises de jure or de facto control over further discussion). reasons, we are rescinding the new all foreign-owned PRC companies. (For shipper review with respect to Luoyang. further discussion, see the control Rescission of Administrative Review criteria of our separate rates test arising Separate Rates Pursuant to 19 CFR 351.213(d)(3), we out of the Final Determination of Sales have preliminarily determined that, In proceedings involving NME at Less Than Fair Value: Sparklers from during the POR, the three exporter/ countries, the Department begins with a the People’s Republic of China, 56 FR producer combinations which received rebuttable presumption that all 20588 (May 6, 1991) and amplified in zero rates in the LTFV investigation did companies within the country are the Final Determination of Sales at Less not make shipments of subject subject to government control and thus Than Fair Value: Silicon Carbide from merchandise to the United States during should be assessed a single antidumping the People’s Republic of China, 59 FR the POR. Specifically, we preliminarily duty deposit rate (i.e., a PRC-wide rate). 22585 (May 2, 1994) (‘‘Silicon determined that during the POR, (1) The cooperative respondent in the Carbide’’).) In Hongfa’s case, since this neither CAIEC nor Laizhou CAPCO new shipper review, Hongfa, is wholly company is wholly foreign-owned, it is exported brake rotors to the United foreign-owned. Thus, for Hongfa, not necessary to apply the separate rates States that were manufactured by because we have no evidence indicating test to it (see discussion above). producers other than Laizhou CAPCO; that it is under the control of the PRC Therefore, the petitioner’s claim that (2) neither Shenyang Honbase nor government, a separate rates analysis is certain sections of the 1990 Rules for Laizhou Luyuan exported brake rotors not necessary to determine whether it is Foreign-Capital Enterprises indicate de to the United States that were independent from government control jure and de facto government control is manufactured by producers other than (see Notice of Final Determination of moot. Shenyang Honbase or Laizhou Luyuan; Sales at Less Than Fair Value: Creatine Finally with respect to the petitioner’s and (3) Xinjiang did not export brake Monohydrate from the People’s request that the Department should rotors to the United States that were Republic of China, 64 FR 71104, 71105 conduct visits of MOFTEC and NICAB manufactured by producers other than (December 20, 1999); Preliminary based on the requirements contained in Zibo (see October 25, 2000, Results of First New Shipper Review and the Rules for Foreign Enterprises, the Memorandum from the case analyst to First Antidumping Duty Administrative Department does not consider the the file). In order to make this Review: Certain Preserved Mushrooms contents of that law to provide sufficient determination, we first examined POR from the People’s Republic of China, 65 grounds for conducting visits at subject merchandise shipment data FR 66703, 66705 (November 7, 2000); MOFTEC and NICAB in order to further maintained by the Customs Service. We and Notice of Final Determination of interpret the regulations contained in then requested the Customs Service to Sales at Less Than Fair Value: Bicycles the above-mentioned document. examine the documentation filed at the From the People’s Republic of China U.S. port for selected entries made by (‘‘Bicycles’’) 61 FR 19026 (April 30, Fair Value Comparisons the exporters at issue to determine the 1996)). To determine whether sales of the manufacturer of the merchandise. Based With respect to the petitioner’s subject merchandise by Hongfa to the on the results of our query, we are November 15, 2000, claim that Hongfa United States were made at LTFV, we preliminarily rescinding the should be denied a separate rate because compared the export price to the normal administrative review because we found it withheld information at verification, value, as described in the ‘‘Export no evidence that the exporter/producer we find that Hongfa complied fully with Price’’ and ‘‘Normal Value’’ sections of combinations subject to this review the Department’s request for this notice, below. made U.S. shipments of the subject information. Specifically, the Export Price merchandise during the POR. Department requested Hongfa to provide documentation on the registered capital We used export price methodology in Partial Rescission of New Shipper requirements for wholly-foreign owned accordance with section 772(a) of the Review companies in the PRC. In response to Act because the subject merchandise We are also preliminarily rescinding the Department’s request for was sold by the exporter directly to an in part the fourth new shipper review information, Hongfa provided an unaffiliated customer in the United with respect to Luoyang based on its excerpt from the PRC law, Rules for States prior to importation and decision not to submit a response to the Foreign-Capital Enterprises, which constructed export price was not Department’s supplemental discussed the timeframe PRC companies otherwise indicated. questionnaire and not to cooperate in (such as Hongfa) had in order to meet For Hongfa, we calculated export this review which Luoyang itself registered capital requirements for price based on packed, FOB foreign port requested. As a consequence of obtaining business licenses (see page prices to the first unaffiliated purchaser Luoyang’s decision to discontinue five of the Hongfa verification report). in the United States. Where appropriate,

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1307 we made deductions from the starting Technologies v. United States, CIT Slip of economic development comparable to price (gross unit price) for foreign Op. 00–84 (July 17, 2000).) As described that of the NME country, and (2) are inland freight and foreign brokerage and in the Hongfa verification report, we significant producers of comparable handling charges in the PRC, in verified that Hongfa made only one sale merchandise. India and Indonesia are accordance with section 772(c) of the to the U.S. market during the POR and among the countries comparable to the Act. Because foreign inland freight and that Hongfa has made no other sales to PRC in terms of overall economic foreign brokerage and handling fees the United States since the POR (i.e., as development (see June 12, 2000, were provided by PRC service providers of the date of verification). Therefore, Memorandum from the Office of Policy or paid for in a reminbi, we based those unlike Mushrooms from the PRC, we to the case analyst). In addition, based charges on surrogate rates from India could not compare sales prices for the on publicly available information (see ‘‘Surrogate Country’’ section below subject merchandise during the POR placed on the record, India is a for further discussion of our surrogate with sales prices after the POR. significant producer of the subject country selection). To value foreign Moreover, we have no evidence on the merchandise. Accordingly, we inland trucking charges, we used a record to support a conclusion that the considered India the primary surrogate November 1999 average truck freight price for the reviewed sale is not country for purposes of valuing the value based on price quotes from Indian commercially reasonable or the result of factors of production because it meets trucking companies. We most recently arm’s-length bargaining. There is also no the Department’s criteria for surrogate used this rate in the second record evidence that the importer resold country selection. Where we could not administrative review of brake rotors the merchandise at a loss. Furthermore, find surrogate values from India, we from the PRC (see Brake Rotors from the the transportation costs and other used values from Indonesia. People’s Republic of China: Final expenses borne by the importer based C. Factors of Production Results of Third New Shipper Review on the respondent’s terms of sale are and Final Results and Partial Rescission consistent with those incurred by other In accordance with section 773(c) of of Second Antidumping Duty importers of the subject merchandise in the Act, we calculated normal value Administrative Review, 65 FR 64664 previous administrative reviews, new based on the factors of production (October 30, 2000) (which cites to the shipper reviews and the LTFV which included, but were not limited to: ‘‘Issues and Decision Memorandum’’ investigation. In addition, while the sale (A) hours of labor required; (B) from Richard W. Moreland, Deputy occurred shortly before the end of the quantities of raw materials employed; (C) amounts of energy and other utilities Assistant Secretary for Import POR, the timing of the transaction is not consumed; and (D) representative Administration, to Troy H. Cribb, a basis in-and-of-itself to render the capital costs, including depreciation. Assistant Secretary for Import transaction less than bona fide (see We used the factors reported by Hongfa Administration, dated October 24, Mushrooms from the PRC, 65 at FR which produced the brake rotors it 2000)) (‘‘Brake Rotors Second 66706). Therefore, absent evidence to exported to the United States during the Administrative Review’’)). To value the contrary, we have determined POR. To calculate normal value, we foreign brokerage and handling Hongfa’s sale to be a bona fide multiplied the reported unit factor expenses, we relied on public transaction for purposes of this review. quantities by publicly available Indian information reported in the 1997–1998 Normal Value or Indonesian values. Based on our antidumping duty new shipper review verification findings, we revised (1) the of stainless steel wire rod from India A. Non-Market Economy Status factor for lug bolts; (2) the factor for (see also Brake Rotors Second In every case conducted by the packing labor; and (3) the distances Administrative Review). Based on our Department involving the PRC, the PRC from Hongfa to each of its suppliers (see verification findings, we revised the has been treated as a NME country. page three of the Hongfa verification reported distance from Hongfa to the Pursuant to section 771(18)(C)(i) of the report and December 18, 2000, port of exportation (see Hongfa Act, any determination that a foreign Memorandum from case analyst to the verification report at page 3). country is a NME country shall remain file). In its pre-verification comments, the in effect until revoked by the In its October 18, 2000, publicly petitioner claimed that Hongfa’s POR administering authority (see Notice of available information submission, the sale is not a bona fide transaction due Preliminary Results of Antidumping petitioner argued that the Department to the circumstances surrounding the Duty Administrative Review and New should use price data from International sale. In prior cases, the Department has Shipper Reviews, Partial Rescission of Business Information Services (‘‘IBIS’’) considered factors such as timing, sale the Antidumping Duty Administrative rather than from the Indian government price, transportation costs, other Review, and Rescission of a New publication Monthly Statistics of the expenses borne by the importer, and Shipper Review: Freshwater Crawfish Foreign Trade of India (‘‘Monthly whether the merchandise was resold by Tail Meat From the People’s Republic of Statistics’’) to value a number of direct the importer at a loss to determine China, 65 FR 60399, 60404 (October 11, and packing material inputs because the whether a sale was a bona fide 2000). None of the parties to this IBIS data is (1) the most transaction (see Preliminary Results of proceeding has contested such contemporaneous with the POR; (2) it is First New Shipper Review and First treatment. Accordingly, we calculated based on Indian Customs statistics; and Antidumping Duty Administrative normal value in accordance with section (3) it has been used to value inputs in Review: Certain Preserved Mushrooms 773(c) of the Act, which applies to NME previous NME cases. In its October 25, from the People’s Republic of China, 65 countries. 2000, rebuttal comments, the FR 66703, 66706 (November 7, 2000)) respondent pointed out that the IBIS (‘‘Mushrooms from the PRC’’). (See also B. Surrogate Country data, though more contemporaneous to Certain Cut-to-Length Carbon Steel Plate Section 773(c)(4) of the Act requires the POR than Monthly Statistics, is less from Romania: Notice of Rescission of the Department to value a NME representative of the import prices paid Antidumping Duty Administrative producer’s factors of production, to the for the inputs in question because the Review, 63 FR 47232 (September 4, extent possible, in one or more market values the petitioner submitted from 1998) and American Silicon economy countries that (1) are at a level IBIS either were based on specific

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1308 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices shipments from only a few market Business Line. To value firewood, we Reserve Bank of India Bulletin to economy countries or the values were used a 1991 domestic value from the calculate the interest income amount. not specific to the input reported by the Food and Agricultural Organization of For example, if an Indian company’s respondent. After considering the data the United Nations’ working paper, financial statement indicated that the and arguments made by the parties with Wood Materials from Non-Forest Areas, company had miscellaneous receipts or respect to this issue, for these which is the most recent value available other income under the general category preliminary results, we have relied on for this input. To value electricity, we ‘‘other income,’’ we applied a ratio data from Monthly Statistics rather than used data from the Indian publications (based on data contained in Reserve IBIS to value the inputs in question 1995 Conference of Indian Industries: Bank of India Bulletin) to that because either the former data were Handbook of Statistics and The Center miscellaneous receipts or other income more representative of Indian import for Monitoring Indian Economy and the figure in the financial statement to prices or the latter data did not allow methodology used in two recent NME determine the amount associated with the Department to value properly the cases. (See Persulfates from the People’s short-term interest income. To avoid factor reported by the respondent (see Republic of China: Final Results of double-counting, we treated the line detailed discussion below). Antidumping Duty Administrative item ‘‘packing, freight, and delivery The Department’s selection of the Review and Partial Rescission of charges’’ as expenses to be valued surrogate values applied in this Administrative Review, 65 FR 46691, separately. Specifically, to determine determination was based on the quality, 46692 (July 31, 2000); Manganese Metal the packing expense, we used Hongfa’s specificity, and contemporaneity of the from the People’s Republic of China: reported packing material factors. We data. As appropriate, we adjusted input Final Results of Antidumping Duty used the corrected distance (per prices to make them delivered prices. Administrative Review, 65 FR 30067, verification findings) to determine the For those values not contemporaneous 30068 (May 10, 2000); and Preliminary foreign inland freight expense (see page with the POR and quoted in a foreign Results Valuation Memorandum). three of the Hongfa verification report currency, we adjusted for inflation using We valued labor based on a for further discussion). For a further wholesale price indices published in the regression-based wage rate, in discussion of other adjustments made, International Monetary Fund’s accordance with 19 CFR 351.408(c)(3). see the Preliminary Results Valuation International Financial Statistics. To value selling, general, and Memorandum. To value pig iron, ferrosilicon, and administrative (‘‘SG&A’’) expenses, All inputs were shipped by truck. ferromanganese, we used April 1998- factory overhead and profit, we used the Therefore, to value PRC inland freight, December 1998 average import values 1998 financial data of Jayaswals Neco we used a November 1999 average truck from Monthly Statistics. For steel scrap Limited and the 1998–1999 financial freight value based on price quotes from and lubrication oil, we used April 1998- data of Kalyani Brakes Limited Indian trucking companies. August 1998 average import values from (‘‘Kalyani’’) and Rico Auto Industries In accordance with the decision of the Monthly Statistics. For limestone, we Limited (‘‘Rico’’). Court of Appeals for the Federal Circuit used an April 1998–March 1999 average Where appropriate, we removed from in Sigma Corp. v. United States, 117 F. import value from Monthly Statistics the surrogate overhead and SG&A 3d 1401 (1997), we revised our rather than the May 1999–March 2000 calculations the excise duty amount methodology for calculating source-to- IBIS value. Monthly Statistics provided listed in the financial reports (see Brake factory surrogate freight for those a more representative Indian import Rotors Investigation, 62 FR at 9164). We material inputs that are valued based on value for limestone because it covers all made certain adjustments to the ratios CIF import values in the surrogate imports of limestone into India. The calculated as a result of reclassifying country. Therefore, we have added to IBIS data appears to be based on a certain expenses contained in the CIF surrogate values from India a limited number of shipments of financial reports. In utilizing the surrogate freight cost using the shorter limestone to India. Furthermore, one of financial data of the Indian companies, of the reported distances from either the those limestone shipments is from an we treated the line item labeled ‘‘stores closest PRC port of importation to the unknown exporting country accounting and spares consumed’’ as part of factory factory, or from the domestic supplier to for 51 percent of the total import value overhead because stores and spares are the factory on an input-specific basis. based on the IBIS data. not direct materials consumed in the To value corrugated cartons and steel The brake rotors Hongfa produced production process. Based on publicly strip, we used April 1998–December during the POR use lug bolts and ball available information, we considered 1998 average import values from bearing cups. Because we could not the molding materials (i.e., sand, Monthly Statistics. For plastic bags, we obtain a product-specific price from bentonite, coal powder, steel pellets, used an April 1997–March 1998 average India to value lug bolts (see Bicycles, 61 lead powder, and waste oil) to be import value for plastic bags from FR at 19040 (Comment 17)), we used a indirect materials included in the Monthly Statistics because that data January-March 1999 product-specific ‘‘stores and spares consumed’’ category (which was based on plastic bag imports import value from the Indonesian of the financial statements. We based from 18 market economy countries) was government publication Foreign Trade our factory overhead calculation on the a more representative Indian import Statistical Bulletin. To value ball cost of manufacturing. We also included value for plastic bags than the more bearing cups, we used an April 1998- interest and/or financial expenses in the contemporaneous IBIS data (which was December 1998 average import value SG&A calculation. In addition, we only based on one shipment from one from Monthly Statistics. reduced interest and financial expenses country). To value adhesive tape and To value coking coal, we used an by amounts for interest income if the nails, we used April 1998–March 1999 April 1998-August 1998 average import Indian financial report noted that the average import values from Monthly price from Monthly Statistics. We also income was short-term in nature. Where Statistics because the data (which was added an amount for loading and a company did not distinguish interest based on imports of adhesive tape from additional transportation charges income as a line item within total ‘‘other 26 market economy countries and associated with delivering coal to the income,’’ we used the ratio of interest imports of nails from 10 market factory based on June 1999 Indian price income to total other income as reported economy countries) was also more data contained in the periodical for the Indian metals industry in the representative of Indian import prices

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1309 for tape and nails than the more five pages and a table of statutes, that exporter. These requirements, when contemporaneous IBIS data (which was regulations, and cases cited. imposed, shall remain in effect until based on one shipment of tape and 12 The Department will issue the final publication of the final results of the shipments of nails from one country). results of these administrative and new next administrative review. To value pallet wood, we used an April shipper reviews, including the results of Notification to Importers 1995–March 1996 import value per its analysis of issues raised in any such kilogram from Monthly Statistics rather written briefs or at the hearing, if held, This notice serves as a preliminary than values obtained after March 1996, not later than 120 days after the date of reminder to importers of their because the more contemporaneous publication of this notice. responsibility under 19 CFR 351.402(f)(2) to file a certificate values appeared aberrational relative to Assessment Rates the overall value of the subject regarding the reimbursement of merchandise (see Brake Rotors Second The Department shall determine, and antidumping duties prior to liquidation Administrative Review). Moreover, we Customs shall assess, antidumping of the relevant entries during this used the value per kilogram from duties on all appropriate entries. review period. Failure to comply with Monthly Statistics rather than the more Pursuant to 19 CFR 351.212(b)(1), we this requirement could result in the contemporaneous value per piece from will calculate importer-specific ad Secretary’s presumption that IBIS because the value from IBIS did not valorem duty assessment rates based on reimbursement of antidumping duties indicate the size or weight of a piece of the ratio of the total amount of the occurred and the subsequent assessment wood in a manner which would have dumping margins calculated for the of double antidumping duties. allowed the Department to value the examined sales to the total entered These administrative and new shipper factor reported by the respondent. value of those same sales. In order to administrative reviews and notice are in estimate the entered value, we will accordance with section 751(a)(1) and Preliminary Results of the Review subtract applicable movement expenses (2)(B) of the Act (19 U.S.C. 1675(a)(1) We preliminarily determine that the from the gross sales value. In and (2)(B)) and 19 CFR 351.213 and following margin exists for Hongfa accordance with 19 CFR 351.106(c)(2), 351.214. we will instruct Customs to liquidate during the period April 1, 1999, through Dated: January 2, 2001. March 31, 2000: without regard to antidumping duties all entries of subject merchandise Troy H. Cribb, Assistant Secretary for Import Margin during the POR for which the importer- Manufacturer/producer/exporter percent specific assessment rate is zero or de Administration. minimis (i.e., less than 0.50 percent). [FR Doc. 01–457 Filed 1–5–01; 8:45 am] Hongfa Machinery (Dalian) Co., For entries subject to the PRC-wide rate, BILLING CODE 3510±DS±P Ltd...... 0.00 Customs shall assess ad valorem duties at the rate established in the LTFV We will disclose the calculations used investigation. The Department will issue DEPARTMENT OF COMMERCE in our analysis to parties to this appropriate appraisement instructions International Trade Administration proceeding within five days of the date directly to Customs upon completion of of publication of this notice. Any this review. [A±201±817] interested party may request a hearing within 30 days of publication of this Cash Deposit Requirements Oil Country Tubular Goods from notice. Any hearing, if requested, will Upon completion of this new shipper Mexico: Extension of Time Limit for be held on January 31, 2001. review, for entries from Hongfa, we will Final Results of Antidumping Duty Interested parties who wish to request require cash deposits at the rate Administrative Review a hearing or to participate if one is established in the final results pursuant AGENCY: requested, must submit a written to 19 CFR 351.214(e) and as further Import Administration, request to the Assistant Secretary for described below. International Trade Administration, Import Administration, Room B–099, The following deposit requirements Department of Commerce. within 30 days of the date of publication will be effective upon publication of the EFFECTIVE DATE: January 8, 2001. of this notice. Requests should contain: final results of these administrative and FOR FURTHER INFORMATION CONTACT: (1) The party’s name, address, and new shipper antidumping duty Phyllis Hall at (202) 482–1398 or Dena telephone number; (2) the number of administrative reviews for all shipments Aliadinov at (202) 482–2667, Import participants; and (3) a list of issues to be of brake rotors from the PRC entered, or Administration, International Trade discussed. See 19 CFR 351.310(c). withdrawn from warehouse, for Administration, U.S. Department of Issues raised in the hearing will be consumption on or after the publication Commerce, 14th Street and Constitution limited to those raised in case briefs and date, as provided by section 751(a)(1) of Ave, NW, Washington, DC 20230. rebuttal briefs. Case briefs from the Act: (1) The cash deposit rate for SUPPLEMENTARY INFORMATION: interested parties may be submitted not Hongfa will be the rate established in later than 30 days after the date of the final results; (2) the cash deposit rate Statutory Time Limits publication of this notice. Rebuttal for PRC exporters who received a Section 751(a)(3)(A) of the Tariff Act briefs, limited to issues raised in the separate rate in a prior segment of the of 1930, as amended (‘‘the Act’’), case briefs, will be due not later 37 days proceeding will continue to be the rate requires the Department of Commerce after the date of publication of this assigned in that segment of the (‘‘the Department’’) to make a notice. Parties who submit case briefs or proceeding; (3) the cash deposit rate for preliminary determination within 245 rebuttal briefs in this proceeding are the PRC NME entity (including days after the last day of the anniversary requested to submit with each argument Luoyang) will continue to be 43.32 month of an order for which a review (1) a statement of the issue and (2) a percent; and (4) the cash deposit rate for is requested, and a final determination brief summary of the argument. Parties non-PRC exporters of subject within 120 days after the date on which are also encouraged to provide a merchandise from the PRC will be the the preliminary determination is summary of the arguments not to exceed rate applicable to the PRC supplier of published. However, if it is not

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1310 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices practicable to complete the review DEPARTMENT OF COMMERCE Dated: January 2, 2001. within these time periods, section Joseph A. Spetrini, 751(a)(3)(A) of the Act allows the International Trade Administration Deputy Assistant Secretary, AD/CVD Department to extend the time limit for [A±475±824] Enforcement Group III. the preliminary determination to a [FR Doc. 01–452 Filed 1–5–01; 8:45 am] Notice of Extension of the Time Limit maximum of 365 days and for the final BILLING CODE 3510±DS±P determination to 180 days (or 300 days for Preliminary Results of Antidumping if the Department does not extend the Duty Administrative Review: Stainless time limit for the preliminary Steel Sheet and Strip in Coils From DEPARTMENT OF COMMERCE determination) from the date of Italy publication of the preliminary AGENCY: Import Administration, International Trade Administration determination. International Trade Administration, University of Rochester; Notice of Department of Commerce. Background Decision on Application for Duty-Free EFFECTIVE DATE: January 8, 2001. Entry of Scientific Instrument On August 31,1999, Tubos de Acero FOR FURTHER INFORMATION CONTACT: de Mexico, S.A. de C.V. (‘‘TAMSA’’) Carrie Blozy, AD/CVD Enforcement This decision is made pursuant to and Hylsa S.A. de C.V. (‘‘Hylsa’’) Group III, Office 9, Import section 6(c) of the Educational, requested that the Department conduct Administration, International Trade Scientific, and Cultural Materials an administrative review of the Administration, U.S. Department of Importation Act of 1966 (Pub. Law 89– Commerce, 14th Street and Constitution antidumping duty order on oil country 651, 80 Stat. 897; 15 CFR part 301). Avenue, NW., Washington, DC 20230; tubular goods (‘‘OCTG’’) from Mexico. Related records can be viewed between telephone: (202) 482–0165. The Department initiated this review on 8:30 A.M. and 5:00 P.M. in Room 4211, SUPPLEMENTARY INFORMATION: September 24, 1999. See 64 FR 53318 U.S. Department of Commerce, 14th and (October 1, 1999). On September 12, The Applicable Statute Constitution Avenue, NW., Washington, 2000, the Department published the Unless otherwise indicated, all DC. preliminary results of the review in the citations to the Tariff Act of 1930, as Docket Number: 00–034. Applicant: Federal Register (65 FR 54998). The amended (the Act) are to the provisions University of Rochester, Rochester, NY final results are due no later than effective January 1, 1995, the effective 14623. Instrument: Scanning Nearfield January 10, 2001. date of the amendments made to the Act Optical Microscope. Manufacturer: Extension of Time Limit for Preliminary by the Uruguay Round Agreements Act. WITec, Germany. Intended Use: See Results of Review In addition, unless otherwise indicated, notice at 65 FR 65296, November 1, all citations to the Department of 2000. We determine that it is not practicable Commerce’s (the Department’s) Comments: None received. Decision: to complete the final results of this regulations are to 19 CFR part 351 Approved. No instrument of equivalent review within the original time limits (2000). scientific value to the foreign mandated by section 751 (a)(3)(A) of the Background instrument, for such purposes as it is Act. The Department is therefore intended to be used, is being extending the time limit for completion On October 30, 2000, the Department published a notice of initiation of the manufactured in the United States. of the final results until no later than administrative review of the Reasons: The foreign instrument March 12, 2001. See Decision antidumping duty order on Stainless provides: (1) an atomic force microscope Memorandum from Richard Weible to Steel Sheet and Strip in Coils from Italy, with a metal probe operating in a Joseph A. Spetrini, dated December 29, covering the period January 4, 1999 vertical displacement AC mode and (2) 2000, which is on file in the Central through June 30, 2000 (65 FR 64662). simultaneous scanning atomic-force and Records Unit, Room B–099 of the main The preliminary results are currently near-field-optical microscopy on Commerce building. due no later than April 2, 2001. identical sample zones maintaining This extension of the time limit is in Extension of Time Limit for Preliminary sample registration with nanometer accordance with section 751 (a)(3)(A) of Results accuracy. The National Institute of the Act and 19 CFR 351.213(h)(2). Standards and Technology advised Because of the complex issues December 21, 2000 that (1) these Dated: December 29, 2000. enumerated in the Memorandum from capabilities are pertinent to the Joseph A. Spetrini, Edward C. Yang to Joseph A. Spetrini, applicant’s intended purpose and (2) it Deputy Assistant Secretary, Enforcement Extension of Time Limit for the knows of no domestic instrument or Group III. Preliminary Results of Administrative apparatus of equivalent scientific value [FR Doc. 01–453 Filed 1–5–01; 8:45 am] Review of Certain Stainless Steel Sheet to the foreign instrument for the BILLING CODE 3510±DS±P and Strip in Coils from Italy, dated January 2, 2001, and on file in the applicant’s intended use. Central Records Unit (CRU) of the Main We know of no other instrument or Commerce Building, Room B–099, we apparatus of equivalent scientific value find that it is not practicable to to the foreign instrument which is being complete this review by the scheduled manufactured in the United States. deadline. Therefore, in accordance with section 751(a)(3)(A) of the Act, the Gerald A. Zerdy, Department is extending the time period Program Manager, Statutory Import Programs for issuing the preliminary results of Staff. review by 90 days (i.e., until July 2, [FR Doc. 01–454 Filed 1–5–01; 8:45 am] 2001). BILLING CODE 3510±DS±P

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DEPARTMENT OF COMMERCE Scientific, and Cultural Materials ADDRESSES: National Reconnaissance Importation Act of 1966 (Pub. Law 89– Office, 14675 Lee Road Chantilly, VA International Trade Administration 651, 80 Stat. 897; 15 CFR part 301). 20151–1715. Related records can be viewed between FOR FURTHER INFORMATION CONTACT: Ms. University of Wisconsin-Madison; 8:30 A.M. and 5:00 P.M. in Room 4211, Barbara Freimann at (703) 808–5029. Notice of Decision on Application for U.S. Department of Commerce, 14th and SUPPLEMENTARY INFORMATION: The Duty-Free Entry of Scientific Constitution Avenue, NW., Washington, Instrument National Reconnaissance Office systems DC. of records notices subject to the Privacy This decision is made pursuant to Docket Number: 00–037. Applicant: Act of 1974, (5 U.S.C. 552a), as section 6(c) of the Educational, Washington University School of amended, have been published in the Scientific, and Cultural Materials Medicine, St. Louis, MO 63110. Federal Register and are available from Importation Act of 1966 (Pub. Law 89– Instrument: Flash Lamp System with the address above. 651, 80 Stat. 897; 15 CFR part 301). Accessories. Manufacturer: Rapp The proposed system report, as Related records can be viewed between OptoElectronic, Germany. Intended Use: required by 5 U.S.C. 552a(r) of the 8:30 A.M. and 5:00 P.M. in Room 4211, See notice at 65 FR 70549, November Privacy Act of 1974, as amended, was U.S. Department of Commerce, 14th and 24, 2000. submitted on December 20, 2000, to the Constitution Avenue, NW., Washington, Comments: None received. Decision: House Committee on Government DC. Approved. No instrument of equivalent Reform, the Senate Committee on Docket Number: 00–036. Applicant: scientific value to the foreign Governmental Affairs, and the Office of University of Wisconsin-Madison, instrument, for such purposes as it is Management and Budget (OMB) Madison, WI 53706. Instrument: intended to be used, is being pursuant to paragraph 4c of Appendix I Telecommunications Instrumentation manufactured in the United States. to OMB Circular No. A–130, ‘Federal Modeling System, Model TIMS–301. Reasons: The foreign instrument Agency Responsibilities for Maintaining Manufacturer: Emona Instruments Pty provides special filters for applications Records About Individuals,’ dated ∂ Ltd., Australia. Intended Use: See notice using caged Ca2 compounds with an February 8, 1996 (February 20, 1996, 61 at 65 FR 68981, November 15, 2000. energy density of 400 mJ/cm2 in the UV. FR 6427). Comments: None received. Decision: The National Institutes of Health Dated: December 21, 2000. Approved. No instrument of equivalent advises in its memorandum of scientific value to the foreign December 5, 2000 that (1) this capability Patricia L. Toppings, instrument, for such purposes as it is is pertinent to the applicant’s intended Alternate OSD Federal Register Liaison intended to be used, is being purpose and (2) it knows of no domestic Officer, Department of Defense. manufactured in the United States. instrument or apparatus of equivalent NRO±23 Reasons: The foreign instrument scientific value to the foreign provides expandable and customizable instrument for the applicant’s intended SYSTEM NAME: rack-mounted student workstations for use. Counterintelligence Issue Files. laboratory instruction of optical and RF- We know of no other instrument or SYSTEM LOCATION: based telecommunication techniques apparatus of equivalent scientific value Office of Counterintelligence, with 49 basic and advanced project to the foreign instrument which is being National Reconnaissance Office, 14675 modules currently available. A manufactured in the United States. university department of electrical Lee Road, Chantilly, VA 20151–1715. Gerald A. Zerdy, engineering advised December 21, 2000 CATEGORIES OF INDIVIDUALS COVERED BY THE that (1) these capabilities are pertinent Program Manager, Statutory Import Programs SYSTEM: Staff. to the applicant’s intended purpose and National Reconnaissance Office [FR Doc. 01–456 Filed 1–5–01; 8:45 am] (2) it knows of no domestic instrument civilian, military, and contractor or apparatus of equivalent scientific BILLING CODE 3510±DS±P personnel who have had foreign travel value to the foreign instrument for the contacts, incidents, or concerns, and applicant’s intended use. any persons relating to a We know of no other instrument or counterintelligence concern, incident or apparatus of equivalent scientific value DEPARTMENT OF DEFENSE inquiry, as well as the points of contact. to the foreign instrument which is being manufactured in the United States. National Reconnaissance Office; CATEGORIES OF RECORDS IN THE SYSTEM: Privacy Act of 1974; System of Name, Social Security Number, Gerald A. Zerdy, Records Program Manager, Statutory Import Programs organization, company, date and place Staff. AGENCY: National Reconnaissance of birth, country, action officer, date [FR Doc. 01–455 Filed 1–5–01; 8:45 am] Office, DOD. received, point of contact, and status of the case including investigatory BILLING CODE 3510±DS±P ACTION: Notice to add a system of records. materials and files. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: SUMMARY: The National Reconnaissance DEPARTMENT OF COMMERCE 5 U.S.C. 301, Departmental Office is adding a system of records Regulations; 10 U.S.C. 424; National International Trade Administration notice to its inventory of record systems Security Act of 1947, as amended, 50 subject to the Privacy Act of 1974, (5 U.S.C. 401 et seq.; E.O. 12333; E.O. Washington University School of U.S.C. 552a), as amended. Medicine; Notice of Decision on 12958; E.O. 12968; and E.O. 9397 (SSN). DATES: Application for Duty-Free Entry of This proposed action will be PURPOSE(S): Scientific Instrument effective without further notice on February 7, 2001, unless comments are Information is used to assign, This decision is made pursuant to received which result in a contrary categorize and administratively track section 6(c) of the Educational, determination. foreign travel, contacts, and incidents or

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1312 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices concerns; monitor, analyze, and track accordance with 28 U.S.C. 1746, in the law or for which he would otherwise be counterintelligence activities; and following format: eligible, as a result of the maintenance prepare and pursue investigations If executed without the United States: of such information, the individual will involving counterintelligence activities. ‘I declare (or certify, verify, or state) be provided access to such information under penalty of perjury under the laws except to the extent that disclosure ROUTINE USES OF RECORDS MAINTAINED IN THE of the United States of America that the would reveal the identity of a SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES: foregoing is true and correct. Executed confidential source. on (date). (Signature)’. Investigatory material compiled solely In addition to those disclosures If executed within the United States, for the purpose of determining generally permitted under 5 U.S.C. its territories, possessions, or suitability, eligibility, or qualifications 552a(b) of the Privacy Act, these records commonwealths: ‘I declare (or certify, for federal civilian employment, or information contained therein may verify, or state) under penalty of perjury military service, federal contracts, or specifically be disclosed outside the that the foregoing is true and correct. access to classified information may be DoD as a routine use pursuant to 5 Executed on (date). (Signature)’. exempt pursuant to 5 U.S.C. 552a(k)(5), U.S.C. 552a(b)(3) as follows: but only to the extent that such material The DoD ‘Blanket Routines Uses’ RECORD ACCESS PROCEDURES: would reveal the identity of a published at the beginning of the NRO Individuals seeking to access confidential source. compilation of systems of records information about themselves contained An exemption rule for this exemption notices apply to this system. in this system should address written has been promulgated in accordance POLICIES AND PRACTICES FOR STORING, inquiries to the National with requirements of 5 U.S.C. 553(b)(1), RETRIEVING, ACCESSING, RETAINING, AND Reconnaissance Office, Information (2), and (3), (c) and (e) and published in DISPOSING OF RECORDS IN THE SYSTEM: Access and Release Center, 14675 Lee 32 CFR part 505. For additional Road, Chantilly, VA 20151–1715. STORAGE: information contact the system manager. Request should include the Paper files and on automated individual’s full name, and any aliases [FR Doc. 01–415 Filed 1–5–01; 8:45 am] information systems. or nicknames, address, Social Security BILLING CODE 5001±10±U RETRIEVABILITY: Number, current citizenship status, date Name, Social Security Number, and place of birth. DEPARTMENT OF DEFENSE organization, company, country, date In addition, the requester must received, action officer, point of contact provide a notarized statement or an Department of the Army and case status. unsworn declaration made in accordance with 28 U.S.C. 1746, in the Privacy Act of 1974; System of SAFEGUARDS: following format: Records Records are stored in a secure, gated If executed without the United States: AGENCY: Department of the Army, DOD. facility, guard, badge, and password ‘I declare (or certify, verify, or state) access protected. Access to and use of under penalty of perjury under the laws ACTION: Notice to alter a system of these records are limited to the of the United States of America that the records. foregoing is true and correct. Executed Counterintelligence staff whose official SUMMARY: The Department of the Army on (date). (Signature)’. duties require such access. Electronic is proposing to alter a system of records If executed within the United States, data is stored on a networked (Local notice to its existing inventory of record its territories, possessions, or Area Network) PC, password restricted systems subject to the Privacy Act of commonwealths: ‘I declare (or certify, to the use of the Counterintelligence 1974, (5 U.S.C. 552a), as amended. The verify, or state) under penalty of perjury Staff. alteration expands the categories of that the foregoing is true and correct. individuals covered to include any RETENTION AND DISPOSAL: Executed on (date). (Signature)’. Records are permanent. individual on any DoD base or CONTESTING RECORD PROCEDURES: installation whose privately owned SYSTEM MANAGER(S) AND ADDRESS: The NRO rules for accessing records, animal receives veterinary care. Director, Office of for contesting contents and appealing Previously, the system of records Counterintelligence, National initial agency determinations are covered only those individuals whose Reconnaissance Office, 14675 Lee Road, published in NRO Directive 110–3 and animals were treated on Army Chantilly, VA 20151–1715. NRO Instruction 110–5; 32 CFR part installations and activities. 326; or may be obtained from the DATES: This proposed action will be NOTIFICATION PROCEDURE: Privacy Act Coordinator, National effective without further notice on Individuals seeking to determine Reconnaissance Office, 14675 Lee Road, February 7, 2001 unless comments are whether this system of records contains Chantilly, VA 20151–1715. received which result in a contrary information about themselves should determination. address written inquiries to the National RECORD SOURCE CATEGORIES: ADDRESSES: Records Management Reconnaissance Office, Information Information is supplied by the Access and Release Center, 14675 Lee Division, U.S. Army Records individual, by parties other than the Management and Declassification Road, Chantilly, VA 20151–1715. individual, and by government agencies. Request should include the Agency, ATTN: TAPC–PDD–RP, Stop individual’s full name and any aliases EXEMPTIONS CLAIMED FOR THE SYSTEM: 5603, Ft. Belvoir, VA 22060–5603. or nicknames, address, Social Security Investigatory material compiled for FOR FURTHER INFORMATION CONTACT: Ms. Number, current citizenship status, date law enforcement purposes may be Janice Thornton at (703) 806–4390 or and place of birth. exempt pursuant to 5 U.S.C. 552a(k)(2). DSN 656–4390 or Ms. Christie King at In addition, the requester must However, if an individual is denied any (703) 806–3711 or DSN 656–3711. provide a notarized statement or an right, privilege, or benefit for which he SUPPLEMENTARY INFORMATION: The unsworn declaration made in would otherwise be entitled by Federal Department of the Army systems of

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SAFEGUARDS: The proposed system report, as CATEGORIES OF INDIVIDUALS COVERED BY THE Records are maintained in buildings required by 5 U.S.C. 552a(r) of the SYSTEM: which are locked when unattended and Privacy Act of 1974, as amended, was Persons who privately own animals are accessed only by authorized submitted on December 19, 2000, to the which receive veterinary care on any personnel having an official need-to- House Committee on Government DoD base or installation. know. Reform, the Senate Committee on RETENTION AND DISPOSAL: Governmental Affairs, and the Office of CATEGORIES OF RECORDS IN THE SYSTEM: Destroy upon death of the animal, Management and Budget (OMB) Name, Social Security Number, home transfer of owner, or 2 years after last pursuant to paragraph 4c of Appendix I address and telephone number of entry in the record. to OMB Circular No. A–130, ‘Federal animal’s owner; record of treatment of Agency Responsibilities for Maintaining animal; and related information. SYSTEM MANAGER(S) AND ADDRESS: Records About Individuals,’ dated Chief Information Officer, Office of February 8, 1996 (February 20, 1996, 61 AUTHORITY FOR MAINTENANCE OF THE SYSTEM: the Surgeon General, U.S. Army FR 6427). 10 U.S.C. 3013, Secretary of the Army; Medical Command, ATTN: MCIM, 2050 Dated: December 20, 2000. DoD Directive 6015.5, Joint Use of Worth Road, Suite 13, Fort Sam Patricia L. Toppings, Military Health and Medical Facilities Houston, TX 78234–6013. and Service; Army Regulation 40–905, Alternate OSD Federal Register Liaison NOTIFICATION PROCEDURE: Officer, Department of Defense. Veterinary Health Services; and E.O. 9397 (SSN). Individuals seeking to determine if A0040±905 DASG information about themselves is PURPOSE(S): contained in this record system should SYSTEM NAME: To record registration, vaccination, address written inquiries to the Privately Owned Animal Record Files and/or treatment of animals; to compile veterinary facility at the installation (August 7, 1997, 62 FR 24534). statistical data; and to identify animals where the animal was treated or registered with the Veterinary euthanized. CHANGES: Treatment Facility. Used by Animal owner should provide the full * * * * * veterinarians and health care authorities name, Social Security Number, home address and telephone number and the SYSTEM NAME: to identify the animal, verify ownership, record history, and to insure veterinary animal’s rabies vaccination number. Add ‘Defense’ to beginning of entry. care, treatment and immunizations RECORD ACCESS PROCEDURES: provided to animals of authorized SYSTEM LOCATION: Individuals seeking access to records owners is recorded; to compile Delete entry and replace with about themselves contained in this statistical data; conduct research; teach; ‘Medical facilities on DoD bases and record system should address written assist in law enforcement, to include installations where veterinary services inquiries to the veterinary facility at the investigation and litigation; and are provided.’ installation where the animal was evaluate the care provided. treated or euthanized. CATEGORIES OF INDIVIDUALS COVERED BY THE Animal owner should provide the full SYSTEM: ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND name, Social Security Number, home Delete entry and replace with ‘Persons THE PURPOSES OF SUCH USES: address and telephone number and the who privately own animals which In addition to those disclosures animal’s rabies vaccination number. receive veterinary care on any DoD base generally permitted under 5 U.S.C. Personal visits may be made to the or installation.’ 552a(b) of the Privacy Act, these records veterinary facility where animal was * * * * * or information contained therein may treated. Owner must provide personal identification such as a valid military AUTHORITY FOR MAINTENANCE OF THE SYSTEM: specifically be disclosed outside the DoD as a routine use pursuant to 5 identification card or driver’s license. Add to entry ‘DoD Directive 6015.5, U.S.C. 552a(b)(3) as follows: Joint Use of Military Health and Medical CONTESTING RECORD PROCEDURES: Facilities and Service; and Army The information may be used to aid The Army’s rules for accessing Regulation 40–905, Veterinary Health in preventive health and communicable records, and for contesting contents and Services.’ disease control programs, report appealing initial agency determinations medical conditions required by law to * * * * * are contained in Army Regulation 340– Federal, state, and local agencies. 21; 32 CFR part 505; or may be obtained STORAGE: The DoD ‘Blanket Routine Uses’ set from the system manager. forth at the beginning of the Army’s Delete entry and replace with ‘Paper RECORD SOURCE CATEGORIES: records in file folders and electronic compilation of systems of records From the animal owner, veterinarian storage media.’ notices also apply to this system. Policies and practices for storing, reports, and similar or related * * * * * retrieving, accessing, retaining, and documents. A0040±905 DASG disposing of records in the system: EXEMPTIONS CLAIMED FOR THE SYSTEM:

SYSTEM NAME: STORAGE: None. Defense Privately Owned Animal Paper records in file folders and [FR Doc. 01–410 Filed 1–5–01; 8:45 am] Record Files. electronic storage media. BILLING CODE 5001±10±P

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DEPARTMENT OF DEFENSE CATEGORIES OF INDIVIDUALS COVERED BY THE CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: SYSTEM: Department of the Army Delete entry and replace with ‘Active Active duty enlisted and reserve duty enlisted and reserve personnel personnel separated from military Privacy Act of 1974; System of separated from military service service (excluding active duty for Records (excluding active duty for military for military for training) and all personnel training) and all personnel immediately immediately re-enlisting after AGENCY: Department of the Army, DOD. reenlisting after separation.’ separation. ACTION: Notice to alter a system of records. CATEGORIES OF RECORDS IN THE SYSTEM: CATEGORIES OF RECORDS IN THE SYSTEM: Delete entry and replace with ‘Name, Name, Social Security Number, rank, SUMMARY: The Department of the Army Social Security Number, rank, eligibility eligibility for re-enlistment, character of is altering a system of records notice in for reenlistment, character of separation, separation, program designator, date its existing inventory of record systems program designator, date and location of and location of separation, reenlistment, subject to the Privacy Act of 1974, (5 separation, reenlistment, moral waiver moral waiver and specialty, and DD U.S.C. 552a), as amended. The alteration and specialty, and DD Form 214, Form 214, Certificate of Discharge of adds a new category of individuals Certificate of Discharge of Release from Release from Active Duty. covered, i.e., reserve personnel. Active Duty.’ AUTHORITY FOR MAINTENANCE OF THE SYSTEM: DATES: This proposed action will be PURPOSE(S): 10 U.S.C. 3013, Secretary of the Army; effective without further notice on Delete entry and replace with ‘To Army Regulation 601–280, Army February 7, 2001 unless comments are monitor separations of active duty and Retention Program; Army Regulation received which result in a contrary reserve personnel as a means of 635–200, Enlisted Personnel; and E.O. determination. controlling strength and record 9397 (SSN). ADDRESSES: Records Management accountability, and re-enlistment PURPOSE(S): processing, and to ensure separation Division, U.S. Army Records To monitor separations of active duty documents are filed in official military Management and Declassification and reserve personnel as a means of record. Agency, ATTN: TAPC–PDD–RP, Stop controlling strength and record 5603, Ft. Belvoir, VA 22060–5603. * * * * * accountability, and re-enlistment FOR FURTHER INFORMATION CONTACT : Ms. STORAGE: processing, and to ensure separation Janice Thornton at (703) 806–4390 or Delete entry and replace with documents are filed in official military DSN 656–4390 or Ms. Christie King at ‘Magnetic tapes/discs and electronic record. (703) 806–3711 or DSN 656–3711. Routine uses of records maintained in storage media.’ SUPPLEMENTARY INFORMATION: The the system, including categories of users Department of the Army systems of RETENTION AND DISPOSAL: and the purposes of such uses: records notices subject to the Privacy Delete entry and replace with In addition to those disclosures Act of 1974, (5 U.S.C. 552a), as ‘Separation records and related generally permitted under 5 U.S.C. amended, have been published in the documents are maintained for six 552a(b) of the Privacy Act, these records Federal Register and are available from months and then destroyed. or information contained therein may the address above. Reenlistment eligibility records are specifically be disclosed outside the DoD as a routine use pursuant to 5 The proposed system report, as forwarded for incorporation into the U.S.C. 552a(b)(3) as follows: required by 5 U.S.C. 552a(r) of the military personnel jacket, destroy upon The DoD ‘Blanket Routine Uses’ set Privacy Act of 1974, as amended, was reenlistment of individual. forth at the beginning of the Army’s submitted on December 19, 2000, to the Military Personnel Transition Point compilation of systems of records House Committee on Government Processing Master File (Disposition pending. Until the National Archives notices also apply to this system. Reform, the Senate Committee on Policies and practices for storing, Governmental Affairs, and the Office of and Records Administration has approved the retention and disposal retrieving, accessing, retaining, and Management and Budget (OMB) disposing of records in the system: pursuant to paragraph 4c of Appendix I schedule for these records, treat as to OMB Circular No. A–130, ‘Federal permanent.’ STORAGE: Agency Responsibilities for Maintaining * * * * * Magnetic tapes/discs and electronic Records About Individuals,’ dated storage media. A0635±5 TAPC February 8, 1996 (February 20, 1996, 61 RETRIEVABILITY: FR 6427). SYSTEM NAME: By name and/or Social Security Dated: December 20, 2000. Separation Transaction Control/ Number. Patricia L. Toppings, Records Transfer System. SAFEGUARDS: Alternate OSD Federal Register Liaison SYSTEM LOCATION: Officer, Department of Defense. Records are protected by physical Commander, U.S. Total Army security devices, guards, computer A0635±5 TAPC Personnel Command, Retirements and software and hardware safeguard Separations Branch, 200 Stovall Street, features, and personnel clearances. SYSTEM NAME: Alexandria, VA 22332–0478; Separation Transaction Control/ U.S. Army Enlisted Records and RETENTION AND DISPOSAL: Records Transfer System (February 22, Evaluation Center, Fort Benjamin Separation records and related 1993, 58 FR 10002). Harrison, IN 46249–5301; documents are maintained for six U.S. Army Reserve Components and months and then destroyed. CHANGES: Personnel Center, 9700 Page Avenue, St. Reenlistment eligibility records are * * * * * Louis, MO 63132–5200. forwarded for incorporation into the

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RETRIEVABILITY: Records Administration disposition is Delete entry and replace with ‘By DATES: This proposed action will be approved. member’s name, amateur and or effective without further notice on Military Affiliate Radio call signs.’ SYSTEM MANAGER(S) AND ADDRESS: February 7, 2001 unless comments are Commander, U.S. Total Army received which result in a contrary SAFEGUARDS: Personnel Command, Retirements and determination. Delete entry and replace with Separations Branch, 200 Stovall Street, ADDRESSES: Records Management ‘Information is maintained in buildings Alexandria, VA 22332–0478. Division, U.S. Army Records accessible to authorized personnel in Management and Declassification the performance of their duties. NOTIFICATION PROCEDURE: Agency, ATTN: TAPC–PDD–RP, Stop Automated records are further protected Individuals seeking to determine if 5603, Ft. Belvoir, VA 22060–5603. by a password assigned to designated information about themselves is FOR FURTHER INFORMATION CONTACT: Ms. personnel.’ contained in this record system should Janice Thornton at (703) 806–4390 or * * * * * address written inquiries to the DSN 656–4390 or Ms. Christie King at Commander, U.S. Total Army Personnel A0025±6USASC (703) 806–3711 or DSN 656–3711. Command, Retirements and Separations SYSTEM NAME: Branch, 200 Stovall Street, Alexandria, SUPPLEMENTARY INFORMATION: The VA 22332–0478. Department of the Army systems of Military Affiliate Radio System Individual should provide the full records notices subject to the Privacy (August 7, 1997, 62 FR 42523). Act of 1974, (5 U.S.C. 552a), as name, Social Security Number, military SYSTEM LOCATION: status, and if separated, date of amended, have been published in the U.S. Army Signal Command, Fort separation. Federal Register and are available from the address above. Huachuca, AZ 85613–5000. RECORD ACCESS PROCEDURES: The specific changes to the records CATEGORIES OF INDIVIDUALS COVERED BY THE Individuals seeking access to records systems being amended are set forth SYSTEM: about themselves contained in this below followed by the notices, as Individuals having a valid amateur record system should address written amended, published in their entirety. radio station license issued by the inquiries to the Commander, U.S. Total The proposed amendments are not Federal Communications Commission, Army Personnel Command, Retirements within the purview of subsection (r) of Army Military Affiliate Radio System and Separations Branch, 200 Stovall the Privacy Act of 1974, (5 U.S.C. 552a), call-sign, relevant inquiries, records and Street, Alexandria, VA 22332–0478. as amended, which requires the reports. Individual should provide the full submission of a new or altered system name, Social Security Number, military report. CATEGORIES OF RECORDS IN THE SYSTEM: status, and if separated, date of Dated: December 20, 2000. Applicant’s name, home address and separation. Patricia L. Toppings, telephone number, licensing data and CONTESTING RECORD PROCEDURES: Alternate OSD Federal Register Liaison call-sign provided by Federal Communications Commission, Army The Army’s rules for accessing Officer, Department of Defense. MARS call-sign, relevant inquiries/ records, contesting contents and A0025±6USASC records and reports. appealing initial agency determinations are contained in Army Regulation 340– SYSTEM NAME: AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 21; 32 CFR part 505; or may be obtained Military Affiliate Radio System 10 U.S.C. 3013, Secretary of the Army: from the system manager. (August 7, 1997, 62 FR 42523). DoD Directive 4650.2, Military Affiliate RECORD SOURCE CATEGORIES: CHANGES: Radio System; Army Regulation 25–6, Military Affiliate Radio System; and From relevant Army records and * * * * * reports. E.O. 9397 (SSN). CATEGORIES OF RECORDS IN THE SYSTEM: PURPOSE(S): EXEMPTIONS CLAIMED FOR THE SYSTEM: Replace last sentence with the None. To provide a potential reserve of following ‘Federal Communications trained radio communications [FR Doc. 01–411 Filed 1–5–01; 8:45 am] Commission, Army Military Affiliate personnel for military duty when BILLING CODE 5001±10±P Radio System call-sign, relevant needed and/or to provide auxiliary inquiries, records and reports.’ communications for military, civil, and/ * * * * * or disaster officials during periods of DEPARTMENT OF DEFENSE ROUTINE USES OF RECORDS MAINTAINED IN THE emergency. Department of the Army SYSTEM, INCLUDING CATEGORIES OF USERS AND ROUTINE USES OF RECORDS MAINTAINED IN THE THE PURPOSES OF SUCH USES: SYSTEM, INCLUDING CATEGORIES OF USERS AND Privacy Act of 1974; System of Delete second paragraph and replace THE PURPOSES OF SUCH USES: Records with ‘Information may be disclosed to In addition to those disclosures federal supply agencies in connection AGENCY: Department of the Army, DoD. generally permitted under 5 U.S.C. with individual’s participation in the 552a(b) of the Privacy Act, these records ACTION: Notice to amend systems of Army MARS Equipment Program.’ or information contained therein may records. * * * * * specifically be disclosed outside the

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DoD as a routine use pursuant to 5 CONTESTING RECORD PROCEDURES: destroy. Proficiency awards are U.S.C. 552a(b)(3) as follows: The Army’s rules for accessing destroyed on transfer of the individual. Information may be disclosed to records, and for contesting contents and Public award cases: Exercising approval federal supply agencies in connection appealing initial agency determinations authority maintain records for 56 years with individual’s participation in the are contained in Army Regulation 340– then destroy; Non-approval authority Army MARS Equipment Program. 21; 32 CFR part 505; or may be obtained offices maintain records for 2 years then The DoD ‘Blanket Routine Uses’ set from the system manager. destroy. Special achievement awards: forth at the beginning of the Army’s Exercising awarding authority maintain RECORD SOURCE CATEGORIES: compilation of systems of records records for 5 years then destroy; Non- notices also apply to this system. From the individual and the Federal Award authority offices maintain for 2 Communications Commission. years then destroy.’’ POLICIES AND PRACTICES FOR STORING, EXEMPTIONS CLAIMED FOR THE SYSTEM: RETRIEVING, ACCESSING, RETAINING, AND SYSTEM MANAGER(S) AND ADDRESS: DISPOSING OF RECORDS IN THE SYSTEM: None. Delete entry and replace with STORAGE: A0672±5±1 TAPC ‘Commander, U.S. Total Army Personnel Command, Awards Policy Cards, paper records in file folders, SYSTEM NAME: Division, 200 Stovall Street, Alexandria, discs, listings and electronic storage Military Awards Case File (February VA 22332–0471.’ media. 22, 1993, 58 FR 10002). * * * * * RETRIEVABILITY: CHANGES: A0600±8±22 TAPC By member’s name, amateur and or SYSTEM IDENTIFIER: Military Affiliate Radio call signs. SYSTEM NAME: Delete entry and replace with ‘A0600– Military Awards Case File. SAFEGUARDS: 8–22 TAPC’. Information is maintained in * * * * * SYSTEM LOCATION: buildings accessible to authorized U.S. Total Army Personnel Command, AUTHORITY FOR MAINTENANCE OF THE SYSTEM: personnel in the performance of their 200 Stovall Street, Alexandria, VA duties. Automated records are further Delete entry and replace with ‘10 22332–0471. Segments exist at Army protected by a password assigned to U.S.C. Chapters 57 and 357, Decorations commands which have been delegated designated personnel. and Awards; 10 U.S.C. 3013, Secretary authority for approval of an award. of the Army; Army Regulation 600–8– Official mailing addresses may be RETENTION AND DISPOSAL: 22, Military Awards; and E.O. 9397 obtained from the U.S. Total Army Destroy on each renewal or two years (SSN).’ Personnel Command, 200 Stovall Street, after termination of membership. * * * * * Alexandria, VA 22332–0471.

SYSTEM MANAGER(S) AND ADDRESS: STORAGE: CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Commander, U.S. Army Signal Delete entry and replace with ‘Paper Command, Fort Huachuca, AZ 95613– records in file folders and electronic Military personnel on active duty, 5000. storage media.’ members of reserve components, U.S. civilians serving with U.S. Army units RETRIEVABILITY: NOTIFICATION PROCEDURE: in a combat zone, and deceased former Individual seeking to determine Delete entry and replace with ‘By members of the U.S. Army. nominee’s name, service number and/or whether information about themselves CATEGORIES OF RECORDS IN THE SYSTEM: is contained in this system should Social Security Number.’ Files include recommendations for an address written inquiries to the SAFEGUARDS: award; endorsements; award board Commander, U.S. Army Signal Delete entry and replace with approvals/disapprovals; citation texts; Command, Fort Huachuca, AZ 95613– ‘Records are maintained in locked file Department of Army letter orders/ 5000. cabinets in secure buildings and are general orders; related papers Individual should provide the name accessible only to designated personnel supporting the award; correspondence under which licensed is the Army in the performance of their assigned among the Army; service member, and Military Affiliate Radio System duties.’ individuals having knowledge/ program, amateur and or Military information relating to the service RETENTION AND DISPOSAL: Affiliate Radio System call sign, present member concerned or the act or address, call sign, and signature. Delete entry and replace with achievement for which an award is ‘Documents related to providing recommended. RECORD ACCESS PROCEDURES: information about awards given to Individuals seeking to access records individuals, i.e. announcements, lists, AUTHORITY FOR MAINTENANCE OF THE SYSTEM: about themselves contained in this cards, and similar information destroy 10 U.S.C. Chapters 57 and 357, record system should address written after 2 years. Approval and disapproval Decorations and Awards; 10 U.S.C. inquiries to the Commander, U.S. Army authority: Approved awards relating to 3013, Secretary of the Army; Army Signal Command, Fort Huachuca, AZ wartime and combat activities are held Regulation 600–8–22, Military Awards; 95613–5000. permanently; Approved peacetime and E.O. 9397 (SSN). Individual should provide the name awards and all disapproved awards are under which licensed is the Army retired to the Washington National PURPOSE(S): Military Affiliate Radio System Records Center and are destroyed after To consider individual nominations program, amateur and or Military 25 years. Offices not within the for awards and/or decorations; record Affiliate Radio System call sign, present disapproval or approval authority final action; maintain individual award address, call sign, and signature. maintain records for 2 years then case files.

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ROUTINE USES OF RECORDS MAINTAINED IN THE NOTIFICATION PROCEDURE: received that would result in a contrary SYSTEM, INCLUDING CATEGORIES OF USERS AND Individuals seeking to determine determination. THE PURPOSES OF SUCH USES: whether information about themselves ADDRESSES: Records Management In addition to those disclosures is contained in this system should Division, U.S. Army Records generally permitted under 5 U.S.C. address written inquiries to the Management and Declassification 552a(b) of the Privacy Act, these records Commander, U.S. Total Army Personnel Agency, ATTN: TAPC-PDD-RP, Stop or information contained therein may Command, Awards Policy Division, 200 5603, Ft. Belvoir, VA 22060–5603. specifically be disclosed outside the Stovall Street, Alexandria, VA 22332– FOR FURTHER INFORMATION CONTACT: Ms. DoD as a routine use pursuant to 5 0471. Janice Thornton at (703) 806–4390 or U.S.C. 552a(b)(3) as follows: Individual should provide the full DSN 656–4390 or Ms. Christie King at Information may be disclosed to name, service number and/or Social (703) 806–3711 or DSN 656–3711. public and private organizations Security Number, grade and branch of SUPPLEMENTARY INFORMATION: The including news media, which grant or service, name of award/honor, and Department of the Army notices for publicize awards or honors. current address. records systems subject to the Privacy The DoD ‘Blanket Routine Uses’ set Act of 1974 (5 U.S.C. 552a), as amended, forth at the beginning of the Army’s RECORD ACCESS PROCEDURES: have been published in the Federal compilation of systems of records Individuals seeking access to Register and are available from the notices also apply to this system. information about themselves contained in this system should address written address above. POLICIES AND PRACTICES FOR STORING, inquiries to the Commander, U.S. Total The proposed system report, as RETRIEVING, ACCESSING, RETAINING, AND Army Personnel Command, Awards required by 5 U.S.C. 552a(r) of the DISPOSING OF RECORDS IN THE SYSTEM: Policy Division, 200 Stovall Street, Privacy Act was submitted on December STORAGE: Alexandria, VA 22332–0471. 19, 2000, to the House Committee on Individual should provide the full Government Reform, the Senate Paper records in file folders and Committee on Governmental Affairs, electronic storage media. name, service number and/or Social Security Number, grade and branch of and the Office of Management and RETRIEVABILITY: service, name of award/honor, and Budget (OMB) pursuant to paragraph 4c By nominee’s name, service number current address. of Appendix I to OMB Circular No. A– and/or Social Security Number. 130, ‘Federal Agency Responsibilities CONTESTING RECORD PROCEDURES: for Maintaining Records About SAFEGUARDS: The Army’s rules for accessing Individuals,’ dated February 8, 1996, (61 Records are maintained in locked file records, and for contesting contents and FR 6427, February 20, 1996). cabinets in secure buildings and are appealing initial agency determinations Dated: December 21, 2000. are contained in Army Regulation 340– accessible only to designated personnel Patricia L. Toppings, in the performance of their assigned 21; 32 CFR part 505; or may be obtained from the system manager. Alternate OSD Federal Register Liaison duties. Officer, Department of Defense. RECORD SOURCE CATEGORIES: RETENTION AND DISPOSAL: A0614±100/200 USMA Documents related to providing From Recommendation for Awards SYSTEM NAME: information about awards given to (DA Form 638) with supporting records, individuals, i.e., announcements, lists, forms, statements, letters, and similar Evaluation/Assignment of Academic cards, and similar information destroy documents originated by persons other Instructors (February 22, 1993, 58 FR after 2 years. Approval and disapproval than the awardee and other individuals 10002). having information useful in making an authority: Approved awards relating to CHANGES: wartime and combat activities are held award determination. * * * * * permanently; Approved peacetime EXEMPTIONS CLAIMED FOR THE SYSTEM: awards and all disapproved awards are None. CATEGORIES OF INDIVIDUALS COVERED BY THE retired to the Washington National SYSTEM: Records Center and are destroyed after [FR Doc. 01–413 Filed 1–5–01; 8:45 am] Delete entry and replace with 25 years. Offices not within the BILLING CODE 5001±10±P ‘Civilian and military personnel who disapproval or approval authority apply and/or serve on the Staff and maintain records for 2 years then Faculty, U.S. Military Academy.’ destroy. Proficiency awards are DEPARTMENT OF DEFENSE CATEGORIES OF RECORDS IN THE SYSTEM: destroyed on transfer of the individual. Department of the Army Public award cases: Exercising approval Delete entry and replace with authority maintain records for 56 years Privacy Act of 1974; System of ‘Individual’s application consisting of then destroy; Non-approval authority Records name, grade or position, Social Security offices maintain records for 2 years then Number, educational and professional destroy. Special achievement awards: AGENCY: Department of the Army, DoD. qualifications such as the Graduate Exercising awarding authority maintain ACTION: Notice to alter systems of Record Examination (GRE) or Graduate records for 5 years then destroy; Non- records. Management Admission Test (GMAT); Award authority offices maintain for 2 evaluations; Officer Record Briefs years then destroy. SUMMARY: The Department of the Army (military only); personnel actions; proposes to alter two systems of records appointments; official photographs; SYSTEM MANAGER(S) AND ADDRESS: notices in its inventory of record curriculum vitae; letters of Commander, U.S. Total Army systems subject to the Privacy Act of endorsement; award recommendations; Personnel Command, Awards Policy 1974 (5 U.S.C. 552a), as amended. assignment orders; application/ Division, 200 Stovall Street, Alexandria, DATES: This action will be effective on acceptance for advanced civil schooling; VA 22332–0471. February 7, 2001, unless comments are correspondence between the U.S.

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Military Academy and the Total Army PURPOSE(S): record system should address written Personnel Command; and other relevant Used by the U.S. Military Academy inquiries to the Associate Dean for Plans documents.’ Dean of Academic Board and and Resources, Office of the Dean, U.S. department heads to assess Military Academy, Dean of Academic PURPOSE(S): qualifications and suitability, and Board, West Point, NY 10996–5000. Delete entry and replace with ‘Used manage civilian and military personnel Individual should provide the full by the U.S. Military Academy Dean of for assignment to the Staff and Faculty, name, Social Security Number, Academic Board and department heads U.S. Military Academy. sufficient details to locate records, to assess qualifications and suitability, current mailing address, and signature. and manage civilian and military ROUTINE USES OF RECORDS MAINTAINED IN THE personnel for assignment to the Staff SYSTEM, INCLUDING CATEGORIES OF USERS AND CONTESTING RECORD PROCEDURES: THE PURPOSES OF SUCH USES: and Faculty, U.S. Military Academy.’ The Army’s rules for accessing * * * * * In addition to those disclosures records, and for contesting contents and generally permitted under 5 U.S.C. appealing initial agency determinations SAFEGUARDS: 552a(b) of the Privacy Act, these records are contained in Army Regulation 340– Delete entry and replace with or information contained therein may 21; 32 CFR part 505; or may be obtained ‘Information is available only to specifically be disclosed outside the from the system manager. designated people who have a need-to- DoD as a routine use pursuant to 5 know.’ U.S.C. 552a(b)(3) as follows: RECORD SOURCE CATEGORIES: The DoD ‘Blanket Routine Uses’ set RETENTION AND DISPOSAL: From the individual; official Army or forth at the beginning of the Army’s other Service records; academic Delete entry and replace with compilation of systems of records institutions; letters of endorsement from ‘Disposition pending (until the National notices also apply to this system. third parties; U.S. Army Military Archive and Records Administration Personnel Center; similar relevant approves the retention and disposition POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND documents. schedule, treat records as permanent).’ DISPOSING OF RECORDS IN THE SYSTEM: * * * * * EXEMPTIONS CLAIMED FOR THE SYSTEM: STORAGE: None. A0614±100/200 USMA Paper records and electronic storage A0635±40 TAPC SYSTEM NAME: medium. Evaluation/Assignment of Academic RETRIEVABILITY: SYSTEM NAME: Instructors. By individual’s name and Social Temporary Disability Retirement SYSTEM LOCATION: Security Number. Master List (TDRL) (February 22, 1993, 58 FR 10002). Associate Dean for Plans and SAFEGUARDS: Resources, Office of the Dean, U.S. Information is available only to CHANGES: Military Academy, Dean of Academic designated people who have a need-to- * * * * * Board, West Point, NY 10996–5000. know. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: CATEGORIES OF INDIVIDUALS COVERED BY THE RETENTION AND DISPOSAL: SYSTEM: Delete entry and replace with ‘10 Disposition pending (until the Civilian and military personnel who U.S.C. 1376, Temporary Disability National Archive and Records Retired Lists; 10 U.S.C. 3013, Secretary apply and/or serve on the Staff and Administration approves the retention Faculty, U.S. Military Academy. of the Army; Army Regulation 635–40, and disposition schedule, treat records Physical Evaluation for Retention, CATEGORIES OF RECORDS IN THE SYSTEM: as permanent). Retirement of Separation; and E.O. 9397 Individual’s application consisting of SYSTEM MANAGER(S) AND ADDRESS: (SSN). name, grade or position, Social Security Associate Dean for Plans and * * * * * Number, educational and professional Resources, Office of the Dean, Dean of ROUTINE USES OF RECORDS MAINTAINED IN THE qualifications such as the Graduate Academic Board, West Point, NY Record Examination (GRE) or Graduate SYSTEM, INCLUDING CATEGORIES OF USERS AND 10996–5000. THE PURPOSES OF SUCH USES: Management Admission Test (GMAT); evaluations; Officer Record Briefs NOTIFICATION PROCEDURE: Add a new paragraph ‘To the (military only); personnel actions; Individuals seeking to determine if Department of Veterans Affairs to appointments; official photographs; information about themselves is facilitate claims for veteran disability curriculum vitae; letters of contained in this record system should benefits.’ endorsement; award recommendations; address written inquiries to the STORAGE: assignment orders; application/ Associate Dean for Plans and Resources, acceptance for advanced civil schooling; Office of the Dean, U.S. Military Paper records in file folders, correspondence between the U.S. Academy, Dean of Academic Board, automated database, computer Military Academy and the Total Army West Point, NY 10996–5000. printouts, magnetic tapes and disks. Personnel Command; and other relevant Individual should provide the full RETRIEVABILITY: documents. name, Social Security Number, sufficient details to locate records, Add ‘name’ to entry. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: current mailing address, and signature. SAFEGUARDS: 10 U.S.C. 3013, Secretary of the Army; 10 U.S.C. 4334, Command and RECORD ACCESS PROCEDURES: Add to entry ‘Records are retained in Supervision; 10 U.S.C. 4337, Civilian Individuals seeking access to records secure offices within secure buildings.’ Faculty and E.O. 9397 (SSN). about themselves contained in this * * * * *

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RECORD SOURCE CATEGORIES: specifically be disclosed outside the Physical Disability Agency, Walter Reed Delete entry and replace with ‘From DoD as a routine use pursuant to 5 Army Medical Center, 6900 Georgia the individual, medical treatment U.S.C. 552a(b)(3) as follows: Avenue, NW, Building 7, Washington, facilities, and other Army records and To the Department of Veterans Affairs DC 20307–5001. reports.’ to facilitate claims for veteran disability Individual should provide the full * * * * * benefits. name, Social Security Number, current The DoD ‘Blanket Routine Uses’ set address and telephone number, and A0635±40 TAPC forth at the beginning of the Army’s signature. compilation of systems of records Inquiries are restricted to issues SYSTEM NAME: notices also apply to this system. relating to the Temporary Disability Temporary Disability Retirement Retirement List only; issues of pay must Master List (TDRL). POLICIES AND PRACTICES FOR STORING, be made at the Defense Finance and RETRIEVING, ACCESSING, RETAINING, AND Accounting Service, 8899 East 56th SYSTEM LOCATION: DISPOSING OF RECORDS IN THE SYSTEM: Street, Indianapolis, IN 46249–5000. PRIMARY LOCATION: STORAGE: CONTESTING RECORD PROCEDURES: Chief, U.S. Army Physical Disability Paper records in medical treatment Agency, Walter Reed Army Medical facilities; magnetic tape, disc. The Army’s rules for accessing Center, 6900 Georgia Avenue, NW, records, and for contesting contents and Building 7, Washington, DC 20307– RETRIEVABILITY: appealing initial agency determinations 5001. By name, Social Security Number and are contained in Army Regulation 340– date. 21; 32 CFR part 505; or may be obtained SECONDARY LOCATION: from the system manager. SAFEGUARDS: Defense Finance and Accounting RECORD SOURCE CATEGORIES: Service, 8899 East 56th Street, Access to all records is restricted to Indianapolis, IN 46249–5000. individuals having need therefor in the From the individual, medical performance of duties. Automated treatment facilities, and other Army CATEGORIES OF INDIVIDUALS COVERED BY THE media are further protected by records and reports. SYSTEM: authorized password for system, EXEMPTIONS CLAIMED FOR THE SYSTEM: Army personnel who are on controlled access to operation rooms None. temporary disability retirement. and controlled output distribution. Records are retained in secure offices [FR Doc. 01–414 Filed 1–5–01; 8:45 am] CATEGORIES OF RECORDS IN THE SYSTEM: within secure buildings. BILLING CODE 5001±10±U File contains, Social Security Number, name, address, Department of RETENTION AND DISPOSAL: Army special order number, percentage Information is maintained for 3 years DEPARTMENT OF DEFENSE of disability, doctor code, re- after the member is found physically fit, examination date, date placed on TDRL, separates or retires. Defense Logistics Agency hospital code, travel code, Army SYSTEM MANAGER(S) AND ADDRESS: component, pay termination code, Privacy Act of 1974; Computer requirement for board code, record Chief, U.S. Army Physical Disability Matching Program Agency, Walter Reed Army Medical control number, hospital name and AGENCY: Defense Manpower Data Center, 6900 Georgia Avenue, NW, address. Center, Defense Logistics Agency, DOD. Building 7, Washington, DC 20307– AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 5001. ACTION: Notice of a computer matching 10 U.S.C. 1376, Temporary Disability program. NOTIFICATION PROCEDURE: Retired Lists; 10 U.S.C. 3013, Secretary SUMMARY: Individuals seeking to determine if Subsection (e)(12) of the of the Army; Army Regulation 635–40, Privacy Act of 1974, as amended, (5 Physical Evaluation for Retention, information about themselves is contained in this record system should U.S.C. 552a) requires agencies to Retirement of Separation; and E.O. 9397 publish advance notice of any proposed (SSN). address written inquiries to the Chief, U.S. Army Physical Disability Agency, or revised computer matching program by the matching agency for public PURPOSE(S): Walter Reed Army Medical Center, 6900 Georgia Avenue, NW, Building 7, comment. The Department of Defense To coordinate with medical treatment (DoD), as the matching agency under the facilities for scheduling medical Washington, DC 20307–5001. Individual should provide the full Privacy Act, is hereby giving notice to examinations; to issue travel orders for the record subjects of a computer individual to report to medical name, Social Security Number, current address and telephone number, and matching program between Office of treatment facility for annual medical Personnel Management (OPM) and DoD examination; to determine individual’s signature. Inquiries are restricted to issues that records are being matched by status by the end of the fifth year of computer. The goal of the match is to being on the TDRL, i.e., whether relating to the Temporary Disability Retirement List only; issues of pay must identify individuals who are improperly individual is to be permanently retired receiving credit for military service in for disability, or returned to duty. be made at the Defense Finance and Accounting Service, 8899 East 56th their civil service annuities or annuities ROUTINE USES OF RECORDS MAINTAINED IN THE Street, Indianapolis, IN 46249–5000. based on the ‘‘guaranteed minimum’’ SYSTEM, INCLUDING CATEGORIES OF USERS AND disability formula. This match will THE PURPOSES OF SUCH USES: RECORD ACCESS PROCEDURES: identify and/or prevent erroneous In addition to those disclosures Individuals seeking access to records payments under the CSRA and FERSA generally permitted under 5 U.S.C. about themselves contained in this Pay system. 552a(b) of the Privacy Act, these records record system should address written DATES: This proposed action will or information contained therein may inquiries to the Chief, U.S. Army become effective February 7, 2001 and

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1320 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices the computer matching will proceed Department of Defense for Retired apparent violation of law, i.e., the civil accordingly without further notice, Military Pay. service annuity is based on military unless comments are received which A. Participating agencies: Participants service other than that which was would result in a contrary in this computer matching program are awarded (1) on account of a service determination or if the Office of the Office of Personnel Management connected disability incurred in combat Management and Budget or Congress (OPM) and the Defense Manpower Data with an enemy of the United States; (2) objects thereto. Any public comment Center (DMDC), Department of Defense on account of a service connected must be received before the effective (DoD). The Office of Personnel disability caused by an instrumentality date. Management is the source agency, i.e., of war and incurred in the line of duty the activity disclosing the records for during a period of war; or (3) based on ADDRESSES: Any interested party may the purpose of the match. The DMDC is submit written comments to the non-regular (i.e., reserve) service under the specific recipient activity or Director, Defense Privacy Office, 1941 the provisions of 10 U.S.C. 12731– matching agency, i.e., the agency that Jefferson Davis Highway, Suite 920, 12739. actually performs the computer The data elements provided by OPM Arlington, VA 22202–4502. matching. for the match file will contain the FOR FURTHER INFORMATION CONTACT: Mr. B. Purpose of the match: The purpose names, addresses, social security Vahan Moushegian, Jr. at (703) 607– of this agreement is to establish the number, date of birth, OPM retirement 2943. conditions for a computer matching claim number, OPM provision retired SUPPLEMENTARY INFORMATION: Pursuant program between the OPM as the source codes, and annuity payment and service to subsection (o) of the Privacy Act of agency and DMDC as the recipient data of individuals currently receiving 1974, as amended, (5 U.S.C. 552a), the agency. The goal of the match is to benefits from OPM. DoD and OPM have concluded an identify individuals who are improperly The DMDC database contains agreement to conduct a computer receiving credit for military service in approximately 1.9 million records of matching program between the agencies. their civil service annuities or annuities military retired personnel. The purpose of the match is to exchange based on the ‘‘guaranteed minimum’’ F. Individual notice and opportunity personal data between the agencies for disability formula. This match will to contest: Due process procedures will identification of individuals who are identify and/or prevent erroneous be provided by OPM to those improperly receiving military retired payments under the CSRA and FERSA individuals matched (hits) consisting of pay. Pay system. OPM’S verification of debt; a minimum A copy of the computer matching C. Authority for conducting the of 30-day written notice to the debtor agreement between the OPM and DoD is match: It is OPM’s responsibility to explaining the debtor’s rights; available upon request to the public. monitor retirement and survivor opportunity for the debtor to examine Requests should be submitted to the benefits paid under 5 U.S.C. 8331 and copy OPM documentation relating address caption above or to the Chief, (CSRA), et seq. and 5 U.S.C. 8401 to the debt; provision for debtor to seek Retirement Inspection Branch, Room (FESRA), et seq. Specifically, 5 U.S.C. the OPM review of the debt (or in the 2309, Retirement and Insurance Service, 8332 is the legal authority for CSRA and case of the salary offset provision, Office of Personnel Management, 1900 E 5 U.S.C. 8411 is the legal authority for opportunity for a hearing before an Street, NW, Washington, DC 20415. FESRA for determining whether individual who is not under the Set forth below is a public notice of military service may be credited for civil supervision or control of the agency); the establishment of the computer service retirement purposes. and opportunity for the individual to matching program required by D. Records to be matched: The enter into a written agreement paragraph 6.c. of the Office of systems of records described below satisfactory to the OPM for repayment. Management and Budget Guidelines on contain an appropriate routine use Only when all of the steps have been computer matching published on June provisions which permits disclosure of taken will OPM disclose information, 19, 1989, at 54 FR 25818. information between agencies. pursuant to a routine use, to effect an The matching agreement, as required OPM will use the system of records administrative or salary offset. Unless by 5 U.S.C. 552a(r) of the Privacy Act, identified as OPM/Central-1, ‘Civil the individual notifies OPM within 30 and an advance copy of this notice were Service Retirement and Insurance days from the date of the notice, OPM submitted on December 20, 2000, to the Records,’ published at 60 FR 63081, will infer that the data provided the House Committee on Government December 8, 1995, as amended at 63 FR individual is accurate and correct and Reform, the Senate Committee on 45881, August 27, 1998 and at 65 FR will take the next step, as authorized by Governmental Affairs, and the 25775, May 3, 2000. law, to recoup the delinquent debt. Administrator of the Office of DoD will use the system of records G. Inclusive dates of the matching Information and Regulatory Affairs, identified as S322.10 DMDC, ‘Defense program: This computer matching Office of Management and Budget Manpower Data Center Data Base,’ program is subject to review by the pursuant to paragraph 4d of Appendix published at 65 FR 43302, July 13, 2000. Office of Management and Budget and I to OMB Circular No. A–130, ‘Federal E. Description of computer matching Congress. If the mandatory 30 day Agency Responsibilities for Maintaining program: The OPM will provided period for public comment has expired Records about Individuals,’ dated DMDC with an electronic file which and if no objections are raised by either February 8, 1996 (February 20, 1996, 61 contains specified data elements of Congress or the Office of Management FR 6427). individual CSRA and FESRA and Budget within 40 days of being annuitants. Upon receipt of the notified of the proposed match, the Dated: December 22, 2000. electronic file, DMDC will perform a computer matching program becomes Patricia L. Toppings, computer match using all nine digits of effective and the respective agencies Alternate OSD Federal Register Liaison the SSN’s in the OPM file against the may begin the exchange of data at a Officer, Department of Defense. DMDC computer database on military mutually agreeable time and will be Notice of a Computer Matching retired pay data. repeated on an bi-annual basis. By Program between the Office of The data will be matched to identify agreement between OPM and DoD, the Personnel Management, and the those individuals who are being paid in matching program will be in effect and

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AUTHORITY FOR MAINTENANCE OF THE SYSTEM: PURPOSE(S): SUMMARY: The Department of the Navy Delete entry and replace with ‘‘5 proposes to alter seven system of To provide a record of individual U.S.C. 301, Departmental Regulations records notices in its inventory of record inquiries and JAG responses concerning and 42 U.S.C. 10601 et seq., Victim’s military justice related matters, and to systems subject to the Privacy Act of Rights and Restitution Act of 1990 as 1974 (5 U.S.C. 552a), as amended. maintain background information on implemented by DoD Instruction military justice matters to assist in DATES: This action will be effective on 1030.2, Victim and Witness Assistance responding to inquiries. Procedures.’’ February 7, 2001 unless comments are To provide information and support received that would result in a contrary PURPOSE(S): to victims and witnesses in compliance determination. Add a new paragraph ‘‘To provide with the Victim and Witness Assistance ADDRESSES: Send comments to the information and support to victims and Program, the Sexual Assault Prevention Department of the Navy, PA/FOIA witnesses in compliance with the and Response Program, and the Victims’ Policy Branch, Chief of Naval Victim and Witness Assistance Program, Rights and Restitution Act of 1990. Operations (N09B30), 2000 Navy the Sexual Assault Prevention and ROUTINE USES OF RECORDS MAINTAINED IN THE Pentagon, Washington, DC 20350–2000. Response Program, and the Victims’ SYSTEM, INCLUDING CATEGORIES OF USERS AND Rights and Restitution Act of 1990.’’ THE PURPOSES OF SUCH USES: FOR FURTHER INFORMATION CONTACT: Mrs. Doris Lama at (202) 685–6545 or DSN ROUTINE USES OF RECORDS MAINTAINED IN THE In addition to those disclosures 325–6545. SYSTEM, INCLUDING CATEGORIES OF USERS AND generally permitted under 5 U.S.C. THE PURPOSES OF SUCH USES: 552a(b) of the Privacy Act, these records SUPPLEMENTARY INFORMATION: The Add a new paragraph ‘‘To victims and or information contained therein may Department of the Navy’s record system witnesses to comply with the Victim specifically be disclosed outside the notices for records systems subject to and Witness Assistance Program, the DoD as a routine use pursuant to 5 the Privacy Act of 1974 (5 U.S.C. 552a), Sexual Assault Prevention and U.S.C. 552a(b)(3) as follows: as amended, have been published in the Response Program, and the Victims’ To victims and witnesses to comply Federal Register and are available from Rights and Restitution Act of 1990.’’ with the Victim and Witness Assistance the address above. * * * * * Program, the Sexual Assault Prevention The proposed system report, as and Response Program, and the Victims’ required by 5 U.S.C. 552a(r) of the N05810±2 Rights and Restitution Act of 1990. Privacy Act was submitted on December SYSTEM NAME: The DoD ‘‘Blanket Routine Uses’’ that 19, 2000, to the House Committee on appear at the beginning of the Navy’s Military Justice Correspondence and compilation of system notices apply to Government Reform, the Senate Information File. Committee on Governmental Affairs, this system. and the Office of Management and SYSTEM LOCATION: POLICIES AND PRACTICES FOR STORING, Budget (OMB) pursuant to paragraph 4c Office of the Judge Advocate General RETRIEVING, ACCESSING, RETAINING, AND of Appendix I to OMB Circular No. A– (Code 20), Department of the Navy, 716 DISPOSING OF RECORDS IN THE SYSTEM: 130, ‘‘Federal Agency Responsibilities Sicard Street SE, Suite 1000, for Maintaining Records About Washington Navy Yard, DC 20374–5047 STORAGE: Individuals,’’ dated February 8, 1996 (61 and duplicate copies may be maintained File folders, binder-notebooks, and FR 6427, February 20, 1996). in local legal office file. computer hard drive and floppy disks.

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RETRIEVABILITY: may be made to the Criminal Law SYSTEM LOCATION: Files are kept in alphabetical order Division, Office of the Judge Advocate Navy and Marine Corps Appellate according to the last name of the General at the above address. Review Activity, Office of the Judge individual who is the subject of the file. Individuals making such visits should Advocate General, Department of the be able to provide some acceptable Navy, 716 Sicard Street SE, Suite 1000, SAFEGUARDS: identification, e.g., Armed Forces’ Washington Navy Yard, DC 20374– Files are maintained in file cabinets identification card, driver’s license, etc. 5047. and other storage devices under the control of authorized personnel during CONTESTING RECORD PROCEDURES: CATEGORIES OF INDIVIDUALS COVERED BY THE working hours; the office space in The Navy’s rules for accessing SYSTEM: which the file cabinets and storage records, and for contesting contents and Active duty Navy and Marine Corps devices are located is locked outside of appealing initial agency determinations personnel tried by general courts- working hours. are published in Secretary of the Navy martial. RETENTION AND DISPOSAL: Instruction 5211.5; 32 CFR part 701; or CATEGORIES OF RECORDS IN THE SYSTEM: may be obtained from the system Records are maintained in office for manager. General courts-martial records of trial. two years and then forwarded to the AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Federal Records Center, Suitland, MD RECORD SOURCE CATEGORIES: 20409 for storage; files containing 5 U.S.C. 301, Departmental Records in this system are compiled background material are maintained on Regulations; 10 U.S.C. 865; and 42 from information received from naval computer hard drive for two years and U.S.C. 10601 et seq., Victim’s Rights and field offices, records of trial, and then purged. Restitution Act of 1990 as implemented correspondence. by DoD Instruction 1030.2, Victim and SYSTEM MANAGER(S) AND ADDRESS: EXEMPTIONS CLAIMED FOR THE SYSTEM: Witness Assistance Procedures. Assistant Judge Advocate General (Military Justice), Office of the Judge None. PURPOSE(S): Advocate General, Department of the N05813±3 To complete appellate review as Navy, 716 Sicard Street SE, Suite 1000, required under 10 U.S.C. 866, 867, 869 Washington Navy Yard, DC 20374– SYSTEM NAME: and provide central repository 5047. Records of Trial of General Courts- accessible to the public who may request information concerning the NOTIFICATION PROCEDURE: Martial (August 3, 1999, 64 FR 42106). appellate review or want copies of Individuals seeking to determine CHANGES: individual public records. whether this system of records contains * * * * * To provide information and support information about themselves should to victims and witnesses in compliance address written inquiries to the Deputy AUTHORITY FOR MAINTENANCE OF THE SYSTEM: with the Victim and Witness Assistance Assistant Judge Advocate General Delete entry and replace with ‘‘5 Program, the Sexual Assault Prevention (Criminal Law), Office of the Judge U.S.C. 301, Departmental Regulations; and Response Program, and the Victims’ Advocate General, Department of the 10 U.S.C. 865; and 42 U.S.C. 10601 et Rights and Restitution Act of 1990. Navy, 716 Sicard Street SE, Suite 1000, seq., Victim’s Rights and Restitution Act Washington Navy Yard, DC 20374– of 1990 as implemented by DoD ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND 5047. Instruction 1030.2, Victim and Witness THE PURPOSES OF SUCH USES: Information may be obtained by Assistance Procedures.’’ written request stating the full name of In addition to those disclosures the individual concerned. Written PURPOSE(S): generally permitted under 5 U.S.C. requests must be signed by the Add a new paragraph ‘‘To provide 552a(b) of the Privacy Act, these records requesting individual. Personal visits information and support to victims and or information contained therein may may be made to the Criminal Law witnesses in compliance with the specifically be disclosed outside the Division, Office of the Judge Advocate Victim and Witness Assistance Program, DoD as a routine use pursuant to 5 General at the above address. the Sexual Assault Prevention and U.S.C. 552a(b)(3) as follows: Individuals making such visits should Response Program, and the Victims’ To victims and witnesses of a crime be able to provide some acceptable Rights and Restitution Act of 1990.’’ for purposes of providing information, identification, e.g., Armed Forces’ consistent with the requirements of the identification card, driver’s license, etc. ROUTINE USES OF RECORDS MAINTAINED IN THE Victim and Witness Assistance Program, SYSTEM, INCLUDING CATEGORIES OF USERS AND regarding the investigation and RECORD ACCESS PROCEDURES: THE PURPOSES OF SUCH USES: disposition of an offense. Individuals seeking access to records Add a new paragraph ‘‘To victims and The DoD ‘Blanket Routine Uses’ that about themselves should address witnesses of a crime for purposes of appear at the beginning of the Navy’s written inquiries to the Deputy providing information, consistent with compilation of systems of records Assistant Judge Advocate General the requirements of the Victim and notices apply to this system. (Criminal Law), Office of the Judge Witness Assistance Program, regarding POLICIES AND PRACTICES FOR STORING, Advocate General, Department of the the investigation and disposition of an RETRIEVING, ACCESSING, RETAINING, AND Navy, 716 Sicard Street SE, Suite 1000, offense.’’ Washington Navy Yard, DC 20374– DISPOSING OF RECORDS IN THE SYSTEM: * * * * * 5047. STORAGE: Information may be obtained by N05813±3 File folders. written request stating the full name of the individual concerned. Written SYSTEM NAME: RETRIEVABILITY: requests must be signed by the Records of Trial of General Courts- Files are kept by Navy courts-martial requesting individual. Personal visits Martial. number and each case is cross-

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Individuals making such visits awarded a bad conduct discharge, and personnel during working hours; the should be able to provide acceptable all Navy and Marine Corps office space in which the file cabinets identification, e.g., Armed Forces commissioned officers tried by special are located is locked outside official identification card, driver’s license, etc. working hours. courts-martial. CONTESTING RECORD PROCEDURES: RETENTION AND DISPOSAL: CATEGORIES OF RECORDS IN THE SYSTEM: The Navy’s rules for accessing Special courts-martial which resulted Records are maintained in office for records, and for contesting contents and in a bad conduct discharge, or involving three years and then forwarded to the appealing initial agency determinations commissioned officers. Washington Federal Records Center, are published in Secretary of the Navy 4205 Suitland Road, Suitland, MD Instruction 5211.5; 32 CFR part 701; or AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 20409 for storage. may be obtained from the system 5 U.S.C. 301, Departmental SYSTEM MANAGER(S) AND ADDRESS: manager. Regulations; 10 U.S.C. 865; 10 U.S.C. 866(b); and 42 U.S.C. 10601 et seq., Assistant Judge Advocate General RECORD SOURCE CATEGORIES: (Military Law), Office of the Judge Victim’s Rights and Restitution Act of Proceedings by a general courts- 1990 as implemented by DoD Advocate General, Department of the martial. Navy, 716 Sicard Street SE, Suite 1000, Instruction 1030.2, Victim and Witness Washington Navy Yard, DC 20374– EXEMPTIONS CLAIMED FOR THE SYSTEM: Assistance Procedures. 5047. None. PURPOSE(S): NOTIFICATION PROCEDURE: N05813±5 To complete appellate review as Individuals seeking to determine required under 10 U.S.C. 866(b) and whether this system contains SYSTEM NAME: provide central repository accessible to information about themselves should Record of Trial of Special Courts- the public who may request information address written inquiries to the Division Martial Resulting in Bad Conduct concerning the appellate review or want Director, Administrative Support Discharges or Concerning Officers (June copies of individual public records. Division, Navy and Marine Corps 8, 1999, 64 FR 30497) To provide information and support to victims and witnesses in compliance Appellate Review Activity, Office of the CHANGES: Judge Advocate General, Department of with the Victim and Witness Assistance * * * * * the Navy, 716 Sicard Street SE, Suite Program, the Sexual Assault Prevention 1000, Washington Navy Yard, DC PURPOSE(S): and Response Program, and the Victims’ Rights and Restitution Act of 1990. 20374–5047. Add a new paragraph ‘‘To provide The request should contain full name information and support to victims and ROUTINE USES OF RECORDS MAINTAINED IN THE and address of the individual concerned witnesses in compliance with the SYSTEM, INCLUDING CATEGORIES OF USERS AND and should be signed. Victim and Witness Assistance Program, THE PURPOSES OF SUCH USES: Personal visits may be made to the the Sexual Assault Prevention and In addition to those disclosures Administrative Support Division, Navy Response Program, and the Victims’ generally permitted under 5 U.S.C. and Marine Corps Appellate Review Rights and Restitution Act of 1990.’’ 552a(b) of the Privacy Act, these records Activity, Office of the Judge Advocate Routine uses of records maintained in or information contained therein may General, Department of the Navy, 716 the system, including categories of users specifically be disclosed outside the Sicard Street SE, Suite 1000, and the purposes of such uses: DoD as a routine use pursuant to 5 Washington Navy Yard, DC 20374– Add a new paragraph ‘‘To victims and U.S.C. 552a(b)(3) as follows: 5047. Individuals making such visits witnesses of a crime for purposes of To victims and witnesses of a crime should be able to provide acceptable providing information, consistent with for purposes of providing information, identification, e.g., Armed Forces the requirements of the Victim and consistent with the requirements of the identification card, driver’s license, etc. Witness Assistance Program, regarding Victim and Witness Assistance Program, RECORD ACCESS PROCEDURES: the investigation and disposition of an regarding the investigation and Individuals seeking access to offense.’’ disposition of an offense. The DoD ‘Blanket Routine Uses’ that information about themselves contained * * * * * appear at the beginning of the Navy’s in this system of records should address N05813±5 compilation of systems of records apply written inquiries to the Division to this system. Director, Administrative Support SYSTEM NAME: Division, Navy and Marine Corps Record of Trial of Special Courts- POLICIES AND PRACTICES FOR STORING, Appellate Review Activity, Office of the Martial Resulting in Bad Conduct RETRIEVING, ACCESSING, RETAINING, AND Judge Advocate General, Department of Discharges or Concerning Officers. DISPOSING OF RECORDS IN THE SYSTEM: the Navy, 716 Sicard Street SE, Suite STORAGE: SYSTEM LOCATION: 1000, Washington Navy Yard, DC File folders. 20374–5047. Administrative Support Division, The request should contain full name Navy and Marine Corps Appellate RETRIEVABILITY: and address of the individual concerned Review Activity, Office of the Judge Files are kept by Navy courts-martial and should be signed. Advocate General, Department of the number and each case is cross-

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Personal visits may be made to the CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Administrative Support Division, Navy SAFEGUARDS: and Marine Corps Appellate Review Navy and Marine Corps enlisted Files are maintained in file cabinets Activity, Office of the Judge Advocate personnel tried by summary courts- and other storage devices under the General, Department of the Navy, 716 martial or by special courts-martial control of authorized personnel during Sicard Street SE, Suite 1000, which did not result in a bad conduct working hours; the office space in Washington Navy Yard, DC 20374– discharge (BCD). which the file cabinets and storage 5047. Individuals making such visits CATEGORIES OF RECORDS IN THE SYSTEM: devices are located is locked outside should be able to provide acceptable Summary courts-martial and non-BCD official working hours. identification, e.g., Armed Forces special courts-martial records of trial. identification card, driver’s license, etc. RETENTION AND DISPOSAL: AUTHORITY FOR MAINTENANCE OF THE SYSTEM: CONTESTING RECORD PROCEDURES: Records are maintained in office for 5 U.S.C. 301, Departmental three years and then forwarded to the The Navy’s rules for accessing Regulations; 10 U.S.C. 865; and 42 Washington Federal Records Center, records, and for contesting contents and U.S.C. 10601 et seq., Victim’s Rights and 4205 Suitland Road, Suitland, MD appealing initial agency determinations Restitution Act of 1990 as implemented 20409 for storage. are published in Secretary of the Navy by DoD Instruction 1030.2, Victim and Instruction 5211.5; 32 CFR part 701; or Witness Assistance Procedures. SYSTEM MANAGER(S) AND ADDRESS: may be obtained from the system Assistant Judge Advocate General manager. PURPOSE(S): (Military Justice), Office of the Judge RECORD SOURCE CATEGORIES: To complete appellate review as Advocate General, Department of the required under 10 U.S.C. 864(a) and Special courts-martial proceedings. Navy, 716 Sicard Street SE, Suite 1000, provide repositories accessible to the Washington Navy Yard, DC 20374– EXEMPTIONS CLAIMED FOR THE SYSTEM: public who may request information 5047. None. concerning the appellate review or want copies of individual public records. NOTIFICATION PROCEDURE: N05813±6 To provide information and support Individuals seeking to determine to victims and witnesses in compliance SYSTEM NAME: whether this system contains with the Victim and Witness Assistance information about themselves should Summary and Non-BCD Special Program, the Sexual Assault Prevention address written inquiries to the Division Courts-Martial Records of Trial (June 8, and Response Program, and the Victims’ Director, Administrative Support 1999, 64 FR 30497). Rights and Restitution Act of 1990. Division, Navy and Marine Corps CHANGES: ROUTINE USES OF RECORDS MAINTAINED IN THE Appellate Review Activity, Office of the * * * * * SYSTEM, INCLUDING CATEGORIES OF USERS AND Judge Advocate General, Department of THE PURPOSES OF SUCH USES: the Navy, 716 Sicard Street SE, Suite PURPOSE S ( ): In addition to those disclosures 1000, Washington Navy Yard, DC Add a new paragraph ‘‘To provide generally permitted under 5 U.S.C. 20374–5047. information and support to victims and 552a(b) of the Privacy Act, these records The request should contain full name witnesses in compliance with the or information contained therein may and address of the individual concerned Victim and Witness Assistance Program, specifically be disclosed outside the and should be signed. the Sexual Assault Prevention and DoD as a routine use pursuant to 5 Personal visits may be made to the Response Program, and the Victims’ U.S.C. 552a(b)(3) as follows: Administrative Support Division, Navy Rights and Restitution Act of 1990.’’ To victims and witnesses of a crime and Marine Corps Appellate Review for purposes of providing information, Activity, Office of the Judge Advocate ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND consistent with the requirements of the General, Department of the Navy, 716 THE PURPOSES OF SUCH USES: Victim and Witness Assistance Program, Sicard Street SE, Suite 1000, regarding the investigation and Washington Navy Yard, DC 20374– Add a new paragraph ‘‘To victims and witnesses of a crime for purposes of disposition of an offense. 5047. Individuals making such visits The DoD ‘Blanket Routine Uses’ that should be able to provide acceptable providing information, consistent with the requirements of the Victim and appear at the beginning of the Navy’s identification, e.g., Armed Forces compilation of systems of records identification card, driver’s license, etc. Witness Assistance Program, regarding the investigation and disposition of an notices apply to this system. RECORD ACCESS PROCEDURES: offense.’’ POLICIES AND PRACTICES FOR STORING, Individuals seeking access to * * * * * RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: information about themselves contained N05813±6 in this system of records should address STORAGE: written inquiries to the Division SYSTEM NAME: File folders. Director, Administrative Support Summary and Non-BCD Special Division, Navy and Marine Corps Courts-Martial Records of Trial. RETRIEVABILITY: Appellate Review Activity, Office of the Type of courts-martial, date, Judge Advocate General, Department of SYSTEM LOCATION: command which convened the courts- the Navy, 716 Sicard Street SE, Suite Organizational elements of the martial, name of individual defendant, 1000, Washington Navy Yard, DC Department of the Navy. Official and command which completed the 20374–5047. mailing addresses are published as an supervisory authority’s action.

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SAFEGUARDS: type of courts-martial (summary or courts-martial sentence, as finally Files are maintained in file cabinets special), the name of the command approved, includes a punitive and other storage devices under the which held the courts-martial, and the discharge. control of authorized personnel during date of the courts-martial proceedings. working hours; the office space in Written requests must be signed by the CATEGORIES OF RECORDS IN THE SYSTEM: which the file cabinets and storage requesting individual. Courts-martial information on special devices are located is locked outside courts-martial if sentence, as finally official working hours. CONTESTING RECORD PROCEDURES: approved, includes a punitive discharge The Navy’s rules for accessing and all general courts-martial including RETENTION AND DISPOSAL: records, and for contesting contents and name, Social Security Number, pleas, Records are retained for two years appealing initial agency determinations convening authority action, supervisory after final action by officers having are published in Secretary of the Navy authority action, and Court of Military supervisory authority over shore Instruction 5211.5; 32 CFR part 701; or Review action. Information is available activities, and for three months by may be obtained from the system from 1970 through 1986 only. officers having supervisory authority manager. over fleet activities. At the termination AUTHORITY FOR MAINTENANCE OF THE SYSTEM: RECORD SOURCE CATEGORIES: of the appropriate retention period, 5 U.S.C. 301, Departmental records are forwarded for storage to the Proceedings of summary courts- Regulations; 42 U.S.C. 10601 et seq., National Personnel Records Center martial and special courts-martial which Victim’s Rights and Restitution Act of (Military Personnel Records), GSA, 9700 did not result in a bad conduct 1990 as implemented by DoD Page Avenue, St. Louis, MO 63132– discharge. Instruction 1030.2, Victim and Witness 5100. Records are destroyed 15 years EXEMPTIONS CLAIMED FOR THE SYSTEM: Assistance Procedures; and E.O. 9397 after final action has been taken. None. (SSN). SYSTEM MANAGER(S) AND ADDRESS: PURPOSE(S): Assistant Judge Advocate General N05814±3 To collect data on general and bad (Military Justice), Office of the Judge SYSTEM NAME: conduct discharge special courts- Advocate General, Department of the Courts-Martial Information (August 3, martial. Navy, 716 Sicard Street SE, Suite 1000, 1999, 64 FR 42106). Washington Navy Yard, DC 20374–5047 To provide information and support or appropriate officer having CHANGES: to victims and witnesses in compliance with the Victim and Witness Assistance supervisory authority over the naval * * * * * activity which convened the court- Program, the Sexual Assault Prevention martial. PURPOSE(S): and Response Program, and the Victims’ Add a new paragraph ‘‘To provide Rights and Restitution Act of 1990. NOTIFICATION PROCEDURE: information and support to victims and Individuals seeking to determine ROUTINE USES OF RECORDS MAINTAINED IN THE witnesses in compliance with the SYSTEM, INCLUDING CATEGORIES OF USERS AND whether this system of records contains Victim and Witness Assistance Program, THE PURPOSES OF SUCH USES: information about themselves should the Sexual Assault Prevention and In addition to those disclosures address written inquiries to the Division Response Program, and the Victims’ generally permitted under 5 U.S.C. Director, Administrative Support Rights and Restitution Act of 1990.’’ Division, Navy-Marine Corps Appellate 552a(b) of the Privacy Act, these records Review Activity, Office of the Judge ROUTINE USES OF RECORDS MAINTAINED IN THE or information contained therein may Advocate General, Department of the SYSTEM, INCLUDING CATEGORIES OF USERS AND specifically be disclosed outside the THE PURPOSES OF SUCH USES: Navy, 716 Sicard Street SE, Suite 1000, DoD as a routine use pursuant to 5 Washington Navy Yard, DC 20374– Add a new paragraph ‘‘To victims and U.S.C. 552a(b)(3) as follows: 5047. witnesses to comply with the Victim To governmental, public and private The request should include the full and Witness Assistance Program, the organizations and individuals, as name of the individual concerned, the Sexual Assault Prevention and required. type of courts-martial (summary or Response Program, and the Victims’ To victims and witnesses to comply special), the name of the command Rights and Restitution Act of 1990.’’ with the Victim and Witness Assistance which held the courts-martial, and the * * * * * Program, the Sexual Assault Prevention date of the courts-martial proceedings. and Response Program, and the Victims’ N05814±3 Written requests must be signed by the Rights and Restitution Act of 1990. requesting individual. SYSTEM NAME: The DoD ‘Blanket Routine Uses’ that Courts-Martial Information. appear at the beginning of the Navy’s RECORD ACCESS PROCEDURES: compilation of systems of records also Individuals seeking access to records SYSTEM LOCATION: apply to this system. about themselves contained in this Administrative Support Division Policies and practices for storing, system of records should address (Code 40), Navy-Marine Corps Appellate retrieving, accessing, retaining, and written inquiries to the Division Review Activity, Office of the Judge disposing of records in the system: Director, Administrative Support Advocate General, 716 Sicard Street SE, STORAGE: Division, Navy-Marine Corps Appellate Suite 1000, Washington Navy Yard, DC Review Activity, Office of the Judge 20374–5047. Index card file. Advocate General, Department of the Navy, 716 Sicard Street SE, Suite 1000, CATEGORIES OF INDIVIDUALS COVERED BY THE RETRIEVABILITY: Washington Navy Yard, DC 20374– SYSTEM: Index cards are filed by year appellate 5047. Navy and Marine Corps personnel review of the case was completed and The request should include the full tried by general courts-martial and by alphabetically by last name within a name of the individual concerned, the special courts-martial when the special given year.

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SAFEGUARDS: CONTESTING RECORD PROCEDURES: CATEGORIES OF RECORDS IN THE SYSTEM: Office is located in a secure building The Navy’s rules for accessing Files contain individual service which is guarded 24 hours a day. records, and for contesting contents and member’s petition together with all Admission is allowed only to personnel appealing initial agency determinations forwarding endorsements and copy of on official business and authorized are published in Secretary of the Navy action taken by the Judge Advocate visitors. Instruction 5211.5; 32 CFR part 701; or General with supporting memorandum. may be obtained from the system RETENTION AND DISPOSAL: AUTHORITY FOR MAINTENANCE OF THE SYSTEM: manager. Indefinite. 5 U.S.C. 301, Departmental RECORD SOURCE CATEGORIES SYSTEM MANAGER(S) AND ADDRESS: : Regulations; Article 69, Uniform Code of Military Justice, 10 U.S.C. 869) and Assistant Judge Advocate General Navy Judge Advocate General Form 42 U.S.C. 10601 et seq., Victim’s Rights (Military Justice), Office of the Judge 5813/1. and Restitution Act of 1990 as Advocate General, 716 Sicard Street SE, EXEMPTIONS CLAIMED FOR THE SYSTEM: implemented by DoD Instruction Suite 1000, Washington Navy Yard, DC 1030.2, Victim and Witness Assistance 20374–5047. None. Procedures. NOTIFICATION PROCEDURE: N05814±4 PURPOSE(S): Individuals seeking to determine SYSTEM NAME: whether this system contains To complete appellate review as information about themselves should Article 69(b) Petitions (May 28, 1999, required under 10 U.S.C. 869(b) and to address written inquiries to the Division 64 FR 29009). provide a central repository accessible Director, Administrative Support to the public who may request CHANGES: information concerning the appellate Division, Navy and Marine Corps * * * * * Appellate Review Activity, Office of the review or want copies of individual public records. Judge Advocate General, Department of PURPOSE(S): the Navy, 716 Sicard Street SE, Suite To provide information and support Add a new paragraph ‘‘To provide to victims and witnesses in compliance 1000, Washington Navy Yard, DC information and support to victims and 20374–5047. with the Victim and Witness Assistance witnesses in compliance with the Program, the Sexual Assault Prevention The request should contain full name Victim and Witness Assistance Program, and address of the individual concerned and Response Program, and the Victims’ the Sexual Assault Prevention and Rights and Restitution Act of 1990. and should be signed. Response Program, and the Victims’ Personal visits may be made to the Rights and Restitution Act of 1990.’’ ROUTINE USES OF RECORDS MAINTAINED IN THE Administrative Support Division, Navy SYSTEM, INCLUDING CATEGORIES OF USERS AND and Marine Corps Appellate Review ROUTINE USES OF RECORDS MAINTAINED IN THE THE PURPOSES OF SUCH USES: Activity, Office of the Judge Advocate SYSTEM, INCLUDING CATEGORIES OF USERS AND In addition to those disclosures General, Department of the Navy, 716 THE PURPOSES OF SUCH USES: generally permitted under 5 U.S.C. Sicard Street SE, Suite 1000, Add a new paragraph ‘‘To victims and 552a(b) of the Privacy Act, these records Washington Navy Yard, DC 20374– witnesses of a crime for purposes of or information contained therein may 5047. Individuals making such visits providing information, consistent with specifically be disclosed outside the should be able to provide acceptable the requirements of the Victim and DoD as a routine use pursuant to 5 identification, e.g., Armed Forces Witness Assistance Program, regarding U.S.C. 552a(b)(3) as follows: identification card, driver’s license, etc. the investigation and disposition of an To victims and witnesses of a crime RECORD ACCESS PROCEDURES: offense.’’ for purposes of providing information, Individuals seeking access to * * * * * consistent with the requirements of the Victim and Witness Assistance Program, information about themselves contained N05814±4 in this system of records should address regarding the investigation and disposition of an offense. written inquiries to the Division SYSTEM NAME: The DoD ‘Blanket Routine Uses’ that Director, Administrative Support Article 69(b) Petitions. appear at the beginning of the Navy’s Division, Navy and Marine Corps compilation of systems of records apply Appellate Review Activity, Office of the SYSTEM LOCATION: to this system. Judge Advocate General, Department of Administrative Support Division, the Navy, 716 Sicard Street SE, Suite Navy and Marine Corps Appellate POLICIES AND PRACTICES FOR STORING, 1000, Washington Navy Yard, DC Review Activity, Office of the Judge RETRIEVING, ACCESSING, RETAINING, AND 20374–5047. Advocate General, Department of the DISPOSING OF RECORDS IN THE SYSTEM: The request should contain full name Navy, 716 Sicard Street SE, Suite 1000, STORAGE: and address of the individual concerned Washington Navy Yard, DC 20374– File folders. and should be signed. 5047. Personal visits may be made to the RETRIEVABILITY: Administrative Support Division, Navy CATEGORIES OF INDIVIDUALS COVERED BY THE Records are maintained in SYSTEM: and Marine Corps Appellate Review chronological calendar order with Activity, Office of the Judge Advocate Navy and Marine Corps personnel alphabetical cross-referencing system. General, Department of the Navy, 716 who were tried by courts-martial which Sicard Street SE, Suite 1000, were not reviewed by the Navy-Marine SAFEGUARDS: Washington Navy Yard, DC 20374– Corps Court of Criminal Appeals and Files are maintained in file cabinets 5047. Individuals making such visits when such service member has and other storage devices under the should be able to provide acceptable petitioned the Judge Advocate General control of authorized personnel during identification, e.g., Armed Forces pursuant to Article 69(b), Uniform Code working hours; the office spaces in identification card, driver’s license, etc. of Military Justice, for review. which the file cabinets and storage

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Assistant Judge Advocate General 5 U.S.C. 301, Departmental (Military Justice), Office of the Judge RECORD SOURCE CATEGORIES: Regulations; Article 73, Uniform Code Advocate General, Department of the The records comprise of the following of Military Justice, 10 U.S.C. 873); and Navy, 716 Sicard Street SE, Suite 1000, source materials: (1) Petitions for relief, 42 U.S.C. 10601 et seq., Victim’s Rights Washington Navy Yard, DC 20374– (2) forwarding endorsements thereon by and Restitution Act of 1990 as 5047. petitioner’s commanding officer and implemented by DoD Instruction 1030.2, Victim and Witness Assistance NOTIFICATION PROCEDURE: convening/supervisory authorities of courts-martial (above information is Procedures. Individuals seeking to determine omitted if petitioner is former service PURPOSE(S): whether this system contains member), and (3) action of the Judge information about themselves should Advocate General on petition. To provide a record of individual address written inquiries to the Division petitions in order to answer inquiries Director, Administrative Support EXEMPTIONS CLAIMED FOR THE SYSTEM: from the individual concerned and to Division, Navy and Marine Corps None. provide additional advice to commands Appellate Review Activity, Office of the involved when and if such petitions are Judge Advocate General, Department of N05814±5 granted. the Navy, 716 Sicard Street SE, Suite 1000, Washington Navy Yard, DC SYSTEM NAME: ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND 20374–5047. Article 73 Petitions for New Trial THE PURPOSES OF SUCH USES: The request should contain full name (June 8, 1999, 64 FR 30497). In addition to those disclosures and address of the individual concerned generally permitted under 5 U.S.C. and should be signed. CHANGES: * * * * * 552a(b) of the Privacy Act, these records Personal visits may be made to the or information contained therein may Administrative Support Division, Navy ROUTINE USES OF RECORDS MAINTAINED IN THE specifically be disclosed outside the and Marine Corps Appellate Review SYSTEM, INCLUDING CATEGORIES OF USERS AND DoD as a routine use pursuant to 5 Activity, Office of the Judge Advocate THE PURPOSES OF SUCH USES: U.S.C. 552a(b)(3) as follows: General, Department of the Navy, 716 To victims and witnesses of a crime Sicard Street SE, Suite 1000, Add a new paragraph ‘‘To victims and for purposes of providing information, Washington Navy Yard, DC 20374– witnesses of a crime for purposes of consistent with the requirements of the 5047. Individuals making such visits providing information, consistent with Victim and Witness Assistance Program, should be able to provide acceptable the requirements of the Victim and regarding the investigation and identification, e.g., Armed Forces Witness Assistance Program, regarding disposition of an offense. identification card, driver’s license, etc. the investigation and disposition of an offense.’’ The DoD ‘Blanket Routine Uses’ that RECORD ACCESS PROCEDURES: appear at the beginning of the Navy’s N05814±5 compilation of systems of records apply Individuals seeking access to to this system. information about themselves contained SYSTEM NAME: in this system of records should address Article 73 Petitions for New Trial. POLICIES AND PRACTICES FOR STORING, written inquiries to the Division RETRIEVING, ACCESSING, RETAINING, AND Director, Administrative Support SYSTEM LOCATION: DISPOSING OF RECORDS IN THE SYSTEM: Division, Navy and Marine Corps Administrative Support Division, STORAGE: Appellate Review Activity, Office of the Navy and Marine Corps Review File folders. Judge Advocate General, Department of Activity, Office of the Judge Advocate the Navy, 716 Sicard Street SE, Suite General, Department of the Navy, 716 RETRIEVABILITY: 1000, Washington Navy Yard, DC Sicard Street SE, Suite 1000, Files are kept in alphabetical order 20374–5047. Washington Navy Yard, DC 20374– according to the last name of the The request should contain full name 5047. individual concerned. and address of the individual concerned and should be signed. CATEGORIES OF INDIVIDUALS COVERED BY THE SAFEGUARDS: SYSTEM: Personal visits may be made to the Files are maintained in file cabinets Administrative Support Division, Navy Navy and Marine Corps personnel and other storage devices under the and Marine Corps Appellate Review who submitted petitions for new trial to control of authorized personnel during Activity, Office of the Judge Advocate the Judge Advocate General within two working hours; the office space in General, Department of the Navy, 716 years after approval of their courts- which the file cabinets and storage Sicard Street SE, Suite 1000, martial sentence by the convening devices are located is locked outside Washington Navy Yard, DC 20374– authority but after their case had been official working hours. 5047. Individuals making such visits reviewed by the Navy-Marine Corps should be able to provide acceptable Court of Criminal Appeals or the Court RETENTION AND DISPOSAL: identification, e.g., Armed Forces of Appeals for the Armed Forces, if Records are maintained in the office identification card, driver’s license, etc. appropriate. for four years and then destroyed.

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SYSTEM MANAGER(S) AND ADDRESS: RECORD SOURCE CATEGORIES: Dated: December 21, 2000. Assistant Judge Advocate General The records are comprised of the Patricia L. Toppings, (Military Justice), Office of the Judge following source materials: (1) Petitions Alternate OSD Federal Register Liaison Advocate General, Department of the for new trial; (2) forwarding Officer, Department of Defense. Navy, 716 Sicard Street SE, Suite 1000, endorsements thereon by petitioner’s N05527±1 Washington Navy Yard, DC 20374– commanding officer and convening/ 5047. supervisory authorities of courts-martial SYSTEM NAME: NOTIFICATION PROCEDURE: (above information is omitted if Security Incident System (March 2, Individuals seeking to determine petitioner is former service member); 1994, 59 FR 9972). and (3) action of the Judge Advocate whether this system contains CHANGES: information about themselves should General on petitions. System identifier address written inquiries to the Division EXEMPTIONS CLAIMED FOR THE SYSTEM: Delete entry and replace with Director, Administrative Support ‘N05580–1’. Division, Navy and Marine Corps None. * * * * * Appellate Review Activity, Office of the [FR Doc. 01–412 Filed 1–5–01; 8:45 am] Judge Advocate General, Department of BILLING CODE 5001±10±P ROUTINE USES OF RECORDS MAINTAINED IN THE the Navy, 716 Sicard Street SE, Suite SYSTEM, INCLUDING CATEGORIES OF USERS AND 1000, Washington Navy Yard, DC THE PURPOSES OF SUCH USES: 20374–5047. DEPARTMENT OF DEFENSE Add a new paragraph ‘To individuals The request should contain full name involved in base incidents, their and address of the individual concerned Department of the Navy insurance companies, and/or attorneys and should be signed. for the purpose of adjudicating a claim, Personal visits may be made to the Privacy Act of 1974; System of such as personal injury, traffic accident, Administrative Support Division, Navy Records or other damage to property. The release and Marine Corps Appellate Review Activity, Office of the Judge Advocate AGENCY: Department of the Navy, DoD. of personal information is limited to that required to adjudicate a claim.’ General, Department of the Navy, 716 ACTION: Notice to alter a system of Sicard Street SE, Suite 1000, records. * * * * * Washington Navy Yard, DC 20374– RETENTION AND DISPOSAL: 5047. Individuals making such visits SUMMARY: The Department of the Navy Delete entry and replace with should be able to provide acceptable proposes to alter a system of records identification, e.g., Armed Forces ‘Maintained for two years and then notice in its inventory of record systems destroyed.’ identification card, driver’s license, etc. subject to the Privacy Act of 1974 (5 * * * * * RECORD ACCESS PROCEDURES: U.S.C. 552a), as amended. Individuals seeking access to DATES: This action will be effective on N05580±1 February 7, 2001, unless comments are information about themselves contained SYSTEM NAME: in this system of records should address received that would result in a contrary written inquiries to the Division determination. Security Incident System. Director, Administrative Support ADDRESSES: Send comments to the SYSTEM LOCATION: Division, Navy and Marine Corps Department of the Navy, PA/FOIA Organizational elements of the Appellate Review Activity, Office of the Policy Branch, Chief of Naval Department of the Navy. Official Judge Advocate General, Department of Operations (N09B30), 2000 Navy mailing addresses are published as an the Navy, 716 Sicard Street SE, Suite Pentagon, Washington, DC 20350–2000. appendix to the Navy’s compilation of 1000, Washington Navy Yard, DC systems of records notices. 20374–5047. FOR FURTHER INFORMATION CONTACT: Mrs. The request should contain full name Doris Lama at (202) 685–6545 or DSN CATEGORIES OF INDIVIDUALS COVERED BY THE and address of the individual concerned 325–6545. SYSTEM: and should be signed. SUPPLEMENTARY INFORMATION: The Individuals involved in or witnessing Personal visits may be made to the Department of the Navy’s record system incidents requiring the attention of base, Administrative Support Division, Navy notices for records systems subject to station, or activity security personnel. and Marine Corps Appellate Review the Privacy Act of 1974 (5 U.S.C. 552a), Activity, Office of the Judge Advocate CATEGORIES OF RECORDS IN THE SYSTEM: as amended, have been published in the General, Department of the Navy, 716 Federal Register and are available from Incident/complaint report, Sicard Street SE, Suite 1000, the address above. investigator’s report, data sheets which Washington Navy Yard, DC 20374– contain information on victims and 5047. Individuals making such visits The proposed system report, as perpetrators, military magistrate’s should be able to provide acceptable required by 5 U.S.C. 552a(r) of the records, confinement records, traffic identification, e.g., Armed Forces Privacy Act was submitted on December accident and violation records, traffic identification card, driver’s license, etc. 19, 2000, to the House Committee on court file, citations to appear before U.S. Government Reform, the Senate Magistrate. CONTESTING RECORD PROCEDURES: Committee on Governmental Affairs, The Navy’s rules for accessing and the Office of Management and AUTHORITY FOR MAINTENANCE OF THE SYSTEM: records, and for contesting contents and Budget (OMB) pursuant to paragraph 4c 5 U.S.C. 301, Departmental appealing initial agency determinations of Appendix I to OMB Circular No. A– Regulations and E.O. 9397 (SSN). are published in Secretary of the Navy 130, ‘Federal Agency Responsibilities Instruction 5211.5; 32 CFR part 701; or for Maintaining Records About PURPOSE(S): may be obtained from the system Individuals,’ dated February 8, 1996, (61 To track and prosecute offenses, manager. FR 6427, February 20, 1996). counsel victims, and other

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1329 administrative actions; to support information about themselves should under Section 605 of the Higher insurance claims and civil litigation; to address written inquiries to the Education Act (HEA), as amended. revoke base, station, or activity driving Commanding Officer or head of the SUPPLEMENTARY INFORMATION: Section privileges. activity where assigned. Official mailing 605 of the HEA authorizes the addresses are published as an appendix International Research and Studies ROUTINE USES OF RECORDS MAINTAINED IN THE to the Navy’s compilation of systems of SYSTEM, INCLUDING CATEGORIES OF USERS AND Program. Under this program, the THE PURPOSES OF SUCH USES: records notices. Secretary awards grants and contracts Written requests should contain full In addition to those disclosures for— name, Social Security Number, and (a) Studies and surveys to determine generally permitted under 5 U.S.C. must be signed by the individual. the needs for increased or improved 552a(b) of the Privacy Act, these records instruction in modern foreign languages, or information contained therein may RECORD ACCESS PROCEDURES: area studies, or other international specifically be disclosed outside the Individuals seeking access to fields, including the demand for foreign DoD as a routine use pursuant to 5 information about themselves should language, area, and other international U.S.C. 552a(b)(3) as follows: address written inquiries to the specialists in government, education, To individuals involved in base Commanding Officer or head of the and the private sector; incidents, their insurance companies, activity where assigned. Official mailing (b) Studies and surveys to assess the and/or attorneys for the purpose of addresses are published as an appendix use of graduates of programs supported adjudicating a claim, such as personal to the Navy’s compilation of systems of under Title VI by governmental, injury, traffic accident, or other damage records notices. educational, and private sector to property. The release of personal Written requests should contain full organizations and other studies information is limited to that required to name, Social Security Number, and assessing the outcomes and adjudicate a claim. must be signed by the individual. effectiveness of programs so supported; The DoD ‘Blanket Routine Uses’ that (c) Evaluation of the extent to which CONTESTING RECORD PROCEDURES: appear at the beginning of the Navy’s programs assisted under Title VI that compilation of systems of records The Navy’s rules for accessing address national needs would not notices apply to this system. records, and for contesting contents and otherwise be offered; appealing initial agency determinations POLICIES AND PRACTICES FOR STORING, (d) Comparative studies of the RETRIEVING, ACCESSING, RETAINING, AND are published in Secretary of the Navy effectiveness of strategies to provide DISPOSING OF RECORDS IN THE SYSTEM: Instruction 5211.5; 32 CFR part 701; or international capabilities at institutions may be obtained from the system of higher education; STORAGE: manager. (e) Research on more effective File folders, card files, personal methods of providing instruction and RECORD SOURCE PROCEDURES: computer, magnetic tape. achieving competency in foreign Individual concerned, other records of RETRIEVABILITY: languages, area studies, or other the activity, investigators, witnesses, international fields; Name, Social Security Number, case and correspondents. (f) The development and publication number, and organization. EXEMPTIONS CLAIMED FOR THE SYSTEM: of specialized materials for use in SAFEGUARDS: foreign language, area studies, and other Parts of this system may be exempt Access provided on a need-to-know international fields, or for training pursuant to 5 U.S.C. 552a(j)(2) if the foreign language, area, and other basis only. Manual records are information is compiled and maintained maintained in file cabinets under the international specialists; by a component of the agency which (g) Studies and surveys of the uses of control of authorized personnel during performs as its principle function any working hours. The office space in technology in foreign language, area activity pertaining to the enforcement of studies, and international studies which the file cabinets are located is criminal laws. locked outside of official working hours. programs; An exemption rule for this system has (h) Studies and evaluations of Computer terminals are located in been published in accordance with the effective practices in the dissemination supervised areas. Access is controlled requirements of 5 U.S.C. 553(b)(1), (2) of international information, materials, by password or other user code system. and (3), (c) and (e) and published in 32 research, teaching strategies, and testing RETENTION AND DISPOSAL: CFR part 701, subpart G. For additional techniques throughout the education information contact the system manager. Maintained for two years and then community, including elementary and destroyed. [FR Doc. 01–417 Filed 1–5–01; 8:45 am] secondary schools; and BILLING CODE 5001±10±U (i) Research on applying performance SYSTEM MANAGER(S) AND ADDRESS: tests and standards across all areas of Policy Official: Commander, Naval foreign language instruction and Criminal Investigative Service, DEPARTMENT OF EDUCATION classroom use. Washington Navy Yard, Building 111, 2000 Program Activities 716 Sicard Street SE, Washington Navy The International Research and Yard, DC 20388–5380. Studies Program In fiscal year 2000, 19 new grants Record Holder: Commanding Officer ($1,893,600) and 15 continuation grants of the activity in question. Official AGENCY: Department of Education. ($1,981,400) were awarded under the mailing addresses are published as an ACTION: Publication of the year 2000 International Research and Studies appendix to the Navy’s compilation of annual report. Program. These grants are active systems of records notices. currently and will be monitored through SUMMARY: The Secretary announces the progress reports submitted by grantees. NOTIFICATION PROCEDURE: publication of the annual report listing Grantees have 90 days after the Individuals seeking to determine the books and research materials expiration of the grant to submit the whether this system contains produced with assistance provided products resulting from their research to

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Title Author/Location

Yemeni Arabic-English Dictionary ...... Hamdi A. Qafisheh, Near Eastern Studies, University of Arizona, P.O. Box 210080, Tucson, AZ 85721±0080. U.S.-Mexico Relations Curriculum Project ...... Walter Falcon, Institute for International, Studies, C100 Encina Hall, Stanford University, Stanford, CA 94305±6055. Internet Living Swahili Dictionary ...... Ann Biersteker, Yale University, Council on African Studies, 155 Whit- ney Avenue, New Haven, CT 06511. A National Survey of Foreign Language Instruction in Elementary and Nancy C. Rhodes and Lucinda E. Branaman, Center for Applied Lin- Secondary Schools 1995±1998 which contains: The National Survey, guistics (CAL), 4646 40th Street, NW, Washington, DC 20016. A National Directory of Early Foreign Language Programs: Search- able Web Database, and Lessons Learned from Model Early Foreign Language Programs. Development of Curriculum Materials on China and Japan ...... Linda K. Menton and Eileen H. Tamura, Curriculum Research and De- velopment Group, University of Hawaii at Manoa, 1776 University Avenue, Honolulu, HI 96822. SEAsite: A World Wide Web Site for the Languages of Southeast Asia George M. Henry, Department of Computer Science, Northern Illinois University, Dekalb, IL 60115. Starfestival Net: An Internet Prototype for International Studies in the Shigeru Miyagawa, Massachusetts Institute of Technology, Department Less-Commonly Taught Languages. of Foreign Languages and Literatures, 77 Massachusetts Avenue, 14N±305, Cambridge, MA 02139. Beyond the Oral Proficiency Interview (OPI): The Standards Assess- Elvira Swender, American Council on the Teaching of Foreign Lan- ment Design Project: The PAU Project. guages, Inc. (ACTFL), 6 Executive Plaza, Yonkers, NY 10701±6801. Survey of Foreign Language Registrations in United States Colleges Richard Brod, Modern Language Association of America, 10 Astor and Universities, Fall 1998 with Comparative Registration Data for Place, New York, NY 10003. 1960, 1968, 1986, 1990 and 1995. Audio Program for Chinese: Communicating in the Culture ...... Galal Walker, The Ohio State University, 1960 Kenny Road, Foreign Language Center, Columbus, OH 43210±1063. Multimedia Chinese Courseware for Classroom And Distance Learning Ching-I Tu, East Asian Languages and Cultures, Rutgers University, Curriculum. Scott Hall 330, 43 College Avenue, New Brunswick, NJ 08901± 1164.

To obtain a copy of a completed Document Format (PDF) on the Internet DEPARTMENT OF ENERGY study, contact the author at the given at either of the following sites: address. National Nuclear Security http://ocfo.ed.gov/fedreg.htm Administration FOR FURTHER INFORMATION CONTACT: For http://www.ed.gov/news.html a copy of the 2000 annual report and Notice of Availability of the Draft Site- further information regarding the To use PDF you must have Adobe Wide Environmental Impact Statement International Research and Studies Acrobat Reader, which is available free for the Oak Ridge Y±12 Plant Program, write to Jose L. Martinez, at either of the previous sites. If you have questions about using PDF, call the AGENCY: Energy, National Nuclear Program Officer, International Security Administration, DOE. Education and Graduate Programs U.S. Government Printing Office (GPO), ACTION: Notice of availability and public Service, U.S. Department of Education, toll free, at 1–888–293–6498; or in the hearings 1990 K Street, NW., Washington, DC Washington, DC area at (202) 512–1530. 20006–8521. Telephone: (202) 502– Note: The official version of this document SUMMARY: The National Nuclear 7635. is the document published in the Federal Security Administration (NNSA), a If you use a telecommunication Register. Free Internet access to the official semi-autonomous agency within the device for the deaf (TDD), you may call edition of the Federal Register and the Code Department of Energy (DOE), announces the Federal Information Relay Service of Federal Regulations is available on GPO the availability of the Draft Site-Wide (FIRS) at 1–800–877–8339. Access at: Environmental Impact Statement for the Oak Ridge Y–12 Plant [Y–12 Draft Individuals with disabilities may http://www.access.gpo.gov/nara/ SWEIS] (DOE/EIS–0309), and the dates obtain this document or the 2000 annual index.html and locations for public hearings to report referred to in this notice in an Program Authority: 20 U.S.C. 1125. receive comments on the Y–12 Draft alternative format (e.g. Braille, large SWEIS. The Y–12 Draft SWEIS Dated: January 3, 2001. print, audiotape, or computer diskette) evaluates the potential environmental on request to the program contact A. Lee Fritschler, impacts associated with the continued person listed under FOR FURTHER Assistant Secretary, Office of Postsecondary operations of the Y–12 Plant, as well as INFORMATION CONTACT. Education. with alternatives for modernizing Y–12 Electronic Access to This Document [FR Doc. 01–461 Filed 1–5–01; 8:45 am] facilities to ensure its capability to meet BILLING CODE 4000±01±P future nuclear weapon stockpile needs You may view this document, as well in the post-Cold War era. The as all other Department of Education alternatives include construction and documents published in the Federal operation of new facilities for two of Y– Register, in text or Adobe Portable 12’s missions: Highly Enriched Uranium

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(HEU) Materials Storage mission and Washington, DC 20585, telephone 202– Issued in Washington, DC this 29th day of Special Materials mission. The preferred 586–4600, or leave a message at 1–800– December, 2000. alternative is to construct and operate a 472–2756. Madelyn R. Creedon, new HEU Materials Storage Facility and Deputy Administrator for Defense Programs, a new Special Materials Complex. SUPPLEMENTARY INFORMATION: The National Nuclear Security Administration, Preferred sites on Y–12 for these new NNSA is responsible for providing the Department of Energy. facilities have not been selected, but Nation with nuclear weapons and [FR Doc. 01–443 Filed 1–5–01; 8:45 am] will be identified in the Y–12 Final ensuring that those nuclear weapons BILLING CODE 6450±01±P SWEIS. remain safe, secure, and reliable. As one of the major production facilities, the DATES: Comments on the Y–12 Draft Oak Ridge Y–12 Plant has been DOE’s DEPARTMENT OF ENERGY SWEIS may be submitted to DOE (see primary site for enriched uranium Addresses below) until February 5, processing and storage, and one of the PhA Environmental Restoration 2001. To ensure consideration in the Y– manufacturing facilities for maintaining Corporation 12 Final SWEIS, comments must be postmarked by February 5, 2001. Late the U.S. nuclear weapons stockpile. In AGENCY: Office of the General Counsel, comments will be considered to the recent years, the emphasis of the U.S. DOE. extent practicable. Two public hearings weapons program has shifted from ACTION: Notice of intent to grant to discuss issues and receive oral developing and producing new weapons exclusive patent licenses. comments on the Y–12 Draft SWEIS will to dismantlement and maintenance of a be held as follows: Thursday, January smaller stockpile. SUMMARY: Notice is hereby given of an 25, 2001, in the Cumberland Room at The Y–12 Draft SWEIS evaluates the intent to grant to PhA Environmental the Oak Ridge Conference Center potential environmental impacts from Restoration Corp., of Oak Hill, Virginia, located at the Oak Ridge Mall, Oak continued operation of the Oak Ridge exclusive licenses to practice the Ridge, Tennessee. The first hearing will Y–12 Plant, and the construction and inventions described in U.S. Patent No. 5,324,661, entitled ‘‘Chemotactic be held from 1–4 p.m. The second operation of new facilities for two of Y– Selection of Pollutant Degrading public hearing will be held from 6–9 12’s missions: HEU Materials Storage Bacteria’’ and U.S. Patent No. 5,326,703, p.m. The public hearings will provide mission and Special Materials mission. entitled ‘‘Method of Degrading the public with an opportunity to Alternatives considered for the HEU Pollutants in Soil.’’ The inventions are present comments, ask questions, and Materials Storage mission include owned by the United States of America, discuss concerns with DOE/NNSA constructing and operating a new HEU officials regarding the Y–12 Draft as represented by the U.S. Department Materials Facility at one of two of Energy (DOE). SWEIS. candidate sites, or expanding and DATES: Written comments or ADDRESSES: Comments on the Y–12 operating Building 9215. Three nonexclusive license applications are to Draft SWEIS may be submitted by mail candidate sites are evaluated for a new be received at the address listed below (U.S. Department of Energy, Oak Ridge Special Materials Complex for the no later than March 9, 2001. Operations Office, Attn: Mr. Gary Special Materials mission at Y–12. More ADDRESSES: Office of the Assistant Hartman, P.O. Box 2001, Oak Ridge, TN specifically, the Y–12 Draft SWEIS General Counsel for Technology 37831), by fax (1–865–576–1237), by analyzes potential impacts on land uses, Transfer and Intellectual Property, U.S. phone (1–865–576–0273), or transportation, socioeconomics, geology Department of Energy, 1000 electronically ([email protected]). and soils, hydrology, biological Independence Avenue, SW., Specific information regarding the resources, air quality/noise, site Washington, DC 20585. public meetings can be obtained by facilities and support activities, waste FOR FURTHER INFORMATION CONTACT: calling 1–865–576–0273, writing to the management, and cultural resources. In Robert J. Marchick, Office of the address above, or electronically via the addition, environmental justice, Assistant General Counsel for Y–12 SWEIS web site: http:// radiological and chemical impacts www.ttclients.com/y12/. Copies of the Technology Transfer and Intellectual during normal operations, and effects of Y–12 Draft SWEIS and/or its Summary Property, U.S. Department of Energy, accidents on workers and the public are may also be obtained by contacting Mr. Forrestal Building, Room 6F–067, 1000 included in the assessment. A Gary Hartman by any of the means Independence Avenue, SW., disclaimer statement was mistakenly described above. The Y–12 Draft SWEIS Washington, DC 20585; Telephone (202) is also available for review at the U.S. printed on the inside cover of each 586–4792. volume of the Draft SWEIS. DOE wishes Department of Energy Public Reading SUPPLEMENTARY INFORMATION: 35 U.S.C. to inform the public that the Room at 230 Warehouse Road, Oak 209 provides the Department with information contained in the Draft Ridge, TN 37830. authority to grant exclusive licenses in SWEIS is accurate and complete. Please FOR FURTHER INFORMATION CONTACT: For Department-owned inventions, if, disregard this disclaimer statement. general information on the NNSA NEPA among other things, the agency finds process, please contact: Mr. Henry The preferred alternative is to that the public will be served by the Garson, NEPA Compliance Officer for construct and operate a new HEU granting of the license. The statute Defense Programs, U.S. Department of Materials Storage Facility and a new requires that no exclusive license may Energy/NNSA, 1000 Independence Special Materials Complex. Preferred be granted unless public notice of the Avenue, SW., Washington, DC 20585; or sites on Y–12 for these new facilities intent to grant the license has been telephone 1–800–832–0885, ext. 30470. have not been selected, but will be provided, and the agency has For general information on the DOE identified in the Y–12 Final SWEIS. The considered all comments received, in NEPA process, please contact: Ms. Carol Y–12 Final SWEIS is scheduled to be response to that public notice, before M. Borgstrom, Director, Office of NEPA completed in August 2001. A Record of the end of the comment period. Policy and Compliance (EH–42), U.S. Decision would be issued no sooner PhA Environmental Restoration Department of Energy, 1000 than 30 days after the Y–12 Final SWEIS Corporation, of Oak Hill, Virginia, has Independence Avenue, SW., is issued. applied for exclusive license to practice

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1332 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices the inventions embodied in U.S. Patent DATES: BPA has established a 45-day The proposed project has several Nos. 5,324,661 and 5,326,703, and has scoping period during which affected components. They include an electrical plans for commercialization of the landowners, concerned citizens, special connection at BPA’s McNary Substation inventions. interest groups, local governments, and for the Umatilla Generating Company, The exclusive licenses will each be any other interested parties are invited L.P.; a natural-gas-fired, combined-cycle subject to a license and other rights to comment on the scope of the combustion turbine; electric-power- retained by the U.S. Government, and proposed EIS. Written comments are generation plant (Umatilla Generating other terms and conditions to be due to the address below no later than Project); a natural-gas pipeline; and new negotiated. DOE intends to negotiate to February 22, 2001. Comments may also and modified electric-power- grant the licenses, unless, within 60 be made at an EIS scoping open house transmission lines. All proposed days of this notice, the Assistant meeting to be held on January 30, 2001. facilities would be located within Umatilla County, Oregon. General Counsel for Technology ADDRESSES: To comment, telephone toll- The Umatilla Generating Project is Transfer and Intellectual Property, free 1–800–622–4519; send an e-mail to proposed by the Umatilla Generating Department of Energy, Washington, DC the BPA Internet address Company, L.P., an independent power 20585, receives in writing any of the [email protected]; or mail comments to producer. They would build and operate following, together with supporting Communications, Bonneville Power documents: the power plant, and would also pay for Administration—KC–7, P.O. Box 12999, the construction of approximately three- (i) A statement from any person Portland, Oregon, 97212. To be placed setting forth reasons why it would not quarters of a mile of new transmission on the project mail list, call 1–800–622– lines and modification of approximately be in the best interests of the United 4520. States to grant either of the proposed 11 miles of existing transmission lines An EIS open house will be held on licenses; or owned by the Umatilla Electric (ii) An application for a nonexclusive January 30, 2001, 7:00 p.m. to 9:00 p.m., Cooperative. The new transmission license to either invention, in which at Hermiston High School, 600 S. First lines would be owned by the Umatilla applicant states that he already has Street, Hermiston, Oregon. At this Electric Cooperative. PG&E Gas brought either invention to practical informal scoping meeting, BPA staff will Transmission-Northwest Corporation application or is likely to bring either answer questions and accept oral and (GTN) or Cascade Natural Gas would invention to practical application written comments, and representatives build a natural-gas pipeline up to 5 expeditiously. of BPA and the Umatilla Generating miles in length to supply fuel to the The Department will review all timely Company, L.P., will be available to power plant. written responses to this notice, and discuss the proposed project and the A. Proposed Action. The proposed will proceed with negotiating the topics to be addressed in the EIS. Umatilla Generating Project would be a licenses if, after consideration of written Information on the proposed project combustion turbine/combined-cycle responses to this notice, a finding is will be available for review. electric power plant with a nominal made that the licenses are in the public Scoping will help BPA ensure that a generating capacity of 550 megawatts. interest. full range of issues related to this The energy facility site would be located proposal is addressed in the EIS, and about 4 miles southwest of the city of Issued in Washington, DC, on January 2, also will identify significant or Hermiston and about one-half mile west 2001. potentially significant impacts that may of the existing Hermiston Generating Paul A. Gottlieb, result from the proposed project. When Plant. Assistant General Counsel for Technology, completed, the Draft EIS will be The proposed Umatilla Generating Transfer and Intellectual Property. circulated for review and comment, and Project would consist of two essentially [FR Doc. 01–441 Filed 1–5–01; 8:45 am] BPA will hold a public comment identical combustion turbine generators, BILLING CODE 6450±01±P meeting on the Draft EIS. BPA will two heat-recovery steam generators consider and respond in the Final EIS (HRSG) and one steam turbine. The to comments received on the Draft EIS. proposed generating project would be DEPARTMENT OF ENERGY fueled by natural gas from the existing FOR FURTHER INFORMATION CONTACT: GTN pipeline that passes approximately Bonneville Power Administration Thomas C. McKinney, Bonneville Power 5 miles south of the energy facility site. Administration—KEC–4, P.O. Box 3621, Umatilla Generating Project Natural gas would be burned in the Portland, Oregon, 97208–3621; toll-free combustion turbines. Expanding gases telephone 1–800–282–3713; direct AGENCY: Bonneville Power from combustion would turn rotors telephone 503–230–4749; or e-mail Administration (BPA), Department of within the turbines that are connected [email protected]. Additional Energy (DOE). to electric generators. The hot gases information can be found at BPA’s web exhausted from the combustion turbines ACTION: Notice of intent to prepare an site: www.bpa.gov. Environmental Impact Statement (EIS). would be used to raise steam in the SUPPLEMENTARY INFORMATION: The EIS HRSGs. Steam from the HRSGs would SUMMARY: This notice announces BPA’s will assess the environmental be expanded through a steam turbine intention to prepare an EIS, under the consequences of the agreement which that drives its own electric generator. National Environmental Policy Act BPA proposes with Umatilla Generating Water would be needed at the facility (NEPA), on a proposed electrical Company, L.P., and of any to generate steam and cool the steam interconnection requested by Umatilla modifications to the transmission process. Water would be supplied from Generating Company, L.P., to integrate system needed to provide an electrical the Port of Umatilla’s regional water electrical power from the Umatilla connection under the terms of the supply pipeline that currently extends Generating Project into the Federal agreement. In addition to these Federal to the Hermiston Generating Plant. A transmission grid. BPA proposes to actions, the EIS will consider the recirculating cooling system employing execute an agreement with Umatilla environmental consequences of mechanically induced draft evaporative Generating Company L.P., to provide construction and operation of the cooling towers would be used to them with an interconnection. Umatilla Generating Project. minimize water use. Water would be

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1333 added to the cooling system to Project would depend on the references various Schedules which compensate for evaporative losses modifications at BPA’s McNary were inadvertently omitted in Exelon’s (make-up water) and blowdown. Substation to connect with BPA’s December 8, 2000 filing. Per an informal Blowdown is the water bled from the transmission grid, and (2) no other request of FERC Staff, ComEd is cooling system to limit the build-up of Federal or State agency is currently accordingly submitting with this salts. Blowdown would be conveyed by preparing an EIS on the proposed transmittal letter the Agreement, along pipeline to Madison Farms, located project. Because no other EIS is being with the previously omitted Schedules approximately 3 miles south of the prepared, the scope of BPA’s EIS will referenced in said Agreement. proposed generating project, where it cover both the interconnection elements FERC Staff has advised ComEd that would be applied to crops. and the Umatilla Generating Project. making this amended filing should not The proposed Umatilla Generating The principal issues identified thus affect the effective date of January 1, Project would deliver electric power to far for consideration in the Draft EIS 2001 requested by ComEd in its the regional power grid at BPA’s with respect to the Umatilla Generating December 8, 2000 filing in this docket. McNary Substation in Umatilla using Project are as follows: (1) Air quality Comment date: January 11, 2001, in the Umatilla Electric Cooperative’s impacts, (2) noise impacts from plant accordance with Standard Paragraph E existing Westland-McNary operation, (3) aesthetic impacts, (4) at the end of this notice. Transmission Line. A new 230-kilovolt socioeconomic impacts created by an 2. Commonwealth Edison Company (kV) radial transmission line tap would influx of construction workers into a be constructed to connect the sparsely populated area, and (5) impacts [Docket No. ER01–628–001] switchyard at the proposed Umatilla on wildlife habitat. The principal issues Take notice that on December 21, Generating Project to the Westland- identified thus far for consideration in 2000, Commonwealth Edison Company McNary Transmission Line. Presently, the Draft EIS with respect to the electric (ComEd) tendered for filing an the transmission line consists of one power transmission facilities are as amendment to its December 8, 2000, 115-kV circuit and one 230-kV circuit. follows: (1) Impacts of transmission line filing to revise Schedules 4, 4A and 4G The existing 115-kV line would be construction on wetlands and wildlife to ComEd’s Open Access Transmission removed and replaced with a 230-kV habitat, (2) aesthetic impacts, and (3) Tariff (OATT). Second Revised Sheet line. BPA would modify the McNary cultural resource impacts. No. 124 of ComEd’s OATT references Substation to accept electric power from These issues, together with any Schedule 1 of the Ancillary and Other the Umatilla Generating Project. additional significant issues identified Control Area Services Resource In addition, the section of the 115–kV through the scoping process, will be Purchase Agreement (Agreement) transmission line between the Umatilla addressed in the EIS. between ComEd and Exelon Generation, Generating Project and the Hermiston Generating Plant would be Issued in Portland, Oregon, on December L.L.C., filed contemporaneously in reconductored for 230 kV. This portion 27, 2000. Docket No. ER01–627–000 with the of the circuit reconductoring would Stephen J. Wright, revisions to Schedules 4, 4A and 4G. Per increase the overall efficiency and Acting Administrator and Chief Executive an informal request of FERC Staff, reliability of the transmission line. Officer. ComEd is amending its filing to include B. Process to Date. BPA is the lead [FR Doc. 01–442 Filed 1–5–01; 8:45 am] Schedule 1 of the Agreement as Attachment A to Schedule 4, instead of Federal agency for the project EIS. The BILLING CODE 6450±01±U State of Oregon Energy Facility Siting merely referencing it in Schedule 4 to Council is currently evaluating the ComEd’s OATT. Application for a Site Certificate for the DEPARTMENT OF ENERGY Comment date: January 11, 2001, in Umatilla Generating Project submitted accordance with Standard Paragraph E by the Umatilla Generating Company, Federal Energy Regulatory at the end of this notice. Commission L.P. Oregon’s site evaluation process, 3. Southwestern Electric Power like NEPA, provides opportunity for [Docket No. ER01±627±001, et al.] Company public participation. Umatilla Generating Company, L.P., held a public Commonwealth Edison Company, et [Docket No. ER01–651–001] informational meeting on December 7, al.; Electric Rate and Corporate Take notice that on December 21, 2000. Umatilla Generating Company, Regulation Filings 2000, Southwestern Electric Power L.P., expects to submit an application Company (SWEPCO) tendered for filing for Air Contaminant Discharge and January 2, 2001. in this subdocket rate sheets reflecting Prevention of Significant Deterioration Take notice that the following filings a proposed fixed return on common Permit for the proposed project to the have been made with the Commission: equity (ROE) to be used in establishing Oregon Department of Environmental 1. Commonwealth Edison Company estimated and final redetermined Quality in January 2001. formula rates for wholesale service to C. Alternatives Proposed for [Docket No. ER01–627–001] the City of Bentonville, Arkansas Consideration. Alternatives thus far Take notice that on December 21, (Bentonville). SWEPCO currently identified for evaluation in the EIS are: 2000, Exelon Corporation (Exelon), on provides service to Bentonville and its (1) The proposed action, and (2) no behalf of its subsidiaries, other wholesale formula rate customers action. Other alternatives may be Commonwealth Edison Company under contracts which provide for identified through the scoping process. (ComEd) and Exelon Generation, L.L.C. periodic changes in rates and charges D. Identification of Environmental (Exelon Generation), tendered for filing determined in accordance with cost-of- Issues. BPA intends to prepare an EIS an amendment to its December 8, 2000, service formulas, including a formulaic addressing both the Umatilla Generating filing of a form of agreement entitled determination of the ROE. SWEPCO has Project and the associated electric Ancillary and Other Control Area proposed in this docket to replace the power interconnection facilities. BPA Services Resource Purchase Agreement formulaic ROE with a fixed ROE. The decided to prepare the EIS for two (hereafter the Agreement). Due to an filing in this subdocket is solely to file reasons: (1) The Umatilla Generating administrative oversight, the Agreement the proposed Bentonville rate sheets

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1334 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices that have been conformed to Order No. System Operator Corporation (ISO), sell to Select Energy, Inc. a portion of 614. tendered for filing a revision to the its energy entitlement pursuant to the SWEPCO seeks an effective date of Transmission Control Agreement (TCA) Firm Energy Contract between NEPOOL January 1, 2001 and, accordingly, seeks for acceptance by the Commission. The Phase II Participants and HydroQuebec, waiver of the Commission’s notice ISO states that the purpose of the dated October 4, 1984. requirements. Copies of the filing were amendment is (1) to clarify A copy of this filing was served on the served on Bentonville, all parties to this responsibilities in the TCA concerning service list in this docket, and on Select proceeding and the Arkansas Public the ISO Maintenance Standards and to Service Commission. include a new Appendix F identifying Energy, Inc. In addition, a copy of the Comment date: January 11, 2001, in the persons to contact at each party for rate schedule is available for inspection accordance with Standard Paragraph E notice purposes; (2) to address the at the offices of Citizens’ Vermont at the end of this notice. Commission’s statement in Mid- Electric Division during regular Continent Area Power Pool, 92 FERC business hours. 4. Tampa Electric Company ¶ 61,229 that contractual arrangements Comment date: January 11, 2001, in [Docket No. ER01–713–001] involving regional transmission service accordance with Standard Paragraph E Take notice that on December 21, should be crafted to ensure that at the end of this notice. 2000, Tampa Electric Company (Tampa responsibilities of all parties with Electric) tendered for filing a service respect to issues such as refunds are 9. FirstEnergy Operating Companies agreement with Enron Power Marketing, delineated in advance; (3) to clarify four [Docket No. ER00–3771–002] Inc. (Enron) under Tampa Electric’s provisions of the current TCA in market-based sales tariff. Tampa Electric response to issues raised by the City of Take notice that on December 21, submitted an amended service Vernon, California (Vernon), which has 2000, The Cleveland Electric agreement designation on December 21, applied to become a Participating Illuminating Company, Ohio Edison 2000. Transmission Owner; and (4) to identify Company, Pennsylvania Power Tampa Electric proposes that the the transmission interests that Vernon Company and The Toledo Edison service agreement be made effective on would be turning over to the ISO’s Company (collectively, the FirstEnergy December 1, 2000, and gives notice of Operational Control if Vernon executes Operating Companies) tendered for its termination as of January 1, 2001. the amended TCA unconditionally. filing their FERC Electric Tariff, First Copies of the filing have been served The ISO states that this filing has been Revised Volume No. 3, pursuant to on Enron and the Florida Public Service served the Public Utilities Commission which they are offering to make Commission. of California, the California Energy available ancillary services and Comment date: January 11, 2001, in Commission, the California Electricity interconnected operations services. The accordance with Standard Paragraph E Oversight Board, and all parties, FirstEnergy Operating Companies state at the end of this notice. including Vernon, with effective that this tariff contains modifications to Scheduling Coordinator Agreements 5. Illinois Power Company a tariff submitted in September 2000 under the ISO Tariff. that were required by the Order [Docket No. ER01–740–000] The ISO is requesting waiver of the Accepting for Filing, as Modified, Take notice that on December 21, 60-day notice requirement to allow the Proposed Tariff and Service Agreement 2000, Illinois Power Company (Illinois TCA to be made effective January 1, which was issued in this proceeding on 2001. Power), 500 South 27th Street, Decatur, November 22, 2000. Illinois 65251–2200, filed with the Comment date: January 11, 2001, in Commission a Service Agreement for accordance with Standard Paragraph E Comment date: January 11, 2001, in Firm Short-Term Point-To-Point at the end of this notice. accordance with Standard Paragraph E at the end of this notice. Transmission Service with Wisconsin 7. Wisconsin Electric Power Company Public Service Corporation (WPS) 10. New England Power Pool entered into pursuant to Illinois Power’s [Docket No. ER01–252–001] Open Access Transmission Tariff. Also Take notice that on December 21, [Docket No. ER00–3577–003] on December 22, 2000, Illinois Power 2000, Wisconsin Electric Power Take notice that on December 22, filed a letter clarifying a statement in its Company (Wisconsin Electric) 2000, the New England Power Pool request for waiver filed with the above- submitted a filing containing (NEPOOL) Participants Committee and designations pursuant to Order No. 614, mentioned Service Agreement. ISO New England Inc. submitted a joint Illinois Power requests an effective in compliance with the letter order report of compliance in response to date of November 9, 2000 for the issued December 11, 2000 in Docket No. requirements of the Commission’s Agreement and accordingly seeks a ER01–252–000 in which the waiver of the Commission’s notice Commission accepted the filing, November 22, 2000 order in Docket No. requirement based on extraordinary effective January 1, 2001. ER00–3577–000. New England Power circumstances. Comment date: January 11, 2001, in Pool, 93 FERC ¶ 61,195 (2000). Illinois Power has served a copy of accordance with Standard Paragraph E The NEPOOL Participants Committee the filing on WPS. at the end of this notice. states that copies of these materials were Comment date: January 11, 2001, in 8. Citizens Communications Company sent to all persons identified on the accordance with Standard Paragraph E service list in the captioned proceeding, at the end of this notice. [Docket No. ER01–249–001] the NEPOOL Participants and the six 6. California Independent System Take notice that on December 21, New England state governors and Operator Corporation 2000, in compliance with the regulatory commissions. Commission’s December 6, 2000 letter Comment date: January 11, 2001, in [Docket No. ER01–724–000] order in this proceeding, Citizens accordance with Standard Paragraph E Take notice that on December 21, Communications Company filed on a at the end of this notice. 2000, the California Independent non-confidential basis an Agreement to

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11. Sithe Edgar LLC; Sithe New Boston 15. Wolverine Power Supply 18. Dynegy Danskammer, L.L.C. LLC; Sithe Framingham LLC; Sithe Cooperative, Inc. [Docket No. EG01–82–000] West Medway LLC; Sithe Wyman LLC; [Docket No. ER98–411–010] Sithe Mystic LLC; AG-Energy, L.P.; Take notice that on December 21, Take notice that on December 22, Power City Partners, L.P.; Seneca 2000, Dynegy Danskammer, L.L.C., 1000 2000, Wolverine Power Supply Power Partners, L.P.; Sterling Power Louisiana, Suite 5800, Houston, Texas Cooperative, Inc. (Wolverine), filed a Partners, L.P.; Sithe Power Marketing, filed with the Federal Energy Regulatory revised Generation Market Dominance L.P.; Sithe Power Marketing, Inc. Commission an application for Analysis, in compliance with the determination of exempt wholesale [Docket No. ER00–3691–001] Commission’s Order in Wolverine generator status pursuant to Part 365 of Power Supply Cooperative, Inc., 81 Take notice that on December 21, the Commission’s Regulations. FERC ¶ 61,369 (1997). Dynegy Danskammer, L.L.C. is a 2000, the above referenced applicants Comment date: January 12, 2001, in (the Sithe Jurisdictional Affiliates) filed Delaware limited liability company, and accordance with Standard Paragraph E is engaged directly and exclusively in with the Commission proposed rate at the end of this notice. schedule designations in compliance owning and/or operating an electric with Order No. 614, and the Order 16. Dynegy Roseton, L.L.C. generating facility in New York, and selling electric energy at wholesale. issued in this proceeding on November [Docket No. EG01–80–000] Comment date: January 23, 2001, in 24, 2000. Take notice that on December 21, accordance with Standard Paragraph E Comment date: January 11, 2001, in 2000, Dynegy Roseton, L.L.C., 1000 at the end of this notice. The accordance with Standard Paragraph E Louisiana, Suite 5800, Houston, Texas Commission will limit its consideration filed with the Federal Energy Regulatory at the end of this notice. of comments to those that concern the Commission an application for adequacy or accuracy of the application. 12. Commonwealth Edison Company determination of exempt wholesale [Docket Nos. ER00–2814–003] generator status pursuant to Part 365 of Standard Paragraphs the Commission’s Regulations. E. Any person desiring to be heard or Take notice that on December 21, Dynegy Roseton, L.L.C. is a Delaware to protest such filing should file a 2000, Commonwealth Edison Company limited liability company, and is motion to intervene or protest with the (ComEd) submitted for filing an engaged directly and exclusively in Federal Energy Regulatory Commission, executed Dynamic Scheduling owning and/or operating an electric 888 First Street, NE., Washington, DC Agreement (Agreement) with its generating facility in New York, and 20426, in accordance with rules 211 and Wholesale Merchant Function Division selling electric energy at wholesale. (WMD) under ComEd’s Open Access Comment date: January 23, 2001, in 214 of the Commission’s Rules of Transmission Tariff (OATT) in accordance with Standard Paragraph E Practice and Procedure (18 CFR 385.211 compliance with the Commission’s at the end of this notice. The and 385.214). All such motions or December 14, 2000 Order issued in Commission will limit its consideration protests should be filed on or before the Docket Nos. ER00–2814–000, ER00– of comments to those that concern the comment date. Protests will be 2814–001, and ER00–2814–002. adequacy or accuracy of the application. considered by the Commission in Commonwealth Edison Company, 93 determining the appropriate action to be FERC & 61,271 (2000). 17. Harquahala Generating Company, taken, but will not serve to make LLC protestants parties to the proceeding. Comment date: January 11, 2001, in Any person wishing to become a party accordance with Standard Paragraph E [Docket No. EG01–81–000] must file a motion to intervene. Copies at the end of this notice. Take notice that on December 21, 2000, Harquahala Generating Company, of these filings are on file with the 13. UtiliCorp United Inc. LLC (Harquahala), a limited liability Commission and are available for public inspection. This filing may also be [Docket No. ER99–203–002] company with its principal place of business at 7500 Old Georgetown Road, viewed on the Internet at http:// Take notice that on December 22, Bethesda, Maryland 20814, filed with www.ferc.fed.us/online/rims.htm (call 2000, UtiliCorp United Inc. filed the the Federal Energy Regulatory 202–208–2222 for assistance). required three-year updated market Commission an application for Linwood A. Watson, Jr., analysis in this docket. determination of exempt wholesale Acting Secretary. Comment date: January 12, 2001, in generator status pursuant to Part 365 of [FR Doc. 01–439 Filed 1–5–01; 8:45 am] accordance with Standard Paragraph E the Commission’s regulations. BILLING CODE 6717±01±P at the end of this notice. Harquahala proposes to construct, own or lease and operate a natural gas- 14. Bangor Energy Resale, Inc. fired, combined cycle power plant of DEPARTMENT OF ENERGY [Docket No. ER98–459–009] approximately 1050 MW capacity in Maricopa County, Arizona. The Federal Energy Regulatory Take notice that on December 22, proposed power plant is expected to Commission 2000, Bangor Energy Resale, Inc. commence commercial operation in (Bangor Energy) filed an updated market 2003. All output from the plant will be [Docket No. ER01±739±000, et al.] analysis as required by the sold by Harquahala exclusively at Commission’s December 23, 1997 order wholesale. Duke Electric Transmission, et al.; in Docket No. ER98–459–000 granting Comment date: January 22, 2001, in Electric Rate and Corporate Regulation Bangor Energy market based rate accordance with Standard Paragraph E Filings authority. at the end of this notice. The Comment date: January 12, 2001, in Commission will limit its consideration December 29, 2000. accordance with Standard Paragraph E of comments to those that concern the Take notice that the following filings at the end of this notice. adequacy or accuracy of the application. have been made with the Commission:

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1. Duke Electric Transmission, a Copies of the filing have been served plant of approximately 1,050 MW Division of Duke Energy Corporation upon RISEP and the Rhode Island capacity in Maricopa County near the [Docket No. ER01–739–000] Public Utilities Commission. town of Tonopah, Arizona. Comment date: January 12, 2001, in Comment date: January 12, 2001, in Take notice that on December 21, accordance with Standard Paragraph E accordance with Standard Paragraph E 2000, Duke Electric Transmission (Duke at the end of this notice. at the end of this notice. ET), tendered for filing First Revised Service Agreement No. 194 with 5. Consumers Energy Company 8. Ameren Services Company Carolina Power & Light Company, for [Docket No. ER01–746–000] [Docket No. ER01–749–000] Transmission Service under Duke ET’s Take notice that on December 21, Take notice that on December 21, Open Access Transmission Tariff. 2000, Consumers Energy Company 2000, Ameren Services Company (ASC), Duke requests that the proposed (Consumers), tendered for filing a tendered for filing a Service Agreement Revised Service Agreement be permitted Facilities Agreement Between for Firm Point-to-Point Transmission to become effective on January 1, 2001. Consumers and Wolverine Power Services between ASC and Ameren Duke states that this filing is in Supply Cooperative, Inc, (Wolverine), Energy, Inc., (customer). ASC asserts accordance with Part 35 of the dated November 30, 2000 (Agreement). that the purpose of the Agreement is to Commission’s Regulations and a copy Under the Agreement, Consumers is to permit ASC to provide transmission has been served on the North Carolina build, operate and maintain certain service to customer pursuant to Utilities Commission. facilities interconnecting Wolverine’s Ameren’s Open Access Transmission Comment date: January 12, 2001, in Vestaburg substation and Consumers’ Tariff. accordance with Standard Paragraph E transmission system. Comment date: January 12, 2001, in at the end of this notice. Consumers requested that the accordance with Standard Paragraph E Agreement be allowed to become at the end of this notice. 2. Puget Sound Energy, Inc. effective October 23, 1998. 9. WPS Resources Operating [Docket No. ER01–743–000] Copies of the filing were served upon Companies Take notice that on December 21, Wolverine and the Michigan Public 2000, Puget Sound Energy, Inc., as Service Commission. [Docket No. ER01–750–000] Transmission Provider, tendered for Comment date: January 12, 2001, in Take notice that on December 21, filing a Service Agreement for Firm accordance with Standard Paragraph E 2000, WPS Resources Operating Point-To-Point Transmission Service at the end of this notice. Companies (WPSR), tendered for filing and a Service Agreement for Non-Firm 6. Attala Generating Company, LLC a revised executed service agreement Point-To-Point Transmission Service with Stratford Water & Electric Utility with The Legacy Energy Group, LLC [Docket No. ER01–747–000] (Stratford) for ancillary services and (Legacy) as Transmission Customer. Take notice that on December 21, distribution service under WPSR’s open A copy of the filing was served upon 2000, Attala Generating Company, LLC access transmission tariff, FERC Electric Legacy. (Attala), tendered for filing pursuant to Tariff, Original Volume No. 1 (OATT). Comment date: January 12, 2001, in Section 205 of the Federal Power Act, WPSR requests a January 1, 2001 accordance with Standard Paragraph E and Part 35 of the Commission’s effective date. Copies of the filing were served upon at the end of this notice. Regulations, an application for authorization to make sales of capacity, Stratford, the Michigan Public Service 3. Puget Sound Energy, Inc. energy, and certain Ancillary Services at Commission and the Public Service [Docket No. ER01–744–000 ] market-based rates; to reassign Commission of Wisconsin. transmission capacity; and to resell firm Comment date: January 12, 2001, in Take notice that on December 21, transmission rights (FTRs). Attala accordance with Standard Paragraph E 2000, Puget Sound Energy, Inc., as proposes to own or lease and operate a at the end of this notice. Transmission Provider, tendered for natural gas-fired, combined cycle power filing a Service Agreement for Firm 10. Mountain View Power Partners, plant of approximately 500 MW LLC Point-To-Point Transmission Service capacity in Attala County, Mississippi. and a Service Agreement for Non-Firm Comment date: January 12, 2001, in [Docket No. ER01–751–000] Point-To-Point Transmission Service accordance with Standard Paragraph E Take notice that on December 21, with El Paso Merchant Energy, L.P. at the end of this notice. 2000, Mountain View Power Partners, (EPME), as Transmission Customer. LLC (Mountain View) tendered for filing 7. Harquahala Generating Company, A copy of the filing was served upon with Commission an application for LLC EPME. acceptance of Mountain View’s Rate Comment date: January 12, 2001, in [Docket No. ER01–748–000] Schedule FERC No. 1; the granting of accordance with Standard Paragraph E Take notice that on December 21, certain blanket approvals, including the at the end of this notice. 2000, Harquahala Generating Company, authority to sell electric energy, capacity 4. New England Power Company LLC (Harquahala), tendered for filing, and ancillary services at market-based pursuant to Section 205 of the Federal rates; and the waiver of certain [Docket No. ER01–745–000] Power Act, and Part 35 of the Commission regulations. Take notice that on December 21, Commission’s Regulations, an Comment date: January 12, 2001, in 2000, New England Power Company application for authorization to make accordance with Standard Paragraph E (NEP) tendered for filing a service sales of capacity, energy, and certain at the end of this notice. agreement between NEP and Rhode Ancillary Services at market-based rates; 11. PJM Interconnection, L.L.C. Island State Energy Partners, L.P. to reassign transmission capacity; and to (RISEP) for Firm Local Generation resell firm transmission rights (FTRs). [Docket No. ER01–752–000] Delivery Service under NEP’s FERC Harquahala proposes to construct a Take notice that on December 21, Electric Tariff, Original Volume No. 9. natural gas-fired, combined cycle power 2000, PJM Interconnection, L.L.C. (PJM),

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Agreement of PJM Interconnection, Marketing—FERC Electric Tariff Vol. A copy of the filing was served upon L.L.C. (OA): No. 2, Service Agreement No. 145. No Illinois Power Company. First Revised Sheet No. 42 service has commenced at this time. Comment date: January 12, 2001, in PJM states that the Tariff and OA Comment date: January 9, 2001, in accordance with Standard Paragraph E revisions are related to the restructuring accordance with Standard Paragraph E at the end of this notice. at the end of this notice. of the Mid-Atlantic Area Council, which 17. West Texas Utilities Company is the reliability council for the PJM 14. Public Service Company of New region. Mexico [Docket No. ER01–758–000] PJM requests an effective date of [Docket No. ER01–755–000] Take notice that on December 21, January 1, 2001 for the tariff and OA 2000, West Texas Utilities Company Take notice that on December 21, revisions. (WTU), tendered for filing a revised 2000, Public Service Company of New Comment date: January 12, 2001, in service agreement (Service Agreement) Mexico (PNM), tendered for filing a accordance with Standard Paragraph E under WTU’s Wholesale Power Choice revised service agreement (dated August at the end of this notice. Tariff (WPC Tariff) between WTU and 4, 2000), for electric power and energy Pedernales Electric Cooperative, Inc., 12. Enron Power Marketing, Inc.; Enron sales at negotiated rates under the terms (Pedernales). WTU states that the Energy Services, Inc.; Clinton Energy of PNM’s Power and Energy Sales Tariff, Service Agreement originally was Management Services, Inc.; New with American Electric Power Service between WTU and Kimble Electric Albany Power I, L.L.C.; Enron Energy Corporation. PNM’s filing is available Cooperative, Inc. (Kimble) and that, on Marketing Corp.; The New Power for public inspection at its offices in July 14, 2000, Kimble transferred all Company Albuquerque, New Mexico. right, title and interest in the service Copies of the filing have been sent to [Docket No. ER01–753–000] agreement to Pedernales. The only American Electric Power Services Take notice that on December 21, change to the Service Agreement is the Corporation and to the New Mexico 2000, the above listed marketing change in names. affiliates of Enron Corp., tendered for Public Regulation Commission. Comment date: January 12, 2001, in WTU requests an effective date for the filing proposed changes in their revised service agreement of July 14, respective Rate Schedule FERC No. 1 accordance with Standard Paragraph E at the end of this notice. 2000. Accordingly, WTU requests and the proposed elimination of Codes waiver of the Commission’s notice of Conduct. The changes consist of 15. PJM Interconnection, L.L.C. requirements. removing restrictions on the sale of WTU states that a copy of the filing power and non-power goods and [Docket No. ER01–756–000] Take notice that on December 21, was served on Pedernales and on the services between the listed Enron Public Utility Commission of Texas. Marketing Affiliates and Portland 2000, PJM Interconnection, L.L.C. (PJM), Comment date: January 12, 2001, in General Electric Company (PGE), based tendered for filing an executed accordance with Standard Paragraph E on Enron Corp.’s pending sale of PGE. interconnection service agreement at the end of this notice. That sale would cause the above-listed between PJM and Bethlehem Steel Enron Marketing Affiliates no longer to Corporation. 18. Connecticut Yankee Atomic Power be affiliated with PGE. PJM requests a waiver of the Company Comment date: January 12, 2001, in Commission’s 60-day notice [Docket No. ER01–813–000] accordance with Standard Paragraph E requirement to permit the effective dates at the end of this notice. agreed to by the parties. Take notice that on December 21, Copies of this filing were served upon 2000, Connecticut Yankee Atomic 13. Tucson Electric Power Company Bethlehem Steel Corporation and the Power Company (Connecticut Yankee), [Docket No. ER01–754–000] state electric utility regulatory tendered for filing a limited general Take notice that on December 21, commissions within the PJM control policy compliance filing proposing to 2000, Tucson Electric Power Company area. change the application of certain funds tendered for filing one (1) umbrella Comment date: January 12, 2001, in collected for post-retirement benefits service agreement (for short-term firm accordance with Standard Paragraph E other than pensions (PBOP) into the service) and one (1) service agreement at the end of this notice. external nonqualified nuclear decommissioning trust fund until such (for non-firm service) pursuant to Part II 16. Wayne-White Counties Electric time as they are needed to meet PBOP of Tucson’s Open Access Transmission Cooperative Tariff, which was filed in Docket No. obligations. Connecticut Yankee states ER00–771–000. [Docket No. ER01–757–000] that the proposed change would have no The details of the service agreements Take notice that on December 21, impact on its revenue requirement. are as follows: 2000, Wayne-White Counties Electric Connecticut Yankee states that copies (1) Umbrella Agreement for Short- Cooperative (WWCEC or Cooperative), of the filing have been provided to its Term Firm Point-to-Point Transmission tendered for filing an executed Service jurisdictional customers and to state Service dated as of November 30, 2000 Agreement for Firm Point-to-Point regulatory authorities in Vermont, New by and between Tucson Electric Power Transmission Service with Illinois Hampshire, Maine, Massachusetts, Company and Tri-State G&T Power Power Company. Under the Service Connecticut and Rhode Island.

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Comment date: January 12, 2001, in SUMMARY: The U.S. Environmental Environmental Justice, US EPA, Room accordance with Standard Paragraph E Protection Agency (US EPA) announces 2224 Ariel Rios Building, 1200 at the end of this notice. the availability of Federal Assistance to Pennsylvania Avenue NW, Washington, conduct an intern program to provide DC 20004, Telephone: 202–564–2602. 19. Southern California Water on the job training for students Company, d/b/a Bear Valley Electric FOR FURTHER INFORMATION CONTACT: interested in careers in environmental Service, Complainant, v. Southern Linda K. Smith, US EPA, Phone: 202– protection. The need for wise California Edison Company, 564–2602, E-mail: [email protected], stewardship of the nation’s Respondent. or by Fax: 202–501–1162. environmental resources is increasing SUPPLEMENTARY INFORMATION: [Docket No. EL01–25–000] and with it a need to enlarge the pool Take notice that on December 28, of skilled environmental professionals Background 2000, Southern California Water and at the same time increase the The environmental protection student Company, d/b/a Bear Valley Electric diversity of this pool. EPA recognizes internship program is designed to Service, tendered for filing a complaint that there is a shortage of skilled provide undergraduate and graduate against Southern California Edison environmental professionals. The students from accredited universities Company alleging that Edison was programmatic objective of this intern and colleges with opportunities for seeking unlawfully to terminate the program is to provide unique environmental training experiences at Added Facilities Agreement between opportunities for cooperative study, EPA and other venues in which the the parties, Southern California Edison research, and development that would student intern can receive a meaningful FERC Electric Rate Schedule No. 394.4. increase the number and diversity of learning experience. The Program will Comment date: January 18, 2001, in skilled engineers, scientists, policy be managed by the Office of accordance with Standard Paragraph E makers, legal professionals, and Environmental Justice. EPA managers at at the end of this notice. Answers to the managers in the environmental arena by Headquarters, Regional Offices, and complaint shall also be due on or before affording ‘‘on the job training’’ Laboratories will develop and sponsor January 18, 2001. opportunities for students interested in new training or research projects that public or private sector careers in Standard Paragraphs will further the student interns’ environmental protection. understanding of environmental and E. Any person desiring to be heard or This solicitation is to find a qualified health protection issues and abatement to protest such filing should file a non-profit organization to carry out this techniques. The projects are sufficiently motion to intervene or protest with the student intern program. The student narrow in scope to allow the student to Federal Energy Regulatory Commission, interns will be considered employees of complete the project in a 3–6 month 888 First Street, N.E., Washington, D.C. the cooperative partner rather than EPA period by working full-time during the 20426, in accordance with Rules 211 during their training period. All student summer and/or part-time during the and 214 of the Commission’s Rules of interns must be enrolled in an school year. Students selected to receive Practice and Procedure (18 CFR 385.211 undergraduate or graduate program, or an internship are awarded a stipend and 385.214). All such motions or accepted into an undergraduate or based on their level of education and protests should be filed on or before the graduate program that will commence length of the project period. comment date. Protests will be within nine months of selection as a EPA is expanding its institutional considered by the Commission in student intern. This partner would be commitment to Environmental determining the appropriate action to be responsible for locating candidate Stewardship and Health Protection. The taken, but will not serve to make interns, selecting the interns and Agency has identified several areas in protestants parties to the proceeding. administering the funding to the which student interns would benefit by Any person wishing to become a party Interns/Associates. USEPA would practical, on the job training must file a motion to intervene. Copies identify the intern/associate experiences. These areas include but are of these filings are on file with the opportunities at EPA or EPA not limited to: Commission and are available for public stakeholder facilities, provide advice to • Environmental Policy, Regulation, inspection. This filing may also be the cooperative partner in the selection & Law—Training in this area includes viewed on the Internet at http:// of the candidate interns and provide participation in the review and www.ferc.fed.us/online/rims.htm (call space, technical guidance and training evaluation of existing policies and 202–208–2222 for assistance). to the Interns/associates during their regulations, as well as the development Linwood A. Watson, Jr., period of internship at either an EPA of new policies. Training relating to facility or an EPA stakeholder facility. Acting Secretary. compliance with policies and This program will start on or about [FR Doc. 01–438 Filed 1–5–01; 8:45 am] regulations is included. April 1, 2001 and continue for a three • Environmental Management & BILLING CODE 6717±01±P year period. Administration—This area focuses on DATES: Applications must be received providing training in how to implement no later than 5:00 p.m., Eastern Time, and improve management goals; how to ENVIRONMENTAL PROTECTION February 23, 2001. develop cooperative environmental AGENCY ADDRESSES: Applicants must submit one management strategies. [FRL±6927±8] signed original plus two (2) copies of • Environmental Science—This area the application including all focuses in training on field studies and Financial Assistance for an information required by the application laboratory research. Environmental Professional Intern kit. Applications must be mailed to: • Public Relations and Program Linda K. Smith, EPA Intern Program, US Communications—This broad category AGENCY: Environmental Protection EPA (2201A), Washington, DC 20460. If provides the Intern with the opportunity Agency. delivered by courier service, the address to receive training relating to how is: Linda K. Smith, Associate Director public opinion affects environmental ACTION: Notice. for Resources Management, Office of issues. Internet surveys, tools for

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Marine Protection, Research, and individual training plans shall be would receive training relating to Sanctuaries Act, Section 203: conduct developed by the recipient in developing computer programs for research, investigations, experiments, consultation with the Project Officer or reaching different stakeholders. A training, demonstrations, surveys, and the individual Technical Advisor in project of this type could easily be a studies relating to the minimizing or accordance with the ‘‘Statement of training opportunity at a community or ending of ocean dumping of hazardous Substantial Involvement between US grassroots organization facility. materials and the development of EPA and the Recipient’’ described A primary objective of the EPA is to alternatives to ocean dumping. below. plan and support active stewardship of Catalog of Federal Domestic Assistance The maximum period that a student the environment, of the public health, (CFDA) intern may participate in the program and to sustain communities at a time of on a full or part time basis with funding This EPA Intern Program is listed in increased pressures on these resources from EPA is six months. The Agency the Catalog of Federal Domestic and decreasing funds for programs. Part may fund one additional three month Assistance under 66.607 Training and of the strategy is to transfer US EPA’s extension of an internship to enable the Fellowships for the Environmental technologies, techniques, and methods student to complete a project. Protection Agency. to the community-at-large, especially The recipient may establish the next generation of environmental Program Description environmental protection internship opportunities with organizations other professionals is to both increase their The objective of the program is to capability and to increase their than EPA. EPA may choose to fund and provide training opportunities to sponsor these internships or the diversity. EPA’s programs and activities students interested in pursuing offer unique training opportunities to recipient can obtain sponsorship or environmental careers. The proposed funding from non-EPA sources. Please develop skills that can be transferred to cooperative program will be the non-Federal community. An note that under OMB Circular A–122 administered by the Recipient in applicable to assistance agreements with effective mechanism to affect this response to intern opportunities transfer is through the establishment of non profit organizations, general fund- available at US EPA or other Federal or raising costs are not allowable. a student internship program. This non-Federal organizations which offer cooperative agreement between US EPA There is not a fixed number of opportunities for training in Internships per year under this program. and the recipient will promote these environmental protection. objectives The statutes under which the The actual number will depend on In cooperation with EPA, the opportunities and funding identified by US EPA will conduct this intern recipient will select and employ student program include: offices within US EPA. Internships may interns to work on individual projects in be located at US EPA or at facilities of a. Clean Water Act, Section 104(b)(3): response to internship opportunities other organizations with missions conduct and promote the coordination established by the program offices relating to environmental protection. If of research, investigations, experiments, within US EPA. Student interns are not interns are required to relocate to such training, demonstration, surveys, and EPA employees and the recipient, and locations for the duration of the studies relating to the causes, extent, cooperation with EPA, will develop an internship, EPA will provide financial prevention, reduction, and elimination orientation program that will explain assistance to the recipient in an amount of water pollution. the intern’s roles, responsibilities, and up to $500 to offset the interns b. Safe Drinking Water Act, Sections limitations. The student interns must be relocation expenses. Interns will be 1442(b)(3): develop, expand, or carry undergraduate students, graduate provided individual project assignments out a program (that may combine students, or college graduates who have for each internship. training, education, and employment) been accepted into graduate programs Under this Cooperative Agreement, for occupations relating to the public and will begin their studies within 9 the Recipient shall make an effort to health aspects of providing safe months of accepting an internship advertise and promote the availability of drinking water. position. Student interns may be these internships to Native Americans, c. Solid Waste Disposal Act, Section studying areas such as environmental Hispanic, African, Asian and other 8001(a): conduct and promote the science, earth science, environmental minorities (including women) at all coordination of research, investigations, engineering, geodesy, chemistry, levels so as to provide opportunities for experiments, training, demonstrations, physics, oceanography, biology, fishery a diverse group of students to surveys, public education programs, and science, geography, resource economics, participate in this program. studies relating to solid waste risk assessment, policy analysis, management and hazardous waste computer science, and law. The EPA Definitions management. Code of Federal Regulations, 40 CFR 1. Student Intern—Individual trainee d. Clean Air Act, Section 103(b)(3): part 45.135(a), states that ‘‘Trainees who will be provided with and perform conduct and promote the coordination must be citizens of the United States, its internships under this cooperative and acceleration of research, territories, or possessions, or lawfully agreement. investigations, experiments, admitted to the United States for 2. Project Officer—The US EPA demonstrations, surveys, and studies permanent residence.’’ Project Officer is that individual related to the causes, effects (including All internship projects will be carried specifically named by US EPA to health and welfare effects), extent, out under a written training plan with manage this program. prevention, and control of air pollution. the technical guidance of a mentor or 3. Technical Advisor—The US EPA e. Toxic Substances Control Act, Technical advisor from EPA or another employee responsible for providing Section 10(a): conduct research, sponsoring organization. These projects technical guidance on the specific

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1340 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices project(s) assigned to the Intern and for announcement of Internships and they the programmatic objectives of this the Intern’s individual development and may occur throughout the year. Cooperative Agreement. progress. Because the student interns *Summary Section: The Matching Requirements will be employees of the recipient programmatic objective of this intern organization rather than the Agency, Cost sharing is not required for the program is to provide unique training EPA technical advisors do not provide internship program. opportunities for cooperative study, day to day supervision of student Type of Funding Instrument research, and development that would interns. be of major benefit in advancing the 4. Intern Opportunity/Project—An The US EPA Intern Program shall be number and diversity of environmental opportunity for an internship which is awarded as a Cooperative Agreement professionals. documented and has funds obligated for since EPA anticipates that there will be Eligibility Criteria its costs. In general, these opportunities substantial involvement between the will be assignments within existing US EPA, the Recipient, and the Interns Any non profit organization as EPA programs and ongoing projects and (after their selection). described in OMB Circular A–122 may will be performed at the site of the Statement of Substantial Involvement submit a proposal. Please note that there project an EPA facility. In some cases, between US EPA and the Recipient are restrictions on the extent to which the assignment may involve an intern EPA can award financial assistance to training at locations other than an EPA In carrying out the work program set organizations described by Section facility such as a community forth in the project description, US EPA 501(c)(4) of the Internal Revenue Code organization facility; a non-profit and the Recipient agree to meet the who engage in lobbying. programmatic objective of this organization facility; or a local Award Period government, state government, or tribal agreement as stated.* US EPA government facility. involvement will consist of the The initial Master Agreement shall be following activities: for a period of three (3) years. US EPA Maximum EPA Financial Participation 1. US EPA will provide descriptions shall consider continued funding for the in Stipends (per Week) and General of available student intern opportunities project upon: (a) Satisfactory progress Background Requirements of including academic background and toward the stated agreement goals, and Internships prior work experience that would make the determination by US EPA that the 1. $400 ($10.00/hr) 1–4 full years of the internship experience meaningful to continuation of the program would be in academic study. the student. the best interest of the Government; and 2. $500 ($12.50/hr) Undergraduate 2. EPA personnel will discuss (b) availability of funds. The awards degree and acceptance in graduate internship opportunities with must have scopes of work that can school. prospective interns and provide advice easily be separated into annual 3. $600 ($15.00/hr) Undergraduate to the recipient relating to the ‘‘fit’’ increments of meaningful work which Degree and superior academic standard between a prospective intern’s academic represent solid accomplishments if (top 1/3, 2.9/4 GPA overall, & 3.5/4 GPA background and work experience and prospective funding is not made in Major) and accepted into graduate the training available under the available to the applicant. This school. internship opportunity. However, EPA submission in no way obligates US EPA 4. $700 ($17.50/hr) Completed 60 hrs personnel will not select or make offers to extend this agreement, nor is this Graduate level or completed Masters or to prospective intern. paragraph to be interpreted as a promise law degree and accepted into PhD or 3. After considering EPA’s advice, and that future funds will be available. L.L.M. program. making its own assessment of the fit Stipend levels, and benefits may be Unless included in the Intern between prospective interns’ adjusted for Cost of Living Allowances opportunity description, overtime is not qualifications and interests and the for each continuation year. anticipated. In the event that overtime is internship opportunity, the Recipient is required, the duration of the internship responsible for selecting the intern, Administrative Costs shall be reduced or additional funds making the offer of the internship, and Funds to support the environmental shall be obligated or Compensatory time arranging an orientation program and professional intern program shall be shall be given in lieu of overtime to pay start date. given directly to the Recipient. for it. 4. The recipient and EPA will Administrative costs shall be negotiated 5. In the event that an Intern collaboratively develop the student as part of the Master Agreement award voluntarily terminates or is terminated interns training plan. EPA will provide and shall be based on and paid on a per by the recipient for cause (e.g. failing to a technical advisor to interact with each Internship basis. These costs may be carry out his or her training plan or student intern as the intern carries out fixed, time dependent, Intern stipend engaging in disruptive behavior), the his or her training plan. The technical dependent, or a combination as Recipient shall make every effort to monitor shall provide technical proposed by the Recipient. select another intern and, if not guidance and support to the Intern in practicable, advise EPA to de-obligate developing the skills necessary to Indirect Costs the remaining funds committed to the perform the work in the chosen The total dollar amount of the indirect internship. environmental arena. However, EPA’s costs proposed in an application under technical advisor will not supervise the this program must not exceed the Funding Availability intern on a day to day basis. The indirect cost rate negotiated and US EPA funding for this Program will Recipient must manage time and approved by a cognizant Federal agency be a minimum of $500,000 from FY01 attendance and monitor the interns’ prior to the proposed effective date of funds during the first year. Each progress towards completing his or her the award. internship or group of internships, training plan. beyond the first, shall be funded as a 5. EPA shall provide liaison to Application Requirements separate amendment to the master interact with the Recipient and Senior Each Prospective Recipient shall agreement. There is no set timetable for Management on the progress of meeting submit a package containing completed:

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1. SF–424 (including SF–424A & SF– programs, and how carrying out the of at least three individuals in addition 424B). (Available on the Internet at environmental professional internship to the Selecting Official US EPA Federal http://www.whitehouse.gov/OMB/ program will further the applicant’s Program Officer, will review, evaluate, grants/#forms). mission. and rank all applications based on the 2. A budget with necessary supporting (e) Ability to use the Internet for all criteria stated above. The final decision details. This budget should be based on aspects of the intern program. on award will be based upon the panel’s a hypothetical intern opportunity at a 9. Proof of Status For First Time overall ranking of the application and a stipend level of $500 per week, with an Eligible Non-Profit Applicants. determination by the Selecting Official allowance for required field trip travel 10. EPA Form 5700–48 ‘‘Procurement that the Recipient’s application meets of $2,000, and a relocation allowance of System Certification’’ the Project Funding Priorities. $500. Because it is anticipated that this 11. EPA Form 4700–4 ‘‘Pre-award Other Requirements agreement will be extended to include Compliance Review report for All additional internships beyond the first, Applicants * * *.’’ Travel Expenses of selected Interns supporting information should be Application Forms and Kit EPA may provide additional financial included to determine the full cost to support for travel and transportation for the government of additional The Grant Application Kit can be student interns assigned to EPA projects internships which may have any of the obtained by calling 202–564–5310. It is requiring field work as documented in suggested stipend levels, have durations also available in PDF format at http:// the description of the Intern ranging 6 to 9 months, and be with or www.epa.gov/ogd/appkit.htm. Opportunity and the Intern’s training You can also visit your local public without relocation or travel allowances. plan. The funds will be included as part library and copy the forms from the This information should also contain of the original funding to the Recipient Federal Register in which this details on what services and benefits are at the time the internship project is document is published; many federal included (i.e. sick leave, tax initiated or at a later date by way of an offices use the forms and have copies withholding, insurance, etc.) and their amendment. Student interns shall available. A tutorial for grant applicants estimated cost to interns; as well as, complete Recipient’s travel approval is available at: http://www.epa.gov/ what, if any, allowances are made for form prior to each trip, complete a travel seahome/grants/src/grant.htm where vacation leave and/or sick leave. reimbursement form at the conclusion the forms can be printed. Holidays observed by the office hosting of each trip, and a travel experience the intern will be considered paid Project Funding Priorities report at the conclusion of each trip for holidays. Responsiveness of the application to the Recipient. The US EPA Technical 3. Curriculum Vitae for each Advisor shall sign the form to individual and critical senior staff the programmatic objectives of the Intern program as noted in the Summary acknowledge the trip is consistent with assigned to the program, the intern’s training plan prior to any 4. Copy of a current approved section and restated in the Type of Funding Instrument section above. action by the Recipient. Travel advances Negotiated Indirect Cost Rate for Interns shall be available from the Agreement, Evaluation Criteria Recipient as needed. All travel and 5. SF-LLL ‘‘Disclosure of Lobbying transportation required for field work Activities’’ The proposals from applicants will be evaluated and ranked on a ‘‘high, shall be paid by the Recipient out of 6. ‘‘Certifications Regarding Lobbying funds included in the agreement. Activities’’ medium or low’’ basis. High rankings 7. EPA Form 5700–49 ‘‘Certification are the most desirable. These rankings Restrictions will be considered by EPA management Regarding Debarment, Suspension, and This is a short term training program Other Responsibility Matters’’ in deciding which proposal, on balance, will provide the best value to both the for students. Interns will not be used to 8. A narrative description of the replace US EPA employees formerly applicant’s proposed plan for carrying Government and prospective interns. The evaluation factors that will be employed under the Office of Personnel out its environmental professional Management student appointing internship program. This narrative shall considered include: 1. Costs for operating the proposed authorities, to replace temporary or term include: Intern Program. appointments, or to replace or fill-in for (a) A description of the Intern Program, 2. The applicant’s proposed approach full or part-time US EPA positions how they would implement it and to carrying out the program and vacated by the Voluntary Separation conduct its operation. Alternatives proposed time lines for filling Program or Reduction in Force. and variations with regard to the internships. Participants will not be selected or used timing of items 4 and 5 within the 3. Services and benefits available to to perform personal services. The ‘‘Description of the Intended the Interns relative to their cost to EPA, Recipient and the Agency shall avoid Operation of the Intern Program for the applicant and the student interns any actions that create the appearance each Internship’’ detailed above may 4. Proposed method for advertising for that the intern is a Federal employee or be proposed. and pre-screening candidate Interns. is being used by EPA to obtain personal (b) Proposed method of advertising for 5. Past history of the prospective services. The relationship between the and pre-screening candidate Interns Recipient in operating similar programs. Recipient and Interns is that of and supervising interns as they carry 6. Qualifications of proposed senior Employer and Employee. The Recipient out their training plans. staff. must provide a health benefits option, (c) Proposed benefits offered to Interns must deduct applicable state and federal (e.g. tax withholding, health Selection Procedures taxes, and is responsible for payment, insurance, liability insurance, Each application will receive an discipline, leave approval, termination, workman’s compensation, etc.) as independent, objective review by a etc. for each Intern. Nothing in this employees of the applicant. panel qualified to evaluate the agreement or its supplements shall be (d) Past history of the prospective applications submitted. The deemed to create an employer-employee Recipient in carrying out similar Independent Review Panel, consisting relationship between the US EPA and

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However, (1) Federal Policies and Procedures. defined at 15 CFR part 26, section a limited number of the public may also Recipients are subject to all Federal 605) are subject to 15 CFR part 26, attend through a telephonic link, thirty- laws and Federal and USEPA policies, subpart F, ‘‘Government requirements two lines have been reserved for this regulations, and procedures applicable for Drug-Free Workplace (Grants)’’ purpose. Additional instructions about to Federal financial assistance awards. and related section of the certification how to participate in the meeting can be (2) Past Performance. Unsatisfactory form prescribed above applies; obtained by calling Ms. Wanda Fields performance under prior Federal awards iii. Anti-Lobbying. Persons (as defined at prior to the meeting at (see contact will be considered in evaluating an 15 CFR part 26, section 105) are information below). applicant’s proposal. subject to the lobbying provisions of Purpose of the Meeting—The (3) Preaward Activities. If applicants 31 U.S.C. 1352, ‘‘Limitations on use of Committee is planning a teleconference incur any costs prior to an award being appropriated funds to influence for the above noted date on a made, they do so solely at their own risk certain Federal contracting and contingency basis. The teleconference of not being reimbursed by the financial transactions,’’ and the will be convened only if, in the opinion Government. Notwithstanding any lobbying section of the certification of the DRRC Chair, it is needed to verbal or written assurance that may form prescribed above applies to address issues that require further have been received, there is no applications/bids for grants, discussion prior to completion of the obligation on the part of the USEPA to cooperative agreements, and contracts Committee’s report. A decision as cover pre-award costs except to the for more than $100,000 * * *.’’ whether or not the teleconference extent authorized at 40 CFR 30.25(f). iv. Anti-Lobbying Disclosures. Any (announced in this meeting notice) will (4) No Obligation for Future Funding. applicant that has paid or will pay for be convened will be made by close of If an application is selected for funding, lobbying using any funds must submit business, Friday, January 12, 2000, 11 the USEPA has no obligation to provide an SF–LLL, ‘‘Disclosure of Lobbying days prior to the tentatively scheduled any additional future funding in Activities,’’ as required under 15 CFR date. The decision on the teleconference connection with the award. Renewal of part 28, Appendix B. will be posted to the SAB website an award to increase funding or extend (8) False Statements. A False (www.epa.gov/sab); or members of the the period of performance is at the total statement on an application is grounds public may call or email Ms. Wanda discretion of the USEPA. for denial or termination of funds and Fields at the telephone and email (5) Delinquent Federal Debts. No grounds for possible punishment by a address provided below. award of Federal funds shall be made to fine or imprisonment as provided in 18 Availability of Review Materials—If an applicant who has an outstanding U.S.C. 1001. the teleconference is to be held, a list of delinquent Federal debt until either: (9) Intergovernmental Review. the issues to be discussed, along with a i. The delinquent account is paid in full, Applications under this program are not draft meeting agenda, will be posted on ii. A negotiated repayment schedule is subject to executive Order 12372, the SAB website (www.epa.gov/sab) established and at least one payment ‘‘Intergovernmental Review of Federal under the Agenda heading on January is received, or Programs.’’ 12, 2000. If the meeting is canceled, a iii. Other arrangements satisfactory to Approved for Publication: notice will be posted on the SAB USEPA are made. Dated: December 22, 2000. website to that effect as well. (6) Name Check Review. All non- Barry E. Hill, FOR FURTHER INFORMATION: Any member profit applicants are subject to a name Director, Office of Environmental Justice, U.S. of the public wishing further check review process. Name checks are Environmental Protection Agency. information concerning this meeting intended to reveal if any key individuals [FR Doc. 01–419 Filed 1–5–01; 8:45 am] should contact Mr. Samuel Rondberg, Interned with the applicant have been BILLING CODE 6560±50±P Designated Federal Officer, EPA Science convicted of or are presently facing Advisory Board (1400A), U.S. criminal charges such as fraud, theft, Environmental Protection Agency, 1200 perjury, or other matters which ENVIRONMENTAL PROTECTION Pennsylvania Avenue, NW, Washington, significantly reflect on the applicant’s AGENCY DC 20460; telephone (301) 812–2560, management honesty or financial FAX (410) 286–2689; or via e-mail at: integrity. Key individuals cannot be [FRL±6930±4] [email protected]. Because of the currently suspended, debarred, or limited time for discussion during the otherwise ineligible from participating Science Advisory Board; Notification of Public Advisory Committee Meeting teleconference, oral comments from the in Federal financial assistance. public will not be taken (extensive oral (7) Primary Applicant Certifications. Pursuant to the Federal Advisory comments were taken earlier at the All primary applicants must submit a Committee Act, Public Law 92–463, November 1–2, 2000 meeting—see 65 completed form CD–511, ‘‘Certifications notice is hereby given that the Dioxin FR 60190, dated October 10, 2000). Regarding Debarment, Suspension and Reassessment Review Committee Written comments may be submitted for Other Responsibility Matters; Drug-free (DRRC) of the US EPA Science Advisory consideration by the Committee, and Workplace Requirements and Board (SAB), may, depending on should be sent to Ms. Wanda Fields, Lobbying,’’ and the following progress achieved in developing its EPA Science Advisory Board, Mail Code explanations are hereby provided: report (see below), meet in a public 1400A, U.S. Environmental Protection i. Nonprocurement Debarment and teleconference on Tuesday, January 23, Agency, 1200 Pennsylvania Ave., NW, Suspension. Prospective participants 2000 between 2 and 4:30 p.m. The Washington DC 20460. (Telephone (202) (as defined at 15 CFR part 26, section meeting will be coordinated through a 564–4539, FAX (202) 501–0582; or via 105) are subject to 15 CFR part 26, conference call connection in Room e-mail at [email protected]).

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Comments should be supplied in the revised national ambient air quality FOR FURTHER INFORMATION: Members of following formats: one hard copy with standards (NAAQS) for particulate the public desiring additional original signature (and 25 copies), and matter. information about the meeting should one electronic copy via e-mail to Mr. Purpose of the Meeting—At this contact Mr. Robert Flaak, Designated Rondberg or Ms. Fields (acceptable file meeting, the Subcommittee will gather Federal Officer, Clean Air Scientific formats: WordPerfect, Word, or Rich information and receive briefings from Advisory Committee, Science Advisory Text files (in IBM–PC/Windows 95/98 Agency Staff and outside entities. Board (1400A), Suite 6450, U.S. EPA, format). Written comments must arrive Currently, EPA is in the process of 1200 Pennsylvania Avenue, NW, at the SAB no later than January 16, preparing a revised criteria document Washington, DC 20460; telephone/voice 2000. Please note that the Committee and related materials in anticipation of mail at (202) 564–4546; fax at (202) 501– had earlier extended the period for reviewing the National Ambient Air 0582; or via e-mail at accepting written comments. The date Quality Standard (NAAQS) for [email protected]. A copy of the given above is the deadline for receipt Particulate Matter (PM). As part of that draft agenda will be posted on the SAB of ALL written comments. review and in light of the ongoing effort Website (www.epa.gov/sab) (under the Meeting Access—Individuals to monitor particles, particularly fine ‘‘Agenda’’ subheading) approximately requiring special accommodation at this particles, there is an increasing need to 12 days before the meeting. meeting, including wheelchair access to have effective and efficient methods to Members of the public who wish to the conference room, should contact Mr. continuously monitor PM mass. Such make a brief oral presentation to the Rondberg at least five business days monitoring presents significant Subcommittee, or make arrangements prior to the meeting so that appropriate problems and currently, the regulations for a poster, must contact Mr. Flaak in arrangements can be made. in place make it difficult to qualify a writing (by letter or by fax—see continuous monitor as an equivalent previously stated information) no later Dated: December 21, 2000. than 12 noon Eastern Time, Wednesday, Donald G. Barnes, method to the designated Federal Reference Method (FRM) approach. January 17, 2001 in order to be included Staff Director, Science Advisory Board. on the Agenda. Public comments will be [FR Doc. 01–464 Filed 1–5–01; 8:45 am] The CASAC Technical Subcommittee for Fine Particle Monitoring is soliciting limited to approximately ten minutes BILLING CODE 6560±50±P public input on the development of per speaker or organization, unless other arrangements have been made in technologies and approaches that would advance with Mr. Flaak for additional provide continuous monitoring of ENVIRONMENTAL PROTECTION time. The request should identify the airborne PM with a sufficient accuracy AGENCY name of the individual making the and precision that it could be used for presentation, the organization (if any) [FRL±6930±5] regulatory purposes. We invite they will represent, any requirements interested individuals, companies, and Science Advisory Board; Notification for audio visual equipment (e.g., state and local regulatory agencies to of Public Advisory Committee Meeting overhead projector, 35mm projector, submit ideas (in writing or at the chalkboard, etc.), and at least 35 copies meeting) as to a framework in which SUMMARY: Pursuant to the Federal of an outline of the issues to be Advisory Committee Act, Public Law conflicting demands of convenience in addressed or of the presentation itself. 92–463, notice is hereby given that the monitoring, accuracy, precision, and Those requesting a poster should Clean Air Scientific Advisory concordance with the existing base of provide their requirements in the same Committee (CASAC) Technical monitoring data could be developed. At request (Posters, or other display Subcommittee for Fine Particle this time, we are not looking for materials can be wall mounted, or Monitoring will meet on Monday, descriptions of specific devices, but placed on panels or tables). January 22, 2001 at the US EPA rather possible approaches (within the Environmental Research Center (ERC), regulatory environment) that would Providing Oral or Written Comments at Classroom 2, Route 54 and Alexander encourage development, testing, and SAB Meetings Drive, Research Triangle Park, NC. The qualification of new instruments for this The Science Advisory Board expects meeting will begin at 8:30 am and end purpose. that public statements presented at its no later than 5 pm, Eastern Time. The Presentations may be made to the meetings will not be repetitive of meeting is open to the public, however, Subcommittee either orally or via a previously submitted oral or written due to limited space, seating will be on poster. Posters will be set up either statements. In general, each individual a first-come basis. For further within the meeting room or in the or group making an oral presentation information concerning the meeting, hallway outside, depending on the will be limited to a total time of ten please contact the individuals listed number of posters requested. minutes. For conference call meetings, below. Important Notice: Documents Appropriate time will be allocated opportunities for oral comment will be that are the subject of CASAC reviews during the mid-point of the meeting to limited to no more than five minutes per are normally available from the evaluate posters and to discuss these speaker and no more than fifteen originating EPA office and are not posters with presenters. minutes total. Written comments (at available from the CASAC Office— Availability of Review Materials—A least 35 copies) received in the SAB information concerning availability of brief white paper, outlining some of the Staff Office sufficiently prior to a documents from the relevant Program issues under consideration, will be meeting date, may be mailed to the Office is included below. available from EPA Staff on or about relevant SAB committee or Background—This technical January 9th. For further details, or to subcommittee prior to its meeting; subcommittee of CASAC was obtain a copy of the draft white paper, comments received too close to the established in 1996 to provide advice please contact Tim Hanley, US EPA, meeting date will normally be provided and comment to EPA (through CASAC) Office of Air Quality Planning and to the committee at its meeting. Written on appropriate methods and network Standards (MD–14), Research Triangle comments may be provided to the strategies for monitoring fine particles Park, NC 20771, phone (919) 541–4417 relevant committee or subcommittee up in the context of implementing the or via e-mail at: [email protected]. until the time of the meeting.

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Additional information concerning shellfish tissue criterion to SUPPLEMENTARY INFORMATION: This the Science Advisory Board, its concentrations of methylmercury in the Supplementary Information Section is structure, function, and composition, water column. EPA also plans to organized as follows: may be found on the SAB Website develop more detailed guidance to assist I. Introduction (http://www.epa.gov/sab) and in The States and Tribes with implementation II. Background Information FY2000 Annual Report of the Staff of the methylmercury criterion in water A. What are human health ambient water Director which is available from the quality standards and related programs. quality criteria? SAB Publications Staff at (202) 564– EPA believes that flexibility will be B. How is the 2000 Human Health 4533 or via fax at (202) 501–0256. needed when designing control Methodology used? Individuals requiring special programs to meet this water quality C. How does EPA use its recommended criterion because mercury is highly section 304(a) water quality criteria? accommodation at this meeting, D. What water quality criteria must a State including wheelchair access, should persistent in the environment and or authorized Tribe adopt into its water contact Mr. Flaak at least five business because air deposition is the primary quality standards? days prior to the meeting so that source of mercury for many E. May States and authorized Tribes adopt appropriate arrangements can be made. waterbodies. water quality criteria based on local conditions? Dated: December 28, 2000. ADDRESSES: Copies of the complete F. How does 40 CFR 131.21 affect water Donald G. Barnes, document, titled Water Quality Criterion quality standards adopted by States and Staff Director, Science Advisory Board. for the Protection of Human Health: authorized Tribes? [FR Doc. 01–465 Filed 1–5–01; 8:45 am] Methylmercury can be obtained from III. Mercury Sources, Environmental Fate, EPA’s National Service Center for and Implications for Water Quality BILLING CODE 6560±50±P Environmental Publications (NSCEP), Criterion Derivation telephone number 1–800–490–9198. A. What are the mercury emissions and Alternatively, the document and related deposition sources in the United States? ENVIRONMENTAL PROTECTION B. How does mercury cycle in the AGENCY fact sheet can be obtained from EPA’s web site at http://www.epa.gov/ environment? [FRL±6924±8] C. Does methylmercury bioaccumulate? waterscience/standards/methylmercury/ D. Why is the section 303(a) human health on the Internet. Copies of the draft EPA water quality criterion for Water Quality Criteria: Notice of internal report National Availability of Water Quality Criterion methylmercury expressed as a fish tissue Bioaccumulation Factors for residue value? for the Protection of Human Health: Methylmercury, the peer review report IV. Current Activities to Address Mercury Methylmercury on the draft bioaccumulation factors, Pollution A. Fish consumption advisory activities AGENCY: Environmental Protection responses to public comments on the notice of intent to develop a B. Water quality standards Agency (EPA). C. Total maximum daily load methylmercury water quality criterion, ACTION: Notice of availability of water D. Pollution minimization activities quality criterion for the protection of and responses to peer review comments E. National air emissions regulations human health: methylmercury. on the methylmercury reference dose V. Derivation of the Methylmercury Fish are in Water Docket W–00–20 Tissue Residue Water Quality Criterion SUMMARY: Pursuant to the Clean Water methylmercury. These materials are A. What is the health risk assessment for Act (CWA) section 304(a), EPA is available for inspection at the Water methylmercury? announcing the availability of its Docket Room EB 57, 401 M Street SW, B. How are mercury exposure and relative Washington, DC 20460, open between 9 source contribution assessed? recommended water quality criterion for C. How is the methylmercury water quality methylmercury. This water quality am and 3:30 pm EST. Appointments to criterion calculated? criterion describes the concentration of review the material may be made by VI. How Can the Fish Tissue Residue Water methylmercury in freshwater and calling 202–260–3027. Quality Criterion Be Related to a estuarine fish and shellfish tissue that FOR FURTHER INFORMATION CONTACT: For Mercury Concentration in Water? should not be exceeded to protect general questions regarding the VII. What is the Relationship Between Fish consumers of fish and shellfish among methylmercury water quality criterion Advisories and the Fish Tissue Residue the general population. EPA expects the guidance, contact Mary Manibusan, Water Quality Criterion? VIII. How Does EPA Suggest Implementing criterion recommendation to be used as USEPA, Health and Ecological Criteria the Methylmercury Water Quality guidance by States, authorized Tribes, Division (4304), Office of Science and Criterion? and EPA in establishing or updating Technology, 1200 Pennsylvania IX. Literature Cited water quality standards for waters of the Avenue, NW, Washington, DC 20460; or United States and in issuing fish and call (202) 260–3688; fax (202) 260–1036; I. Introduction shellfish consumption advisories. This or e-mail [email protected]. For Pursuant to section 304(a)(1) of the is the first time EPA has issued a water specific issues regarding mercury Clean Water Act (CWA), the quality criterion expressed as a fish and bioaccumulation, contact Erik Environmental Protection Agency is shellfish tissue value rather than as a Winchester, USEPA, Health and announcing the availability of EPA’s water column value. This approach is a Ecological Criteria Division (4304), recommended section 304(a) human direct consequence of the scientific Office of Science and Technology, 1200 health water quality criterion for consensus that consumption of Pennsylvania Avenue, NW, Washington, methylmercury. Section 304(a) human contaminated fish and shellfish is the DC 20460; or call (202) 260–6107. For health ambient water quality criteria are primary human route of exposure to questions about implementation of the numeric guidance values considered to methylmercury. EPA recognizes that water quality criterion, contact William be protective of human health for this approach differs from traditional Morrow, USEPA, Standards and Health pollutant concentrations in aquatic water column criteria, and will pose Protection Division, Office of Science media, such as ambient waters and implementation challenges. In this and Technology, 1200 Pennsylvania edible tissues of aquatic organisms. notice, EPA is providing suggested Avenue, NW, Washington, DC 20460; or EPA’s recommended section 304(a) approaches for relating the fish and call (202) 260–3657. water quality criteria provide guidance

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1345 for States and authorized Tribes to use tissue residue water quality criterion to impacts or the technological feasibility in establishing water quality standards concentrations of methylmercury in of meeting the pollutant concentrations and, when adopted into water quality water. EPA also plans to develop in ambient water. Section 304(a)(1) of standards and approved for CWA guidance to assist States and Tribes to the CWA requires EPA to develop and purposes, may form a basis for implement this methylmercury water publish, and from time to time revise, controlling discharges or releases of quality criterion in their water quality criteria for water quality accurately pollutants. Section 304(a) water quality programs. EPA believes that the range of reflecting the latest scientific criteria also provide guidance to EPA implementation issues would be knowledge. EPA’s recommended section when promulgating Federal regulations addressed best through broad national 304(a) water quality criteria may serve under CWA section 303(c) when such implementation guidance, and will as guidance for States and authorized actions are necessary. Under the CWA work to develop such guidance with Tribes in establishing water quality and its implementing regulations, States input from the public. Mercury is highly standards. The resulting standards may and authorized Tribes are to adopt water persistent in the environment and ultimately may provide a basis for quality criteria to protect designated reductions in environmental controlling discharges or releases of uses. EPA’s recommended human concentrations are likely to occur over pollutants. Section 304(a) water quality health water quality criteria do not years or decades. For many waterbodies criteria also provide guidance to EPA substitute for the Act or regulations, nor the primary source of mercury pollution when promulgating Federal regulations are they regulations themselves. Thus, is through air deposition and not pont under CWA Section 303(c) when such EPA’s recommended section 304(a) source discharge, EPA believes that actions are necessary. water quality criteria do not impose flexibility may be appropriate as water B. How Is the 2000 Human Health legally binding requirements. States and quality standards based on this Methodology Used? authorized Tribes retain the discretion methylmercury water quality criterion to adopt, where appropriate, other are implemented. Flexible approaches In November 2000, EPA published the scientifically defensible water quality will enable environmental protection to revised Methodology for Deriving standards that differ from these be achieved efficiently given the Ambient Water Quality Criteria for the recommendations. EPA may change the resource constraints that exist for both Protection of Human Health (2000) section 304(a) water quality criteria in regulators and the regulated community. (hereafter the 2000 Human Health the future. This notice also discusses the unique Methodology (USEPA, 2000a). See 65 Mercury is a complex multi-media aspects of mercury and methylmercury FR 66444 (November 3, 2000). Previous pollutant that requires a more unique as an environmental pollutant; to this, recommended human health approach to source management, announces EPA’s intention to publish ambient water quality criteria were pollution reduction and control, and methylmercury water quality criterion developed using the 1980 Ambient development of a water quality criterion implementation guidance, which will Water Quality Criteria National than is typically required for a less support prevention and reduction of Guidelines (hereafter the 1980 complex pollutant. In the United States, mercury contamination of surface water Methodology; USEPA 1980). The 2000 Human Health Methodology humans are exposed primarily to and fish; and invites the public to incorporates significant scientific methylmercury rather than to inorganic provide information and their views on advances that have occurred over the mercury. The dominant exposure approaches to prevent or reduce last two decades, particularly in the pathway is through consumption of mercury pollution and to implement areas of cancer and noncancer risk contaminated fish and shellfish rather water quality standards for assessments (using new information, than from ambient water. The water methylmercury. quality criterion published in this notice This document has been approved for procedures, and published Agency Guidelines), exposure assessments is for methylmercury, and it is publication by the Office of Water, (using new studies on human intake and expressed as a fish tissue (including United States Environmental Protection exposure patterns, and new Agency shellfish) residue criterion rather than a Agency. Mention of trade names or Guidelines) and methodologies to water column criterion. Henceforth, commercial products does not EPA will refer to today’s methylmercury estimate bioaccumulation in fish. constitute endorsement or EPA intends to use the 2000 Human water quality criterion as a fish tissue recommendation for use. residue criterion, which should be Health Methodology to develop new understood to include shellfish as well. II. Background Information section 304(a) water quality criteria for The Agency’s basis for expressing the additional pollutants and to revise A. What Are Human Health Ambient existing section 304(a) water quality methylmercury water quality criterion Water Quality Criteria? in this format is discussed later in this criteria. The 2000 Human Health notice and in more detail in the water Human health ambient water quality Methodology is an important quality criterion document titled Water criteria (AWQC) are numeric values component of EPA’s efforts to improve Quality Criterion for the Protection of considered to be protective of human the quality of the Nation’s waters and Human Health: Methylmercury (USEPA, health for pollutant concentrations in enhance the overall scientific basis of 2001), which is available today. aquatic media, such as ambient waters water quality criteria. Furthermore, the EPA recognizes that a fish tissue and edible tissues of organisms. Under 2000 Human Health Methodology residue water quality criterion is new to section 304(a) of the Clean Water Act should help States and authorized States and authorized Tribes and will (CWA), water quality criteria are based Tribes address their unique water pose implementation challenges for solely on data and scientific judgments quality issues and make risk traditional water quality standards about the relationship between management decisions to protect human programs. Water quality standards, pollutant concentrations and health consistent with section 303(c). It water quality-based effluent limits, total environmental and human health will also afford them greater flexibility maximum daily loads, and other effects. Protective assumptions are made in developing their water quality activities generally employ a water regarding potential human exposure programs. The 2000 Human Health column value. In this notice, EPA intakes. Water quality criteria do not provides the detailed means for suggests approaches for relating the fish reflect consideration of economic developing water quality criteria,

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1346 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices including systematic procedures for accumulation by fish and shellfish for designated uses. See CWA section evaluating cancer risk, noncancer health chemicals where exposure from food 303(c)(2)(A). Water quality criteria must effects, human exposure, and and sediment is important (e.g., highly be based on a sound scientific rationale bioaccumulation potential in fish. persistent, hydrophobic chemicals). and must contain sufficient parameters One particular area of new science is EPA prefers to use high quality field or components to protect the designated in developing the Reference Dose (RfD) data (e.g., water and fish data collected uses, See 40 CFR 131.11(a). Water value. An RfD is an estimate (with in the waterbody of interest) to derive quality criteria may be expressed in uncertainty spanning perhaps an order BAFs over laboratory or model-derived either narrative or numeric format. of magnitude) of daily exposure to the estimates of BAFs. This preference is States and authorized Tribes may human population (including sensitive because field data best reflect site- employ one of four approaches when subgroups) that is likely to be protective specific factors that can affect the extent adopting water quality criteria: (1) without an appreciable risk of of bioaccumulation (e.g., chemical Establish numerical values based on deleterious health effects during a metabolism, food web structure). section 304(a) recommended water lifetime. For noncarcinogenic quality criteria; (2) modify the section C. How Does EPA Use Its Recommended pollutants, the process for deriving a 304(a) recommended water quality Section 304(a) Water Quality Criteria? level of exposure considered to be criteria to reflect site-specific without appreciable risk of effect has Water quality standards consist of conditions; (3) use other scientifically evolved over time. EPA has developed designated uses, water quality criteria to defensible methods to derive protective guidance on assessing noncarcinogenic protect those uses, a policy for water quality criteria; and (4) establish effects of chemicals and for the RfD antidegradation, and general policies for narrative water quality criteria where derivation. The 2000 Human Health application and implementation. As numeric criteria cannot be determined Methodology recommends part of the water quality standards or to supplement numeric water quality consideration of other issues related to triennial review process defined in criteria. See 40 CFR 131.11(b). the RfD process including integrating section 303(c)(1) of the CWA, States and EPA encourages States and authorized reproductive and developmental, authorized Tribes are responsible for Tribes to use EPA’s CWA section 304(a) immunotoxicity, and neurotoxicity data maintaining and revising water quality water quality criteria as guidance in into the calculation. In the 2000 Human standards. Section 303(c)(1) requires adopting water quality standards Health Methodology, EPA recommends States and authorized Tribes to review, consistent with section 303(c) of the using quantitative dose-response and modify if appropriate, their water CWA and the implementing Federal modeling for the derivation of RfDs quality standards at least once every regulations at 40 CFR Part 131. These when the available data support its use. three years. water quality criteria are contained in EPA has provided additional guidance EPA’s recommended section 304(a) EPA’s last compilation of National (in its Risk Assessment Technical water quality criteria form the basis for Recommended Water Quality Criteria. Support Document (USEPA, 2000b)) to Agency decisions, both regulatory and See 63 FR 68354, December 10, 1998; States and authorized Tribes on nonregulatory, until superseded by EPA correction in 64 FR 19781, April 22, conducting their own risk assessments. publication of new or revised section 1999. In the future, EPA will be For exposure assessment, States and 304(a) water quality criteria. These publishing new and revised section authorized Tribes are encouraged to use recommended water quality criteria are 304(a) water quality criteria guidance local studies on human fish and used in the following ways: (1) As for pollutants of high priority and shellfish consumption that better reflect guidance to States and authorized national importance based upon the local intake patterns and choices. In the Tribes in adopting water quality 2000 Human Health Methodology. absence of local data, EPA recommends standards; (2) as guidance to EPA in Because this process will take time, EPA separate default fish consumption promulgating Federal water quality encourages States and authorized values for the general population, standards; (3) to interpret a State’s Tribes, prior to publication of a revised recreational fishers and subsistence narrative water quality standard (in the section 304(a) water quality criterion, to fishers. A factor to account for other absence of a State adopted numeric make appropriate changes when sources of exposure, such as other fish, standard) in order to establish National necessary to their water quality non-fish food, and air, is included when Pollutant Discharge Elimination System standards to reflect the guidance in the deriving AWQC for noncarcinogens and (NPDES) water quality-based permit 2000 Human Health Methodology. EPA for carcinogens based on a nonlinear limits; and (4) for all other purposes of expects that it would promptly consider low-dose extrapolation. In other words, section 304(a) under the Act. It is for approval any new or revised water consumption of contaminated water and important to emphasize the two distinct quality criterion submitted by a State or fish (including shellfish) are not the purposes that are served by the section authorized Tribe that is based on the only exposures considered. 304(a) water quality criteria. The first is 2000 Human Health Methodology. The 2000 Human Health Methodology as guidance to the States and authorized Once EPA publishes new or revised places greater emphasis on the use of Tribes in the development and adoption section 304(a) water quality criteria bioaccumulation factors (BAFs) for of water quality criteria that will protect guidance that reflects the 2000 Human estimating potential human exposure to designated uses (e.g., aquatic life, Health Methodology, EPA expects States contaminants via the consumption of primary contact recreation). The second and authorized Tribes to reassess their contaminated fish and shellfish than did is as the basis for promulgation of water quality standards and, where the 1980 Methodology. BAFs reflect the Federal water quality criteria for States necessary, establish new or revised accumulation of chemicals by aquatic or authorized Tribes when such action water quality criteria consistent with organisms from all surrounding media is necessary. one of the four approaches described (includes water, food, and sediment). above. With today’s publication of this Compared with bioconcentration D. What Water Quality Criteria Must a section 304(a) human health water factors, which reflect chemical State or Authorized Tribe Adopt Into Its quality criterion for methylmercury, accumulation by aquatic organisms from Water Quality Standards? EPA is withdrawing the previous water only, BAFs are considered to be States and authorized Tribes must ambient human health water quality better predictors of chemical adopt water quality criteria that protect criteria for mercury (see 63 FR 68354,

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December 10, 1998; correction in 64 FR approval of any new or revised water deposited through wet and dry 19781, April 22, 1999) as the quality standards. Therefore, any new or deposition within the lower 48 States. recommended section 304(a) water revised water quality criterion for The remaining two-thirds quality criteria for States and authorized methylmercury adopted by States or (approximately 107 tons) of Tribes to use as guidance in adopting authorized Tribes would not take effect anthropogenically emitted mercury is water quality standards. Implementation for CWA purposes until after EPA transported outside of the United States’ issues for this criterion are discussed in approves such standards. borders where it enters the global Section VIII of today’s Notice. reservoir. In addition to mercury III. Mercury Sources, Environmental deposited from United States sources, E. May States and Authorized Tribes Fate, and Implications for Water approximately another 35 tons of Adopt Water Quality Criteria Based on Quality Criterion Derivation mercury from the global reservoir is Local Conditions? The 1997 Mercury Study Report to deposited for a total deposition of EPA encourages States and authorized Congress (The Mercury Study) (USEPA, roughly 87 tons within the lower 48 Tribes to develop and adopt water 1997a) describes mercury emission States. In the United States, the highest quality criteria to reflect local and sources, fate and transport, exposure to deposition rates from anthropogenic and regional conditions. In the 2000 Human humans and wildlife, human health and global contributions for mercury are Health Methodology, EPA published ecological impacts of mercury exposure, predicted to occur in the southern Great default values for risk level, fish intake, and control technologies for air Lakes and Ohio River valley, the drinking water intake, and body weight emissions. The most recent data and Northeast and scattered areas in the for use by EPA or States in deriving reviews on human health impacts are South, with the Miami and Tampa areas human health water quality criteria. described and updated in the Water having the most elevated levels in the EPA also intends to publish default Quality Criterion for the Protection of South. The location of sources, the bioaccumulation factors and relative Human Health: Methylmercury (USEPA, chemical species of mercury emitted, source contribution (RSC) factors as 2001), that we are announcing the and the climate and meterology are key chemical-specific water quality criteria availability of today. factors in where and how rapidly are developed or revised. EPA believes A. What Are the Mercury Emissions and mercury deposition occurs. these default values result in water Deposition Sources in the United quality criteria protective of the general B. How Does Mercury Cycle in the States? population. States and authorized Environment? Tribes may also use these default values Based on the EPA’s National Toxics Mercury cycles in the environment as when deriving their own water quality Inventory, the highest emitters of a result of natural and human criteria, or they may use other values mercury to the air include coal-burning (anthropogenic) activities. The amount more representative of local conditions electric utilities, municipal waste of mercury mobilized and released into if data have been collected supporting combustors, medical waste incinerators, the biosphere has increased since the the alternative values. However, when chlor-alkali plants, hazardous waste beginning of the industrial age. Most of establishing a numeric value based on a combustors, and cement manufacturers. the mercury in the atmosphere is section 304(a) water quality criterion The Mercury Study estimated that the elemental mercury vapor, which can modified to reflect site-specific annual anthropogenic United States circulate in the atmosphere for up to a conditions, or water quality criteria emissions of mercury in 1994–1995 was year (USEPA, 1997a). Mercury in the based on other scientifically defensible 158 tons. Roughly 87 percent of these atmosphere can be widely dispersed methods, EPA strongly cautions States emissions were from combustion and transported thousands of miles from and authorized Tribes not to selectively sources, including waste and fossil fuel likely sources of emission (USEPA, apply data in order to ensure water combustion. Contemporary 1997a). Inorganic mercury in the quality criteria less stringent than EPA’s anthropogenic emissions are only one atmosphere, when either bound to section 304(a) water quality criteria. part of the mercury cycle. Releases from airborne particles or in a gaseous form, Such an approach would inaccurately human activities today are adding to the is deposited to soils and waterbodies characterize risk. mercury reservoirs that already exist in through wet and dry deposition events. land, water, and air, both naturally and Wet deposition as precipitation is the F. How Does 40 CFR 131.21 Affect Water as a result of previous human activities. primary mechanism for transporting Quality Criteria Adopted by States and The deposition of mercury from the mercury from the atmosphere to surface Authorized Tribes? atmosphere to land or water at any waters and land. After it deposits, On April 27, 2000, EPA published location comes from: (1) The natural mercury can be emitted back to the new regulations addressing its review global cycle (including re-emissions atmosphere, either as a gas or associated and approval of water quality standards from the oceans); (2) regional sources; with particles, to be re-deposited adopted by States and authorized and (3) local sources. Local sources can elsewhere. As it cycles among the Tribes. See 65 FR 24642 April 27, 2000. include direct water discharges in atmosphere, land, and water, mercury Under the new regulations, which are addition to mercury from air emissions. undergoes a series of complex chemical codified at 40 CFR 131.21(c)–(f), State or Past uses of mercury, such as fungicide and physical transformations, many of authorized Tribal water quality application to crops, are also a which are not completely understood. standards that were adopted, in effect, component of the present mercury Most of the mercury that ends up in and submitted to EPA prior to May 30, burden in the environment. The water, soil, sediments, and plants and 2000, are in effect for CWA purposes Mercury Study estimated that, for 1995, animals is in the form of inorganic unless superseded by replacement the United States sources contributed mercury salts and organic forms of Federal water quality standards. See 40 approximately 3 percent (or 165 tons) of mercury, such as methylmercury. CFR 131.21(c). However, under the new the total global mercury emissions Detailed discussions of mercury regulation, State or authorized Tribal (5,500 tons). The Mercury Study further chemistry can be found in Nriagu (1979) water quality criteria adopted and in estimated that, of United States and Mason et al. (1994). effect after May 30, 2000, are in effect anthropogenic mercury emissions, Mercury from air emissions can be for CWA purposes only after EPA approximately one-third (52 tons) are deposited to watershed soils, where a

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1348 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices portion of it can be methylated through Numerous factors can influence the kg) that relates the concentration of a soil microbial activity. Mercury in soils bioaccumulation of mercury in aquatic chemical in water to its expected can be washed from the watershed into biota. These include, but are not limited concentration in commonly consumed wetlands, lakes, streams, and rivers to, the acidity (pH) of the water, length aquatic organisms in a specified trophic where microbial activity in sediments of the aquatic food chain, temperature, level (USEPA, 2000a). A national BAF is converts inorganic mercury to and dissolved organic material. Physical meant to be broadly applicable to all methylmercury. In particular, wetlands and chemical characteristics of a waters in the United States, whereas a appear to be key environments for watershed, such as soil type and erosion site-specific BAF is based on local data microbially enhanced conversion of or proportion of area that is wetlands, and integrates local spacial and mercury into methylmercury. Once in affect the amount of mercury that is temporal factors that can influence aquatic systems, mercury can exist in transported from soils to water bodies. bioaccumulation. Some pollutants not dissolved or particulate forms and can Interrelationships among these factors only bioaccumulate, but also biomagnify undergo a number of chemical are poorly understood and are likely to in aquatic food webs. Biomagnification transformations. Contaminated be site-specific. No single factor is a process whereby chemical sediments at the bottom of surface (including pH) has been correlated with concentrations increase in aquatic waters can serve as an important extent of mercury bioaccumulation in organisms of each successively higher mercury reservoir, with sediment-bound all cases examined. Two lakes that are trophic level due to increasing dietary mercury recycling back into the aquatic similar biologically, physically, and exposures (e.g., increasing ecosystem for decades or longer. chemically can have different concentrations from algae, to Mercury also has a long retention time methylmercury concentrations in water, zooplankton, to forage fish, to predator in soils; as a result, mercury that has fish, and other aquatic organisms (Cope fish). For pollutants that biomagnify, accumulated in soils may continue to be et al., 1990; Grieb et al., 1990; Jackson, EPA’s preferred approach for deriving released to surface waters and other 1991; Lange et al., 1993). For more national BAFs for use in deriving media for long periods of time, possibly indepth discussions about the chemical, section 304(a) water quality criteria is to hundreds of years. physical, and biological interactions use empirical field data collected in the affecting methylmercury C. Does Methylmercury Bioaccumulate? natural environment. With this bioaccumulation in aquatic organism preference in mind, EPA explored the Methylmercury is highly see the compilation of papers in feasibility of developing field-derived bioaccumulative and is the form of Mercury Pollution: Integration and national methylmercury BAFs for each mercury that bioaccumulates most Synthesis (Watras and Huckabee, 1994). trophic level of the aquatic food chain efficiently in the aquatic food web. Because mercury methylation and consumed by humans (i.e., trophic Methylation of mercury is a key step in entrance of methylmercury at the base levels 2–4). Using Agency guidance on the entrance of mercury into food of the food web is critical to the overall BAFs contained in the 2000 Human chains. The biotransformation of bioaccumulation process and magnitude Health Methodology and procedures inorganic mercury species to methylated of biomagnification, it is EPA’s belief outlined in Volume III, Appendix D of organic species in water bodies can that reductions in the available pool of the peer reviewed Mercury Study, EPA occur in the sediment and the water total mercury will ultimately lead to empirically derived draft national column. Inorganic mercury can be reduced concentrations in fish and methylmercury BAFs for each trophic absorbed by aquatic organisms but is shellfish typically consumed by level of the aquatic food chain. The draft generally taken up at a slower rate and humans. The extent to which national BAFs were single value trophic with lower efficiency than is concentrations of methylmercury will level-specific BAFs calculated as the methylmercury. Methylmercury be reduced in fish and shellfish as a geometric mean of field data collected continues to accumulate in fish as they result of reduced pools of total mercury across the United States and reported in age. Predatory organisms at the top of in the environment will be location the open literature as well as other aquatic and terrestrial food webs specific and depend on the unique publically available reports. These draft generally have higher methylmercury chemical, physical, and biological methylmercury BAFs were compiled in concentrations because methylmercury interactions that occur in a given a draft internal report and submitted to is typically not completely eliminated system. by organisms and is transferred up the a panel of external scientific experts for food chain when predators feed on prey; D. Why Is the 304(a) Human Health peer review. The methylmercury water for example, when a largemouth bass Water Quality Criterion for quality criterion document presents a feeds on a bluegill sunfish, which fed on Methylmercury Expressed as a Fish summary of the draft internal BAF aquatic insects and smaller fish, all of Tissue Residue Value? report as well as a summary of the peer which could contain some amount of To derive section 304(a) water quality review comments. The entire internal methylmercury that gets transferred to criteria for the protection of human draft methylmercury BAF report and the predator. Nearly 100 percent of the health, EPA needs to conduct a human peer review report can be obtained from mercury that bioaccumulates in upper health risk assessment on the pollutant the Water Docket. See the ADDRESSES trophic level fish (predator) tissue is in question and gather information on section of today’s Notice to obtain a methylmercury (Bloom, 1992; Akagi, the target population’s exposure to the copy of the BAF peer report from the 1995; Kim, 1995; Becker and Bigham, pollutant. Traditionally, EPA has Water Docket. 1995). Methylmercury BAFs for upper expressed its section 304(a) water Within any given trophic level, the trophic level freshwater and estuarine quality criteria guidance to protect individual empirically derived draft fish and shellfish typically consumed by human health in the form of pollutant methylmercury BAFs generally ranged humans generally range between concentrations in ambient surface water. up to two orders of magnitude. This 500,000 and 10,000,000 (Glass et al. To account for human exposure through range in BAFs reflects the various biotic 1999; Lores et al., 1998; Miles and Fink, the aquatic food pathway when deriving factors (such as food chain interactions 1998; Monson and Brezonik, 1998; a water column-based water quality and fish age/size) and abiotic factors Watras et al., 1998; Mason and Sullivan, criterion, EPA uses national BAFs (such as pH and dissolved organic 1997). (USEPA, 2000a). A BAF is a ratio (in L/ carbon). The large range in the

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Current Activities To Address waters of the United States. Presently, it Mercury Pollution is EPA’s understanding that the Section V.A. of this Notice), and the mechanisms that underlie many of the methylmercury BAF peer review EPA is very aware of the multimedia character of mercury as an influencing factors are not well comments, EPA concluded that it is environmental contaminant. As has understood and cannot be accurately more appropriate at this time to derive been discussed, releases of mercury are predicted. As the science of a fish tissue (including shellfish) residue water quality criterion for largely into the air, but releases directly methylmercury improves, in the future methylmercury rather than a water into water and onto the land can also be it may be possible to predict or model column-based water quality criterion. significant. Moreover, statutory these processes and use such EPA believes a fish tissue residue water authority over mercury releases into information to more accurately predict quality criterion for methylmercury is various media are under the purview of bioaccumulation. Until such time, EPA appropriate for many reasons. A fish all of EPA’s statutes. To coordinate its is unable to improve the predictive tissue residue water quality criterion various activities dealing with mercury, power of the methylmercury BAFs by integrates spacial and temporal EPA issued a draft Mercury Action Plan universally accounting for influencing complexity that occurs in aquatic for public comment in 1998 and expects factors. This is not the case for other systems and that affect methylmercury to issue a revised Plan shortly. The Plan highly bioaccumulative pollutants, for bioaccumulation. A fish tissue residue lays out a comprehensive program to example polychlorinated biphenyls water quality criterion in this instance address all aspects of the mercury (PCBs). For such pollutants, EPA has is more closely tied to the CWA goal of problem from all sources and into all methods that improve the predictive protecting the public health because it media, using all of the Agency’s tools, capability of empirically derived or is based directly on the dominant and includes the issuance and model predicted BAFs (e.g., normalizing human exposure route for implementation of this human health fish tissue concentrations to lipid and methylmercury. The concentration of water-quality criterion. Some of the normalizing ambient water methylmercury is also generally easier approaches currently employed to concentrations to dissolved and to quantify in fish tissue than in water inform the public of the human health particulate organic carbon). EPA is and is less variable in fish and shellfish risks of mercury, and to manage, actively involved in, and will continue tissue over the time periods in which control, and reduce its release to the to support, various types of research water quality standards are typically environment are briefly discussed aimed at better understanding the fate of implemented in water quality-based below. mercury in the environment and the controls, such as NPDES permits. Thus, A. Fish Consumption Advisory processes that underlie methylmercury the data used in permitting activities Activities bioaccumulation. EPA hopes that results can be based on a more consistent and of new research will enable EPA to measurable endpoint. Finally, this States and authorized Tribes have make better predictions about approach is consistent with how fish primary responsibility for protecting methylmercury bioaccumulation. advisories are issued. Fish advisories for residents from the health risks of consuming contaminated The BAF peer reviewers recognized mercury are also based on the amount of methylmercury in fish tissue that is noncommercially caught fish and the need for methylmercury BAFs and considered acceptable, although such wildlife. They do this by issuing fish were supportive of most aspects of the advisories are usually issued for a consumption advisories for the general methodology used to derive the draft certain fish or shellfish species in terms population, recreational and subsistence national methylmercury BAFs. The peer of a meal size. A fish tissue residue fishers, as well as for sensitive reviewers did have issues with certain water quality criterion should enhance subpopulations (such as pregnant data used to derive the methylmercury harmonization between these two women, nursing mothers, and children). BAFs and certain assumptions about approaches for protecting the public These advisories inform the public that food chain relationships. Overall, most health. unacceptable concentrations of of the peer reviewers believed that Because EPA did not use national, chemical contaminants (e.g., derivation of single-value trophic level- empirically derived methylmercury methylmercury and dioxins) have been specific national BAFs for BAFs to establish today’s section 304(a) found in local fish and wildlife. The methylmercury that would be generally recommended methylmercury water advisories include recommendations to applicable to all waters of the United quality criterion, EPA has deferred limit or avoid consumption of certain States under all conditions is difficult at further efforts to derive national BAFs fish and wildlife species from specific best. This opinion was based on for methylmercury at this time. EPA waterbodies or, in some cases, from consideration of the highly site-specific notes, however, that there may be specific waterbody types (e.g., all lakes). nature of methylmercury adequate field data for some States typically issue five major types of bioaccumulation in aquatic waterbodies or geographical regions to advisories and bans to protect both the environments and the large range in the derive, accurate predictive, site-specific general population and specific empirically derived draft methylmercury BAFs. EPA may subpopulations. When levels of methylmercury BAFs. These peer reconsider developing national chemical contamination pose a health reviewers recommended developing methylmercury BAFs in the future once risk to the general public, States may methylmercury BAFs on a more local or more field data is available for a broader issue a no consumption advisory for the regional scale, if not on a site-specific range of species and aquatic ecosystems, general population. When contaminant basis. See the Addresses section of or once more information is available levels pose a health risk to sensitive

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1350 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices subpopulations, States may issue a no This value is based on a tissue residue As discussed above, water quality consumption advisory for the sensitive value and bioconcentration factor and standards consist of designated uses, subpopulation. In waterbodies where was derived using an aquatic life criteria water quality criteria to protect chemical contamination is less severe, methodology that was superceded by designated uses, an antidegradation States may issue an advisory the 1985 aquatic life guidelines policy, and general policies for recommending that either the general (Stephen et al., 1985). EPA’s application and implementation. States population or a sensitive subpopulation promulgation of the National Toxics and authorized Tribes have considerable restrict their consumption of the Rule in 1992 (see 40 CFR 131.36) discretion in designating uses, and may specific species for which the advisory included this value with an additional find that changes in use designations are is issued. A commercial fishing ban can footnote directing States to measure warranted. EPA reviews any new or be issued, that prohibits the commercial methylmercury in the edible portion of revised use designation, including harvest and sale of fish, shellfish, and/ aquatic species of concern, and initiate refinement of a designated use, adopted or wildlife species from a designated a revision of its criterion in water by States and authorized Tribes to waterbody and, by inference, the quality standards to protect designated determine if the standards meet the consumption of all species identified in uses, if the ambient water concentration requirements of the CWA and the fishing ban from that waterbody. exceeds 12 ng/L more than once in a implementing regulations. Under 40 EPA has published guidance for three year period. CFR 131.10(j), a use attainability States and Tribes to use in deriving their More recently, many States have analysis (UAA) must be conducted recommended fish consumption limits. adopted EPA’s 1997 criteria whenever a State or authorized Tribe See Guidance for Assessing Chemical recommendations of 50 ng/L total designates or has designated uses that Contaminant Data for Use in Fish mercury for human health protection do not include the uses specified in Advisories, Volume 2 (USEPA, 2000e). from the consumption water and Section 101(a)(2) of the CWA (i.e., That guidance addresses chemical organisms and 51 ng/L total mercury for suitable for fishing and swimming), or contaminants with carcinogenic and/or human health protection from the when the State wishes to remove a noncarcinogenic effects, calculating consumption of organisms only. See 62 designated use that is specified in consumption limits for a single FR 42160. These value was derived section 101(a)(2) of the Act, or adopt contaminant in a multiple species diet using toxicological and exposure input subcategories of uses that require less or for multiple contaminants causing values current at the time of its stringent criteria. Uses are considered the same chronic health effects publication, including a by EPA to be attainable, at a minimum, endpoints. The guidance recommends bioconcentration factor. The criterion if the uses can be achieved (1) when expressing species-specific published today reflects EPA’s 2000 effluent limitations under Section consumption limits as fish meals per Human Health Methodology, reflects the 301(b)(1)(A) and (B) and Section 306 are month, calculated at various fish tissue best available science, and supercedes imposed on point source dischargers, concentrations for both noncancer and all previous section 304(a) human and (2) when cost effective and cancer endpoints. Developing fish health mercury criteria reasonable best management practices consumption limits requires making recommendations published by EPA, are imposed on nonpoint source assumptions about the edible portions except for the waters of the Great Lakes dischargers. 40 CFR 131.10 lists grounds of fish because most chemical System as discussed below. EPA upon which to base a finding that contaminants are not evenly distributed encourages States and authorized Tribes attaining the designated use is not throughout the fish. The fish advisory to adopt the methylmercury criterion feasible, as long as the designated use is guidance also recommends that human published today in their water quality not an existing use. exposure via sources of contaminants standards to protect human health. States and authorized Tribes may also other than consumption of States and authorized Tribes may adopt water quality standards variances. recreationally or subsistence caught fish alternatively develop data which EPA believes variances are particularly should be quantified. indicates a site-specific water quality suitable when the cause of criteria for a particular pollutant is nonattainment is discharger-specific B. Mercury Water Quality Standards appropriate and take action to adopt and/or it appears that the designated use As discussed above, once EPA such a criteria into their water quality in question will eventually be publishes new or revised section 304(a) standards. Site-specific criteria are attainable. EPA has approved the water quality criteria guidance that allowed by regulation and are subject to granting of water quality standards reflects the 2000 Human Health EPA review and approval. variances by States in circumstances Methodology, EPA expects States and In 1995, EPA promulgated the Final which would otherwise justify changing authorized Tribes to reassess their water Water Quality Guidance for the Great a use designation on grounds of quality standards and, where necessary, Lakes System. See 60 FR 15366, 40 CFR nonattainability (i.e., the six establish new or revised water quality 132). This rule established a numeric circumstances contained in 40 CFR criteria consistent with one of the four criterion, based in part on 131.10(g)). In contrast to a change in approaches described above. bioaccumulation factors (BAFs) and a standards which removes a use EPA has published numerous factor to account for other exposure designation for a water body, a water recommended water quality criteria for sources, of 3.1 ng/L for total mercury in quality standards variance can apply mercury throughout the years, reflecting ambient waters of the Great Lakes only to the discharger to whom it is changes in the best available scientific System for human health protection. granted and only to the pollutant information. Consistent with CWA EPA continues to view this criterion as parameter(s) upon which the finding of Section 303(c)(2)(B), States and appropriately protective for these nonattainability was based; the authorized Tribes have adopted a waters. Great Lakes States and underlying standard remains in effect numeric criterion, or an appropriate authorized Tribes are also encouraged to for all other purposes. narrative translator, for mercury. Some adopt today’s criterion for The essential elements of a variance States have adopted a previously methylmercury in fish tissue in addition are: a variance should be granted only recommended AWQC for aquatic life of to the ambient water criterion for where there is a demonstration that one 0.12 ng/L total mercury (USEPA, 1984). mercury contained in 40 CFR 132. of the use removal factors (see 40 CFR

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131.10(g)) has been satisfied; a variance variance to the individual discharge. In deposition of mercury was identified as is granted to an individual discharger this case, each variance is also a source of impairment in over 600 for a specific pollutant(s) and does not submitted to EPA for review and action. waterbody segments. As States are not otherwise modify the standards; a It is important to note that Ohio’s required to identify atmospheric variance identifies and justifies the mercury variance relieves individual deposition as a source of impairment, numerical criteria that will apply during dischargers of the responsibility to this is likely to be an underestimate. the existence of the variance; a variance demonstrate social and economic EPA is currently conducting pilot is established as close to the underlying impacts of complying with the mercury studies to assist States in developing numerical criteria as is possible; a criteria. Individual dischargers must TMDLs for waterbodies impaired by variance is reviewed every three years, still demonstrate that end of pipe mercury from atmospheric deposition. at a minimum, and extended only where treatment is the only viable compliance One goal of the pilot studies is to the conditions for granting the variance option. In addition, in this case EPA evaluate modeling approaches, such as still apply; upon expiration of the retains review and approval authority techniques for identifying the relative variance, the underlying numerical over individual variance decisions, but contribution of various types of mercury criteria have full regulatory effect; a EPA’s review is limited to the technical sources to a waterbody. Another goal of variance does not exempt the discharger merits of the alternatives analysis (e.g., the studies is to examine how TMDLs from compliance with applicable are there options other than end of pipe can incorporate ongoing efforts to technology or other water quality-based treatment). address sources of mercury, pollution including programs under the Clean Air limits; and, a variance does not affect C. Total Maximum Daily Load effluent limitations for other Act and water-related pollution dischargers. Section 303(d) of the CWA requires prevention activities. In l995, EPA and the Great Lakes States and authorized Tribes to identify D. Pollution Minimization Activities states agreed to a comprehensive plan to and establish a priority ranking for restore the health of the Great Lakes. waters for which existing pollution The CWA prohibits the discharge of Using the Final Water Quality Guidance controls are not stringent enough to any pollutant (other than dredged of fill for the Great Lakes System (see 40 CFR attain and maintain applicable water material) from a point source into 132), Great Lakes States and authorized quality standards; to establish total waters of the United States except in Tribes established water quality criteria, maximum daily loads (TMDLs) for those compliance with an NPDES permit. See methodologies, policies and procedures waters; and to submit from time to time section 301(a) and section 402 of the to establish consistent, enforceable, long the list of waters and TMDLs to EPA. CWA. NPDES permits are issued by EPA term protection for fish and shellfish in Section 303(d) of the CWA requires EPA or by States and Tribes that are the Great Lakes and their tributaries, as to review and approve or disapprove authorized to administer the NPDES well as the people and wildlife who lists and TMDLs within 30 days of the program. These permits commonly consume them. Under 40 CFR 132, the date they are submitted. If EPA contain numerical limits on the State of Ohio adopted, and EPA disapproves a State’s or Tribe’s amounts of specified pollutants that approved, a statewide variance identification of waters or a TMDL, EPA may be discharged. In place of or in specifically for mercury. must establish the list or a TMDL for the addition to numerical limits, permits The basis for this mercury variance State or authorized Tribe. may contain best management practices was the adverse social and economic TMDLs specify the amount of a (BMPs) (e.g., practices or procedures impacts of end of pipe treatment to particular pollutant that may be present that a facility installs or follows that attain effluent limits for mercury of less in the water and still allow the result in a reduction of pollutants to than 12 ng/L total mercury. Ohio waterbody to meet applicable water waters of the United States). These determined a cost of $10 million per quality standards, including a margin of ‘‘effluent limitations’’ implement both pound for mercury removal from safety and after considering seasonal technology-based and water quality- NPDES permitted discharges. Ohio also variability. TMDLs allocate the based requirements of the Act. specified implementation procedures allowable pollutant loads among point Technology-based effluent limitations whereby the discharger requests and nonpoint sources of pollution. represent the degree of control that can coverage under the mercury variance; TMDLs also provide the basis for be achieved by point sources using describes the mercury control measures attaining or maintaining applicable various levels of pollution control taken to date; provides a plan of study water quality standards through technology. See sections 301, 304, and intended to identify and control sources implementation of pollutant reductions 306 of the CWA For a publicly owned of mercury (including documenting in the NPDES permit program and in treatment works (POTW), section current influent and effluent nonpoint source controls programs. 301(b)(1)(B) of the CWA specifies the concentrations, identifying known On the 1998 lists of impaired applicable technology-based control sources, describing how known sources waterbodies, 33 States reported at least standard as ‘‘secondary treatment.’’ See will be reduced or eliminated, one waterbody as being impaired due to CWA sections 301(b)(1)(B). identifying other potential sources, and mercury contamination. Over 1,000 As discussed above, the CWA directs providing a schedule for evaluating individual waterbody segments were the States to establish water quality sources and control methods); and, identified by the States as specifically standards. See CWA section 303(c). If provides an explanation of the having mercury contamination. In necessary to achieve applicable water permittee’s basis for concluding that addition, over 3,900 waterbody quality standards, NPDES permits must there are no readily available means of segments were identified as impaired contain water quality-based limitations complying without resorting to end of due to contamination by metals, which (WQBELs) more stringent than the pipe treatment. Where the discharger may include mercury. applicable technology-based demonstration is inadequate (including In many cases, as described earlier in requirements. See CWA section an inadequate demonstration that end of this document, atmospheric deposition 301(b)(1)(C). The need for a WQBEL is pipe treatment is the only readily can be a significant source of mercury based on a determination that pollutants available option for complying), Ohio to waterbodies. On the 1998 lists of in a discharger’s effluent will cause, denies the applicability of the mercury impaired waters, atmospheric have the reasonable potential to cause,

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EPA has point source dischargers install about 24 percent of total national revised the current RfD for treatment technologies that will treat mercury emissions into the air in 1990. methylmercury. The value of the RfD their effluent, resulting in lower EPA issued emission standards for has not changed from 0.1 µg/kg/day, but quantities of mercury in their medical waste incinerators in 1997. the basis for the RfD has been updated discharged effluent. In addition, point When fully implemented, the final rule using the most current data and sources that discharge mercury to the is expected to reduce mercury emissions analyses. This RfD is protective of all Great Lakes System are required to from medical waste incinerators by populations in the United States, develop a pollutant minimization about 94 percent from 1990 emission including sensitive subpopulations. It is program (PMP) for mercury whenever levels. applied to lifetime daily exposure as are their WQBELs for mercury are —Hazardous waste combustors other RfDs. The basis for the RfD update calculated to be less than the emitted about 2.5 percent of total is discussed below. quantification level of the applicable national mercury emissions in 1990. In EPA previously published two RfDs analytical method. See 40 CFR 132, February 1999, EPA issued emission for methylmercury representing the Appendix F, Procedure 8.D. standards for these facilities, which Agency’s views at the time. An RfD of Implementation of PMPs should be include incinerators, cement kilns, and 0.3 µg/kg/day was established in 1985 viewed as an iterative process as new light weight aggregate kilns that burn and published on EPA’s Integrated Risk and improved methods to reduce or hazardous waste. When fully Information System (IRIS) in 1986. The eliminate mercury become available, implemented, these standards are critical effects were multiple central including a control strategy which predicted to reduce mercury emissions nervous system (CNS) effects, including identifies control measures to be from hazardous waste combustors by ataxia (problems with muscle co- implemented that become enforceable more than 50 percent from 1990 ordination) and paresthesia (changes in requirements in their NPDES permit. emission levels. the sense of touch) in Iraqi adults who These PMPs are subject to revision as In addition to the above regulations, had eaten methylmercury-contaminated the implementation of PMPs is viewed EPA is developing a regulation that will grain (summarized by Clarkson et al., as an iterative process recognizing that limit mercury emissions from chlorine 1976; Nordberg and Strangert, 1976; and there will be new and improved WHO, 1976). production plants. Proposed and final µ methods to reduce or eliminate mercury rules are scheduled for late 2000 and An RfD of 0.1 g/kg/day was that are not currently available. 2001, respectively. Under the Integrated established as the Agency consensus Some pollution prevention strategies Urban Air Toxics Strategy, which was estimate in 1995. It was published in focus on changing existing processes or published in 1999, EPA is developing IRIS in 1996 and in extended form in replacing uses of mercury in production emissions standards for categories of 1997 in the Mercury Study (which activities with alternative substances as smaller sources of air toxics, including included a state-of-the-science a way of achieving water quality-based mercury, that pose the greatest risk to evaluation of the health effects of effluent limitations. Also, some facilities human health in urban areas. These methylmercury). Prior to the 1997 with mercury do not discharge mercury standards are expected to be issued by Mercury Study, many scientists and to waters of the United States, but rather 2004. other concerned parties had questioned transport the waste to hazardous waste Also, on December 14, 2000 EPA whether the 1985 RfD based on effects disposal facilities or incinerate it. EPA announced that it intends to develop a in exposed adults was protective against expects mercury dischargers to use one regulation to limit mercury emissions developmental effects. The 1995 RfD or a combination of these approaches to from coal-fired power plants. A was thus set on clinical neurological signs and symptoms in 81 Iraqi children reduce or eliminate discharges of proposal is expected in late 2003 and a who had been exposed when their mercury to the environment. Pollution final regulation at the end of 2004. mothers ate methylmercury- prevention, however, is the preferred These plants are the largest source of contaminated grain while pregnant. approach because it reduces mercury mercury emissions in the United States Maternal hair mercury was the releases to the environment in general. of mercury emissions from coal-fired indication of exposure. EPA used a power plants will be a significant next E. National Air Emissions Regulations mathematical procedure, calculation of step in this ongoing effort to address Most of the mercury currently a benchmark dose (BMD), to estimate mercury emissions. entering the United States environment the functional equivalent of a no is the result of air emissions of mercury V. Derivation of the Methylmercury adverse effect level from the data. A one that are deposited on land or water. In Fish Tissue Water Quality Criterion compartment pharmacokinetic model addition to publishing mercury water was used to determine an amount of quality criteria guidance under the A. What Is the Health Risk Assessment daily methylmercury ingestion which Clean Water Act, under the Clean Air for Methylmercury? would result in the BMD. An Act EPA has issued a number of Methylmercury is highly toxic to uncertainty factor of 10 was applied to regulations to reduce mercury pollution mammalian species and causes a deal with the following areas of through air emissions. The following number of adverse effects. There are no uncertainty and variability: Wide summarize the key regulations data to indicate that it is carcinogenic in variation in half-life of methylmercury pertaining to air sources of mercury. humans, and it induces tumors in in the body and the variation that occurs —Municipal waste combustors animals only at highly toxic doses. The in the hair-to-blood ratio for mercury; emitted about 20 percent of total quantitative health risk assessment for a lack of a two-generation reproductive national mercury emissions into the air non-carcinogen is a reference dose study; and lack of data on possible

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Congress directed EPA effects on a number of information. In the Water Quality through the House Appropriations neuropsychological endpoints. The Criterion for the Protection of Human Report for FY99 to contract with the Faroe Islands study is the larger of the Health: Methylmercury, EPA uses the National Research Council (NRC) to latter two studies and has been NRC recommended BMDL of 58 ppb evaluate the data on the health effects of extensively peer reviewed. EPA has mercury in cord blood as an example in methylmercury, with emphasis on data used the Faroe Islands study for the dose conversion and RfD available after the 1997 Mercury Study. derivation of the RfD. A BMD was calculation. NRC was to provide recommendations chosen as the most appropriate method The BMDL of 58 ppb mercury in cord on issues relevant to the derivation of an of quantifying the dose-effect blood was converted to an ingested appropriate RfD for methylmercury. relationship. The BMD EPA used is the daily dose using a one-compartment EPA received the NRC report lower limit (BMDL) on a 5% effect level pharmacokinetic model similar to that Toxicological Effects of Methylmercury obtained by applying a K power model used in the Mercury Study. The in July, 2000 (NRC, 2000). EPA has (K ≥ 1) to dose-response data based on ingested daily dose at the benchmark thoroughly reviewed this document and mercury measured in cord blood. dose is 1 µg/kg per day. generally concurs with the NRC findings There are several endpoints which are In the water quality criterion guidance and recommendations. Based on the sensitive measures of methylmercury for methylmercury, EPA discusses NRC report, EPA has revised the RfD for effects in the Faroese children. EPA several sources of variability and methylmercury. A draft EPA RfD considered the recommendations of the uncertainty in its estimate and chose an document was submitted for external NRC and our external peer review panel uncertainty factor of 10. This was based scientific review in late October 2000; at in coming to a decision as to the on a factor of 3 for pharmacokinetic the same time it was circulated for appropriate endpoint. The NRC inter-individual variability (particularly comment to other Federal Agencies recommended the use of a BMDL of 58 methylmercury half-life and uncertainty through the Committee on Environment ppb mercury in cord blood from the concerning the relationship between and Natural Resources (CENR) and Boston Naming Test (BNT). This is a test cord and maternal blood mercury Office of Science and Technology Policy in which the subject is shown drawings concentrations). An additional factor of (OSTP). See the ADDRESSES section of and is asked to name what they depict. 3 was applied for pharmacodynamic this Notice to obtain a copy of the RfD The BNT score is related to language variability and uncertainty. EPA also peer review report from the Water ability, assessing word formulation and describes additional areas of concern Docket. A public scientific review word retrieval. NRC considered the including inability to quantify long-term meeting was held November 15, 2000; score from the whole cohort to be the sequelae; concern for effects that may be the final peer review report was most sensitive, reliable endpoint. The observed at exposures below the BMDL; delivered to EPA on December 7, 2000. NRC noted that the scores for the and lack of a two-generation See the ADDRESSES section of today’s Continuous Performance Test (CPT) reproductive effects assay. Given the Notice to inspect the peer review report gave a lower BMDL, 46 ppb mercury in over all robustness of the data base for in the Water Docket. The draft RfD cord blood, but that these results were methylmercury, EPA considered that a document was revised to reflect the from a smaller number of children composite uncertainty factor of 10 was scientific critique received from the peer (there had been test administration sufficient; this conclusion was affirmed review, and it is now available as the problems in one year of the study). by the external peer review panel. risk assessment chapter in the water The external peer panel disagreed The resulting RfD for methylmercury quality criterion document for with the NRC choice. They felt that the is, thus, 0.1 µg/kg per day. This RfD is methylmercury. BNT scores showed an effect of applied to lifetime daily exposure for all The revised RfD was derived to be concomitant PCB exposure in some populations in the United States, protective of the population (including analyses. They preferred a PCB-adjusted including sensitive subpopulations. sensitive subgroups) against the many BMDL of 71 ppb mercury in cord blood B. How Are Mercury Exposure and adverse health effects associated with for the BNT. A difficulty with this Relative Source Contribution Assessed? methylmercury exposure. Most data are choice is that this BMDL is based on on neurotoxicity, particularly in scores from only about one-half of the The exposure assessment and developing organisms; there is a total cohort. estimate of the relative source substantial amount of data on effects of EPA prepared a comparison of the contribution (RSC) for methylmercury methylmercury on human development. NRC and peer reviewer recommended follows the recently published 2000 The brain is considered to be the most approaches; this analysis also includes Human Health Methodology. When an sensitive target organ for which there BMDLs from mercury-associated AWQC is based on noncarcinogenic are data suitable for derivation of an Faroese endpoint, results of the NRC effects, anticipated exposures from RfD. integrated analysis and geometric means sources other than drinking water and The NRC report and EPA’s review of four scores from the Faroes. The table freshwater/estuarine fish and shellfish considered human epidemiological, of comparisons can be found in the ingestion are taken into account so that longitudinal developmental studies methylmercury water quality criterion the entire RfD is not apportioned to from the Seychelles Islands, the Faroe document. When one completes the drinking water and freshwater/estuarine Islands, and New Zealand in assessing dose conversion and applies an fish and shellfish consumption alone. the quantitative risk from mercury uncertainty factor (see paragraphs The amount of exposure attributed to exposure. These are all studies wherein below), the calculated RfD values each source compared to total exposure effects were measured in children of converge at the same point: 0.1 µg/kg/ is referred to as the RSC. The RSC is

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In units of µg/kg-day, non-fish recommended default fish intake rate to differs depending on several factors: (1) sources of intake are in the range of protect the general population of The magnitude of total exposure 10¥5 to 10¥9 µg/kg-day for adults in the consumers of freshwater/estuarine fish compared with the RfD; (2) the general population (USEPA, 2001). The is 17.5 grams/day. This value is the 90th adequacy of data available; (3) whether combined methylmercury exposure percentile from the CSFII 94–96 survey more than one criterion is to be set for intakes from water ingestion, non-fish (USEPA, 2000f). As described in the methylmercury; and (4) whether there is diet, air, and soil represent 2000 Human Health Methodology, the more than one significant exposure approximately 0.07 percent of total Agency selected this default intake rate source for the chemical and population estimated exposure to methylmercury as protective of a majority of the of concern. The population of concern, (less than 1⁄100 of one percent of the population. The recommended body sources of methylmercury exposure, and RfD). Therefore, these exposures were weight for the general adult population estimates of exposure and the RSC for not factored into the RSC. used in this estimate is 70 kg (USEPA, the identified population are discussed Ingestion of marine fish is a 2000a). While EPA acknowledges that in detail in the 2001 methylmercury significant contributor to total consumers of freshwater/estuarine fish water quality criterion document. methylmercury exposure. This intake are also typically consumers of marine The population basis for the exposure has been accounted for in the derivation fish, EPA does not believe that the high- estimate are adults in the general of the fish tissue water quality criterion end consumer of freshwater/estuarine population. The health risk measure, the value. The estimate of marine fish fish is also a high-end consumer of RfD, is intended to be protective of the methylmercury exposure is based on marine fish. EPA believes that it is more whole population, including sensitive data available primarily from the appropriate, and a reasonably subpopulations. This is not a National Marine Fisheries Survey. See conservative assumption, to use a developmental RfD per se; even though the exposure section of the 2001 central tendency intake rate the critical endpoint was neurotoxic methylmercury water quality criterion (approximately 12.5 grams/day) for the effects observed in children, application document. Species-specific mean marine fish component of the RSC of the RfD is not restricted to pregnancy concentrations of methylmercury in estimate. only, or to developmental periods only. marine fish and shellfish were used to For deriving the fish tissue water The exposure assessment section of estimate daily exposure from quality criterion for methylmercury, the the 2001 methylmercury water quality methylmercury. A consumption- mean daily exposure estimate from criterion document characterizes the weighted mean concentration of ingestion of marine fish for adult sources of methylmercury exposure in methylmercury for all marine fish and consumers in the general population environmental media, provides shellfish was then calculated by EPA (which is also protective of the available information on levels of (USEPA 2001) based on the mean developmental endpoint), 2.7 × 10¥5 occurrence, and provides estimates of consumption rates from the United mg/kg-day, is used for the RSC in the intake from the relevant sources. States Department of Agriculture’s subtraction approach to calculate the Specifically, the evaluation includes Continuing Survey of Food Intake by methylmercury fish tissue water quality estimates of methylmercury in ambient Individuals (CSFII) 1994–1996 (USDA criterion. surface water, drinking water, fish, non- 1998). The CSFII 1994–1996 C. How Is the Methylmercury Water fish foods, air, soil and sediment. consumption rates are also the source of Quality Criterion Calculated? As discussed in the 2000 Human EPA’s recommended intake rates for Health Methodology, the Agency’s RSC freshwater/estuarine fish. Detailed The derivation of a methylmercury policy approach allows for use of a discussion of this procedure is included water quality criterion requires a human subtraction method to account for other in the methylmercury water quality health risk assessment (e.g., an RfD), exposures when one health-based water criterion document (USEPA, 2001). exposure data (e.g., the amount of quality criterion is relevant for the Following the Mercury Study (USEPA, pollutant ingested or inhaled per day), chemical in question. In this 1997a), 100 percent of the mercury in and data about the target population to circumstance, other sources of exposure marine fish was assumed to be present be protected. The equation for can be considered ‘‘background’’ and as methylmercury. The estimated calculating the methylmercury fish can be subtracted from the RfD. Such is weighted-average methylmercury tissue residue water quality criterion for the case with methylmercury; that is, concentrations in marine fish is 0.157 the protection of human health is: there are no health-based criteria, mg methylmercury/kg fish tissue, and pesticide tolerances, or other regulatory BW×−() Rf D RSC the estimated average exposure to TRC = activities to apportion with the alternate methylmercury from marine fish is 2.7 4 ¥ percentage approach (see discussion in × 10 5 mg methylmercury/kg fish ∑ FIi the 2000 Human Health Methodology). tissue-day. This exposure represents i=2 The assessment of human exposure in almost 30 percent of the RfD. Where: the methylmercury water quality As indicated above, the RSC from TRC = Fish tissue residue criterion criterion document includes estimates marine fish has been calculated with an (mg methylmercury/kg fish tissue) from multiple media sources. Based on assumed average intake of 12.46 gm/day for freshwater and estuarine fish available data, human exposures to of marine fish based on the CSFII, for all and shellfish methylmercury from all media sources respondents aged 18 and over. The RfD = Reference Dose (based on except freshwater/estuarine and marine Mercury Study (USEPA, 1997a) noncancer human health effects). fish are negligible, both in comparison indicates that in the general population For methylmercury it is 0.0001 mg/ to exposures from fish and compared to of fish consumers, those that consume kg BW-day (0.1 µg/kg BW-day)

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RSC = Relative source contribution determining the allowable discharge represent what occurs in nature. At this (subtracted from the RfD to account load to a waterbody by conducting time, the general science of for marine fish consumption) TMDL and waste load allocation (WLA) bioaccumulation modeling, especially estimated to be 2.7 × 10¥5 mg/kg calculations. The traditional approach for mercury, is not advanced to the stage BW-day for monitoring, measuring compliance, where models are readily available and BW = Human body weight default and ultimately controlling the discharge applicable to all types of pollutants and value of 70kg (for adults) of a pollutant is based on the aquatic systems. Three examples of FI = Fish intake at trophic level (TL) concentration of the pollutant in water; mechanistic-type bioaccumulation i (i = 2, 3, 4); total default intake is thus, a mechanism is needed to relate models are: the Mercury Cycling Model 0.0175 kg fish/day for general adult concentrations of methylmercury in fish (Tetra Tech, 1999); EPA’s aquatic food population. Trophic level breakouts tissue to concentrations in water. EPA chain model AQUATOX (USEPA, for the general population are: TL2 has provided three recommended 2000g); and the Quantitative = 0.0038 kg fish/day; TL3 = 0.0080 approaches in order to relate the Environmental Analysis food chain kg fish/day; and TL4 = 0.0057 kg methylmercury fish tissue water quality model QEAFDCHN (QEA, 2000). There fish/day. criterion to concentrations of mercury in are only a few models that might be This equation is the same equation used water. Each approach has its own used to predict methylmercury in the 2000 Human Health Methodology advantages, limitations, and bioaccumulation. Such models to calculate a water quality criterion for uncertainties as discussed below. generally have not been widely used a noncarcinogenic pollutant, but is EPA’s preferred approach for relating and have only been applied to mercury rearranged to solve for a protective a concentration of methylmercury in in a few aquatic ecosystems under concentration in fish tissue rather than fish tissue to a concentration of mercury specific environmental conditions. Of in water. Thus, it does not include a in ambient water is to derive site- the examples listed above, only the BAF or drinking water intake value (as specific BAFs based on water and fish Mercury Cycling Model was developed discussed above, exposure from collected in the waterbody of concern. solely for mercury. The others have drinking water is negligible). When all This recommendation is consistent with been generally developed for nonionic of the numeric values are put into the EPA’s bioaccumulation guidance organic chemicals that bioaccumulate. generalized equation, the Tissue contained in the 2000 Human Health They might be applied to mercury with Residue Criterion = 0.3 mg Methodology. Furthermore, this substantial modifications. Most methylmercury/kg fish (rounded to one recommendation is consistent with the bioaccumulation models are based upon significant digit from 0.292 mg views expressed by the methylmercury a chemical mass balance approach for methylmercury/kg fish tissue). This is BAF peer reviewers. See the Addresses fish or other aquatic organisms, which the concentration in fish tissue that section of today’s Notice to obtain peer requires considerable understanding of should not be exceeded based on a total review responses from the Water mercury loadings to the environment fish and shellfish consumption- Docket. EPA prefers the use of site- and how mercury moves through the weighted rate of 0.0175 kg fish/day (17.5 specific BAFs because they inherently environment. Each model results in a g/day). On a site-specific or local level, incorporate the net effects of the biotic BAF with some level of uncertainty. States and authorized Tribes can chose and abiotic factors at a particular None of the example models can predict to apportion all of the 0.0175 kg fish/ location that can affect bioaccumulation bioaccumulation without considerable day to the highest trophic level in the aquatic food chain, and thus site-specific information and at least provide an accurate accounting of the consumed for their population or some degree of calibration to the uptake of methylmercury. When modify it based on local or regional waterbody of interest, and in some cases sampling fish and water to derive a site- consumption patterns. EPA strongly considerable modification of the model. specific BAF, one needs to consider encourages States and authorized Tribes The amount and quality of data required how best to sample so that issues such to develop a water quality criterion for for proper model application may equal as seasonal variability in fish exposure methylmercury using local or regional or exceed that necessary to develop a data over the default values if they to methylmercury, spacial variability, site-specific methylmercury BAF. Other believe that such a water quality and fish size are taken into account. types of models could also be used if criterion would be more appropriate for These issues and others should also be they are scientifically defensible. their target population. assessed in relation to the fish consumption patterns of the exposed Regardless of the type of model, if a VI. How Can the Fish Tissue Residue human population. EPA expects to model is chosen, the issues discussed in Water Quality Criterion Be Related to a publish specific guidance for deriving the bioaccumulation guidance Mercury Concentration in Water? field-measured site-specific BAFs in late contained in the 2000 Human Health EPA recognizes that a State’s water 2001. However, until then the recently Methodology should be carefully quality criterion in the form of a fish published procedures in the 2000 considered. The derivation of site- tissue residue value may pose Human Health Methodology for specific parameters used in the model implementation challenges under deriving BAFs can be used as a general should also be documented, and some traditional water quality based control guide. In addition, the Bioaccumulation indication given of the uncertainty programs. Under a water quality-based Technical Support Document (TSD) for surrounding the BAFs predicted by the approach to controlling pollutants, the 2000 Human Health Methodology model. NPDES permit compliance with water (expected to be published in late 2001) EPA acknowledges that derivation of quality standards is usually determined will provide additional information and site-specific field-measured BAFs may by comparing the allowable guidance on deriving site-specific BAFs. not be feasible in all situations. concentration of a pollutant in the water Another approach for deriving Therefore, in the absence of site-specific column to the actual pollutant methylmercury BAFs is to use a methylmercury bioaccumulation data, a concentration measured in the water bioaccumulation model. Most possible third approach is to use EPA’s column over some specific period of bioaccumulation models are generally empirically derived draft time. Mechanisms to control pollutants process-based or mechanistic type methylmercury BAFs. As previously in waterbodies usually involve mathematical models that are meant to discussed, as part of initial efforts to

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TABLE 1.ÐEMPIRICALLY DERIVED BAFS FOR METHYLMERCURY

BAF trophic BAF trophic BAF trophic level 2 level 3 level 4

BAF ...... 160,000 680,000 2,700,000

The BAF peer reviewers expressed risk management decision made based other water quality-based pollution concerns about the predictive capability on the need for a mechanism to relate control activities are traditionally based of these draft BAFs and about using a fish tissue concentration of on the total concentration of the them to derive a section 304(a) water methylmercury to a water column inorganic metal form, not the dissolved quality criterion for methylmercury that concentration. EPA has selected the organic form. Many of the issues would be accurately protective for geometric mean of the field-measured surrounding the uncertainty in waterbodies across the nation. However, BAFs obtained from the open literature predictability and transferability of EPA believes that the methylmercury as the empirically derived BAFs for methylmercury BAFs across different BAFs in Table 1 are sufficiently each trophic level. EPA believes the waterbodies also pertain to relating predictive of bioaccumulation to be geometric mean is the central tendency methylmercury in water to a given total used in implementing a fish tissue value that best represents the wide mercury concentration. As with BAFs, based methylmercury water quality range of environmental and biological EPA’s preferred approach for translating criterion in a State’s or authorized conditions present in the waters of the between total and methylmercury is for Tribe’s water quality standards in the United States. Choosing a value near the States and authorized Tribes to measure absence of any other site-specific extremes of the distribution (e.g., 10th total mercury and methylmercury and or 90th percentile) may introduce an bioaccumulation data. Thus, EPA will in the waterbody of interest. However, unacceptable level of uncertainty into consider water quality standards EPA will consider standards the CWA goal of protecting public implementation approaches that use implemented with empirically derived health. Furthermore, EPA believes a translators. As part of exercise to these empirically derived BAFs. EPA geometric mean is most appropriate recognizes that these methylmercury because the underlying processes of develop draft methylmercury BAFs, BAF values are not entirely methylmercury bioaccumulation are EPA derived methylmercury-to-total representative of the methylmercury more likely multiplicative than additive. mercury translator factors for rivers/ bioaccumulation potential in all Other empirical, modeling, or newly streams and lakes. Like the BAFs, the waterbodies across the United States, developed bioaccumulation prediction methylmercury-to-total mercury and they may over- or underestimate approaches may be used to relate translators were empirically derived site-specific bioaccumulation potential. concentrations of methylmercury in fish based on water data collected in the There is uncertainty in using these tissue to concentrations of field from a variety of locations across BAFs as they collapse a very complex methylmercury in water, provided the the United States. Depending on the nonlinear process into a simplistic and approach is scientifically defensible and available mercury water data, more than linear approach to predicting adequately documented. one translation may be necessary to bioaccumulation and assume that the In addition to using BAFs to relate translate to the total concentration of biotic and abiotic process affecting concentrations of methylmercury in fish mercury in ambient waters. Table 2 lists mercury fate and bioaccumulation are tissue to methylmercury concentrations the translator factors that could be used similar across different waterbodies. in water, a factor is needed to translate to translate between methylmercury and The decision to publish these methylmercury in water to its total mercury in ambient surface waters in empirically derived BAFs is an Agency mercury equivalent. NPDES permits and the absence of any site-specific data.

TABLE 2.ÐSUMMARY OF MERCURY TRANSLATORS

Translation Lakes and Rivers and reservoirs 1 streams 1

Fraction of total mercury that is dissolved ...... 0.60 0.37 Fraction of total mercury that is dissolved methylmercury ...... 0.032 0.014 Fraction of total methylmercury that is dissolved methylmercury ...... 0.61 0.49 1 Values are from Section II, Table 15, of the EPA internal draft report National Bioaccumulation Factors for Methylmercury, available from the Water Docket.

VII. What Is the Relationship Between developing fish advisories that is similar Tribes may not be adequately warning Fish Advisories and the Fish Tissue to the approach recommended in EPA’s the public of health risks. A small Residue Water Quality Criterion? Guidance for Assessing Chemical number of States continue to use fish Contaminant Data for Use in Fish consumption advisory approaches that A majority of States and authorized Advisories (EPA 2000 e, h). However, are considered by EPA to be inadequate Tribes with fish advisory programs have due to variations in State and Tribal fish for protecting public health. The use of adopted a risk-based approach to advisory programs, some States and these approaches may lead to significant

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These are and associated procedures for with implementation, State and Tribal appropriate for use in the commercial determining attainment of the water water quality managers will need to market place, but are considered to be quality criterion and status of identify which species to target for inappropriate for establishing local designated use impairment based on sampling, determine sample advisory needs and should not be used fish residue data; (5) harmonization compositing procedures and frequency for that purpose. with fish consumption advisory of sampling, and relate sampling and Both today’s section 304(a) human programs, (6) procedures for analysis procedures to the consumption health water quality criterion guidance determining the need for a water patterns intended for protection by the for methylmercury and EPA’s quality-based effluent limit (WQBEL) in water quality criterion. The Agency has recommended fish consumption limit NPDES permits for point source published guidance on field sampling for mercury (which EPA encourages discharges of mercury; (7) procedures and analysis as part of the package of States and authorized Tribes to use as for developing and implementing guidance to States and Tribes for issuing guidance in setting fish advisories) are WQBELs for NPDES permits; and, (8) fish consumption advisories. EPA meant to protect humans from procedures for developing targets for anticipates that this guidance will also consumption of mercury-contaminated TMDL load and waste load allocations. be useful for implementing State or fish. The procedures for deriving these To help States and authorized Tribes Tribal water quality criterion for two values are consistent with each adopt the recommended section 304(a) methylmercury based on today’s other, but in deriving the section 304(a) water quality criterion for criterion guidance. methylmercury water quality criterion, methylmercury as part of their Three translations are necessary to EPA used an RSC of 2.7 10¥5 mg/kg-day standards, and to implement those relate the methylmercury water quality to account for exposure from non- standards, EPA plans to begin criterion for fish tissue expressed in this freshwater and non-estuarine fish. See development implementation notice to a total mercury concentration section IV.B of today’s Notice. The procedures and guidance documents by in ambient water or effluent, for NPDES guidance for setting fish consumption the end of 2001. These will be part of or TMDL purposes. The first translation limits (USEPA, 2000e) also discusses a broad national implementation policy is to determine the fraction of measured using an RSC to account for exposures for this water quality criterion. The mercury in fish that is methylmercury. other than noncommercially caught fish, implementation policy will be Although this can vary in practice, the but does not specifically require this to developed with consideration of the methylmercury fraction is typically very be done. The RSC guidance in the 2000 draft Mercury Action Plan submitted for high in freshwater and estuarine fish, Human Health Methodology provides public comment in 1998 and expected and approaches 100 percent for higher more detail and specific quantitative to be revised soon. EPA expects States trophic level organisms. The second procedures to account for other and authorized Tribes to adopt new or translation is from methylmercury in exposure pathways. EPA recommends revised human health mercury water fish to methylmercury in water. As that States and authorized Tribes quality criteria and to use the discussed in detail above, the best consider using an RSC to account other procedures and guidance contained in means of determining this relationship sources of mercury exposure when the forthcoming implementation policy is through site-specific analysis of deriving a fish consumption limit and to adopt their water quality criteria bioaccumulation patterns. The third setting a fish advisory for mercury. within five years from today’s translation is from methylmercury in publication. EPA generally believes that water to total mercury in water. As with VIII. How Does EPA Suggest five years from the date of EPA’s the BAFs, the preferred method to do Implementing the Methylmercury publication of new or revised section this translation is to measure the Water Quality Criterion? 304(a) water quality criteria guidance is concentrations of methylmercury and EPA encourages States and authorized a reasonable time by which States and total mercury in ambient water. Tribes to adopt the fish tissue residue Tribes should take action to adopt new As mentioned, EPA believes an water quality criterion for or revised water quality criteria implementation policy is necessary that methylmercury outlined in this notice necessary to protect the designated uses addresses recommendations for into their water quality standards to of their waters. See 63 FR 68353. establishing sampling protocols and protect CWA section 101(a) designated EPA recently published a new determining attainment of State or uses related to human consumption of analytical method (method 1631) for Tribal methylmercury water quality fish. This recommended water quality detecting and measuring total and criterion, NPDES permitting and TMDL criterion reflects the most current and dissolved mercury in water and fish development, and source management best science. EPA recognizes and samples (USEPA, 1999b). This method and control strategies. For example, the emphasizes that States and authorized is approximately 400 times more water quality standards portion of this Tribes will need additional, specific sensitive than EPA’s previously policy would address issues such as procedures and water quality program recommended analytical method and is how the water quality standards guidance in order to implement water capable of measuring mercury variance and use attainability analysis quality criteria they adopt based on this concentrations well into the ranges processes could be used to address guidance. These procedures include, but identified in this notice for fish legacy contaminants. Also, EPA expects are not necessarily limited to: (1) An concentrations as well as those that, as a result of this revised analytical method for detecting and anticipated for associated water methylmercury water quality criterion, measuring concentrations in fish and concentrations (detection limit of 0.2 together with the more sensitive method water; (2) a field sampling plan for ng/L in water). This method determines for detecting mercury, there will be an collecting fish and protocols for the amount of total mercury, not increase in the number of waterbodies

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1358 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices reported on State 303(d) lists as environment. EPA is interested in affecting bioavailability of methylmercury impaired due to mercury contamination. obtaining information, views, in Florida Bay. Soc. Environ. Toxicol. Thus, the policy would also discuss suggestions, and innovative approaches Chem. 19th Annual Meeting. Charlotte, approaches for managing the from the public. EPA is particularly NC. Abstr. No. 468. p. 101. Mason, R.P., W.F. Fitzgerald and F.M.M. development of TMDLs for waterbodies interested in specific examples or model Morel. 1994. The Biogeochemical Cycling impaired by mercury. This would approaches for management of mercury of Elemental Mercury: Anthropogenic include approaches for addressing contamination at the Federal, State, Influences. Geochimica et Cosmochimicia waterbodies where much of the mercury Tribal, and local level. EPA anticipates Acta. 58(15):3191–3198. is from atmospheric sources, and how this dialogue will be facilitated by a Mason, R.P. and K.A. Sullivan. 1997. TMDLs can take into account ongoing variety of means, which may include Mercury in Lake Michigan. Environ. Sci. efforts to address sources of mercury, public meetings, meetings with Technol. 31:942–947. such as programs under the Clean Air stakeholders, and written Miles, C.J. and L.E. Fink. 1998. Monitoring and mass budget for mercury in the Act and pollution prevention activities. correspondence and responses. The policy would also address Everglades nutrient removal project. Arch. IX. Literature Cited Environ. Contam. Toxicol. 35:549–557. numerous issues associated with point Monson, B.A. and P.L. Brezonik. 1998. Akagi, H., O. Malm,Y. Kinjo, M. Harada, source discharges of mercury such as Seasonal patterns of mercury species in F.J.P. Branches, W.C. Pfeiffer and H. Kato determining the need for a WQBEL in water and plankton from softwater lakes in (1995). Methylmercury pollution in the NPDES permits and, where needed, Northeastern Minnesota. Biogeochem. Amazon, Brazil. Sci. Total Environ. 40:147–162. developing and implementing those 175:85–95. Nordberg, G. F. and P. Strangert. 1976. limits. EPA intends to take the following Becker, D. S. and G.N. Bigham. 1995. Estimations of a dose-response curve for factors or assumptions into account Distribution of Mercury in the Aquatic long-term exposure to methylmercuric when it addresses these issues: the Food Web of Onondaga Lake, New York. unique properties of mercury; EPA’s Water Air Soil Pollu. 80:563–571. compounds in human being taking into Bloom, N.S. 1992. On the chemical form of account availability of critical organ expectation that there will likely be a concentration and biological half-time: A substantial increase in the number of mercury in edible fish and marine invertebrate tissue. Can. J. Fish. Aquat. Sci. preliminary communication. In: Effects point source discharges needing and Dose-Response Relationships of Toxic WQBELs as a result of the new more 49:1010–1017. Cope, W.G., J.G. Wiener and R.G. Rada. 1990. Metals, G.F. Nordberg, Ed. Elsevier, sensitive method; and, in most cases, Mercury accumulation in yellow perch in Amsterdam. p. 273–282. the relatively small contribution from Wisconsin seepage lakes: Relation to lake NRC (National Research Council). 2000. point source discharges to the total characteristics. Environ. Toxicol. Chem. Toxicological Effects of Methylmercury. loadings of mercury to a waterbody. 9:931–940. Committee on the Toxicological Effects of Given the ongoing atmospheric Clarkson, T. W., L. Amin-Zaki, and S. Al- Methylmercury, National Academy Press, sources of mercury and the long-term Tikriti. 1976. An outbreak of Washington, D.C. July. ??pp. cycling of mercury in the environment, methylmercury poisoning due to Nriagu, J. O. 1979. The Biogeochemistry of Mercury in the Environment. Elsevier/ the most effective means of protecting consumption of contaminated grain. Fed. Proc. 35: 2395–2399. North Holland. Biomedical Press: New public health for the next few decades York. will continue to be the issuance of fish Davidson, P., G. Myers, C. Cox, C. Shamlaye, D. Marsh, M. Tanner, M. Berlin, J. Sloane- QEA (Quantitative Environmental Analysis, consumption advisories by State and Reeves, E. Cernichiari, O. Choisy, A. Choi, LLC). 2000. Bioaccumulation Model Tribal authorities, to ensure the public and T. Clarkson. 1995. Longitudinal QUAFDCHN v1.0. Montvale, NJ. knows what level of fish consumption neurodevelopmental study of Seychellois September. from specific waters is safe. EPA also children following in utero exposure to Stephan, C.E., D.I. Mount, D.J. Hansen, J.H. emphasizes that the science underlying methylmercury from maternal fish Gentile, G.A. Chapman and W.A. Brungs. today’s recommended section 304(a) ingestion: outcomes at 19 and 29 months. 1985. Guidelines for deriving numerical water quality criterion is sound and Neurotoxicology 16:677–688. national water quality criteria for the Glass, G., J.A. Sorenson, and G.R. Rapp, Jr. protection of aquatic organisms and their recommends that States and authorized uses. NTIS Publication No.: PB85–227049. Tribes consider using an appropriate 1999. Mercury deposition and lake quality trends. Final report Project: I–11/I–15, Tetra Tech.. 1999. Dynamic Mercury Cycling RSC in establishing and issuing fish Legislative Commission on Minnesota Model for Windows 95/NT. A Model for consumption advisories as described in Resources, St Paul, MN. Mercury Cycling in Lakes. D–MCM Version the fish advisory guidance (USEPA, Grieb, T.M., C.T. Driscoll, S.P. Gloss, C.L. 1.0. Users Guide and Technical Reference. 2000e). However, effective source Schofield, G.L. Bowie and D.B. Porcella. Prepared by Tetra Tech Inc. for EPRI. control and management programs need 1990. Factors affecting mercury Lafayette, CA. April. to be initiated and developed in the accumulation in fish in the upper USDA (U.S. Department of Agriculture). coming few years to begin the long-term Michigan peninsula. Environ. Toxicol. 1998. 1994–1996 Continuing Survey of process of recovery from the widespread Chem. 9:919–930. Food Intakes by Individuals and 1994– Jackson, T.A. 1991. Biological and 1996 Diet and Health Knowledge Survey. mercury contamination evident in our environmental control of mercury Agricultural Research Service, USDA. aquatic environments, with the goal of accumulation by fish in lakes and NTIS CD–ROM, accession number PB98– reducing mercury contamination so that reservoirs of northern Manitoba, Canada. 500457. fish consumption advisories can be Can. J. Fish. Aquat. Sci. 48:2449–2470. USEPA (U.S. Environmental Protection removed. Kim, J.P. 1995. Methylmercury in rainbow Agency). 1980. Guidelines and EPA believes that flexibility may be trout (Oncorhynchus mykiss) from Lakes methodology used in the preparation of appropriate as water quality standards Okareka, Okaro, Rotmahana, Rotorua and health effect assessment chapters of the based on today’s methylmercury water Tarawera, North Island, New Zealand. Sci. consent decree water criteria documents. quality criterion are implemented. Total Environ. 164:209–219. Federal Register 45:79347, Appendix C. Today’s notice serves as an initiation of Lange, T.R., H.E. Royals and L.L. Connor. USEPA (U.S. Environmental Protection 1993. Influence of water chemistry on Agency). 1984. Ambient Water Quality dialogue with stakeholders on mercury concentration in largemouth bass Criteria for Mercury 1984. Office of Water, recommended approaches for using from Florida lakes. Trans. Am. Fish. Soc. Washington, DC EPA440/5–84–026. today’s section 304(a) water quality 122:74–84. January 1985. criterion guidance and managing Lores, E.M., J. Macauley, L.R. Goodman, R.G. USEPA (U.S. Environmental Protection mercury contamination in the aquatic Smith and D.M. Wells. 1998. Factors Agency). 1995. Final Water Quality

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Guidance for the Great Lakes System. USEPA (U.S. Environmental Protection Alexander Hunt, Office of Information Federal Register 60:15366. Agency). 2001. Water Quality Criterion for and Regulatory Affairs, Office of USEPA (U.S. Environmental Protection the Protection of Human Health: Management and Budget, New Agency). 1997a. Mercury Study Report to Methylmercury. Office of Water. Executive Office Building, Room 3208, Congress. U.S. Washington, DC December. Washington, DC EPA–823–R–01–001. USEPA (U.S. Environmental Protection January. Washington, DC 20503. Agency). 1997b. Final Rule for Hazardous Watras, C.J. and J.W. Huckabee, Eds. (1994). FOR FURTHER INFORMATION CONTACT: Air Pollutants for Hospital/Medical/ Mercury pollution: Integration and Tamara R. Manly, at the address Infectious Waste Incinerators. Federal Synthesis. Lewis Publishers, New York, identified above. Register 62:48379. NY., 727pp. SUPPLEMENTARY INFORMATION: USEPA (U.S. Environmental Protection Watras, C.J., R.C. Back, S. Halvorsen. R.J.M. Agency). 1998. National recommended Hudson, K.A. Morrison and S.P. Wente. Proposal to renew the following water quality criteria; Notice; 1998. Bioaccumulation of mercury in currently approved collection of Republication. Federal Register 63:68354, pelagic freshwater food webs. Sci. Total information: December 10, 1998. Environ. 219:183–208. Title: Occasional Qualitative Surveys. USEPA (U.S. Environmental Protection WHO (World Health Organization). 1976. OMB Number: 3064–0127. Agency). 1999a. National Recommended Environmental Health Criteria: Mercury. Water Quality Criteria—Correction. Frequency of Response: On occasion. World Health Organization, Geneva, Affected Public: All financial Federal Register 64:19781, April 22, 1999. Switzerland, 121. Office of Water. Washington, DC EPA–822– institutions. Z–99–001. April. Dated: December 21, 2000. Estimated Number of Respondents: USEPA (U.S. Environmental Protection J. Charles Fox, 5,000. Agency). 1999b. Method 1631, Revision B: Assistant Administrator for Water. Estimated Time per Response: 1 hour. Mercury in Water by Oxidation, Purge and Estimated Total Annual Burden: Trap, and Cold Vapor Atomic Fluorescence [FR Doc. 01–217 Filed 1–5–01; 8:45 am] Spectrometry. Office of Water. Washington, BILLING CODE 6560±50±P 5,000 hours. DC EPA–821–R–99–005. May. General Description of Collection: The USEPA (U.S. Environmental Protection collection involves the occasional use of Agency). 2000a. Methodology for Deriving FEDERAL DEPOSIT INSURANCE qualitative surveys to gather anecdotal Ambient Water Quality Criteria for the CORPORATION information about regulatory burden, Protection of Human Health (2000). Office problems or successes in the bank of Water. Washington DC EPA–822–B–00– Agency Information Collection supervisory process (including both 004. October. USEPA (U.S. Environmental Protection Activities: Proposed Collection; safety-and-soundness and consumer- Agency). 2000b. Methodology for Deriving Comment Request related exams), and similar concerns. Ambient Water Quality Criteria for the AGENCY: Request for Comment Protection of Human Health (2000). Federal Deposit Insurance Technical Support Document. Volume 1: Corporation (FDIC). Comments are invited on: (a) Whether Risk Assessment. Office of Water. EPA– ACTION: Notice and request for comment. the collection of information is 822–B–00–005. October. necessary for the proper performance of SUMMARY: The FDIC, as part of its USEPA (U.S. Environmental Protection the FDIC’s functions, including whether continuing effort to reduce paperwork Agency). 2000c. Revisions to the the information has practical utility; (b) Methodology for Deriving Ambient Water and respondent burden, invites the the accuracy of the estimates of the Quality Criteria for the Protection of general public and other Federal burden of the information collection, Human Health (2000). Federal Register agencies to take this opportunity to including the validity of the 65:66444, November 3, 2000. comment on proposed and/or USEPA (U.S. Environmental Protection methodology and assumptions used; (c) continuing information collections, as Agency). 2000d. Review and approval of ways to enhance the quality, utility, and required by the Paperwork Reduction State and Tribal water quality standards. clarity of the information to be Act of 1995 (44 U.S.C. chapter 35). Federal Register 65:24642. collected; and (d) ways to minimize the Currently, the FDIC is soliciting USEPA (U.S. Environmental Protection burden of the information collection on Agency). 2000e. Guidance for Assessing comments concerning an information respondents, including through the use Chemical Contaminant Data for Use in Fish collection titled ‘‘Occasional Qualitative of automated collection techniques or Advisories. Volume 2: Risk Assessment Surveys.’’ and Fish Consumption Limits. Office of other forms of information technology. DATES: Comments must be submitted on Water. Washington, DC EPA–823–B–00– At the end of the comment period, the 008. or before March 9, 2001. comments and recommendations USEPA (U.S. Environmental Protection ADDRESSES: Interested parties are received will be analyzed to determine Agency). 2000f. Estimated Per Capita Fish invited to submit written comments to the extent to which the collection Consumption in the United States: Based Tamara R. Manly, Management Analyst should be modified prior to submission on Data Collected by the United States (Regulatory Analysis), (202) 898–7453, Department of Agriculture’s 1994–1996 to OMB for review and approval. Office of the Executive Secretary, Room Comments submitted in response to this Continuing Survey of Food Intake by F–4058, Attention: Comments/OES, Individuals. Office of Science and notice also will be summarized or Technology, Office of Water, Washington, Federal Deposit Insurance Corporation, included in the FDIC’s requests to OMB DC March. 550 17th Street NW., Washington, DC for renewal of this collection. All USEPA (U.S. Environmental Protection 20429. All comments should refer to comments will become a matter of Agency). 2000g. AQUATOX. EPA Release ‘‘Occasional Qualitative Surveys.’’ public record. 1. File Version 1.69. Office of Water. Comments may be hand-delivered to the Washington, DC EPA–823–C–00–001. guard station at the rear of the 17th Dated at Washington, DC, this 2nd day of January, 2001. September. Street Building (located on F Street), on USEPA (U.S. Environmental Protection business days between 7 a.m. and 5 p.m. Federal Deposit Insurance Corporation Agency). 2000h. Guidance for Assessing Robert E. Feldman, Chemical Contaminant Data for Use in Fish [FAX number (202) 898–3838; Internet Executive Secretary. Advisories. Volume 1: Fish Sampling and address: comments@ fdic.gov]. Analysis. Office of Water. Washington, DC Comments may also be submitted to the [FR Doc. 01–437 Filed 1–5–01; 8:45 am] EPA–823–B–00–007. OMB desk officer for the FDIC: BILLING CODE 6714±01±P

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FEDERAL RESERVE SYSTEM FEDERAL RESERVE SYSTEM PLACE: Marriner S. Eccles Federal Reserve Board Building, 20th and C Formations of, Acquisitions by, and Sunshine Act Meeting; Notice Streets, NW., Washington, DC 20551. Mergers of Bank Holding Companies AGENCY HOLDING THE MEETING: Board of STATUS: Closed. The companies listed in this notice Governors of the Federal Reserve MATTERS TO BE CONSIDERED: System have applied to the Board for approval, 1. Personnel actions (appointments, pursuant to the Bank Holding Company TIME AND DATE: 10 a.m., Wednesday, promotions, assignments, Act of 1956 (12 U.S.C. 1841 et seq.) January 10, 2001. reassignments, and salary actions) (BHC Act), Regulation Y (12 CFR Part PLACE: Marriner S. Eccles Federal involving individual Federal Reserve 225), and all other applicable statutes Reserve Board Building, C Street System employees. and regulations to become a bank entrance between 20th and 2lst Streets, 2. Any matters carried forward from a holding company and/or to acquire the NW., Washington, DC 20551 previously announced meeting. assets or the ownership of, control of, or STATUS: Open the power to vote shares of a bank or CONTACT PERSON FOR MORE INFORMATION: MATTERS TO BE CONSIDERED: bank holding company and all of the Lynn S. Fox, Assistant to the Board; banks and nonbanking companies Discussion Agenda 202–452–3204. owned by the bank holding company, 1. Consideration of a final rule under SUPPLEMENTARY INFORMATION: You may including the companies listed below. Regulation Y (Bank Holding Companies call 202–452–3206 beginning at The applications listed below, as well and Change in Bank Control) to approximately 5 p.m. two business days as other related filings required by the implement provisions of the Gramm- before the meeting for a recorded Board, are available for immediate Leach-Bliley Act governing merchant announcement of bank and bank inspection at the Federal Reserve Bank banking investments made by financial holding company applications indicated. The application also will be holding companies (Docket No. R– scheduled for the meeting; or you may available for inspection at the offices of 1065). This rule revises and replaces an contact the Board’s Web site at http:// the Board of Governors. Interested interim rule published for comment last www.federalreserve.gov for an persons may express their views in year. electronic announcement that not only writing on the standards enumerated in 2. Any items carried forward from a lists applications, but also indicates the BHC Act (12 U.S.C. 1842(c)). If the previously announced meeting. procedural and other information about the meeting. proposal also involves the acquisition of Note: This meeting will be recorded for the a nonbanking company, the review also benefit of those unable to attend. Cassettes Dated: January 3, 2001. will be available for listening in the Board’s Robert deV. Frierson, includes whether the acquisition of the Freedom of Information Office, and copies nonbanking company complies with the may be ordered for $6 per cassette by calling Associate Secretary of the Board. standards in section 4 of the BHC Act 202–452–3684 or by writing to: Freedom of [FR Doc. 01–502 Filed 1–4–01; 11:01 am] (12 U.S.C. 1843). Unless otherwise Information Office, Board of Governors of the BILLING CODE 6210±01±P noted, nonbanking activities will be Federal Reserve System, Washington, D.C. conducted throughout the United States. 20551. Additional information on all bank CONTACT PERSON FOR MORE INFORMATION: holding companies may be obtained Lynn S. Fox, Assistant to the Board; GENERAL SERVICES from the National Information Center 202–452–3204. ADMINISTRATION/U.S. OFFICE OF PERSONNEL MANAGEMENT website at www.ffiec.gov/nic/. SUPPLEMENTARY INFORMATION: You may Unless otherwise noted, comments call 202–452–3206 for a recorded Office of Communications regarding each of these applications announcement of this meeting; or you must be received at the Reserve Bank may contact the Board’s Web site at Cancellation of a Standard Form indicated or the offices of the Board of http://www.federalreserve.gov for an Governors not later than February 1, electronic announcement. (The Web site AGENCY: General Services 2001. also includes procedural and other Administration. information about the open meeting.) A. Federal Reserve Bank of St. Louis ACTION: Notice. (Randall C. Sumner, Vice President) 411 Dated: January 3, 2001. Locust Street, St. Louis, Missouri Robert deV. Frierson, SUMMARY: The U.S. Office of Personnel 63166–2034: Associate Secretary of the Board. Management is cancelling the following [FR Doc. 01–501 Filed 1–4–01; 11:05 am] 1. Midwest Community Bancshares, Standard Form because of low usage: SF Inc., Marion, Illinois; to acquire 100 BILLING CODE 6210±01±P 144A, Statement of Prior Federal Service—Worksheet. percent of the voting shares of The Egyptian State Bank, Carrier Mills, FEDERAL RESERVE SYSTEM DATES: Effective January 8, 2001. Illinois. FOR FURTHER INFORMATION CONTACT: Ms. Sunshine Act Meeting; Notice Board of Governors of the Federal Reserve Barbara Williams, General Services System, January 2, 2001. AGENCY HOLDING THE MEETING: Board of Administration, (202) 501–0581. Robert deV. Frierson Governors of the Federal Reserve Dated: December 20, 2000. Associate Secretary of the Board. System. Barbara M. Williams, [FR Doc. 01–398 Filed 1–5–01; 8:45 am] TIME AND DATE: Approximately 10:30 Deputy Standard and Optional Forms BILLING CODE 6210±01±S a.m., Wednesday, January 10, 2001, Management Officer. following a recess at the conclusion of [FR Doc. 01–427 Filed 1–5–01; 8:45 am] the open meeting. BILLING CODE 6820±34±M

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DEPARTMENT OF HEALTH AND III. Training, Education, Certification, provide a report, through the Secretary HUMAN SERVICES Credentialing, Licensing, and of the Department of Health and Human Accountability of Health Care Services, on legislative and White House Commission on Practitioners in Complementary and administrative recommendations for Complementary and Alternative Alternative Medicine assuring that public policy maximizes Medicine Policy; Notice of Meeting (A) How can uniform standards of the benefits of complementary and education, training, licensing and alternative medicine to Americans. Because of the need to obtain the Notice is given of the third Town Hall certification be applied to all CAM views of the public on these issues as Meeting of the White House practitioners? soon as possible and because of the Commission on Complementary and (B) What training and education early deadline for the report required of Alternative Medicine Policy. The should be required of all health care the Commission, this notice is being purpose of the meeting is to convene the providers to assure access to safe and provided at the earliest possible time. Commission for a public hearing to effective CAM practices and Public Participation: The Town Hall receive public testimony from interventions? meeting is open to the public with individuals and organizations interested (C) What sources of funds exist for the attendance limited by the availability of in the subject of federal policy regarding education and training of CAM space on a first come, first serve basis. complementary and alternative practitioners? Members of the public who wish to (D) Are performance standards or medicine. Comments received at the present oral comment may register by practice guidelines needed to ensure the meeting may be used by the calling 1–800–953–3298 or by accessing public will have access to the full range Commission to prepare the report to the the website at http://whccamp.hhs.gov of safe and effective CAM practices and President as required by the Executive no later than January 16, 2001. Order. interventions? Oral comments will be limited to five Comments should focus on the four IV. Delivery of Reliable and Useful minutes. Individuals who register to areas that follow. Questions for Information on Complementary and speak will be assigned in the order in consideration include, but are not Alternative Medicine to Health Care which they registered. Due to time limited to those presented below. For Professionals and the Public constraints, only one representative from each organization will be allotted each question, please consider (A) How can useful, reliable, and time for oral testimony. The number of including in your response concerns, updated information about CAM speakers and the time allotted may also possible obstacles, existing programs, practices and interventions be made be limited by the number of registrants. and suggested solutions to guide the more accessible? How would you like to All requests to register should include Commission in their deliberations. receive such information? the name, address, telephone number, (B) As a consumer, what kinds of and business or professional affiliation I. Coordinated Research and information about CAM practices and of the interested party, and should Development to Increase Knowledge of interventions are most needed and indicate the area of interest or question Complementary and Alternative important to you? Medicine Practices and Interventions (C) As a health care provider, what (as described above) to be addressed. kinds of information about CAM Individuals interested in attending the (A) What can be done to expand the meeting to observe the proceedings but current research environment so that practices and interventions are most needed and important to you? not to provide oral testimony should practices and interventions that lie The Town Hall Meeting is open to the also register. outside conventional science are Any person attending the meeting public and opportunities for oral who has not registered to speak in adequately and appropriately comments and written statements by the advance of the meeting will be allowed addressed? public will be provided. to make a brief oral statement at the (B) What types of incentives are Name of Committee: The White conclusion of the morning and needed to stimulate the research of House Commission on Complementary afternoon sessions, if time permits, and CAM practices and interventions by the and Alternative Medicine Policy. at the chairperson’s discretion. Date: January 23, 2001. public and private sectors? Individuals unable to attend the Time: 9 a.m.–9 p.m. (C) How can we more effectively meeting, or any interested parties, may Place: Ames Auditorium, Lighthouse integrate the CAM and conventional send written comments by mail, fax, or International Conference Center, 111 research communities to stimulate and electronically to the staff office of the East 59th Street, New York, New York coordinate research? Commission for inclusion in the public 10022–1201. record. When mailing or faxing written Contact Persons: Stephen C. Groft, II. Guidance for Access to, Delivery of, comments, please provide, if possible, Pharm. D., Executive Director, or and Reimbursement for an electronic version or a diskette. Complementary and Alternative Michele Chang, CMT, MPH, Executive Persons needing special assistance, Medicine Practices and Interventions Secretary, 6701 Rockledge Drive, Room such as sign language interpretation or 1010, MSC–7707, Bethesda, MD 20817– other special accommodations, should (A) Do you have ready access to CAM 7707, Phone: (301) 435–7592 or 866– contact the Commission staff at the practices and interventions? 373–1124 (Toll-Free), Fax: (301) 480– address or telephone number listed no (B) How can access to safe and 1691, E-Mail: [email protected]. later than January 16, 2001. The President established the White effective CAM practices and Dated: December 28, 2000. interventions be improved? House Commission on Complementary and Alternative Medicine Policy on Anna Snouffer, (C) What types of CAM practices and March 7, 2000 by Executive Order Acting Director, Office of Federal Advisory interventions should be reimbursable 13147. The mission of the White House Committee Policy. through federal programs or other health Commission on Complementary and [FR Doc. 01–409 Filed 1–5–01; 8:45 am] care coverage systems? Alternative Medicine Policy is to BILLING CODE 4140±01±M

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DEPARTMENT OF HEALTH AND Management Specialist, Radiation community needs relative to HUMAN SERVICES Studies Branch, Division of environmental health. Close attention Environmental Hazards and Health will be given to minority and female Centers for Disease Control and Effects, National Center for representation so long as the Prevention (CDC) Environmental Health, 1600 Clifton effectiveness of the Subcommittee is not Road, NE., Mail Stop E–39, Atlanta, impaired. Request for Nominations of Georgia 30333. Nominations may be Nominations for new members will be Candidates To Serve on the Citizens faxed to 404/639–2575. accepted by fax or written Advisory Committee on Public Health The Director, Management Analysis correspondence. Information must Service Activities and Research at and Services Office, has been delegated include a description the qualifications Department of Energy Sites: Idaho the authority to sign Federal Register of the nominee to serve, the assets the National Engineering and notices pertaining to announcements of nominee would bring to the work of the Environmental Laboratory Health meetings and other committee Subcommittee and a current resume or Effects Subcommittee management activities, for both CDC curriculum vitae. The closing date for The Centers for Disease Control and and ATSDR. this round of nominations is January 26, Prevention and the Agency for Toxic Dated: January 2, 2001. 2001. Nominations must be postmarked Substances and Disease Registry are Carolyn J. Russell, on or before the closing date. soliciting additional nominations for Director, Management Analysis and Services Nominations should be sent to: Ms. possible membership on the Citizens Office, Centers for Disease Control and Kitty Armstrong, Senior Committee Advisory Committee on Public Health Prevention. Management Specialist, Radiation Service Activities and Research at [FR Doc. 01–422 Filed 1–5–01; 8:45 am] Studies Branch, Division of Department of Energy (DOE) Sites: BILLING CODE 4163±70±P Environmental Hazards and Health Idaho National Engineering and Effects, National Center for Environmental Laboratory Health Environmental Health, 1600 Clifton Effects Subcommittee. DEPARTMENT OF HEALTH AND Road, NE., Mail Stop E–39, Atlanta, The Subcommittee is charged with HUMAN SERVICES Georgia 30333. Nominations may be providing advice and recommendations faxed to 404/639–2575. to the Director, CDC and Administrator, Centers for Disease Control and The Director, Management Analysis ATSDR, pertaining to CDC’s and Prevention (CDC) and Services Office, has been delegated ATSDR’s public health activities and the authority to sign Federal Register Request for Nominations of research at respective DOE sites. notices pertaining to announcements of Candidates To Serve on the Citizens Activities shall focus on providing the meetings and other committee Advisory Committee on Public Health public and sovereign nations with a management activities, for both CDC Service Activities and Research at vehicle to express concerns and provide and ATSDR. Department of Energy Sites: Savannah advice and recommendations to CDC River Site Health Effects Dated: January 2, 2001. and ATSDR. The Idaho National Subcommittee Carolyn J. Russell, Engineering and Environmental Director, Management Analysis and Services Laboratory Health Effects Subcommittee The Centers for Disease Control and Office, Centers for Disease Control and (INEELHES) was established to advise Prevention and the Agency for Toxic Prevention. ATSDR and CDC on human health Substances and Disease Registry are [FR Doc. 01–423 Filed 1–5–01; 8:45 am] studies and public health activities that soliciting additional nominations for BILLING CODE 4163±70±P the agencies may undertake to address possible membership on the Citizens human exposures to historical releases Advisory Committee on Public Health of hazardous materials from the Idaho Service Activities and Research at DEPARTMENT OF HEALTH AND National Engineering and Department of Energy (DOE) Sites: HUMAN SERVICES Environmental Laboratory. Savannah River Site Health Effects CDC and ATSDR are seeking Subcommittee. Centers for Disease Control and candidates with an interest in science, The Subcommittee is charged with Prevention and a knowledge and understanding of providing advice and recommendations community needs relative to to the Director, CDC and Administrator, Mine Safety and Health Research environmental health. Close attention ATSDR, pertaining to CDC’s and Advisory Committee: Meeting will be given to minority and female ATSDR’s public health activities and representation so long as the research at respective DOE sites. In accordance with section 10(a)(2) of effectiveness of the Subcommittee is not Activities shall focus on providing the the Federal Advisory Committee Act impaired. public and sovereign nations with a (Pub. L. 92–463), the Centers for Disease Nominations for new members will be vehicle to express concerns and provide Control and Prevention (CDC), accepted by fax or written advice and recommendations to CDC announces the following committee correspondence. Information must and ATSDR. The Savannah River Site meeting. include a description the qualifications Health Effects Subcommittee (SRSHES) Name: Mine Safety and Health of the nominee to serve, the assets the was established to advise the ATSDR Research Advisory Committee nominee would bring to the work of the and CDC on human health studies and (MSHRAC). Subcommittee and a current resume or public health activities that the agencies Time and Date: 9 a.m.–4 p.m., January curriculum vitae. The closing date for may undertake to address human 24, 2001. nominations is January 26, 2001. exposures to historical releases of Place: The Washington Court, 525 Nominations must be postmarked on or hazardous materials from the Savannah New Jersey Avenue, NW, Washington, before the closing date. River Site. CDC and ATSDR are seeking DC 20001–1527. Nominations should be sent to: Ms. candidates with an interest in science, Status: Open to the public, limited Kitty Armstrong, Senior Committee and a knowledge and understanding of only by space available. The meeting

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(1) Plans, coordinates, and provides as appropriate. Matters to be Discussed: Agenda items CDC-wide administrative, technical, Delete the functional statement for the include the Acting Director’s comments; management, and information services Management Analysis Branch (CA597) Report from Associate Director-Mining; in the following areas: policy and insert the following: Dust Monitoring Update; Ground development and consultation, studies (1) Provides consultation and Control Update; Self-contained Self- and surveys, delegations of authorities, assistance to CDC program officials on rescuer Initiative Update; NIOSH organizations and functions, the establishment, modification, or Activities as Related to Libby, MT, information security, Privacy Act, abolishment of organizational structures Asbestos Issue; and future activities of confidentiality management, records and functions; reviews and analyzes the Committee. management, printing procurement and organizational changes; and develops Agenda items are subject to change as reproduction, classroom and meeting documents for approval by appropriate priorities dictate. management, forms design and CDC or HHS officials; (2) conducts CONTACT PERSON FOR MORE INFORMATION: management, publications distribution, management and operational studies for Lewis V. Wade, Ph.D., Executive mail services, public inquiries, reports CDC to improve the effectiveness and Secretary, MSHRAC, NIOSH, CDC, 200 and committee management, special efficiency of management and Independence Avenue, SW., Room 715– events coordination; (2) develops and administrative systems techniques, H Humphrey Building, Washington, DC implements policies and procedures in policies, and organizational structures; 20201, telephone 202/401–2192, fax these areas; (3) conducts management (3) interprets, analyzes, and makes 202/260–4464. control reviews and coordinates IG/ recommendations concerning The Director, Management Analysis GAO audits; (4) maintains liaison with delegations and redelegations of and Services Office has been delegated HHS, General Services Administration, program and administrative authorities, the authority to sign Federal Register the Government Printing Office, and develops appropriate delegating notices pertaining to announcements of National Archives and Records documents; (4) develops and meetings and other committee Administration, and other Government coordinates the implementation and management activities, for both the and private agencies. conduct of CDC-wide information Centers for Disease Control and Delete the functional statement for the security programs; (5) conducts a CDC- Prevention and the Agency for Toxic Committee Management and Program wide records management program, Substances and Disease Registry. Panels Activity (CA592) and insert the including provision of technical following: assistance in the development and Dated: January 2, 2001. (1) Develops and manages, in conduct of electronic records Carolyn J. Russell, conjunction with CDC’s grants management activities; (6) plans, Director, Management Analysis and Services management requirements, a CDC-wide directs, and coordinates requirements of Office, Centers for Disease Control and special emphasis panel that is the OMB Circulars A–76 and A–123 to Prevention (CDC). primary review mechanism for assuring conduct management review activities [FR Doc. 01–424 Filed 1–5–01; 8:45 am] scientific and programmatic review of and to determine whether certain BILLING CODE 4163±19±P applications for grant support; (2) Agency functions might be more coordinates committee management appropriately carried out through or by activities, including Federal advisory commercial sources; (7) plans, develops, DEPARTMENT OF HEALTH AND committees, for CDC; (3) plans and and implements policies and HUMAN SERVICES coordinates CDC special events. procedures in these areas, as Delete the functional statement for the appropriate. Centers for Disease Control and Management Procedures Branch Delete the functional statement for the Prevention (CA594) and insert the following: Management Services Branch (CA598) Statement of Organization, Functions, (1) Manages the CDC policy issuance and insert the following: and Delegations of Authority system to include policy development, (1) Plans and conducts a publications dissemination, and advisory services; management program, including Part C (Centers for Disease Control interprets HHS and other directives and development, production, procurement, and Prevention) of the Statement of assesses their impact on CDC policy, distribution, and storage of CDC Organization, Functions, and and maintains the official CDC library of publications; (2) plans, directs, Delegations of Authority of the administrative management policy and coordinates, and implements CDC-wide Department of Health and Human procedures manuals; (2) directs the information distribution services and Services (45 FR 67772–76, dated agency-wide confidentiality mail and messenger services, including October 14, 1980, and corrected at 45 FR management function to process the establishment and maintenance of 69296, October 20, 1980, as amended applications for approval to collect mailing lists; (3) maintains liaison with most recently at 65 FR 70916, dated sensitive research data in accordance contract suppliers, HHS, the November 28, 2000) is amended to with special confidentiality authorities Government Printing Office, and other revise the mission statement for the in Sections 301(d) and 308(d) of the Government agencies on matters Management Analysis and Services Public Health Service Act; (3) pertaining to printing, copy preparation,

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The other forms of information technology. receives and reviews requests received primary objectives of this first wave of Direct Comments to OMB from the public for information and this longitudinal study is to understand publications, and responds to the the relationships between alcohol Written comments and/or suggestions requests or forwards to the appropriate consumption, alcohol use disorders and regarding the item(s) contained in this CDC program for action; (6) manages the their related disabilities with a view notice, especially regarding the CDC learning environment through towards designing more effective estimated public burden and associated classroom and meeting support for treatment and intervention programs. response time, should be directed to the: CDC’s Atlanta campuses; (7) plans, The findings will provide valuable Office of Management and Budget, develops, and implements policies and information concerning: (1) Trends in Office of Regulatory Affairs, New procedures in these areas, as alcohol use disorders and their related Executive Office Building, Room 10235, appropriate. disabilities in subgroups of the Washington, DC 20503, Attention: Desk Dated: December 18, 2000. population of special concern; (2) Officer for NIH. To request more information on the proposed project or Jeffrey P. Koplan, identification of subgroups at high risk for alcohol use disorders that may be to obtain a copy of the data collection Director. complicated by associated psychological plans and instruments, contact Dr. [FR Doc. 01–462 Filed 1–5–01; 8:45 am] and medical disabilities; (3) incidence Bridget Grant, Chief, Biometry Branch, BILLING CODE 4160±18±M of alcohol use disorders and their Division of Biometry and Epidemiology, associated disabilities with a view NIAAA, NIH, Willco Building, Suite toward understanding their natural 514, 6000 Executive Boulevard, DEPARTMENT OF HEALTH AND history; (4) treatment utilization of Bethesda, Maryland 20892–7003, or call HUMAN SERVICES alcohol use disorders in order to non-toll-free number (301) 443–7370 or National Institutes of Health determine unmet treatment need and E-mail your request, including your linguistic, social, economic and cultural address to: [email protected]. Submission for OMB Review; barriers to treatment; (5) the college- Comments Due Date Comment Request; The National aged segment of the population at high Epidemiologic Survey on Alcohol and risk for binge drinking and its adverse Comments regarding this information Related Conditions consequences; and (6) the identification collection are best assured of having of safe and hazardous levels of drinking their full effect if received on or before SUMMARY: Under the provisions of as they relate to the development of February 7, 2001. Section 3507(a)(1)(D) of the Paperwork alcohol use disorders and their Dated: November 22, 2000. Reduction Act of 1995, the National associated disabilities. Frequency of Stephen Long, Institute on Alcohol Abuse and Response: On occasion. Affected Public: Executive Officer, NIAAA. Alcoholism (NIAAA), the National Individuals. Type of Respondents: Institutes of Health (NIH) has submitted Adults. The annual reporting burden is [FR Doc. 01–408 Filed 1–5–01; 8:45 am] to the Office of Management and Budget as follows: Estimated Number of BILLING CODE 4140±01±M (OMB) a request for review and Respondents: 48,000; Estimated Number approval of the information collection of Responses per Respondent: 1; listed below. This proposed information Average Burden Hours Per Response: DEPARTMENT OF THE INTERIOR collection was previously published in 1.00; and Estimated Total Annual the Federal Register on October 17, Burden Hours Requested: 48,000. The Fish and Wildlife Service 2000, page 61342 and allowed 60-days annualized cost to respondents is Notice of Receipt of Request to Amend for public comment. No public estimated at: $576,000.00. There are no Endangered Species Permit comments was received. The purpose of Capital Costs to report. There are no this notice is to allow an additional 30 Operating or Maintenance Costs to AGENCY: Fish and Wildlife Service, days for public comment. The National report. Interior. Institutes of Health may not conduct or ACTION: Notice of receipt. sponsor, and the respondent is not Request for Comments required to respond to, an information Written comments and/or suggestions The following applicant requests a collection that has been extended, from the public and affected agencies permit amendment to conduct certain revised, or implemented on or after are invited on one or more of the activities with endangered species. This October 1, 1995, unless it displays a following points: (1) Whether the notice is provided pursuant to section currently valid OMB control number. proposed collection of information is 10(c) of the Endangered Species Act of necessary for the proper performance of 1973, as amended (16 U.S.C. 1531 et Proposed Collection the function of the agency, including seq.): Title: The National Epidemiologic whether the information will have Applicant: Assistant Regional Director, Survey on Alcohol and Related practical utility; (2) The accuracy of the Ecological Services, U.S. Fish and Wildlife Conditions. Type of Information agency’s estimate of the burden of the Service, Hadley, Massachusetts Collection Request: NEW. Need and Use proposed collection of information, of Information Collection: This study including the validity of the Permit No.: TE–697823 will determine the incidence and methodology and assumptions used; (3) This applicant requests to amend prevalence of alcohol use disorders in a Ways to enhance the quality, utility, and their current permit for take activities representative sample of the United clarity of the information to be for all listed species in the states of States population with the primary collected; and (4) Ways to minimize the Connecticut, Delaware, Maine, purpose of estimating the extent and burden of the collection of information Maryland, Massachusetts, New

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Hampshire, New Jersey, New York, Anchorage, Alaska 99513–7599; 907– seeking public review and comment of Pennsylvania, Rhode Island, Vermont, 267–1403. the NPDES permit and explanatory fact Virginia, West Virginia, and the District sheet which are included as Appendix Daniel L. Johnson, of Columbia for the purpose of scientific I in the draft EIS. research and enhancement of survival of Chief, Branch of Field Surveys. The Liberty prospect is located on the the species, to include the recently [FR Doc. 01–404 Filed 1–5–01; 8:45 am] OCS in the Beaufort Sea northeast of the listed Gulf of Maine distinct population BILLING CODE 1410±BK±P Prudhoe Bay oil field. The MMS is the segment of Atlantic salmon (Salmo lead agency which developed the EIS, in salar). cooperation with the COE and the EPA, DEPARTMENT OF THE INTERIOR as required by the National DATES: Written comments on this Environmental Policy Act (NEPA) of request for a permit amendment must be Minerals Management Service (MMS) 1969, as amended (42 U.S.C. 4371 et received on or before February 7, 2001. seq.). In February 1998, BPXA ADDRESSES: Written data or comments Outer Continental Shelf (OCS), Alaska Region, Beaufort Sea, Proposed submitted a DPP, subsequently revised should be submitted to the Regional in November 1998 (Revision 1) and July Endangered Species Permits Liberty Development and Production Plan (DPP) 2000 (Revision 2), describing how they Coordinator, U.S. Fish and Wildlife proposed to produce, develop, and Service, 300 Westgate Center Drive, AGENCY: Minerals Management Service, transport oil from the Liberty Prospect Hadley, Massachusetts 01035; facsimile: Interior. using a manmade gravel island 413–253–8482. ACTION: Notice of Availability of the constructed on the Federal OCS and FOR FURTHER INFORMATION CONTACT: Draft Environmental Impact Statement located in 22 feet of water about 6.1 Documents and other information (EIS) and Locations and Dates of Public miles offshore in Foggy Island Bay and submitted with this request for an Hearings for British Petroleum 1.5 miles west of the abandoned Tern amendment are available for review, Exploration (Alaska) (BPXA) Inc.’s Island. The Liberty Island facility would subject to the requirements of the Proposed Liberty DPP Offshore Alaska. be a self-contained offshore drilling Privacy Act and Freedom of Information operation with processing facilities. Oil Act, by any party who submits a written SUMMARY: The MMS is issuing a draft would be transported to shore in a request for a copy of such documents EIS for the BPXA Inc.’s proposed common carrier pipeline which within 20 days of the date of publication Liberty Development Project DPP in the connects with the Trans-Alaska Pipeline of this notice to the address above; Beaufort Sea, Alaska. The U.S. Army System. A new gravel mine site and telephone: 413–253–8628. Corps of Engineers (COE) and the offshore and onshore ice roads are part Dated: December 19, 2000. Environmental Protection Agency (EPA) of the proposed project. The MMS based Dr. Mamie A. Parker, were cooperating agencies, with the the EIS analyses on estimates of the Acting Regional Director. MMS, in preparing the EIS. Information kinds and amounts of activity onshore and offshore that could result from [FR Doc. 01–403 Filed 1–5–01; 8:45 am] on the availability of the EIS and dates and locations for public hearings and transporting personnel and equipment BILLING CODE 4310±55±M submission of comments are presented offshore, constructing the self-contained in this notice. manmade gravel island and structures, DEPARTMENT OF THE INTERIOR FOR FURTHER INFORMATION CONTACT: For installing structures and equipment on matters pertaining to this notice, contact the island, drilling wells, and Bureau of Land Management; Alaska Mr. Fred King (Alaska OCS Region, constructing a common carrier oil pipeline buried in an undersea trench to [AK±921±1410±BK±P] Anchorage) at (907) 271–6696 or toll free at 1–800–764–2627. an onshore landfall and then elevated onshore by vertical support members to Notice for Publication; Filing of Plat of DATES: Comments on the draft EIS will a tie-in with the existing onshore Survey; Alaska be accepted until March 13, 2001. Badami oil pipeline, then to the Trans- The plat of survey of the following SUPPLEMENTARY INFORMATION: The MMS, Alaska Pipeline System. described land was officially filed in the in cooperation with the COE and EPA, The EIS addresses a range of Alaska State Office, Anchorage, Alaska, prepared a draft EIS on BPXA Inc.’s potentially applicable technologies and on the date indicated. proposed Liberty Development Project construction options. The EIS evaluates A plat representing the dependent DPP. This EIS additionally serves as the the BPXA Proposal, a No-Action resurvey of Tract A, U.S. Survey No. environmental analysis for the BPXA’s alternative, and a variety of alternatives 465, Alaska, situated near the westerly Oil Discharge Prevention and that were developed in light of the most shore of Shelikof Strait, in Alaska, was Contingency Plan (ODPCP) and the significant issues raised from scoping. accepted November 1, 2000, and was construction and operation of a pipeline The alternatives examine three island officially filed November 8, 2000. that would be associated with any locations and pipeline routes, four This plat was prepared at the request Right-of-Way (ROW) for the OCS pipeline designs, two types of upper of the National Park Service to delineate portion of the proposed Liberty slope protection for the production the surrounding public lands. pipeline. The public review for the DPP, island, two gravel mine sites, and two This plat will immediately become ODPCP, and ROW will be announced pipeline burial depths. The EIS also the basic record for describing the land separately by the MMS Alaska OCS evaluates the effects of oil spill response for all authorized purposes. This survey Region. activities described in the ODPCP. has been placed in the open files in the This EIS is also intended to meet EIS Availability: You may obtain Alaska State Office and is available to NEPA compliance and public notice single copies of the draft EIS, ‘‘OCS EIS, the public as a matter of information. requirements for EPA’s issuance of a MMS 2001–001’’ (three volumes), from All inquiries relating to these lands National Pollutant Discharge the MMS, Alaska OCS Region, should be sent to the Alaska State Elimination System (NPDES) permit, Attention: Mr. Fred R. King, (MS 8303), Office, Bureau of Land Management, pursuant to Section 402 of the Clean 949 E. 36th Avenue, Room 308, 222 West Seventh Avenue, #13, Water Act. By this notice, the EPA is Anchorage, Alaska 99508–4363, or by

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1366 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices calling 1–800–764–2627. The Executive Marston Theatre , 3600 Denali Street, and Enforcement (OSM) is announcing Summary of this draft EIS is also Anchorage; that the information collection request available as a separate document: February 19, 2001, 7:30–10 p.m., for 30 CFR 816, Permanent Program Executive Summary, MMS 2001–002. In Inupiaq Heritage Center, Barrow; Performance Standards—Surface addition, the complete EIS is available February 20, 2001, 7–10 p.m., Kaktovik Mining Activities, has been forwarded on CD-ROM (MMS 2001–001 CD) and Community Center, Kaktovik; to the Office of Management and Budget on the Internet at (http://www.mms.gov/ February 21, 2001, 7–10 p.m., at Kisik (OMB) for review and approval. The alaska/cproject/liberty). Community Center, Nuiqsut; information collection request describes You may look at copies of the draft February 22, 2001, 6–9 p.m., at the the nature of the information collection EIS in the following libraries and offices Alaskaland Exhibit Hall, 2600 Airport and the expected burden and cost. in Alaska: Way, Fairbanks. DATES: OMB has up to 60 days to Alaska MMS Public Information An Inupiat translator will be available approve or disapprove the information Resource Center, 949 E. 36th Avenue, at the public hearings held in Barrow, collections but may respond after 30 Anchorage; Alaska Resources Library Kaktovik, and Nuiqsut. Oral and written days. Therefore, public comments and Information Services, U.S. comments on the draft EIS will be should be submitted to OMB by Department of the Interior, 3150 C addressed in the final EIS. February 7, 2001, in order to be assured Street, Suite 100, Anchorage; If you wish to testify at a hearing, you of consideration. may register prior to the hearing to Alaska State Library, State Office FOR FURTHER INFORMATION CONTACT: To Building, 333 Willoughby, Juneau; schedule a preferred time by contacting request a copy of the information Army Corps of Engineers Library, U.S. the Alaska OCS Region at the above collection request, explanatory Department of Defense, Elmendorf Air address or Mr. Fred King at (907) 271– information and related form, contact Force Base, Anchorage; 6696 or toll free 1–800–764–2627 not John A. Trelease at (202) 208–2783, or Fairbanks North Star Borough Public later than 3 days prior to the hearing electronically to [email protected]. date. Every effort will be made to Library (Noel Wien Library), 1215 SUPPLEMENTARY INFORMATION: The Office Cowles Street, Fairbanks; accommodate individuals who have not pre-registered to testify. Time of Management and Budget (OMB) Kaveolook School Library, Kaktovik; regulations at 5 CFR 1320, which Juneau Public Library, 292 Marine Way, limitations may make it necessary to limit the length of oral statements to 10 implement provisions of the Paperwork Juneau; Reduction Act of 1995 (Pub. L. 104–13), North Slope Borough School District minutes. You may supplement an oral statement with a more complete written require that interested members of the Library/Media Center, Barrow; public and affected agencies have an Northern Alaska Environmental Center statement and submit it to a hearing official at the hearing or by mail until opportunity to comment on information Library, 218 Driveway, Fairbanks; collection and recordkeeping activities Nuiqsut Library, Nuiqsut; March 13, 2001. Written statements [see 5 CFR 1320.8(d)]. OSM has Tuzzy Consortium Library, Barrow; submitted at a hearing will be submitted a request to OMB to renew its University of Alaska Anchorage, considered part of the hearing record. If approval of the collection of information Consortium Library, 3211 Providence you are unable to attend the hearing, found at 30 CFR 816, Permanent Drive, Anchorage; you may submit written statements at Program Performance Standards— University of Alaska Fairbanks, Elmer E. the address below. Surface Mining Activities. OSM is Rasmuson Library, 310 Tanana Drive, We will accept comments on the draft requesting a 3-year term of approval for Fairbanks; EIS until March 13, 2001. Address your University of Alaska, Fairbanks Institute comments to the Regional Director, this information collection activity. An agency may not conduct or of Arctic Biology, 311 Irving Building, Alaska OCS Region, Minerals sponsor, and a person is not required to Fairbanks; Management Service, 949 East 36th respond to, a collection of information University of Alaska-Juneau Library, Avenue, Room 308, Anchorage, Alaska unless it displays a currently valid OMB 11120 Glacier Highway, Juneau; 99508–4363. control number. The OMB control Valdez Consortium Library, 200 Dated: December 21, 2000. number for this collection of Fairbanks Street, Valdez; Carolita U. Kallaur, Z. J. Loussac Library, 3600 Denali Street, information is listed in 30 CFR 816, Anchorage; Associate Director for Offshore Minerals which is 1029–0047. Management. As required under 5 CFR 1320.8(d), a Alaska Eskimo Whaling Commission Federal Register notice soliciting Office, Barrow; [FR Doc. 01–426 Filed 1–5–01; 8:45 am] comments on this collection of Alaska Inter-Tribal Council, 431 West BILLING CODE 4310±MR±P information was published on October 7th Avenue, Suite 201, Anchorage; Barrow City Office, Barrow; 17, 2000 (65 FR 61363). No comments DEPARTMENT OF THE INTERIOR North Slope Borough Office, Barrow; were received. This notice provides the public with an additional 30 days in Kaktovik City Office, Kaktovik; Office of Surface Mining Reclamation Nuiqsut City Office, Nuiqsut. which to comment. and Enforcement The following information is provided Public Hearings: Five public hearings for the information collection: (1) Title will be held to receive comments on the Notice of Proposed Information of the information collection; (2) OMB draft EIS. The hearings will provide us Collection control number; (3) summary of the with additional information that will AGENCY: information collection activity; and (4) help in evaluating the potential effects Office of Surface Mining Reclamation and Enforcement Interior. frequency of collection, description of of the proposed project. Hearings will be the respondents, estimated total annual held in Anchorage, Barrow, Kaktovik, ACTION: Notice and request for comments. responses, and the total annual Nuiqsut, and Fairbanks on the following reporting and recordkeeping burden for dates and times: SUMMARY: In compliance with the the collection of information. Where February 15, 2001, 12–3 p.m. and 7–9 Paperwork Reduction Act of 1995, the appropriate, OSM has revised burden p.m., Z. J. Loussac Library, Wilda; Office of Surface Mining Reclamation estimates to reflect current reporting

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices 1367 levels and adjustments based on PLACE: Room 101, 500 E Street S.W., ADDRESSES: National Aeronautics and reestimates of the burden or number of Washington, DC 20436, Telephone: Space Administration, Room 9H40, 300 respondents. (202) 205–2000. E Street, SW, Washington, DC 20546. Title: Permanent Program STATUS: Open to the public. FOR FURTHER INFORMATION CONTACT: Ms. Performance Standards—Surface MATTERS TO BE CONSIDERED: Mary-Ellen McGrath, Office of Mining Activities, 30 CFR Part 816. Aerospace Technology, National OMB Control Number: 1029–0047. 1. Agenda for future meeting: none. Aeronautics and Space Administration, Summary: Section 525 of the Surface 2. Minutes. 3. Ratification List. Washington, DC 20546 (202/358–4729). Mining Control and Reclamation Act of 4. Inv. Nos. 731–TA–624–625 SUPPLEMENTARY INFORMATION: The 1977 provides that permittees (Review)(Helical Spring Lock Washers from meeting will be open to the public up conducting surface coal mining China and Taiwan)—briefing and vote. (The to the seating capacity of the room. The operations shall meet all applicable Commission is currently scheduled to agenda for the meeting is as follows: performance standards of the Act. The transmit its determination and information collected is used by the Commissioners’ opinions to the Secretary of Tuesday, February 6, 2001 regulatory authority in monitoring and Commerce on January 25, 2001.) —Aviation Noise Reduction Overview inspecting surface coal mining activities 5. Inv. Nos. 731–TA–470–472 —Noise Reduction Strategic Thrust Weights to ensure that they are conducted in (Review)(Silicon Metal from Argentina, —Noise Reduction Technologies Briefing Brazil, and China)—briefing and vote. (The compliance with the requirements of the —NASA Progress Toward Noise Reduction Commission is currently scheduled to Targets Act. transmit its determination and Bureau Form Number: None. —Noise Reduction Assessment, Priorities, Commissioners’ opinions to the Secretary of and Directions Frequency of Collection: Once, on Commerce on January 25, 2001.) —Subcommittee Caucus occasion, quarterly and annually. 6. Inv. Nos. 731–TA–671–673 Description of Respondents: Surface (Review)(Silicomanganese from Brazil, Wednesday, February 7, 2001 coal mining operators. China, and Ukraine)—briefing and vote. (The —Aviation Safety Overview Total Annual Responses: 731,787. Commission is currently scheduled to —Aviation Safety Strategic Thrust Weights Total Annual Burden Hours: 355,405. transmit its determination and —Aviation Safety Technologies Briefing Commissioners’ opinions to the Secretary of Send comments on the need for the —NASA Progress Toward Safety Targets Commerce on January 25, 2001.) —Overall Safety Assessment, Priorities, and collection of information for the 7. Outstanding action jackets: none. Directions performance of the functions of the In accordance with Commission —Analysis Issues and Developments agency; the accuracy of the agency’s —Subcommittee Caucus burden estimates; ways to enhance the policy, subject matter listed above, not In addition, for those interested, there quality, utility and clarity of the disposed of at the scheduled meeting, will be an Integrated Space information collection; and ways to may be carried over to the agenda of the Transportation Plan (ISTP) presentation minimize the information collection following meeting. from 9 a.m.–11 a.m., February 8, 2001. burden on respondents, such as use of By order of the Commission. The presentation will provide updated automated means of collection of the Issued: January 2, 2001. program long-term goals and directions. information, to the following address. Donna R. Koehnke, It is imperative that the meeting be held Please refer to the appropriate OMB Secretary. on these dates to accommodate the control number in all correspondence. [FR Doc. 01–578 Filed 1–4–01; 2:26 pm] scheduling priorities of the key ADDRESSES : Office of Information and BILLING CODE 7020±02±P participants. Regulatory Affairs, Office of Management and Budget, Attention: Beth M. McCormick, Department of Interior Desk Officer, 725 Advisory Committee Management Officer, 17th Street, NW., Washington, DC NATIONAL AERONAUTICS AND National Aeronautics and Space Administration. 20503; and to John A. Trelease, Office SPACE ADMINISTRATION of Surface Mining Reclamation and [FR Doc. 01–432 Filed 1–5–01; 8:45 am] BILLING CODE 7510±01±P Enforcement, 1951 Constitution Ave., [Notice 01±001] NW., Room 210–SIB, Washington, DC 20240. NASA Advisory Council (NAC), Aero- Dated: January 3, 2001. Space Technology Advisory OFFICE OF PERSONNEL MANAGEMENT Richard G. Bryson, Committee, Goals Subcommittee; Meeting. Chief, Division of Regulatory Support. Submission for OMB Review; Request [FR Doc. 01–428 Filed 1–5–01; 8:45 am] AGENCY: National Aeronautics and for Review of an Expiring Information BILLING CODE 4310±05±M Space Administration. Collection: OPM Form 805 Series ACTION: Notice of meeting. AGENCY: Office of Personnel Management. SUMMARY: In accordance with the UNITED STATES INTERNATIONAL ACTION: Notice. TRADE COMMISSION Federal Advisory Committee Act, Pub. L. 92–463, as amended, the National SUMMARY: In accordance with the [USITC SE±01±001] Aeronautics and Space Administration Paperwork Reduction Act of 1995 announces a forthcoming meeting of the (Public Law 104–13, May 22, 1995), this Notice of Sunshine Meeting NASA Advisory Council, Aero-Space notice announces that the Office of Technology Advisory Committee, Goals Personnel Management has submitted AGENCY HOLDING THE MEETING: United Subcommittee. simultaneously with publication of this States International Trade Commission. DATES: Tuesday, February 6, 2001, 8:30 notice a request to the Office of TIME AND DATE: January 12, 2001 at 11 a.m. to 5 p.m.; Wednesday, February 7, Management and Budget for review of a.m. 2001, 8:30 a.m. to 5 p.m. an expiring information collection: OPM

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Form 805 Series. OPM Form 805, Retirement Board (RRB) has submitted DEPARTMENT OF STATE Application to be Listed Under the the following proposal(s) for the [Public Notice 3534] Voting Rights Act of 1965, is used to collection of information to the Office of elicit information from persons applying Management and Budget for review and Culturally Significant Objects Imported for voter registration under the authority approval. for Exhibition Determinations: ``Van of the Voting Rights Act of 1965. The Gogh Portraits: Face to Face'' requirements for voter eligibility vary Summary of Proposal(s) from State to State; therefore, OPM AGENCY: United States Department of (1) Collection title: Railroad Form 805 is a blanket number covering State. Unemployment Insurance Act a number of forms that conform to the ACTION: Amendment. individual State’s requirements. For a Applications. number of years, there were forms for 10 (2) Form(s) submitted: SI–1a, SI–1b, SUMMARY: On February 16, 2000, Notice States: Alabama, Arizona, Georgia, SI–3, SI–7, SI–8, ID–7H, ID–11A, ID– was published on page 7902 of the Louisiana, Mississippi, New Mexico, 11B. Federal Register (Volume 65, Number 32) by the Department of State pursuant North Carolina, South Carolina, Texas (3) OMB Number: 3220–0039. (English and Spanish language to Public Notice 3228 relating to the versions), and Utah. Because OPM has (4) Expiration date of current OMB exhibit ‘‘Van Gogh Portraits: Face to never been asked to list voters in clearance: 4/30/2001. Face.’’ The referenced Notice is hereby Arizona, New Mexico, North Carolina, (5) Type of request: Revision of a amended to add a venue. After ‘‘January and Utah, we allowed the approval of currently approved collection. 14, 2001 and before ‘‘is in the national those forms to lapse in 1997 at the interest,’’ insert the following additional (6) Respondents: Individuals or language: ‘‘and at the Museum of request of the Voting Rights Section in Households, Business or other for-profit. the Civil Rights Division of the Modern Art, New York, NY from Department of Justice. The form requires (7) Estimated annual number of January 30, 2001, through May 15, 20 minutes to complete. Approximately respondents: 55,400. 2001.’’ 10 individuals complete the form (8) Total annual responses: 271,900. FOR FURTHER INFORMATION CONTACT: For annually for a total public burden of 4 (9) Total annual reporting hours: further information, including a list of hours. 27,971. exhibit objects, contact Jacqueline For copies of this proposal, call Ms. Caldwell, Attorney-Adviser, Office of Mary Beth Smith-Toomey on (202) 606– (10) Collection description: Under the Legal Adviser, U.S. Department of 8358 or email [email protected]. Section 2 of the Railroad State (telephone: 202/619–6982). The DATES: Comments on this proposal Unemployment Insurance Act, address is U.S. Department of State, SA– should be received on or before unemployment and sickness benefits are 44; 301 4th Street, S.W., Room 700, February 7, 2001. provided for qualified railroad Washington, D.C. 20547–0001. ADDRESSES: Send or deliver comments employees. The collection obtains Dated: December 28, 2000. information needed to determine to— William B. Bader, eligibility for an amount of such benefits Anna Marie Schuh, Assistant Director Assistant Secretary for Educational and for Merit Systems Oversight, Office of from railroad employees and Cultural Affairs, United States Department Personnel Management, 1900 E Street, physicians. Also collects information of State. NW., Room 7677, Washington, DC from individuals acting on behalf of sick [FR Doc. 01–458 Filed 1–5–01; 8:45 am] 20415–6000 or injured employees and supplemental BILLING CODE 4710±08±P and information from railroad employers Joseph Lackey, OPM Desk Officer, regarding settlement of injuries or Office of Information and Regulatory accidents for which sickness benefits TENNESSEE VALLEY AUTHORITY Affairs, Office of Management and were paid. Budget, New Executive Office Meeting of the Regional Resource Building, NW., Room 10235, Additional Information or Comments Stewardship Council Washington, DC 20503 Copies of the forms and supporting AGENCY: Tennessee Valley Authority FOR INFORMATION REGARDING documents can be obtained from Chuck ADMINISTRATIVE COORDINATION, CONTACT: (TVA). Mierzwa, the agency clearance officer P. Kaziah Clayton, Office of Merit ACTION: Notice of meeting. (312–751–3363). Comments regarding Systems, Oversight and Effectiveness, SUMMARY: The Regional Resource (202) 606–2531, [email protected]. the information collection should be addressed to Ronald J. Hodapp, Railroad Stewardship Council (Regional Council) U.S. Office of Personnel Management. Retirement Board, 844 North Rush will hold a meeting to consider various Janice R. Lachance, Street, Chicago, Illinois, 60611–2092 matters. Notice of this meeting is given Director. and the OMB reviewer, Joe Lackey (202– under the Federal Advisory Committee [FR Doc. 01–429 Filed 1–5–01; 8:45 am] 395–7316), Office of Management and Act, 5 U.S.C. App. 2, (FACA). BILLING CODE 6325±01±P Budget, Room 10230, New Executive The meeting agenda includes the Office Building, Washington, DC 20503. following/briefings: 1. Instream flows and recreation. RAILROAD RETIREMENT BOARD Chuck Mierzwa, 2. Tax exempt payments. Clearance Officer. 3. Recommendation from the Water Quality Subcommittee on aquatic plant Agency Forms Submitted for OMB [FR Doc. 01–405 Filed 1–5–01; 8:45 am] Review management. BILLING CODE 7905±01±M 4. Public comments. SUMMARY: In accordance with the 5. Subcommittee reports. Paperwork Reduction Act of 1995 (44 6. Water quality issues below U.S.C. Chapter 35), the Railroad tributary reservoirs.

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It is the Regional Council’s practice to FOR FURTHER INFORMATION CONTACT: mailing list to receive further provide an opportunity for members of Robin Schroeder, Program Operations information as the project develops, the public to make oral public Director or Amy Fox, Environmental contact Mr. Andras Fekete at the comments at its meetings. Public Coordinator, Federal Highway address above. comment session is scheduled from Administration, 840 Bear Tavern Road, (Catalog of Federal Domestic Assistance 11:00 a.m.–noon CST. Members of the Suite 310, West Trenton, NJ 08628. Program Number 20.205, Highway Research, public who wish to make oral public SUPPLEMENTARY INFORMATION: Pursuant Planning and Construction. The regulations comments may do so during the Public to Title 23, Code of Federal Regulations, implementing Executive Order 12372 comments portion of the agenda. Up to Part 771, Environmental Impact and regarding intergovernmental consultation of one hour will be allotted for the Public Related Procedures, the FHWA, in Federal programs and activities apply to this program) comments with participation available cooperation with the New Jersey on a first-come, first-served basis. Department of Transportation (NJDOT), Issued on: December 28, 2000. Speakers addressing the Council are will prepare an environmental impact Robin Schroeder, requested to limit their remarks to no statement in accordance with the Program Operations Director, FHWA—New more than 5 minutes. Persons wishing National Environmental Policy Act Jersey Division, Trenton. to speak register at the door and are then (NEPA), on alternatives for [FR Doc. 01–406 Filed 1–5–01; 8:45 am] called on by the Council Chair during modifications to Route 1 and BILLING CODE 4910±22±M the public comment period. Hand-out intersecting roadways in the Penn’s materials should be limited to one Neck Area, to improve transportation printed page. Written comments are also service. Generally, the section of Route DEPARTMENT OF TRANSPORTATION invited and may be mailed to the 1 under evaluation extends from National Highway Traffic Safety Regional Resource Stewardship Council, Alexander Road Interchange in West Administration Tennessee Valley Authority, 400 West Windsor Township in Mercer County to Summit Hill Drive, WT 11A, Knoxville, Scudders Mill Road Interchange in [Docket Number NHTSA±2000±8273] Tennessee 37902. Middlesex County. The EIS will DATE: The meeting will be held on evaluate the No-Action and Build Reports, Forms, and Recordkeeping Thursday, January 18, 2001, from 8:30 Alternatives to determine potential Requirements a.m. to 5 p.m. CST. impacts and costs associated with each. AGENCY: National Highway Traffic ADDRESS: The meeting will be held in An Environmental Assessment (EA)/ Safety Administration (NHTSA), Nashville, Tennessee, at the Sheraton Section 4(F) Evaluation of some Department of Transportation. alternative solutions for mobility and Downtown Hotel, 623 Union Street, ACTION: Request for public comment on congestion problems in the Penn’s Neck Nashville, Tennessee 37219, and will be proposed collections of information. open to the public. Anyone needing area of Route 1 was developed by special access or accommodations FHWA and NJDOT and made available SUMMARY: Before a Federal agency can should let the contact below know at to the public and review agencies collect certain information from the least a week in advance. during October 2000. Subsequently, a public, it must receive approval from FOR FURTHER INFORMATION CONTACT: decision was made by Governor the Office of Management and Budget Sandra L Hill, 400 West Summit Hill Christine Todd Whitman to prepare an (OMB). Under procedures established Drive, WT 11A, Knoxville, Tennessee EIS to allow broader public by the Paperwork Reduction Act of 37902, (865) 632–2333. participation in the process and a fuller 1995, before seeking OMB approval, evaluation of alternatives and impacts. Dated: December 19, 2000. Federal agencies must solicit public After publication of this Notice, the comment on proposed collections of Kathryn J. Jackson, FHWA in cooperation with NJDOT will information, including extensions and Executive Vice President, River System continue the scoping process begun reinstatements of previously approved Operations & Environment, Tennessee Valley during the preparation of the EA to Authority. collections. evaluate alternatives already under This document describes two [FR Doc. 01–425 Filed 1–5–01; 8:45 am] review and to identify additional collections of information for which BILLING CODE 8120±08±P possible alternatives. This process will NHTSA intends to seek OMB approval. also identify significant issues to be DATES: Comments must be received on addressed in the EIS. or before March 9, 2001. DEPARTMENT OF TRANSPORTATION To ensure that issues involving this proposed action are addressed fully and ADDRESSES: Comments must refer to the Federal Highway Administration significant concerns are identified, docket and notice number cited at the written comments, suggestions or beginning of this notice and be Environmental Impact Statement: questions should be directed to the submitted to U.S. Department of Mercer and Middlesex Counties, New FHWA at the address provided above or Transportation Dockets, Room PL–401, Jersey directed to: Mr. Andras Fekete, 400 Seventh Street, SW., Washington, DC 20590. Please identify the proposed AGENCY: Federal Highway Manager, Bureau of Environmental collection of information for which a Administration (FHWA), USDOT. Services, New Jersey Department of comment is provided, by referencing its ACTION: Notice of intent. Transportation, 1035 Parkway Avenue, Trenton, NJ 08625–0600, Telephone: OMB Control Number. It is requested, SUMMARY: The FHWA is issuing this 609–530–2824. but not required, that one original plus notice to advise the public that an The public will receive notices on two copies of the comments be Environmental Impact Statement (EIS) location and time of future provided. The Docket Section is open will be prepared for changes being opportunities for participation at on weekdays from 10:00 a.m. to 5:00 considered to Route 1 and intersecting meetings and public hearings through p.m. roadways in the greater Penn’s Neck newspaper advertisements and other FOR FURTHER INFORMATION CONTACT: Area to improve transportation service. means. If you wish to be placed on the Complete copies of each request for

VerDate 112000 17:05 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\08JAN1.SGM pfrm10 PsN: 08JAN1 1370 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices collection of information may be automobile manufacturers comply with Proposed Frequency of Response to the obtained at no charge from Ms. 49 CFR part 537—Automotive Fuel Collection of Information): NHTSA Henrietta L. Spinner, NHTSA, 400 Economy Reports. Part 537 requires that anticipates that no more than 17 vehicle Seventh Street, Southwest, Room 5320, automobile manufacturers submit manufacturers will be affected by the NPS–32, Washington, DC 20590. Ms. reports to NHTSA regarding their efforts reporting requirements. NHTSA does Spinner’s telephone number is (202) to improve automotive fuel economy. not believe any of these 17 366–0846. Please identify the relevant Section 32907 of Chapter 329 of title manufacturers are a small business (i.e., collection of information by referring to 49 of the United States Code requires one that employs less than 500 persons). its OMB clearance number. each automobile manufacturer (other NHTSA anticipates a total of about 40 SUPPLEMENTARY INFORMATION: than those low volume manufacturers responses may be filed by these 17 Under the Paperwork Reduction Act which were granted an alternative fuel manufacturers. Most manufacturers will of 1995, before an agency submits a economy standard under section 32902 respond semiannually; however, a few proposed collection of information to (d)) to submit semi-annual reports to the manufacturers may respond more OMB for approval, it must publish a agency relating to that manufacturers’ frequently. document in the Federal Register efforts to comply with average fuel Estimate of the Total Annual providing a 60-day comment period and economy standards. One report is due Reporting and Recordkeeping Burden otherwise consult with members of the during the 30-day period preceding the Resulting from the Collection of public and affected agencies concerning beginning of each model year (the ‘‘pre- Information: NHTSA estimates that the each proposed collection of information. model year report’’) and the other is due vehicle manufacturers will incur a total OMB has promulgated regulations during the 30-day period beginning on annual reporting and cost burden of describing what must be included in the 180th day of the model year (the 3,300 hours and $645,000. such a document. Under OMB’s ‘‘mid-model year report’’). Title: 49 CFR 583—Automobile Parts regulation (at 5 CFR 1320.8 (d)), an Section 32907 (a)(1) of Chapter 329 Content Labeling. agency must ask for public comment on provides that each report must contain Type of Request: Extension of a the following: a statement as to whether the currently approved collection. (i) Whether the proposed collection of manufacturer will comply with average OMB Control Number: 2127–0573. Form Number: This collection of information is necessary for the proper fuel economy standards for that year, a information uses no standard form. performance of the functions of the plan describing the steps the manufacturer took or will take to Requested Expiration Date of agency, including whether the Approval: Three years from approval information will have practical utility; comply with the standards, and any other information the agency may date. (ii) The accuracy of the agency’s Summary of the Collection of estimate of the burden of the proposed require. Whenever a manufacturer determines that a plan it has submitted Information: NHTSA ensures that collection of information, including the automobile manufacturers comply with validity of the methodology and in one of its reports is no longer adequate to assure compliance, it must 49 CFR Part 583—Automobile Parts assumptions used; Content Labeling. Part 583 establishes (iii) How to enhance the quality, submit a revised plan. requirements for the disclosure of utility, and clarity of the information to Description of the Need for the information relating to the countries of be collected; and Information and Proposed Use of the (iv) How to minimize the burden of Information: This information assists origin of the equipment of new the collection of information on those NHTSA in evaluating automobile passenger motor vehicles. Description of the Need for the who are to respond, including the use manufacturers’ plans for complying Information and Proposed Use of the of appropriate automated, electronic, with average fuel economy standards Information: This information will be mechanical, or other technological and in preparing an annual review of used by NHTSA to determine whether collection techniques or other forms of the average fuel economy standards. manufacturers are complying with the information technology, e.g., permitting The information is collected by NHTSA American Automobile Labeling Act (49 electronic submission of responses. by having the automobile manufacturers In compliance with these mail their semi-annual automotive fuel United States Code 32304). The requirements, NHTSA asks for public economy reports and/or submit a copy American Automobile Labeling Act comment on the following current on computer diskette to the agency. The requires all new passenger motor collections of information for which the required information is used for four vehicles (including passenger cars, agency is seeking extension of their basic purposes. These purposes are: (a) certain small buses, all light trucks and approval from OMB: To give NHTSA advance indication if multipurpose passenger vehicles with a Title: 49 CFR 537—Automotive Fuel any manufacturer will fail to comply gross vehicle weight rating of 8,500 Economy Reports. with the applicable average fuel pounds or less), to bear labels providing OMB Control No.: 2127–0019. economy standards; (b) to give NHTSA information about domestic and foreign Form Number: This collection of necessary information to prepare fuel content of their equipment. With the information uses no standard form. economy reports; (c) to assist NHTSA in affixed label on the new passenger Abstract: Part 537 requires automobile responding to general information motor vehicle, it serves as an aid to manufacturers to submit semi-annual requests concerning automotive fuel potential purchasers in the selection of reports to NHTSA regarding their efforts economy, which are routinely received new passenger motor vehicles by to improve fuel economy. from Congress, other parts of the providing them with information about Type of Request: Extension of a Executive branch, and the public; and the value of the U.S./Canadian and currently approved collection. (d) to provide NHTSA with detailed and foreign parts of each vehicle, the Affect Public: Business or other for- accurate technical and economic countries of origin of the engine and profit organizations. information used to evaluate possible transmission, and the site of the Requested Expiration Date: Three future average fuel economy standards vehicle’s final assembly. years from approval date. which may be established by NHTSA. Description of the Likely Respondents Summary of the Collection of Description of the Likely Respondents (Including Estimated Number, and Information: NHTSA ensures that (Including Estimated Number, and Proposed Frequency of Response to the

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Collection of Information): NHTSA and operate a lined owned by Crown in DEPARTMENT OF TRANSPORTATION anticipates that no more than 17 vehicle Detroit, MI.1 Surface Transportation Board manufacturers will be affected by these Applicants state that (i) the rail lines reporting requirements. NHTSA does of Riverview and Jefferson will not [STB Finance Docket No. 33980] not believe any of these 17 connect with each other, (ii) the manufacturers are a small business (i.e., transaction is not part of a series of Riverview Trenton Railroad one that employs less than 500 persons). transactions that would connect the CompanyÐAcquisition and Operation Manufacturers of new passenger motor ExemptionÐCrown Enterprises, Inc. vehicles, including passenger cars, railroads with each other and there is no certain small buses, and light trucks other railroad in the corporate family, Riverview Trenton Railroad Company with a gross vehicle weight rating of and (iii) the transaction does not involve (Riverview), a noncarrier, has filed a 8,500 pounds or less, must file a report a Class I carrier. Therefore, the verified notice of exemption under 49 annually. transaction is exempt from the prior CFR 1150.31 to acquire from Crown Estimate of the Total Annual approval requirements of 49 U.S.C. Enterprises, Inc. and operate Reporting and Recordkeeping Burden 11323. See 49 CFR 1180.2(d)(2). approximately 1.5 miles of rail line Resulting from the Collection of Under 49 U.S.C. 10502(g), the Board within a 76-acre parcel in Riverview Information: NHTSA estimates that the may not use its exemption authority to and Trenton, MI.1 The line connects vehicle manufacturers will incur a total relieve a rail carrier of its statutory with the track of the Canadian National annual reporting and cost burden of obligation to protect the interests of its Railway Company subsidiary Grand 6,066 hours and $4,700,000. The employees. Section 11326(c), however, Trunk Western Railroad, Inc. (CN), over amount includes annual burden hours does not provide for labor protection for which Consolidated Rail Corporation (Conrail) has operated, at the exit from incurred by multi-stage manufacturers transactions under sections 11324 and the southwesterly edge of the 195.45- and motor vehicle equipment suppliers. 11325 that involve only Class III rail acre DSC site, as the track traverses Issued on: January 2, 2001. carriers. Because this transaction diagonally across the intersection of Noble N. Bowie, involves Class III rail carriers only, the King Road and W. Jefferson Avenue, in Acting Associate Administrator for Safety, Board, under the statute, may not Trenton, near the FN Tower and CN Performance Standards. impose labor protective conditions for River Subdivision milepost 10.96. The [FR Doc. 01–433 Filed 1–5–01; 8:45 am] this transaction. line also connects with the track of the BILLING CODE 4910±59±P If the notice contains false or CN as the line exits the 76-acre parcel misleading information, the exemption at the northwest corner where it traverses W. Jefferson Avenue near its DEPARTMENT OF TRANSPORTATION is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) junction with Ford Avenue in Riverview Surface Transportation Board may be filed at any time. The filing of and extends into the so-called CN Penn a petition to revoke will not Salt Yard, over which Conrail has automatically stay the transaction. operated, near CN River Subdivision [STB Finance Docket No. 33979] milepost 9.39.2 An original and 10 copies of all CenTra, Inc., et al.ÐContinuance in This transaction is related to STB pleadings, referring to STB Finance Finance Docket No. 33979, CenTra, Inc., Control ExemptionÐRiverview Trenton Docket No. 33979, must be filed with Railroad Company et al.—Continuance in Control the Surface Transportation Board, Office Exemption—Riverview Trenton Railroad CenTra, Inc. (CenTra) and Crown of the Secretary, Case Control Unit, 1925 Company, wherein CenTra, Inc., et al. Enterprises, Inc. (Crown) (collectively K Street, NW., Washington, DC 20423– has filed a verified notice to continue in applicants), noncarriers, have filed a 0001. In addition, a copy of each control of Riverview upon its becoming verified notice of exemption to continue pleading must be served on Daniel C. a Class III rail carrier. in control of the Riverview Trenton Sullivan, Esq., Sullivan & Hincks, 122 The transaction was expected to be Railroad Company (Riverview), upon W. 22nd Street, Suite 350, Oak Brook, consummated immediately after the Riverview’s becoming a Class III IL 60523. effective date of the exemption. The railroad. Board decisions and notices are earliest the transaction could be The transaction was expected to be available on our website at consummated was December 20, 2000, 7 3 consummated on the effective date of ‘‘WWW.STB.DOT.GOV.’’ days after the exemption was filed. the exemption. The earliest the transaction could be consummated was Decided: December 29, 2000. 1 In addition, Riverview has acquired from DSC December 20, 2000, 7 days after the By the Board, David M. Konschnik, Ltd. (DSC), a noncarrier and nonaffiliate, related track and trackage rights within a 195.45-acre exemption was filed. Director, Office of Proceedings. industrial site located adjacent to Riverview’s 76- This transaction is related to STB Vernon A. Williams, acre parcel. Finance Docket No. 33980, Riverview Secretary. 2 Riverview reports that all operations will occur within the Conrail Detroit Shared Asset Area as Trenton Railroad Company— [FR Doc. 01–329 Filed 1–8–01; 8:45 am] Acquisition and Operation Exemption— designated in a transaction approved by the Board, BILLING CODE 4915±00±P and consummated by the parties on June 1, 1999. Crown Enterprises, Inc., wherein See CSX Corporation and CSX Transportation, Inc., Riverview seeks to acquire a line of Norfolk Southern Corporation and Norfolk railroad approximately 1.5 miles long in Southern Railway Company—Control and Operating Leases/Agreements—Conrail Inc. and 1 The notice of exemption was filed in Jefferson Riverview and Trenton, MI. Consolidated Rail Corporation, STB Finance Docket CenTra controls Crown and Crown Terminal Railroad Co.—Acquisition and Operation No. 33388, Decision No. 89 (STB served July 23, controls Jefferson Terminal Railroad Exemption—Crown Enterprises, Inc., STB Finance 1998). Company (Jefferson), an entity formed to Docket No. 33950 (STB served and published at 65 3 Riverview notes that it will apply to CN and FR 66802 on Nov. 7, 2000). A petition filed by the Conrail for switching and interchanging of traffic to become a Class III railroad, which has City of Detroit to revoke the exemption is currently and from the tracks it owns, and/or will operate filed a notice of exemption to acquire pending. Continued

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If the verified notice contains false or at any time. The filing of a petition to be made available promptly to those misleading information, the exemption revoke will not automatically stay the requesting it. is void ab initio. Petitions to reopen the transaction. The interest of railroad employees proceeding to revoke the exemption An original and 10 copies of all will be protected by the conditions set under 49 U.S.C. 10502(d) may be filed pleadings, referring to STB Finance forth in Oregon Short Line R. Co.— at any time. The filing of a petition to Docket No. 33985, must be filed with Abandonment—Goshen, 360 I.C.C. 91 revoke will not automatically stay the the Surface Transportation Board, Office (1979). transaction. of the Secretary, Case Control Unit, 1925 By issuance of this notice, the Board An original and 10 copies of all K Street, NW., Washington, DC 20423– is instituting an exemption proceeding pleadings, referring to STB Finance 0001. In addition, a copy of each pursuant to 49 U.S.C. 10502(b). A final Docket No. 33980, must be filed with pleading must be served on John F. decision will be issued by April 6, 2001. the Surface Transportation Board, Office McHugh, McHugh & Barnes, P.C., 20 Any offer of financial assistance of the Secretary, Case Control Unit, 1925 Exchange Place, New York, NY 10005. (OFA) under 49 CFR 1152.27(b)(2) will K Street, NW., Washington, DC 20423– Board decisions and notices are be due no later than 10 days after 0001. In addition, a copy of each available on our website at service of a decision granting the pleading must be served on Daniel C. ‘‘WWW.STB.DOT.GOV.’’ petition for exemption. Each offer must Sullivan, Esq., Sullivan & Hincks, 122 Decided: December 29, 2000. be accompanied by a $1,000 filing fee. W. 22nd Street, Suite 350, Oak Brook, By the Board, David M. Konschnik, See 49 CFR 1002.2(f)(25). IL 60523. Director, Office of Proceedings. All interested persons should be Board decisions and notices are Vernon A. Williams, aware that, following abandonment of available on our website at Secretary. rail service and salvage of the line, the ‘‘WWW.STB.DOT.GOV.’’ line may be suitable for other public [FR Doc. 01–331 Filed 1–5–01; 8:45 am] use, including interim trail use. Any Decided: December 29, 2000. BILLING CODE 4915±00±P request for a public use condition under By the Board, David M. Konschnik, 49 CFR 1152.28 or for trail use/rail Director, Office of Proceedings. DEPARTMENT OF TRANSPORTATION banking under 49 CFR 1152.29 will be Vernon A. Williams due no later than January 29, 2001. Each Secretary. Surface Transportation Board trail use request must be accompanied [FR Doc. 01–330 Filed 1–5–01; 8:45 am] by a $150 filing fee. See 49 CFR BILLING CODE 4915±00±P [STB Docket No. AB±577X] 1002.2(f)(27). All filings in response to this notice Mohall Railroad, Inc.ÐAbandonment must refer to STB Docket No. AB–577X ExemptionÐin Bottineau, Renville, DEPARTMENT OF TRANSPORTATION and must be sent to: (1) Surface Ward and McHenry Counties, ND Transportation Board, Office of the Surface Transportation Board On December 19, 2000, Mohall Secretary, Case Control Unit, 1925 K [STB Finance Docket No. 33985] Railroad, Inc. (MRI) filed with the Street, N.W., Washington, DC 20423– Surface Transportation Board (Board) a 0001; and (2) Mark S. Radke and Byron LB Railco, Inc.ÐLease and Operation petition under 49 U.S.C. 10502 for D. Olsen, Felhaber, Larson, Fenlon & ExemptionÐSan Francisco Port exemption from the provisions of 49 Vogt, P.A., 601 Second Ave., South, Commission U.S.C. 10903 to abandon a line of Suite 4200, Minneapolis, MN 55402. LB Railco, Inc. (LB Railco) has filed a railroad known as the Mohall Line, Replies to the petition are due on or verified notice of exemption under 49 extending from milepost 5.25 to before January 29, 2001. CFR 1150.31 to operate lines leased milepost 35.0, a distance of 29.75 miles Persons seeking further information from the San Francisco Port in Bottineau, Renville, Ward and concerning abandonment procedures Commission between a junction with McHenry Counties ND.1 The line may contact the Board’s Office of Public Union Pacific Services, near Amador traverses U.S. Postal Service Zip Codes Services at (202) 565–1592 or refer to Street and Cargo Way, and the 58731, 58740, 58741, and 58750, and the full abandonment or discontinuance Intermodal Container Transfer Facility, includes the stations of Deering regulations at 49 CFR part 1152. and thence beyond to Piers 92, 94, and (milepost 12.9), Wolseth (approximately Questions concerning environmental 96, a total distance of approximately milepost 18), and Glenburn (milepost issues may be directed to the Board’s one-half mile in San Francisco, CA. 24.3). Section of Environmental Analysis LB Railco indicates that it intends to The line does not contain federally (SEA) at (202) 565–1545. [TDD for the commence operations by December 30, granted rights-of-way. Any hearing impaired is available at 1–800– 2000. The earliest the transaction can be documentation in MRI’s possession will 877–8339.] consummated is December 29, 2000 (7 An environmental assessment (EA) (or days after the exemption was filed). 1 The Burlington Northern and Santa Fe Railway environmental impact statement (EIS), if Company (BNSF), as successor to the Burlington necessary) prepared by SEA will be If the verified notice contains false or Northern Railroad Company, is generally prohibited misleading information, the exemption from abandoning in excess of 350 miles of rail lines served upon all parties of record and is void ab initio. Petitions to reopen the in North Dakota, a mileage total BNSF has already upon any agencies or other persons who proceeding to revoke the exemption reached. See section 402 of the Department of commented during its preparation. Transportation and Related Agencies Appropriation Other interested persons may contact under 49 U.S.C. 10502(d) may be filed Act of 1982 (Pub. L. No. 97–102, 1982). This limitation applies to the abandonment of any BNSF SEA to obtain a copy of the EA (or EIS). under a trackage and right-of-way agreement to lines in North Dakota, even after their sale to third EAs in these abandonment proceedings furnish cars, containers and trailers for the parties, and would thus normally be applicable to normally will be made available within movement of traffic of Riverview and to provide the Mohall Line. However, by an amendment 60 days of the filing of the petition. The service to move the resulting traffic generated by effective October 5, 2000, the specific segment of the proposed operation focusing upon intermodal track involved here may be abandoned without deadline for submission of comments on shipments, but that it will not enter or operate any being counted against this 350-mile limitation. See the EA will generally be within 30 days track or right-of-way of CN or Conrail. Pub. L. No. 106–940, sec. 372. of its service.

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Board decisions and notices are Clearance Officer: Garrick Shear, OMB Reviewer: Alexander T. Hunt, available on our website at Internal Revenue Service, Room 5244, (202) 395–7860, Office of Management ‘‘WWW.STB.DOT.GOV.’’ 1111 Constitution Avenue, NW, and Budget, Room 10202, New Decided: January 3, 2001. Washington, DC 20224. Executive Office Building, Washington, By the Board, David M. Konschnik, OMB Reviewer: Alexander T. Hunt, DC 20503. (202) 395–7860, Office of Management Director, Office of Proceedings. Lois K. Holland, Vernon A. Williams, and Budget, Room 10202, New Executive Office Building, Washington, Departmental Reports Management Officer. Secretary. DC 20503. [FR Doc. 01–445 Filed 1–5–01; 8:45 am] [FR Doc. 01–503 Filed 1–5–01; 8:45 am] BILLING CODE 4830±01±U BILLING CODE 4915±00±P Lois K. Holland, Departmental Reports Management Officer. [FR Doc. 01–444 Filed 1–5–01; 8:45 am] DEPARTMENT OF THE TREASURY DEPARTMENT OF THE TREASURY BILLING CODE 4830±01±U Office of Thrift Supervision Submission for OMB Review; Comment Request DEPARTMENT OF THE TREASURY Proposed Agency Information Collection Activities; Comment December 28, 2000. Submission for OMB Review; Request The Department of Treasury has Comment Request submitted the following public ACTION: Notice and request for information collection requirement(s) to January 2, 2001. comments. OMB for review and clearance under the The Department of Treasury has SUMMARY: Paperwork Reduction Act of 1995, submitted the following public The Department of the Public Law 104–13. Copies of the information collection requirement(s) to Treasury, as part of its continuing effort submission(s) may be obtained by OMB for review and clearance under the to reduce paperwork and respondent calling the Treasury Bureau Clearance Paperwork Reduction Act of 1995, burden, invites the general public and Officer listed. Comments regarding this Public Law 104–13. Copies of the other Federal agencies to comment on information collection should be submission(s) may be obtained by proposed and continuing information addressed to the OMB reviewer listed calling the Treasury Bureau Clearance collections, as required by the and to the Treasury Department Officer listed. Comments regarding this Paperwork Reduction Act of 1995, Clearance Officer, Department of the information collection should be Public Law 104–13. Today, the Office of Treasury, Room 2110, 1425 New York addressed to the OMB reviewer listed Thrift Supervision within the Avenue, NW., Washington, DC 20220. and to the Treasury Department Department of the Treasury solicits comments on the Lending and DATES: Clearance Officer, Department of the Written comments should be Investment Package. received on or before February 7, 2001 Treasury, Room 2110, 1425 New York to be assured of consideration. Avenue, NW., Washington, DC 20220. DATES: Submit written comments on or DATES: Written comments should be before March 9, 2001. Internal Revenue Service (IRS) received on or before February 7, 2001 ADDRESSES: OMB Number: 1545–0016. to be assured of consideration. Mail: Send comments to Manager, Form Number: IRS Form 706-A. Dissemination Branch, Information Type of Review: Extension. Internal Revenue Service (IRS) Management and Services Division, Title: United States Additional Estate OMB Number: 1545–1573. Office of Thrift Supervision, 1700 G Tax Return. Regulation Project Number: REG– Street, NW., Washington, DC 20552, Description: Form 706–A is used by 130477–00 and REG–130481–00 NPRM Attention 1550–0078. individuals to compute and pay the (formerly REG–209463–82 NPRM). Delivery: Hand deliver comments to additional estate taxes due under Code Type of Review: Extension. the Guard’s Desk, East Lobby Entrance, section 2032A(c). IRS uses the Title: Required Distributions from 1700 G Street, NW., from 9:00 a.m. to information to determine that the taxes Retirement Plans. 4:00 p.m. on business days, Attention have been properly computed. The form Description: The regulation permits a 1550–0078. is also used for the basis election of taxpayer to name a trust as the Facsimiles: Send facsimile section 1016(c)(1). beneficiary of the employee’s benefit transmissions to FAX Number (202) Respondents: Individuals or under a retirement plan and use the life 906–7755, Attention 1550–0078; or households. expectancies of the beneficiaries of the (202) 906–6956 (if comments are over 25 Estimated Number of Respondents/ trust to determine the required pages). Recordkeepers: 180. minimum distribution, if certain E–Mail: Send e-mails to conditions are satisfied. ‘‘[email protected]’’, Attention ESTIMATED BURDEN HOURS PER Respondents: Individuals or 1550–0078, and include your name and RESPONDENT/RECORDKEEPER households. telephone number. Estimated Number of Respondents: Public Inspection: Interested persons Recordkeeping ...... 3 hr., 17 min. 1,000. may inspect comments at the Public Learning about the law or 2 hr., 11 min. the form. Estimated Burden Hours Per Reference Room, 1700 G St. NW., from Preparing the form ...... 1 hr., 40 min. Respondent: 20 minutes. 10:00 a.m. until 4:00 p.m. on Tuesdays Copying, assembling, and 1 hr., 3 min. Estimated Total Reporting/ and Thursdays or obtain comments and/ sending the form to the Recordkeeping Burden: 333 hours. or an index of comments by facsimile by IRS. Clearance Officer: Garrick Shear, telephoning the Public Reference Room Internal Revenue Service, Room 5244, at (202) 906–5900 from 9:00 a.m. until Estimated Total Reporting/ 1111 Constitution Avenue, NW., 5:00 p.m. on business days. Comments Recordkeeping Burden: 1,474 hours. Washington, DC 20224. and the related index will also be posted

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Corrections Federal Register Vol. 66, No. 5

Monday, January 8, 2001

This section of the FEDERAL REGISTER COMMODITY FUTURES TRADING number and OMB approval number are contains editorial corrections of previously COMMISSION corrected to read as set forth above. published Presidential, Rule, Proposed Rule, and Notice documents. These corrections are 17 CFR Part 1 [FR Doc. C0–32655 Filed 1–5–01; 8:45 am] prepared by the Office of the Federal BILLING CODE 1505±01±D Register. Agency prepared corrections are issued as signed documents and appear in RIN 3038-AB56 the appropriate document categories elsewhere in the issue. Investment of Customer Funding DEPARTMENT OF LABOR Correction Employment and Training In rule document 00–32976 beginning Administration DEPARTMENT OF COMMERCE on page 82270 in the issue of Thursday, December 28, 2000, make the following 20 CFR Part 655 National Oceanic and Atmospheric correction: Administration On page 82271, in the second column, RIN 1215±AB09 in the first full paragraph, ten lines from 50 CFR Part 679 the bottom, ‘‘permit’’ should read Labor Condition Applications and [Docket No. 001213348±0366±02; I.D. ‘‘permittted’’. Requirements for Employers Using 121100A] Nonimmigrants on H±1B Visas in [FR Doc. C0–32976 Filed 1–5–01; 8:45 am] Specialty Occupations and as Fashion RIN 0648±AO44 BILLING CODE 1505±01±D Models; Labor Certification Process Fisheries of the Exclusive Economic for Permanent Employment of Aliens Zone Off Alaska; Removal of in the United States Groundfish Closure DEPARTMENT OF THE INTERIOR Correction Correction Bureau of Land Management In rule document 00–32088 beginning In rule document 00–33162 beginning on page 80110 in the issue of Wednesday, December 20, 2000, make on page 82298 in the issue of Thursday, [WO±310±1310±PB±01±24 1A] December 28, 2000, make the following the following correction: correction: Extension of Approved Information §655.736 [Corrected] Collection, OMB Approval Number §679.22 [Corrected] On page 80224, in the second column, 1004±0160 On page 82299, in the third column, in §655.736(b)(2)(iii), the second in §679.22(l), paragraph designation Correction paragraph designation ‘‘(ii)’’ should read ‘‘(k)’’ should read ‘‘(l)’’. ‘‘(iii)’’. In notice document 00–32655 [FR Doc. C0–33162 Filed 1–5–01; 8:45 am] beginning on page 80904 in the issue of [FR Doc. C0–32088 Filed 1–5–01; 8:45 am] BILLING CODE 1505±01±D Friday, December 22, 2000, the docket BILLING CODE 1505±01±D

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Part II

Department of the Treasury Internal Revenue Service 26 CFR Part 54 Department of Labor Pension and Welfare Benefits Administration 29 CFR Part 2590 Department of Health and Human Services Health Care Financing Administration 45 CFR Part 146

Nondiscrimination in Health Coverage in the Group Market; Interim Final Rules and Proposed Rules

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DEPARTMENT OF THE TREASURY must be received by the Departments on room 309–G of the Department of Health or before April 9, 2001. and Human Services, 200 Independence Internal Revenue Service ADDRESSES: Written comments should Avenue, SW., Washington, DC from 8:30 be submitted with a signed original and a.m. to 5 p.m. 26 CFR Part 54 three copies (except for electronic FOR FURTHER INFORMATION CONTACT: Russ [TD 8931] submissions to the Internal Revenue Weinheimer, Internal Revenue Service, Service (IRS) or Department of Labor) to Department of the Treasury, at (202) RIN 1545±AW02 any of the addresses specified below. 622–6080; Amy J. Turner, Pension and DEPARTMENT OF LABOR Any comment that is submitted to any Welfare Benefits Administration, Department will be shared with the Department of Labor, at (202) 219–7006; Pension and Welfare Benefits other Departments. or Ruth A. Bradford, Health Care Administration Comments to the IRS can be Financing Administration, Department addressed to: CC:M&SP:RU (REG– of Health and Human Services, at (410) 29 CFR Part 2590 109707–97), Room 5226, Internal 786–1565. Revenue Service, POB 7604, Ben SUPPLEMENTARY INFORMATION: RIN 1210±AA77 Franklin Station, Washington, DC Customer Service Information: DEPARTMENT OF HEALTH AND 20044. HUMAN SERVICES In the alternative, comments may be Individuals interested in obtaining hand-delivered between the hours of 8 additional information on HIPAA’s Health Care Financing Administration a.m. and 5 p.m. to: CC:M&SP:RU (REG– nondiscrimination rules may request a 109707–97), Courier’s Desk, Internal copy of the Department of Labor’s 45 CFR Part 146 Revenue Service, 1111 Constitution booklet entitled ‘‘Questions and Avenue, NW., Washington, DC 20224. Answers: Recent Changes in Health Care RIN 0938±AI08 Alternatively, comments may be Law’’ by calling the PWBA Toll-Free transmitted electronically via the IRS Publication Hotline at 1–800–998–7542 Interim Final Rules for Internet site at: http://www.irs.gov/tax or may request a copy of the Health Care Nondiscrimination in Health Coverage regs/regslist.html. Financing Administration’s new in the Group Market Comments to the Department of Labor publication entitled ‘‘Protecting Your AGENCIES: Internal Revenue Service, can be addressed to: U.S. Department of Health Insurance Coverage’’ by calling Department of the Treasury; Pension Labor, Pension and Welfare Benefits (410) 786–1565. Information on and Welfare Benefits Administration, Administration, 200 Constitution HIPAA’s nondiscrimination rules and Department of Labor; Health Care Avenue NW., Room C–5331, other recent health care laws is also Financing Administration, Department Washington, DC 20210, Attention: available on the Department of Labor’s of Health and Human Services. Nondiscrimination Comments. website (http://www.dol.gov/dol/pwba) ACTION: Interim final rules with request Alternatively, comments may be and the Department of Health and for comments. hand-delivered between the hours of 9 Human Services’ website (http:// a.m. and 5 p.m. to the same address. hipaa.hcfa.gov). SUMMARY: This document contains Comments may also be transmitted by e- interim final rules governing the mail to: [email protected]. I. Background provisions prohibiting discrimination Comments to HHS can be addressed The Health Insurance Portability and based on a health factor for group health to: Health Care Financing Accountability Act of 1996 (HIPAA), plans and issuers of health insurance Administration, Department of Health Public Law 104–191, was enacted on coverage offered in connection with a and Human Services, Attention: HCFA– August 21, 1996. HIPAA amended the group health plan. The rules contained 2022–IFC, P.O. Box 26688, Baltimore, Internal Revenue Code of 1986 (Code), in this document implement changes MD 21207. the Employee Retirement Income made to the Internal Revenue Code of In the alternative, comments may be Security Act of 1974 (ERISA), and the 1986 (Code), the Employee Retirement hand-delivered between the hours of Public Health Service Act (PHS Act) to Income Security Act of 1974 (ERISA), 8:30 a.m. and 5 p.m. to either: Room provide for, among other things, and the Public Health Service Act (PHS 443–G, Hubert Humphrey Building, 200 improved portability and continuity of Act) enacted as part of the Health Independence Avenue, SW., health coverage. HIPAA added section Insurance Portability and Washington, DC 20201 or Room C5–14– 9802 of the Code, section 702 of ERISA, Accountability Act of 1996 (HIPAA). 03, 7500 Security Boulevard, Baltimore, and section 2702 of the PHS Act, which DATES: Effective date. The interim final MD 21244–1850. prohibit discrimination in health rules are effective March 9, 2001. All submissions to the IRS will be coverage. Interim final rules Applicability dates. For rules open to public inspection and copying implementing the HIPAA provisions describing when this section applies to in room 1621, 1111 Constitution were first made available to the public group health plans and group health Avenue, NW., Washington, DC from 9 on April 1, 1997 (published in the insurance issuers, see paragraph (i) of a.m. to 4 p.m. Federal Register on April 8, 1997, 62 FR 1 these interim regulations. All submissions to the Department of 16894) (April 1997 interim rules). On Comment date. Written comments on Labor will be open to public inspection December 29, 1997, the Departments these interim regulations are invited and and copying in the Public Documents published a clarification of the April Room, Pension and Welfare Benefits 1997 interim rules as they relate to 1 References in this preamble to a specific paragraph in the interim regulations are to Administration, U.S. Department of individuals who were denied coverage paragraphs in each of the three sets of regulations Labor, Room N–1513, 200 Constitution before the effective date of HIPAA on being published as part of this document. Avenue, NW., Washington, DC from the basis of any health factor (62 FR Specifically, references are to paragraphs in 26 CFR 8:30 a.m. to 5:30 p.m. 67689). 54.9802–1 and 26 CFR 54.9802–1T (see discussion and table in ‘‘C. Format of Regulations’’ below), 29 All submissions to HHS will be open In the preamble to the April 1997 CFR 2590.702, and 45 CFR 146.121. to public inspection and copying in interim rules, the Departments invited

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1379 comments on whether additional • Explain the application of these Commenters cited language in the guidance was needed concerning— provisions to premiums; conference report that states, ‘‘The • The extent to which the statute • Describe similarly situated inclusion of evidence of insurability in prohibits discrimination against individuals; the definition of health status is individuals in eligibility for particular • Explain the application of these intended to ensure, among other things, benefits; provisions to actively-at-work and that individuals are not excluded from • The extent to which the statute may nonconfinement clauses; and health care coverage due to their permit benefit limitations based on the • Clarify that more favorable participation in activities such as source of an injury; treatment of individuals with medical motorcycling, snowmobiling, all-terrain • The permissible standards for needs generally is permitted. vehicle riding, horseback riding, skiing defining groups of similarly situated Described elsewhere in this issue of and other similar activities.’’ H.R. Conf. individuals; the Federal Register are proposed Rep. No. 736, 104th Cong., 2d Sess. 186 • Application of the prohibitions on standards for defining bona fide (1996). The interim regulations clarify discrimination between groups of wellness programs. that evidence of insurability includes similarly situated individuals; and Of course, plans and benefits that are participation in activities listed in the • The permissible standards for not subject to the HIPAA portability conference report. In addition, the determining bona fide wellness provisions (set forth in Chapter 100 of interim regulations incorporate the programs. the Code, part 7 of subtitle B of title I statutory clarification that evidence of In the preamble to the April 1997 of ERISA, and title XXVII of the PHS insurability includes conditions arising interim rules, the Departments stated Act) are not subject to the HIPAA out of acts of domestic violence. See that they intend to issue further nondiscrimination requirements. also the discussion below concerning regulations on the nondiscrimination Accordingly, the following plans and source-of-injury restrictions under the rules and that in no event would the benefits are not subject to the HIPAA heading ‘‘Application to Benefits.’’ Departments take any enforcement nondiscrimination requirements: Late enrollees and special enrollees. action against a plan or issuer that had benefits that qualify under the HIPAA Some commenters asked whether sought to comply in good faith with portability provisions as excepted treating late enrollees differently from section 9802 of the Code, section 702 of benefits; plans with fewer than two other enrollees is discrimination based ERISA, and section 2702 of the PHS Act participants who are current employees on one or more health factors. HIPAA before the additional guidance is on the first day of the plan year;3 and was designed to encourage individuals provided. Accordingly, with the self-funded non-Federal governmental to enroll in health coverage when first issuance of these interim regulations, plans that elect, under 45 CFR 146.180, eligible and to maintain coverage for as the Departments have determined that to be exempt from these long as they continue to be eligible. the period for nonenforcement in cases nondiscrimination requirements. In Permitting plans and issuers to treat late of good faith compliance ends in addition, under a proposed regulation enrollees less favorably than other accordance with the rules described in published by the Department of the enrollees is consistent with this paragraph (i) of these interim Treasury and described elsewhere in objective. The interim regulations regulations.2 However, because the this issue of the Federal Register, clarify that the decision whether to elect interim regulations do not include a certain church plans are treated as not health coverage, including the time an discussion of bona fide wellness violating the general HIPAA individual chooses to enroll, such as programs (see proposed rules relating to nondiscrimination provisions if the plan late enrollment, is not itself within the bona fide wellness programs published requires evidence of good health for the scope of any health factor. Thus, the elsewhere in this issue of the Federal coverage of certain individuals. interim regulations permit plans and issuers to treat late enrollees differently Register), the period for good faith Health Factors compliance continues with respect to from similarly situated individuals who those provisions until further guidance The HIPAA nondiscrimination enroll when first eligible. is issued. provisions set forth eight health status- Although the HIPAA related factors. The interim regulations nondiscrimination requirements do not II. Overview of the Regulations refer to these as ‘‘health factors.’’ The prohibit different treatment of special Section 9802 of the Code, section 702 eight health factors are health status, enrollees, any differential treatment of ERISA, and section 2702 of the PHS medical condition (including both would violate the HIPAA special Act (the HIPAA nondiscrimination physical and mental illnesses), claims enrollment requirements. These interim provisions) establish rules generally experience, receipt of health care, regulations provide a cross-reference to prohibiting group health plans and medical history, genetic information, the HIPAA regulations requiring special group health insurance issuers from evidence of insurability, and disability. enrollees to be treated the same as discriminating against individual These terms are largely overlapping and, individuals who enroll when first participants or beneficiaries based on in combination, include any factor eligible. any health factor of such participants or related to an individual’s health. Prohibited Discrimination in Rules for beneficiaries. These interim regulations Evidence of insurability. Several Eligibility interpret the HIPAA nondiscrimination commenters urged that the health factor provisions. Among other things, the ‘‘evidence of insurability’’ be These interim regulations provide that interim regulations— interpreted to prohibit plans and issuers group health plans and group health • Explain the application of these from denying coverage to individuals insurance issuers generally may not provisions to benefits; who engage in certain types of activities. establish any rule for eligibility of any • Clarify the relationship between the individual to enroll for benefits under HIPAA nondiscrimination provisions 3 However, a State may impose the requirements the terms of the plan or group health and the HIPAA preexisting condition of the HIPAA portability provisions, in whole or in insurance coverage that discriminates part, on health insurance coverage sold to groups exclusion limitations; that contain fewer than 2 current employees on the based on any health factor that relates first day of the plan year. See sections 2723 and to that individual or a dependent of that 2 See footnote 1. 2791(e) of the PHS Act. individual. Under these interim

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1380 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations regulations, rules for eligibility include, or issuer to impose a $100 lifetime limit based on a determination of whether the but are not limited to, rules relating to on a particular individual with a history benefits are experimental or not enrollment, the effective date of of high health claims (provided that the medically necessary, but only if the coverage, waiting (or affiliation) periods, individual is permitted to enroll in the benefit limitation or exclusion applies late and special enrollment, eligibility plan and is charged the same premium uniformly to all similarly situated for benefit packages (including rules for as similarly situated individuals), while individuals and is not directed at individuals to change their selection imposing a $1 million lifetime limit on individual participants or beneficiaries among benefit packages), benefits (as all other participants in the plan. based on any health factor of the described below under the heading At the other extreme, the statutory participants or beneficiaries. In ‘‘Application to Benefits’’), continued language could be interpreted to addition, a plan or issuer may impose eligibility, and terminating coverage of mandate parity in health benefits. This annual, lifetime, or other limits on any individual under the plan. interpretation would prevent plans and benefits and may require the satisfaction The rules for eligibility apply in issuers from designing benefit packages of a deductible, copayment, tandem with the rules describing that control costs and are responsive to coinsurance, or other cost-sharing similarly situated individuals (described employees’ preferences for balancing requirement in order to obtain a benefit below under the heading ‘‘Similarly additional benefits with additional if the limit or cost-sharing requirement Situated Individuals’’) to prevent costs. applies uniformly to all similarly discrimination in eligibility based on In the preamble to the April 1997 situated individuals and is not directed any health factor. Thus, while it is interim rules, the Departments at individual participants or permissible for a plan or issuer to specifically invited comments on beneficiaries based on any health factor impose waiting periods of different whether guidance was needed of the participants or beneficiaries.4 lengths on different groups of similarly concerning this issue. The comments These interim regulations clarify that situated individuals, a plan or issuer received ranged between these two whether any plan provision with respect would violate the interim regulations if extremes. The approach in these interim to benefits complies with the interim it imposed a longer waiting period for regulations takes into account the regulations does not affect whether the individuals within the same group of concerns expressed by commenters, as provision is permitted under the similarly situated individuals based on well as the conference report. Americans with Disabilities Act (ADA), the higher claims of those individuals Specifically, the conference report states or any other law, whether State or (or based on any other adverse health that: federal.5 factor of those individuals). Accordingly, for example, a group While the interim regulations clarify It is the intent of the conferees that a plan health plan may apply a lifetime limit that late enrollment itself is not within cannot knowingly be designed to exclude individuals and their dependents on the on all benefits provided to each the scope of any health factor, eligibility basis of health status. However, generally participant covered under the plan. for late enrollment comes within the applicable terms of the plan may have a While this limitation on all benefits may scope of rules for eligibility under disparate impact on individual enrollees. For adversely impact individuals with which discrimination based on one or example, a plan may exclude all coverage of serious medical conditions, the more health factors is prohibited. The a specific condition, or may include a limitation is permitted provided that it effect of these rules is to permit plans lifetime cap on all benefits, or a lifetime cap applies to all similarly situated or issuers to treat late enrollees on specific benefits. Although individuals individuals and is not directed at differently from individuals who enroll with the specific condition would be individual participants or beneficiaries. when first eligible but to prohibit plans adversely affected by an exclusion of Similarly, a plan or issuer may establish and issuers from distinguishing among coverage for that condition * * * such plan characteristics would be permitted as long as a specific lifetime limit on the treatment applicants for late enrollment based on they are not directed at individual sick of a particular condition (such as the any health factor of the applicant. Thus, employees or dependents. treatment of temporomandibular joint a plan could impose an 18-month syndrome (TMJ)) for all similarly preexisting condition exclusion on late H.R. Conf. Rep. No. 736, 104th Cong., 2d situated individuals in the plan. enrollees while imposing no preexisting Sess. 186–187 (1996). Although individuals with TMJ may be condition exclusion on individuals who The interim regulations clarify that adversely affected by this limitation, enroll in the plan when first eligible, but they do not require a plan or issuer to because benefits for the treatment of a plan would violate the interim provide coverage for any particular TMJ are available uniformly to all regulations if it conditioned the ability benefit to any group of similarly similarly situated individuals and to enroll as a late enrollee on the situated individuals. However, benefits because the limit on benefits for TMJ passing of a physical examination (or on provided under a plan or group health applies to all similarly situated any other health factor of the individual, insurance coverage must be uniformly individuals, the limit is permissible. such as having incurred health claims available to all similarly situated Under these interim regulations, plans during a past period below a certain individuals. Likewise, any restriction on and issuers therefore have significant dollar amount). a benefit or benefits must apply flexibility in designing benefits. uniformly to all similarly situated However, to prevent plans and issuers Application to Benefits individuals and must not be directed at from restricting benefits based on a General rules. The extent to which the individual participants or beneficiaries statutory language prohibits based on any health factor of the 4 For special rules that apply to cost-sharing discrimination against individuals in participants or beneficiaries mechanisms that are part of a bona fide wellness program, see the proposed regulations relating to eligibility for particular benefits is (determined based on all the relevant bona fide wellness programs published elsewhere subject to a wide range of facts and circumstances). Thus, for in this issue of the Federal Register. interpretations. At one extreme, the example, a plan or issuer may limit or 5 In this regard, the Equal Employment language could be interpreted as exclude benefits in relation to a specific Opportunity Commission has commented, by letter applying only to enrollment and to disease or condition, limit or exclude of July 7, 1997, ‘‘Title I of the ADA prohibits disability-based employment discrimination, premiums. Under this interpretation, for benefits for certain types of treatments including discrimination in fringe benefits such as example, it would be possible for a plan or drugs, or limit or exclude benefits health insurance plans.’’

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1381 specific health factor of an individual generally provides benefits for a type of The examples illustrate that a typical under the plan, the interim regulations injury, the plan or issuer may not use preexisting condition exclusion prohibit benefit restrictions, even if a source-of-injury restriction to deny permitted under the HIPAA preexisting applied uniformly to all similarly benefits otherwise provided for condition exclusion requirements does situated individuals, from being treatment of the injury if it results from not violate the HIPAA directed at individual participants or an act of domestic violence or a medical nondiscrimination requirements even beneficiaries based on any health factor condition (including both physical and though the exclusion inherently of the participants or beneficiaries. The mental health conditions). An example discriminates based on one or more interim regulations clarify that a plan in the interim regulations clarifies that health factors. The examples also amendment applicable to all individuals benefits for injuries generally covered illustrate that a plan nonetheless must in one or more groups of similarly under the plan cannot be excluded apply the preexisting condition situated individuals under the plan and merely because they were self-inflicted exclusion to similarly situated made effective no earlier than the first or were sustained in connection with a individuals in a uniform manner and day of the first plan year after the suicide or attempted suicide if the cannot apply a longer preexisting amendment is adopted is not considered injuries resulted from a medical condition exclusion period based on the to be directed at individual participants condition such as depression. Another submission of claims during the first and beneficiaries. This exception to the example illustrates that a plan can part of the exclusion period. general facts and circumstances nonetheless exclude benefits for injuries Prohibited Discrimination in Premiums determination that a change is directed because they were sustained in or Contributions at an individual is necessary to preserve connection with various recreational the flexibility of small employers that activities if the accident did not result Under the interim regulations, a group might otherwise be disproportionately from any medical condition (or from health plan, and a health insurance affected and prevented from adopting domestic violence). issuer offering health insurance changes in benefit design. If small coverage in connection with a group The Relationship Between the HIPAA employers are unable to modify future health plan, may not require an Nondiscrimination Provisions and the benefits to keep health coverage individual, as a condition of enrollment HIPAA Preexisting Condition Exclusion affordable, their alternative may be to or continued enrollment under the plan Provisions eliminate health coverage entirely. At or group health insurance coverage, to the same time, the exception reflects the Restrictions on benefits based on the pay a premium or contribution that is common practice of modifying the terms fact that a medical condition was greater than the premium or of a plan on an annual basis. Finally, present before the first day of coverage contribution for a similarly situated changes in benefit design that are discriminate against individuals based individual enrolled in the plan or group effective earlier than the first day of the on one or more health factors. The health insurance coverage, based on any next plan year remain subject to a facts statute nonetheless provides that the health factor that relates to that and circumstances determination nondiscrimination provisions are individual or a dependent of that regarding whether the change is intended to be construed in a manner individual. Under the interim directed at individual participants and consistent with the HIPAA provisions regulations, when determining an beneficiaries. specifically allowing the application of individual’s premium or contribution An example illustrates that if an preexisting condition exclusions. These rate, discounts, rebates, payments in individual files a claim for the treatment latter provisions restrict the ability of a kind, or other premium differential of a condition, and shortly thereafter the group health plan or group health mechanisms are taken into account.7 plan is modified to restrict benefits for insurance issuer to apply preexisting In general, the interim regulations do the treatment of the condition, effective condition exclusions, both by restricting not restrict the amount that an employer before the beginning of the next plan the circumstances under which an may be quoted or charged by an issuer year, the restriction would be directed at individual’s condition is considered (or, in the case of a multiemployer plan, the individual based on a health factor preexisting and by limiting the length of by the plan) for coverage of a group of (absent additional facts to indicate that the exclusion period. The interim similarly situated individuals. However, the change was made independent of regulations clarify that a preexisting the interim regulations prohibit certain the claim) and the plan would violate condition exclusion that satisfies the billing practices because in many these interim regulations. requirements of the HIPAA preexisting instances they could directly or Source-of-injury restrictions. While a condition exclusion provisions is indirectly result in an individual’s being person cannot be excluded from a plan permitted under the HIPAA charged more than a similarly situated for engaging in certain recreational nondiscrimination requirements if the individual based on a health factor. activities (see previous discussion on exclusion applies uniformly to Some health insurance issuers that evidence of insurability under the individuals within the same group of offer health insurance coverage in heading ‘‘Health Factors’’), benefits for a similarly situated individuals and is not connection with a group health plan use particular injury can, in some cases, be directed at individual participants or billing practices with separate excluded based on the source of an beneficiaries based on any health factor individual rates that vary based, in part, injury. These plan restrictions are of the participants or beneficiaries. A on the health factors of the individuals known as source-of-injury restrictions.6 plan amendment relating to a who are eligible to participate in the Under these interim regulations, if a preexisting condition exclusion plan. This practice is generally known plan or group health insurance coverage applicable to all individuals in one or as list billing. List billing based on a more groups of similarly situated 6 A commenter pointed out that this type of individuals under the plan and made 7 However, a group health plan or a health restriction is distinct from two other restrictions effective no earlier than the first day of insurance issuer offering group health insurance sometimes referred to as ‘‘source-of-injury the first plan year after the amendment coverage may establish premium or contribution restrictions’’—(1) those based on the geographic differentials through a bona fide wellness program. location where the injury occurred, and (2) those is adopted is not considered to be (See proposed regulations relating to bona fide based on when the injury occurred and whether directed at individual participants or wellness programs published elsewhere in this other coverage was in effect. beneficiaries. issue of the Federal Register).

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1382 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations health factor is prohibited under the within a group of similarly situated classifications based on occupation or interim regulations. individuals. Thus, these interim geographic location. In this connection, The HIPAA nondiscrimination regulations do not prohibit commenters had two principal requirements do not prohibit an issuer discrimination between or among concerns. First, there was a concern from considering all relevant health groups of similarly situated individuals. about reclassifications targeting factors of individuals in order to However, these interim regulations also unhealthy individuals. For example, a establish aggregate rates for coverage provide that if the creation or participant receiving expensive medical provided under the group health plan. modification of an employment or treatment might be reclassified to a However, an individual may not be coverage classification is directed at separate employment category either required to pay a higher premium based individual participants or beneficiaries with reduced health benefits or none at on any health factor of the individual. based on any health factor of the all. The broad anti-abuse standard of Under the interim regulations, an issuer participants or beneficiaries, the these interim regulations is intended, (or a multiemployer plan) may not quote classification is not permitted. This is among other things, to prohibit or charge an employer different intended to be a broad anti-abuse reclassifications directed at individuals premium rates on an individual-by- standard that applies based on the such as this. individual basis in a group of similarly relevant facts and circumstances of each A second concern that commenters situated individuals based on any health case. had was that plans and issuers might factor of the individuals, even if the The permissibility of discrimination design health benefits differently for employer does not pass the different between or among groups of similarly employees in different occupations or rates through to the individuals. If an situated individuals increases the geographic locations based, at least in issuer wishes to increase rates to cover possibility of abuse in establishing part, on the health factors of these the additional exposure to expenses that groups of similarly situated individuals. groups of individuals. One example is a may result from an individual’s health Most commenters addressing this issue plan that offers fewer benefits to factor, the issuer must blend the focused on the classification of employees in one occupation than to increase into an overall group rate and participants and suggested that employees in another occupation at then quote or charge a higher per- classifications should be based on work least in part because of the higher participant rate. Nonetheless, the activities and not on a health factor or average historical claims of the prohibition on the practice of list billing on activities unrelated to employment. employees in the first occupation. A based on a health factor does not restrict The interim regulations provide second example is a plan that charges communications between issuers and generally that participants may be employees in one area more than plans regarding rate calculations. treated as two or more groups of employees in another area at least in similarly situated individuals if the part because the cost of medical care is Similarly Situated Individuals distinction between or among the generally higher in the first area. The The statutory HIPAA groups is based on a bona fide statute and legislative history appear to nondiscrimination requirements clarify employment-based classification allow this practice, and thus these that the general rule prohibiting consistent with the employer’s usual interim regulations do not prohibit the discrimination in eligibility does not business practice. The validity of a provision of different health benefits for prevent a group health plan or group category as a bona fide employment- employees in different occupations or health insurance coverage from based classification is determined based geographic locations, based at least in establishing limitations or restrictions on all the relevant facts and part on the health factors of the group on the amount, level, extent, or nature circumstances. Relevant facts and as a whole, if the classifications are not of benefits for ‘‘similarly situated circumstances include whether the directed at individual participants or individuals’’ enrolled in the plan or employer uses the classification for beneficiaries based on a health factor of coverage. The statutory rule prohibiting purposes independent of qualification the participants or beneficiaries. discrimination in charging individuals for health coverage (for example, These interim regulations also permit premiums or contributions prohibits a determining eligibility for other plans and issuers, in certain plan or issuer from requiring any employee benefits or determining other circumstances, to treat beneficiaries as individual, based on any health factor of terms of employment). Subject to the different groups of similarly situated that individual or a dependent of that anti-abuse standard (described in the individuals. Beneficiaries may be individual, to pay a premium or preceding paragraph), the interim treated as a group of similarly situated contribution that is greater than the regulations allow distinctions to be individuals separate from participants, premium or contribution required of a made based on full-time versus part- and different treatment is permitted ‘‘similarly situated individual.’’ In the time status, different geographic among beneficiaries based on bona fide preamble to the April 1997 interim location, membership in a collective employment-based classifications of the rules, the Departments requested bargaining unit, date of hire, length of participants through whom the comments both on the permissible service, current employee versus former beneficiaries are receiving coverage. standards for defining groups of employee status, and different Thus, if the plan provides different similarly situated individuals and on occupations. benefits to full-time employees than to the application of the prohibitions on Some commenters expressed concern part-time employees, then it may also discrimination between groups of that allowing similarly situated provide different benefits to dependents similarly situated individuals. individuals to be determined based on of full-time employees than to Many commenters suggested that occupation or geographic location dependents of part-time employees. discrimination between groups of would allow plans and issuers to create Similarly, different treatment is similarly situated individuals should be artificial classifications, ostensibly permitted based on the beneficiary’s permitted, with the caveat that it should based on occupation or geographic relationship to the participant (for not be permissible to define a group location, that are actually designed to example, as a spouse or as a dependent based on a health factor. These interim discriminate based on a health factor of child). Different treatment is also regulations provide that the an individual or individuals. These permitted based on the beneficiary’s nondiscrimination rules apply only interim regulations permit bona fide marital status, based on a dependent

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1383 child’s age or student status, or based on individual to enroll for benefits or from work due to any health factor is any other factor if the factor is not a charge any individual a higher premium considered being actively at work. health factor. (or contribution) based on any These interim regulations also The rules in these interim regulations individual’s ability to engage in normal provide an exception for the first day of allowing the different treatment of life activities. However, these interim work to the general prohibition against individuals in different groups of regulations provide an exception that actively-at-work clauses. Under the similarly situated individuals are permits plans and issuers to distinguish exception, a plan or issuer may require distinct from rules requiring that among employees based on the an individual to begin work before qualified beneficiaries under a COBRA performance of services. Although in coverage may become effective. continuation provision 8 have available practice nonconfinement clauses The interim regulations explain the the same coverage as similarly situated generally apply only to dependents, in relationship between the rules non-COBRA beneficiaries. Although some cases they apply also to governing actively-at-work clauses and these interim regulations would not employees. Thus, the interim the rules describing similarly situated prohibit making benefit packages regulations clarify that a individuals. Under the interim available to non-COBRA beneficiaries nonconfinement clause would also be regulations, a plan or issuer is generally (such as current employees) that are not impermissible if applied to an permitted to distinguish between groups made available to COBRA qualified employee. of similarly situated individuals (provided the distinction is not directed beneficiaries (such as former These rules are of particular interest at individual participants or employees), the COBRA continuation in the case of a group health plan beneficiaries based on a health factor). provisions prohibit such a difference. switching coverage from one health Examples illustrate that a plan or issuer Finally, all of the requirements insurance issuer to a succeeding health may condition coverage on an relating to determining groups of insurance issuer. In such a case, the individual’s meeting the plan’s similarly situated individuals are HIPAA nondiscrimination provisions requirement of working full-time (such subject to other rules in these interim prohibit the succeeding issuer from as a minimum of 250 hours in a three- regulations permitting favorable denying eligibility to any individual due treatment of individuals with certain month period or 30 hours per week). In to confinement to a hospital or other addition, a plan or issuer may terminate adverse health factors (discussed below health care institution because such a under the heading ‘‘More Favorable coverage for former employees while denial would discriminate in eligibility providing coverage to current Treatment of Individuals with Adverse based on one or more health factors. The Health Factors Permitted’’). employees without violating the HIPAA obligation of the succeeding issuer to nondiscrimination provisions if the Nonconfinement Provisions provide coverage to such an individual rules describing similarly situated Some group health plans and health does not preempt any obligation that the individuals are satisfied, even if the insurance issuers refuse to provide prior issuer may have under other former employee is unable to work due benefits to an individual based on the applicable law, including State to a health factor. Similarly, a plan or individual’s confinement to a hospital extension of benefits laws. issuer may charge a higher premium to or other health care institution at the Actively-at-Work and Other Service employees no longer performing time coverage otherwise would become Requirements services than to employees currently effective. Plan provisions like these are performing services without violating often called ‘‘nonconfinement clauses.’’ Some group health plans and health the HIPAA nondiscrimination Any reasonable interpretation or insurance issuers refuse to provide provisions if the rules describing application of the statutory HIPAA benefits to an individual if the similarly situated individuals are met. nondiscrimination provisions prohibits individual is not actively at work on the An example illustrates that the interim a plan or issuer from imposing a day the individual would otherwise regulations would not, however, permit nonconfinement clause.9 Thus, a plan or become eligible for benefits. Plan a plan or issuer to treat individuals on issuer may not deny the eligibility of provisions like these are often called annual or bereavement leave better than any individual to enroll for benefits or ‘‘actively-at-work clauses.’’ These individuals on sick leave because charge any individual a higher premium interim regulations provide that a plan groups of similarly situated individuals (or contribution) because the individual, or issuer generally may not impose an cannot be established based on any or a dependent of the individual, is ‘‘actively-at-work clause.’’ That is, these health factor (including the taking of confined to a hospital or other health interim regulations prohibit a plan or sick leave). care institution. In addition, some plans issuer from denying the eligibility of In any case, other federal or State and issuers refuse to provide benefits to any individual to enroll for benefits or laws, including the COBRA an individual based on an individual’s charging any individual a higher continuation provisions and the Family inability to engage in normal life premium or contribution based on and Medical Leave Act of 1993 (FMLA), activities. A plan or issuer generally whether an individual is actively at may require individuals to be offered may not deny the eligibility of any work (including whether an individual coverage and set limits on the premium is continuously employed). However, an or contribution rate. 8 actively-at-work clause is permitted if The term COBRA continuation provision is Bona Fide Wellness Programs defined in 26 CFR 54.9801–2T, 29 CFR 2590.701– individuals who are absent from work 2, and 45 CFR 144.103. due to any health factor (for example, The HIPAA nondiscrimination 9 For an example illustrating that the imposition individuals taking sick leave) are provisions do not prevent a plan or of a nonconfinement clause is not a good faith interpretation of the HIPAA nondiscrimination treated, for purposes of health coverage, issuer from establishing premium provisions, and the rule requiring that individuals as if they are actively at work. discounts or rebates or modifying denied enrollment without a good faith Accordingly, plan provisions that delay otherwise applicable copayments or interpretation of the law be provided an enrollment until an individual is deductibles in return for adherence to opportunity to enroll, see the discussion below under the heading ‘‘Transitional Rule for actively at work on a day following a programs of health promotion and Individuals Previously Denied Coverage Based on a waiting period (or for a continuous disease prevention. Thus, there is an Health Factor.’’ period) are prohibited unless absence exception to the general rule prohibiting

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1384 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations discrimination based on a health factor Premiums. These interim regulations No Effect on Other Laws if the reward, such as a premium also address the circumstances under Compliance with these interim discount or waiver of a cost-sharing which differential premiums (or regulations is not determinative of requirement, is based on participation contributions) may be charged to an compliance with any other provision of in a program of health promotion or individual based on an adverse health ERISA, or any other State or federal law, disease prevention. The April 1997 factor. These interim regulations permit including the Americans with interim rules, these interim regulations, plans and issuers to charge a higher rate Disabilities Act. Therefore, while these and proposed regulations published in some situations and also a lower rate interim regulations generally do not elsewhere in this issue of the Federal to individuals based on an adverse impose any new disclosure Register refer to programs of health health factor, such as disability. A requirements on plans or issuers, other promotion and disease prevention higher rate may be charged only in applicable law continues to apply. For allowed under this exception as ‘‘bona situations where the individual with the example, under Title I of ERISA, fide wellness programs.’’ For a adverse health factor would not have administrators of ERISA-covered group discussion of bona fide wellness coverage were it not for the adverse health plans are required to provide programs, see the preamble to proposed participants and beneficiaries with a regulations published elsewhere in this health factor. Thus, in a case where a plan or issuer makes extended coverage summary plan description that is issue of the Federal Register. sufficiently accurate and comprehensive available to employees no longer to reasonably apprise such participants More Favorable Treatment of performing services only if the Individuals With Adverse Health and beneficiaries of their rights and employee is unable to work due to 11 Factors Permitted obligations under the plan. In disability, the plan could require a addition, some courts have held that Many group health plans make certain higher payment from the employee only fiduciaries of ERISA-covered group periods of extended coverage available while the employee is receiving health plans are obligated to ensure that to employees no longer performing coverage under that special eligibility plan documents and disclosures are services only if the employee is unable provision. However, the plan could not consistent with applicable disclosure to work due to disability, and many charge a disabled employee a higher rate requirements and do not serve to plans make coverage available to than nondisabled employees while the mislead or misinform participants and dependent children past a certain age disabled employee was still eligible beneficiaries concerning their rights and only if the child is disabled. Some plans under a generally-applicable eligibility obligations under the plans in which waive or reduce the required employee provision, rather than the special they participate.12 Fiduciaries are contribution for coverage if the extended coverage provision. advised to take steps to ensure that plan employee or a member of the Accordingly, under the interim disclosures are accurate and are not employee’s immediate family is in a regulations, a plan or issuer could misleading. critical medical condition for a charge a higher rate for COBRA coverage These interim regulations are also not prolonged period. Disability and during the disability extension than for determinative of compliance with the medical condition are listed in the COBRA coverage outside the disability COBRA continuation provisions, or any other State or federal law, such as the statute as health factors, and several extension (and the result is the same if Americans with Disabilities Act. commenters recognized that, under one the extended coverage for disability is possible interpretation of the HIPAA provided pursuant to State law or plan Applicability Date nondiscrimination requirements, plan provision rather than pursuant to a provisions or practices such as these These interim regulations generally COBRA continuation provision).10 would be impermissible. These apply for plan years beginning on or commenters asked for guidance Although charging a higher rate based after July 1, 2001 (although some clarifying that plan provisions and on an adverse health factor is limited to provisions apply earlier, as discussed practices like these would be the situation in which coverage would below under the heading ‘‘III. Format of permissible. Other commenters cited the not be available but for the adverse Regulations’’). As noted above, in the rule under the COBRA continuation health factor, under these interim preamble to the April 1997 interim rules provisions permitting plans to require regulations a plan or issuer is always the Departments stated that they payment of a higher amount during the permitted to charge an individual a intended to issue further regulations on disability extension than during other lower rate based on an adverse health the statutory nondiscrimination rules. That preamble also stated that in no periods of COBRA coverage and asked factor. Thus, even though an employee event would the Departments take any whether following this COBRA rule is is receiving coverage under the same enforcement action against a plan or permissible under the HIPAA eligibility provision as other employees issuer that had sought to comply in nondiscrimination requirements. who are required to pay the full Eligibility. These interim regulations good faith with the statutory employee share of the premium, under nondiscrimination provisions before the permit plans and issuers to establish the interim regulations it is permissible rules for eligibility favoring individuals additional guidance was issued. The to waive or reduce the employee share Departments will not take any based on an adverse health factor, such of the premium if the employee or a as disability. Thus, a plan or issuer does enforcement action against a plan or family member is in critical medical issuer with respect to efforts to comply not violate the HIPAA condition for a prolonged period. nondiscrimination requirements by in good faith with the statutory nondiscrimination provisions before the making extended coverage available to 10 This result is consistent with the result under employees no longer providing services first plan year beginning on or after July the COBRA continuation provisions. Under those 1, 2001. (See the description of only if the employee is unable to work provisions, plans are generally permitted to require due to disability nor by making coverage payment of up to 102 percent of the applicable premium but are permitted to require payment for 11 See ERISA section 102, and the Department of available to dependent children past a coverage of a disabled qualified beneficiary of up Labaor’s regulations issued thereunder. certain age only if the child is disabled. to 150 percent of the applicable premium during 12 See Varity Corp v. Howe, 516 U.S. 489, 506 Examples clarify this rule. the disability extension period. (1996).

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Upon the applicability of rules in the clarification apply whether individual must be given an option to these regulations, however, good faith or not the plan offered late enrollment. have coverage effective either (1) efforts to comply with the statutory Neither the April 1997 interim rules prospectively from the date the plan provisions addressed by these interim nor the December 1997 guidance clearly receives a request for enrollment in regulations may not be sufficient to addressed the situation where an connection with the enrollment avoid adverse enforcement actions by individual was denied only late opportunity or (2) retroactively to the the Departments. Therefore, for plan enrollment based on a health factor first day of the first plan year beginning years beginning on or after July 1, 2001, prior to the effective date of HIPAA and, on HIPAA’s effective date for the plan plans and issuers must comply with the by the effective date of HIPAA, the plan (or, if the individual otherwise first requirements of these regulations in eliminated late enrollment. For became eligible to enroll for coverage order to avoid adverse enforcement example, prior to HIPAA many plans after that date, on the date the actions. As discussed earlier, under the and issuers allowed individuals to individual was otherwise eligible to heading ‘‘Background,’’ the period for enroll when first eligible without regard enroll in the plan). good faith compliance continues with to health status, but allowed late The reason for giving the individual respect to bona fide wellness programs enrollees to enroll only if they could the opportunity to elect retroactive until further guidance is issued. pass a physical examination (or present coverage is to make the individual evidence of good health). Upon the whole; that is, to put the individual in Transitional Rules for Individuals effective date of HIPAA, some of these the same financial condition that the Previously Denied Coverage Based on a plans and issuers eliminated late individual would have been in had the Health Factor enrollment. individual not been denied enrollment. The April 1997 interim rules clarified Any plan or issuer that permitted Thus, if the individual elects retroactive that a plan or issuer violates the HIPAA these individuals to enroll once the coverage, the plan or issuer may require nondiscrimination requirements if it HIPAA nondiscrimination provisions the individual to pay premiums or requires an individual to pass a physical took effect, of course, is in compliance contributions for the retroactive period examination as a condition for with this provision of the (but the plan or issuer cannot charge enrollment, even if the condition is nondiscrimination rules. In contrast, a interest on that amount). imposed only on late enrollees. The plan or issuer that continued to deny The rule differs for situations where HIPAA nondiscrimination requirements coverage to these individuals may have coverage was denied to individuals apply both to eligibility and continued done so based on a good faith based on one or more health factors but eligibility of any individual to enroll interpretation of the statute and the where the denial was based on a good under a plan. Consequently, once Departments’ published guidance. For faith interpretation of the statute or the HIPAA became effective with respect to example, a plan or issuer might Departments’ prior published guidance. a plan or health insurance issuer, it was reasonably have thought that HIPAA did In those situations, these interim a violation of the nondiscrimination not require it to remedy pre-HIPAA regulations require plans and issuers to requirements to continue to deny an denials of late enrollment based on a give the individuals an opportunity to individual eligibility to enroll if the health factor for individuals who could enroll that continues for at least 30 days reason the individual was denied have enrolled initially without regard to and with coverage effective not later enrollment previously was due to one or their health if the plan or issuer than July 1, 2001. more health factors (such as requiring eliminated late enrollment by the In both situations (whether the denial the individual to pass a physical effective date of HIPAA. of coverage was or was not based on a examination). The interim regulations provide good faith interpretation), the interim On December 29, 1997, the transitional rules for situations where regulations also clarify that, once Departments issued in the Federal coverage was denied to individuals enrolled, these individuals cannot be Register a clarification of the April 1997 based on one or more health factors, treated as late enrollees. The interim rules relating to individuals both where the denial was based on a individual’s enrollment date under the who were denied coverage due to a good faith interpretation of the statute or plan is the effective date of HIPAA (or, health factor before the effective date of the Departments’ published guidance if later, the date the individual would HIPAA (62 FR 67689). The clarification and where it was not. In either event, a have otherwise been eligible to enroll). restates the requirement of the April safe harbor provides that the In addition, any period between an 1997 interim rules that an individual Departments will not take any individual’s enrollment date and the cannot be denied coverage based on a enforcement action with respect to such effective date of coverage is treated as a health factor on or after the effective a denial of coverage if the plan or issuer waiting period. Thus, for example, with date of HIPAA. The clarification then complies with the transitional rules. respect to a calendar year plan that is states that individuals to whom Where the denial was not based on a not collectively bargained, an individual coverage had not been made available good faith interpretation, the interim who was previously denied late before the effective date of HIPAA based regulations provide that the plan or enrollment due to a health factor before on a health factor and who enrolled issuer is required to give the individual the effective date of HIPAA has an when first eligible on or after the an opportunity to enroll (including enrollment date of January 1, 1998 effective date of the HIPAA notice of an opportunity to enroll) that (HIPAA’s effective date for that plan) nondiscrimination provisions could not continues for at least 30 days. This and a waiting period that begins on that be treated as a late enrollee for purposes opportunity must be presented not later date. Moreover, because any waiting of the HIPAA preexisting condition than March 9, 2001. If the opportunity period must begin on the individual’s exclusion provisions. Under the is presented within the first plan year enrollment date, January 1, 1998, and clarification, individuals to whom beginning on or after the effective date the maximum preexisting exclusion coverage had not been made available of the statutory HIPAA period that can be applied is 12 months,

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1386 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations individuals who enroll in the plan on that an application for coverage would temporary and cross-referencing July 1, 2001 cannot be subject to any have been denied based on a health proposed regulations. The April 1997 preexisting condition exclusion period. factor.) The notice must specify the interim rules were originally issued by effective date of compliance, and inform Treasury in the form of temporary and Special Transitional Rule for Self- the individual regarding any enrollment cross-referencing proposed regulations. Funded Non-Federal Governmental restrictions that may apply under the Under section 7805(e)(2) of the Code, Plans Exempted Under 45 CFR 146.180 terms of the plan once the plan comes however, any temporary regulation The sponsor of a self-funded non- into compliance. The plan may not treat issued under the Code expires within Federal governmental plan may elect the individual as a late enrollee or a three years after the date issued. under section 2721(b)(2) of the PHS Act special enrollee. Coverage must be Treasury is issuing final regulations that and 45 CFR 146.180 to exempt its group effective no later than the date the restate the rules relating to the HIPAA health plan from the nondiscrimination exemption election under 45 CFR nondiscrimination requirements from requirements of section 2702 of the PHS 146.180 (with regard to these the April 1997 regulations without Act and 45 CFR 146.121. If the plan nondiscrimination requirements) no significant modification. The final sponsor subsequently chooses to bring longer applies, or July 1, 2001 (if later) regulations apply March 9, 2001. Table the plan into compliance with these and the plan was acting in accordance 1 identifies which paragraphs of the nondiscrimination requirements, the with a good faith interpretation of the final regulation issued today correspond plan must provide notice to that effect statutory HIPAA nondiscrimination to which paragraphs of the April 1997 to individuals who were denied provisions and guidance published by regulation. New guidance being enrollment based on one or more health the Health Care Financing published today by Treasury is being factors, and afford those individuals an Administration. issued as temporary and cross- opportunity, that continues for at least III. Format of Regulations referencing proposed regulations. This 30 days, to enroll in the plan. (An guidance will apply to group health individual is considered to have been Final and Temporary Treasury plans beginning with the first plan year denied coverage if he or she failed to Regulations on or after July 1, 2001. (These new apply for coverage because, given an The Department of the Treasury is temporary regulations will also expire exemption election under 45 CFR issuing a portion of these regulations as after three years pursuant to section 146.180, it was reasonable to believe final regulations and a portion as 7805(e) of the Code.)

TABLE 1.ÐCOMPARISON OF TREASURY'S APRIL 1997 REGULATIONS WITH TREASURY'S FINAL REGULATIONS

April 1997 regulations Final regulation under § 9802

§ 54.9802±1T(a)(1) ...... § 54.9802±1(a)(1),(2); (b)(1) § 54.9802±1T(a)(2)(i) ...... § 54.9802±1(b)(2)(i)(A) § 54.9802±1T(a)(3) ...... [The corresponding provision is in the new temporary regulations.] § 54.9802±1T(a)(4) ...... § 54.9802±1(b)(1)(iii) § 54.9802±1T(b)(1) ...... § 54.9802±1(c)(1)(i) § 54.9802±1T(b)(2)(i) ...... § 54.9802±1(c)(2)(i) § 54.9802±1T(b)(2)(ii) ...... § 54.9802±1(b)(2)(i); (c)(3) § 54.9802±1T(b)(3) ...... [The corresponding provision is in the new proposed regulations for wellness programs.]

Interim Final Labor and HHS Regulations The guidance issued by the Departments of Labor (Labor) and Health and Human Services (HHS) in April 1997 is not subject to a statutory expiration date. Accordingly, the Labor and HHS guidance is being published as interim final regulations. These regulations contain two applicability dates that parallel the two separate applicability dates in the Treasury guidance. Table 2 identifies which paragraphs of the interim final regulation issued today are applicable on March 9, 2001 and which paragraphs apply on or after July 1, 2001.

TABLE 2.ÐAPPLICABILITY DATES FOR THE INTERIM FINAL REGULATIONS

Applies plan Paragraph of the interim final years begin- Subject regulations Applies 3/9/01 ning on or after 7/1/2001

Health factors ...... (a)(1) ...... ✔ ...... Health factorsÐEvidence of insurabilityÐConditions arising out of an (a)(2)(i) ...... ✔ ...... act of domestic violence. Health factorsÐEvidence of insurabilityÐParticipation in certain activi- (a)(2)(ii) ...... ✔ ties. Health factorsÐThe decision whether health coverage is elected ...... (a)(3) ...... ✔ Prohibited discrimination in rules for eligibilityÐGeneral rule ...... (b)(1)(i) ...... ✔ ...... Prohibited discrimination in rules for eligibilityÐRules for eligibility de- (b)(1)(ii) ...... ✔ scribed. Prohibited discrimination in eligibilityÐGeneral ruleÐExample 1 ...... (b)(1)(iii) Example 1 ...... ✔ ...... Prohibited discrimination in eligibilityÐGeneral ruleÐExamples 2 (b)(1)(iii) Examples 2 through 4 ...... ✔ through 4. Prohibited discrimination in eligibilityÐApplication to benefitsÐNo bene- (b)(2)(i)(A) ...... ✔ ...... fits mandated.

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TABLE 2.ÐAPPLICABILITY DATES FOR THE INTERIM FINAL REGULATIONSÐContinued

Applies plan Paragraph of the interim final years begin- Subject regulations Applies 3/9/01 ning on or after 7/1/2001

Prohibited discrimination in eligibilityÐApplication to benefitsÐNon- (b)(2)(i)(B), (C), & (D) ...... ✔ discriminatory benefit restrictions permitted. Prohibited discrimination in eligibilityÐApplication to benefitsÐCertain (b)(2)(ii) ...... ✔ ...... cost-sharing mechanisms. Prohibited discrimination in eligibilityÐApplication to benefitsÐSource- (b)(2)(iii) ...... ✔ of-injury exclusions. Prohibited discrimination in eligibilityÐApplication to benefitsÐRelation- (b)(3) ...... ✔ ship to HIPAA preexisting condition exclusion rules. Prohibited discrimination in premiums or contributionsÐGeneral rule ..... (c)(1)(i) ...... ✔ ...... Prohibited discrimination in premiums or contributionsÐDetermining an (c)(1)(ii) ...... ✔ individual's premium rate. Prohibited discrimination in premiums or contributionsÐGroup rating on (c)(2)(i) ...... ✔ ...... health factors not restricted. Prohibited discrimination in premiums or contributionsÐList billing (c)(2)(ii) & (iii) ...... ✔ based on a health factor prohibited. Prohibited discrimination in premiums or contributionsÐException for (c)(3) ...... ✔ ...... bona fide wellness programs. Similarly situated individuals ...... (d) ...... ✔ Nonconfinement and actively-at-work provisions ...... (e) ...... ✔

Bona fide wellness programs ...... (f) [Reserved.] ...... See proposed regulations published elsewhere in this Federal Register.

More favorable treatment of individuals with adverse health factors per- (g) ...... ✔ mitted. No effect on other laws ...... (h) ...... ✔ IV. Interim Final Regulations With discrimination against individuals in Departments ‘‘promptly complete Request for Comments eligibility for particular benefits; the regulations related to HIPAA’s non- The principal purpose of these extent to which the statute may permit discrimination provisions’’ (GAO/HEHS interim final regulations is to provide benefit limitations based on the source 00–85). Therefore, the Departments have additional guidance on how to comply of an injury; the permissible standards determined that it is appropriate to with the HIPAA nondiscrimination for defining groups of similarly situated issue the guidance on an interim final individuals; the application of the basis, with the exception of the bona provisions contained in section 9802 of 13 the Code, section 702 of ERISA, and prohibitions on discrimination between fide wellness program provisions. section 2702 of the PHS Act. Code groups of similarly situated individuals; With respect to these last provisions, the section 9833, ERISA section 734, and and the permissible standards for Departments would like to better PHS Act section 2792 authorize the determining bona fide wellness develop the administrative record before any provisions regarding such programs Secretaries of the Treasury, Labor, and programs. Numerous comments were go into effect. HHS to issue any interim final rules as received in response to this request. The Secretaries believe that this After evaluating all of the comments, the Secretaries deem are appropriate to period of interim effectiveness will and after speaking with various carry out certain provisions of HIPAA, provide ample opportunity for the interested parties in the course of an including the nondiscrimination regulated community to comment extensive educational outreach provisions. As explained below, the specifically on this comprehensive campaign, the Departments have Secretaries have determined that these guidance, providing a sound basis for developed these comprehensive regulations should be issued as interim developing final rules. The Departments regulations. Among other things, the final rules with requests for comments. are seeking comments from all those HIPAA was enacted in August of comments reflected the need for more affected by these regulations, and the 1996. The Secretaries first issued comprehensive guidance on the Departments will consider such interim final rules providing guidance application of the nondiscrimination comments and will reevaluate these on HIPAA’s nondiscrimination provisions. In the period since HIPAA regulations following the comment provisions in April of 1997. In was enacted and the April 1997 period in the same way that it would if publishing this guidance, the Secretaries regulations were issued, numerous the regulations had been published in relied on the authority granted in issues have arisen concerning how proposed form. Based on such section 9833 of the Code, section 734 of plans and issuers should apply the comments and other information ERISA, and section 2792 of the PHS Act, nondiscrimination provisions. In obtained through the administration of as well as other authority including addition, the number of comments and the nondiscrimination requirements, the section 101(g)(4) of HIPAA and section the breadth of issues raised Departments will make any necessary 505 of ERISA. As part of the April 1997 demonstrates that these regulations modifications to the regulations when rulemaking, the Secretaries requested should go into effect on an interim basis they are issued in final form. comments on whether additional pending receipt of further comments. guidance was needed concerning the This need to act on an interim basis is 13 See proposed rules relating to bona fide extent to which the statutory HIPAA also supported by the General wellness programs published elsewhere in this nondiscrimination provisions prohibit Accounting Office’s request that the issue of the Federal Register.

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V. Economic Impact and Paperwork cost incurred by group health plans to Executive Order. Consistent with the Burden provide coverage under HIPAA’s Executive Order, the Departments have statutory nondiscrimination provisions assessed the costs and benefits of this Summary—Department of Labor and to individuals previously denied regulatory action. The Departments’ Department of Health and Human coverage or offered restricted coverage assessment, and the analysis underlying Services based on health factors are offset by the that assessment, is detailed below. The HIPAA’s nondiscrimination commensurate or greater benefits Departments performed a provisions generally prohibit group realized by the newly eligible comprehensive, unified analysis to health plans and group health plan participants on whose behalf the estimate the costs and benefits issuers from discriminating against premiums or claims are paid. Although attributable to the interim regulation for individuals in eligibility or premium on the Departments are not aware of any purposes of compliance with the the basis of health status factors. The published estimates of transfers Executive Order 12866, the Regulatory Departments crafted this regulation to attributable to HIPAA’s statutory Flexibility Act, and the Paperwork secure these protections as intended by nondiscrimination provisions, a rough Reduction Act. Congress in as economically efficient a attempt to gauge the order of magnitude 1. Statement of Need for Proposed manner as possible, and believe that the of this transfer suggests that it may Action economic benefits of the regulation amount to more than $400 million outweigh its costs. annually, which is a small fraction of 1 These interim regulations are needed The primary economic benefits percent of total expenditures by group to clarify and interpret the HIPAA associated with securing HIPAA’s plans. The regulation clarifies at the nondiscrimination provisions nondiscrimination provisions derive margin exactly what practices are (prohibiting discrimination against from increased access to affordable permitted or prohibited by these individual participants and group health plan coverage for provisions, and may have the effect of beneficiaries based on health status) individuals with health problems. slightly increasing the amount of this under section 702 of the Employee Increased access benefits both newly transfer. Retirement Income Security Act of 1974 covered individuals and society at large. (ERISA), section 2702 of the Public It fosters expanded insurance coverage, Executive Order 12866—Department of Health Service Act, and section 9802 of timelier and fuller medical care, better Labor and Department of Health and the Internal Revenue Code of 1986. The health outcomes, and improved Human Services provisions are needed to ensure that productivity and quality of life. This is Under Executive Order 12866, the group health plans and group health especially true for the individuals most Departments must determine whether a insurers and issuers do not discriminate affected by HIPAA’s nondiscrimination regulatory action is ‘‘significant’’ and against individuals, participants, and provisions—those with adverse health therefore subject to the requirements of beneficiaries based on any health factors conditions. Denied insurance, the Executive Order and subject to with respect to health care coverage and individuals in poorer health are more review by the Office of Management and premiums. Additional guidance was likely to suffer economic hardship, to Budget (OMB). Under section 3(f), the required to explain the application of forgo badly needed care for financial order defines a ‘‘significant regulatory the statute to benefits, clarify the reasons, and to suffer adverse health action’’ as an action that is likely to relationship between the HIPAA outcomes as a result. For them, gaining result in a rule (1) having an annual nondiscrimination provisions and the insurance is more likely to mean gaining effect on the economy of $100 million HIPAA preexisting condition exclusion economic security, receiving timely, or more, or adversely and materially limitations, explain the applications of quality care, and living healthier, more affecting a sector of the economy, these provisions to premiums, describe productive lives. productivity, competition, jobs, the similarly situated individuals, explain Additional economic benefits derive environment, public health or safety, or the application of the provisions to directly from the improved clarity State, local or tribal governments or actively-at-work and nonconfinement provided by the regulation. The communities (also referred to as clauses, clarify that more favorable regulation will reduce uncertainty and ‘‘economically significant’’); (2) creating treatment of individuals with medical costly disputes and promote confidence serious inconsistency or otherwise needs generally is permitted, and in health benefits’ value, thereby interfering with an action taken or describe plans’ and issuers’ obligations improving labor market efficiency and planned by another agency; (3) with respect to plan amendments. fostering the establishment and materially altering the budgetary 2. Costs and Benefits continuation of group health plans. impacts of entitlement grants, user fees, The Departments estimate that the or loan programs or the rights and The primary economic benefits cost of plans to implement amendments obligations of recipients thereof; or (4) associated with the HIPAA in order to comply with this regulation, raising novel legal or policy issues nondiscrimination provisions derive revise materials accordingly, and arising out of legal mandates, the from increased access to affordable provide notices of opportunities to President’s priorities, or the principles group health plan coverage for enroll as required by the regulation will set forth in the Executive Order. individuals with health problems. amount to less than $19 million. This is Pursuant to the terms of the Executive Expanding access benefits both newly a one-time cost distinguishable from the Order, it has been determined that this covered individuals and society at large transfer that will result from the self- action raises novel policy issues arising by fostering expanded insurance implementing requirements of HIPAA’s out of legal mandates. In addition, the coverage, timelier and fuller medical nondiscrimination provisions and the magnitude of the transfer that arises care, better health outcomes, and discretion exercised by the Departments from the implementation of HIPAA’s improved productivity and quality of in this regulation. statutory nondiscrimination provisions life. Additional economic benefits Such a transfer occurs when resources is estimated to exceed $100 million. derive directly from the improved are redistributed without any direct Therefore, this notice is ‘‘significant’’ clarity provided by the regulation. By change in aggregate social welfare. In and subject to OMB review under clarifying employees’ rights and plan this instance, the premium and claims Sections 3(f)(1) and 3(f)(4) of the sponsors’ obligations under HIPAA’s

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1389 nondiscrimination provisions, the certain requirements with respect to those costs across the much larger regulation will reduce uncertainty and Federal rules that are subject to the number of small plans that buy them. costly disputes and promote confidence notice and comment requirements of These same small plans will incur costs in health benefits’ value, thereby section 553(b) of the Administrative of $10 million to prepare and distribute improving labor market efficiency and Procedure Act (5 U.S.C. 551 et seq.) and notices of enrollment opportunities as fostering the establishment and likely to have a significant economic required by the regulation, the continuation of group health plans. impact on a substantial number of small Departments estimate. The total The Departments estimate that the entities. Unless an agency certifies that economic cost to small plans to comply cost to plans to implement amendments a proposed rule will not have a with this regulation is estimated to be in order to comply with this regulation, significant economic impact on a $14 million. This is a one-time cost revise materials accordingly, and substantial number of small entities, distinguishable from the transfer that provide notices of opportunities to section 603 of the RFA requires that the will result from the self-implementing enroll as required by the regulation will agency present an initial regulatory requirements of HIPAA’s amount to less than $19 million. This is flexibility analysis at the time of the nondiscrimination provisions and the a one-time cost distinguishable from the publication of the notice of proposed discretion exercised by the Departments transfer that will result from the self- rule making describing the impact of the in this regulation. implementing requirements of HIPAA’s rule on small entities and seeking public Such a transfer occurs when resources nondiscrimination provisions and the comment on such impact. Small entities are redistributed without any direct discretion exercised by the Departments include small businesses, organizations, change in aggregate social welfare. In in this regulation. and governmental jurisdictions. this instance, the premium and claims Such a transfer occurs when resources Because these rules are being issued cost incurred by group health plans to are redistributed without any direct as interim final rules and not as a notice provide coverage under HIPAA’s change in aggregate social welfare. In of proposed rule making, the RFA does statutory nondiscrimination provisions this instance, the premium and claims not apply and the Departments are not to individuals previously denied cost incurred by group health plans to required to either certify that the rule coverage or offered restricted coverage provide coverage under HIPAA’s will not have a significant impact on a based on health factors are offset by the statutory nondiscrimination provisions substantial number of small businesses commensurate or greater benefits to individuals previously denied or conduct a regulatory flexibility realized by the newly eligible coverage or offered restricted coverage analysis. The Departments nonetheless participants on whose behalf the based on health factors are offset by the crafted this regulation in careful premiums or claims are paid. The commensurate or greater benefits consideration of its effects on small Departments note that transfers to small realized by the newly eligible entities, and have conducted an analysis plans attributable to HIPAA’s statutory participants on whose behalf the of the likely impact of the rules on small nondiscrimination provisions may premiums or claims are paid. Although entities. amount to approximately $110 million. the Departments are not aware of any For purposes of this discussion, the The regulation clarifies at the margin published estimates of transfers Departments consider a small entity to exactly what practices are permitted or attributable to HIPAA’s statutory be an employee benefit plan with fewer prohibited by these provisions, and may nondiscrimination provisions, a rough than 100 participants. The basis of this have the effect of slightly increasing the attempt to gauge the order of magnitude definition is found in section 104(a)(2) amount of this transfer. The of this transfer suggests that it may of ERISA, which permits the Secretary Departments note that this transfer is of Labor to prescribe simplified annual amount to more than $400 million the direct reflection of the intent and reports for pension plans which cover annually. The regulation clarifies at the beneficial effect of HIPAA’s fewer than 100 participants. The margin exactly what practices are nondiscrimination provisions: Departments believe that assessing the permitted or prohibited by these increasing access to affordable group impact of this interim final rule on provisions, and may have the effect of health plan coverage for individuals small plans is an appropriate substitute slightly increasing the amount of this with health problems. They also note for evaluating the effect on small transfer. The Departments note that this that even the full transfer to small plans entities as that term is defined in the transfer is the direct reflection of the attributable to HIPAA’s statutory RFA. intent and beneficial effect of HIPAA’s nondiscrimination provisions amounts nondiscrimination provisions: Small plans in particular will benefit from the regulations’ provisions that to a small fraction of total expenditures increasing access to affordable group by these plans. health plan coverage for individuals affirm and clarify the flexibility with health problems. They also note available to plans under HIPAA’s Paperwork Reduction Act—Department that even the full transfer to plans nondiscrimination requirements. of Labor and Department of the attributable to HIPAA’s statutory Consideration of small plans’ needs and Treasury circumstances played an important part nondiscrimination provisions probably 1. Department of Labor amounts to a small fraction of 1 percent in the development of these provisions. of total expenditures by these plans. These provisions are discussed in more The Department of Labor, as part of its The Departments believe that the detail below. continuing effort to reduce paperwork benefits of the regulation outweigh its The Departments estimate that plans and respondent burden, conducts a costs. with 100 or fewer participants will preclearance consultation program to A fuller discussion of the incur costs of $4 million on aggregate to provide the general public and federal Departments assessment of the costs and amend their provisions to comply with agencies with an opportunity to benefits of this regulation is provided the regulation and revise their materials comment on proposed and continuing below. accordingly. These costs generally will collections of information in accordance fall directly to issuers who supply small with the Paperwork Reduction Act of Regulatory Flexibility Act group insurance products and stop-loss 1995 (PRA 95), 44 U.S.C. 3506(c)(2)(A). The Regulatory Flexibility Act (5 insurers who provide services to small This helps to ensure that requested data U.S.C. 601 et seq.) (RFA) imposes self-insured plans, who will spread can be provided in the desired format,

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1390 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations reporting burden (time and financial (202) 219–4782; Fax: (202) 219–4745 and (iii) describe the requirement that resources) is minimized, collection (these are not toll-free numbers). individuals previously denied coverage instruments are clearly understood, and under a group health plan be provided 2. Department of the Treasury the impact of collection requirements on with an opportunity to enroll in the respondents can be properly assessed. The collection of information is in 26 plan, and a notice concerning this Currently, the Pension and Welfare CFR 54.9802–1T(i)(3)(ii) and (iii). This opportunity. Pursuant to paragraph Benefits Administration (PWBA) is information is required to be provided (i)(3)(ii), where coverage denials were soliciting comments concerning the so that participants who have been not based on a good faith interpretation proposed information collection request denied group health plan coverage of section 702 of the ERISA and section (ICR) included in the Interim Final based on a health status factor may be 9802 of the Code, notices of the Rules for Nondiscrimination in Health made aware of the opportunity to enroll opportunity for individuals previously Coverage in the Group Market. in the plan. The likely respondents are denied coverage to enroll are required to The Department has submitted this business or other for-profit institutions, be provided within 60 days of ICR using emergency review procedures non-profit institutions, small businesses publication of this interim final rule. to the Office of Management and Budget or organizations, and Taft-Hartley trusts. Where coverage was denied based on a (OMB) for its review and clearance in Responses to this collection of good faith interpretation of section 702 accordance with PRA 95. OMB approval information are mandatory for affected of ERISA and section 9802 of the Code, has been requested by March 9, 2001. group health plans. the plan or issuer must provide notice The Department and OMB are Books or records relating to a of the opportunity to enroll that particularly interested in comments collection of information must be continues for at least 30 days, with that: retained as long as their contents may coverage effective no later than July 1, • Evaluate whether the proposed become material in the administration 2001. collection of information is necessary of any internal revenue law. Generally, The method of estimating the hour for the proper performance of the tax returns and tax return information and cost burdens of the information functions of the agency, including are confidential, as required by 26 collection request is described in the whether the information will have U.S.C. 6103. section of this preamble appearing practical utility; Comments on the collection of below entitled Costs and Benefits of the information should be sent to the Office • Evaluate the accuracy of the Regulation. Generally, the Departments of Management and Budget, Attn: Desk agency’s estimate of the burden of the have conservatively estimated that all Officer for the Department of the proposed collection of information, group health plans that excluded Treasury, Office of Information and including the validity of the individuals on the basis of health status Regulatory Affairs, Washington, DC, methodology and assumptions used; factors prior to HIPAA’s enactment will 20503, with copies to the Internal • Enhance the quality, utility, and provide a notice of the opportunity to Revenue Service, Attn: IRS Reports clarity of the information to be enroll to all participants. The total Clearance Officer, T:FP, Washington, DC collected; and burden of providing notices to 20224. Comments on the collection of • Minimize the burden of the participants of private employers is information should be received by collection of information on those who divided equally between the February 7, 2001. In light of the request are to respond, including through the Departments of Labor and Treasury. for OMB clearance by March 9, 2001, use of appropriate automated, Paragraph (h), No effect on other laws, the early submission of comments is electronic, mechanical, or other is not considered to include an encouraged to ensure their technological collection techniques or information collection request because consideration. Comments are other forms of information technology, the provision makes no substantive or specifically requested concerning: material change to the Department of e.g., permitting electronic submission of • Whether the proposed collection of Labor’s existing information collection the responses. information is necessary for the proper Comments on the collection of request for the Summary Plan performance of the functions of the Description and Summary of Material information should be sent to the Office Internal Revenue Service, including of Information and Regulatory Affairs, Modifications currently approved under whether the information will have OMB control number 1210–0039. Office of Management and Budget, practical utility; Room 10235, New Executive Office Type of Review: New. • How to enhance the quality, utility, Agency: Pension and Welfare Benefits Building, Washington DC 20503; and clarity of the information to be Administration, Department of Labor; Attention: Desk Officer for the Pension collected; U.S. Department of the Treasury, and Welfare Benefits Administration. • How to minimize the burden of Internal Revenue Service. Although comments may be submitted complying with the proposed collection Title: Notice of Opportunity To through March 9, 2001, OMB requests of information, including the Enroll. that comments be received within application of automated collection OMB Number: 1210–0NEW; 1545– February 7, 2001 of the publication of techniques or other forms of information 0NEW. the Interim Final Rule to ensure their technology; and Affected Public: Individuals or consideration in OMB’s review of the • Estimates of capital or start up costs households; Business or other for-profit request for emergency approval. All and costs of operation, maintenance, institutions; Not-for-profit institutions. comments will be shared among the and purchase of services to provide Total Respondents: 120,000. Departments. information. Frequency of Response: One time. Requests for copies of the ICR may be Total Responses: 2.0 million. addressed to: Gerald B. Lindrew, Office 3. Description of Collection of Estimated Burden Hours: 5,950 of Policy and Research, U.S. Department Information (Pension and Welfare Benefits of Labor, Pension and Welfare Benefits 29 CFR 2590.702(i)(3)(ii) and (iii) and Administration); 5,950 (Internal Administration, 200 Constitution 26 CFR 54.9802–1T(i)(3)(ii) and (iii) of Revenue Service). Avenue, NW, Room N–5647, these interim rules include information Estimated Annual Costs (Operating Washington, DC, 20210. Telephone: collection requests. Paragraphs (i)(3)(ii) and Maintenance): $5.1 million

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(Pension and Welfare Benefits beneficiaries are not subject to unfair exempted under 45 CFR 146.180. Administration); $5.1 million (Internal discrimination. Paragraph (4)(i) requires that if coverage Revenue Service). HCFA is requesting OMB review and has been denied to any individual Estimated Total Annual Costs: $5.1 approval of this collection 60 working because the sponsor of a self-funded million (Pension and Welfare Benefits days after the publication of this rule, non-Federal governmental plan has Administration); $5.1 million (Internal with a 180-day approval period. Written elected under § 146.180 of this part to Revenue Service). comments and recommendations will be exempt the plan from the requirements Comments submitted in response to accepted from the public if received by of this section, and the plan sponsor the information collection provisions of the individuals designated below within subsequently chooses to bring the plan these Interim Final, final, and temporary 30 working days after the publication of into compliance with the requirements rules will be shared among the this rule. of this section, the plan must: notify the Departments and summarized and/or During this 180-day period, we will individual that the plan will be coming included in the request for continuing publish a separate Federal Register into compliance with the requirements OMB approval of the information notice announcing the initiation of an of this section; afford the individual an collection request; they will also extensive 60-day agency review and opportunity that continues for at least become a matter of public record. public comment period on these 30 days, specify the effective date of requirements. We will submit the compliance; and inform the individual Paperwork Reduction Act—Department requirements for OMB review and an regarding any enrollment restrictions of Health and Human Services extension of this emergency approval. that may apply under the terms of the Under the Paperwork Reduction Act We are soliciting public comment on plan once the plan is in compliance of 1995 (PRA), agencies are required to each of the issues for the provisions with this section (as a matter of provide a 60-day notice in the Federal summarized below that contain administrative convenience; the notice information collection requirements: Register and solicit public comment may be disseminated to all employees). before a collection of information Section 146.121 Prohibiting The regulation clarifies that self- requirement is submitted to the OMB for Discrimination Against Participants and funded non-Federal governmental plans review and approval. In order to fairly Beneficiaries Based on a Health Factor. are required to give individuals who were previously discriminated against evaluate whether an information (h) No effect on other laws. Although collection should be approved by OMB, an opportunity to enroll, including this section generally does not impose notice of an opportunity to enroll. The section 3506(c)(2)(A) of the PRA new disclosure obligations on plans and requires that we solicit comment on the development of the number of plans issuers, this paragraph (h) states that that are required to notify individuals following issues: this section does not affect any other • Whether the information collection were conservatively arrived at by laws, including those that require assuming that all plans which have is necessary and useful to carry out the accurate disclosures and prohibit excluded individuals must notify all proper functions of the agency; intentional misrepresentation. individuals who are eligible to • The accuracy of the agency’s Therefore, plan documents (including, participate in the plan. Development of estimate of the information collection for example, group health insurance the transitional notices are estimated to burden; policies and certificates of insurance) • take 0 hours for State governmental The quality, utility, and clarity of must be amended if they do not plans and 200 hours for local the information to be collected; and accurately reflect the requirements set • governmental plans. The corresponding Recommendations to minimize the forth in this section, by the applicability burden for work performed by service information collection burden on the date of this section. providers is anticipated to be $1,000 for affected public, including automated The revisions to the plan documents State governmental plans and $535,000 collection techniques. are intended to eliminate provisions for local governmental plans. The We are, however, requesting an that do not comply with the HIPAA Department estimates that the burden to emergency review of this interim final nondiscrimination statute and distribute transitional notices will rule with comment period. In regulations. In particular, it is require State governmental plans 800 compliance with section 3506(c)(2)(A) anticipated that changes will be hours and 1,400 hours for local of the PRA, we are submitting to OMB required to the majority of actively-at- governmental plans. The corresponding the following requirements for work provisions and nonconfinement distribution burden performed by emergency review. We are requesting an clauses found in plan documents. The service providers is $72,000 for State emergency review because the modifications are to be made by the governmental plans and $158,000 for collection of this information is needed applicability date of the regulation and local governmental plans. before the expiration of the normal time the requirements do not impose any on- The above costs will be reduced to the limits under OMB’s regulations at 5 CFR going burden. The revisions are extent that State and local governmental Part 1320, to ensure compliance with anticipated to take 100 hours for state plans have elected to opt out of the section 2702 of the PHS Act. This governmental plans and 4,900 hours for HIPAA requirements. As of the date of section generally prohibits group health local governmental plans. The changes publishing, approximately 600 plans plans and group health insurance are expected to involve one hour of an have opted out of the HIPAA statutory issuers from discriminating against attorney’s time at a $72 hourly rate. The and regulatory requirements. individual participants or beneficiaries corresponding plan amendment cost to We have submitted a copy of this rule based on any health factor of such be performed by service providers who to OMB for its review of the information participants or beneficiaries. We cannot are acting on behalf of the plans, is collection requirements. These reasonably comply with normal $32,000 for State governmental plans requirements are not effective until they clearance procedures because public and $1,311,000 for local governmental have been approved by OMB. A notice harm is likely to result if the agency plans. will be published in the Federal cannot enforce the requirements of this (i) Special transitional rule for self- Register when approval is obtained. section 2702 of the PHS Act in order to funded non-Federal governmental plans If you comment on any of these ensure that individual participants or information collection and record

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1392 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations keeping requirements, please mail In the Departments’ view, these Departments’ understanding that the copies directly to the following: interim final regulations do not have vast majority of States have in fact Health Care Financing Administration, federalism implications, because they implemented provisions which meet or Office of Information Services, do not have substantial direct effects on exceed the minimum requirements of Information Technology Investment the States, the relationship between the the HIPAA non-discrimination Management Group, Division of national government and States, or on provisions. HCFA Enterprise Standards, Room the distribution of power and HIPAA provides that the States may C2–26–17, 7500 Security Boulevard, responsibilities among various levels of enforce the provisions of HIPAA as they Baltimore, MD 21244–1850, Attn: government. This is largely because, pertain to issuers, but that the Secretary John Burke HCFA–2022, with respect to health insurance issuers, of Health and Human Services must the vast majority of States have enacted enforce any provisions that a State fails and laws which meet or exceed the federal to substantially enforce. When Office of Information and Regulatory standards in HIPAA prohibiting exercising its responsibility to enforce Affairs, Office of Management and discrimination based on health factors. the provisions of HIPAA, HCFA works Budget, Room 10235, New Executive Therefore, the regulations are not likely cooperatively with the States for the Office Building, Washington, DC to require substantial additional purpose of addressing State concerns 20503, Attn.: Allison Herron Eydt, oversight of States by the Department of and avoiding conflicts with the exercise HCFA–2022. Health and Human Services. of State authority.14 HCFA has Small Business Regulatory Enforcement In general, through section 514, developed procedures to implement its Fairness Act ERISA supersedes State laws to the enforcement responsibilities, and to extent that they relate to any covered afford the States the maximum This interim final rule is subject to the employee benefit plan, and preserves opportunity to enforce HIPAA’s provisions of the Small Business State laws that regulate insurance, requirements in the first instance. Regulatory Enforcement Fairness Act of banking, or securities. While ERISA HCFA’s procedures address the 1996 (5 U.S.C. 801 et seq.) and is being prohibits States from regulating a plan handling of reports that States may not transmitted to Congress and the as an insurance or investment company be enforcing HIPAA’s requirements, and Comptroller General for review. The or bank, HIPAA added a new the mechanism for allocating interim final rule, is a ‘‘major rule,’’ as preemption provision to ERISA (as well enforcement responsibility between the that term is defined in 5 U.S.C. 804, as to the PHS Act) preserving the States and HCFA. To date, HCFA has because it is likely to result in an annual applicability of State laws establishing had occasion to enforce the HIPAA non- effect on the economy of $100 million requirements for issuers of group health discrimination provisions in only two or more. As such, this interim final rule insurance coverage, except to the extent States. is being transmitted to Congress and the that these requirements prevent the Although the Departments conclude Comptroller General for review. application of the portability, access, that these interim final rules do not Unfunded Mandates Reform Act and renewability requirements of have federalism implications, in HIPAA. The nondiscrimination keeping with the spirit of the Executive For purposes of the Unfunded provisions that are the subject of this Order that agencies closely examine any Mandates Reform Act of 1995 (Pub. L. rulemaking are included among those policies that may have federalism 104–4), as well as Executive Order requirements. implications or limit the policy making 12875, this interim final rule does not In enacting these new preemption discretion of the States, the Department include any Federal mandate that may provisions, Congress indicated its intent of Labor and HCFA have engaged in result in expenditures by State, local, or to establish a preemption of State numerous efforts to consult with and tribal governments, nor does it include insurance requirements only to the work cooperatively with affected State mandates which may impose an annual extent that those requirements prevent and local officials. burden of $100 million or more on the the application of the basic protections For example, the Departments were private sector. set forth in HIPAA. HIPAA’s Conference aware that some States commented on the way the federal provisions should be Federalism Statement—Department of Report states that the conferees intended interpreted. Therefore, the Departments Labor and Department of Health and the narrowest preemption of State laws have sought and received input from Human Services with regard to health insurance issuers. H.R. Conf. Rep. No. 736, 104th Cong. 2d State insurance regulators and the Executive Order 13132 (August 4, Session 205 (1996). Consequently, National Association of Insurance 1999) outlines fundamental principles under the statute and the Conference Commissioners (NAIC). The NAIC is a of federalism, and requires the Report, State insurance laws that are non-profit corporation established by adherence to specific criteria by federal more stringent than the federal the insurance commissioners of the 50 agencies in the process of their requirements are unlikely to ‘‘prevent States, the District of Columbia, and the formulation and implementation of the application of’’ the HIPAA four U.S. territories, that among other policies that have substantial direct nondiscrimination provisions. effects on the States, the relationship Accordingly, States are given 14 This authority applies to insurance issued with between the national government and significant latitude to impose respect to group health plans generally, including plans covering employees of church organizations. States, or on the distribution of power requirements on health insurance Thus, this discussion of federalism applies to all and responsibilities among the various issuers that are more restrictive than the group health insurance coverage that is subject to levels of government. Agencies federal law. In many cases, the federal the PHS Act, including those church plans that promulgating regulations that have law imposes minimum requirements provide coverage through a health insurance issuer (but not to church plans that do not provide these federalism implications must which States are free to exceed. coverage through a health insurance issuer). For consult with State and local officials, Guidance conveying this interpretation additional information relating to the application of and describe the extent of their was published in the Federal Register these nondiscrimination rules to church plans, see consultation and the nature of the on April 8, 1997 and these regulations the preamble to regulations being proposed elsewhere in this issue of the Federal Register concerns of State and local officials in do not reduce the discretion given to the regarding section 9802(c) of the Code relating to the preamble to the regulation. States by the statute. It is the church plans.

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1393 things provides a forum for the conferences in March 1999 and June 2. Costs and Benefits of HIPAA’s development of uniform policy when 2000, the Implementation and Statutory Nondiscrimination Provisions uniformity is appropriate. Its members Enforcement of HIPAA National State- As noted above, HIPAA’s statutory meet, discuss, and offer solutions to Federal Conferences in August 1999 and nondiscrimination provisions are mutual problems. The NAIC sponsors 2000. Furthermore, both the Department largely self-implementing even in the quarterly meetings to provide a forum of Labor and HCFA websites offer links absence of interpretive guidance. It is for the exchange of ideas, and in-depth to important State websites and other the Departments’ policy where consideration of insurance issues by resources, facilitating coordination practicable to evaluate such impacts regulators, industry representatives, and between the State and federal regulators separately from the impact of discretion consumers. HCFA and Department of and the regulated community. exercised in regulation. The Labor staff have attended the quarterly In conclusion, throughout the process Departments provide qualitative meetings consistently to listen to the assessments of the nature of the costs, concerns of the State Insurance of developing these regulations, to the extent feasible within the specific benefits, and transfers that are expected Departments regarding HIPAA issues, to derive from statutory provisions, and including the nondiscrimination preemption provisions of HIPAA, the Departments have attempted to balance provide summaries of any credible, provisions. In addition to the general empirical estimates of these effects that discussions, committee meetings and the States’ interests in regulating health insurance issuers, and Congress’s intent are available. task groups, the NAIC sponsors the To the Departments’ knowledge, there following two standing HIPAA meetings to provide uniform minimum protections to consumers in every State. is no publicly available work that for members during the quarterly quantifies the magnitude or presents the conferences: Unified Analysis of Costs and Benefits nature of these benefits, costs, and • HCFA/DOL Meeting on HIPAA transfers. In its initial scoring of the Issues (This meeting provides HCFA 1. Introduction statute, the Congressional Budget Office and Labor the opportunity to provide did not separately quantify the costs of updates on regulations, bulletins, HIPAA’s nondiscrimination the nondiscrimination provisions. enforcement actions and outreach provisions generally prohibit group Therefore, this analysis considers the efforts regarding HIPAA.) health plans and group health plan • The NAIC/HCFA Liaison Meeting issuers from discriminating against nature of anticipated costs, benefits, and (This meeting provides HCFA and the individuals on the basis of health status transfers, and offers a basis for NAIC the opportunity to discuss HIPAA factors. The primary effect and intent of estimating separately the impacts of the and other health care programs.) the provision is to increase access to statute and regulatory discretion, but In addition, in developing these affordable group health coverage for does not present a detailed description interim final regulations, the individuals with health problems. This of any other quantitative analysis of the Departments consulted with the NAIC effect, and the economic costs, benefits, statute’s impact. and requested their assistance to obtain and transfers attendant to it, generally HIPAA’s statutory nondiscrimination information from the State Insurance flow directly from the HIPAA’s statutory provisions entail new economic costs and benefits, as well as transfers of Departments. Specifically, we sought provisions, which are largely self- health care costs among plan sponsors and received their input on certain implementing. However, the statute insurance rating practices and late and participants. alone leaves room for varying The primary statutory economic enrollment issues. interpretations of exactly which The Departments employed the benefits associated with the HIPAA practices are prohibited or permitted at nondiscrimination provisions derive States’ insights on insurance rating the margin. This regulation draws on practices in developing the provisions from increased access to affordable the Departments’ authority to clarify group health plan coverage for prohibiting ‘‘list-billing,’’ and their and interpret HIPAA’s statutory experience with late enrollment in individuals with certain health status- nondiscrimination provisions in order related factors. Expanding access crafting the regulatory provision to secure the protections intended by clarifying the relationship between the benefits both newly covered individuals Congress for plan participants and and society at large. Individuals without nondiscrimination provisions and late beneficiaries. The Departments crafted it enrollment. Specifically, the regulations health insurance are less likely to get to satisfy this mandate in as preventive care and less likely to have clarify that while late enrollment, if economically efficient a manner as offered by a plan, must be available to a regular source of care.15 A lack of possible, and believe that the economic health insurance generally increases the all similarly situated individuals benefits of the regulation outweigh its regardless of any health factor, an likelihood that needed medical costs. The analysis underlying this individual’s status as a late enrollee is treatment will be forgone or delayed. conclusion takes into account both the not itself within the scope of any health Forgoing or delaying care increases the effect of the statute and the impact of factor. risk of adverse health outcomes. These The Departments also cooperate with the discretion exercised in the adverse outcomes in turn spawn higher the States in several ongoing outreach regulation. medical costs which are often shifted to initiatives, through which information The nondiscrimination provisions of public funding sources (and therefore to on HIPAA is shared among federal the HIPAA statute and of this regulation taxpayers) or to other payers. They also regulators, State regulators, and the generally apply to both group health erode productivity and the quality of regulated community. In particular, the plans and to issuers of group health life. Improved access to affordable group Department of Labor has established a plan policies. Economic theory predicts health coverage for individuals with Health Benefits Education Campaign that issuers will pass their costs of health problems under HIPAA’s with more than 70 partners, including compliance back to plans, and that HCFA, NAIC and many business and plans may pass some or all of issuers’ 15 Kaiser Family Foundation and the NewsHour, and their own costs of compliance to ‘‘Newshour/Kaiser Spotlights Misconceptions consumer groups. HCFA has sponsored About the Medically Uninsured: Survey Examines four conferences with the States—the participants. This analysis is carried out Difficulties Faced by Those Without Health Consumer Outreach and Advocacy in light of this prediction. Coverage,’’ News Release, May 16, 2000.

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1394 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations nondiscrimination provisions will lead because of health factors.17 A simple (or to other plan participants if sponsors to more insurance coverage, timelier assessment suggests that the total cost of pass those costs back evenly to them). and fuller medical care, better health coverage for such employees could And it imposes economic costs in the outcomes, and improved productivity exceed $400 million. However, this form of administrative burdens to and quality of life. This is especially potential statutory transfer is small design and implement necessary plan true for the individuals most affected by relative to the overall cost of amendments. HIPAA’s nondiscrimination employment-based health coverage. The Departments lack any basis on provisions—those with adverse health Group health plans will spend about which to distinguish these benefits, conditions. Denied insurance, $431 billion this year to cover costs, and transfers from those of the individuals in poorer health are more approximately 77 million participants statute itself. It is unclear how many likely to suffer economic hardship, to and their dependents. Transfers under plans might be engaging in the forgo badly needed care for financial HIPAA’s nondiscrimination provision discriminatory practices targeted for reasons, and to suffer adverse health will represent a very small fraction of prohibition by these regulatory outcomes as a result. For them, gaining one percent of total group health plan provisions. Because these provisions insurance is more likely to mean gaining expenditures. operate largely at the margin of the economic security, receiving timely, 3. Costs and Benefits of the Regulation statutory requirements, it is likely that quality care, and living healthier, more the effects of these provisions will be far productive lives. Prohibiting Discrimination—Many of smaller than the similar statutory Plans and issuers will incur economic the provisions of this regulation serve to effects. The Departments are confident, costs as a result of the law. These are specify more precisely than the statute however, that by securing employees’ generally limited to administrative alone exactly what practices are access to affordable coverage at the costs, such as those incurred to change prohibited by HIPAA as unlawful margin, the regulation, like the statute, plan design and pricing structures and discrimination in eligibility or employee will yield benefits in excess of costs. update plan materials. premium among similarly situated Clarifying Requirements—Additional The premiums and claims costs employees. For example, under the economic benefits derive directly from incurred by group health plans to regulation eligibility generally may not the improved clarity provided by the provide coverage to individuals who be restricted based on an individuals’ regulation. The regulation provides were previously denied coverage or participation in risky activities, clarity through both its provisions and offered restricted coverage based on confinement to an institution or absence its examples of how those provisions health factors are offset by the from work on enrollment day due to apply in various circumstances. By commensurate or greater benefits illness, or status as a late enrollee. The clarifying employees’ rights and plan realized by the newly eligible regulation provides that various plan sponsors’ obligations under HIPAA’s participants on whose behalf the features including waiting periods and nondiscrimination provisions, the premiums or claims are paid. As such, eligibility for certain benefits constitute regulation will reduce uncertainty and these premiums and claims costs are rules for eligibility which may not vary costly disputes over these rights and properly characterized as transfers across similarly situated employees obligations. It will promote employers’ rather than as new economic costs. based on health status factors. It and employees’ common understanding These transfers shift the burden of provides that individuals who were of the value of group health plan health care costs from one party to previously denied eligibility based on benefits and confidence in the security another without any direct change in health status factors (or who failed to and predictability of those benefits, aggregate social welfare. For example, as enroll in anticipation of such denial) thereby improving labor market individuals’ insurance status changes must be given an opportunity to enroll. efficiency and fostering the from insured through an individual It provides that plans may not reclassify establishment and continuation of group policy to insured through an employees based on health status factors health plans by employers.18 employment based group health plan, in order to create separate groups of health care costs are transferred from similarly situated employees among 18 The voluntary nature of the employment-based these individuals to their employers. which discrimination would be health benefit system in conjunction with the open permitted. and dynamic character of labor markets make Similarly, as individuals’ insurance explicit as well as implicit negotiations on status changes from uninsured to All of these provisions have the effect of clarifying and ensuring certain compensation a key determinant of the prevalence insured through a group health plan, of employee benefits coverage. It is likely that 80% health care costs are transferred from participants’ right to freedom from to 100% of the cost of employee benefits is borne by workers through reduced wages (see for example the individuals and public funding discrimination in eligibility and premium amounts, thereby securing Jonathan Gruber and Alan B. Krueger, ‘‘The sources to employers. Incidence of Mandated Employer-Provided The HIPAA nondiscrimination their access to affordable group health Insurance: Lessons from Workers Compensation statutory transfer is likely to be plan coverage. The costs and benefits Insurance,’’ Tax Policy and Economy (1991); substantial. Annual per-participant attributable to these provisions resemble Jonathan Gruber, ‘‘The Incidence of Mandated those attendant to HIPAA’s statutory Maternity Benefits,’’ American Economic Review, group health plan costs average more Vol. 84 (June 1994), pp. 622–641; Lawrence H. than $4,000,16 and it is likely that nondiscrimination provisions. Securing Summers, ‘‘Some Simple Economics of Mandated average costs would be higher for participants’ access to affordable group Benefits,’’ American Economic Review, Vol. 79, No. individuals who had faced coverage provides economic benefits by 2 (May 1989); Louise Sheiner, ‘‘Health Care Costs, reducing uninsurance and thereby Wages, and Aging,’’ Federal Reserve Board of discrimination due to health status Governors working paper, April 1999; and Edward factors. Prior to HIPAA’s enactment improving health outcomes. It entails Montgomery, Kathryn Shaw, and Mary Ellen approximately 106,000 employees were transfers of costs from the employees Benedict, ‘‘Pensions and Wages: An Hedonic Price denied employment based coverage whose rights are secured (and/or from Theory Approach,’’ International Economic Review, other parties who would otherwise pay Vol. 33 No. 1, Feb. 1992.) The prevalence of benefits is therefore largely dependent on the efficacy of this 16 Gabel, Jon R. Job-based Health Insurance, for their health care) to plan sponsors exchange. If workers perceive that there is the 1977–1998: The Accidental System Under Scrutiny. potential for inappropriate denial of benefits they Health Affairs. November/December 1999. Volume 17 February 1997 Current Population Survey, will discount their value to adjust for this risk. This 18, Number 6. Contingent Worker Supplement. discount drives a wedge in the compensation

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Amending Plans—The regulation is employee premium provisions but required by the regulation to prepare expected to entail some new economic instead choose from a relatively small and distribute notices. The Departments costs, in the form of two new menu of standardized products offered assumed that preparing the notice will administrative burdens, which are by issuers. The Departments accordingly require one hour of time billed at a $72 distinguishable from those attributable assumed that issuers will amend their hourly rate. The cost to develop notices to the statute. First, it is likely that some standardized group insurance products, is therefore estimated to be $9 million. of the regulation’s nondiscrimination passing the associated cost back to the The Departments assumed that plans provisions will effectively require some plans that buy them. They estimate that will distribute notices to all individuals plans to amend their terms and revise a total of approximately 33,000 group who are eligible for coverage under the plan materials. Second, as noted above, insurance products will be so amended, plan. It might be necessary to notify the regulation requires that individuals and that the cost of these amendments individuals who are currently enrolled who were previously denied eligibility will be spread across a universe of because such individuals may have based on health status factors (or who approximately 2.6 million fully insured dependents for whom eligibility was failed to enroll in anticipation of such plans. The Departments assumed that denied based on a health status factor or denial) must be given an opportunity to small self-insured plans (which may have failed to enroll dependents enroll. It also requires that plans notify generally fall outside state regulation of because they expected that eligibility such individuals of their right enroll. insurance products) choose from a would be so denied for them. This Providing notices under these much larger menu of products and that assumption probably results in an requirements will entail new large self-insured plans each have overestimate of the true cost. Some administrative costs. unique eligibility rules will need to be affected plans may already have notified Plans that, prior to HIPAA’s effective amended independently. This implies a affected individuals of their right to date, included provisions since total of approximately 76,000 self- enroll under HIPAA. Others may have prohibited by HIPAA’s insured plan configurations requiring historical records of plan enrollment nondiscrimination requirements, were amendment. that are sufficiently detailed to allow for effectively required by HIPAA to Assuming that each affected group the notification of only specific implement conforming amendments insurance product and self-insured plan individuals. Based on the 1997 Robert and to revise plan materials accordingly. configuration would require 1 hour of Wood Johnson Foundation survey, the The costs associated with these actions professional time billed at $72 per hour Departments estimate that a total of 2.3 generally are attributable to the HIPAA to design and implement amendments, million employees are eligible for statute and not to this regulation. the aggregate cost to amend plans would coverage under the 128,000 plans that However, it is likely that some of the be $8 million. are required to provide notices. The regulation’s nondiscrimination Separate from the cost to design and Departments assumed that distributing provisions will effectively require some implement plan amendments is the cost each notice costs $0.37 for mailing and plans to amend their terms and revise to revise plan materials to reflect the materials plus 2 minutes of their materials. For example, the amendments. The Departments note that photocopying and mailing billed at a Departments understand that plans the cost to revise plan materials can $15 per hour clerical rate for a total per- commonly require employees to be generally be attributed to legal notice distribution cost of $0.87. The actively at work on a designated requirements other than the HIPAA cost to distribute notices is therefore enrollment day in order to qualify for statute or this regulation. It is the policy estimated to be $2 million. enrollment. It is possible that some of the Department of Labor to attribute The estimated combined cost to plans failed to interpret HIPAA’s the cost of revising private-sector group prepare and distribute notices therefore statutory provisions to prohibit this health plan materials to its regulation amounts to $11 million. The practice. Such plans will need to amend implementing ERISA’s Summary Plan Departments note that this is a one-time their terms and materials to provide that Description requirements. Various state cost which will be incurred concurrent employees will not be denied laws compel issuers to provide accurate with the regulation’s applicability date. enrollment solely because they were materials, and the Departments believe The Department’s note that the absent due to a health status factor. that State and local governmental plan provision of notices will benefit Such plans will incur administrative sponsors and private plan sponsors employees who newly learn of costs. routinely update plan materials as a opportunities to enroll themselves or The Departments have no basis for matter of either law or compensation their dependents. The result will be estimating how many plans might need and employment policy. fuller realization of HIPAA’s intent and to implement amendments beyond Notifying Employees of Enrollment employees’ associated rights, as well as those implemented in response to the Opportunities—In estimating the costs improved access to affordable group HIPAA’s statutory nondiscrimination associated with the notification coverage and reduced rates of provisions in order to comply with the requirements, the Departments uninsurance for affected employees. regulation’s corresponding provisions. separately considered the cost of They adopted conservative assumptions preparing notices and the cost of 4. Summary of Cost Estimates in order to develop an upper bound distributing them. The cost estimates presented here are estimate of the cost to amend plans and Based on a 1993 Robert Wood compiled in the table below. Upper materials to conform with the Johnson Foundation survey of bound cost estimates attributable to the regulation. They assumed that all plans employers, the Departments estimate regulation include $8 million to amend will require at least some amendment to that 128,000 group health plans plans and revise documents and $11 conform with this regulation. excluded individuals on the basis of million to prepare and distribute notices A large majority of fully insured plans health status factors prior to HIPAA’s of enrollment opportunities, or a total of do not have unique eligibility and enactment and will therefore be $19 million. negotiation, limiting its efficiency. With workers workers perceive a federal regulation supported by employers costs and workers willingness to accept unwilling to bear the full cost of the benefit, fewer enforcement authority to improve the security and wage offsets is minimized. benefits will be provided. The extent to which quality of benefits, the differential between the

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Source of cost $MM Explanatory notes

Amending plans and revising materials ...... $8 ...... Upper bound of new economic cost incurred as plans are amended to comply with the regulation. One-time cost. Notifying employees of enrollment opportunities ...... $11 ...... Upper bound of new economic cost to prepare and distribute notices. One-time cost. Prohibiting discrimination...... >$400 ...... Transfer attributable to HIPAA's statutory nondiscriminatory provisions. Transfers attributable to the regulation were not estimated but are expected to be a very small fraction of this amount. Ongoing annual level.

5. Assessment of Likelihood of Adverse The Department of Labor interim final Authority: 26 U.S.C. 7805 * * * Secondary Effects rule is adopted pursuant to the authority Par. 2. Section 54.9802–1T is contained in sections 107, 209, 505, The Departments considered whether removed. employers might reduce or eliminate 701–703, 711–713, and 731–734 of Par. 3. Section 54.9802–1 is added to health insurance benefits for all ERISA (29 U.S.C. 1027, 1059, 1135, read as follows: employees as a result of this regulation. 1171–1173, 1181, 1182, and 1191– They believe that this is highly unlikely 1194), as amended by HIPAA (Public § 54.9802±1 Prohibiting discrimination because the regulation affirms and Law 104–191, 110 Stat. 1936), MHPA against participants and beneficiaries clarifies plan sponsors’ flexibility and and NMHPA (Public Law 104–204, 110 based on a health factor. because its costs will be very small Stat. 2935), and WHCRA (Public Law (a) Health factors. (1) The term health relative to group health plan 105–277, 112 Stat. 2681–436), section factor means, in relation to an expenditures. 101(g)(4) of HIPAA, and Secretary of individual, any of the following health The regulation affirms plan sponsors’ Labor’s Order No. 1–87, 52 FR 13139, status-related factors: flexibility to design plans and control April 21, 1987. (i) Health status; plan costs in many ways. It affirms and The Department of HHS interim final (ii) Medical condition (including both clarifies plans’ flexibility under HIPAA rule is adopted pursuant to the authority physical and mental illnesses); contained in sections 2701 through to exclude from coverage or limit (iii) Claims experience; 2763, 2791, and 2792 of the PHS Act (42 coverage for certain conditions or (iv) Receipt of health care; U.S.C. 300gg through 300gg–63, 300gg– services, to require employees to (v) Medical history; perform services before coverage 91, and 300gg–92), as amended by (vi) Genetic information; becomes effective, and to provide HIPAA (Public Law 104–191, 110 Stat. (vii) Evidence of insurability; or different benefits or charge different 1936), MHPA and NMHPA (Public Law (viii) Disability. premiums for employees in different 104–204, 110 Stat. 2935), and WHCRA bona fide employment classes. It also (Public Law 105–277, 112 Stat. 2681– (2) Evidence of insurability clarifies that more favorable treatment of 436). includes— individuals with adverse health factors (i) Conditions arising out of acts of List of Subjects is permitted, thereby allowing domestic violence; and employers to assist employees and their 26 CFR Part 54 (ii) [Reserved] For further guidance, families dealing with disabilities, see § 54.9802–1T(a)(2)(ii). Excise taxes, Health care, Health medical conditions, or other health (b) Prohibited discrimination in rules insurance, Pensions, Reporting and factors by extending coverage or for eligibility—(1) In general—(i) A recordkeeping requirements. lowering premiums. group health plan may not establish any Both the transfer of health insurance 29 CFR Part 2590 rule for eligibility (including continued costs and the administrative costs eligibility) of any individual to enroll Employee benefit plans, Employee generated by this regulation will be very for benefits under the terms of the plan Retirement Income Security Act, Health small relative to total group health plan that discriminates based on any health care, Health insurance, Reporting and expenditures. The $19 million economic factor that relates to that individual or recordkeeping requirements. cost estimate attributed to this a dependent of that individual. This regulation amounts to a tiny fraction of 45 CFR Part 146 rule is subject to the provisions of one percent of the $431 billion that paragraph (b)(2) of this section Health care, Health insurance, (explaining how this rule applies to group health plans will spend this year. Reporting and recordkeeping Even the more than $400 million benefits), paragraph (b)(3) of this section requirements, State regulation of health (allowing plans to impose certain transfer of cost attributed to HIPAA’s insurance. statutory nondiscrimination provisions preexisting condition exclusions), amount to a very small fraction of one Adoption of Amendments to the paragraph (d) of this section (containing percent of that spending. Plan sponsors Regulations rules for establishing groups of similarly situated individuals), paragraph (e) of wishing to do so generally can pass Internal Revenue Service these costs back to participants with this section (relating to nonconfinement, small, across the board changes to 26 CFR Chapter I actively-at-work, and other service employee premiums or benefits. requirements), paragraph (f) of this Accordingly, 26 CFR part 54 is section (relating to bona fide wellness Statutory Authority amended as follows: programs), and paragraph (g) of this The Department of the Treasury final PART 54ÐPENSION EXCISE TAXES section (permitting favorable treatment and temporary rules are adopted of individuals with adverse health pursuant to the authority contained in Paragraph 1. The authority citation factors). sections 7805 and 9833 of the Code (26 for part 54 continues to read in part as (ii) [Reserved] For further guidance, U.S.C. 7805, 9833). follows: see § 54.9802–1T(b)(1)(ii).

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(iii) The rules of this paragraph (b)(1) not restricted under this section. under section 9801(f) a plan must treat are illustrated by the following Nothing in this section restricts the special enrollees the same as similarly examples: aggregate amount that an employer may situated individuals who are enrolled Example 1. (i) Facts. An employer sponsors be charged for coverage under a group when first eligible.) a group health plan that is available to all health plan. (b) Prohibited discrimination in rules employees who enroll within the first 30 (ii) List billing based on a health for eligibility—(1) In general—(i) days of their employment. However, factor prohibited. [Reserved] For further [Reserved] For further guidance, see employees who do not enroll within the first guidance, see § 54.9802–1T(c)(2)(ii). § 54.9802–1(b)(1)(i). 30 days cannot enroll later unless they pass (3) Exception for bona fide wellness (ii) For purposes of this section, rules a physical examination. programs. Notwithstanding paragraphs for eligibility include, but are not (ii) Conclusion. In this Example 1, the (c)(1) and (2) of this section, a plan may limited to, rules relating to— requirement to pass a physical examination establish a premium or contribution (A) Enrollment; in order to enroll in the plan is a rule for differential based on whether an (B) The effective date of coverage; eligibility that discriminates based on one or (C) Waiting (or affiliation) periods; more health factors and thus violates this individual has complied with the requirements of a bona fide wellness (D) Late and special enrollment; paragraph (b)(1). (E) Eligibility for benefit packages Example 2. [Reserved] program. (d) Similarly situated individuals. (including rules for individuals to (2) Application to benefits—(i) [Reserved] For further guidance, see change their selection among benefit General rule—(A) Under this section, a § 54.9802–1T(d). packages); group health plan is not required to (F) Benefits (including rules relating (e) Nonconfinement and actively-at- provide coverage for any particular to covered benefits, benefit restrictions, work provisions. [Reserved] For further benefit to any group of similarly and cost-sharing mechanisms such as guidance, see § 54.9802–1T(e). situated individuals. (f) Bona fide wellness programs. coinsurance, copayments, and (B) [Reserved] For further guidance, [Reserved] deductibles), as described in paragraphs see § 54.9802–1T(b)(2)(i)(B). (g) Benign discrimination permitted. (b) (2) and (3) of this section; (G) Continued eligibility; and (C) [Reserved] For further guidance, [Reserved] For further guidance, see see § 54.9802–1T(b)(2)(i)(C). (H) Terminating coverage (including § 54.9802–1T(g). disenrollment) of any individual under (D) [Reserved] For further guidance, (h) No effect on other laws. [Reserved] the plan. see § 54.9802–1T(b)(2)(i)(D). For further guidance, see § 54.9802– (ii) Cost-sharing mechanisms and (iii) The rules of this paragraph (b)(1) 1T(h). are illustrated by the following wellness programs. A group health plan (i) Effective dates—(1) Final rules with a cost-sharing mechanism (such as examples: apply March 9, 2001. This section Example 1. [Reserved] For further a deductible, copayment, or applies March 9, 2001. coinsurance) that requires a higher guidance, see § 54.9802–1(b)(iii). Example 1. (2) Cross-reference to temporary rules Example 2. (i) Facts. Under an employer’s payment from an individual, based on a applicable for plan years beginning on group health plan, employees who enroll health factor of that individual or a or after July 1, 2001. See § 54.9802– during the first 30 days of employment (and dependent of that individual, than for a 1T(i)(2), which makes the rules of that during special enrollment periods) may similarly situated individual under the section applicable for plan years choose between two benefit packages: an plan (and thus does not apply uniformly indemnity option and an HMO option. beginning on or after July 1, 2001. However, employees who enroll during late to all similarly situated individuals) (3) Cross-reference to temporary does not violate the requirements of this enrollment are permitted to enroll only in the transitional rules for individuals HMO option and only if they provide paragraph (b)(2) if the payment previously denied coverage based on a evidence of good health. differential is based on whether an health factor. See § 54.9802–1T(i)(3) for (ii) Conclusion. In this Example 2, the individual has complied with the transitional rules that apply with requirement to provide evidence of good requirements of a bona fide wellness respect to individuals previously denied health in order to be eligible for late program. coverage under a group health plan enrollment in the HMO option is a rule for eligibility that discriminates based on one or (iii) Specific rule relating to source-of- based on a health factor. injury exclusions. [Reserved] For further more health factors and thus violates this Par. 4. Section 54.9802–1T is added guidance, see § 54.9802–1T(b)(2)(iii). paragraph (b)(1). However, if the plan did not to read as follows: require evidence of good health but limited (3) Relationship to section 9801(a), late enrollees to the HMO option, the plan’s (b), and (d). [Reserved] For further § 54.9802±1T Prohibiting discrimination rules for eligibility would not discriminate guidance, see § 54.9802–1T(b)(3). against participants and beneficiaries based on any health factor, and thus would (c) Prohibited discrimination in based on a health factor (temporary). not violate this paragraph (b)(1), because the premiums or contributions—(1) In (a) Health factors. (1) [Reserved] For time an individual chooses to enroll is not, general—(i) A group health plan may further guidance, see § 54.9802–1(a). itself, within the scope of any health factor. not require an individual, as a condition (2) Evidence of insurability Example 3. (i) Facts. Under an employer’s group health plan, all employees generally of enrollment or continued enrollment includes— may enroll within the first 30 days of under the plan, to pay a premium or (i) [Reserved] For further guidance, employment. However, individuals who contribution that is greater than the see § 54.9802–1(a)(2)(i). participate in certain recreational activities, premium or contribution for a similarly (ii) Participation in activities such as including motorcycling, are excluded from situated individual (described in motorcycling, snowmobiling, all-terrain coverage. paragraph (d) of this section) enrolled in vehicle riding, horseback riding, skiing, (ii) Conclusion. In this Example 3, the plan based on any health factor that and other similar activities. excluding from the plan individuals who relates to the individual or a dependent (3) The decision whether health participate in recreational activities, such as coverage is elected for an individual motorcycling, is a rule for eligibility that of the individual. discriminates based on one more health (ii) [Reserved] For further guidance, (including the time chosen to enroll, factors and thus violates this paragraph see § 54.9802–1T(c)(1)(ii). such as under special enrollment or late (b)(1). (2) Rules relating to premium rates— enrollment) is not, itself, within the Example 4. (i) Facts. A group health plan (i) Group rating based on health factors scope of any health factor. (However, applies for a group health policy offered by

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1398 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations an issuer. As part of the application, the factor of the participants or for a conclusion that the issuer violates rules issuer receives health information about beneficiaries. In the case of a cost- under 29 CFR 2590.702(b)(2)(i) and 45 CFR individuals to be covered under the plan. sharing requirement, see also paragraph 146.121(b)(2)(i) similar to the rules under this Individual A is an employee of the employer (b)(2)(ii) of this section, which permits paragraph (b)(2)(i) because the rider maintaining the plan. A and A’s dependents excluding benefits for the condition that C have a history of high health claims. Based variances in the application of a cost- has is directed at C even though it applies by on the information about A and A’s sharing mechanism made available its terms to all participants and beneficiaries dependents, the issuer excludes A and A’s under a bona fide wellness program. under the plan. dependents from the group policy it offers to (Whether any plan provision or practice Example 4. (i) Facts. A group health plan the employer. with respect to benefits complies with has a $2,000 lifetime limit for the treatment (ii) Conclusion. See Example 4 in 29 CFR this paragraph (b)(2)(i) does not affect of temporomandibular joint syndrome (TMJ). 2590.702(b)(1) and 45 CFR 146.121(b)(1) for whether the provision or practice is The limit is applied uniformly to all similarly a conclusion that the exclusion by the issuer permitted under any other provision of situated individuals and is not directed at individual participants or beneficiaries. of A and A’s dependents from coverage is a the Code, the Americans with rule for eligibility that discriminates based on (ii) Conclusion. In this Example 4, the limit one or more health factors and violates rules Disabilities Act, or any other law, does not violate this paragraph (b)(2)(i) under 29 CFR 2590.702(b)(1) and 45 CFR whether State or federal.) because $2000 of benefits for the treatment of 146.121(b)(1) similar to the rules under this (C) For purposes of this paragraph TMJ are available uniformly to all similarly paragraph (b)(1). (If the employer is a small (b)(2)(i), a plan amendment applicable situated individuals and a plan may limit employer under 45 CFR 144.103 (generally, to all individuals in one or more groups benefits covered in relation to a specific an employer with 50 or fewer employees), of similarly situated individuals under disease or condition if the limit applies the issuer also may violate 45 CFR 146.150, the plan and made effective no earlier uniformly to all similarly situated which requires issuers to offer all the policies than the first day of the first plan year individuals and is not directed at individual they sell in the small group market on a participants or beneficiaries. after the amendment is adopted is not Example 5. (i) Facts. A group health plan guaranteed available basis to all small considered to be directed at any employers and to accept every eligible applies a $2 million lifetime limit on all individual in every small employer group.) If individual participants or beneficiaries. benefits. However, the $2 million lifetime the plan provides coverage through this (D) The rules of this paragraph limit is reduced to $10,000 for any policy and does not provide equivalent (b)(2)(i) are illustrated by the following participant or beneficiary covered under the coverage for A and A’s dependents through examples: plan who has a congenital heart defect. other means, the plan will also violate this Example 1. (i) Facts. A group health plan (ii) Conclusion. In this Example 5, the paragraph (b)(1). applies a $500,000 lifetime limit on all lower lifetime limit for participants and benefits to each participant or beneficiary beneficiaries with a congenital heart defect (2) Application to benefits—(i) covered under the plan. The limit is not violates this paragraph (b)(2)(i) because General rule—(A) [Reserved] For further directed at individual participants or benefits under the plan are not uniformly guidance, see § 54.9802–1(b)(2)(i)(A). beneficiaries. available to all similarly situated individuals (B) However, benefits provided under (ii) Conclusion. In this Example 1, the limit and the plan’s lifetime limit on benefits does a plan must be uniformly available to all does not violate this paragraph (b)(2)(i) not apply uniformly to all similarly situated similarly situated individuals (as because $500,000 of benefits are available individuals. described in paragraph (d) of this uniformly to each participant and beneficiary Example 6. (i) Facts. A group health plan limits benefits for prescription drugs to those section). Likewise, any restriction on a under the plan and because the limit is applied uniformly to all participants and listed on a drug formulary. The limit is benefit or benefits must apply uniformly beneficiaries and is not directed at individual applied uniformly to all similarly situated to all similarly situated individuals and participants or beneficiaries. individuals and is not directed at individual must not be directed at individual Example 2. (i) Facts. A group health plan participants or beneficiaries. participants or beneficiaries based on has a $2 million lifetime limit on all benefits (ii) Conclusion. In this Example 6, the any health factor of the participants or (and no other lifetime limits) for participants exclusion from coverage of drugs not listed beneficiaries (determined based on all covered under the plan. Participant B files a on the drug formulary does not violate this the relevant facts and circumstances). claim for the treatment of AIDS. At the next paragraph (b)(2)(i) because benefits for Thus, for example, a plan may limit or corporate board meeting of the plan sponsor, prescription drugs listed on the formulary are the claim is discussed. Shortly thereafter, the uniformly available to all similarly situated exclude benefits in relation to a specific plan is modified to impose a $10,000 lifetime individuals and because the exclusion of disease or condition, limit or exclude limit on benefits for the treatment of AIDS, drugs not listed on the formulary applies benefits for certain types of treatments effective before the beginning of the next uniformly to all similarly situated or drugs, or limit or exclude benefits plan year. individuals and is not directed at individual based on a determination of whether the (ii) Conclusion. Under the facts of this participants or beneficiaries. benefits are experimental or not Example 2, the plan violates this paragraph Example 7. (i) Facts. Under a group health medically necessary, but only if the (b)(2)(i) because the plan modification is plan, doctor visits are generally subject to a benefit limitation or exclusion applies directed at B based on B’s claim. $250 annual deductible and 20 percent uniformly to all similarly situated Example 3. (i) A group health plan applies coinsurance requirement. However, prenatal for a group health policy offered by an issuer. doctor visits are not subject to any deductible individuals and is not directed at Individual C is covered under the plan and or coinsurance requirement. These rules are individual participants or beneficiaries has an adverse health condition. As part of applied uniformly to all similarly situated based on any health factor of the the application, the issuer receives health individuals and are not directed at individual participants or beneficiaries. In information about the individuals to be participants or beneficiaries. addition, a plan may impose annual, covered, including information about C’s (ii) Conclusion. In this Example 7, lifetime, or other limits on benefits and adverse health condition. The policy form imposing different deductible and may require the satisfaction of a offered by the issuer generally provides coinsurance requirements for prenatal doctor deductible, copayment, coinsurance, or benefits for the adverse health condition that visits and other visits does not violate this other cost-sharing requirement in order C has, but in this case the issuer offers the paragraph (b)(2)(i) because a plan may plan a policy modified by a rider that establish different deductibles or coinsurance to obtain a benefit if the limit or cost- excludes benefits for C for that condition. requirements for different services if the sharing requirement applies uniformly The exclusionary rider is made effective the deductible or coinsurance requirement is to all similarly situated individuals and first day of the next plan year. applied uniformly to all similarly situated is not directed at individual participants (ii) Conclusion. See Example 3 in 29 CFR individuals and is not directed at individual or beneficiaries based on any health 2590.702(b)(2)(i) and 45 CFR 146.121(b)(2)(i) participants or beneficiaries.

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(ii) Cost-sharing mechanisms and any health factor of the participants or (c) Prohibited discrimination in wellness programs. [Reserved] For beneficiaries. For purposes of this premiums or contributions—(1) In further guidance, see § 54.9802– paragraph (b)(3)(i)(C), a plan general—(i) [Reserved] For further 1(b)(2)(ii). amendment relating to a preexisting guidance, see § 54.9802–1(c)(1)(i). (iii) Specific rule relating to source-of- condition exclusion applicable to all (ii) Discounts, rebates, payments in injury exclusions—(A) If a group health individuals in one or more groups of kind, and any other premium plan generally provides benefits for a similarly situated individuals under the differential mechanisms are taken into type of injury, the plan may not deny plan and made effective no earlier than account in determining an individual’s benefits otherwise provided for the first day of the first plan year after premium or contribution rate. (For rules treatment of the injury if the injury the amendment is adopted is not relating to cost-sharing mechanisms, see results from an act of domestic violence considered to be directed at any paragraph (b)(2) of this section or a medical condition (including both individual participants or beneficiaries. (addressing benefits).) physical and mental health conditions). (ii) The rules of this paragraph (b)(3) (2) Rules relating to premium rates— (B) The rules of this paragraph are illustrated by the following (i) Group rating based on health factors (b)(2)(iii) are illustrated by the following examples: not restricted under this section. examples: Example 1. (i) Facts. A group health plan [Reserved] For further guidance, see Example 1. (i) Facts. A group health plan imposes a preexisting condition exclusion on § 54.9802–1(c)(1)(i). generally provides medical/surgical benefits, all individuals enrolled in the plan. The (ii) List billing based on a health including benefits for hospital stays, that are exclusion applies to conditions for which factor prohibited. However, a group medically necessary. However, the plan medical advice, diagnosis, care, or treatment health plan may not quote or charge an excludes benefits for self-inflicted injuries or was recommended or received within the six- employer (or an individual) a different injuries sustained in connection with month period ending on an individual’s premium for an individual in a group of enrollment date. In addition, the exclusion attempted suicide. Individual D suffers from similarly situated individuals based on depression and attempts suicide. As a result, generally extends for 12 months after an individual’s enrollment date, but this 12- a health factor. (But see paragraph (g) of D sustains injuries and is hospitalized for this section permitting favorable treatment of the injuries. Pursuant to the month period is offset by the number of days exclusion, the plan denies D benefits for of an individual’s creditable coverage in treatment of individuals with adverse treatment of the injuries. accordance with section 9801(a). There is health factors.) (ii) Conclusion. In this Example 1, the nothing to indicate that the exclusion is (iii) Examples. The rules of this suicide attempt is the result of a medical directed at individual participants or paragraph (c)(2) are illustrated by the condition (depression). Accordingly, the beneficiaries. following examples: denial of benefits for the treatments of D’s (ii) Conclusion. In this Example 1, even though the plan’s preexisting condition Example 1. (i) Facts. An employer sponsors injuries violates the requirements of this a group health plan and purchases coverage paragraph (b)(2)(iii) because the plan exclusion discriminates against individuals based on one or more health factors, the from a health insurance issuer. In order to provision excludes benefits for treatment of determine the premium rate for the an injury resulting from a medical condition. preexisting condition exclusion does not violate this section because it applies upcoming plan year, the issuer reviews the Example 2. (i) Facts. A group health plan claims experience of individuals covered provides benefits for head injuries generally. uniformly to all similarly situated individuals, is not directed at individual under the plan. The issuer finds that The plan also has a general exclusion for any Individual F had significantly higher claims injury sustained while participating in any of participants or beneficiaries, and complies with section 9801(a), (b), and (d) (that is, the experience than similarly situated a number of recreational activities, including individuals in the plan. The issuer quotes the bungee jumping. However, this exclusion requirements relating to the six-month look- back period, the 12-month (or 18-month) plan a higher per-participant rate because of does not apply to any injury that results from F’s claims experience. a medical condition (nor from domestic maximum exclusion period, and the creditable coverage offset). (ii) Conclusion. See Example 1 in 29 CFR violence). Participant E sustains a head 2590.702(c)(2) and 45 CFR 146.121(c)(2) for injury while bungee jumping. The injury did Example 2. (i) Facts. A group health plan excludes coverage for conditions with respect a conclusion that the issuer does not violate not result from a medical condition (nor from the provisions of 29 CFR 2590.702(c)(2) and domestic violence). Accordingly, the plan to which medical advice, diagnosis, care, or treatment was recommended or received 45 CFR 146.121(c)(2) similar to the denies benefits for E’s head injury. provisions of this paragraph (c)(2) because (ii) Conclusion. In this Example 2, the plan within the six-month period ending on an individual’s enrollment date. Under the plan, the issuer blends the rate so that the provision that denies benefits based on the employer is not quoted a higher rate for F source of an injury does not restrict benefits the preexisting condition exclusion generally extends for 12 months, offset by creditable than for a similarly situated individual based based on an act of domestic violence or any on F ’s claims experience. medical condition. Therefore, the provision coverage. However, if an individual has no is permissible under this paragraph (b)(2)(iii) claims in the first six months following Example 2. (i) Facts. Same facts as and does not violate this section. (However, enrollment, the remainder of the exclusion Example 1, except that the issuer quotes the if the plan did not allow E to enroll in the period is waived. employer a higher premium rate for F, plan (or applied different rules for eligibility (ii) Conclusion. In this Example 2, the because of F ’s claims experience, than for a to E) because E frequently participates in plan’s preexisting condition exclusions similarly situated individual. bungee jumping, the plan would violate violate this section because they do not meet (ii) Conclusion. See Example 2 in 29 CFR paragraph (b)(1) of this section.) the requirements of this paragraph (b)(3); 2590.702(c)(2) and 45 CFR 146.121(c)(2) for specifically, they do not apply uniformly to a conclusion that the issuer violates (3) Relationship to section 9801(a), all similarly situated individuals. The plan provisions of 29 CFR 2590.702(c)(2) and 45 (b), and (d). (i) A preexisting condition provisions do not apply uniformly to all CFR 146.121(c)(2) similar to the provisions of exclusion is permitted under this similarly situated individuals because this paragraph (c)(2). Moreover, even if the section if it— individuals who have medical claims during plan purchased the policy based on the quote (A) Complies with section 9801(a), the first six months following enrollment are but did not require a higher participant (b), and (d); not treated the same as similarly situated contribution for F than for a similarly individuals with no claims during that situated individual, see Example 2 in 29 CFR (B) Applies uniformly to all similarly period. (Under paragraph (d) of this section, 2590.702(c)(2) and 45 CFR 146.121(c)(2) for situated individuals (as described in the groups cannot be treated as two separate a conclusion that the issuer would still paragraph (d) of this section); and groups of similarly situated individuals violate 29 CFR 2590.702(c)(2) and 45 CFR (C) Is not directed at individual because the distinction is based on a health 146.121(c)(2) (but in such a case the plan participants or beneficiaries based on factor.) would not violate this paragraph (c)(2)).

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(3) Exception for bona fide wellness whom the beneficiary is receiving distinction between spouses and dependent programs. [Reserved] For further coverage; children is permitted under paragraph (d)(2) guidance, see § 54.9802–1(c)(3). (B) Relationship to the participant of this section and is not prohibited under (d) Similarly situated individuals. The (e.g., as a spouse or as a dependent paragraph (d)(3) of this section because it is not directed at individual participants or requirements of this section apply only child); beneficiaries. It is also permissible to treat within a group of individuals who are (C) Marital status; dependent children who are under age 19 (or treated as similarly situated individuals. (D) With respect to children of a full-time students under age 25) as a group A plan may treat participants as a group participant, age or student status; or of similarly situated individuals separate of similarly situated individuals (E) Any other factor if the factor is not from those who are age 25 or older (or age separate from beneficiaries. In addition, a health factor. 19 or older if they are not full-time students) participants may be treated as two or (ii) Paragraph (d)(2)(i) of this section because the classification is permitted under more distinct groups of similarly does not prevent more favorable paragraph (d)(2) of this section and is not situated individuals and beneficiaries treatment of beneficiaries with adverse directed at individual participants or health factors in accordance with beneficiaries. may be treated as two or more distinct Example 3. (i) Facts. A university sponsors groups of similarly situated individuals paragraph (g) of this section. a group health plan that provides one health in accordance with the rules of this (3) Discrimination directed at benefit package to faculty and another health paragraph (d). Moreover, if individuals individuals. Notwithstanding benefit package to other staff. Faculty and have a choice of two or more benefit paragraphs (d)(1) and (2) of this section, staff are treated differently with respect to packages, individuals choosing one if the creation or modification of an other employee benefits such as retirement benefit package may be treated as one or employment or coverage classification is benefits and leaves of absence. There is no more groups of similarly situated directed at individual participants or evidence to suggest that the distinction is beneficiaries based on any health factor directed at individual participants or individuals distinct from individuals beneficiaries. choosing another benefit package. of the participants or beneficiaries, the (ii) Conclusion. In this Example 3, the (1) Participants. Subject to paragraph classification is not permitted under this classification is permitted under this (d)(3) of this section, a plan may treat paragraph (d), unless it is permitted paragraph (d) because there is a distinction participants as two or more distinct under paragraph (g) of this section based on a bona fide employment-based groups of similarly situated individuals (permitting favorable treatment of classification consistent with the employer’s if the distinction between or among the individuals with adverse health factors). usual business practice and the distinction is groups of participants is based on a Thus, if an employer modified an not directed at individual participants and beneficiaries. bona fide employment-based employment-based classification to Example 4. (i) Facts. An employer sponsors classification consistent with the single out, based on a health factor, a group health plan that is available to all employer’s usual business practice. individual participants and current employees. Former employees may Whether an employment-based beneficiaries and deny them health also be eligible, but only if they complete a classification is bona fide is determined coverage, the new classification would specified number of years of service, are on the basis of all the relevant facts and not be permitted under this section. enrolled under the plan at the time of circumstances. Relevant facts and (4) Examples. The rules of this termination of employment, and are circumstances include whether the paragraph (d) are illustrated by the continuously enrolled from that date. There employer uses the classification for following examples: is no evidence to suggest that these distinctions are directed at individual purposes independent of qualification Example 1. (i) Facts. An employer sponsors participants or beneficiaries. for health coverage (for example, a group health plan for full-time employees (ii) Conclusion. In this Example 4, determining eligibility for other only. Under the plan (consistent with the imposing additional eligibility requirements employee benefits or determining other employer’s ususal business practice), on former employees is permitted because a terms of employment). Subject to employees who normally work at least 30 classification that distinguishes between paragraph (d)(3) of this section, hours per week are considered to be working current and former employees is a bona fide full-time. Other employees are considered to examples of classifications that, based employment-based classification that is be working part-time. There is no evidence permitted under this paragraph (d), provided on all the relevant facts and to suggest that the classification is directed circumstances, may be bona fide that it is not directed at individual at individual participants or beneficiaries. participants or beneficiaries. In addition, it is include full-time versus part-time (ii) Conclusion. In this Example 1, treating permissible to distinguish between former status, different geographic location, the full-time and part-time employees as two employees who satisfy the service membership in a collective bargaining separate groups of similarly situated requirement and those who do not, provided unit, date of hire, length of service, individuals is permitted under this paragraph that the distinction is not directed at current employee versus former (d) because the classification is bona fide and individual participants or beneficiaries. employee status, and different is not directed at individual participants or (However, former employees who do not occupations. However, a classification beneficiaries. satisfy the eligibility criteria may, Example 2. (i) Facts. Under a group health based on any health factor is not a bona nonetheless, be eligible for continued plan, coverage is made available to coverage pursuant to a COBRA continuation fide employment-based classification, employees, their spouses, and their provision or similar State law.) unless the requirements of paragraph (g) dependent children. However, coverage is Example 5. (i) Facts. An employer sponsors of this section are satisfied (permitting made available to a dependent child only if a group health plan that provides the same favorable treatment of individuals with the dependent child is under age 19 (or benefit package to all seven employees of the adverse health factors). under age 25 if the child is continuously employer. Six of the seven employees have (2) Beneficiaries—(i) Subject to enrolled full-time in an institution of higher the same job title and responsibilities, but paragraph (d)(3) of this section, a plan learning (full-time students)). There is no Employee G has a different job title and may treat beneficiaries as two or more evidence to suggest that these classifications different responsibilities. After G files an are directed at individual participants or distinct groups of similarly situated expensive claim for benefits under the plan, beneficiaries. coverage under the plan is modified so that individuals if the distinction between or (ii) Conclusion. In this Example 2, treating employees with G’s job title receive a among the groups of beneficiaries is spouses and dependent children differently different benefit package that includes a based on any of the following factors: by imposing an age limitation on dependent lower lifetime dollar limit than in the benefit (A) A bona fide employment-based children, but not on spouses, is permitted package made available to the other six classification of the participant through under this paragraph (d). Specifically, the employees.

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(ii) Conclusion. Under the facts of this Under the rules of paragraphs (b) and (c) day that the employee reports to work. Example 5, changing the coverage of this section and subject to the Individual H is scheduled to begin work on classification for G based on the existing exception for the first day of work in August 3. However, H is unable to begin employment classification for G is not paragraph (e)(2)(ii) of this section, a work on that day because of illness. H begins permitted under this paragraph (d) because working on August 4, and H’s coverage is the creation of the new coverage plan may not establish a rule for effective on August 4. classification for G is directed at G based on eligibility (as described in paragraph (ii) Conclusion. In this Example 1, the plan one or more health factors. (b)(1)(ii) of this section) or set any provision does not violate this section. (e) Nonconfinement and actively-at- individual’s premium or contribution However, if coverage for individuals who do rate based on whether an individual is not report to work on the first day they were work provisions—(1) Nonconfinement scheduled to work for a reason unrelated to provisions—(i) General rule. Under the actively at work (including whether an individual is continuously employed), a health factor (such as vacation or rules of paragraphs (b) and (c) of this bereavement) becomes effective on the first section, a plan may not establish a rule unless absence from work due to any day they were scheduled to work, then the for eligibility (as described in paragraph health factor (such as being absent from plan would violate this section. (b)(1)(ii) of this section) or set any work on sick leave) is treated, for Example 2. (i) Facts. Under a group health individual’s premium or contribution purposes of the plan, as being actively plan, coverage for new employees becomes effective on the first day of the month rate based on whether an individual is at work. (B) The rules of this paragraph (e)(2)(i) following the employee’s first day of work, confined to a hospital or other health are illustrated by the following regardless of whether the employee is care institution. In addition, under the examples: actively at work on the first day of the month. rules of paragraphs (b) and (c) of this Individual J is scheduled to begin work on section, a plan may not establish a rule Example 1. (i) Facts. Under a group health March 24. However, J is unable to begin work plan, an employee generally becomes eligible on March 24 because of illness. J begins for eligibility or set any individual’s to enroll 30 days after the first day of premium or contribution rate based on working on April 7 and J’s coverage is employment. However, if the employee is not effective May 1. an individual’s ability to engage in actively at work on the first day after the end (ii) Conclusion. In this Example 2, the plan normal life activities, except to the of the 30-day period, then eligibility for provision does not violate this section. extent permitted under paragraphs enrollment is delayed until the first day the However, as in Example 1, if coverage for (e)(2)(ii) and (3) of this section employee is actively at work. individuals absent from work for reasons (permitting plans, under certain (ii) Conclusion. In this Example 1, the plan unrelated to a health factor became effective circumstances, to distinguish among violates this paragraph (e)(2) (and thus also despite their absence, then the plan would violates paragraph (b) of this section). employees based on the performance of violate this section. However, the plan would not violate (3) Relationship to plan provisions services). paragraph (e)(2) or (b) of this section if, under (ii) Examples. The rules of this the plan, an absence due to any health factor defining similarly situated individuals— paragraph (e)(1) are illustrated by the is considered being actively at work. (i) Notwithstanding the rules of following examples: Example 2. (i) Facts. Under a group health paragraphs (e)(1) and (2) of this section, Example 1. (i) Facts. Under a group health plan, coverage for an employee becomes a plan may establish rules for eligibility plan, coverage for employees and their effective after 90 days of continuous service; or set any individual’s premium or dependents generally becomes effective on that is, if an employee is absent from work contribution rate in accordance with the the first day of employment. However, (for any reason) before completing 90 days of rules relating to similarly situated coverage for a dependent who is confined to service, the beginning of the 90-day period is individuals in paragraph (d) of this a hospital or other health care institution measured from the day the employee returns section. Accordingly, a plan may to work (without any credit for service before does not become effective until the distinguish in rules for eligibility under confinement ends. the absence). (ii) Conclusion. In this Example 2, the plan the plan between full-time and part-time (ii) Conclusion. In this Example 1, the plan employees, between permanent and violates this paragraph (e)(1) because the violates this paragraph (e)(2) (and thus also plan delays the effective date of coverage for paragraph (b) of this section) because the 90- temporary or seasonal employees, dependents based on confinement to a day continuous service requirement is a rule between current and former employees, hospital or other health care institution. for eligibility based on whether an individual and between employees currently Example 2. (i) Facts. In previous years, a is actively at work. However, the plan would performing services and employees no group health plan has provided coverage not violate this paragraph (e)(2) or paragraph longer performing services for the (b) of this section if, under the plan, an through a group health insurance policy absence due to any health factor is not employer, subject to paragraph (d) of offered by Issuer M. However, for the current considered an absence for purposes of this section. However, other federal or year, the plan provides coverage through a measuring 90 days of continuous service. State laws (including the COBRA group health insurance policy offered by continuation provisions and the Family Issuer N. Under Issuer N ’s policy, items and (ii) Exception for the first day of services provided in connection with the work—(A) Notwithstanding the general and Medical Leave Act of 1993) may confinement of a dependent to a hospital or rule in paragraph (e)(2)(i) of this section, require an employee or the employee’s other health care institution are not covered a plan may establish a rule for eligibility dependents to be offered coverage and if the confinement is covered under an that requires an individual to begin set limits on the premium or extension of benefits clause from a previous work for the employer sponsoring the contribution rate even though the health insurance issuer. plan (or, in the case of a multiemployer employee is not performing services. (ii) Conclusion. See Example 2 in 29 CFR (ii) The rules of this paragraph (e)(3) 2590.702(e)(1) and 45 CFR 146.121(e)(1) for plan, to begin a job in covered employment) before coverage becomes are illustrated by the following a conclusion that Issuer N violates provisions examples: of 29 CFR 2590.702(e)(1) and 45 CFR effective, provided that such a rule for 146.121(e)(1) similar to the provisions of this eligibility applies regardless of the Example 1. (i) Facts. Under a group health paragraph (e)(1) because Issuer N restricts reason for the absence. plan, employees are eligible for coverage if benefits based on whether a dependent is (B) The rules of this paragraph they perform services for the employer for 30 confined to a hospital or other health care or more hours per week or if they are on paid (e)(2)(ii) are illustrated by the following leave (such as annual, sick, or bereavement institution that is covered under an extension examples: leave). Employees on unpaid leave are of benefits from a previous issuer. Example 1. (i) Facts. Under the eligibility treated as a separate group of similarly (2) Actively-at-work and continuous provision of a group health plan, coverage for situated individuals in accordance with the service provisions—(i) General rule—(A) new employees becomes effective on the first rules of paragraph (d) of this section.

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(ii) Conclusion. In this Example 1, the plan (ii) Conclusion. In this Example 4, the plan provision, a group health plan generally provisions do not violate this section. provision terminating C’s coverage upon the makes COBRA continuation coverage However, if the plan treated individuals cessation of C’s performance of services does available for a maximum period of 18 months performing services for the employer for 30 not violate this section. in connection with a termination of or more hours per week, individuals on (f) Bona fide wellness programs. employment but makes the coverage annual leave, and individuals on [Reserved] available for a maximum period of 29 months bereavement leave as a group of similarly (g) More favorable treatment of to certain disabled individuals and certain situated individuals separate from individuals with adverse health factors members of the disabled individual’s family. individuals on sick leave, the plan would Although the plan generally requires violate this paragraph (e) (and thus also permitted—(1) In rules for eligibility—(i) payment of 102 percent of the applicable would violate paragraph (b) of this section) Nothing in this section prevents a group premium for the first 18 months of COBRA because groups of similarly situated health plan from establishing more continuation coverage, the plan requires individuals cannot be established based on a favorable rules for eligibility (described payment of 150 percent of the applicable health factor (including the taking of sick in paragraph (b)(1) of this section) for premium for the disabled individual’s leave) under paragraph (d) of this section. individuals with an adverse health COBRA continuation coverage during the Example 2. (i) Facts. To be eligible for factor, such as disability, than for disability extension if the disabled individual coverage under a bona fide collectively individuals without the adverse health would not be entitled to COBRA bargained group health plan in the current factor. Moreover, nothing in this section continuation coverage but for the disability. calendar quarter, the plan requires an (ii) Conclusion. In this Example 3, the plan individual to have worked 250 hours in prevents a plan from charging a higher provision allowing extended COBRA covered employment during the three-month premium or contribution with respect to continuation coverage for disabled period that ends one month before the individuals with an adverse health individuals satisfies this paragraph (g)(1) beginning of the current calendar quarter. factor if they would not be eligible for (and thus does not violate this section). In The distinction between employees working the coverage were it not for the adverse addition, the plan is permitted, under this at least 250 hours and those working less health factor. (However, other laws, paragraph (g)(1), to charge the disabled than 250 hours in the earlier three-month including State insurance laws, may set individuals a higher premium for the period is not directed at individual or limit premium rates; these laws are extended coverage if the individuals would participants or beneficiaries based on any not be eligible for COBRA continuation health factor of the participants or not affected by this section.) coverage were it not for the disability. beneficiaries. (ii) The rules of this paragraph (g)(1) (Similarly, if the plan provided an extended (ii) Conclusion. In this Example 2, the plan are illustrated by the following period of coverage for disabled individuals provision does not violate this section examples: pursuant to State law or plan provision rather because, under the rules for similarly Example 1. (i) Facts. An employer sponsors than pursuant to a COBRA continuation situated individuals allowing full-time a group health plan that generally is available coverage provision, the plan could likewise employees to be treated differently than part- to employees, spouses of employees, and charge the disabled individuals a higher time employees, employees who work at dependent children until age 23. However, premium for the extended coverage.) least 250 hours in a three-month period can dependent children who are disabled are (2) In premiums or contributions—(i) be treated differently than employees who eligible for coverage beyond age 23. Nothing in this section prevents a group fail to work 250 hours in that period. The (ii) Conclusion. In this Example 1, the plan provision allowing coverage for disabled health plan from charging individuals a result would be the same if the plan premium or contribution that is less permitted individuals to apply excess hours dependent children beyond age 23 satisfies from previous periods to satisfy the this paragraph (g)(1) (and thus does not than the premium (or contribution) for requirement for the current quarter. violate this section). similarly situated individuals if the Example 3. (i) Facts. Under a group health Example 2. (i) Facts. An employer sponsors lower charge is based on an adverse plan, coverage of an employee is terminated a group health plan, which is generally health factor, such as disability. when the individual’s employment is available to employees (and members of the (ii) The rules of this paragraph (g)(2) terminated, in accordance with the rules of employee’s family) until the last day of the are illustrated by the following example: paragraph (d) of this section. Employee B has month in which the employee ceases to perform services for the employer. The plan Example. (i) Facts. Under a group health been covered under the plan. B experiences plan, employees are generally required to pay a disabling illness that prevents B from generally charges employees $50 per month for employee-only coverage and $125 per $50 per month for employee-only coverage working. B takes a leave of absence under the and $125 per month for family coverage Family and Medical Leave Act of 1993. At month for family coverage. However, an employee who ceases to perform services for under the plan. However, employees who are the end of such leave, B terminates the employer by reason of disability may disabled receive coverage (whether employment and consequently loses coverage remain covered under the plan until the last employee-only or family coverage) under the under the plan. (This termination of coverage day of the month that is 12 months after the plan free of charge. is without regard to whatever rights the month in which the employee ceased to (ii) Conclusion. In this Example, the plan employee (or members of the employee’s perform services for the employer. During provision waiving premium payment for family) may have for COBRA continuation this extended period of coverage, the plan disabled employees is permitted under this coverage.) charges the employee $100 per month for paragraph (g)(2) (and thus does not violate (ii) Conclusion. In this Example 3, the plan employee-only coverage and $250 per month this section). provision terminating B’s coverage upon B’s for family coverage. (This extended period of (h) No effect on other laws. termination of employment does not violate coverage is without regard to whatever rights this section. Compliance with this section is not the employee (or members of the employee’s determinative of compliance with any Example 4. (i) Facts. Under a group health family) may have for COBRA continuation plan, coverage of an employee is terminated coverage.) other provision of the Code (including when the employee ceases to perform (ii) Conclusion. In this Example 2, the plan the COBRA continuation provisions) or services for the employer sponsoring the provision allowing extended coverage for any other State or federal law, such as plan, in accordance with the rules of disabled employees and their families the Americans with Disabilities Act. paragraph (d) of this section. Employee C is satisfies this paragraph (g)(1) (and thus does Therefore, although the rules of this laid off for three months. When the layoff not violate this section). In addition, the plan section would not prohibit a plan or begins, C’s coverage under the plan is is permitted, under this paragraph (g)(1), to issuer from treating one group of terminated. (This termination of coverage is charge the disabled employees a higher without regard to whatever rights the premium during the extended period of similarly situated individuals employee (or members of the employee’s coverage. differently from another (such as family) may have for COBRA continuation Example 3. (i) Facts. To comply with the providing different benefit packages to coverage.) requirements of a COBRA continuation current and former employees), other

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In discriminated based on a health factor; and Accountability Act of 1996 (or, if addition, although this section generally or the individual otherwise first became does not impose new disclosure (B) Was not offered an opportunity to eligible to enroll for coverage after that obligations on plans, this section does enroll in the plan and the failure to give date, on the date the individual was not affect any other laws, including such an opportunity violates this otherwise eligible to enroll in the plan), those that require accurate disclosures section. even if the individual chooses under and prohibit intentional (ii) Individuals denied coverage paragraph (i)(3)(ii)(A) of this section to misrepresentation. without a good faith interpretation of have coverage effective only (i) Effective dates—(1) Final rules the law—(A) Opportunity to enroll prospectively. In addition, any period apply March 9, 2001. [Reserved] For required. If a plan has denied coverage between the individual’s enrollment further guidance, see § 54.9802–1(i)(1). to any individual based on a health date and the effective date of coverage factor and that denial was not based on (2) This section applies for plan years is treated as a waiting period. a good faith interpretation of section beginning on or after July 1, 2001. 9802 or any guidance published by the (C) Examples. The rules of this Except as provided in paragraph (i)(3) of Secretary, the plan is required to give paragraph (i)(3)(ii) are illustrated by the this section, this section applies for plan the individual an opportunity to enroll following examples: years beginning on or after July 1, 2001. (including notice of an opportunity to Example 1. (i) Facts. Employer X maintains Except as provided in paragraph (i)(3) of enroll) that continues for at least 30 a group health plan with a plan year this section, with respect to efforts to beginning October 1 and ending September days. This opportunity must be comply with section 9802 before the 30. Individual F was hired by Employer X presented not later than March 9, 2001. first plan year beginning on or after July before the effective date of section 9802. (1) If this enrollment opportunity was Before the effective date of section 9802 for 1, 2001, the Secretary will not take any presented before or within the first plan enforcement action against a plan that this plan (October 1, 1997), the terms of the year beginning on or after July 1, 1997 plan allowed employees and their has sought to comply in good faith with (or in the case of a collectively dependents to enroll when the employee was section 9802. bargained plan, before or within the first first hired, and on each January 1 thereafter, (3) Transitional rules for individuals plan year beginning on the effective date but in either case, only if the individual previously denied coverage based on a for the plan described in section could pass a physical examination. F ’s health factor. This paragraph (i)(3) 401(c)(3) of the Health Insurance application to enroll when first hired was denied because F could not pass a physical provides rules relating to individuals Portability and Accountability Act of previously denied coverage under a examination. Upon the effective date of 1996), the coverage must be effective section 9802 for this plan (October 1, 1997), group health plan based on a health within that first plan year. factor of the individual. Paragraph the plan is amended to delete the (2) If this enrollment opportunity is requirement to pass a physical examination. (i)(3)(i) clarifies what constitutes a presented after such plan year, the In November of 1997, the plan gives F an denial of coverage under this paragraph individual must be given the choice of opportunity to enroll in the plan (including (i)(3). Paragraph (i)(3)(ii) of this section having the coverage effective on either notice of the opportunity to enroll) without applies with respect to any individual of the following two dates— passing a physical examination, with who was denied coverage if the denial (i) The date the plan receives a request coverage effective January 1, 1998. was not based on a good faith for enrollment in connection with the (ii) Conclusion. In this Example 1, the plan interpretation of section 9802 or the enrollment opportunity; or complies with the requirements of this paragraph (i)(3)(ii). Secretary’s published guidance. Under (ii) Retroactively to the first day of the that paragraph, such an individual must Example 2. (i) Facts. The plan year of a first plan year beginning on the effective group health plan begins January 1 and ends be allowed to enroll retroactively to the date for the plan described in section December 31. Under the plan, a dependent effective date of section 9802, or, if later, 401(c)(1) or (3) of the Health Insurance who is unable to engage in normal life the date the individual meets eligibility Portability and Accountability Act of activities on the date coverage would criteria under the plan that do not 1996 (or, if the individual otherwise otherwise become effective is not enrolled discriminate based on any health factor. first became eligible to enroll for until the dependent is able to engage in Paragraph (i)(3)(iii) of this section coverage after that date, on the date the normal life activities. Individual G is a applies with respect to any individual individual was otherwise eligible to dependent who is otherwise eligible for coverage, but is unable to engage in normal who was denied coverage based on a enroll in the plan). If an individual good faith interpretation of section 9802 life activities. The plan has not allowed G to elects retroactive coverage, the plan is enroll for coverage. or the Secretary’s published guidance. required to provide the benefits it would (ii) Conclusion. In this Example 2, Under that paragraph, such an have provided if the individual had beginning on the effective date of section individual must be given an opportunity been enrolled for coverage during that 9802 for the plan (January 1, 1998), the plan to enroll effective July 1, 2001. In either period (irrespective of any otherwise provision is not permitted under any good event, whether under paragraph (i)(3)(ii) applicable plan provisions governing faith interpretation of section 9802 or any or (iii) of this section, the Secretary will timing for the submission of claims). guidance published by the Secretary. not take any enforcement action with The plan may require the individual to Therefore, the plan is required, not later than March 9, 2001, to give G an opportunity to respect to denials of coverage addressed pay whatever additional amount the in this paragraph (i)(3) if the plan has enroll (including notice of the opportunity to individual would have been required to enroll), with coverage effective, at G’s option, complied with the transitional rules of pay for the coverage (but the plan either retroactively from January 1, 1998 or this paragraph (i)(3). cannot charge interest on that amount). prospectively from the date G’s request for (i) Denial of coverage clarified. For (B) Relation to preexisting condition enrollment is received by the plan. If G elects purposes of this paragraph (i)(3), an rules. For purposes of Chapter 100 of coverage to be effective beginning January 1,

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1998, the plan can require G to pay employee interpretation of section 9802 (and guidance (3) The decision whether health premiums for the retroactive coverage. published by the Secretary), the failure of Y’s coverage is elected for an individual (iii) Individuals denied coverage plan to allow H to enroll effective February (including the time chosen to enroll, based on a good faith interpretation of 1, 1998 was permissible on that date. such as under special enrollment or late the law—(A) Opportunity to enroll However, under the transitional rules of this paragraph (i)(3)(iii), Y’s plan must give H an enrollment) is not, itself, within the required. If a plan has denied coverage opportunity to enroll that continues for at scope of any health factor. (However, to any individual before the first day of least 30 days, with coverage effective no later under § 2590.701–6, a plan or issuer the first plan year beginning on or after than July 1, 2001. (In addition, February 1, must treat special enrollees the same as July 1, 2001 based in part on a health 1998 is H’s enrollment date under the plan similarly situated individuals who are factor and that denial was based on a and the period between February 1, 1998 and enrolled when first eligible.) good faith interpretation of section 9802 July 1, 2001 is treated as a waiting period. (b) Prohibited discrimination in rules or guidance published by the Secretary, Accordingly, any preexisting condition for eligibility—(1) In general—(i) A the plan is required to give the exclusion period permitted under section 9801 will have expired before July 1, 2001.) group health plan, and a health individual an opportunity to enroll insurance issuer offering health (including notice of an opportunity to Robert E. Wenzel, insurance coverage in connection with a enroll) that continues for at least 30 Deputy Commissioner of Internal Revenue. group health plan, may not establish days, with coverage effective no later Approved: any rule for eligibility (including than July 1, 2001. Individuals required Dated: August 8, 2000. continued eligibility) of any individual to be offered an opportunity to enroll Jonathan Talisman, to enroll for benefits under the terms of include individuals previously offered Acting Assistant Secretary of the Treasury. the plan or group health insurance enrollment without regard to a health coverage that discriminates based on factor but subsequently denied For the reasons set forth above, 29 any health factor that relates to that enrollment due to a health factor. CFR Part 2590 is amended as follows: individual or a dependent of that (B) Relation to preexisting condition PART 2590 [AMENDED]ÐRULES AND individual. This rule is subject to the rules. For purposes of Chapter 100 of REGULATIONS FOR HEALTH provisions of paragraph (b)(2) of this Subtitle K, the individual may not be INSURANCE PORTABILITY AND section (explaining how this rule treated as a late enrollee or as a special RENEWABILITY FOR GROUP HEALTH applies to benefits), paragraph (b)(3) of enrollee. Moreover, the individual’s PLANS this section (allowing plans to impose enrollment date under the plan is the certain preexisting condition effective date for the plan described in 1. The authority citation for Part 2590 exclusions), paragraph (d) of this section section 401(c)(1) or (3) of the Health is revised to read as follows: (containing rules for establishing groups Insurance Portability and Authority: Secs. 107, 209, 505, 701–703, of similarly situated individuals), Accountability Act of 1996 (or, if the 711–713, and 731–734 of ERISA (29 U.S.C. paragraph (e) of this section (relating to individual otherwise first became 1027, 1059, 1135, 1171–1173, 1181–1183, nonconfinement, actively-at-work, and eligible to enroll for coverage after that and 1191–1194), as amended by HIPAA other service requirements), paragraph date, on the date the individual was (Public Law 104–191, 110 Stat. 1936), MHPA (f) of this section (relating to bona fide otherwise eligible to enroll in the plan). and NMHPA (Public Law 104–204, 110 Stat. wellness programs), and paragraph (g) of In addition, any period between the 2935), and WHCRA (Public Law 105–277, this section (permitting favorable individual’s enrollment date and the 112 Stat. 2681–436), section 101(g)(4) of treatment of individuals with adverse effective date of coverage is treated as a HIPAA, and Secretary of Labor’s Order No. health factors). waiting period. 1–87, 52 FR 13139, April 21, 1987. (ii) For purposes of this section, rules (C) Example. The rules of this 2. Section § 2590.702 is revised to for eligibility include, but are not paragraph (i)(3)(iii) are illustrated by the read as follows: limited to, rules relating to— following example: § 2590.702 Prohibiting discrimination (A) Enrollment; Example. (i) Facts. Individual H was hired against participants and beneficiaries (B) The effective date of coverage; by Employer Y on May 3, 1995. Y maintains based on a health factor. (C) Waiting (or affiliation) periods; a group health plan with a plan year (a) Health factors. (1) The term health (D) Late and special enrollment; beginning on February 1. Under the terms of factor means, in relation to an (E) Eligibility for benefit packages the plan, employees and their dependents are (including rules for individuals to allowed to enroll when the employee is first individual, any of the following health status-related factors: change their selection among benefit hired (without a requirement to pass a packages); physical examination), and on each February (i) Health status; 1 thereafter if the individual can pass a (ii) Medical condition (including both (F) Benefits (including rules relating physical examination. H chose not to enroll physical and mental illnesses), as to covered benefits, benefit restrictions, for coverage when hired in May of 1995. On defined in § 2590.701–2; and cost-sharing mechanisms such as February 1, 1997, H tried to enroll for (iii) Claims experience; coinsurance, copayments, and coverage under the plan. However, H was (iv) Receipt of health care; deductibles), as described in paragraphs denied coverage for failure to pass a physical (v) Medical history; (b)(2) and (3) of this section; examination. Shortly thereafter, Y’s plan (vi) Genetic information, as defined in (G) Continued eligibility; and eliminated late enrollment, and H was not § 2590.701–2; (H) Terminating coverage (including given another opportunity to enroll in the (vii) Evidence of insurability; or disenrollment) of any individual under plan. There is no evidence to suggest that Y’s (viii) Disability. the plan. plan was acting in bad faith in denying (2) Evidence of insurability (iii) The rules of this paragraph (b)(1) coverage under the plan beginning on the includes— effective date of section 9802 (February 1, are illustrated by the following 1998). (i) Conditions arising out of acts of examples: (ii) Conclusion. In this Example, because domestic violence; and Example 1. (i) Facts. An employer sponsors coverage previously had been made available (ii) Participation in activities such as a group health plan that is available to all with respect to H without regard to any motorcycling, snowmobiling, all-terrain employees who enroll within the first 30 health factor of H and because Y’s plan was vehicle riding, horseback riding, skiing, days of their employment. However, acting in accordance with a good faith and other similar activities. employees who do not enroll within the first

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30 days cannot enroll later unless they pass (2) Application to benefits—(i) (D) The rules of this paragraph a physical examination. General rule—(A) Under this section, a (b)(2)(i) are illustrated by the following (ii) Conclusion. In this Example 1, the group health plan or group health examples: requirement to pass a physical examination insurance issuer is not required to in order to enroll in the plan is a rule for Example 1. (i) Facts. A group health plan eligibility that discriminates based on one or provide coverage for any particular applies a $500,000 lifetime limit on all more health factors and thus violates this benefit to any group of similarly benefits to each participant or beneficiary paragraph (b)(1). situated individuals. covered under the plan. The limit is not Example 2. (i) Facts. Under an employer’s (B) However, benefits provided under directed at individual participants or group health plan, employees who enroll a plan or through group health beneficiaries. during the first 30 days of employment (and insurance coverage must be uniformly (ii) Conclusion. In this Example 1, the limit during special enrollment periods) may does not violate this paragraph (b)(2)(i) available to all similarly situated because $500,000 of benefits are available choose between two benefit packages: an individuals (as described in paragraph indemnity option and an HMO option. uniformly to each participant and beneficiary However, employees who enroll during late (d) of this section). Likewise, any under the plan and because the limit is enrollment are permitted to enroll only in the restriction on a benefit or benefits must applied uniformly to all participants and HMO option and only if they provide apply uniformly to all similarly situated beneficiaries and is not directed at individual evidence of good health. individuals and must not be directed at participants or beneficiaries. (ii) Conclusion. In this Example 2, the individual participants or beneficiaries Example 2. (i) Facts. A group health plan requirement to provide evidence of good based on any health factor of the has a $2 million lifetime limit on all benefits health in order to be eligible for late participants or beneficiaries (and no other lifetime limits) for participants covered under the plan. Participant B files a enrollment in the HMO option is a rule for (determined based on all the relevant eligibility that discriminates based on one or claim for the treatment of AIDS. At the next more health factors and thus violates this facts and circumstances). Thus, for corporate board meeting of the plan sponsor, paragraph (b)(1). However, if the plan did not example, a plan or issuer may limit or the claim is discussed. Shortly thereafter, the require evidence of good health but limited exclude benefits in relation to a specific plan is modified to impose a $10,000 lifetime late enrollees to the HMO option, the plan’s disease or condition, limit or exclude limit on benefits for the treatment of AIDS, rules for eligibility would not discriminate benefits for certain types of treatments effective before the beginning of the next based on any health factor, and thus would or drugs, or limit or exclude benefits plan year. not violate this paragraph (b)(1), because the based on a determination of whether the (ii) Conclusion. Under the facts of this time an individual chooses to enroll is not, benefits are experimental or not Example 2, the plan violates this paragraph itself, within the scope of any health factor. (b)(2)(i) because the plan modification is Example 3. (i) Facts. Under an employer’s medically necessary, but only if the directed at B based on B’s claim. group health plan, all employees generally benefit limitation or exclusion applies Example 3. (i) A group health plan applies may enroll within the first 30 days of uniformly to all similarly situated for a group health policy offered by an issuer. employment. However, individuals who individuals and is not directed at Individual C is covered under the plan and participate in certain recreational activities, individual participants or beneficiaries has an adverse health condition. As part of including motorcycling, are excluded from based on any health factor of the the application, the issuer receives health coverage. participants or beneficiaries. In information about the individuals to be (ii) Conclusion. In this Example 3, addition, a plan or issuer may impose covered, including information about C ’s excluding from the plan individuals who annual, lifetime, or other limits on adverse health condition. The policy form participate in recreational activities, such as offered by the issuer generally provides motorcycling, is a rule for eligibility that benefits and may require the satisfaction benefits for the adverse health condition that discriminates based on one more health of a deductible, copayment, C has, but in this case the issuer offers the factors and thus violates this paragraph coinsurance, or other cost-sharing plan a policy modified by a rider that (b)(1). requirement in order to obtain a benefit excludes benefits for C for that condition. Example 4. (i) Facts. A group health plan if the limit or cost-sharing requirement The exclusionary rider is made effective the applies for a group health policy offered by applies uniformly to all similarly first day of the next plan year. an issuer. As part of the application, the situated individuals and is not directed (ii) Conclusion. In this Example 3, the issuer receives health information about at individual participants or issuer violates this paragraph (b)(2)(i) individuals to be covered under the plan. beneficiaries based on any health factor because benefits for C ’s condition are Individual A is an employee of the employer available to other individuals in the group of maintaining the plan. A and A’s dependents of the participants or beneficiaries. In similarly situated individuals that includes C have a history of high health claims. Based the case of a cost-sharing requirement, but are not available to C. Thus, the benefits on the information about A and A’s see also paragraph (b)(2)(ii) of this are not uniformly available to all similarly dependents, the issuer excludes A and A’s section, which permits variances in the situated individuals. Even though the dependents from the group policy it offers to application of a cost-sharing mechanism exclusionary rider is made effective the first the employer. made available under a bona fide day of the next plan year, because the rider (ii) Conclusion. In this Example 4, the wellness program. (Whether any plan does not apply to all similarly situated issuer’s exclusion of A and A’s dependents provision or practice with respect to individuals, the issuer violates this paragraph from coverage is a rule for eligibility that benefits complies with this paragraph (b)(2)(i). discriminates based on one or more health Example 4. (i) Facts. A group health plan factors, and thus violates this paragraph (b)(2)(i) does not affect whether the has a $2,000 lifetime limit for the treatment (b)(1). (If the employer is a small employer provision or practice is permitted under of temporomandibular joint syndrome (TMJ). under 45 CFR 144.103 (generally, an any other provision of the Act, the The limit is applied uniformly to all similarly employer with 50 or fewer employees), the Americans with Disabilities Act, or any situated individuals and is not directed at issuer also may violate 45 CFR 146.150, other law, whether State or federal.) individual participants or beneficiaries. which requires issuers to offer all the policies (C) For purposes of this paragraph (ii) Conclusion. In this Example 4, the limit they sell in the small group market on a (b)(2)(i), a plan amendment applicable does not violate this paragraph (b)(2)(i) guaranteed available basis to all small to all individuals in one or more groups because $2000 of benefits for the treatment of employers and to accept every eligible of similarly situated individuals under TMJ are available uniformly to all similarly individual in every small employer group.) If situated individuals and a plan may limit the plan provides coverage through this the plan and made effective no earlier benefits covered in relation to a specific policy and does not provide equivalent than the first day of the first plan year disease or condition if the limit applies coverage for A and A’s dependents through after the amendment is adopted is not uniformly to all similarly situated other means, the plan will also violate this considered to be directed at any individuals and is not directed at individual paragraph (b)(1). individual participants or beneficiaries. participants or beneficiaries.

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Example 5. (i) Facts. A group health plan benefits otherwise provided for considered to be directed at any applies a $2 million lifetime limit on all treatment of the injury if the injury individual participants or beneficiaries. benefits. However, the $2 million lifetime results from an act of domestic violence (ii) The rules of this paragraph (b)(3) limit is reduced to $10,000 for any are illustrated by the following participant or beneficiary covered under the or a medical condition (including both plan who has a congenital heart defect. physical and mental health conditions). examples: (ii) Conclusion. In this Example 5, the (B) The rules of this paragraph Example 1. (i) Facts. A group health plan lower lifetime limit for participants and (b)(2)(iii) are illustrated by the following imposes a preexisting condition exclusion on beneficiaries with a congenital heart defect examples: all individuals enrolled in the plan. The exclusion applies to conditions for which violates this paragraph (b)(2)(i) because Example 1. (i) Facts. A group health plan medical advice, diagnosis, care, or treatment benefits under the plan are not uniformly generally provides medical/surgical benefits, available to all similarly situated individuals was recommended or received within the six- including benefits for hospital stays, that are month period ending on an individual’s and the plan’s lifetime limit on benefits does medically necessary. However, the plan not apply uniformly to all similarly situated enrollment date. In addition, the exclusion excludes benefits for self-inflicted injuries or individuals. generally extends for 12 months after an injuries sustained in connection with Example 6. (i) Facts. A group health plan individual’s enrollment date, but this 12- attempted suicide. Individual D suffers from limits benefits for prescription drugs to those month period is offset by the number of days depression and attempts suicide. As a result, listed on a drug formulary. The limit is of an individual’s creditable coverage in D sustains injuries and is hospitalized for applied uniformly to all similarly situated accordance with § 2590.701–3. There is treatment of the injuries. Pursuant to the individuals and is not directed at individual nothing to indicate that the exclusion is exclusion, the plan denies D benefits for participants or beneficiaries. directed at individual participants or (ii) Conclusion. In this Example 6, the treatment of the injuries. beneficiaries. exclusion from coverage of drugs not listed (ii) Conclusion. In this Example 1, the (ii) Conclusion. In this Example 1, even on the drug formulary does not violate this suicide attempt is the result of a medical though the plan’s preexisting condition paragraph (b)(2)(i) because benefits for condition (depression). Accordingly, the exclusion discriminates against individuals prescription drugs listed on the formulary are denial of benefits for the treatments of D’s based on one or more health factors, the uniformly available to all similarly situated injuries violates the requirements of this preexisting condition exclusion does not individuals and because the exclusion of paragraph (b)(2)(iii) because the plan violate this section because it applies drugs not listed on the formulary applies provision excludes benefits for treatment of uniformly to all similarly situated uniformly to all similarly situated an injury resulting from a medical condition. individuals, is not directed at individual individuals and is not directed at individual Example 2. (i) Facts. A group health plan participants or beneficiaries, and complies participants or beneficiaries. provides benefits for head injuries generally. with § 2590.701–3 (that is, the requirements Example 7. (i) Facts. Under a group health The plan also has a general exclusion for any relating to the six-month look-back period, plan, doctor visits are generally subject to a injury sustained while participating in any of the 12-month (or 18-month) maximum $250 annual deductible and 20 percent a number of recreational activities, including exclusion period, and the creditable coverage coinsurance requirement. However, prenatal bungee jumping. However, this exclusion offset). doctor visits are not subject to any deductible does not apply to any injury that results from Example 2. (i) Facts. A group health plan or coinsurance requirement. These rules are a medical condition (nor from domestic excludes coverage for conditions with respect applied uniformly to all similarly situated violence). Participant E sustains a head to which medical advice, diagnosis, care, or individuals and are not directed at individual injury while bungee jumping. The injury did treatment was recommended or received participants or beneficiaries. not result from a medical condition (nor from within the six-month period ending on an (ii) Conclusion. In this Example 7, domestic violence). Accordingly, the plan individual’s enrollment date. Under the plan, imposing different deductible and denies benefits for E’s head injury. the preexisting condition exclusion generally coinsurance requirements for prenatal doctor (ii) Conclusion. In this Example 2, the plan extends for 12 months, offset by creditable visits and other visits does not violate this provision that denies benefits based on the coverage. However, if an individual has no paragraph (b)(2)(i) because a plan may source of an injury does not restrict benefits claims in the first six months following establish different deductibles or coinsurance based on an act of domestic violence or any enrollment, the remainder of the exclusion requirements for different services if the medical condition. Therefore, the provision period is waived. deductible or coinsurance requirement is is permissible under this paragraph (b)(2)(iii) (ii) Conclusion. In this Example 2, the applied uniformly to all similarly situated and does not violate this section. (However, plan’s preexisting condition exclusions individuals and is not directed at individual if the plan did not allow E to enroll in the violate this section because they do not meet participants or beneficiaries. plan (or applied different rules for eligibility the requirements of this paragraph (b)(3); (ii) Cost-sharing mechanisms and to E) because E frequently participates in specifically, they do not apply uniformly to wellness programs. A group health plan bungee jumping, the plan would violate all similarly situated individuals. The plan paragraph (b)(1) of this section.) or group health insurance coverage with provisions do not apply uniformly to all a cost-sharing mechanism (such as a (3) Relationship to § 2590.701–3. (i) A similarly situated individuals because deductible, copayment, or coinsurance) preexisting condition exclusion is individuals who have medical claims during the first six months following enrollment are that requires a higher payment from an permitted under this section if it — (A) Complies with § 2590.701–3; not treated the same as similarly situated individual, based on a health factor of individuals with no claims during that that individual or a dependent of that (B) Applies uniformly to all similarly period. (Under paragraph (d) of this section, individual, than for a similarly situated situated individuals (as described in the groups cannot be treated as two separate individual under the plan (and thus paragraph (d) of this section); and groups of similarly situated individuals does not apply uniformly to all similarly (C) Is not directed at individual because the distinction is based on a health situated individuals) does not violate participants or beneficiaries based on factor.) the requirements of this paragraph (b)(2) any health factor of the participants or (c) Prohibited discrimination in if the payment differential is based on beneficiaries. For purposes of this premiums or contributions—(1) In whether an individual has complied paragraph (b)(3)(i)(C), a plan general—(i) A group health plan, and a with the requirements of a bona fide amendment relating to a preexisting health insurance issuer offering health wellness program. condition exclusion applicable to all insurance coverage in connection with a (iii) Specific rule relating to source-of- individuals in one or more groups of group health plan, may not require an injury exclusions—(A) If a group health similarly situated individuals under the individual, as a condition of enrollment plan or group health insurance coverage plan and made effective no earlier than or continued enrollment under the plan generally provides benefits for a type of the first day of the first plan year after or group health insurance coverage, to injury, the plan or issuer may not deny the amendment is adopted is not pay a premium or contribution that is

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The coverage; individual. requirements of this section apply only (B) Relationship to the participant (ii) Discounts, rebates, payments in within a group of individuals who are (e.g., as a spouse or as a dependent kind, and any other premium treated as similarly situated individuals. child); differential mechanisms are taken into A plan or issuer may treat participants (C) Marital status; account in determining an individual’s as a group of similarly situated (D) With respect to children of a premium or contribution rate. (For rules individuals separate from beneficiaries. participant, age or student status; or relating to cost-sharing mechanisms, see In addition, participants may be treated (E) Any other factor if the factor is not paragraph (b)(2) of this section as two or more distinct groups of a health factor. (ii) Paragraph (d)(2)(i) of this section (addressing benefits).) similarly situated individuals and does not prevent more favorable (2) Rules relating to premium rates— beneficiaries may be treated as two or treatment of individuals with adverse (i) Group rating based on health factors more distinct groups of similarly health factors in accordance with not restricted under this section. situated individuals in accordance with paragraph (g) of this section. Nothing in this section restricts the the rules of this paragraph (d). Moreover, if individuals have a choice (3) Discrimination directed at aggregate amount that an employer may individuals. Notwithstanding be charged for coverage under a group of two or more benefit packages, individuals choosing one benefit paragraphs (d)(1) and (2) of this section, health plan. if the creation or modification of an (ii) List billing based on a health package may be treated as one or more groups of similarly situated individuals employment or coverage classification is factor prohibited. However, a group directed at individual participants or health insurance issuer, or a group distinct from individuals choosing another benefit package. beneficiaries based on any health factor health plan, may not quote or charge an of the participants or beneficiaries, the employer (or an individual) a different (1) Participants. Subject to paragraph (d)(3) of this section, a plan or issuer classification is not permitted under this premium for an individual in a group of paragraph (d), unless it is permitted similarly situated individuals based on may treat participants as two or more distinct groups of similarly situated under paragraph (g) of this section a health factor. (But see paragraph (g) of (permitting favorable treatment of this section permitting favorable individuals if the distinction between or among the groups of participants is individuals with adverse health factors). treatment of individuals with adverse based on a bona fide employment-based Thus, if an employer modified an health factors.) classification consistent with the employment-based classification to (iii) Examples. The rules of this employer’s usual business practice. single out, based on a health factor, paragraph (c)(2) are illustrated by the Whether an employment-based individual participants and following examples: classification is bona fide is determined beneficiaries and deny them health Example 1. (i) Facts. An employer sponsors on the basis of all the relevant facts and coverage, the new classification would a group health plan and purchases coverage circumstances. Relevant facts and not be permitted under this section. from a health insurance issuer. In order to (4) Examples. The rules of this determine the premium rate for the circumstances include whether the upcoming plan year, the issuer reviews the employer uses the classification for paragraph (d) are illustrated by the claims experience of individuals covered purposes independent of qualification following examples: under the plan. The issuer finds that for health coverage (for example, Example 1. (i) Facts. An employer sponsors Individual F had significantly higher claims determining eligibility for other a group health plan for full-time employees experience than similarly situated employee benefits or determining other only. Under the plan (consistent with the individuals in the plan. The issuer quotes the terms of employment). Subject to employer’s ususal business practice), plan a higher per-participant rate because of paragraph (d)(3) of this section, employees who normally work at least 30 F ’s claims experience. hours per week are considered to be working examples of classifications that, based full-time. Other employees are considered to (ii) Conclusion. In this Example 1, the on all the relevant facts and issuer does not violate the provisions of this be working part-time. There is no evidence paragraph (c)(2) because the issuer blends the circumstances, may be bona fide to suggest that the classification is directed rate so that the employer is not quoted a include full-time versus part-time at individual participants or beneficiaries. higher rate for F than for a similarly situated status, different geographic location, (ii) Conclusion. In this Example 1, treating individual based on F ’s claims experience. membership in a collective bargaining the full-time and part-time employees as two Example 2. (i) Facts. Same facts as unit, date of hire, length of service, separate groups of similarly situated Example 1, except that the issuer quotes the current employee versus former individuals is permitted under this paragraph (d) because the classification is bona fide and employer a higher premium rate for F, employee status, and different because of F ’s claims experience, than for a is not directed at individual participants or occupations. However, a classification beneficiaries. similarly situated individual. based on any health factor is not a bona (ii) Conclusion. In this Example 2, the Example 2. (i) Facts. Under a group health issuer violates this paragraph (c)(2). fide employment-based classification, plan, coverage is made available to employees, their spouses, and their Moreover, even if the plan purchased the unless the requirements of paragraph (g) dependent children. However, coverage is policy based on the quote but did not require of this section are satisfied (permitting made available to a dependent child only if a higher participant contribution for F than favorable treatment of individuals with the dependent child is under age 19 (or for a similarly situated individual, the issuer adverse health factors). under age 25 if the child is continuously would still violate this paragraph (c)(2) (but (2) Beneficiaries—(i) Subject to enrolled full-time in an institution of higher in such a case the plan would not violate this paragraph (d)(3) of this section, a plan learning (full-time students)). There is no paragraph (c)(2)). or issuer may treat beneficiaries as two evidence to suggest that these classifications (3) Exception for bona fide wellness or more distinct groups of similarly are directed at individual participants or programs. Notwithstanding paragraphs situated individuals if the distinction beneficiaries.

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(ii) Conclusion. In this Example 2, treating coverage under the plan is modified so that institution that is covered under an extension spouses and dependent children differently employees with G’s job title receive a of benefits clause from a previous issuer. by imposing an age limitation on dependent different benefit package that includes a This section does not affect any obligation children, but not on spouses, is permitted lower lifetime dollar limit than in the benefit Issuer M may have under applicable State under this paragraph (d). Specifically, the package made available to the other six law to provide any extension of benefits and distinction between spouses and dependent employees. does not affect any State law governing children is permitted under paragraph (d)(2) (ii) Conclusion. Under the facts of this coordination of benefits. of this section and is not prohibited under Example 5, changing the coverage (2) Actively-at-work and continuous paragraph (d)(3) of this section because it is classification for G based on the existing not directed at individual participants or employment classification for G is not service provisions—(i) General rule—(A) beneficiaries. It is also permissible to treat permitted under this paragraph (d) because Under the rules of paragraphs (b) and (c) dependent children who are under age 19 (or the creation of the new coverage of this section and subject to the full-time students under age 25) as a group classification for G is directed at G based on exception for the first day of work of similarly situated individuals separate one or more health factors. described in paragraph (e)(2)(ii) of this from those who are age 25 or older (or age (e) Nonconfinement and actively-at- section, a plan or issuer may not 19 or older if they are not full-time students) work provisions—(1) Nonconfinement establish a rule for eligibility (as because the classification is permitted under provisions—(i) General rule. Under the described in paragraph (b)(1)(ii) of this paragraph (d)(2) of this section and is not directed at individual participants or rules of paragraphs (b) and (c) of this section) or set any individual’s premium beneficiaries. section, a plan or issuer may not or contribution rate based on whether Example 3. (i) Facts. A university sponsors establish a rule for eligibility (as an individual is actively at work a group health plan that provides one health described in paragraph (b)(1)(ii) of this (including whether an individual is benefit package to faculty and another health section) or set any individual’s premium continuously employed), unless absence benefit package to other staff. Faculty and or contribution rate based on whether from work due to any health factor staff are treated differently with respect to an individual is confined to a hospital (such as being absent from work on sick other employee benefits such as retirement or other health care institution. In leave) is treated, for purposes of the benefits and leaves of absence. There is no plan or health insurance coverage, as evidence to suggest that the distinction is addition, under the rules of paragraphs directed at individual participants or (b) and (c) of this section, a plan or being actively at work. beneficiaries. issuer may not establish a rule for (B) The rules of this paragraph (e)(2)(i) (ii) Conclusion. In this Example 3, the eligibility or set any individual’s are illustrated by the following classification is permitted under this premium or contribution rate based on examples: paragraph (d) because there is a distinction an individual’s ability to engage in Example 1. (i) Facts. Under a group health based on a bona fide employment-based normal life activities, except to the plan, an employee generally becomes eligible classification consistent with the employer’s extent permitted under paragraphs to enroll 30 days after the first day of usual business practice and the distinction is (e)(2)(ii) and (3) of this section employment. However, if the employee is not not directed at individual participants and (permitting plans and issuers, under actively at work on the first day after the end beneficiaries. of the 30-day period, then eligibility for Example 4. (i) Facts. An employer sponsors certain circumstances, to distinguish enrollment is delayed until the first day the a group health plan that is available to all among employees based on the employee is actively at work. current employees. Former employees may performance of services). (ii) Conclusion. In this Example 1, the plan also be eligible, but only if they complete a (ii) Examples. The rules of this violates this paragraph (e)(2) (and thus also specified number of years of service, are paragraph (e)(1) are illustrated by the violates paragraph (b) of this section). enrolled under the plan at the time of following examples: However, the plan would not violate termination of employment, and are Example 1. (i) Facts. Under a group health paragraph (e)(2) or (b) of this section if, under continuously enrolled from that date. There plan, coverage for employees and their the plan, an absence due to any health factor is no evidence to suggest that these dependents generally becomes effective on is considered being actively at work. distinctions are directed at individual the first day of employment. However, Example 2. (i) Facts. Under a group health participants or beneficiaries. coverage for a dependent who is confined to plan, coverage for an employee becomes (ii) Conclusion. In this Example 4, a hospital or other health care institution effective after 90 days of continuous service; imposing additional eligibility requirements does not become effective until the that is, if an employee is absent from work on former employees is permitted because a confinement ends. (for any reason) before completing 90 days of classification that distinguishes between (ii) Conclusion. In this Example 1, the plan service, the beginning of the 90-day period is current and former employees is a bona fide violates this paragraph (e)(1) because the measured from the day the employee returns employment-based classification that is plan delays the effective date of coverage for to work (without any credit for service before permitted under this paragraph (d), provided dependents based on confinement to a the absence). that it is not directed at individual hospital or other health care institution. (ii) Conclusion. In this Example 2, the plan participants or beneficiaries. In addition, it is Example 2. (i) Facts. In previous years, a violates this paragraph (e)(2) (and thus also permissible to distinguish between former group health plan has provided coverage paragraph (b) of this section) because the 90- employees who satisfy the service through a group health insurance policy day continuous service requirement is a rule requirement and those who do not, provided offered by Issuer M. However, for the current for eligibility based on whether an individual that the distinction is not directed at year, the plan provides coverage through a is actively at work. However, the plan would individual participants or beneficiaries. group health insurance policy offered by not violate this paragraph (e)(2) or paragraph (However, former employees who do not Issuer N. Under Issuer N’s policy, items and (b) of this section if, under the plan, an satisfy the eligibility criteria may, services provided in connection with the absence due to any health factor is not nonetheless, be eligible for continued confinement of a dependent to a hospital or considered an absence for purposes of coverage pursuant to a COBRA continuation other health care institution are not covered measuring 90 days of continuous service. provision or similar State law.) if the confinement is covered under an (ii) Exception for the first day of Example 5. (i) Facts. An employer sponsors extension of benefits clause from a previous work—(A) Notwithstanding the general a group health plan that provides the same health insurance issuer. rule in paragraph (e)(2)(i) of this section, benefit package to all seven employees of the (ii) Conclusion. In this Example 2, Issuer a plan or issuer may establish a rule for employer. Six of the seven employees have N violates this paragraph (e)(1) because the the same job title and responsibilities, but group health insurance coverage restricts eligibility that requires an individual to Employee G has a different job title and benefits (a rule for eligibility under paragraph begin work for the employer sponsoring different responsibilities. After G files an (b)(1)) based on whether a dependent is the plan (or, in the case of a expensive claim for benefits under the plan, confined to a hospital or other health care multiemployer plan, to begin a job in

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When the layoff examples: or more hours per week or if they are on paid begins, C ’s coverage under the plan is Example 1. (i) Facts. Under the eligibility leave (such as vacation, sick, or bereavement terminated. (This termination of coverage is provision of a group health plan, coverage for leave). Employees on unpaid leave are without regard to whatever rights the new employees becomes effective on the first treated as a separate group of similarly employee (or members of the employee’s day that the employee reports to work. situated individuals in accordance with the family) may have for COBRA continuation Individual H is scheduled to begin work on rules of paragraph (d) of this section. coverage.) August 3. However, H is unable to begin (ii) Conclusion. In this Example 1, the plan (ii) Conclusion. In this Example 4, the plan work on that day because of illness. H begins provisions do not violate this section. provision terminating C ’s coverage upon the working on August 4, and H’s coverage is However, if the plan treated individuals cessation of C ’s performance of services does effective on August 4. performing services for the employer for 30 not violate this section. (ii) Conclusion. In this Example 1, the plan or more hours per week, individuals on (f) Bona fide wellness programs. provision does not violate this section. vacation leave, and individuals on [Reserved.] However, if coverage for individuals who do bereavement leave as a group of similarly (g) More favorable treatment of not report to work on the first day they were situated individuals separate from scheduled to work for a reason unrelated to individuals on sick leave, the plan would individuals with adverse health factors a health factor (such as vacation or violate this paragraph (e) (and thus also permitted—(1) In rules for eligibility—(i) bereavement) becomes effective on the first would violate paragraph (b) of this section) Nothing in this section prevents a group day they were scheduled to work, then the because groups of similarly situated health plan or group health insurance plan would violate this section. individuals cannot be established based on a issuer from establishing more favorable Example 2. (i) Facts. Under a group health health factor (including the taking of sick rules for eligibility (described in plan, coverage for new employees becomes leave) under paragraph (d) of this section. paragraph (b)(1) of this section) for effective on the first day of the month Example 2. (i) Facts. To be eligible for individuals with an adverse health following the employee’s first day of work, coverage under a bona fide collectively factor, such as disability, than for regardless of whether the employee is bargained group health plan in the current actively at work on the first day of the month. calendar quarter, the plan requires an individuals without the adverse health Individual J is scheduled to begin work on individual to have worked 250 hours in factor. Moreover, nothing in this section March 24. However, J is unable to begin work covered employment during the three-month prevents a plan or issuer from charging on March 24 because of illness. J begins period that ends one month before the a higher premium or contribution with working on April 7 and J’s coverage is beginning of the current calendar quarter. respect to individuals with an adverse effective May 1. The distinction between employees working health factor if they would not be (ii) Conclusion. In this Example 2, the plan at least 250 hours and those working less eligible for the coverage were it not for provision does not violate this section. than 250 hours in the earlier three-month the adverse health factor. (However, However, as in Example 1, if coverage for period is not directed at individual other laws, including State insurance individuals absent from work for reasons participants or beneficiaries based on any unrelated to a health factor became effective health factor of the participants or laws, may set or limit premium rates; despite their absence, then the plan would beneficiaries. these laws are not affected by this violate this section. (ii) Conclusion. In this Example 2, the plan section.) (3) Relationship to plan provisions provision does not violate this section (ii) The rules of this paragraph (g)(1) defining similarly situated individuals— because, under the rules for similarly are illustrated by the following (i) Notwithstanding the rules of situated individuals allowing full-time examples: paragraphs (e)(1) and (2) of this section, employees to be treated differently than part- Example 1. (i) Facts. An employer sponsors a plan or issuer may establish rules for time employees, employees who work at a group health plan that generally is available eligibility or set any individual’s least 250 hours in a three-month period can to employees, spouses of employees, and be treated differently than employees who dependent children until age 23. However, premium or contribution rate in fail to work 250 hours in that period. The accordance with the rules relating to dependent children who are disabled are result would be the same if the plan eligible for coverage beyond age 23. similarly situated individuals in permitted individuals to apply excess hours (ii) Conclusion. In this Example 1, the plan paragraph (d) of this section. from previous periods to satisfy the provision allowing coverage for disabled Accordingly, a plan or issuer may requirement for the current quarter. dependent children beyond age 23 satisfies distinguish in rules for eligibility under Example 3. (i) Facts. Under a group health this paragraph (g)(1) (and thus does not the plan between full-time and part-time plan, coverage of an employee is terminated violate this section). employees, between permanent and when the individual’s employment is Example 2. (i) Facts. An employer sponsors temporary or seasonal employees, terminated, in accordance with the rules of a group health plan, which is generally paragraph (d) of this section. Employee B has between current and former employees, available to employees (and members of the been covered under the plan. B experiences employee’s family) until the last day of the and between employees currently a disabling illness that prevents B from month in which the employee ceases to performing services and employees no working. B takes a leave of absence under the perform services for the employer. The plan longer performing services for the Family and Medical Leave Act of 1993. At generally charges employees $50 per month employer, subject to paragraph (d) of the end of such leave, B terminates for employee-only coverage and $125 per this section. However, other federal or employment and consequently loses coverage month for family coverage. However, an State laws (including the COBRA under the plan. (This termination of coverage employee who ceases to perform services for continuation provisions and the Family is without regard to whatever rights the the employer by reason of disability may and Medical Leave Act of 1993) may employee (or members of the employee’s remain covered under the plan until the last family) may have for COBRA continuation day of the month that is 12 months after the require an employee or the employee’s coverage.) month in which the employee ceased to dependents to be offered coverage and (ii) Conclusion. In this Example 3, the plan perform services for the employer. During set limits on the premium or provision terminating B’s coverage upon B’s this extended period of coverage, the plan contribution rate even though the termination of employment does not violate charges the employee $100 per month for employee is not performing services. this section. employee-only coverage and $250 per month

VerDate 112000 19:33 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1410 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations for family coverage. (This extended period of paragraph (g)(2) (and thus does not violate who was denied coverage if the denial coverage is without regard to whatever rights this section). was not based on a good faith the employee (or members of the employee’s (h) No effect on other laws. interpretation of section 702 of the Act family) may have for COBRA continuation Compliance with this section is not or the Secretary’s published guidance. coverage.) determinative of compliance with any Under that paragraph, such an (ii) Conclusion. In this Example 2, the plan other provision of the Act (including the provision allowing extended coverage for individual must be allowed to enroll disabled employees and their families COBRA continuation provisions) or any retroactively to the effective date of satisfies this paragraph (g)(1) (and thus does other State or federal law, such as the section 702 of the Act, or, if later, the not violate this section). In addition, the plan Americans with Disabilities Act. date the individual meets eligibility is permitted, under this paragraph (g)(1), to Therefore, although the rules of this criteria under the plan that do not charge the disabled employees a higher section would not prohibit a plan or discriminate based on any health factor. premium during the extended period of issuer from treating one group of Paragraph (i)(3)(iii) of this section coverage. similarly situated individuals applies with respect to any individual Example 3. (i) Facts. To comply with the differently from another (such as who was denied coverage based on a requirements of a COBRA continuation providing different benefit packages to good faith interpretation of section 702 provision, a group health plan generally current and former employees), other makes COBRA continuation coverage of the Act or the Secretary’s published available for a maximum period of 18 months federal or State laws may require that guidance. Under that paragraph, such an in connection with a termination of two separate groups of similarly situated individual must be given an opportunity employment but makes the coverage individuals be treated the same for to enroll effective July 1, 2001. In either available for a maximum period of 29 months certain purposes (such as making the event, whether under paragraph (i)(3)(ii) to certain disabled individuals and certain same benefit package available to or (iii) of this section, the Secretary will members of the disabled individual’s family. COBRA qualified beneficiaries as is not take any enforcement action with Although the plan generally requires made available to active employees). In respect to denials of coverage addressed payment of 102 percent of the applicable addition, although this section generally in this paragraph (i)(3) if the plan has premium for the first 18 months of COBRA does not impose new disclosure complied with the transitional rules of continuation coverage, the plan requires obligations on plans and issuers, this payment of 150 percent of the applicable this paragraph (i)(3). premium for the disabled individual’s section does not affect any other laws, (i) Denial of coverage clarified. For COBRA continuation coverage during the including those that require accurate purposes of this paragraph (i)(3), an disability extension if the disabled individual disclosures and prohibit intentional individual is considered to have been would not be entitled to COBRA misrepresentation. denied coverage if the individual— continuation coverage but for the disability. (i) Applicability dates—(1) (A) Failed to apply for coverage (ii) Conclusion. In this Example 3, the plan Paragraphs applicable March 9, 2001. because it was reasonable to believe that provision allowing extended COBRA Paragraphs (a)(1), (a)(2)(i), (b)(1)(i), an application for coverage would have continuation coverage for disabled (b)(1)(iii) Example 1, (b)(2)(i)(A), been futile due to a plan provision that individuals satisfies this paragraph (g)(1) (b)(2)(ii), (c)(1)(i), (c)(2)(i), and (c)(3) of discriminated based on a health factor; (and thus does not violate this section). In this section and this paragraph (i)(1) or addition, the plan is permitted, under this (B) Was not offered an opportunity to paragraph (g)(1), to charge the disabled apply to group health plans and health individuals a higher premium for the insurance issuers offering group health enroll in the plan and the failure to give extended coverage if the individuals would insurance coverage March 9, 2001. such an opportunity violates this not be eligible for COBRA continuation (2) Paragraphs applicable for plan section. coverage were it not for the disability. years beginning on or after July 1, 2001. (ii) Individuals denied coverage (Similarly, if the plan provided an extended Except as provided in paragraph (i)(3) of without a good faith interpretation of period of coverage for disabled individuals this section, the provisions of this the law—(A) Opportunity to enroll pursuant to State law or plan provision rather section not listed in paragraph (i)(1) of required. If a plan or issuer has denied than pursuant to a COBRA continuation this section apply to group health plans coverage to any individual based on a coverage provision, the plan could likewise and health insurance issuers offering health factor and that denial was not charge the disabled individuals a higher group health insurance coverage for based on a good faith interpretation of premium for the extended coverage.) plan years beginning on or after July 1, section 702 of the Act or any guidance (2) In premiums or contributions—(i) 2001. Except as provided in paragraph published by the Secretary, the plan or Nothing in this section prevents a group (i)(3) of this section, with respect to issuer is required to give the individual health plan or group health insurance efforts to comply with section 702 of the an opportunity to enroll (including issuer from charging individuals a Act before the first plan year beginning notice of an opportunity to enroll) that premium or contribution that is less on or after July 1, 2001, the Secretary continues for at least 30 days. This than the premium (or contribution) for will not take any enforcement action opportunity must be presented not later similarly situated individuals if the against a plan that has sought to comply than March 9, 2001. lower charge is based on an adverse in good faith with section 702 of the (1) If this enrollment opportunity was health factor, such as disability. Act. presented before or within the first plan (ii) The rules of this paragraph (g)(2) (3) Transitional rules for individuals year beginning on or after July 1, 1997 are illustrated by the following example: previously denied coverage based on a (or in the case of a collectively Example. (i) Facts. Under a group health health factor. This paragraph (i)(3) bargained plan, before or within the first plan, employees are generally required to pay provides rules relating to individuals plan year beginning on the effective date $50 per month for employee-only coverage previously denied coverage under a for the plan described in section and $125 per month for family coverage group health plan or group health 101(g)(3) of the Health Insurance under the plan. However, employees who are insurance coverage based on a health disabled receive coverage (whether Portability and Accountability Act of employee-only or family coverage) under the factor of the individual. Paragraph 1996), the coverage must be effective plan free of charge. (i)(3)(i) clarifies what constitutes a within that first plan year. (ii) Conclusion. In this Example, the plan denial of coverage under this paragraph (2) If this enrollment opportunity is provision waiving premium payment for (i)(3). Paragraph (i)(3)(ii) of this section presented after such plan year, the disabled employees is permitted under this applies with respect to any individual individual must be given the choice of

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1411 having the coverage effective on either a physical examination. In November of for coverage after that date, on the date of the following two dates— 1997, the plan gives F an opportunity to the individual was otherwise eligible to (i) The date the plan receives a request enroll in the plan (including notice of the enroll in the plan). In addition, any for enrollment in connection with the opportunity to enroll) without passing a period between the individual’s enrollment opportunity; or physical examination, with coverage effective January 1, 1998. enrollment date and the effective date of (ii) Retroactively to the first day of the (ii) Conclusion. In this Example 1, the plan coverage is treated as a waiting period. first plan year beginning on the effective complies with the requirements of this (C) Example. The rules of this date for the plan described in sections paragraph (i)(3)(ii). paragraph (i)(3)(iii) are illustrated by the 101(g)(1) and (3) of the Health Insurance Example 2. (i) Facts. The plan year of a following example: Portability and Accountability Act of group health plan begins January 1 and ends Example. (i) Facts. Individual H was hired 1996 (or, if the individual otherwise December 31. Under the plan, a dependent by Employer Y on May 3, 1995. Y maintains first became eligible to enroll for who is unable to engage in normal life a group health plan with a plan year coverage after that date, on the date the activities on the date coverage would beginning on February 1. Under the terms of individual was otherwise eligible to otherwise become effective is not enrolled the plan, employees and their dependents are until the dependent is able to engage in allowed to enroll when the employee is first enroll in the plan). If an individual normal life activities. Individual G is a hired (without a requirement to pass a elects retroactive coverage, the plan or dependent who is otherwise eligible for physical examination), and on each February issuer is required to provide the benefits coverage, but is unable to engage in normal 1 thereafter if the individual can pass a it would have provided if the individual life activities. The plan has not allowed G to physical examination. H chose not to enroll had been enrolled for coverage during enroll for coverage. for coverage when hired in May of 1995. On that period (irrespective of any (ii) Conclusion. In this Example 2, February 1, 1997, H tried to enroll for otherwise applicable plan provisions beginning on the effective date of section 702 coverage under the plan. However, H was governing timing for the submission of of the Act for the plan (January 1, 1998), the denied coverage for failure to pass a physical examination. Shortly thereafter, Y’s plan claims). The plan or issuer may require plan provision is not permitted under any good faith interpretation of section 702 of the eliminated late enrollment, and H was not the individual to pay whatever Act or any guidance published by the given another opportunity to enroll in the additional amount the individual would Secretary. Therefore, the plan is required, not plan. There is no evidence to suggest that Y’s have been required to pay for the later than March 9, 2001, to give G an plan was acting in bad faith in denying coverage (but the plan or issuer cannot opportunity to enroll (including notice of the coverage under the plan beginning on the charge interest on that amount). opportunity to enroll), with coverage effective date of section 702 of the Act (B) Relation to preexisting condition effective, at G’s option, either retroactively (February 1, 1998). rules. For purposes of part 7 of subtitle from January 1, 1998 or prospectively from (ii) Conclusion. In this Example, because coverage previously had been made available B of title I of the Act, the individual may the date G’s request for enrollment is received by the plan. If G elects coverage to with respect to H without regard to any not be treated as a late enrollee or as a health factor of H and because Y’s plan was special enrollee. Moreover, the be effective beginning January 1, 1998, the plan can require G to pay any required acting in accordance with a good faith individual’s enrollment date is the employee premiums for the retroactive interpretation of section 702 (and guidance effective date for the plan described in coverage. published by the Secretary), the failure of Y’s sections 101(g)(1) and (3) of the Health plan to allow H to enroll effective February (iii) Individuals denied coverage 1, 1998 was permissible on that date. Insurance Portability and based on a good faith interpretation of Accountability Act (or, if the individual However, under the transitional rules of this the law—(A) Opportunity to enroll paragraph (i)(3)(iii), Y’s plan must give H an otherwise first became eligible to enroll required. If a plan or issuer has denied opportunity to enroll that continues for at for coverage after that date, on the date coverage to any individual before the least 30 days, with coverage effective no later the individual was otherwise eligible to first day of the first plan year beginning than July 1, 2001. (In addition, February 1, enroll in the plan), even if the on or after July 1, 2001 based in part on 1998 is H’s enrollment date under the plan individual chooses under paragraph a health factor and that denial was and the period between February 1, 1998 and (i)(3)(ii)(A) of this section to have July 1, 2001 is treated as a waiting period. based on a good faith interpretation of Accordingly, any preexisting condition coverage effective only prospectively. In section 702 of the Act or guidance addition, any period between the exclusion period permitted under published by the Secretary, the plan or § 2590.701–3 will have expired before July 1, individual’s enrollment date and the issuer is required to give the individual 2001.) effective date of coverage is treated as a an opportunity to enroll (including 3. The heading, paragraph (a)(1), and waiting period. notice of an opportunity to enroll) that (C) Examples. The rules of this the first sentence of paragraph (a)(2) of continues for at least 30 days, with paragraph (i)(3)(ii) are illustrated by the § 2590.736 are revised to read as coverage effective no later than July 1, following examples: follows: 2001. Individuals required to be offered Example 1. (i) Facts. Employer X maintains an opportunity to enroll include § 2590.736 Applicability dates. a group health plan with a plan year individuals previously offered beginning October 1 and ending September (a) General applicability dates—(1) 30. Individual F was hired by Employer X enrollment without regard to a health Non-collectively bargained plans. Part 7 before the effective date of section 702 of the factor but subsequently denied of Subtitle B of Title I of the Act and Act. Before the effective date of section 702 enrollment due to a health factor. §§ 2590.701–1 through 2590.701–7, of the Act for this plan (October 1, 1997), the (B) Relation to preexisting condition 2590.703, 2590.731 through 2590.734, terms of the plan allowed employees and rules. For purposes of Part 7 of Subtitle and this section apply with respect to their dependents to enroll when the B of Title I of the Act, the individual group health plans, and health employee was first hired, and on each may not be treated as a late enrollee or insurance coverage offered in January 1 thereafter, but in either case, only as a special enrollee. Moreover, the connection with group health plans, for if the individual could pass a physical individual’s enrollment date is the examination. F ’s application to enroll when plan years beginning after June 30, 1997, first hired was denied because F had diabetes effective date for the plan described in except as otherwise provided in this and could not pass a physical examination. sections 101(g)(1) and (3) of the Health section. Upon the effective date of section 702 of the Insurance Portability and (2) Collectively-bargained plans. Act for this plan (October 1, 1997), the plan Accountability Act (or, if the individual Except as otherwise provided in this is amended to delete the requirement to pass otherwise first became eligible to enroll section (other than in paragraph (a)(1) of

VerDate 112000 19:33 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1412 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations this section), in the case of a group (ii) Participation in activities such as Example 1. (i) Facts. An employer sponsors health plan maintained pursuant to one motorcycling, snowmobiling, all-terrain a group health plan that is available to all or more collective bargaining vehicle riding, horseback riding, skiing, employees who enroll within the first 30 agreements between employee and other similar activities. days of their employment. However, employees who do not enroll within the first representatives and one or more (3) The decision whether health 30 days cannot enroll later unless they pass employers ratified before August 21, coverage is elected for an individual a physical examination. 1996, Part 7 of Subtitle B of Title I of (including the time chosen to enroll, (ii) Conclusion. In this Example 1, the the Act and §§ 2590.701–1 through such as under special enrollment or late requirement to pass a physical examination 2590.701–7, 2590.703, 2590.731 through enrollment) is not, itself, within the in order to enroll in the plan is a rule for 2590.734, and this section do not apply scope of any health factor. (However, eligibility that discriminates based on one or to plan years beginning before the later under § 146.117, a plan or issuer must more health factors and thus violates this of July 1, 1997, or the date on which the treat special enrollees the same as paragraph (b)(1). Example 2. (i) Facts. Under an employer’s last of the collective bargaining similarly situated individuals who are group health plan, employees who enroll agreements relating to the plan enrolled when first eligible.) during the first 30 days of employment (and terminates (determined without regard (b) Prohibited discrimination in rules during special enrollment periods) may to any extension thereof agreed to after for eligibility—(1) In general—(i) A choose between two benefit packages: an August 21, 1996). * * * group health plan, and a health indemnity option and an HMO option. * * * * * insurance issuer offering health However, employees who enroll during late insurance coverage in connection with a enrollment are permitted to enroll only in the Signed at Washington, DC this 28th day of group health plan, may not establish HMO option and only if they provide December, 2000. evidence of good health. any rule for eligibility (including Leslie B. Kramerich, (ii) Conclusion. In this Example 2, the continued eligibility) of any individual requirement to provide evidence of good Assistant Secretary, Pension and Welfare to enroll for benefits under the terms of Benefits Administration, U.S. Department of health in order to be eligible for late Labor. the plan or group health insurance enrollment in the HMO option is a rule for coverage that discriminates based on eligibility that discriminates based on one or For the reasons set forth above, 45 any health factor that relates to that more health factors and thus violates this CFR Part 146 is amended as follows: individual or a dependent of that paragraph (b)(1). However, if the plan did not require evidence of good health but limited PART 146 [AMENDED]ÐRULES AND individual. This rule is subject to the provisions of paragraph (b)(2) of this late enrollees to the HMO option, the plan’s REGULATIONS FOR HEALTH rules for eligibility would not discriminate INSURANCE PORTABILITY AND section (explaining how this rule based on any health factor, and thus would RENEWABILITY FOR GROUP HEALTH applies to benefits), paragraph (b)(3) of not violate this paragraph (b)(1), because the PLANS this section (allowing plans to impose time an individual chooses to enroll is not, certain preexisting condition itself, within the scope of any health factor. 1. The authority citation for Part 146 exclusions), paragraph (d) of this section Example 3. (i) Facts. Under an employer’s is revised to read as follows: (containing rules for establishing groups group health plan, all employees generally of similarly situated individuals), may enroll within the first 30 days of Authority: Secs. 2701 through 2763, 2791 employment. However, individuals who and 2792 of the Public Health Service Act, paragraph (e) of this section (relating to nonconfinement, actively-at-work, and participate in certain recreational activities, 42 U.S.C. 300gg through 300gg–63, 300gg–91, including motorcycling, are excluded from 300gg–92 as amended by HIPAA (Public Law other service requirements), paragraph coverage. 104–191, 110 Stat. 1936), MHPA and (f) of this section (relating to bona fide (ii) Conclusion. In this Example 3, NMHPA (Public Law 104–204, 110 Stat. wellness programs), and paragraph (g) of excluding from the plan individuals who 2935), and WHCRA (Public Law 105–277, this section (permitting favorable participate in recreational activities, such as 112 Stat. 2681–436), and section 102(c)(4) of treatment of individuals with adverse motorcycling, is a rule for eligibility that HIPAA. health factors). discriminates based on one more health 2. Section 146.121 is revised to read (ii) For purposes of this section, rules factors and thus violates this paragraph as follows: for eligibility include, but are not (b)(1). limited to, rules relating to— Example 4. (i) Facts. A group health plan applies for a group health policy offered by § 146.121 Prohibiting discrimination (A) Enrollment; against participants and beneficiaries an issuer. As part of the application, the based on a health factor. (B) The effective date of coverage; issuer receives health information about (C) Waiting (or affiliation) periods; (a) Health factors. (1) The term health individuals to be covered under the plan. (D) Late and special enrollment; Individual A is an employee of the employer factor means, in relation to an maintaining the plan. A and A’s dependents individual, any of the following health (E) Eligibility for benefit packages (including rules for individuals to have a history of high health claims. Based status-related factors: on the information about A and A’s (i) Health status; change their selection among benefit packages); dependents, the issuer excludes A and A’s (ii) Medical condition (including both dependents from the group policy it offers to physical and mental illnesses), as (F) Benefits (including rules relating the employer. defined in § 144.103; to covered benefits, benefit restrictions, (ii) Conclusion. In this Example 4, the (iii) Claims experience; and cost-sharing mechanisms such as issuer’s exclusion of A and A’s dependents (iv) Receipt of health care; coinsurance, copayments, and from coverage is a rule for eligibility that (v) Medical history; deductibles), as described in paragraphs discriminates based on one or more health (vi) Genetic information, as defined in (b) (2) and (3) of this section; factors, and thus violates this paragraph 45 CFR 144.103; (G) Continued eligibility; and (b)(1). (If the employer is a small employer (H) Terminating coverage (including under 45 CFR 144.103 (generally, an (vii) Evidence of insurability; or employer with 50 or fewer employees), the (viii) Disability. disenrollment) of any individual under issuer also may violate 45 CFR 146.150, (2) Evidence of insurability the plan. which requires issuers to offer all the policies includes— (iii) The rules of this paragraph (b)(1) they sell in the small group market on a (i) Conditions arising out of acts of are illustrated by the following guaranteed available basis to all small domestic violence; and examples: employers and to accept every eligible

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1413 individual in every small employer group.) If of similarly situated individuals under of TMJ are available uniformly to all the plan provides coverage through this the plan and made effective no earlier similarly situated individuals and a plan may policy and does not provide equivalent than the first day of the first plan year limit benefits covered in relation to a specific coverage for A and A’s dependents through after the amendment is adopted is not disease or condition if the limit applies other means, the plan will also violate this uniformly to all similarly situated paragraph (b)(1). considered to be directed at any individuals and is not directed at individual (2) Application to benefits—(i) individual participants or beneficiaries. participants or beneficiaries. (D) The rules of this paragraph General rule—(A) Under this section, a Example 5. (i) Facts. A group health plan (b)(2)(i) are illustrated by the following group health plan or group health applies a $2 million lifetime limit on all examples: insurance issuer is not required to benefits. However, the $2 million lifetime limit is reduced to $10,000 for any provide coverage for any particular Example 1. (i) Facts. A group health plan applies a $500,000 lifetime limit on all participant or beneficiary covered under the benefit to any group of similarly benefits to each participant or beneficiary plan who has a congenital heart defect. situated individuals. covered under the plan. The limit is not (ii) Conclusion. In this Example 5, the (B) However, benefits provided under directed at individual participants or lower lifetime limit for participants and a plan or through group health beneficiaries. beneficiaries with a congenital heart defect insurance coverage must be uniformly (ii) Conclusion. In this Example 1, the limit violates this paragraph (b)(2)(i) because available to all similarly situated does not violate this paragraph (b)(2)(i) benefits under the plan are not uniformly individuals (as described in paragraph because $500,000 of benefits are available available to all similarly situated individuals (d) of this section). Likewise, any uniformly to each participant and beneficiary and the plan’s lifetime limit on benefits does restriction on a benefit or benefits must under the plan and because the limit is not apply uniformly to all similarly situated applied uniformly to all participants and individuals. apply uniformly to all similarly situated beneficiaries and is not directed at individual Example 6. (i) Facts. A group health plan individuals and must not be directed at participants or beneficiaries. limits benefits for prescription drugs to those individual participants or beneficiaries Example 2. (i) Facts. A group health plan listed on a drug formulary. The limit is based on any health factor of the has a $2 million lifetime limit on all benefits applied uniformly to all similarly situated participants or beneficiaries (and no other lifetime limits) for participants individuals and is not directed at individual (determined based on all the relevant covered under the plan. Participant B files a participants or beneficiaries. facts and circumstances). Thus, for claim for the treatment of AIDS. At the next (ii) Conclusion. In this Example 6, the example, a plan or issuer may limit or corporate board meeting of the plan sponsor, exclusion from coverage of drugs not listed exclude benefits in relation to a specific the claim is discussed. Shortly thereafter, the on the drug formulary does not violate this plan is modified to impose a $10,000 lifetime paragraph (b)(2)(i) because benefits for disease or condition, limit or exclude limit on benefits for the treatment of AIDS, prescription drugs listed on the formulary are benefits for certain types of treatments effective before the beginning of the next uniformly available to all similarly situated or drugs, or limit or exclude benefits plan year. individuals and because the exclusion of based on a determination of whether the (ii) Conclusion. Under the facts of this drugs not listed on the formulary applies benefits are experimental or not Example 2, the plan violates this paragraph uniformly to all similarly situated medically necessary, but only if the (b)(2)(i) because the plan modification is individuals and is not directed at individual benefit limitation or exclusion applies directed at B based on B’s claim. participants or beneficiaries. uniformly to all similarly situated Example 3. (i) A group health plan applies Example 7. (i) Facts. Under a group health for a group health policy offered by an issuer. individuals and is not directed at plan, doctor visits are generally subject to a Individual C is covered under the plan and $250 annual deductible and 20 percent individual participants or beneficiaries has an adverse health condition. As part of coinsurance requirement. However, prenatal based on any health factor of the the application, the issuer receives health doctor visits are not subject to any deductible participants or beneficiaries. In information about the individuals to be or coinsurance requirement. These rules are addition, a plan or issuer may impose covered, including information about C’s applied uniformly to all similarly situated annual, lifetime, or other limits on adverse health condition. The policy form individuals and are not directed at individual benefits and may require the satisfaction offered by the issuer generally provides participants or beneficiaries. of a deductible, copayment, benefits for the adverse health condition that (ii) Conclusion. In this Example 7, C has, but in this case the issuer offers the imposing different deductible and coinsurance, or other cost-sharing plan a policy modified by a rider that requirement in order to obtain a benefit coinsurance requirements for prenatal doctor excludes benefits for C for that condition. visits and other visits does not violate this if the limit or cost-sharing requirement The exclusionary rider is made effective the paragraph (b)(2)(i) because a plan may applies uniformly to all similarly first day of the next plan year. establish different deductibles or coinsurance situated individuals and is not directed (ii) Conclusion. In this Example 3, the requirements for different services if the at individual participants or issuer violates this paragraph (b)(2)(i) deductible or coinsurance requirement is beneficiaries based on any health factor because benefits for C’s condition are applied uniformly to all similarly situated of the participants or beneficiaries. In available to other individuals in the group of individuals and is not directed at individual the case of a cost-sharing requirement, similarly situated individuals that includes C participants or beneficiaries. but are not available to C. Thus, the benefits (ii) Cost-sharing mechanisms and see also paragraph (b)(2)(ii) of this are not uniformly available to all similarly section, which permits variances in the situated individuals. Even though the wellness programs. A group health plan application of a cost-sharing mechanism exclusionary rider is made effective the first or group health insurance coverage with made available under a bona fide day of the next plan year, because the rider a cost-sharing mechanism (such as a wellness program. (Whether any plan does not apply to all similarly situated deductible, copayment, or coinsurance) provision or practice with respect to individuals, the issuer violates this paragraph that requires a higher payment from an benefits complies with this paragraph (b)(2)(i). individual, based on a health factor of (b)(2)(i) does not affect whether the Example 4. (i) Facts. A group health plan that individual or a dependent of that provision or practice is permitted under has a $2,000 lifetime limit for the treatment individual, than for a similarly situated of temporomandibular joint syndrome (TMJ). individual under the plan (and thus any other provision of ERISA, the The limit is applied uniformly to all similarly Americans with Disabilities Act, or any situated individuals and is not directed at does not apply uniformly to all similarly other law, whether State or federal.) individual participants or beneficiaries. situated individuals) does not violate (C) For purposes of this paragraph (ii) Conclusion. In this Example 4, the limit the requirements of this paragraph (b)(2) (b)(2)(i), a plan amendment applicable does not violate this paragraph (b)(2)(i) if the payment differential is based on to all individuals in one or more groups because $2,000 of benefits for the treatment whether an individual has complied

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1414 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations with the requirements of a bona fide amendment relating to a preexisting insurance coverage in connection with a wellness program. condition exclusion applicable to all group health plan, may not require an (iii) Specific rule relating to source-of- individuals in one or more groups of individual, as a condition of enrollment injury exclusions—(A) If a group health similarly situated individuals under the or continued enrollment under the plan plan or group health insurance coverage plan and made effective no earlier than or group health insurance coverage, to generally provides benefits for a type of the first day of the first plan year after pay a premium or contribution that is injury, the plan or issuer may not deny the amendment is adopted is not greater than the premium or benefits otherwise provided for considered to be directed at any contribution for a similarly situated treatment of the injury if the injury individual participants or beneficiaries. individual (described in paragraph (d) results from an act of domestic violence (ii) The rules of this paragraph (b)(3) of this section) enrolled in the plan or or a medical condition (including both are illustrated by the following group health insurance coverage based physical and mental health conditions). examples: on any health factor that relates to the (B) The rules of this paragraph Example 1. (i) Facts. A group health plan individual or a dependent of the (b)(2)(iii) are illustrated by the following imposes a preexisting condition exclusion on individual. examples: all individuals enrolled in the plan. The (ii) Discounts, rebates, payments in Example 1. (i) Facts. A group health plan exclusion applies to conditions for which kind, and any other premium generally provides medical/surgical benefits, medical advice, diagnosis, care, or treatment differential mechanisms are taken into was recommended or received within the six- including benefits for hospital stays, that are account in determining an individual’s month period ending on an individual’s medically necessary. However, the plan premium or contribution rate. (For rules enrollment date. In addition, the exclusion excludes benefits for self-inflicted injuries or generally extends for 12 months after an relating to cost-sharing mechanisms, see injuries sustained in connection with individual’s enrollment date, but this 12- paragraph (b)(2) of this section attempted suicide. Individual D suffers from month period is offset by the number of days (addressing benefits).) depression and attempts suicide. As a result, of an individual’s creditable coverage in (2) Rules relating to premium rates— D sustains injuries and is hospitalized for accordance with § 146.111. There is nothing (i) Group rating based on health factors treatment of the injuries. Pursuant to the to indicate that the exclusion is directed at exclusion, the plan denies D benefits for not restricted under this section. individual participants or beneficiaries. Nothing in this section restricts the treatment of the injuries. (ii) Conclusion. In this Example 1, even (ii) Conclusion. In this Example 1, the aggregate amount that an employer may though the plan’s preexisting condition be charged for coverage under a group suicide attempt is the result of a medical exclusion discriminates against individuals condition (depression). Accordingly, the based on one or more health factors, the health plan. denial of benefits for the treatments of D’s preexisting condition exclusion does not (ii) List billing based on a health injuries violates the requirements of this violate this section because it applies factor prohibited. However, a group paragraph (b)(2)(iii) because the plan uniformly to all similarly situated health insurance issuer, or a group provision excludes benefits for treatment of individuals, is not directed at individual health plan, may not quote or charge an an injury resulting from a medical condition. participants or beneficiaries, and complies employer (or an individual) a different Example 2. (i) Facts. A group health plan with § 146.111 (that is, the requirements provides benefits for head injuries generally. premium for an individual in a group of relating to the six-month look-back period, similarly situated individuals based on The plan also has a general exclusion for any the 12-month (or 18-month) maximum injury sustained while participating in any of exclusion period, and the creditable coverage a health factor. (But see paragraph (g) of a number of recreational activities, including offset). this section permitting favorable bungee jumping. However, this exclusion Example 2. (i) Facts. A group health plan treatment of individuals with adverse does not apply to any injury that results from excludes coverage for conditions with respect health factors.) a medical condition (nor from domestic to which medical advice, diagnosis, care, or (iii) Examples. The rules of this violence). Participant E sustains a head treatment was recommended or received paragraph (c)(2) are illustrated by the injury while bungee jumping. The injury did within the six-month period ending on an following examples: not result from a medical condition (nor from individual’s enrollment date. Under the plan, Example 1. (i) Facts. An employer sponsors domestic violence). Accordingly, the plan the preexisting condition exclusion generally a group health plan and purchases coverage denies benefits for E ’s head injury. extends for 12 months, offset by creditable from a health insurance issuer. In order to (ii) Conclusion. In this Example 2, the plan coverage. However, if an individual has no determine the premium rate for the provision that denies benefits based on the claims in the first six months following upcoming plan year, the issuer reviews the source of an injury does not restrict benefits enrollment, the remainder of the exclusion claims experience of individuals covered based on an act of domestic violence or any period is waived. medical condition. Therefore, the provision (ii) Conclusion. In this Example 2, the under the plan. The issuer finds that is permissible under this paragraph (b)(2)(iii) plan’s preexisting condition exclusions Individual F had significantly higher claims and does not violate this section. (However, violate this section because they do not meet experience than similarly situated if the plan did not allow E to enroll in the the requirements of this paragraph (b)(3); individuals in the plan. The issuer quotes the plan (or applied different rules for eligibility specifically, they do not apply uniformly to plan a higher per-participant rate because of to E) because E frequently participates in all similarly situated individuals. The plan F ’s claims experience. bungee jumping, the plan would violate provisions do not apply uniformly to all (ii) Conclusion. In this Example 1, the paragraph (b)(1) of this section.) similarly situated individuals because issuer does not violate the provisions of this individuals who have medical claims during paragraph (c)(2) because the issuer blends the (3) Relationship to § 146.111. (i) A rate so that the employer is not quoted a preexisting condition exclusion is the first six months following enrollment are not treated the same as similarly situated higher rate for F than for a similarly situated permitted under this section if it— individuals with no claims during that individual based on F ’s claims experience. (A) Complies with § 146.111; period. (Under paragraph (d) of this section, Example 2. (i) Facts. Same facts as (B) Applies uniformly to all similarly the groups cannot be treated as two separate Example 1, except that the issuer quotes the situated individuals (as described in groups of similarly situated individuals employer a higher premium rate for F, paragraph (d) of this section); and because the distinction is based on a health because of F ’s claims experience, than for a factor.) similarly situated individual. (C) Is not directed at individual (ii) Conclusion. In this Example 2, the participants or beneficiaries based on (c) Prohibited discrimination in issuer violates this paragraph (c)(2). any health factor of the participants or premiums or contributions—(1) In Moreover, even if the plan purchased the beneficiaries. For purposes of this general—(i) A group health plan, and a policy based on the quote but did not require paragraph (b)(3)(i)(C), a plan health insurance issuer offering health a higher participant contribution for F than

VerDate 112000 19:33 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1415 for a similarly situated individual, the issuer favorable treatment of individuals with dependent children. However, coverage is would still violate this paragraph (c)(2) (but adverse health factors). made available to a dependent child only if in such a case the plan would not violate this (2) Beneficiaries—(i) Subject to the dependent child is under age 19 (or paragraph (c)(2)). under age 25 if the child is continuously paragraph (d)(3) of this section, a plan enrolled full-time in an institution of higher (3) Exception for bona fide wellness or issuer may treat beneficiaries as two learning (full-time students)). There is no programs. Notwithstanding paragraphs or more distinct groups of similarly evidence to suggest that these classifications (c)(1) and (2) of this section, a plan may situated individuals if the distinction are directed at individual participants or establish a premium or contribution between or among the groups of beneficiaries. differential based on whether an beneficiaries is based on any of the (ii) Conclusion. In this Example 2, treating individual has complied with the following factors: spouses and dependent children differently requirements of a bona fide wellness (A) A bona fide employment-based by imposing an age limitation on dependent children, but not on spouses, is permitted program. classification of the participant through under this paragraph (d). Specifically, the (d) Similarly situated individuals. The whom the beneficiary is receiving distinction between spouses and dependent requirements of this section apply only coverage; children is permitted under paragraph (d)(2) within a group of individuals who are (B) Relationship to the participant of this section and is not prohibited under treated as similarly situated individuals. (e.g., as a spouse or as a dependent paragraph (d)(3) of this section because it is A plan or issuer may treat participants child); not directed at individual participants or as a group of similarly situated (C) Marital status; beneficiaries. It is also permissible to treat dependent children who are under age 19 (or individuals separate from beneficiaries. (D) With respect to children of a full-time students under age 25) as a group In addition, participants may be treated participant, age or student status; or of similarly situated individuals separate as two or more distinct groups of (E) Any other factor if the factor is not from those who are age 25 or older (or age similarly situated individuals and a health factor. 19 or older if they are not full-time students) beneficiaries may be treated as two or (ii) Paragraph (d)(2)(i) of this section because the classification is permitted under more distinct groups of similarly does not prevent more favorable paragraph (d)(2) of this section and is not situated individuals in accordance with treatment of individuals with adverse directed at individual participants or beneficiaries. the rules of this paragraph (d). health factors in accordance with Example 3. (i) Facts. A university sponsors Moreover, if individuals have a choice paragraph (g) of this section. a group health plan that provides one health of two or more benefit packages, (3) Discrimination directed at benefit package to faculty and another health individuals choosing one benefit individuals. Notwithstanding benefit package to other staff. Faculty and package may be treated as one or more paragraphs (d)(1) and (2) of this section, staff are treated differently with respect to groups of similarly situated individuals if the creation or modification of an other employee benefits such as retirement distinct from individuals choosing employment or coverage classification is benefits and leaves of absence. There is no directed at individual participants or evidence to suggest that the distinction is another benefit package. directed at individual participants or (1) Participants. Subject to paragraph beneficiaries based on any health factor beneficiaries. (d)(3) of this section, a plan or issuer of the participants or beneficiaries, the (ii) Conclusion. In this Example 3, the may treat participants as two or more classification is not permitted under this classification is permitted under this distinct groups of similarly situated paragraph (d), unless it is permitted paragraph (d) because there is a distinction individuals if the distinction between or under paragraph (g) of this section based on a bona fide employment-based among the groups of participants is (permitting favorable treatment of classification consistent with the employer’s usual business practice and the distinction is based on a bona fide employment-based individuals with adverse health factors). Thus, if an employer modified an not directed at individual participants and classification consistent with the beneficiaries. employer’s usual business practice. employment-based classification to Example 4. (i) Facts. An employer sponsors Whether an employment-based single out, based on a health factor, a group health plan that is available to all classification is bona fide is determined individual participants and current employees. Former employees may on the basis of all the relevant facts and beneficiaries and deny them health also be eligible, but only if they complete a circumstances. Relevant facts and coverage, the new classification would specified number of years of service, are circumstances include whether the not be permitted under this section. enrolled under the plan at the time of employer uses the classification for (4) Examples. The rules of this termination of employment, and are paragraph (d) are illustrated by the continuously enrolled from that date. There purposes independent of qualification is no evidence to suggest that these for health coverage (for example, following examples: distinctions are directed at individual determining eligibility for other Example 1. (i) Facts. An employer sponsors participants or beneficiaries. employee benefits or determining other a group health plan for full-time employees (ii) Conclusion. In this Example 4, terms of employment). Subject to only. Under the plan (consistent with the imposing additional eligibility requirements paragraph (d)(3) of this section, employer’s ususal business practice), on former employees is permitted because a employees who normally work at least 30 classification that distinguishes between examples of classifications that, based hours per week are considered to be working on all the relevant facts and current and former employees is a bona fide full-time. Other employees are considered to employment-based classification that is circumstances, may be bona fide be working part-time. There is no evidence permitted under this paragraph (d), provided include full-time versus part-time to suggest that the classification is directed that it is not directed at individual status, different geographic location, at individual participants or beneficiaries. participants or beneficiaries. In addition, it is membership in a collective bargaining (ii) Conclusion. In this Example 1, treating permissible to distinguish between former unit, date of hire, length of service, the full-time and part-time employees as two employees who satisfy the service current employee versus former separate groups of similarly situated requirement and those who do not, provided employee status, and different individuals is permitted under this paragraph that the distinction is not directed at (d) because the classification is bona fide and occupations. However, a classification individual participants or beneficiaries. is not directed at individual participants or (However, former employees who do not based on any health factor is not a bona beneficiaries. satisfy the eligibility criteria may, fide employment-based classification, Example 2. (i) Facts. Under a group health nonetheless, be eligible for continued unless the requirements of paragraph (g) plan, coverage is made available to coverage pursuant to a COBRA continuation of this section are satisfied (permitting employees, their spouses, and their provision or similar State law.)

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Example 5. (i) Facts. An employer sponsors extension of benefits clause from a previous (ii) Exception for the first day of a group health plan that provides the same health insurance issuer. work—(A) Notwithstanding the general benefit package to all seven employees of the (ii) Conclusion. In this Example 2, Issuer rule in paragraph (e)(2)(i) of this section, employer. Six of the seven employees have N violates this paragraph (e)(1) because the a plan or issuer may establish a rule for the same job title and responsibilities, but group health insurance coverage restricts eligibility that requires an individual to Employee G has a different job title and benefits (a rule for eligibility under paragraph different responsibilities. After G files an (b)(1)) based on whether a dependent is begin work for the employer sponsoring expensive claim for benefits under the plan, confined to a hospital or other health care the plan (or, in the case of a coverage under the plan is modified so that institution that is covered under an extension multiemployer plan, to begin a job in employees with G’s job title receive a of benefits clause from a previous issuer. covered employment) before coverage different benefit package that includes a This section does not affect any obligation becomes effective, provided that such a lower lifetime dollar limit than in the benefit Issuer M may have under applicable State rule for eligibility applies regardless of package made available to the other six law to provide any extension of benefits and the reason for the absence. employees. does not affect any State law governing (B) The rules of this paragraph (ii) Conclusion. Under the facts of this coordination of benefits. Example 5, changing the coverage (e)(2)(ii) are illustrated by the following classification for G based on the existing (2) Actively-at-work and continuous examples: employment classification for G is not service provisions—(i) General rule—(A) Example 1. (i) Facts. Under the eligibility permitted under this paragraph (d) because Under the rules of paragraphs (b) and (c) provision of a group health plan, coverage for the creation of the new coverage of this section and subject to the new employees becomes effective on the first day that the employee reports to work. classification for G is directed at G based on exception for the first day of work one or more health factors. Individual H is scheduled to begin work on described in paragraph (e)(2)(ii) of this August 3. However, H is unable to begin (e) Nonconfinement and actively-at- section, a plan or issuer may not work provisions—(1) Nonconfinement work on that day because of illness. H begins establish a rule for eligibility (as working on August 4, and H’s coverage is provisions—(i) General rule. Under the described in paragraph (b)(1)(ii) of this effective on August 4. rules of paragraphs (b) and (c) of this section) or set any individual’s premium (ii) Conclusion. In this Example 1, the plan section, a plan or issuer may not or contribution rate based on whether provision does not violate this section. However, if coverage for individuals who do establish a rule for eligibility (as an individual is actively at work described in paragraph (b)(1)(ii) of this not report to work on the first day they were (including whether an individual is scheduled to work for a reason unrelated to section) or set any individual’s premium continuously employed), unless absence or contribution rate based on whether a health factor (such as vacation or from work due to any health factor bereavement) becomes effective on the first an individual is confined to a hospital (such as being absent from work on sick day they were scheduled to work, then the or other health care institution. In leave) is treated, for purposes of the plan would violate this section. addition, under the rules of paragraphs plan or health insurance coverage, as Example 2. (i) Facts. Under a group health (b) and (c) of this section, a plan or being actively at work. plan, coverage for new employees becomes issuer may not establish a rule for effective on the first day of the month eligibility or set any individual’s (B) The rules of this paragraph (e)(2)(i) following the employee’s first day of work, premium or contribution rate based on are illustrated by the following regardless of whether the employee is examples: actively at work on the first day of the month. an individual’s ability to engage in Individual J is scheduled to begin work on Example 1. (i) Facts. Under a group health normal life activities, except to the March 24. However, J is unable to begin work extent permitted under paragraphs plan, an employee generally becomes eligible on March 24 because of illness. J begins (e)(2)(ii) and (3) of this section to enroll 30 days after the first day of working on April 7 and J’s coverage is (permitting plans and issuers, under employment. However, if the employee is not effective May 1. actively at work on the first day after the end (ii) Conclusion. In this Example 2, the plan certain circumstances, to distinguish of the 30-day period, then eligibility for among employees based on the provision does not violate this section. enrollment is delayed until the first day the However, as in Example 1, if coverage for performance of services). employee is actively at work. (ii) Examples. The rules of this individuals absent from work for reasons (ii) Conclusion. In this Example 1, the plan unrelated to a health factor became effective paragraph (e)(1) are illustrated by the violates this paragraph (e)(2) (and thus also despite their absence, then the plan would following examples: violates paragraph (b) of this section). violate this section. Example 1. (i) Facts. Under a group health However, the plan would not violate plan, coverage for employees and their paragraph (e)(2) or (b) of this section if, under (3) Relationship to plan provisions dependents generally becomes effective on the plan, an absence due to any health factor defining similarly situated individuals— the first day of employment. However, is considered being actively at work. (i) Notwithstanding the rules of coverage for a dependent who is confined to Example 2. (i) Facts. Under a group health paragraphs (e)(1) and (2) of this section, a hospital or other health care institution plan, coverage for an employee becomes a plan or issuer may establish rules for does not become effective until the effective after 90 days of continuous service; eligibility or set any individual’s confinement ends. that is, if an employee is absent from work premium or contribution rate in (for any reason) before completing 90 days of (ii) Conclusion. In this Example 1, the plan accordance with the rules relating to violates this paragraph (e)(1) because the service, the beginning of the 90-day period is plan delays the effective date of coverage for measured from the day the employee returns similarly situated individuals in dependents based on confinement to a to work (without any credit for service before paragraph (d) of this section. hospital or other health care institution. the absence). Accordingly, a plan or issuer may Example 2. (i) Facts. In previous years, a (ii) Conclusion. In this Example 2, the plan distinguish in rules for eligibility under group health plan has provided coverage violates this paragraph (e)(2) (and thus also the plan between full-time and part-time through a group health insurance policy paragraph (b) of this section) because the 90- employees, between permanent and offered by Issuer M. However, for the current day continuous service requirement is a rule temporary or seasonal employees, year, the plan provides coverage through a for eligibility based on whether an individual between current and former employees, is actively at work. However, the plan would group health insurance policy offered by and between employees currently Issuer N. Under Issuer N’s policy, items and not violate this paragraph (e)(2) or paragraph services provided in connection with the (b) of this section if, under the plan, an performing services and employees no confinement of a dependent to a hospital or absence due to any health factor is not longer performing services for the other health care institution are not covered considered an absence for purposes of employer, subject to paragraph (d) of if the confinement is covered under an measuring 90 days of continuous service. this section. However, other federal or

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State laws (including the COBRA is without regard to whatever rights the the employer by reason of disability may continuation provisions and the Family employee (or members of the employee’s remain covered under the plan until the last and Medical Leave Act of 1993) may family) may have for COBRA continuation day of the month that is 12 months after the require an employee or the employee’s coverage.) month in which the employee ceased to (ii) Conclusion. In this Example 3, the plan perform services for the employer. During dependents to be offered coverage and provision terminating B’s coverage upon B’s this extended period of coverage, the plan set limits on the premium or termination of employment does not violate charges the employee $100 per month for contribution rate even though the this section. employee-only coverage and $250 per month employee is not performing services. Example 4. (i) Facts. Under a group health for family coverage. (This extended period of (ii) The rules of this paragraph (e)(3) plan, coverage of an employee is terminated coverage is without regard to whatever rights are illustrated by the following when the employee ceases to perform the employee (or members of the employee’s examples: services for the employer sponsoring the family) may have for COBRA continuation plan, in accordance with the rules of coverage.) Example 1. (i) Facts. Under a group health paragraph (d) of this section. Employee C is (ii) Conclusion. In this Example 2, the plan plan, employees are eligible for coverage if laid off for three months. When the layoff provision allowing extended coverage for they perform services for the employer for 30 begins, C’s coverage under the plan is disabled employees and their families or more hours per week or if they are on paid terminated. (This termination of coverage is satisfies this paragraph (g)(1) (and thus does leave (such as vacation, sick, or bereavement without regard to whatever rights the not violate this section). In addition, the plan leave). Employees on unpaid leave are employee (or members of the employee’s is permitted, under this paragraph (g)(1), to treated as a separate group of similarly family) may have for COBRA continuation charge the disabled employees a higher situated individuals in accordance with the coverage.) premium during the extended period of rules of paragraph (d) of this section. (ii) Conclusion. In this Example 4, the plan coverage. (ii) Conclusion. In this Example 1, the plan provision terminating C’s coverage upon the Example 3. (i) Facts. To comply with the provisions do not violate this section. cessation of C’s performance of services does requirements of a COBRA continuation However, if the plan treated individuals not violate this section. provision, a group health plan generally performing services for the employer for 30 makes COBRA continuation coverage or more hours per week, individuals on (f) Bona fide wellness programs. available for a maximum period of 18 months vacation leave, and individuals on [Reserved.] in connection with a termination of bereavement leave as a group of similarly (g) More favorable treatment of employment but makes the coverage situated individuals separate from individuals with adverse health factors available for a maximum period of 29 months individuals on sick leave, the plan would permitted—(1) In rules for eligibility—(i) to certain disabled individuals and certain violate this paragraph (e) (and thus also Nothing in this section prevents a group members of the disabled individual’s family. would violate paragraph (b) of this section) health plan or group health insurance Although the plan generally requires because groups of similarly situated payment of 102 percent of the applicable individuals cannot be established based on a issuer from establishing more favorable premium for the first 18 months of COBRA health factor (including the taking of sick rules for eligibility (described in continuation coverage, the plan requires leave) under paragraph (d) of this section. paragraph (b)(1) of this section) for payment of 150 percent of the applicable Example 2. (i) Facts. To be eligible for individuals with an adverse health premium for the disabled individual’s coverage under a bona fide collectively factor, such as disability, than for COBRA continuation coverage during the bargained group health plan in the current individuals without the adverse health disability extension if the disabled individual calendar quarter, the plan requires an factor. Moreover, nothing in this section would not be entitled to COBRA individual to have worked 250 hours in prevents a plan or issuer from charging continuation coverage but for the disability. covered employment during the three-month (ii) Conclusion. In this Example 3, the plan period that ends one month before the a higher premium or contribution with provision allowing extended COBRA beginning of the current calendar quarter. respect to individuals with an adverse continuation coverage for disabled The distinction between employees working health factor if they would not be individuals satisfies this paragraph (g)(1) at least 250 hours and those working less eligible for the coverage were it not for (and thus does not violate this section). In than 250 hours in the earlier three-month the adverse health factor. (However, addition, the plan is permitted, under this period is not directed at individual other laws, including State insurance paragraph (g)(1), to charge the disabled participants or beneficiaries based on any laws, may set or limit premium rates; individuals a higher premium for the health factor of the participants or these laws are not affected by this extended coverage if the individuals would beneficiaries. not be eligible for COBRA continuation (ii) Conclusion. In this Example 2, the plan section.) coverage were it not for the disability. provision does not violate this section (ii) The rules of this paragraph (g)(1) (Similarly, if the plan provided an extended because, under the rules for similarly are illustrated by the following period of coverage for disabled individuals situated individuals allowing full-time examples: pursuant to State law or plan provision rather employees to be treated differently than part- Example 1. (i) Facts. An employer sponsors than pursuant to a COBRA continuation time employees, employees who work at a group health plan that generally is available coverage provision, the plan could likewise least 250 hours in a three-month period can to employees, spouses of employees, and charge the disabled individuals a higher be treated differently than employees who dependent children until age 23. However, premium for the extended coverage.) fail to work 250 hours in that period. The dependent children who are disabled are result would be the same if the plan eligible for coverage beyond age 23. (2) In premiums or contributions—(i) permitted individuals to apply excess hours (ii) Conclusion. In this Example 1, the plan Nothing in this section prevents a group from previous periods to satisfy the provision allowing coverage for disabled health plan or group health insurance requirement for the current quarter. dependent children beyond age 23 satisfies issuer from charging individuals a Example 3. (i) Facts. Under a group health this paragraph (g)(1) (and thus does not premium or contribution that is less plan, coverage of an employee is terminated violate this section). than the premium (or contribution) for when the individual’s employment is Example 2. (i) Facts. An employer sponsors similarly situated individuals if the terminated, in accordance with the rules of a group health plan, which is generally paragraph (d) of this section. Employee B has available to employees (and members of the lower charge is based on an adverse been covered under the plan. B experiences employee’s family) until the last day of the health factor, such as disability. a disabling illness that prevents B from month in which the employee ceases to (ii) The rules of this paragraph (g)(2) working. B takes a leave of absence under the perform services for the employer. The plan are illustrated by the following example: Family and Medical Leave Act of 1993. At generally charges employees $50 per month Example. (i) Facts. Under a group health the end of such leave, B terminates for employee-only coverage and $125 per plan, employees are generally required to pay employment and consequently loses coverage month for family coverage. However, an $50 per month for employee-only coverage under the plan. (This termination of coverage employee who ceases to perform services for and $125 per month for family coverage

VerDate 112000 18:23 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR2.SGM pfrm10 PsN: 08JAR2 1418 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations under the plan. However, employees who are group health plan or group health for the plan described in section 102(c) disabled receive coverage (whether insurance coverage based on a health (3) of the Health Insurance Portability employee-only or family coverage) under the factor of the individual. Paragraph and Accountability Act of 1996), the plan free of charge. (i)(3)(i) clarifies what constitutes a coverage must be effective within that (ii) Conclusion. In this Example, the plan denial of coverage under this paragraph provision waiving premium payment for first plan year. disabled employees is permitted under this (i)(3). Paragraph (i)(3)(ii) of this section (2) If this enrollment opportunity is paragraph (g)(2) (and thus does not violate applies with respect to any individual presented after such plan year, the this section). who was denied coverage if the denial individual must be given the choice of (h) No effect on other laws. was not based on a good faith having the coverage effective on either Compliance with this section is not interpretation of section 2702 of the of the following two dates— determinative of compliance with any PHS Act or the Secretary’s published (i) The date the plan receives a request other provision of the PHS Act guidance. Under that paragraph, such an for enrollment in connection with the (including the COBRA continuation individual must be allowed to enroll enrollment opportunity; or provisions) or any other State or federal retroactively to the effective date of (ii) Retroactively to the first day of the law, such as the Americans with section 2702 of the PHS Act, or, if later, first plan year beginning on the effective Disabilities Act. Therefore, although the the date the individual meets eligibility date for the plan described in sections rules of this section would not prohibit criteria under the plan that do not 102(c)(1) and (3) of the Health Insurance a plan or issuer from treating one group discriminate based on any health factor. Portability and Accountability Act of Paragraph (i)(3)(iii) of this section of similarly situated individuals 1996 (or, if the individual otherwise applies with respect to any individual differently from another (such as first became eligible to enroll for who was denied coverage based on a providing different benefit packages to coverage after that date, on the date the good faith interpretation of section 2702 current and former employees), other individual was otherwise eligible to of the PHS Act or the Secretary’s federal or State laws may require that enroll in the plan). If an individual published guidance. Under that two separate groups of similarly situated elects retroactive coverage, the plan or paragraph, such an individual must be individuals be treated the same for issuer is required to provide the benefits given an opportunity to enroll effective certain purposes (such as making the it would have provided if the individual July 1, 2001. In either event, whether same benefit package available to had been enrolled for coverage during under paragraph (i)(3)(ii) or (iii) of this that period (irrespective of any COBRA qualified beneficiaries as is section, the Secretary will not take any made available to active employees). In otherwise applicable plan provisions enforcement action with respect to governing timing for the submission of addition, although this section generally denials of coverage addressed in this does not impose new disclosure claims). The plan or issuer may require paragraph (i)(3) if the issuer or plan has the individual to pay whatever obligations on plans and issuers, this complied with the transitional rules of section does not affect any other laws, additional amount the individual would this paragraph (i)(3). have been required to pay for the including those that require accurate (i) Denial of coverage clarified. For disclosures and prohibit intentional coverage (but the plan or issuer cannot purposes of this paragraph (i)(3), an charge interest on that amount). misrepresentation. individual is considered to have been (i) Applicability dates—(1) (B) Relation to preexisting condition denied coverage if the individual— rules. For purposes of section 2701 of Paragraphs applicable March 9, 2001. (A) Failed to apply for coverage the PHS Act, the individual may not be Paragraphs (a)(1), (a)(2)(i), (b)(1)(i), because it was reasonable to believe that treated as a late enrollee or as a special (b)(1)(iii) Example 1, (b)(2)(i)(A), an application for coverage would have enrollee. Moreover, the individual’s (b)(2)(ii), (c)(1)(i), (c)(2)(i), and (c)(3) of been futile due to a plan provision that this section and this paragraph (i)(1) discriminated based on a health factor; enrollment date is the effective date for apply to group health plans and health or the plan described in sections 102(c)(1) insurance issuers offering group health (B) Was not offered an opportunity to and (3) of the Health Insurance insurance coverage March 9, 2001. enroll in the plan and the failure to give Portability and Accountability Act (or, if (2) Paragraphs applicable for plan such an opportunity violates this the individual otherwise first became years beginning on or after July 1, 2001. section. eligible to enroll for coverage after that Except as provided in paragraph (i)(3) or (ii) Individuals denied coverage date, on the date the individual was (i)(4) of this section, the provisions of without a good faith interpretation of otherwise eligible to enroll in the plan), this section not listed in paragraph (i)(1) the law—(A) Opportunity to enroll even if the individual chooses under of this section apply to group health required. If a plan or issuer has denied paragraph (i)(3)(ii)(A) of this section to plans and health insurance issuers coverage to any individual based on a have coverage effective only offering group health insurance health factor and that denial was not prospectively. In addition, any period coverage for plan years beginning on or based on a good faith interpretation of between the individual’s enrollment after July 1, 2001. Except as provided in section 2702 of the PHS Act or any date and the effective date of coverage paragraph (i)(3) or (i)(4) of this section, guidance published by the Secretary, is treated as a waiting period. with respect to efforts to comply with the plan or issuer is required to give the (C) Examples. The rules of this section 2702 of the PHS Act before the individual an opportunity to enroll paragraph (i)(3)(ii) are illustrated by the first plan year beginning on or after July (including notice of an opportunity to following examples: 1, 2001, the Secretary will not take any enroll) that continues for at least 30 Example 1. (i) Facts. Employer X maintains enforcement action against an issuer or days. This opportunity must be a group health plan with a plan year plan that has sought to comply in good presented not later than March 9, 2001. beginning October 1 and ending September faith with section 2702 of the PHS Act. (1) If this enrollment opportunity was 30. Individual F was hired by Employer X before the effective date of section 2702 of (3) Transitional rules for individuals presented before or within the first plan the PHS Act. Before the effective date of previously denied coverage based on a year beginning on or after July 1, 1997 section 2702 of the PHS Act for this plan health factor. This paragraph (i)(3) (or in the case of a collectively (October 1, 1997), the terms of the plan provides rules relating to individuals bargained plan, before or within the first allowed employees and their dependents to previously denied coverage under a plan year beginning on the effective date enroll when the employee was first hired,

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Upon the effective date of and (3) of the Health Insurance and inform the individual regarding any section 2702 of the PHS Act for this plan Portability and Accountability Act (or, if enrollment restrictions that may apply (October 1, 1997), the plan is amended to the individual otherwise first became under the terms of the plan once the delete the requirement to pass a physical eligible to enroll for coverage after that plan is in compliance with this section examination. In November of 1997, the plan date, on the date the individual was (as a matter of administrative gives F an opportunity to enroll in the plan otherwise eligible to enroll in the plan). convenience, the notice may be (including notice of the opportunity to In addition, any period between the disseminated to all employees); enroll) without passing a physical individual’s enrollment date and the (B) Must give the individual an examination, with coverage effective January effective date of coverage is treated as a opportunity to enroll that continues for 1, 1998. at least 30 days; (ii) Conclusion. In this Example 1, the plan waiting period. complies with the requirements of this (C) Example. The rules of this (C) Must permit coverage to be paragraph (i)(3)(ii). paragraph (i)(3)(iii) are illustrated by the effective as of the first day of plan Example 2. (i) Facts. The plan year of a following example: coverage for which an exemption group health plan begins January 1 and ends Example. (i) Facts. Individual H was hired election under § 146.180 (with regard to December 31. Under the plan, a dependent by Employer Y on May 3, 1995. Y maintains this section) is no longer in effect (or who is unable to engage in normal life a group health plan with a plan year July 1, 2001, if later, and the plan was activities on the date coverage would beginning on February 1. Under the terms of acting in accordance with a good faith otherwise become effective is not enrolled the plan, employees and their dependents are interpretation of section 2702 of the until the dependent is able to engage in allowed to enroll when the employee is first PHS Act and guidance published by normal life activities. Individual G is a hired (without a requirement to pass a dependent who is otherwise eligible for HCFA); and physical examination), and on each February (D) May not treat the individual as a coverage, but is unable to engage in normal 1 thereafter if the individual can pass a life activities. The plan has not allowed G to late enrollee or a special enrollee. physical examination. H chose not to enroll (ii) For purposes of this paragraph enroll for coverage. for coverage when hired in May of 1995. On (ii) Conclusion. In this Example 2, February 1, 1997, H tried to enroll for (i)(4), an individual is considered to beginning on the effective date of section coverage under the plan. However, H was have been denied coverage if the 2702 of the PHS Act for the plan (January 1, denied coverage for failure to pass a physical individual failed to apply for coverage 1998), the plan provision is not permitted examination. Shortly thereafter, Y’s plan because, given an exemption election under any good faith interpretation of section eliminated late enrollment, and H was not under § 146.180, it was reasonable to 2702 of the PHS Act or any guidance given another opportunity to enroll in the believe that an application for coverage published by the Secretary. Therefore, the plan. There is no evidence to suggest that Y’s would have been denied based on a plan is required, not later than March 9, plan was acting in bad faith in denying 2001, to give G an opportunity to enroll health factor. coverage under the plan beginning on the (iii) The rules of this paragraph (i)(4) (including notice of the opportunity to effective date of section 2702 of the PHS Act enroll), with coverage effective, at G’s option, (February 1, 1998). are illustrated by the following either retroactively from January 1, 1998 or (ii) Conclusion. In this Example, because examples: prospectively from the date G’s request for coverage previously had been made available Example 1. (i) Facts. Individual D was enrollment is received by the plan. If G elects with respect to H without regard to any hired by a non-Federal governmental coverage to be effective beginning January 1, health factor of H and because Y’s plan was employer in June 1996. The employer 1998, the plan can require G to pay any acting in accordance with a good faith maintains a self-funded group health plan required employee premiums for the interpretation of section 2702 of the PHS Act with a plan year beginning on October 1. retroactive coverage. (and guidance published by the Secretary), Under the terms of the plan, employees and (iii) Individuals denied coverage the failure of Y’s plan to allow H to enroll their dependents are allowed to enroll when based on a good faith interpretation of effective February 1, 1998 was permissible on the employee is first hired without regard to that date. However, under the transitional any health factor. If an individual declines to the law—(A) Opportunity to enroll enroll when first eligible, the individual may required. If a plan or issuer has denied rules of this paragraph (i)(3)(iii), Y’s plan must give H an opportunity to enroll that enroll effective October 1 of any plan year if coverage to any individual before the continues for at least 30 days, with coverage the individual can pass a physical first day of the first plan year beginning effective no later than July 1, 2001. (In examination. The plan sponsor elected under on or after July 1, 2001 based in part on addition, February 1, 1998 is H’s enrollment § 146.180 of this part to exempt the plan from a health factor and that denial was date under the plan and the period between the requirements of this section for the plan based on a good faith interpretation of February 1, 1998 and July 1, 2001 is treated year beginning October 1, 1997, and renewed section 2702 of the PHS Act or guidance as a waiting period. Accordingly, any the exemption election for the plan year published by the Secretary, the plan or preexisting condition exclusion period beginning October 1, 1998. That is, the plan sponsor elected to retain the evidence of issuer is required to give the individual permitted under § 146.111 will have expired before July 1, 2001.) good health requirement for late enrollees an opportunity to enroll (including which, absent an exemption election under notice of an opportunity to enroll) that (4) Special transitional rule for self- § 146.180 of this part, would have been in continues for at least 30 days, with funded non-Federal governmental plans violation of this section as of October 1, 1997. coverage effective no later than July 1, exempted under 45 CFR 146.180—(i) If D chose not to enroll for coverage when first 2001. Individuals required to be offered coverage has been denied to any hired. In February of 1998, D was treated for an opportunity to enroll include individual because the sponsor of a self- skin cancer but did not apply for coverage individuals previously offered funded non-Federal governmental plan under the plan for the plan year beginning has elected under § 146.180 to exempt October 1, 1998, because D assumed D could enrollment without regard to a health not meet the evidence of good health factor but subsequently denied the plan from the requirements of this requirement. With the plan year beginning enrollment due to a health factor. section, and the plan sponsor October 1, 1999, the plan sponsor chose not (B) Relation to preexisting condition subsequently chooses to bring the plan to renew its exemption election and brought rules. For purposes of section 2701 of into compliance with the requirements the plan into compliance with this section. the PHS Act, the individual may not be of this section, the plan— However, the terms of the plan, effective

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October 1, 1999, were amended to permit any health factor. If an individual declines to of title XXVII of the PHS Act and enrollment only during the initial 30-day enroll when first eligible, the individual may §§ 146.101 through 146.119, § 146.143, period of employment. The plan no longer enroll effective September 1 of any plan year § 146.145, 45 CFR part 150, and this if the individual can pass a physical permits late enrollment under any section apply with respect to group circumstances, including with respect to examination. All enrollees are subject to a 12- current employees not enrolled in the plan. month preexisting condition exclusion health plans, and health insurance Therefore, D was not given another period. The plan sponsor elected under coverage offered in connection with opportunity to enroll in the plan. There is no § 146.180 of this part to exempt the plan from group health plans, for plan years evidence to suggest that the plan was acting the requirements of this section and beginning after June 30, 1997, except as in bad faith in denying D coverage under the § 146.111 (limitations on preexisting otherwise provided in this section. plan beginning on the effective date of condition exclusion periods) for the plan § 146.121 for the plan (October 1, 1999). year beginning September 1, 1997, and (2) Collectively-bargained plans. (ii) Conclusion. In this Example 1, because renews the exemption election for the plan Except as otherwise provided in this the plan under § 146.180 was previously years beginning September 1, 1998, section (other than paragraph (a)(1) of excluded from the requirements of § 146.121 September 1, 1999, and September 1, 2000. this section), in the case of a group and thereafter was acting in accordance with E chose not to enroll for coverage when first health plan maintained pursuant to one hired. In June of 2001, E is diagnosed as a good faith interpretation of § 146.121 and or more collective bargaining guidance published by HCFA, the failure of having multiple sclerosis (MS). With the plan year beginning September 1, 2001, the plan agreements between employee the plan to give D an opportunity to enroll representatives and one or more effective October 1, 1999 was permissible on sponsor chooses to bring the plan into that date. However, under the transitional compliance with this section, but renews its employers ratified before August 21, exemption election with regard to limitations rules of this paragraph (i)(4), the plan must 1996, Part A of Title XXVII of the PHS on preexisting condition exclusion periods. give D an opportunity to enroll that Act and §§ 146.101 through 146.119, The plan affords E an opportunity to enroll, continues for at least 30 days, with coverage § 146.143, § 146.145, 45 CFR part 150, without a physical examination, effective effective no later than July 1, 2001. September 1, 2001. E is subject to a 12-month and this section do not apply to plan (Additionally, October 1, 1999 is D’s preexisting condition exclusion period with years beginning before the later of July enrollment date under the plan and the respect to any treatment E receives that is 1, 1997, or the date on which the last period between October 1, 1999 and July 1, related to E’s MS, without regard to any prior of the collective bargaining agreements 2001 is treated as a waiting period. creditable coverage E may have. Beginning Furthermore, if the plan sponsor has not relating to the plan terminates September 1, 2002, the plan will cover (determined without regard to any elected to exempt the plan from limitations treatment of E’s MS. on preexisting condition exclusion periods, (ii) Conclusion. In this Example 2, the plan extension thereof agreed to after August any preexisting condition exclusion period complies with the requirements of this 21, 1996). * * * must be administered in accordance with section. (The plan is not required to comply * * * * * § 146.111. Accordingly, any preexisting with the requirements of § 146.111 because condition exclusion period permitted under the plan continues to be exempted from those Dated: June 22, 2000. § 146.111 will have expired before July 1, requirements in accordance with the plan Nancy-Ann Min DeParle, 2001.) sponsor’s election under § 146.180.) Administrator, Health Care Financing Example 2. (i) Facts. Individual E was Administration. hired by a non-Federal governmental 3. The heading, paragraph (a)(1), and employer in February 1995. The employer the first sentence of paragraph (a)(2) of Approved: August 29, 2000. maintains a self-funded group health plan § 146.125 are revised to read as follows: Donna E. Shalala, with a plan year beginning on September 1. Secretary. Under the terms of the plan, employees and § 146.125 Applicability dates. their dependents are allowed to enroll when (a) General applicability dates—(1) [FR Doc. 01–106 Filed 1–5–01; 8:45 am] the employee is first hired without regard to Non-collectively bargained plans. Part A BILLING CODE 4120±01±P; 4830±01±P; 4510±29±P

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DEPARTMENT OF THE TREASURY Revenue Service, 1111 Constitution copy of the Department of Labor’s Avenue, NW., Washington, DC 20224. booklet entitled ‘‘Questions and Internal Revenue Service Alternatively, comments may be Answers: Recent Changes in Health Care transmitted electronically via the IRS Law’’ by calling the PWBA Toll-Free 26 CFR Part 54 Internet site at: http://www.irs.gov/ Publication Hotline at 1–800–998–7542 _ [REG±114084±00] tax regs/regslist.html. or may request a copy of the Health Care Comments to the Department of Labor Financing Administration’s new RIN 1545±AY34 can be addressed to: U.S. Department of publication entitled ‘‘Protecting Your Labor Pension and Welfare Benefits DEPARTMENT OF LABOR Health Insurance Coverage’’ by calling Administration, 200 Constitution (410) 786–1565. Information on Avenue NW., Room C–5331, Pension and Welfare Benefits HIPAA’s nondiscrimination rules and Washington, DC 20210, Attention: Administration other recent health care laws is also Wellness Program Comments. Alternatively, comments may be available on the Department of Labor’s 29 CFR Part 2590 hand-delivered between the hours of 9 website (http://www.dol.gov/dol/pwba) RIN 1210±AA77 a.m. and 5 p.m. to the same address. and the Department of Health and Comments may also be transmitted by e- Human Services’ website (http:// DEPARTMENT OF HEALTH AND mail to: [email protected]. hipaa.hcfa.gov). HUMAN SERVICES Comments to HHS can be addressed I. Background to: Health Care Financing Health Care Financing Administration Administration, Department of Health The Health Insurance Portability and and Human Services, Attention: HCFA– Accountability Act of 1996 (HIPAA), 45 CFR Part 146 2078–P, P.O. Box 26688, Baltimore, MD Public Law 104–191, was enacted on RIN 0938±AK19 21207. August 21, 1996. HIPAA amended the In the alternative, comments may be Internal Revenue Code of 1986 (Code), Notice of Proposed Rulemaking for hand-delivered between the hours of the Employee Retirement Income Bona Fide Wellness Programs 8:30 a.m. and 5 p.m. to either: Security Act of 1974 (ERISA), and the AGENCIES: Internal Revenue Service, Room 443–G, Hubert Humphrey Public Health Service Act (PHS Act) to Department of the Treasury; Pension Building, 200 Independence Avenue, provide for, among other things, and Welfare Benefits Administration, SW., Washington, DC 20201 improved portability and continuity of Department of Labor; Health Care or health coverage. HIPAA added section Financing Administration, Department Room C5–14–03, 7500 Security 9802 of the Code, section 702 of ERISA, of Health and Human Services. Boulevard, Baltimore, MD 21244– and section 2702 of the PHS Act, which ACTION: Notice of proposed rulemaking 1850 prohibit discrimination in health and request for comments. All submissions to the IRS will be coverage. However, the HIPAA open to public inspection and copying nondiscrimination provisions do not SUMMARY: This proposed rule would in room 1621, 1111 Constitution prevent a plan or issuer from implement and clarify the term ‘‘bona Avenue, NW., Washington, DC from 9 establishing discounts or rebates or fide wellness program’’ as it relates to a.m. to 4 p.m. modifying otherwise applicable regulations implementing the All submissions to the Department of copayments or deductibles in return for nondiscrimination provisions of the Labor will be open to public inspection adherence to programs of health Internal Revenue Code, the Employee and copying in the Public Documents promotion and disease prevention. Retirement Income Security Act, and Room, Pension and Welfare Benefits Interim final rules implementing the the Public Health Service Act, as added Administration, U.S. Department of HIPAA provisions were first made by the Health Insurance Portability and Labor, Room N–1513, 200 Constitution available to the public on April 1, 1997 Accountability Act of 1996. Avenue, NW., Washington, DC from (published in the Federal Register on DATES: Written comments on this notice 8:30 a.m. to 5:30 p.m. April 8, 1997, 62 FR 16894) (April 1997 of proposed rulemaking are invited and All submissions to HHS will be open interim rules). must be received by the Departments on to public inspection and copying in or before April 9, 2001. room 309–G of the Department of Health In the preamble to the April 1997 interim rules, the Departments invited ADDRESSES: Written comments should and Human Services, 200 Independence comments on whether additional be submitted with a signed original and Avenue, SW., Washington, DC from 8:30 guidance was needed concerning, three copies (except for electronic a.m. to 5 p.m. submissions to the Internal Revenue FOR FURTHER INFORMATION CONTACT: Russ among other things, the permissible Service (IRS) or Department of Labor) to Weinheimer, Internal Revenue Service, standards for determining bona fide any of the addresses specified below. Department of the Treasury, at (202) wellness programs. The Departments Any comment that is submitted to any 622–6080; Amy J. Turner, Pension and also stated that they intend to issue Department will be shared with the Welfare Benefits Administration, further regulations on the other Departments. Department of Labor, at (202) 219–4377; nondiscrimination rules and that in no Comments to the IRS can be or Ruth A. Bradford, Health Care event would the Departments take any addressed to: CC:M&SP:RU (REG– Financing Administration, Department enforcement action against a plan or 114084–00), Room 5226, Internal of Health and Human Services, at (410) issuer that had sought to comply in Revenue Service, POB 7604, Ben 786–1565. good faith with section 9802 of the Franklin Station, Washington, DC SUPPLEMENTARY INFORMATION: Code, section 702 of ERISA, and section 20044. 2702 of the PHS Act before the In the alternative, comments may be Customer Service Information additional guidance is provided. The hand-delivered between the hours of 8 Individuals interested in obtaining new interim regulations relating to the a.m. and 5 p.m. to: CC:M&SP:RU (REG– additional information on HIPAA’s HIPAA nondiscrimination rules 114084–00), Courier’s Desk, Internal nondiscrimination rules may request a (published elsewhere in this issue of the

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Federal Register) do not include requirements for bona fide wellness Several commenters on the April 1997 provisions relating to bona fide wellness programs apply only to a wellness regulations suggested that the amount of programs. Accordingly, the period for program that provides a reward based a reward should be permitted if it is good faith compliance continues with on the ability of an individual to meet actuarially determined based on the respect to those provisions until further a standard that is related to a health costs associated with the health factor guidance is issued. Compliance with the factor, such as a reward conditioned on measured under the wellness program. provisions of these proposed regulations the outcome of a cholesterol test. However, in some cases, the resulting constitutes good faith compliance with Therefore, without having to comply reward (or penalty) might be so large as the statutory provisions relating to with the requirements for a bona fide to have the effect of denying coverage to wellness programs. wellness program, a wellness program certain individuals. The percentage limitation in the proposed regulations is II. Overview of the Proposed could— • designed to avoid this result. The Regulations Provide voluntary testing of enrollees for specific health problems percentage limitation also avoids the The HIPAA nondiscrimination and make recommendations to address additional administrative costs of a provisions generally prohibit a plan or health problems identified, if the reward based on actuarial cost. issuer from charging similarly situated program did not base any reward on the The Departments recognize that there individuals different premiums or outcome of the health assessment; may be some programs that currently contributions based on a health factor. • Encourage preventive care through offer rewards, individually or in the In addition, under the interim the waiver of the copayment or aggregate, that exceed the specified regulations published elsewhere in this deductible requirement for the costs of percentage. However, as noted below in issue of the Federal Register, cost- well-baby visits; the economic analysis, data is scarce sharing mechanisms such as • Reimburse employees for the cost of regarding practices of wellness deductibles, copayments, and health club memberships, without programs. Thus, the Departments coinsurance are considered restrictions regard to any health factors relating to specifically request comments on the on benefits. Thus, they are subject to the the employees; or appropriateness of the specified same rules as are other restrictions on • Reimburse employees for the costs percentage of the cost of employee-only benefits; that is, they must apply coverage under a plan as the maximum of smoking cessation programs, without uniformly to all similarly situated reward for a bona fide wellness regard to whether the employee quits individuals and must not be directed at program, including whether a larger smoking. individual participants or beneficiaries amount should be allowed for wellness A wellness program that provides a based on any health factor of the programs that include participation by reward based on the ability of an participants or beneficiaries. However, family members (i.e., the specified individual to meet a standard related to the HIPAA nondiscrimination percentage of the cost of family provisions do not prevent a plan or a health factor violates the interim coverage). Note also that, as stated issuer from establishing premium regulations published elsewhere in this above, the period for good faith discounts or rebates or modifying issue of the Federal Register unless it is compliance continues with respect to otherwise applicable copayments or a bona fide wellness program. Under whether wellness programs satisfy the deductibles in return for adherence to these proposed regulations, a wellness statutory requirements. While programs of health promotion and program must meet four requirements to compliance with these proposed disease prevention. Thus, there is an be a bona fide wellness program. regulations constitutes good faith exception to the general rule prohibiting First, the total reward that may be compliance with the statutory discrimination based on a health factor given to an individual under the plan provisions, it is possible that, based on if the reward, such as a premium for all wellness programs is limited. A all the facts and circumstances, a plan’s discount or waiver of a cost-sharing reward can be in the form of a discount, wellness program that provides a requirement, is based on participation a rebate of a premium or contribution, reward in excess of the specified range in a program of health promotion or or a waiver of all or part of a cost- of percentages of the cost of employee- disease prevention. The April 1997 sharing mechanism (such as only coverage may also be found to meet interim rules, the interim regulations deductibles, copayments, or the good faith compliance standard. published elsewhere in this issue of the coinsurance), or the absence of a Under these proposed regulations, the Federal Register, and these proposed surcharge. The reward for the wellness second requirement to be a bona fide regulations refer to programs of health program, coupled with the reward for wellness program is that the program promotion and disease prevention other wellness programs with respect to must be reasonably designed to promote allowed under this exception as ‘‘bona the plan that require satisfaction of a good health or prevent disease for fide wellness programs.’’ In order to standard related to a health factor, must individuals in the program. This prevent the exception to the not exceed a specified percentage of the requirement prevents a program from nondiscrimination requirements for cost of employee-only coverage under being a subterfuge for merely imposing bona fide wellness programs from the plan. The cost of employee-only higher costs on individuals based on a eviscerating the general rule contained coverage is determined based on the health factor by requiring a reasonable in the HIPAA nondiscrimination total amount of employer and employee connection between the standard provisions, these proposed regulations contributions for the benefit package required under the program and the impose certain requirements on under which the employee is receiving promotion of good health and disease wellness programs providing rewards coverage. prevention. Among other things, a that would otherwise discriminate The proposed regulations specify program is not reasonably designed to based on a health factor. three alternative percentages: 10, 15, promote good health or prevent disease A wide range of wellness programs and 20. The Departments welcome unless the program gives individuals exist to promote health and prevent comments on the appropriate level for eligible for the program the opportunity disease. However, many of these the percentage. Comments will be taken to qualify for the reward under the programs are not subject to the bona fide into account in determining the program at least once per year. In wellness program requirements. The standard for the final regulations. contrast, a program that imposes a

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The alternative standards that help improve healthier behavior after initial proposed regulations include model affected plan participants’ health habits enrollment, the program does not have language that can be used to satisfy this and health. The result will be fewer any connection to improving health). requirement; examples also illustrate instances where wellness programs The third requirement to be a bona substantially similar language that merely shift costs to high risk fide wellness program under these would satisfy the requirement. individuals and more instances where proposed regulations is that the reward The proposed regulations contain two they succeed at improving such under the program must be available to clarifications of this fourth requirement. individuals’ health habits and health. all similarly situated individuals. The First, plan materials are not required to Transfers will arise because the size of April 1997 interim rules provided that describe specific reasonable alternative some discounts and surcharges will be if, under the design of the wellness standards. It is sufficient to disclose that reduced, and because some plan program, enrollees might not be able to some reasonable alternative standard participants who did not satisfy achieve a program standard due to a will be made available. Second, any wellness programs’ initial standards health factor, the program would not be plan materials that describe the general will satisfy alternative standards. These a bona fide wellness program. These standard would also have to disclose the transfers are estimated to total between proposed regulations increase flexibility availability of a reasonable alternative $18 million and $46 million annually. for plans by allowing plans to make standard. However, if the program is (The latter figure is an upper bound, individualized adjustments to their merely mentioned (and does not reflecting the case in which all eligible wellness programs to address the health describe the general standard), participants pursue and satisfy factors of the particular individuals for disclosure of the availability of a alternative standards.) whom it is unreasonably difficult to reasonable alternative standard is not New economic costs may be incurred qualify for the benefits under the required. if reductions in discounts or surcharges program. Specifically, the program must reduce wellness programs’ effectiveness, III. Economic Impact and Paperwork but this effect is expected to be very allow any individual for whom it is Burden unreasonably difficult due to a medical small because reductions will be small condition (or for whom it is medically Summary—Department of Labor and and relatively few plans and inadvisable to attempt) to satisfy the Department of Health and Human participants will be affected. Other new initial program standard an opportunity Services economic costs will be incurred by plan to satisfy a reasonable alternative Under the proposed regulation, health sponsors to make available reasonable standard. The examples clarify that a plans generally may vary employee alternative standards where required. reasonable alternative standard must premium contributions or benefit levels The Departments were unable to take into account the relevant health across similarly situated individuals estimate these costs but are confident factor of the individual who needs the based on health status factors only in that these costs in combination with the alternative. A program does not need to connection with bona fide wellness transfers referenced above will not establish the specific reasonable programs. The regulation establishes exceed the estimate of the transfers alternative standard before the program four requirements for such bona fide alone. Affected plan sponsors can commences. To satisfy this third wellness programs. It (1) limits the satisfy the proposed regulation’s third requirement for being a bona fide permissible amount of variation in requirement by making available any wellness program, it is sufficient to employee premium or benefit levels; (2) reasonable standard they choose, determine a reasonable alternative requires that programs be reasonably including low cost alternatives. It is standard once a participant informs the designed to promote health or prevent unlikely that plan sponsors would plan that it is unreasonably difficult for disease; (3) requires programs to permit choose alternative standards whose cost, the participant due to a medical plan participants who for medical in combination with costs transferred condition to satisfy the general standard reasons would incur unreasonable from participants who satisfy them, (or that it is medically inadvisable for difficulty to satisfy the programs’ initial would exceed the cost of providing the participant to attempt to achieve the wellness standards to satisfy reasonable discounts or waiving surcharges for all general standard) under the program. alternative standards instead; and (4) eligible participants. Many commenters asked how the requires certain plan materials to Executive Order 12866—Department of bona fide wellness program disclose the availability of such requirements apply to programs that Labor and Department of Health and alternative standards. The Departments Human Services provide a reward for not smoking. An carefully considered the costs and Under Executive Order 12866, the example in the proposed regulations benefits attendant to these requirements. Departments must determine whether a clarifies that if it is unreasonably The Departments believe that the regulatory action is ‘‘significant’’ and difficult for an individual to stop benefits of these requirements exceed therefore subject to the requirements of smoking due to an addiction to their costs. 1 the Executive Order and subject to nicotine, the individual must be The Departments anticipate that the review by the Office of Management and proposed regulation will result in 1 Under the Diagnostic and Statistical Manual of Budget (OMB). Under section 3(f), the transfers of cost among plan sponsors Mental Disorders, Fourth Edition, American order defines a ‘‘significant regulatory Psychiatric Association, 1994 (DSM IV), nicotine addiction is a medical condition. See also Rev. Rul. in the field of drug addiction agree that nicotine, action’’ as an action that is likely to 99–28, 1999–25 I.R.B. 6 (June 21, 1999), citing a a substance common to all forms of tobacco, is a result in a rule (1) having an annual report of the Surgeon General stating that scientists powerfully addictive drug. effect on the economy of $100 million

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Thus, PWBA believes that ‘‘economically significant’’); (2) creating confident that these costs in assessing the impact of this proposed serious inconsistency or otherwise combination with the transfers rule on small plans is an appropriate interfering with an action taken or referenced above will not exceed the substitute for evaluating the effect on planned by another agency; (3) estimate of the transfers alone. The small entities. For purposes of their materially altering the budgetary Departments believe that the unified IFRA, the Departments adhered impacts of entitlement grants, user fees, regulation’s benefits will exceed its to PWBA’s proposed definition of small or loan programs or the rights and costs. Their unified analysis of the entities. The definition of small entity obligations of recipients thereof; or (4) regulation’s costs and benefits is considered appropriate for this purpose raising novel legal or policy issues detailed later in this preamble. differs, however, from a definition of arising out of legal mandates, the small business which is based on size President’s priorities, or the principles Regulatory Flexibility Act—Department standards promulgated by the Small set forth in the Executive Order. of Labor and Department of Health and Business Administration (SBA) (13 CFR Pursuant to the terms of the Executive Human Services 121.201) pursuant to the Small Business Order, it has been determined that this The Regulatory Flexibility Act (5 Act (15 U.S.C. 631 et seq.). The action raises novel policy issues arising U.S.C. 601 et seq.) (RFA) imposes Departments therefore request out of legal mandates. Therefore, this certain requirements with respect to comments on the appropriateness of the notice is ‘‘significant’’ and subject to Federal rules that are subject to the size standard used in evaluating the OMB review under Section 3(f)(4) of the notice and comment requirements of impact of this proposed rule on small Executive Order. Consistent with the section 553(b) of the Administrative entities. Executive Order, the Departments have Procedure Act (5 U.S.C. 551 et seq.) and Under this proposed regulation, health plans generally may vary assessed the costs and benefits of this which are likely to have a significant employee premium contributions or regulatory action. The Departments’ economic impact on a substantial benefit levels across similarly situated assessment, and the analysis underlying number of small entities. Unless an individuals based on health factors only that assessment, is detailed below. The agency certifies that a proposed rule in connection with bona fide wellness Departments performed a will not have a significant economic programs. The regulation establishes comprehensive, unified analysis to impact on a substantial number of small four requirements for such bona fide estimate the costs and benefits entities, section 603 of the RFA requires wellness programs. attributable to the interim regulation for that the agency present an initial purposes of compliance with Executive The Departments estimate that 36,000 regulatory flexibility analysis (IRFA) at plans with fewer than 100 participants Order 12866, the Regulatory Flexibility the time of the publication of the notice Act, and the Paperwork Reduction Act. vary employee premium contributions of proposed rulemaking describing the or benefit levels across similarly Statement of Need for Proposed Action impact of the rule on small entities and situated individuals based on health These interim regulations are needed seeking public comment on such factors. While this represents just 1 to clarify and interpret the HIPAA impact. Small entities include small percent of all small plans, the nondiscrimination provisions businesses, organizations and Departments nonetheless believe that it (Prohibiting Discrimination Against governmental jurisdictions. represents a substantial number of small Individual Participants and For purposes of analysis under the entities. The Departments also note that Beneficiaries Based on Health Status) RFA, PWBA proposes to continue to at least some premium discounts or under Section 702 of the Employee consider a small entity to be an surcharges may be large. Premium Retirement Income Security Act of 1974 employee benefit plan with fewer than discounts associated with wellness (ERISA), Section 2702 of the Public 100 participants. The basis of this programs are believed to range as high Health Service Act, and Section 9802 of definition is found in section 104(a)(2) as $560 per affected participant per the Internal Revenue Code of 1986. The of the Employee Retirement Income year. Therefore, the Departments believe provisions are needed to ensure that Security Act of 1974 (ERISA), which that the impact of this regulation on at group health plans and group health permits the Secretary of Labor to least some small entities may be insurers and issuers do not discriminate prescribe simplified annual reports for significant. Having reached these against individuals, participants, and pension plans which cover fewer than conclusions, the Departments carried beneficiaries based on any health factors 100 participants. Under section out an IRFA as part of their unified with respect to health care premiums. 104(a)(3), the Secretary may also analysis of the costs and benefits of the Additional guidance was required to provide for exemptions or simplified regulation. The reasoning and define bona fide wellness programs. annual reporting and disclosure for assumptions underlying the welfare benefit plans. Pursuant to the Departments’ unified analysis of the Costs and Benefits authority of section 104(a)(3), the regulation’s costs and benefits are The Departments anticipate that the Department of Labor has previously detailed later in this preamble. proposed regulation will result in issued at 29 CFR 2520.104–20, The regulation’s first requirement transfers of cost among plans sponsors 2520.104–21, 2520.104–41, 2520.104–46 caps maximum allowable variation in and participants and in new economic and 2520.104b–10 certain simplified employee premium contribution and costs and benefits. The economic reporting provisions and limited benefit levels. The Departments estimate benefits of the regulation will include a exemptions from reporting and that 9,300 small plans will be affected reduction in instances where wellness disclosure requirements for small plans, by the cap. These plans can comply programs merely shift costs to high risk including unfunded or insured welfare with this requirement by reducing individuals and an increase in instances plans covering fewer than 100 premiums (or increasing benefits) by

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$1.1 million on aggregate for those alternative standards also have the Business Administration for comment participants whose premiums are higher option of abolishing health-status based on its impact on small business. (or whose benefits are lower) due to variation in employee premiums. The Paperwork Reduction Act health factors. This would constitute an Departments expect that the economic ongoing, annual transfer of cost of $1.1 cost to provide alternatives combined Department of Labor and Department of million, or $122 on average per affected with the associated transfer cost of the Treasury plan. The regulation does not limit granting discounts or waiving This Notice of Proposed Rulemaking small plans’ flexibility to transfer this surcharges will not exceed the transfer includes a requirement that if the plan cost back evenly to all participants in cost associated with granting discounts materials describe the standard required the form of small premium increases or or waiving surcharges for all to be met in order to qualify for a reward benefit cuts. participants who qualify for an such as a premium discount or waiver The regulation’s second requirement alternative, estimated here at $1 million of a cost-sharing requirement, they must provides that wellness programs must to $5 million, or about $55 to $221 per also disclose the availability of a be reasonably designed to promote affected plan. Plans have the flexibility reasonable alternative standard. health or prevent disease. Comments to transfer some or all of this cost evenly However, plan materials are not received by the Departments and to all participants in the form of small required to describe specific reasonable available literature on employee premium increases or benefit cuts. wellness programs suggest that existing The fourth requirement provides that alternatives. The proposal also includes wellness programs generally satisfy this plan materials describing wellness plan examples of disclosures which would requirement. The requirement therefore standards must disclose the availability satisfy the requirements of the proposed is not expected to compel small plans to of reasonable alternative standards. This rule. modify existing wellness programs. It is requirement will affect the 36,000 small Plan administrators of group health not expected to entail economic costs plans that apply discounts or plans covered under Title I of ERISA are nor to prompt transfers. surcharges. These plans will incur required to make certain disclosures The third requirement provides that economic costs to revise affected plan about the terms of a plan and material rewards under wellness programs must materials. The 5,000 to 18,000 small changes in terms through a Summary be available to all similarly situated plan participants who will succeed at Plan Description or Summary of individuals. In particular, programs satisfying these alternative standards Material Modifications pursuant to must allow individuals for whom it will benefit from these disclosures. The sections 101(a) and 102(a) of ERISA. would be unreasonably difficult due to disclosures need not specify what Group health plans and issuers also a medical condition to satisfy initial alternatives are available, and the typically make other informational program standards an opportunity to regulation provides model language that materials available to participants, satisfy reasonable alternative standards. can be used to satisfy this requirement. either as a result of state and local The Departments believe that some Legal requirements other than this requirements, or as part of their usual small plans’ wellness programs do not regulation generally require plans and business practices in connection with currently satisfy this requirement and issuers to maintain accurate materials the offer and promotion of health care will have to be modified. describing plans. Plans and issuers coverage to employees. The Departments estimate that 21,000 generally update such materials on a While this proposal may cause group small plans’ wellness programs include regular basis as part of their normal health plans to modify informational initial standards that may be business practices. This requirement is materials pertaining to wellness unreasonably difficult for some expected to represent a negligible programs, the Departments conclude participants to meet. These plans are fraction of the ongoing, normal cost of that it creates no new information estimated to include 18,000 participants updating plans’ materials. This analysis collection requirements, and that the for whom the standard is in fact therefore attributes no cost to this overall impact on existing information unreasonably difficult to meet. (Many requirement. collection activities will be negligible. small plans are very small, having fewer First, as described earlier, it is estimated than 10 participants, and many will Special Analyses—Department of the that the proposed reasonable alternative include no participant for whom the Treasury requirements for bona fide wellness initial standard is unreasonable difficult It has been determined that this notice programs will impact a maximum of to meet for a medical reason.) of proposed rulemaking is not a 22,000 plans and 229,000 participants. Satisfaction of alternative standards by significant regulatory action as defined These numbers are very small in these participants will result in transfers in Executive Order 12866. Therefore, a comparison with the 2.5 million ERISA of cost as they qualify for discounts or regulatory assessment is not required. It group health plans that cover 65 million escape surcharges. If all of these also has been determined that this participants, and 175,500 state and local participants request and then satisfy an notice of proposed rulemaking does not governmental plans that cover 11.5 alternative standard, the transfer would impose a collection of information on million participants. amount to $5 million annually. If one- small entities and is not subject to In addition, because model language half request alternative standards and section 553(b) of the Administrative is provided in the proposal, these one-half of those meet them, the transfer Procedure Act (5 U.S.C. chapter 5). For modifications are expected to require a would amount to $1 million. these reasons, the Regulatory Flexibility minimal amount of effort, such that they In addition to transfers, small plans Act (5 U.S.C. chapter 6) does not apply fall within the provision of OMB will also incur new economic costs to pursuant to 5 U.S.C. section 603(a), regulations in 5 CFR 1320.3(c)(2). This provide alternative standards. However, which exempts from the Act’s provision excludes from the definition plans can satisfy this requirement by requirements certain rules involving the of collection of information language providing inexpensive alternative internal revenue laws. Pursuant to which is supplied by the Federal standards, and have the flexibility to section 7805(f) of the Internal Revenue government for disclosure purposes. select whatever reasonable alternative Code, this notice of proposed Finally, the Department of Labor’s standard is most desirable or cost rulemaking will be submitted to the methodology in accounting for the efficient. Plans not wishing to provide Chief Counsel for Advocacy of the Small burden of the Summary Plan

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Description (SPD) and Summary of a program is available, without 12875, this proposed rule does not Material Modifications (SMM), as describing its terms, the disclosure is include any Federal mandate that may currently approved under OMB control not required. This requirement will result in expenditures by State, local, or number 1210–0039, incorporates an affect the estimated 1,300 nonfederal tribal governments, nor does it include assumption concerning a constant rate governmental plans that apply premium mandates which may impose an annual of revision in these disclosure materials discounts or surcharges. The burden of $100 million or more on the which is based on plans’ actual development of the materials is private sector. reporting on the annual report/return expected to take 100 hours for Federalism Statement—Department of (Form 5500) of their rates of nonfederal governmental plans. The Labor and Department of Health and modification. This occurrence of SPD corresponding burden performed by Human Services revisions is generally more frequent service providers is estimated to be than the minimum time frames $38,000. Executive Order 13132 (August 4, described in section 104(b) and related We have submitted a copy of this rule 1999) outlines fundamental principles regulations. The annual hour and cost to OMB for its review of the information of federalism, and requires the burdens of the SMM/SPD information collection requirements. These adherence to specific criteria by federal collection request is currently estimated requirements are not effective until they agencies in the process of their at 576,000 hours and $97 million. have been approved by OMB. A notice formulation and implementation of Because the burden of modifying a will be published in the Federal policies that have substantial direct wellness program’s disclosures is Register when approval is obtained. effects on the States, the relationship expected to be negligible, and readily If you comment on any of these between the national government and incorporated in other revisions made to information collection and record States, or on the distribution of power plan materials on an ongoing basis, the keeping requirements, please mail and responsibilities among the various methodology used already accounts for copies directly to the following: levels of government. Agencies promulgating regulations that have this type of change. Therefore, the Health Care Financing Administration, these federalism implications must Department concludes that the Office of Information Services, consult with State and local officials, modification described in this proposal Information Technology Investment and describe the extent of their to the information collection request is Management Group, Division of neither substantive nor material, and consultation and the nature of the HCFA Enterprise Standards, Room concerns of State and local officials in accordingly it attributes no burden to C2–26–17, 7500 Security Boulevard, this regulation. the preamble to the regulation. Baltimore, MD 21244–1850, Attn: In the Departments’ view, these Department of Health and Human John Burke HCFA–2078–P, proposed regulations do not have Services and federalism implications, because they Under the Paperwork Reduction Act Office of Information and Regulatory do not have substantial direct effects on of 1995, we are required to provide 60- Affairs, Office of Management and the States, the relationship between the day notice in the Federal Register and Budget, Room 10235, New Executive national government and States, or on solicit public comment before a Office Building, Washington, DC the distribution of power and collection of information requirement is 20503, Attn.: Allison Herron Eydt, responsibilities among various levels of submitted to the Office of Management HCFA–2078–P. government. This is largely because, and Budget (OMB) for review and with respect to health insurance issuers, Small Business Regulatory Enforcement the vast majority of States have enacted approval. In order to fairly evaluate Fairness Act whether an information collection laws which meet or exceed the federal should be approved by OMB, section The proposed rule is subject to the standards in HIPAA prohibiting 3506(c)(2)(A) of the Paperwork provisions of the Small Business discrimination based on health factors. Reduction Act of 1995 requires that we Regulatory Enforcement Fairness Act of Therefore, the regulations are not likely solicit comment on the following issues: 1996 (5 U.S.C. 801 et seq.) and, if to require substantial additional • The need for the information finalized, will be transmitted to oversight of States by the Department of collection and its usefulness in carrying Congress and the Comptroller General Health and Human Services. out the proper functions of our agency. for review. The rule is not a ‘‘major In general, through section 514, • The accuracy of our estimate of the rule’’ as that term is defined in 5 U.S.C. ERISA supersedes State laws to the information collection burden. 804, because it is not likely to result in extent that they relate to any covered • The quality, utility, and clarity of (1) an annual effect on the economy of employee benefit plan, and preserves the information to be collected. $100 million or more; (2) a major State laws that regulate insurance, • Recommendations to minimize the increase in costs or prices for banking, or securities. While ERISA information collection burden on the consumers, individual industries, or prohibits States from regulating a plan affected public, including automated federal, State, or local government as an insurance or investment company collection techniques. agencies, or geographic regions; or (3) or bank, HIPAA added a new significant adverse effects on preemption provision to ERISA (as well Section 146.121 Prohibiting competition, employment, investment, as to the PHS Act) preserving the discrimination against participants and productivity, innovation, or on the applicability of State laws establishing beneficiaries based on a health factor. ability of United States-based requirements for issuers of group health (f) Bona fide wellness programs enterprises to compete with foreign- insurance coverage, except to the extent Paragraph (1)(iv) requires the plan or based enterprises in domestic or export that these requirements prevent the issuer to disclose in all plan materials markets. application of the portability, access, describing the terms of the program the and renewability requirements of availability of a reasonable alternative Unfunded Mandates Reform Act HIPAA. The nondiscrimination standard required under paragraph For purposes of the Unfunded provisions that are the subject of this (f)(1)(iii) of this section. However, in Mandates Reform Act of 1995 (Public rulemaking are included among those plan materials that merely mention that Law 104–4), as well as Executive Order requirements.

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In enacting these new preemption the mechanism for allocating provisions of HIPAA ‘‘are especially provisions, Congress indicated its intent enforcement responsibility between the significant in their impact on small to establish a preemption of State States and HCFA. To date, HCFA has groups, and particularly in small insurance requirements only to the had occasion to enforce the HIPAA non- groups, where there is a great potential extent that those requirements prevent discrimination provisions in only two for adverse selection and gaming.’’ One the application of the basic protections States. State asked that the Departments’ final set forth in HIPAA. HIPAA’s Conference Although the Departments conclude nondiscrimination provisions be as Report states that the conferees intended that these proposed regulations do not consumer-protective as possible. the narrowest preemption of State laws have federalism implications, in Finally, another State described already- with regard to health insurance issuers. keeping with the spirit of the Executive existing State regulation of issuers H.R. Conf. Rep. No. 736, 104th Cong. 2d Order that agencies closely examine any offering wellness programs in that State Session 205 (1996). Consequently, policies that may have federalism and asked that standards for bona fide under the statute and the Conference implications or limit the policy making wellness programs be left to the States. Report, State insurance laws that are discretion of the States, the Department The Departments considered these more stringent than the federal of Labor and HCFA have engaged in views very carefully when formulating requirements are unlikely to ‘‘prevent numerous efforts to consult with and the wellness program proposal. While the application of’’ the HIPAA work cooperatively with affected State allowing plans a great deal of flexibility nondiscrimination provisions. and local officials. in determining what kinds of incentives Accordingly, States are given For example, the Departments were best encourage the plan’s own significant latitude to impose aware that some States commented on participants and beneficiaries to pursue requirements on health insurance the way the federal provisions should be a healthier lifestyle, the Departments issuers that are more restrictive than the interpreted. Therefore, the Departments proposal ensures that individuals have federal law. In many cases, the federal have sought and received input from an opportunity to qualify for the law imposes minimum requirements State insurance regulators and the premium discount or other reward. If an which States are free to exceed. National Association of Insurance individual is unable to satisfy a Guidance conveying this interpretation Commissioners (NAIC). The NAIC is a wellness program standard due to a was published in the Federal Register non-profit corporation established by health factor, plans are required to make on April 8, 1997 and these regulations the insurance commissioners of the 50 a reasonable alternative standard do not reduce the discretion given to the States, the District of Columbia, and the available to the individual. In addition, States by the statute. It is the four U.S. territories, that among other the Departments reiterate their position Departments’ understanding that the things provides a forum for the that State insurance laws that are more vast majority of States have in fact development of uniform policy when stringent than the federal requirements implemented provisions which meet or uniformity is appropriate. Its members are unlikely to ‘‘prevent the application exceed the minimum requirements of meet, discuss, and offer solutions to of’’ the federal law and therefore are the HIPAA non-discrimination mutual problems. The NAIC sponsors saved from preemption. Therefore, these provisions. quarterly meetings to provide a forum more protective State laws continue to HIPAA provides that the States may for the exchange of ideas, and in-depth apply for individuals receiving health enforce the provisions of HIPAA as they consideration of insurance issues by insurance coverage in connection with a pertain to issuers, but that the Secretary regulators, industry representatives, and group health plan. of Health and Human Services must consumers. HCFA and Department of The Departments welcome further enforce any provisions that a State fails Labor staff have attended the quarterly comment on these issues from the States to substantially enforce. When meetings consistently to listen to the in response to this proposal. exercising its responsibility to enforce concerns of the State Insurance The Departments also cooperate with the provisions of HIPAA, HCFA works Departments regarding HIPAA issues, the States in several ongoing outreach cooperatively with the States for the including the nondiscrimination initiatives, through which information purpose of addressing State concerns provisions. In addition to the general on HIPAA is shared among federal and avoiding conflicts with the exercise discussions, committee meetings and regulators, State regulators, and the of State authority.2 HCFA has developed task groups, the NAIC sponsors the regulated community. In particular, the procedures to implement its following two standing HIPAA meetings Department of Labor has established a enforcement responsibilities, and to for members during the quarterly Health Benefits Education Campaign afford the States the maximum conferences: with more than 70 partners, including opportunity to enforce HIPAA’s • HCFA/DOL Meeting on HIPAA HCFA, NAIC and many business and requirements in the first instance. Issues (This meeting provides HCFA consumer groups. HCFA has sponsored HCFA’s procedures address the and Labor the opportunity to provide four conferences with the States—the handling of reports that States may not updates on regulations, bulletins, Consumer Outreach and Advocacy be enforcing HIPAA’s requirements, and enforcement actions and outreach conferences in March 1999 and June efforts regarding HIPAA.) 2000, the Implementation and 2 This authority applies to insurance issued with • The NAIC/HCFA Liaison Meeting Enforcement of HIPAA National State- respect to group health plans generally, including (This meeting provides HCFA and the Federal Conferences in August 1999 and plans covering employees of church organizations. Thus, this discussion of federalism applies to all NAIC the opportunity to discuss HIPAA 2000. Furthermore, both the Department group health insurance coverage that is subject to and other health care programs.) of Labor and HCFA websites offer links the PHS Act, including those church plans that In their comments on the 1997 to important State websites and other provide coverage through a health insurance issuer interim rules, the NAIC suggested that resources, facilitating coordination (but not to church plans that do not provide coverage through a health insurance issuer). For the permissible standards for between the State and federal regulators additional information relating to the application of determining bona fide wellness and the regulated community. these nondiscrimination rules to church plans, see programs ensure that such programs are In conclusion, throughout the process the preamble to regulations being proposed not used as a proxy for discrimination of developing these regulations, to the elsewhere in this issue of the Federal Register regarding section 9802(c) of the Code relating to based on a health factor. The NAIC also extent feasible within the specific church plans. commented that the nondiscrimination preemption provisions of HIPAA, the

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Departments have attempted to balance This amounts to 11,000 plans covering Percent Dollars the States’ interests in regulating health 415,000 participants. The Departments plans and health insurance issuers, and separately considered the effect of each Single employee total the rights of those individuals that of the four requirements on these plans. premium ...... $2,448 Congress intended to protect through Discount or Sur- For purposes of its estimates, the charge: the enactment of HIPAA. Departments assumed that one-half of low ...... 3 70 Unified Analysis of Costs and Benefits— the plans in the latter group are also average ...... 11 280 Department of Labor and Department of included in the former, thereby high ...... 23 560 Health and Human Services estimating that 37,000 plans covering Cap on discount or 1.4 million participants will be subject surcharge ...... 15 367 Introduction to the four requirements for bona fide Transfers will arise as plans reduce Under the proposed regulation, health wellness programs. discounts and surcharges. Plan sponsors plans generally may vary employee Limit on Dollar Amount—Under the can exercise substantial control over the premium contributions or benefit levels first requirement, any discount or size and direction of these transfers. across similarly situated individuals surcharge, whether applicable to Limiting the size of discounts and based on health factors only in employee premiums or benefit levels, surcharges restricts only the differential connection with bona fide wellness must not exceed a specified percentage treatment of participants who satisfy programs. The regulation establishes wellness program standards and those four requirements for such bona fide of the total premium for employee-only coverage under the plan. The proposed who do not. It does not, for example, wellness programs. restrict plans sponsors’ flexibility to A large body of literature, together regulations specify three alternative determine the respective employer and with comments received by the percentages: 10, 15, and 20. For employee shares of base premiums. Departments, demonstrate that well- purposes of this discussion, the Possible outcomes include a transfer of designed wellness programs can deliver Departments examine the midpoint of costs to plan sponsors from participants benefits well in excess of their costs. For the three alternative percentages, 15 who satisfy wellness program standards, example, the U.S. Centers for Disease percent. from plan sponsors to participants who Control and Prevention estimate that The Departments lack representative do not satisfy the standards, from implementing proven clinical smoking data on the magnitude of the discounts participants who satisfy the standards to cessation interventions can save one and surcharges applied by affected those who do not, or some combination year of life for each $2,587 invested. In plans today. One leading consultant of these. addition to reduced mortality, benefits practicing in this area believes that The Departments developed a very of effective wellness programs can wellness incentive premium discounts rough estimate of the total amount of include reduced absenteeism, improved ranged from about $60 to about $480 transfers that might derive from this productivity, and reduced medical annually in 1998, averaging about $240 requirement. The Departments’ estimate costs. The requirements contained in that year. Expressed as a percentage of assumes that (1) all discounts and the proposed regulation were crafted to surcharges take the form of employee accommodate and not impair such average total premium for employee- only coverage that year, this amounts to premium discounts; (2) discounts are beneficial programs, while combating distributed evenly within both the low- a range of about 3 percent to 23 percent discrimination in eligibility and to-average range and the average-to-high premiums for similarly situated and an average of about 11 percent. This range, and are distributed across these individuals as intended by Congress. suggests that most affected plans, ranges such that their mean equals the including some whose discounts are Detailed Estimates assumed average; and (3) 70 percent of somewhat larger than average, already participants qualify for the discount. Estimation of the economic impacts of comply with the first requirement and This implies that just more than one- the four requirements is difficult will not need to reduce the size of the fourth of plans with discounts or because data on affected plans’ current discounts or surcharges they apply. It surcharges will be impacted by the cap, practices are incomplete, and because appears likely, however, that a sizeable and that these plans’ current discounts plans’ approaches to compliance with minority of plans—perhaps a few and surcharges exceed the cap by $86 the requirements and the effects of those thousand plans covering a few hundred on average. The 9,600 affected plans approaches will vary and cannot be thousand participants—will need to could satisfy this requirement by predicted. Nonetheless, the Departments reduce the size of their discounts or reducing premiums for the 106,000 undertook to consider the impacts fully surcharges in order to comply with the participants who do not qualify by $86 and to develop estimates based on first requirement. The table below annually, for an aggregate, ongoing reasonable assumptions. annual transfer of approximately $9 Based on a 1993 survey of employers summarizes the Departments’ assumptions regarding the size of million. The Departments solicit by the Robert Wood Johnson comments on their assumptions and Foundation, the Departments estimate discounts and surcharges at year 2000 levels, expressed in annual amounts. estimate, and would welcome that 1.6 percent of large plans and 1.2 information supportive of better percent of small plans currently vary The Departments considered the estimates. employee premium contributions across potential economic effects of requiring New economic costs and benefits may similarly situated individuals and will these plans to reduce the size of their arise if changes in the size of discounts be subject to the four requirements for discounts or surcharges. These effects or surcharges result in changes in bona fide wellness programs. This are likely to include transfers of costs participant behavior. amounts to 32,000 plans covering 1.2 among plan sponsors and participants, Net economic welfare might be lost if million participants. According to an as well as new economic costs and some wellness programs’ effectiveness industry survey by Hewitt Associates, benefits. is eroded, but the magnitude and just more than one-third as many plans incidence of such effects is expected to vary benefit levels across similarly be negligible. Consider a wellness situated individuals as vary premiums. program that discounts premiums for

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This effect is or prevent disease. The Departments benefits may arise depending on the expected to be negligible, however. believe that a program that is not so nature of alternatives provided, Based on the assumptions specified designed would not provide economic individuals’ use of these alternatives, above, just 248,000 participants now benefits, but would serve merely to and any changes in the affected qualifying for discounts would be transfer costs from plan sponsors to individuals’ behavioral and health affected. Reductions in discounts are targeted individuals based on health outcomes. Third, some costs may be likely to average about $86 annually, factors. This requirement therefore is transferred from individuals who would which amounts to $7 per month or $3 not expected to impose economic costs fail to satisfy programs’ initial per biweekly pay period. Employee but might prompt transfers of costs from standards, but who will satisfy premiums are often deducted from pay otherwise targeted individuals to their reasonable alternative standards once pre-tax, so the after tax value of these plans’ sponsors (or to other participants available (and thereby qualify for discounts may be even smaller. in their plans if plan sponsors elect to associated discounts), to plan sponsors Moreover, the proposed regulation caps pass these costs back evenly to all (or to other participants in their plans if only discounts and surcharges applied participants). Comments received by the plan sponsors elect to pass these costs to similarly situated individuals in the Departments and available literature on back evenly to all participants). context of a group health plans. It does employee wellness programs, however, The Departments note that some plans not restrict plan sponsors from suggest that existing wellness programs that apply different discounts or employing other motivational tools to generally satisfy this requirement. The surcharges to similarly situated encourage participation in wellness requirement therefore is not expected to individuals and are therefore subject to programs. According to the Hewitt compel plans to modify existing the requirement may not need to survey, among 408 employers that wellness programs. It is not expected to provide alternative standards. The offered incentives for participation in entail economic costs nor to prompt requirement provides that alternative wellness programs, 24 percent offered transfers. The Departments would standards need not be specified or awards or gifts and 62 percent varied appreciate comments on this conclusion provided until a participant for whom it life insurance premiums, while just 14 and information on the types of existing is unreasonably difficult due to a percent varied medical premiums. wellness programs (if any) that would On the other hand, net economic medical condition to satisfy the initial not satisfy requirement. welfare likely will be gained in standard seeks such an alternative. instances where large premium Uniform Availability—The third Some wellness programs’ initial differentials would otherwise have requirement provides that rewards standards may be such that no served to discourage enrollment in under the program must be available to participant would ever find them health plans by employees who did not all similarly situated individuals. In unreasonably difficult to satisfy due to satisfy wellness program requirements. particular, the program must allow any a medical condition. The Departments Consider a plan that provides a very individual for whom it would be reviewed Hewitt survey data on large discount for non-smokers. The unreasonably difficult due to a medical wellness program standards and criteria. very high employee premiums charged condition to satisfy the initial program Based on their review they estimate that to smokers might discourage some from standard an opportunity to satisfy a 20,000 of the 35,000 potentially affected enrolling in the plan at all, and some of reasonable alternative standard. plans have initial wellness program these might be uninsured as a result. It Comments received by the Departments standards that might be unreasonably seems unlikely that the plan sponsor and available literature on employee difficult for some participants to satisfy would respond to the first requirement wellness programs suggest that some due to a medical condition. Moreover, of the proposed regulation by raising wellness programs do not currently because alternatives need not be made premiums drastically for all non- satisfy this requirement and will have to available until they are sought by smokers, driving many out of the plan. be modified. Based on the Hewitt qualified plan participants, it might be Instead, the plan sponsor would reduce survey, the Departments estimate that possible for some of these plans to go for premiums for smokers, and more among employers that provide years or even indefinitely without smokers would enroll. This would incentives for employees to participate needing to make available an alternative result in transfers to newly enrolled in wellness programs, 18 percent standard. This could be particularly smokers from the plan sponsor (and require employees to achieve a low risk likely for small plans. The most possibly from non-smokers if the plan behavior to qualify for the incentive, 79 common standards for wellness sponsor makes other changes to percent require a pledge of compliance, programs pertain to smoking, blood compensation). But it would also result and 38 percent require participation in pressure, and cholesterol levels, in net gains in economic welfare from a program. (These numbers sum to more according to the Hewitt Survey. Based reduced uninsurance. than 100 percent because wellness on U.S. Centers for Disease Control and The Departments believe that the net programs may apply more than one Management data on the incidence of economic gains from prohibiting criterion.) Depending on the nature of certain health habits and conditions in discounts and surcharges so large that the wellness program, it might be the general population, the Departments they could discourage enrollment based unreasonably difficult due to a medical estimate that among companies with 5 on health factors outweigh any net condition for at least some plan employees, about one-fourth probably losses that might derive from the participants to achieve the behavior or employ no smokers, and about one-third negligible reduction of some employees’ to comply with or participate in the probably employ no one with high incentive to participate in wellness program. blood pressure or cholesterol.

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Approximately 96 percent of all plans educational literature. Plan sponsors solicit comments on it. However, the with potentially difficult initial presumably will select higher-cost Departments note that plan sponsors wellness program standards have fewer alternatives only if they thereby derive will have strong motivation to identify than 100 participants. offsetting benefits, such as a higher and provide alternative standards that How many participants might qualify smoking cessation success rate. The have positive net economic effects. They for, seek, and ultimately satisfy Departments also note that the number will be disinclined to provide alternative standards? The Departments of plans with initial wellness program alternatives that undermine their overall lack sufficient data to estimate these standards that might be unreasonably wellness program and worsen counts with confidence. Rough difficult for some participants to satisfy behavioral and health outcomes, or that estimates were developed as follows. is probably small (having been make financial rewards available absent The Departments examined the Hewitt estimated at 22,000, or 1 percent of all meaningful efforts by participants to survey of wellness program provisions plans), as is the number of individuals improve their health habits and health. and U.S. Centers for Disease Control and who would take advantage of alternative Instead they will be inclined to provide Prevention statistics on the incidence of standards (estimated at between 74,000 alternatives that sustain or reinforce certain health habits and conditions in and 148,00, or between 0.1 percent and the general population in order to 0.2 percent of all participants). plan participants’ incentive to improve discern how wellness programs’ initial It seems reasonable to presume that their health habits and health, and/or standards might interact with plan the net cost plan sponsors will incur in that help participants make such participants’ health habits and health the provision of alternatives, including improvements. It therefore seems likely status. Based on these data, it appears transfers as well as new economic costs that gains in economic welfare from this that as many as 29 percent of and benefits, will not exceed the requirement will equal or outweigh participants in plans with discounts or transfer cost of providing discounts (or losses. The Departments anticipate that surcharges, or 394,000 individuals, waiving surcharges) for all plan the requirement to provide reasonable might fail to satisfy wellness programs’ participants who qualify for alternative standards will reduce initial standards. Of these, alternatives, which is estimated below instances where wellness programs approximately 229,000 are in the 22,000 at between $9 million and $37 million. serve only to shift costs to higher risk plans which apply standards that might It is likely that many plan sponsors will individuals and increase instances be unreasonably difficult due to a find more cost effective ways to satisfy where programs succeed at helping high medical condition for some plan this requirement, and that the true net risk individuals improve their health participants to satisfy, the Departments cost to them will therefore be much habits and health. estimate. The standards would in fact be smaller than this. The Departments have What transfers of costs might derive unreasonably difficult to satisfy for no basis for estimating the magnitude of from the availability of (and some subset of these individuals— the cost of providing alternative participants’ satisfaction of) alternative 148,000 by the Departments’ estimate. standards or of potential offsetting standards? The transfers arising from The Departments lack any basis to benefits, however, and therefore solicit estimate how many of these will avail comments from the public on this this requirement may take the form of themselves of an alternative standard, or question. transfers to participants who satisfy new how many that do will succeed in What other economic costs and alternative wellness program standards satisfying that standard. To estimate the benefits might arise where alternative from plan sponsors, to such participants potential impact of this requirement, the standards are made available? A large from other participants, or some Departments considered two number of outcomes are possible. combination of these. The Departments assumptions: an upper bound Consider a program that provides estimated potential transfers as follows. assumption under which all 148,000 premium discounts for non-smokers. Assuming average annual total individuals seek and satisfy alternative It is possible that some individuals premiums for employee-only coverage standards, and an alternative who would have quit smoking in order of $2,448,3 the maximum allowable assumption under which one-half (or to qualify for a discount will discount of 15 percent amounts to $367 74,000) seek an alternative and one-half nonetheless find it unreasonably per year. As noted earlier, discounts of those (37,000) satisfy it. difficult to quit and will obtain the under existing wellness programs Where plans are required to make discount while continuing to smoke by appear to average about 11 percent (or available reasonable alternative satisfying an alternative standard. This $280 per year for a plan costing $2,448), standards, what direct costs will they would represent a net loss of economic ranging from 3 percent ($70) to 23 incur? The regulation does not prescribe welfare from increased smoking. percent ($560). Reducing all discounts a particular type of alternative standard On the other hand, consider greater than $367 per year to that that must be provided. Instead, it individuals who, in the context of the amount will reduce the average, perhaps permits plan sponsors flexibility to initial program, are unable or unwilling to about $251. Assuming that the 37,000 provide any reasonable alternative. The to quit smoking. It seems likely that to 148,000 participants who satisfy Departments expect that plans sponsors some of these individuals could quit alternative standards would not have will select alternatives that entail the with appropriate assistance, and that satisfied the wellness programs’ initial minimum net costs (or, stated some alternative standards provided by standards, the transfers attributable to differently, the maximum net benefits) plan sponsors will provide such their discounts and hence to this that are possible. Plan sponsors may assistance. In such cases, a program requirement would amount to between select low-cost alternatives, such as which had the effect of shifting $9 million and $37 million. The requiring an individual for whom it premium costs to smokers would be Departments solicit comments on their would be unreasonably difficult to quit transformed into one that successfully assumptions and estimates regarding smoking (and thereby qualify for a non- reduced smoking. This would represent smoker discount) to attend a smoking a net gain of economic welfare. 3 Average level based on the Kaiser Family cessation program that is available at Which scenario is more likely? The Foundation/Health Research and Education Trust little or no cost in the community, or to Departments have no concrete basis for Survey of Employer-Sponsored Health benefits, watch educational videos or review answering this question, and therefore 1999, projected by the Departments to 2000 levels.

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This requirement will affect if it does not satisfy the requirements of with you to develop another way to the 37,000 plans that apply discounts or this paragraph (f) for a bona fide qualify for the reward.’’ In addition, surcharges. These plans will incur wellness program. other examples of language that would economic costs to revise affected plan (i) The reward for the wellness satisfy this requirement are set forth in materials. The 37,000 to 148,000 program, coupled with the reward for Examples 4, 5, and 6 of paragraph (f)(2) participants who will succeed at other wellness programs with respect to of this section. satisfying these alternative standards the plan that require satisfaction of a (2) Examples. The rules of this will benefit from these disclosures. The standard related to a health factor, must paragraph (f) are illustrated by the disclosures need not specify what not exceed (10/15/20) percent of the following examples: alternatives are available, and the cost of employee-only coverage under Example 1. (i) Facts. A group health plan regulation provides model language that the plan. For this purpose, the cost of offers a wellness program to participants and can be used to satisfy this requirement. employee-only coverage is determined beneficiaries under which the plan provides The Departments generally account based on the total amount of employer memberships to a local fitness center at a elsewhere for plans’ cost of updating and employee contributions for the discount. such materials to reflect changes in plan benefit package under which the (ii) Conclusion. In this Example 1, the reward under the program is not contingent provisions as required under various employee is receiving coverage. A reward can be in the form of a discount, on satisfying any standard that is related to disclosure requirements and as is part of a health factor. Therefore, there is no usual business practice. This particular a rebate of a premium or contribution, discrimination based on a health factor under requirement is expected to represent a or a waiver of all or part of a cost- either paragraph (b) or (c) of this section and negligible fraction of the ongoing cost of sharing mechanism (such as the requirements for a bona fide wellness updating plans’ materials, and is not deductibles, copayments, or program do not apply. separately accounted for here. coinsurance), or the absence of a Example 2. (i) Facts. An employer sponsors surcharge. a group health plan. The annual premium for List of Subjects (ii) The program must be reasonably employee-only coverage is $2,400 (of which the employer pays $1,800 per year and the 26 CFR Part 54 designed to promote good health or prevent disease. For this purpose, a employee pays $600 per year). The plan Excise taxes, Health care, Health implements a wellness program that offers a program is not reasonably designed to $240 rebate on premiums to program insurance, Pensions, Reporting and promote good health or prevent disease enrollees. recordkeeping requirements. unless the program gives individuals (ii) Conclusion. In this Example 2, the 29 CFR Part 2590 eligible for the program the opportunity program satisfies the requirements of to qualify for the reward under the paragraph (f)(1)(i) of this section because the Employee benefit plans, Employee program at least once per year. reward for the wellness program, $240, does Retirement Income Security Act, Health (iii) The reward under the program not exceed [10/15/20] percent of the total care, Health insurance, Reporting and must be available to all similarly annual cost of employee-only coverage, recordkeeping requirements. [$240/$360/$480]. ($2,400 x [10/15/20]% = situated individuals. A reward is not [$240/$360/$480].) 45 CFR Part 146 available to all similarly situated Example 3. (i) Facts. A group health plan individuals for a period unless the gives an annual premium discount of [10/15/ Health care, Health insurance, program allows— 20] percent of the cost of employee-only Reporting and recordkeeping (A) A reasonable alternative standard coverage to participants who adhere to a requirements, and State regulation of to obtain the reward to any individual wellness program. The wellness program health insurance. for whom, for that period, it is consists solely of giving an annual unreasonably difficult due to a medical cholesterol test to participants. Those Proposed Amendments to the participants who achieve a count under 200 Regulations condition to satisfy the otherwise receive the premium discount for the year. applicable standard for the reward; and Accordingly, 26 CFR part 54 is (ii) Conclusion. In this Example 3, the (B) A reasonable alternative standard program is not a bona fide wellness program. proposed to be amended as follows: to obtain the reward to any individual The program fails to satisfy the requirement of being available to all similarly situated PART 54ÐPENSION EXCISE TAXES for whom, for that period, it is medically inadvisable to attempt to individuals because some participants may Paragraph 1. The authority citation satisfy the otherwise applicable be unable to achieve a cholesterol count of for part 54 continues to read in part as standard for the reward. under 200 and the plan does not make (iv) The plan must disclose in all plan available a reasonable alternative standard follows: for obtaining the premium discount. (In materials describing the terms of the Authority: 26 U.S.C. 7805 * * * addition, plan materials describing the Par. 2. Section 54.9802–1 is amended program the availability of a reasonable program are required to disclose the by adding text to paragraph (b) to read alternative standard required under availability of the reasonable alternative as follows: paragraph (f)(1)(iii) of this section. standard for obtaining the premium (However, in plan materials that merely discount.) Thus, the premium discount § 54.9802±1 Prohibiting discrimination mention that a program is available, violates paragraph (c) of this section because against participants and beneficiaries without describing its terms, this it may require an individual to pay a higher based on a health factor. premium based on a health factor of the disclosure is not required.) The individual than is required of a similarly * * * * * following language, or substantially situated individual under the plan. (f) Bona fide wellness programs—(1) similar language, can be used to satisfy Example 4. (i) Facts. Same facts as Definition. A wellness program is a bona this requirement: ‘‘If it is unreasonably Example 3, except that if it is unreasonably

VerDate 112000 13:56 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP2.SGM pfrm01 PsN: 08JAP2 1432 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules difficult due to a medical condition for a develop another way to have your deductible alternative standard. Thus, the premium participant to achieve the targeted cholesterol waived, such as a dietary regimen.’’ surcharge does not violate this section. count (or if it is medically inadvisable for a (ii) Conclusion. In this Example 5, the * * * * * participant to attempt to achieve the targeted program is a bona fide wellness program cholesterol count), the plan will make because it satisfies the four requirements of Robert E. Wenzel, available a reasonable alternative standard this paragraph (f). First, the program Deputy Commissioner of Internal Revenue. that takes the relevant medical condition into complies with the limits on rewards under a For the reasons set forth above, 29 account. In addition, all plan materials program. Second, it is reasonably designed to describing the terms of the program include CFR Part 2590 is proposed to be promote good health or prevent disease. amended as follows: the following statement: ‘‘If it is Third, the reward under the program is unreasonably difficult due to a medical available to all similarly situated individuals PART 2590 [AMENDED]ÐRULES AND condition for you to achieve a cholesterol because it generally accommodates count under 200, or if it is medically individuals for whom it is unreasonably REGULATIONS FOR HEALTH inadvisable for you to attempt to achieve a difficult due to a medical condition to INSURANCE PORTABILITY AND count under 200, call us at the number below achieve (or for whom it is medically RENEWABILITY FOR GROUP HEALTH and we will work with you to develop inadvisable to attempt to achieve) the PLANS another way to get the discount.’’ Individual targeted body mass index by providing a D is unable to achieve a cholesterol count reasonable alternative standard (walking) and 1. The authority citation for Part 2590 under 200. The plan accommodates D by it accommodates individuals for whom it is continues to read as follows: making the discount available to D, but only unreasonably difficult due to a medical if D complies with a low-cholesterol diet. Authority: Secs. 107, 209, 505, 701–703, condition (or for whom it is medically (ii) Conclusion. In this Example 5, the 711–713, and 731–734 of ERISA (29 U.S.C. inadvisable to attempt) to walk by providing program is a bona fide wellness program 1027, 1059, 1135, 1171–1173, 1181–1183, an alternative standard that is reasonable for because it satisfies the four requirements of and 1191–1194), as amended by HIPAA the individual. Fourth, the plan discloses in this paragraph (f). First, the program (Public Law 104–191, 110 Stat. 1936), MHPA all materials describing the terms of the complies with the limits on rewards under a and NMHPA (Public Law 104–204, 110 Stat. program the availability of a reasonable program. Second, it is reasonably designed to 2935), and WHCRA (Public Law 105–277, alternative standard for every individual. promote good health or prevent disease. 112 Stat. 2681–436), section 101(g)(4) of Thus, the waiver of the deductible does not Third, the reward under the program is HIPAA, and Secretary of Labor’s Order No. violate this section. available to all similarly situated individuals 1–87, 52 FR 13139, April 21, 1987. Example 6. (i) Facts. In conjunction with because it accommodates individuals for 2. Section 2590.702 is proposed to be whom it is unreasonably difficult due to a an annual open enrollment period, a group health plan provides a form for participants amended by adding text to paragraph (b) medical condition to achieve the targeted to read as follows: count (or for whom it is medically to certify that they have not used tobacco inadvisable to attempt to achieve the targeted products in the preceding twelve months. § 2590.702 Prohibiting discrimination count) in the prescribed period by providing Participants who do not provide the against participants and beneficiaries a reasonable alternative standard. Fourth, the certification are assessed a surcharge that is based on a health factor. plan discloses in all materials describing the [10/15/20] percent of the cost of employee- only coverage. However, all plan materials * * * * * terms of the program the availability of a (f) Bona fide wellness programs—(1) reasonable alternative standard. Thus, the describing the terms of the wellness program premium discount does not violate this include the following statement: ‘‘If it is Definition. A wellness program is a bona section. unreasonably difficult due to a medical fide wellness program if it satisfies the Example 5. (i) Facts. A group health plan condition for you to meet the requirements requirements of paragraphs (f)(1)(i) will waive the $250 annual deductible under this program (or if it is medically through (f)(1)(iv) of this section. (which is less than [10/15/20] percent of the inadvisable for you to attempt to meet the However, a wellness program providing annual cost of employee-only coverage under requirements of this program), we will make a reward that is not contingent on the plan) for the following year for available a reasonable alternative standard satisfying a standard related to a health participants who have a body mass index for you to avoid this surcharge.’’ It is unreasonably difficult for Individual E to factor does not violate this section even between 19 and 26, determined shortly if it does not satisfy the requirements of before the beginning of the year. However, stop smoking cigarettes due to an addiction any participant for whom it is unreasonably to nicotine (a medical condition). The plan this paragraph (f) for a bona fide difficult due to a medical condition to attain accommodates E by requiring E to participate wellness program. this standard (and any participant for whom in a smoking cessation program to avoid the (i) The reward for the wellness it is medically inadvisable to attempt to surcharge. E can avoid the surcharge for as program, coupled with the reward for achieve this standard) during the plan year long as E participates in the program, other wellness programs with respect to is given the same discount if the participant regardless of whether E stops smoking (as the plan that require satisfaction of a walks for 20 minutes three days a week. Any long as E continues to be addicted to standard related to a health factor, must participant for whom it is unreasonably nicotine). not exceed [10/15/20] percent of the (ii) Conclusion. In this Example 6, the difficult due to a medical condition to attain cost of employee-only coverage under premium surcharge is permissible as a bona either standard (and any participant for the plan. For this purpose, the cost of whom it is medically inadvisable to attempt fide wellness program because it satisfies the to achieve either standard during the year) is four requirements of this paragraph (f). First, employee-only coverage is determined given the same discount if the individual the program complies with the limits on based on the total amount of employer satisfies a reasonable alternative standard rewards under a program. Second, it is and employee contributions for the that is tailored to the individual’s situation. reasonably designed to promote good health benefit package under which the All plan materials describing the terms of the or prevent disease. Third, the reward under employee is receiving coverage. A wellness program include the following the program is available to all similarly reward can be in the form of a discount, statement: ‘‘If it is unreasonably difficult due situated individuals because it a rebate of a premium or contribution, to a medical condition for you to achieve a accommodates individuals for whom it is or a waiver of all or part of a cost- body mass index between 19 and 26 (or if it unreasonably difficult due to a medical sharing mechanism (such as is medically inadvisable for you to attempt to condition (or for whom it is medically achieve this body mass index) this year, your inadvisable to attempt) to quit using tobacco deductibles, copayments, or deductible will be waived if you walk for 20 products by providing a reasonable coinsurance), or the absence of a minutes three days a week. If you cannot alternative standard. Fourth, the plan surcharge. follow the walking program, call us at the discloses in all materials describing the terms (ii) The program must be reasonably number above and we will work with you to of the program the availability of a reasonable designed to promote good health or

VerDate 112000 13:56 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP2.SGM pfrm01 PsN: 08JAP2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1433 prevent disease. For this purpose, a employee pays $600 per year). The plan inadvisable to attempt to achieve the targeted program is not reasonably designed to implements a wellness program that offers a count) in the prescribed period by providing promote good health or prevent disease $240 rebate on premiums to program a reasonable alternative standard. Fourth, the unless the program gives individuals enrollees. plan discloses in all materials describing the (ii) Conclusion. In this Example 2, the terms of the program the availability of a eligible for the program the opportunity program satisfies the requirements of reasonable alternative standard. Thus, the to qualify for the reward under the paragraph (f)(1)(i) of this section because the premium discount does not violate this program at least once per year. reward for the wellness program, $240, does section. (iii) The reward under the program not exceed [10/15/20] percent of the total Example 5. (i) Facts. A group health plan must be available to all similarly annual cost of employee-only coverage, will waive the $250 annual deductible situated individuals. A reward is not [$240/$360/$480]. ($2,400 x [10/15/20]% = (which is less than [10/15/20] percent of the available to all similarly situated [$240/$360/$480].) annual cost of employee-only coverage under individuals for a period unless the Example 3. (i) Facts. A group health plan the plan) for the following year for gives an annual premium discount of [10/15/ participants who have a body mass index program allows— 20] percent of the cost of employee-only between 19 and 26, determined shortly (A) A reasonable alternative standard coverage to participants who adhere to a before the beginning of the year. However, to obtain the reward to any individual wellness program. The wellness program any participant for whom it is unreasonably for whom, for that period, it is consists solely of giving an annual difficult due to a medical condition to attain unreasonably difficult due to a medical cholesterol test to participants. Those this standard (and any participant for whom condition to satisfy the otherwise participants who achieve a count under 200 it is medically inadvisable to attempt to applicable standard for the reward; and receive the premium discount for the year. achieve this standard) during the plan year (B) A reasonable alternative standard (ii) Conclusion. In this Example 3, the is given the same discount if the participant to obtain the reward to any individual program is not a bona fide wellness program. walks for 20 minutes three days a week. Any The program fails to satisfy the requirement participant for whom it is unreasonably for whom, for that period, it is of being available to all similarly situated difficult due to a medical condition to attain medically inadvisable to attempt to individuals because some participants may either standard (and any participant for satisfy the otherwise applicable be unable to achieve a cholesterol count of whom it is medically inadvisable to attempt standard for the reward. under 200 and the plan does not make to achieve either standard during the year) is (iv) The plan or issuer must disclose available a reasonable alternative standard given the same discount if the individual in all plan materials describing the for obtaining the premium discount. (In satisfies a reasonable alternative standard terms of the program the availability of addition, plan materials describing the that is tailored to the individual’s situation. a reasonable alternative standard program are required to disclose the All plan materials describing the terms of the required under paragraph (f)(1)(iii) of availability of the reasonable alternative wellness program include the following standard for obtaining the premium statement: ‘‘If it is unreasonably difficult due this section. (However, in plan materials discount.) Thus, the premium discount to a medical condition for you to achieve a that merely mention that a program is violates paragraph (c) of this section because body mass index between 19 and 26 (or if it available, without describing its terms, it may require an individual to pay a higher is medically inadvisable for you to attempt to this disclosure is not required.) The premium based on a health factor of the achieve this body mass index) this year, your following language, or substantially individual than is required of a similarly deductible will be waived if you walk for 20 similar language, can be used to satisfy situated individual under the plan. minutes three days a week. If you cannot this requirement: ‘‘If it is unreasonably Example 4. (i) Facts. Same facts as follow the walking program, call us at the difficult due to a medical condition for Example 3, except that if it is unreasonably number above and we will work with you to you to achieve the standards for the difficult due to a medical condition for a develop another way to have your deductible participant to achieve the targeted cholesterol waived, such as a dietary regimen.’’ reward under this program, or if it is count (or if it is medically inadvisable for a (ii) Conclusion. In this Example 5, the medically inadvisable for you to attempt participant to attempt to achieve the targeted program is a bona fide wellness program to achieve the standards for the reward cholesterol count), the plan will make because it satisfies the four requirements of under this program, call us at [insert available a reasonable alternative standard this paragraph (f). First, the program telephone number] and we will work that takes the relevant medical condition into complies with the limits on rewards under a with you to develop another way to account. In addition, all plan materials program. Second, it is reasonably designed to qualify for the reward.’’ In addition, describing the terms of the program include promote good health or prevent disease. other examples of language that would the following statement: ‘‘If it is Third, the reward under the program is satisfy this requirement are set forth in unreasonably difficult due to a medical available to all similarly situated individuals condition for you to achieve a cholesterol because it generally accommodates Examples 4, 5, and 6 of paragraph (f)(2) count under 200, or if it is medically individuals for whom it is unreasonably of this section. inadvisable for you to attempt to achieve a difficult due to a medical condition to (2) Examples. The rules of this count under 200, call us at the number below achieve (or for whom it is medically paragraph (f) are illustrated by the and we will work with you to develop inadvisable to attempt to achieve) the following examples: another way to get the discount.’’ Individual targeted body mass index by providing a Example 1. (i) Facts. A group health plan D is unable to achieve a cholesterol count reasonable alternative standard (walking) and offers a wellness program to participants and under 200. The plan accommodates D by it accommodates individuals for whom it is beneficiaries under which the plan provides making the discount available to D, but only unreasonably difficult due to a medical memberships to a local fitness center at a if D complies with a low-cholesterol diet. condition (or for whom it is medically discount. (ii) Conclusion. In this Example 4, the inadvisable to attempt) to walk by providing (ii) Conclusion. In this Example 1, the program is a bona fide wellness program an alternative standard that is reasonable for reward under the program is not contingent because it satisfies the four requirements of the individual. Fourth, the plan discloses in on satisfying any standard that is related to this paragraph (f). First, the program all materials describing the terms of the a health factor. Therefore, there is no complies with the limits on rewards under a program the availability of a reasonable discrimination based on a health factor under program. Second, it is reasonably designed to alternative standard for every individual. either paragraph (b) or (c) of this section and promote good health or prevent disease. Thus, the waiver of the deductible does not the requirements for a bona fide wellness Third, the reward under the program is violate this section. program do not apply. available to all similarly situated individuals Example 6. (i) Facts. In conjunction with Example 2. (i) Facts. An employer sponsors because it accommodates individuals for an annual open enrollment period, a group a group health plan. The annual premium for whom it is unreasonably difficult due to a health plan provides a form for participants employee-only coverage is $2,400 (of which medical condition to achieve the targeted to certify that they have not used tobacco the employer pays $1,800 per year and the count (or for whom it is medically products in the preceding twelve months.

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Participants who do not provide the § 146.121 Prohibiting discrimination that merely mention that a program is certification are assessed a surcharge that is against participants and beneficiaries available, without describing its terms, [10/15/20] percent of the cost of employee- based on a health factor. this disclosure is not required.) The only coverage. However, all plan materials * * * * * following language, or substantially describing the terms of the wellness program (f) Bona fide wellness programs—(1) similar language, can be used to satisfy include the following statement: ‘‘If it is Definition. A wellness program is a bona unreasonably difficult due to a health factor this requirement: ‘‘If it is unreasonably for you to meet the requirements under this fide wellness program if it satisfies the difficult due to a medical condition for program (or if it is medically inadvisable for requirements of paragraphs (f)(1)(i) you to achieve the standards for the you to attempt to meet the requirements of through (f)(1)(iv) of this section. reward under this program, or if it is this program), we will make available a However, a wellness program providing medically inadvisable for you to attempt reasonable alternative standard for you to a reward that is not contingent on to achieve the standards for the reward avoid this surcharge.’’ It is unreasonably satisfying a standard related to a health under this program, call us at [insert difficult for Individual E to stop smoking factor does not violate this section even cigarettes due to an addiction to nicotine (a telephone number] and we will work if it does not satisfy the requirements of with you to develop another way to medical condition). The plan accommodates this paragraph (f) for a bona fide E by requiring E to participate in a smoking qualify for the reward.’’ In addition, cessation program to avoid the surcharge. E wellness program. other examples of language that would can avoid the surcharge for as long as E (i) The reward for the wellness satisfy this requirement are set forth in participates in the program, regardless of program, coupled with the reward for Examples 4, 5, and 6 of paragraph (f)(2) whether E stops smoking (as long as E other wellness programs with respect to of this section. continues to be addicted to nicotine). the plan that require satisfaction of a (2) Examples. The rules of this (ii) Conclusion. In this Example 6, the standard related to a health factor, must paragraph (f) are illustrated by the premium surcharge is permissible as a bona not exceed [10/15/20] percent of the following examples: fide wellness program because it satisfies the cost of employee-only coverage under four requirements of this paragraph (f). First, the plan. For this purpose, the cost of Example 1. (i) Facts. A group health plan the program complies with the limits on employee-only coverage is determined offers a wellness program to participants and rewards under a program. Second, it is beneficiaries under which the plan provides reasonably designed to promote good health based on the total amount of employer memberships to a local fitness center at a or prevent disease. Third, the reward under and employee contributions for the discount. the program is available to all similarly benefit package under which the (ii) Conclusion. In this Example 1, the situated individuals because it employee is receiving coverage. A reward under the program is not contingent accommodates individuals for whom it is reward can be in the form of a discount, on satisfying any standard that is related to unreasonably difficult due to a medical a rebate of a premium or contribution, a health factor. Therefore, there is no condition (or for whom it is medically or a waiver of all or part of a cost- discrimination based on a health factor under inadvisable to attempt) to quit using tobacco sharing mechanism (such as either paragraph (b) or (c) of this section and products by providing a reasonable deductibles, copayments, or the requirements for a bona fide wellness alternative standard. Fourth, the plan program do not apply. discloses in all materials describing the terms coinsurance), or the absence of a Example 2. (i) Facts. An employer of the program the availability of a reasonable surcharge. sponsors a group health plan. The annual alternative standard. Thus, the premium (ii) The program must be reasonably premium for employee-only coverage is surcharge does not violate this section. designed to promote good health or $2,400 (of which the employer pays $1,800 * * * * * prevent disease. For this purpose, a per year and the employee pays $600 per program is not reasonably designed to year). The plan implements a wellness Signed at Washington, DC this 28th day of promote good health or prevent disease program that offers a $240 rebate on December, 2000. unless the program gives individuals premiums to program enrollees. Leslie B. Kramerich, eligible for the program the opportunity (ii) Conclusion. In this Example 2, the Assistant Secretary, Pension and Welfare to qualify for the reward under the program satisfies the requirements of paragraph (f)(1)(i) of this section because the Benefits Administration, U.S. Department of program at least once per year. Labor. reward for the wellness program, $240, does (iii) The reward under the program not exceed [10/15/20] percent of the total For the reasons set forth above, we must be available to all similarly propose to amend 45 CFR Part 146 as annual cost of employee-only coverage, situated individuals. A reward is not [$240/$360/$480]. ($2,400 x [10/15/20]% = follows: available to all similarly situated [$240/$360/$480].) individuals for a period unless the Example 3. (i) Facts. A group health plan PART 146 [AMENDED]ÐRULES AND program allows— gives an annual premium discount of [10/15/ REGULATIONS FOR HEALTH (A) A reasonable alternative standard 20] percent of the cost of employee-only INSURANCE PORTABILITY AND to obtain the reward to any individual coverage to participants who adhere to a RENEWABILITY FOR GROUP HEALTH for whom, for that period, it is wellness program. The wellness program PLANS consists solely of giving an annual unreasonably difficult due to a medical cholesterol test to participants. Those 1. The authority citation for Part 146 condition to satisfy the otherwise participants who achieve a count under 200 continues to read as follows: applicable standard for the reward; and receive the premium discount for the year. Authority: Secs. 2701 through 2763, 2791 (B) A reasonable alternative standard to (ii) Conclusion. In this Example 3, the and 2792 of the Public Health Service Act, obtain the reward to any individual for program is not a bona fide wellness program. 42 U.S.C. 300gg through 300gg–63, 300gg–91, whom, for that period, it is medically The program fails to satisfy the requirement 300gg–92 as amended by HIPAA (Public Law inadvisable to attempt to satisfy the of being available to all similarly situated 104–191, 110 Stat. 1936), MHPA and otherwise applicable standard for the individuals because some participants may NMHPA (Public Law 104–204, 110 Stat. reward. be unable to achieve a cholesterol count of 2935), and WHCRA (Public Law 105–277, (iv) The plan or issuer must disclose under 200 and the plan does not make available a reasonable alternative standard 112 Stat. 2681–436), and section 102(c)(4) of in all plan materials describing the HIPAA. for obtaining the premium discount. (In terms of the program the availability of addition, plan materials describing the 2. We propose to amend § 146.121 by a reasonable alternative standard program are required to disclose the adding text to paragraph (b) to read as required under paragraph (f)(1)(iii) of availability of the reasonable alternative follows: this section. (However, in plan materials standard for obtaining the premium

VerDate 112000 18:25 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP2.SGM pfrm10 PsN: 08JAP2 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1435 discount.) Thus, the premium discount to a medical condition for you to achieve a condition (or for whom it is medically violates paragraph (c) of this section because body mass index between 19 and 26 (or if it inadvisable to attempt) to quit using tobacco it may require an individual to pay a higher is medically inadvisable for you to attempt to products by providing a reasonable premium based on a health factor of the achieve this body mass index) this year, your alternative standard. Fourth, the plan individual than is required of a similarly deductible will be waived if you walk for 20 discloses in all materials describing the terms situated individual under the plan. minutes three days a week. If you cannot of the program the availability of a reasonable Example 4. (i) Facts. Same facts as follow the walking program, call us at the alternative standard. Thus, the premium Example 3, except that if it is unreasonably number above and we will work with you to surcharge does not violate this section. difficult due to a medical condition for a develop another way to have your deductible * * * * * participant to achieve the targeted cholesterol waived, such as a dietary regimen.’’ count (or if it is medically inadvisable for a (ii) Conclusion. In this Example 5, the Dated: June 22, 2000. participant to attempt to achieve the targeted program is a bona fide wellness program Nancy-Ann Min DeParle, cholesterol count), the plan will make because it satisfies the four requirements of Administrator, Health Care Financing available a reasonable alternative standard this paragraph (f). First, the program Administration. that takes the relevant medical condition into complies with the limits on rewards under a account. In addition, all plan materials program. Second, it is reasonably designed to Approved: August 29, 2000. describing the terms of the program include promote good health or prevent disease. Donna E. Shalala, the following statement: ‘‘If it is Third, the reward under the program is Secretary. unreasonably difficult due to a medical available to all similarly situated individuals [FR Doc. 01–107 Filed 1–5–01; 8:45 am] condition for you to achieve a cholesterol because it generally accommodates count under 200, or if it is medically individuals for whom it is unreasonably BILLING CODE 4120±01±P; 4510±29±P; 4830±01±P inadvisable for you to attempt to achieve a difficult due to a medical condition to count under 200, call us at the number below achieve (or for whom it is medically and we will work with you to develop inadvisable to attempt to achieve) the DEPARTMENT OF THE TREASURY another way to get the discount.’’ Individual targeted body mass index by providing a D is unable to achieve a cholesterol count reasonable alternative standard (walking) and Internal Revenue Service under 200. The plan accommodates D by it accommodates individuals for whom it is making the discount available to D, but only unreasonably difficult due to a medical 26 CFR Part 54 if D complies with a low-cholesterol diet. condition (or for whom it is medically [REG±114082±00] (ii) Conclusion. In this Example 4, the inadvisable to attempt) to walk by providing program is a bona fide wellness program an alternative standard that is reasonable for RIN 1545±AY32 because it satisfies the four requirements of the individual. Fourth, the plan discloses in this paragraph (f). First, the program all materials describing the terms of the HIPAA Nondiscrimination complies with the limits on rewards under a program the availability of a reasonable program. Second, it is reasonably designed to alternative standard for every individual. AGENCY: Internal Revenue Service (IRS), promote good health or prevent disease. Thus, the waiver of the deductible does not Treasury. Third, the reward under the program is violate this section. ACTION: Notice of proposed rulemaking available to all similarly situated individuals Example 6. (i) Facts. In conjunction with by cross-reference to temporary because it accommodates individuals for an annual open enrollment period, a group regulations. whom it is unreasonably difficult due to a health plan provides a form for participants medical condition to achieve the targeted to certify that they have not used tobacco SUMMARY: Elsewhere in this issue of the count (or for whom it is medically products in the preceding twelve months. Federal Register, the IRS is issuing inadvisable to attempt to achieve the targeted Participants who do not provide the temporary and final regulations count) in the prescribed period by providing certification are assessed a surcharge that is a reasonable alternative standard. Fourth, the [10/15/20] percent of the cost of employee- governing the provisions prohibiting plan discloses in all materials describing the only coverage. However, all plan materials discrimination based on a health factor terms of the program the availability of a describing the terms of the wellness program for group health plans. The IRS is reasonable alternative standard. Thus, the include the following statement: ‘‘If it is issuing the temporary and final premium discount does not violate this unreasonably difficult due to a health factor regulations at the same time that the section. for you to meet the requirements under this Pension and Welfare Benefits Example 5. (i) Facts. A group health plan program (or if it is medically inadvisable for Administration of the U.S. Department will waive the $250 annual deductible you to attempt to meet the requirements of of Labor and the Health Care Financing (which is less than [10/15/20] percent of the this program), we will make available a Administration of the U.S. Department annual cost of employee-only coverage under reasonable alternative standard for you to the plan) for the following year for avoid this surcharge.’’ It is unreasonably of Health and Human Services are participants who have a body mass index difficult for Individual E to stop smoking issuing substantially similar interim between 19 and 26, determined shortly cigarettes due to an addiction to nicotine (a final regulations governing the before the beginning of the year. However, medical condition). The plan accommodates provisions prohibiting discrimination any participant for whom it is unreasonably E by requiring E to participate in a smoking based on a health factor for group health difficult due to a medical condition to attain cessation program to avoid the surcharge. E plans and issuers of health insurance this standard (and any participant for whom can avoid the surcharge for as long as E coverage offered in connection with a it is medically inadvisable to attempt to participates in the program, regardless of group health plan under the Employee achieve this standard) during the plan year whether E stops smoking (as long as E Retirement Income Security Act of 1974 is given the same discount if the participant continues to be addicted to nicotine). walks for 20 minutes three days a week. Any (ii) Conclusion. In this Example 6, the and the Public Health Service Act. The participant for whom it is unreasonably premium surcharge is permissible as a bona temporary regulations provide guidance difficult due to a medical condition to attain fide wellness program because it satisfies the to employers and group health plans either standard (and any participant for four requirements of this paragraph (f). First, relating to the group health plan whom it is medically inadvisable to attempt the program complies with the limits on nondiscrimination requirements. The to achieve either standard during the year) is rewards under a program. Second, it is text of those temporary regulations also given the same discount if the individual reasonably designed to promote good health serves as the text of these proposed satisfies a reasonable alternative standard or prevent disease. Third, the reward under regulations. that is tailored to the individual’s situation. the program is available to all similarly All plan materials describing the terms of the situated individuals because it DATES: Written comments and requests wellness program include the following accommodates individuals for whom it is for a public hearing must be received by statement: ‘‘If it is unreasonably difficult due unreasonably difficult due to a medical April 9, 2001.

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ADDRESSES: Send submissions to: Treasury, Office of Information and that section 553(b) of the Administrative CC:M&SP:RU (REG–114082–00), room Regulatory Affairs, Washington, DC Procedure Act (5 U.S.C. chapter 5) does 5226, Internal Revenue Service, POB 20503, with copies to the Internal not apply to this regulation. For further 7604, Ben Franklin Station, Washington, Revenue Service, Attn: IRS Reports information and for analyses relating to DC 20044. Submissions may be hand- Clearance Officer, W:CAR:MP:FP:S:O, the joint rulemaking, see the preamble delivered to: CC:M&SP:RU (REG– Washington, DC 20224. Comments on to the joint rulemaking. Pursuant to 114082–00), room 5226, Internal the collection of information should be section 7805(f) of the Internal Revenue Revenue Service, 1111 Constitution received by April 9, 2001. Comments Code, this notice of proposed Avenue, NW., Washington, DC. are specifically requested concerning: rulemaking will be submitted to the Alternatively, taxpayers may submit • Whether the proposed collection of Chief Counsel for Advocacy of the Small comments electronically via the Internet information is necessary for the proper Business Administration for comment by selecting the ‘‘Tax Regs’’ option on performance of the functions of the on its impact on small business. the IRS Home Page, or by submitting Internal Revenue Service, including Comments and Requests for a Public comments directly to the IRS Internet whether the information will have Hearing site at: http://www.irs.gov/tax_regs/ practical utility; • regslist.html. The accuracy of the estimated Before these proposed regulations are FOR FURTHER INFORMATION CONTACT: burden associated with the proposed adopted as final regulations, Concerning the regulations, Russ collection of information (see the consideration will be given to any Weinheimer at 202–622–6080; preamble to the temporary regulations written comments (a signed original and concerning submissions of comments or published elsewhere in this issue of the eight (8) copies) that are submitted Federal Register); timely to the IRS. Comments are requests for a hearing, Sonya Cruse at • 202–622–7190 (not toll-free numbers). How to enhance the quality, utility, specifically requested on the clarity of and clarity of the information to be SUPPLEMENTARY INFORMATION: the proposed regulations and how they collected; may be made easier to understand. All • Paperwork Reduction Act How to minimize the burden of comments will be available for public complying with the proposed collection The collection of information inspection and copying. A public of information, including the referenced in this notice of proposed hearing may be scheduled if requested application of automated collection rulemaking has been submitted to the in writing by a person that timely techniques or other forms of information Office of Management and Budget for submits written comments. If a public technology; and review in accordance with the hearing is scheduled, notice of the date, • Estimates of capital or start-up costs Paperwork Reduction Act of 1995 (44 time, and place for the hearing will be and costs of operation, maintenance, U.S.C. 3507(d)). published in the Federal Register. and purchase of services to provide An agency may not conduct or Drafting Information sponsor, and a person is not required to information. respond to, a collection of information Background The principal author of these unless it displays a valid control The temporary regulations published proposed regulations is Russ number assigned by the Office of elsewhere in this issue of the Federal Weinheimer, Office of the Operating Management and Budget. Register add a new § 54.9802–1T to the Division Counsel/Associate Chief The collections of information are in Miscellaneous Excise Tax Regulations.1 Counsel (Tax Exempt and Government § 54.9802–1T (see the temporary When these proposed regulations are Entities), IRS. However, other personnel regulations published elsewhere in this published as final regulations, they will from the IRS and Treasury Department issue of the Federal Register). The supplement the final regulations in participated in their development. The collections of information are required § 54.9802–1 being published elsewhere proposed regulations, as well as the so that individuals denied enrollment in in this issue of the Federal Register. The temporary regulations, have been a group health plan based on one or proposed, temporary, and final developed in coordination with more health factors will be apprised of regulations are being published as part personnel from the U.S. Department of their right to enroll in the plan without of a joint rulemaking with the Labor and the U.S. Department of regard to their health. The likely Department of Labor and the Health and Human Services. respondents are business or other for- Department of Health and Human profit institutions, nonprofit List of Subjects in 26 CFR Part 54 Services (the joint rulemaking). institutions, small businesses or Excise taxes, Health insurance, organizations, and Taft-Hartley trusts. Special Analyses Pensions, Reporting and recordkeeping Responses to this collection of This regulation is not subject to the requirements. information are required of plans that Unfunded Mandates Reform Act of 1995 Proposed Amendments to the have denied enrollment to individuals because the regulation is an interpretive Regulations based on one or more health factors. regulation. It has also been determined Books or records relating to a collection of information must be Accordingly, 26 CFR part 54 is 1 A previous § 54.9802–1T was published in the proposed to be amended as follows: retained as long as their contents may Federal Register on April 8, 1997. By operation of become material in the administration section 7805(e) of the Internal Revenue Code, the PART 54ÐPENSION EXCISE TAXES of any internal revenue law. Generally previous § 54.9802–1T expired on April 8, 2000. Proposed regulations containing the same text as tax returns and tax return information previous § 54.9802–1T were also published on Paragraph 1. The authority citation for are confidential, as required by 26 April 8, 1997, and final regulations based on those part 54 continues to read in part as U.S.C. 6103. proposed regulations are being published elsewhere follows: Comments on the collection of in this issue of the Federal Register as § 54.9802– 1. The new § 54.9802–1T being published Authority: 26 U.S.C. 7805 * * * information should be sent to the Office elsewhere in this issue of the Federal Register of Management and Budget, Attn: Desk consists almost entirely of new guidance not Par. 2. Section 54.9802–1 is amended Officer for the Department of the contained in the previous § 54.9802–1T. to read as follows:

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§ 54.9802±1 Prohibiting discrimination the IRS Home Page, or by submitting access, portability, and renewability.1 against participants and beneficiaries comments directly to the IRS Internet However, under section 9802(c), church based on a health factor. site at http://www.irs.gov/tax_regs/ plans satisfying certain requirements [The text of this proposed regslist.html. continuously since July 15, 1997 are not amendments to this section is the same FOR FURTHER INFORMATION CONTACT: treated as failing to meet the section as the text of § 54.9802–1T published Concerning the regulations, Russ 9802 prohibitions against elsewhere in this issue of the Federal Weinheimer at 202–622–6080; discrimination based on any health Register]. concerning submissions of comments or factor solely because the plan requires evidence of good health for the coverage Robert E. Wenzel, requests for a hearing, Sonya Cruse at 202–622–7190 (not toll-free numbers). of certain individuals. Deputy Commissioner of Internal Revenue. The grandfather rule in section [FR Doc. 01–108 Filed 1–5–01; 8:45 am] SUPPLEMENTARY INFORMATION: 9802(c) applies to a church plan for a BILLING CODE 4830±01±P Background plan year only if, on July 15, 1997 and at all times after that date before the This document contains proposed beginning of the plan year, the church DEPARTMENT OF THE TREASURY amendments to the Miscellaneous plan had provisions satisfying one of Excise Tax Regulations (26 CFR part 54) two alternative conditions. The first Internal Revenue Service relating to the exception for certain alternative condition is that the plan grandfathered church plans from the contain provisions requiring evidence of 26 CFR Part 54 nondiscrimination requirements good health of two sets of individuals, applicable to group health plans. The [REG±114083±00] that is, both (1) any employee of an nondiscrimination requirements employer with 10 or fewer employees RIN 1545±AY33 applicable to group health plans were and (2) any self-employed individual. added to the Internal Revenue Code The proposed regulations specify that Exception to the HIPAA (Code), in section 9802, by the Health this condition is not satisfied if the plan Nondiscrimination Requirements for Insurance Portability and requires evidence of good health of only Certain Grandfathered Church Plans Accountability Act of 1996 (HIPAA), one of these sets of individuals. The Public Law 104–191. HIPAA also added AGENCY: Internal Revenue Service (IRS), proposed regulations also clarify that similar nondiscrimination provisions Treasury. the plan provision for the first set of applicable to group health plans and individuals must be exactly 10 or fewer. ACTION: Notice of proposed rulemaking. health insurance issuers (such as health Thus, a plan provision requiring insurance companies and health SUMMARY: This document contains evidence of good health for employees proposed regulations that provide maintenance organizations) under the of an employer of fewer than 10, or of guidance under section 9802(c) of the Employee Retirement Income Security greater than 10, employees does not Internal Revenue Code relating to the Act of 1974 (ERISA), administered by satisfy this condition. For example, a exception for certain grandfathered the U.S. Department of Labor, and the plan provision requiring evidence of church plans from the Public Health Service Act (PHS Act), good health of any employee of an nondiscrimination requirements administered by the U.S. Department of employer of five or fewer employees applicable to group health plans under Health and Human Services. does not satisfy this condition. section 9802(a) and (b). Final, Final and temporary regulations The second alternative condition is temporary, and proposed regulations relating to the HIPAA that the plan contain provisions relating to the nondiscrimination nondiscrimination requirements in requiring evidence of good health of any requirements under section 9802(a) and paragraphs (a) and (b) of section 9802 of individual who enrolls after the first 90 (b) are being published elsewhere in this the Code are being published elsewhere days of initial eligibility. The proposed issue of the Federal Register. The in this issue of the Federal Register. regulations clarify that the period for regulations will generally affect Those regulations are similar to, and these plan provisions must be exactly 90 sponsors of and participants in certain have been developed in coordination days. Thus, a plan provision requiring self-funded church plans that are group with, interim final regulations also evidence of good health of any health plans, and the regulations being published today by the individual who enrolls after the first 120 provide plan sponsors and plan Departments of Labor and Health and days of initial eligibility does not satisfy administrators with guidance necessary Human Services. Guidance under the this condition. The grandfather rule in section to comply with the law. HIPAA nondiscrimination requirements is summarized in a joint preamble to the 9802(c) of the Code is not by its terms DATES: Written or electronic comments final, interim final, and temporary limited in its application to self-funded and requests for a public hearing must regulations. church plans. Section 2702 of the Public be received by April 9, 2001. The exception for certain Health Service Act (PHS Act) imposes ADDRESSES: Send Submissions to: grandfathered church plans was added nondiscrimination requirements on CC:M&SP:RU (REG–114083–00), room to section 9802, in a new subsection (c), health insurance issuers offering group 5226, Internal Revenue Service, POB by section 1532 of the Taxpayer Relief health insurance coverage, and those 7604, Ben Franklin Station, Washington, Act of 1997, Public Law 105–34. These nondiscrimination requirements are DC 20044. Submissions may be hand proposed regulations would provide generally similar to the delivered between the hours of 8 a.m. guidance for this exception. The nondiscrimination requirements and 5 p.m. to: CC:M&SP:RU (REG– guidance is summarized in the imposed on group health plans 114083–00), Courier’s Desk, Internal explanation below. Revenue Service, 1111 Constitution 1 However, church plans are not subject to the Avenue NW., Washington, DC. Explanation of Provisions similar requirements in Part 7 of Subtitle B of Title I of ERISA or to the similar requirements in Title Alternatively, taxpayers may submit Church plans that are group health XXVII of the PHS Act (except for health insurance comments electronically via the Internet plans are generally subject to the Code coverage in connection with a church plan, as by selecting the ‘‘Tax Regs’’ option on provisions in Chapter 100 relating to discussed below).

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(including church plans) under Comments and Requests for a Public insurance issuers providing health paragraphs (a) and (b) of section 9802 of Hearing insurance coverage under a church plan the Code. However, section 2702 of the Before these proposed regulations are that is a group health plan to comply PHS Act does not include an exception adopted as final regulations, with nondiscrimination requirements for health insurance issuers offering consideration will be given to any similar to those that church plans are group health insurance coverage to written comments that are submitted required to comply with under section church plans comparable to the timely (a signed original and eight (8) 9802 and §§ 54.9802–1 and 54.9802–1T exception for church plans in section copies) to the IRS. Comments are except that those nondiscrimination 9802(c) of the Code. Thus, if a church specifically requested on the clarity of requirements do not include an plan providing benefits through group the proposed regulations and how they exception for health insurance issuers health insurance coverage were to may be made easier to understand. All comparable to the exception for church plans under section 9802(c) and this require evidence of good health of comments will be available for public inspection and copying. A public section. certain individuals as permitted under (b) Church plans to which this section hearing may be scheduled if requested section 9802(c) of the Code, the applies—(1) Church plans with certain in writing by a person that timely requirement of evidence of good health coverage provisions in effect on July 15, submits written comments. If a public would cause the health insurance issuer 1997. This section applies to any church providing the coverage to violate the hearing is scheduled, notice of the date, plan (as defined in section 414(e)) for a nondiscrimination requirements of the time, and place for the hearing will be plan year if, on July 15, 1997 and at all PHS Act. In such a case, the sanctions published in the Federal Register. times thereafter before the beginning of under the PHS Act would apply to the Drafting Information the plan year, the plan contains either issuer, but those under the Code would The principal author of these the provisions described in paragraph not apply to the church plan. Thus, proposed regulations is Russ (b)(2) of this section or the provisions assuming that group health insurance Weinheimer, Office of the Operating described in paragraph (b)(3) of this coverage complies with the Division Counsel/Associate Chief section. (2) Plan provisions applicable to nondiscrimination requirements of the Counsel (Tax Exempt and Government individuals employed by employers of PHS Act, the rule in section 9802(c) of Entities). However, other personnel the Code is, in effect, available only to 10 or fewer employees and self- from the IRS and Treasury Department employed individuals—(i) A plan church plans that are not funded participated in their development. through group health insurance because contains the provisions described in this only such church plans do not include List of Subjects in 26 CFR Part 54 paragraph (b)(2) if it requires evidence insurance coverage that is subject to Excise taxes, Health care, Health of good health of both— (A) Any employee of an employer of Title XXVII of the PHS Act. insurance, Pensions, Reporting and 10 or fewer employees (determined Accordingly, the examples in the recordkeeping requirements. without regard to section 414(e)(3)(C), proposed regulations illustrating Proposed Amendments to the under which a church or convention or situations where section 9802(c) is Regulations association of churches is treated as the available are limited to group health employer); and plans that are not funded through group Accordingly, 26 CFR part 54 is proposed to be amended as follows: (B) Any self-employed individual. health insurance in order to avoid (ii) A plan does not contain the misleading insured church plans about PART 54ÐPENSION EXCISE TAXES provisions described in this paragraph the availability of the grandfather rule in (b)(2) if the plan contains only one of section 9802(c). Paragraph 1. The authority citation the provisions described in this for part 54 is amended in part by adding paragraph (b)(2). Thus, for example, a Special Analyses an entry in numerical order to read as plan that requires evidence of good It has been determined that this notice follows: health of any self-employed individual, of proposed rulemaking is not a Authority: 26 U.S.C. 7805 * * * but not of any employee of an employer significant regulatory action as defined Section 54.9802–2 also issued under with 10 or fewer employees, does not in Executive Order 12866. Therefore, a 26 U.S.C. 9802. * * * contain the provisions described in this regulatory assessment is not required. It Par. 2. Section 54.9802–2 is added to paragraph (b)(2). Moreover, a plan does also has been determined that section read as follows: not contain the provision described in 553(b) of the Administrative Procedure paragraph (b)(2)(i)(A) of this section if § 54.9802±2 Special rules for certain the plan requires evidence of good Act (5 U.S.C. chapter 5) does not apply church plans. health of any employee of an employer to these regulations, and because the (a) Exception for certain church of fewer than 10 (or greater than 10) regulations do not impose a collection plans—(1) Church plans in general. A employees. Thus, for example, a plan of information requirement on small church plan described in paragraph (b) does not contain the provision entities, the Regulatory Flexibility Act of this section is not treated as failing to described in paragraph (b)(2)(i)(A) of (5 U.S.C. chapter 6) does not apply. meet the requirements of section 9802 this section if the plan requires evidence Therefore, a Regulatory Flexibility or §§ 54.9802–1 and 54.9802–1T solely of good health of any employee of an Analysis under the Regulatory because the plan requires evidence of employer with five or fewer employees. Flexibility Act (5 U.S.C. chapter 6) is good health for coverage of individuals (3) Plan provisions applicable to not required. Pursuant to section 7805(f) under plan provisions described in individuals who enroll after the first 90 of the Internal Revenue Code, this paragraph (b)(2) or (3) of this section. days of initial eligibility—(i) A plan notice of proposed rulemaking will be (2) Health insurance issuers. See contains the provisions described in this submitted to the Chief Counsel for sections 2702 and 2721(b)(1)(B) of the paragraph (b)(3) if it requires evidence Advocacy of the Small Business Public Health Service Act (42 U.S.C. of good health of any individual who Administration for comment on its 300gg–2 and 300gg–21(b)(1)(B)) and 45 enrolls after the first 90 days of initial impact on small business. CFR 146.121, which require health eligibility under the plan.

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(ii) A plan does not contain the with the church (including a self-employed entities affiliated with the church and self- provisions described in this paragraph minister of the church). Plan O requires employed individuals affiliated with the (b)(3) if it provides for a longer (or evidence of good health in order for any church (such as ministers). On July 15, 1997 shorter) period than 90 days. Thus, for individual of a church entity that has 10 or and at all times thereafter before the beginning of the plan year, Plan P has example, a plan requiring evidence of fewer employees to be covered and in order for any self-employed individual to be required evidence of good health for coverage good health of any individual who covered. On July 15, 1997 and at all times of any individual who enrolls after the first enrolls after the first 120 days of initial thereafter before the beginning of the plan 90 days of initial eligibility under the plan. eligibility under the plan does not year, Plan O has contained all the preceding (ii) Conclusion. In this Example 2, because contain the provisions described in this provisions. Plan P contains the plan provisions described paragraph (b)(3). (ii) Conclusion. In this Example 1, because in paragraph (b)(3) of this section and (c) Examples. The rules of this section Plan O contains the plan provisions because those provisions were in the plan on are illustrated by the following described in paragraph (b)(2) of this section July 15, 1997 and at all times thereafter examples: and because those provisions were in the before the beginning of the plan year, Plan P Example 1. (i) Facts. A church organization plan on July 15, 1997 and at all times will not be treated as failing to meet the maintains two church plans for entities thereafter before the beginning of the plan requirements of section 9802, § 54.9802–1, or affiliated with the church. One plan is a year, Plan O will not be treated as failing to § 54.9802–1T for the plan year solely because group health plan that provides health meet the requirements of section 9802, the plan requires evidence of good health for coverage to all employees (including § 54.9802–1, or § 54.9802–1T for the plan coverage of individuals enrolling after the ministers and lay workers) of any affiliated year solely because the plan requires first 90 days of initial eligibility under the church entity that has more than 10 evidence of good health for coverage of the plan. employees. The other plan is Plan O, which individuals described in those plan is a group health plan that is not funded provisions. (d) Effective date. [Reserved] through insurance coverage and that provides Example 2. (i) Facts. A church organization Robert E. Wenzel, health coverage to any employee (including maintains Plan P, which is a church plan that Deputy Commissioner of Internal Revenue. ministers and lay workers) of any affiliated is not funded through insurance coverage church entity that has 10 or fewer employees and that is a group health plan providing [FR Doc. 01–109 Filed 1–5–01; 8:45 am] and any self-employed individual affiliated health coverage to individuals employed by BILLING CODE 4830±01±P

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Part III

Department of Education Rehabilitation Services Administration Recreational Program; Notice

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DEPARTMENT OF EDUCATION effective and efficient administration of development, leisure education, leisure the program. networking, leisure resource RIN 1820±ZA12 During and after the comment period, development, physical education and Rehabilitation Services Administration you may inspect all public comments sports, scouting and camping, 4-H Recreational Program about this proposed priority in room activities, music, dancing, handicrafts, 3420, Switzer Building, 330 C Street art, and homemaking. Recreational AGENCY: Office of Special Education and SW., Washington, DC, between the services do not include the construction Rehabilitative Services, Department of hours of 9 a.m. and 4:30 p.m., Eastern of facilities for aquatic rehabilitation Education. time, Monday through Friday of each therapy. week except Federal holidays. ACTION: Notice of proposed priority for Projects must provide recreational fiscal year (FY) 2001 and later years. Assistance to Individuals With services to individuals with disabilities Disabilities in Reviewing the in settings with peers who are not SUMMARY: The Assistant Secretary for Rulemaking Record individuals with disabilities. the Office of Special Education and Rehabilitative Services proposes a On request, we will supply an Statutory Requirements priority under the Recreational Program. appropriate aid, such as a reader or All applicants seeking funding under The Assistant Secretary may use this print magnifier, to an individual with a this competition must— disability who needs assistance to priority for competitions in FY 2001 and (a) Describe the manner in which the review the comments or other later years. We take this action to applicant will address the needs of documents in the public rulemaking provide individuals with disabilities individuals with disabilities from record for the proposed priority. If you recreational activities and related minority backgrounds (section 21(c) of want to schedule an appointment for experiences to aid in their employment, the Act); this type of aid, you may call (202) 205– mobility, socialization, independence, (b) Describe the manner in which the and community integration. 8113 or (202) 260–9895. If you use a TDD, you may call the Federal findings and results of the project to be DATES: We must receive your comments Information Relay Service at 1–800– funded under the grant, particularly on or before February 7, 2001. 877–8339. information that facilitates the ADDRESSES: Address all comments about We will announce the final priority in replication of the results of that project, this proposed priority to Mary E. a notice in the Federal Register. We will will be made generally available Chambers, U.S. Department of determine the final priority after (section 305(a)(4)(A) of the Act); Education, 400 Maryland Avenue, SW., considering responses to this notice and (c) Demonstrate ways in which room 3320, Switzer Building, other information available to the recreational activities assist in Washington, DC 20202–2649. If you Department. This notice does not maximizing the independence and prefer to send your comments through preclude us from proposing or funding integration of individuals with the Internet, use the following address: additional priorities, subject to meeting disabilities into community-based recreational programs (section [email protected] applicable rulemaking requirements. 305(a)(1)(C) of the Act); You must include the term Note: This notice does not solicit (d) Assure that the project will ‘‘Recreational Program’’ in the subject applications. In any year in which the maintain, at a minimum, the same level line of your electronic message. Assistant Secretary chooses to use this proposed priority, we invite applications of services over the three-year project FOR FURTHER INFORMATION CONTACT: through a notice in the Federal Register. period (section 305(a)(5) of the Act); Mary E. Chambers. Telephone: (202) Priority (e) Assure that the service program 205–8435 or via Internet: funded under the grant will be _ Mary [email protected] Background continued after Federal assistance ends If you use a telecommunications Authority for the Recreational (section 305(a)(4)(B) of the Act); and device for the deaf (TDD) you may call Program is contained in section 305 of (f) Provide non-Federal resources (in the Federal Information Relay Service the Rehabilitation Act of 1973, as cash or in-kind) to pay the non-Federal (FIRS) at 1–800–877–8339. amended (the Act) (29 U.S.C. 775). This share cost of the project in year two at Individuals with disabilities may proposed priority would support 25 percent of year one Federal grant and obtain this document in an alternative projects that provide individuals with year three at 50 percent of year one format (e.g., Braille, large print, disabilities with recreational activities Federal grant (section 305(a)(3)(B) of the audiotape, or computer diskette) on and experiences that aid in their Act). request to the contact person listed employment, mobility, socialization, under FOR FURTHER INFORMATION National Education Goals independence, and community CONTACT. integration. The eight National Education Goals SUPPLEMENTARY INFORMATION: focus the Nation’s education reform Proposed Priority efforts and provide a framework for Invitation To Comment Under 34 CFR 75.105(c)(3) the improving teaching and learning. We invite you to submit comments Assistant Secretary proposes to give an This proposed priority would address regarding this proposed priority. We absolute preference to applications that the National Education Goal that every invite you to assist us in complying meet the following priority. The American will possess the knowledge with the specific requirements of Assistant Secretary proposes to fund and skills necessary to compete in a Executive Order 12866 and its overall under this competition only global economy requirement of reducing regulatory applications that meet this absolute Executive Order 12866 burden that might result from this priority. proposed priority. Please let us know of Projects must provide recreational This notice of proposed priority has any further opportunities we should services to individuals with disabilities. been reviewed in accordance with take to reduce potential costs or increase Recreational services include, but are Executive Order 12866. Under the terms potential benefits while preserving the not limited to, vocational skills of the order the Assistant Secretary has

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Part IV

Department of Transportation Federal Highway Administration

23 CFR Parts 655 and 940 Intelligent Transportation System Architecture and Standards; Final Rule

Federal Transit Administration

Federal Transit Administration National ITS Architecture Policy on Transit Projects; Notice

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DEPARTMENT OF TRANSPORTATION Electronic Access and Filing technologies, advanced control You may submit or retrieve comments strategies, and electronics to the field of Federal Highway Administration online through the Docket Management transportation. Information technology System (DMS) at: http//dmses.dot.gov/ in general is most effective and cost 23 CFR Parts 655 and 940 submit. Acceptable formats include: MS beneficial when systems are integrated and interoperable. The greatest benefits [FHWA Docket No. FHWA±99±5899] Word (versions 95 to 97), MS Word for Mac (versions 6 to 8), Rich Text Format in terms of safety, efficiency, and costs are realized when electronic systems are RIN 2125±AE65 (RTF), American Standard Code systematically integrated to form a Information Interchange (ASCII) (TXT), whole in which information is shared Intelligent Transportation System Portable Document Format (PDF), and Architecture and Standards with all and systems are interoperable. WordPerfect (version 7 to 8). The DMS In the transportation sector, AGENCY: Federal Highway is available 24 hours each day, 365 days successful ITS integration and Administration (FHWA), DOT. each year. Electronic submission and interoperability require addressing two retrieval help and guidelines are ACTION: Final rule. different and yet fundamental issues; available under the help section of the that of technical and institutional SUMMARY: The purpose of this document web site. integration. Technical integration of is to issue a final rule to implement An electronic copy of this document electronic systems is a complex issue section 5206(e) of the Transportation may be downloaded by using a that requires considerable up-front Equity Act for the 21st Century (TEA– computer, modem, and suitable planning and meticulous execution for 21), enacted on June 9, 1998, which communications software from the electronic information to be stored and required Intelligent Transportation Government Printing Office’s Electronic accessed by various parts of a system. System (ITS) projects funded through Bulletin Board Service at (202) 512– Institutional integration involves the highway trust fund to conform to the 1661. Internet users may also reach the coordination between various agencies National ITS Architecture and Office of the Federal Register’s home and jurisdictions to achieve seamless applicable standards. Because it is page at http://www.nara.gov/fedreg and operations and/or interoperability. highly unlikely that the entire National the Government Printing Office’s web In order to achieve effective ITS Architecture would be fully page at: http://www.access.gpo.gov/ institutional integration of systems, implemented by any single metropolitan nara. The document may also be viewed agencies and jurisdictions must agree on area or State, this rule requires that the at the DOT’s ITS web page at http:// the benefits of ITS and the value of National ITS Architecture be used to www.its.dot.gov. being part of an integrated system. They develop a local implementation of the Background must agree on roles, responsibilities, National ITS Architecture, which is and shared operational strategies. referred to as a ‘‘regional ITS A notice of proposed rulemaking Finally, they must agree on standards architecture.’’ Therefore, conformance (NPRM) concerning this rule was and, in some cases, technologies and with the National ITS Architecture is published at 65 FR 33994 on May 25, operating procedures to ensure defined under this rule as development 2000, and an extension of the comment interoperability. In some instances, of a regional ITS architecture within period to September 23, 2000, was there may be multiple standards that four years after the first ITS project published at 65 FR 45942 on July 26, could be implemented for a single advancing to final design, and the 2000. interface. In this case, agencies will subsequent adherence of ITS projects to In the NPRM on this rule, the FHWA need to agree on a common standard or the regional ITS architecture. The had proposed that the regional ITS agree to implement a technical regional ITS architecture is based on the architecture follow from the ITS translator that will allow dissimilar National ITS Architecture and consist of integration strategy proposed in another standards to interoperate. This several parts including the system NPRM entitled ‘‘Statewide coordination effort is a considerable task functional requirements and Transportation Planning; Metropolitan that will happen over time, not all at information exchanges with planned Transportation Planning’’ published at once. Transportation organizations, and existing systems and subsystems 65 FR 33922 on May 25, 2000. That rule such as, transit properties, State and and identification of applicable is being developed according to a local transportation agencies, and standards, and would be tailored to different schedule and will be issued metropolitan planning organizations address the local situation and ITS separately. For this reason, all must be fully committed to achieving investment needs. references to the proposed integration institutional integration in order for strategy have been removed from this integration to be successful. The EFFECTIVE DATE: February 7, 2001. rule. However, it is still the intent of transportation agencies must also FOR FURTHER INFORMATION CONTACT: For this rule that regional ITS architectures coordinate with agencies for which technical information: Mr. Bob Rupert, be based on established, collaborative transportation is a key, but not a (202) 366–2194, Office of Travel transportation planning processes. The primary part of their business, such as, Management (HOTM–1) and Mr. other major changes to the final rule emergency management and law Michael Freitas, (202) 366–9292, ITS relate to options for developing a enforcement agencies. Joint Program Office (HOIT–1). For legal regional ITS architecture and the time Successfully dealing with both the information: Mr. Wilbert Baccus, Office allowed to develop such an architecture. technical and institutional issues of the Chief Counsel (HCC–32), (202) Additional changes to the final rule requires a high-level conceptual view of 366–1346, Federal Highway largely deal with clarification of terms, the future system and careful, Administration, 400 Seventh Street, improved language dealing with staging comprehensive planning. The SW., Washington, DC 20590. Office and grandfathering issues, and framework for the system is referred to hours are from 8 a.m. to 4:30 p.m., e.t., clarification of use of ITS standards. as the architecture. The architecture Monday through Friday, except Federal Intelligent Transportation Systems defines the system components, key holidays. represent the application of information functions, the organizations involved, SUPPLEMENTARY INFORMATION: processing, communications and the type of information shared

VerDate 112000 14:12 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR3.SGM pfrm01 PsN: 08JAR3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1447 between organizations and parts of the However, the National ITS Architecture interoperability now and into the future, system. The architecture is, therefore, has considerable value as a framework but it leaves selection of technologies to fundamental to successful system for local governments in the local decisionmakers. implementation, integration, and development of regional ITS 4. The architecture provides a sound interoperability. architectures by identifying the many engineering framework for integrating Additional background information functions and information sharing multiple applications and services in a may be found in docket number FHWA– opportunities that may be desired. It can region. 99–5899. assist local governments with both of ITS Architecture and Standards NPRM The National ITS Architecture the key elements: technical interoperability and institutional Discussion of Comments The Intermodal Surface coordination. The FHWA received 105 comments Transportation Efficiency Act of 1991, The National ITS Architecture, on this docket from a wide range of Public Law 102–240, 105 Stat. 1914, because it aids in the development of a stakeholders, including major industry initiated Federal funding for the ITS high-level conceptual view of a future associations, State departments of program. The program at that time was system, can assist local governments in transportation, Metropolitan Planning largely focused on research and identifying applications that will Organizations (MPOs), and local development and operational tests of support their future transportation agencies. The comments were generally technologies. A key part of the program needs. From an institutional favorable about the scope and content, was the development of the National coordination perspective, the National ITS Architecture. The National ITS ITS Architecture helps local but requested additional clarification Architecture provides a common transportation planners to identify other and guidance on implementation of structure for the design of ITS systems. stakeholders who may need to be specific items. On many issues, some The architecture defines the functions involved and to identify potential commenters wanted more specific that could be performed to satisfy user integration opportunities. From a requirements, while others wanted more requirements and how the various technical interoperability perspective, flexibility. Most commenters, including elements of the system might connect to the National ITS Architecture provides major industry associations and public share information. It is not a system a logical and physical architecture and sector agencies, agreed with the overall design, nor is it a design concept. process specifications to guide the scope, but some felt that the specifics However, it does define the framework design of a system. The National ITS might be difficult to implement and around which multiple design Architecture also identifies interfaces asked for clarification of key terms. A approaches can be developed, each one where standards may apply, further few commenters wanted the FHWA to specifically tailored to meet the needs of supporting interoperability. reduce the number of requirements or the user, while maintaining the benefits convert the rulemaking into a guidance of a common approach. Transportation Equity Act for the 21st activity until more ITS deployment The National ITS Architecture, Century experience is gained. Version 3.0 can be obtained from the As noted above, section 5206(e) of the In summary, the FHWA received a ITS Joint Program Office of the DOT in TEA–21, Public Law 105–178, 112 Stat. large number of generally favorable CD–ROM format and on the ITS web 457, requires ITS projects funded from comments about the NPRM that site http://www.its.dot.gov. The effort to the highway trust fund to conform to the suggested minor specific changes and develop a common national system National ITS Architecture, applicable or expressed a need for further guidance architecture to guide the evolution of provisional standards, and protocols. on implementation. Since the general ITS in the United States over the next One of the findings of Congress in tenor of the comments was positive, the 20 years and beyond has been managed section 5202 of the TEA–21, is that FHWA has kept the scope of the NPRM since September 1993 by the DOT. The continued investment in systems and made appropriate clarifications to National ITS Architecture describes in integration is needed to accelerate the the text of the final rule to address detail what types of interfaces should rate at which ITS is incorporated into concerns raised in comments. In exist between ITS components and how the national surface transportation response to the many comments they will exchange information and network. Two of the purposes of the ITS requesting it, starting in early 2001, the work together to deliver the given ITS program, noted in section 5203(b) of the FHWA will also provide a program of user service requirements. TEA–21, are to expedite the deployment guidance, training, and technical The National ITS Architecture and and integration of ITS, and to improve support to assist with the standards can be used to guide multi- regional cooperation and operations implementation of this rule. The level government and private-sector planning for effective ITS deployment. following is a detailed discussion of the business planners in developing and Use of the National ITS Architecture comments and their disposition, deploying nationally compatible provides significant benefits to local organized by subject matter. systems. By ensuring system transportation planners and deployers Section 940.3 Definitions compatibility, the DOT hopes to as follows: accelerate ITS integration nationwide 1. The National ITS Architecture ITS Project. There were 34 comments and develop a strong, diverse provides assistance with technical submitted to the docket concerning the marketplace for related products and design. It saves considerable design time definition of an ITS project. Many of the services. because physical and logical commenters felt the definition was not It is highly unlikely that the entire architectures are already defined. clear enough, was too broad, or was too National ITS Architecture will be fully 2. Information flows and process subject to interpretation. Some implemented by any single metropolitan specifications are defined in the comments questioned how much of a area or State. For example, the National National ITS Architecture, allowing project’s budget would have to be spent ITS Architecture contains information local governments to accelerate the on ITS before a project would be flows for an Automated Highway process of defining system functionality. considered an ITS project. Some System that is unlikely to be part of 3. The architecture identifies suggested specific language to more most regional implementations. standards that will support narrowly define an ITS project by

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There were five supporting legislation is to facilitate the opportunities. While there was no intent comments suggesting a single DOT rule deployment of integrated ITS systems, it to generally restrict the definition to addressing how all ITS projects would is the position of the FHWA that the MPAs or States, the FHWA determined meet the National ITS Architecture definition of an ITS project must be that regional ITS architectures should be conformance requirements of the TEA– fairly broad to include any ITS system based on an integration strategy that was 21 instead of an FHWA rule for highway being funded with highway trust fund developed by an MPO or State as part projects and an FTA policy for transit dollars. It is only by properly of its transportation planning process. projects. Four other comments considering all planned ITS investments Given that the final rule does not acknowledged the need for two policies, in the development of a regional ITS require or reference an integration but recommended they articulate the architecture that the integration strategy, the FHWA feels a need to same process. opportunities and needs can even be provide more specific guidance on the A final transportation planning rule is identified. This consideration should be definition of a region. As such, the being developed on a different schedule carried out in the development of an definition of a region has been revised than this rule, and comments regarding architecture prior to the specific project to indicate that the MPA should be the the portions of the National ITS being advanced. If, in the development minimum area considered when Architecture conformity process of a regional ITS architecture, it is establishing the boundaries of a region included in the transportation planning determined that a specific planned for purposes of developing a regional rule will be addressed as it proceeds ITS architecture within a metropolitan project offers no real integration toward issuance. The FHWA and FTA area. This should not be interpreted to opportunities for the region, then the have chosen to go forward with policies mean that a region must be an MPA, or impact of this rule on that specific that have been developed cooperatively no less than an MPA, but the MPA and project is minimal. to implement the National ITS all the agencies and jurisdictions within Architecture conformance process. This As a response to the comments the MPA should be at least considered FHWA rule and the parallel FTA policy concerning the clarity of the definition, for inclusion in the process of have been developed without reference the definition of an ITS project has been developing a regional ITS architecture to the proposed changes to the slightly modified to remove the within a metropolitan area. This rule is transportation planning process, examples since they were considered silent on other possible limits or including no mention of the misleading. The FHWA recognizes that minimum areas for defining a region, development of an integration strategy. any definition will be subject to relying on the flexible nature of this rule However, the policy statement of this interpretation by the stakeholders and to accommodate those special rule notes a link to established acknowledges the need for guidance in circumstances. The FHWA also transportation planning processes, as this area to ensure clear and consistent acknowledges it is possible that provided under 23 CFR part 450. This interpretation of this rule. Guidance on overlapping regions could be defined rule fully supports these collaborative what constitutes an ITS project and overlapping regional ITS methods for establishing transportation (including examples) will be developed architectures be developed to meet the goals and objectives, and does not to assist the various stakeholders, needs of the regions. provide a mechanism for introducing including the FHWA Division Offices, Other Definitions. There were 20 projects outside of the transportation to better understand what projects comments suggesting that other terms planning processes. should be considered ITS projects. used in the NPRM be defined. These This final rule on National ITS Region. There were 26 comments included ‘‘interoperability,’’ Architecture conformance and the FTA submitted related to the definition of a ‘‘standards,’’ ‘‘concept of operations,’’ policy on the same subject have been region. Seven comments supported the ‘‘conceptual design,’’ and ‘‘integration developed cooperatively and open definition provided in the NPRM, strategy.’’ Several of these are no longer coordinated among the agencies to arguing that the possible integration used in the final rule and, therefore, ensure compatible processes. Any opportunities in an area should define were not defined. Other terms, such as differences between this rule and the the region and that there were too many ‘‘interoperability’’ and ‘‘standards,’’ parallel FTA policy are intended to possible variations to allow a restrictive were determined to be common terms address differences in highway and definition. Six commenters who whose definition did not effect the transit project development and the way expressed concern over varying implementation of the final rule. the FHWA and the FTA administer conditions interpreted the definition to Furthermore, language regarding projects and funds. mean Metropolitan Planning Area standards conformity has been clarified Fifteen commenters questioned the (MPA). Five comments suggested an in the body of the final rule. need for an integration strategy, and the MPA was too restrictive. Eight other relationship between the strategy and comments indicated that the proposed Section 940.5 Policy the regional ITS architecture. definition of a region did not clearly Twenty-eight commenters addressed Given the fact that proposed revisions identify what entity would have the the issue of consistency between the to the FHWA’s transportation planning lead in developing a regional ITS two related FHWA notices of proposed rules are being developed according to architecture or thought the definition rulemaking (23 CFR parts 940 and 1410) a different schedule, this rule has been implied the MPO should have the lead. and the Federal Transit revised to remove any references to an Nine comments suggested various limits Administration’s (FTA) notice (FTA integration strategy. Comments or boundaries to fit specific situations. Docket No. FTA–99–6417) on National regarding the integration strategy will be Ten comments expressed a need for ITS Architecture published at 65 FR addressed in the final transportation

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TEA–21 language that allows for the adopting the proposed extension to four It is the intent of the FHWA that any Secretary to authorize certain years subsequent to beginning to deploy existing ITS planning documents should exceptions to the conformity provision. ITS projects (§ 940.9(c)), or four years be used to the extent practical to meet These exceptions relate to those projects from the effective date of this rule for the requirements of this rule. If a designed to achieve specific research those areas that are currently deploying regional ITS architecture is in place, is objectives or, if three stated criteria are ITS projects (§ 940.9(b)). In clarifying up to date, and addresses all the met, to those intended to upgrade or the time for development, this rule has requirements of a regional ITS expand an ITS system in existence on eliminated any references to specific architecture as described in this rule, the date of enactment of the TEA–21. methods for developing regional ITS there is no requirement to develop a The legislation also included a general architectures. By not prescribing any ‘‘new’’ one. If the existing regional ITS exemption for funds used strictly for methods, the rule provides flexibility to architecture does not address all the operations and maintenance of an ITS a region in deciding how it should requirements of the rule, it may be system in existence on the date of develop its regional ITS architecture. possible to update it so that it meets the enactment of the TEA–21. Guidance and information related to regional ITS architecture requirements The FHWA acknowledges this developing regional ITS architectures is of this rule. What is necessary is that the omission and has included the available from FHWA Division Offices end result is an architecture that meets appropriate language in this section of and from the ITS web site, http:// the requirements of this rule and the rule. www.its.dot.gov, and will be expanded properly addresses the ITS deployments Section 940.9 Regional ITS to provide assistance in meeting the and integration opportunities of that Architecture intent of the rule. region. This issue is specifically Both the terms ‘‘conceptual design’’ addressed in § 940.9(e) of this rule. Several comments were received There were five comments related to and ‘‘concept of operations’’ have been related to the way the proposed rule the impact of this rule on legacy systems deleted from the final rule. In their stead referred to developing regional ITS (i.e., ITS systems already in place) and architectures. Eight comments, from are descriptions of the content that is requesting some sort of State agencies and metropolitan expected to form the basis for a regional ‘‘grandfathering’’ for them. The language planning organizations, supported an ITS architecture. This content has not in § 940.11(g) of the final rule clarifies incremental approach to developing significantly changed from that defined the grandfathering or staging aspects of regional ITS architectures, starting with in the NPRM but is now contained in the process. The final rule does not project ITS architectures and building § 940.9(d). The level of detail required is require any changes or modifications to them together. Four other comments, to the architecture flow level as defined existing systems to conform to the from metropolitan planning in the National ITS Architecture. The National ITS Architecture. It is very organizations and industry associations, regional ITS architecture must identify likely that a regional ITS architecture noted that an ad hoc regional ITS how agencies, modes, and systems will developed by the local agencies and architecture developed incrementally interact and operate if the architecture other stakeholders would call for through projects would result in an is to fulfill the objective of promoting changes to legacy systems over time to architecture less robust than if there ITS integration within a region. support desired integration. However, were a single, initial effort to develop it. The relevant stakeholders for a region such changes would not be required by Also, thirteen comments from the will vary from region to region. The list the FHWA; they would be agreed upon Association of American State Highway articulated in § 940.9(a) is representative by the appropriate stakeholders as part and Transportation Officials (AASHTO) only and not meant to be inclusive or of the development of the regional ITS and a number of States recommended exclusive. On the specific issue of architecture. extending the time for developing private sector participation, if the There were 15 comments dealing with regional ITS architectures, as the private sector is deploying ITS systems the maintenance process and status of proposed two year implementation in a region or otherwise providing an the National ITS Architecture. Two would be too short. Ten of the ITS-based service, it would be comments suggested the need for the commenters preferred four years in appropriate to engage them in the FHWA to formally adopt the National order to acquire the necessary resources development of a regional ITS ITS Architecture. Four other comments for developing regional ITS architecture. Because of these variations also supported the formalization of a architectures. from region to region, the FHWA felt it process for maintaining or updating it Most commenters were in agreement inappropriate to attempt to define an all with the full opportunity for public with the content of the regional ITS inclusive list of stakeholders. The group input. architecture as defined in the proposed of relevant stakeholders will be a Conformance with the National ITS rule. However, there were 19 comments function of how the region is defined Architecture is interpreted to mean the that dealt with confusion over the and how transportation services are use of the National ITS Architecture to definition of both ‘‘conceptual design’’ provided to the public. Section develop a regional ITS architecture, and and ‘‘concept of operations.’’ In 940.9(d)(4) specifies that in the the subsequent adherence of all ITS addition, there were 17 other comments development of the regional ITS projects to that regional ITS on the makeup of the stakeholders, architecture, it shall include ‘‘any architecture. This rule requires that the involvement of the private sector, and agreements (existing or new) required National ITS Architecture be used as a the need and desirability of for operations.’’ The formalization of resource in developing a regional ITS ‘‘agreements’’ between stakeholders. these types of agreements is at the architecture.

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As a technical resource, it is requirements, as provided in 23 U.S.C. order to provide consistency in the important that the National ITS 106 and 133. regional ITS architecture process, the Architecture be maintained and updated Four commenters noted that the systems engineering analysis detailed in as necessary in response to user input proposed rule did not adequately §§ 940.11(a) through 940.11(c) must or to add new user services, but formal address planning for, or committing to, apply to all ITS projects regardless of adoption of the National ITS a defined level of operations and size or budget. However, the analysis Architecture is not necessary. However, maintenance. should be on a scale commensurate with the FHWA recognizes the need to The final rule addresses this concern project scope. To allow for the greatest maintain the National ITS Architecture on two primary levels, in the flexibility at the State and local level, in and to establish an open process for development of the regional ITS § 940.11(c), a minimum number of configuration control that includes architecture and the development of elements have been clearly identified public participation. The process individual projects. Section 940.9(d)(4) for inclusion in the systems engineering currently used by the DOT to maintain specifies that in the development of the analysis. Many of those elements are the National ITS Architecture is very regional ITS architecture, it shall currently required as provided in 23 rigorous and involves significant public include ‘‘any agreements (existing or CFR 655.409, which this rule replaces. participation. That process is currently new) required for operations.’’ The Recognizing the change in some current being reviewed by the DOT with the formalization of these types of practices this type of analysis will intent of establishing a configuration agreements is at the discretion of the require, the FHWA intends to issue management process that engages the region and participating stakeholders. guidance, training, and technical public at key stages and ensures a Also, relative to operations and support in early 2001 to help consensus for updating the National ITS management at a project level, stakeholders meet the requirements of Architecture. § 940.11(c)(7) specifies that the systems the final rule. Four comments suggested that this engineering analysis (required of all ITS Fifty-three comments were submitted rule should not be implemented until projects) includes ‘‘procedures and regarding ITS standards and the National ITS Architecture was resources necessary for the operations interoperability tests. The commenters complete. The National ITS and management of the system.’’ expressed concern about requiring the Architecture will never stop evolving Section 940.11 Project Implementation use of ITS standards and since there always is a potential need to In addition to the comments on interoperability tests prematurely, the regularly update it as more is learned impact on legacy systems of requiring about ITS deployment. The FHWA regional ITS architecture development noted above, the docket received 86 ITS standards, and confusion regarding believes the National ITS Architecture is the term ‘‘adopted by the DOT.’’ developed to a stage where it can be comments on systems engineering and project implementation. These In response to the comments, the used as a resource in developing FHWA has significantly modified the regional ITS architectures, as required comments revealed that the structure of final rule to eliminate reference to the by this rule. the NPRM in discussing regional ITS use of standards and interoperability Seventeen comments asked the architecture development, project FHWA to define the agency that is systems engineering analysis, and tests prior to adoption in § 940.11(f). responsible for the development and project implementation was confusing Section 940.11(g) addresses the maintenance of the regional ITS and difficult to read. applicability of standards to legacy architecture; specifically MPOs and/or To clarify these portions of the rule, systems. It is not the intent of the DOT the State as those entities that are the systems engineering and project to formally adopt any standard before already responsible for the planning implementation sections of the NPRM the standard is mature; and also, not all process. have been combined into § 940.11, ITS standards should, or will, be The FHWA did not define the Project Implementation. Also, formally adopted by the DOT. Formal responsibility for either creating or paragraphs that were in the regional ITS adoption of a standard means that the maintaining the regional ITS architecture section of the NPRM that DOT will go through the rulemaking architecture to a specific entity because discussed major ITS projects and the process, including a period of public of the diversity of transportation requirements for developing project comment, for all standards that are agencies and their roles across the level ITS architectures have been considered candidates for adoption. country. It is recognized that in some rewritten to clarify their applicability. The DOT has developed a set of regions traditional State and MPO Since these paragraphs deal with project criteria to determine when a standard boundaries may not meet the needs of development issues, they have been could be considered for formal the traveling public or the moved to § 940.11(e). A definition for adoption. These criteria include, at a transportation community. This is also ‘‘project level ITS architecture’’ was minimum, the following elements: why the FHWA did not rigidly define a added in § 940.3 and a description of its 1. The standard has been approved by region. The FHWA encourages MPOs contents provided in § 940.11(e). a Standard Development Organization and States to include the development The docket received 33 comments (SDO). of their regional ITS architectures as regarding systems engineering and the 2. The standard has been successfully part of their transportation planning systems engineering analysis section of tested in real world applications as processes. However, the decision is best the proposed rule. Most of the appropriate. left to the region to determine the comments related to the definition, the 3. The standard has received some approach that best reflects their needs, process not being necessary except for degree of acceptance by the community as indicated in § 940.9. It is clear that very large projects, and confusion as to served by the standard. the value of a regional ITS architecture how these requirements relate to 4. Products exist to implement the will only be realized if that architecture existing FHWA policy. standard. is maintained through time. However, in In response to the docket comments, 5. There is adequate documentation to accepting Federal funds under title 23, the definition of systems engineering in support the use of the standard. U.S.C., the State is ultimately § 940.3 has been clarified and is more 6. There is training available in the responsible for complying with Federal consistent with accepted practice. In use of the standard where applicable.

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Therefore, the intent of the rule is to architecture and the associated projects that have not yet advanced to require the use of a standard only when documentation to the needs of the final design are required to conform to these criteria have been met, and there region. Section 940.9(a) of the final rule the system engineering requirements in has been a separate rulemaking on contains specific language allowing § 940.11 upon the effective date of this adoption of the standard. such scaling. rule. Any ITS project that has advanced The only interoperability tests that are to final design by the effective date of Summary of Requirements currently contemplated by the DOT are this rule is exempt from the those associated with the Commercial I. The Regional ITS Architecture requirements of § 940.11. When the Vehicle Operations (CVO) program. This final rule on the ITS Architecture regional ITS architecture is completed, These tests are currently being used by and Standards requires the development project development will be based on States deploying CVO systems and will of a local implementation of the the relevant portions of it which the follow a similar set of criteria for National ITS Architecture referred to as project implements. Prior to completion adoption as those defined for standards. a regional ITS architecture. The regional of the regional ITS architecture, major Section 940.13 Project Administration ITS architecture is tailored to meet local ITS projects will develop project level needs, meaning that it does not address ITS architectures that are coordinated There were nine comments related to with the development of the regional how conformity with the final rule the entire National ITS Architecture and can also address services not included ITS architecture. ITS projects will be would be determined, and by whom. required to use applicable ITS standards There were 11 comments about how in the National ITS Architecture. The regional ITS architecture shall contain a and interoperability tests that have been conformity with the regional ITS officially adopted by the DOT. Where architecture would be determined, and description of the region and the identification of the participating multiple standards exist, it will be the by whom. Six comments specifically responsibility of the stakeholders to suggested methods for determining agencies and other stakeholders; the determine how best to achieve the conformance, including a process roles and responsibilities of the interoperability they desire. similar to current Federal planning participating agencies and other oversight procedures. Six other stakeholders; any agreements needed for Rulemaking Analyses and Notices operation; system functional commenters suggested that Executive Order 12866 (Regulatory requirements; interface requirements determination be made by the MPO or Planning and Review) and DOT and information exchanges with State. For either case, the comments Regulatory Policies and Procedures reflected a lack of clarity as to what planned and existing systems; documentation would be necessary. identification of applicable standards; The FHWA has determined that this There were six related comments and the sequence of projects necessary action is not a significant regulatory suggesting the level of documentation for implementation. Any changes made action within the meaning of Executive be commensurate with the scale of the in a project design that impact the Order 12866 or significant within the planned ITS investments in the region. regional ITS architecture shall be meaning of the Department of In § 940.13 of the final rule, the identified and the appropriate revisions Transportation’s regulatory policies and FHWA has attempted to clarify the made and agreed to in the regional ITS procedures. It is anticipated that the process for determining conformance. architecture. economic impact of this rulemaking will Conformance of an ITS project with a Any region that is currently be minimal. This determination is based regional ITS architecture shall be made implementing ITS projects shall have a upon preliminary and final regulatory prior to authorization of funding for regional ITS architecture within four assessments prepared for this action that project construction or implementation years of the effective date of this rule. indicate that the annual impact of the as provided in 23 U.S.C. 106 and 133. All other regions not currently rule will not exceed $100 million nor We do not intend to create new implementing ITS projects shall have a will it adversely affect the economy, a oversight procedures beyond those regional ITS architecture within four sector of the economy, productivity, provided in 23 U.S.C. 106 and 133, but years of the first ITS project for that jobs, the environment, public health, in those cases where oversight and region advancing to final design. In this safety, or State, local, or tribal approval for ITS projects is assumed by context, a region is a geographical area governments. In addition, the agency the State, the State will be responsible that is based on local needs for sharing has determined that these changes will for ensuring compliance with this information and coordinating not interfere with any action taken or regulation and the FHWA’s oversight operational strategies among multiple planned by another agency and will not will be through existing processes. projects. A region can be specified at a materially alter the budgetary impact of There were 14 comments concerning metropolitan, Statewide, multi-State, or any entitlements, grants, user fees, or the documentation requirements of the corridor level. Within a metropolitan loan programs. Copies of the proposed rule and generally suggesting area, the metropolitan planning area preliminary and final regulatory they be reduced. Certainly the should be the minimum area that is assessments are included in the docket. development of a regional ITS considered when establishing the Costs architecture and evidence of boundaries of a region for purposes of conformance of a specific project to that developing a regional ITS architecture. The FHWA prepared a preliminary regional ITS architecture implies some A regional approach promotes regulatory evaluation (PRE) for the level of documentation be developed. integration of transportation systems. NPRM and comments were solicited. However, to allow flexibility on the part The size of the region should reflect the That analysis estimated the total costs of of the State or local agency in breadth of the integration of this rule over 10 years to be between demonstrating compliance with the transportation systems. $38.1 million and $44.4 million (the net final rule, no specific documentation is present value over 10 years was between required to be developed or submitted II. Project Development $22.3 million and $31.2 million). The to the FHWA for review or approval. Additionally, this rule requires that annual constant dollar impact was The FHWA recognizes the need to be all ITS projects be developed using a estimated to range between $3.2 million able to scale the regional ITS systems engineering analysis. All ITS and $4.4 million. We believe that the

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This is estimates were too low, but provided no so notwithstanding the fact that our This action does not impose further detail or rationale which would planning costs for the ITS integration unfunded mandates as defined by the cause us to reconsider or increase our strategy have been eliminated from the Unfunded Mandates Reform Act of 1995 cost estimates in the initial regulatory final cost estimate. The primary benefits (Pub. L. 104–4, March 22, 1995, 109 evaluation. of this action that result from avoidance Stat. 48). This rule will not result in an These 10-year cost estimates set forth of duplicative development, reduced expenditure by State, local, and tribal in the PRE included transportation overall development time, and earlier governments, in the aggregate, or by the planning cost increases, to MPOs detection of potential incompatibilities private sector, of $100 million or more ranging from $10.8 million to $13.5 will remain the same. in any one year. In sum the agency believes that the million, and to States from $5.2 million Executive Order 13132 (Federalism) to $7.8 million associated with our option chosen in this action will be initial requirement to develop an ITS most effective at helping us to This action has been analyzed in integration strategy that was proposed implement the requirements of section accordance with the principles and as part of the metropolitan and 5206(e) of the TEA–21. In developing criteria contained in Executive Order statewide planning rulemaking effort. the rule, the FHWA has sought to allow 13132, dated August 4, 1999, and the broad discretion to those entities The agency now plans to advance that FHWA has determined that this action impacted, in levels of response and proposed ITS integration strategy in the does not have sufficient federalism approach that are appropriate to planning rule on a different time implications to warrant the preparation particular plans and projects, while schedule than this final rule. Thus, the of a federalism assessment. The FHWA conforming to the requirements of the costs originally set forth in the PRE for has also determined that this action TEA–21. The FHWA has considered the the ITS integration strategy have been does not preempt any State law or State costs and benefits of effective eliminated from the final cost estimate regulation or affect the State’s ability to implementation of ITS through careful in the final regulatory evaluation (FRE) discharge traditional State governmental and comprehensive planning. Based for this rule. functions. upon the information above, the agency In the FRE, the agency estimates the anticipates that the economic impact Executive Order 12372 cost of this rule to be between $1 associated with this rulemaking action (Intergovernmental Review) million an $16 million over ten years, is minimal and a full regulatory which are the estimated costs of this evaluation is not necessary. Catalog of Federal Domestic rule to implementing agencies for the Assistance Program Number 20.205, development of the regional ITS Regulatory Flexibility Act Highway planning and construction. architectures. These costs do not In compliance with the Regulatory The regulations implementing Executive include any potential additional Flexibility Act (5 U.S.C. 601–612), the Order 12372 regarding implementation costs for individual FHWA has evaluated, through the intergovernmental consultation on projects which are expected to be regulatory assessment, the effects of this Federal programs and activities apply to minimal and were extremely difficult to action on small entities and has this program. estimate. Thus, the costs to the industry determined that this action will not Paperwork Reduction Act of 1995 are less than that originally estimated in have a significant economic impact on the agency’s NPRM. a substantial number of small entities. This action does not contain Small businesses and small information collection requirements for Benefits organizations are not subject to this rule, the purposes of the Paperwork In the PRE, the FHWA indicated that which applies to government entities Reduction Act of 1995, 44 U.S.C. 3501– the non-monetary benefits derived from only. Since § 940.9(a) of this rule 3520. the proposed action included savings provides for regional ITS architectures Executive Order 12988 (Civil Justice from the avoidance of duplicative to be developed on a scale Reform) development, reduced overall commensurate with the scope of ITS development time, and earlier detection investment in the region, and This action meets applicable of potential incompatibilities. We stated § 940.11(b) provides for the ITS project standards in sections 3(a) and 3(b)(2) of that, as with project implementation systems engineering analysis to be on a Executive Order 12988, Civil Justice impacts, the benefits of the rule are very scale commensurate with the project Reform, to minimize litigation, difficult to quantify in monetary terms. scope, compliance requirements will eliminate ambiguity, and reduce Thus, we estimated that the vary with the magnitude of the ITS burden. coordination guidance provided through requirements of the entity. Small, less Executive Order 13045 (Protection of implementation of the rule could complex ITS projects have Children) provide savings of approximately correspondingly small compliance $150,000 to any potential entity seeking documentation requirements, thereby We have analyzed this action under to comply with the requirements of accommodating the interest of small Executive Order 13045, Protection of section 5206(e) of the TEA–21 as government entities. Small entities, Children from Environmental Health compared with an entity having to primarily transit agencies, are Risks and Safety Risks. This rule is not undertake compliance individually. The accommodated through these scaling an economically significant rule and costs may be offset by benefits derived provisions that impose only limited does not concern an environmental risk from the reduction of duplicative requirements on small ITS activities. to health or safety that may deployments, reduced overall For these reasons, the FHWA certifies disproportionately affect children.

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Executive Order 12630 (Taking of Subchapter KÐIntelligent Transportation Region is the geographical area that Private Property) Systems identifies the boundaries of the regional ITS architecture and is defined by and This rule does not effect a taking of PART 940ÐINTELLIGENT based on the needs of the participating private property or otherwise have TRANSPORTATION SYSTEM agencies and other stakeholders. In taking implications under Executive ARCHITECTURE AND STANDARDS metropolitan areas, a region should be Order 12630, Government Actions and Sec. no less than the boundaries of the Interference with Constitutionally 940.1 Purpose. metropolitan planning area. Protected Property Rights. 940.3 Definitions. Regional ITS architecture means a National Environmental Policy Act 940.5 Policy. regional framework for ensuring 940.7 Applicability. institutional agreement and technical The agency has analyzed this action 940.9 Regional ITS architecture. 940.11 Project implementation. integration for the implementation of for the purposes of the National ITS projects or groups of projects. Environmental Policy Act of 1969, as 940.13 Project administration. Systems engineering is a structured amended (42 U.S.C. 4321–4347), and Authority: 23 U.S.C. 101, 106, 109, 133, process for arriving at a final design of has determined that this action will not 315, and 508; sec 5206(e), Public Law 105– a system. The final design is selected have any effect on the quality of the 178, 112 Stat. 457 (23 U.S.C. 502 note); and from a number of alternatives that environment. 49 CFR 1.48. would accomplish the same objectives Regulation Identification Number § 940.1 Purpose. and considers the total life-cycle of the This regulation provides policies and project including not only the technical A regulation identification number procedures for implementing section merits of potential solutions but also the (RIN) is assigned to each regulatory 5206(e) of the Transportation Equity Act costs and relative value of alternatives. action listed in the Unified Agenda of for the 21st Century (TEA–21), Public Federal Regulations. The Regulatory Law 105–178, 112 Stat. 457, pertaining § 940.5 Policy. Information Service Center publishes to conformance with the National ITS projects shall conform to the the Unified Agenda in April and Intelligent Transportation Systems National ITS Architecture and standards October of each year. The RIN contained Architecture and Standards. in accordance with the requirements in the heading of this document can be contained in this part. Conformance used to cross reference this proposed § 940.3 Definitions. with the National ITS Architecture is action with the Unified Agenda. Intelligent Transportation System interpreted to mean the use of the List of Subjects (ITS) means electronics, National ITS Architecture to develop a communications, or information regional ITS architecture, and the 23 CFR Part 655 processing used singly or in subsequent adherence of all ITS projects combination to improve the efficiency to that regional ITS architecture. Design standards, Grant programs- or safety of a surface transportation transportation, Highways and roads, Development of the regional ITS system. architecture should be consistent with Incorporation by reference, Signs and ITS project means any project that in symbols, Traffic regulations. the transportation planning process for whole or in part funds the acquisition Statewide and Metropolitan 23 CFR Part 940 of technologies or systems of Transportation Planning. technologies that provide or Design standards, Grant programs- significantly contribute to the provision § 940.7 Applicability. transportation, Highways and roads, of one or more ITS user services as (a) All ITS projects that are funded in Intelligent transportation systems. defined in the National ITS whole or in part with the highway trust Issued on: January 2, 2001. Architecture. fund, including those on the National Kenneth R. Wykle, Major ITS project means any ITS Highway System (NHS) and on non- Federal Highway Administrator. project that implements part of a NHS facilities, are subject to these regional ITS initiative that is multi- provisions. In consideration of the foregoing, the jurisdictional, multi-modal, or (b) The Secretary may authorize FHWA amends Chapter I of title 23, otherwise affects regional integration of exceptions for: Code of Federal Regulations, as set forth ITS systems. (1) Projects designed to achieve below: National ITS Architecture (also specific research objectives outlined in ‘‘national architecture’’) means a the National ITS Program Plan under PART 655Ð[AMENDED] common framework for ITS section 5205 of the TEA–21, or the interoperability. The National ITS 1. The authority citation for part 655 Surface Transportation Research and Architecture comprises the logical continues to read as follows: Development Strategic Plan developed architecture and physical architecture under 23 U.S.C. 508; or Authority: 23 U.S.C. 101(a), 104, 109(d), which satisfy a defined set of user 114(a), 217, 315, and 402(a); 23 CFR 1.32, services. The National ITS Architecture (2) The upgrade or expansion of an and 49 CFR 1.48(b). is maintained by the United States ITS system in existence on the date of enactment of the TEA–21, if the Subpart DÐ[Removed and reserved] Department of Transportation (DOT) and is available on the DOT web site at Secretary determines that the upgrade or http://www.its.dot.gov. expansion: 2. Remove and reserve subpart D of Project level ITS architecture is a (i) Would not adversely affect the part 655, consisting of §§ 655.401, framework that identifies the goals or purposes of Subtitle C 655.403, 655.405, 655.407, 655.409, institutional agreement and technical (Intelligent Transportation Systems Act 655.411. integration necessary to interface a of 1998) of the TEA–21; 3. Add a new subchapter K, consisting major ITS project with other ITS (ii) Is carried out before the end of the of part 940, to read as follows: projects and systems. useful life of such system; and

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(iii) Is cost-effective as compared to and existing systems and subsystems defined in § 940.9(f) to reflect the alternatives that would meet the (for example, subsystems and changes. conformity requirement of this rule. architecture flows as defined in the (e) Prior to the completion of the (c) These provisions do not apply to National ITS Architecture); regional ITS architecture, any major ITS funds used for operations and (7) Identification of ITS standards project funded with highway trust funds maintenance of an ITS system in supporting regional and national that advances to final design shall have existence on June 9, 1998. interoperability; and a project level ITS architecture that is (8) The sequence of projects required § 940.9 Regional ITS architecture. coordinated with the development of for implementation. the regional ITS architecture. The final (a) A regional ITS architecture shall (e) Existing regional ITS architectures design of the major ITS project shall be developed to guide the development that meet all of the requirements of accommodate the interface requirements of ITS projects and programs and be paragraph (d) of this section shall be and information exchanges as specified consistent with ITS strategies and considered to satisfy the requirements of in this project level ITS architecture. If projects contained in applicable paragraph (a) of this section. the project final design is inconsistent transportation plans. The National ITS (f) The agencies and other with the project level ITS architecture, Architecture shall be used as a resource stakeholders participating in the then the project level ITS architecture in the development of the regional ITS development of the regional ITS shall be updated to reflect the changes. architecture. The regional ITS architecture shall develop and The project level ITS architecture is architecture shall be on a scale implement procedures and based on the results of the systems commensurate with the scope of ITS responsibilities for maintaining it, as engineering analysis, and includes the investment in the region. Provision needs evolve within the region. following: should be made to include participation (1) A description of the scope of the from the following agencies, as § 940.11 Project implementation. ITS project; appropriate, in the development of the (a) All ITS projects funded with (2) An operational concept that regional ITS architecture: Highway highway trust funds shall be based on agencies; public safety agencies (e.g., identifies the roles and responsibilities a systems engineering analysis. of participating agencies and police, fire, emergency/medical); transit (b) The analysis should be on a scale operators; Federal lands agencies; State stakeholders in the operation and commensurate with the project scope. implementation of the ITS project; motor carrier agencies; and other (c) The systems engineering analysis operating agencies necessary to fully (3) Functional requirements of the ITS shall include, at a minimum: project; address regional ITS integration. (1) Identification of portions of the (4) Interface requirements and (b) Any region that is currently regional ITS architecture being information exchanges between the ITS implementing ITS projects shall have a implemented (or if a regional ITS project and other planned and existing regional ITS architecture by February 7, architecture does not exist, the systems and subsystems; and 2005. applicable portions of the National ITS (5) Identification of applicable ITS (c) All other regions not currently Architecture); standards. implementing ITS projects shall have a (2) Identification of participating regional ITS architecture within four agencies roles and responsibilities; (f) All ITS projects funded with years of the first ITS project for that (3) Requirements definitions; highway trust funds shall use applicable region advancing to final design. (4) Analysis of alternative system ITS standards and interoperability tests (d) The regional ITS architecture shall configurations and technology options that have been officially adopted include, at a minimum, the following: to meet requirements; through rulemaking by the DOT. (1) A description of the region; (g) Any ITS project that has advanced (2) Identification of participating (5) Procurement options; (6) Identification of applicable ITS to final design by February 7, 2001 is agencies and other stakeholders; exempt from the requirements of (3) An operational concept that standards and testing procedures; and (7) Procedures and resources paragraphs (d) through (f) of this identifies the roles and responsibilities section. of participating agencies and necessary for operations and stakeholders in the operation and management of the system. § 940.13 Project administration. implementation of the systems included (d) Upon completion of the regional (a) Prior to authorization of highway in the regional ITS architecture; ITS architecture required in §§ 940.9(b) trust funds for construction or (4) Any agreements (existing or new) or 940.9(c), the final design of all ITS implementation of ITS projects, required for operations, including at a projects funded with highway trust compliance with § 940.11 shall be minimum those affecting ITS project funds shall accommodate the interface demonstrated. requirements and information interoperability, utilization of ITS (b) Compliance with this part will be exchanges as specified in the regional related standards, and the operation of monitored under Federal-aid oversight ITS architecture. If the final design of the projects identified in the regional procedures as provided under 23 U.S.C. the ITS project is inconsistent with the ITS architecture; 106 and 133. (5) System functional requirements; regional ITS architecture, then the (6) Interface requirements and regional ITS architecture shall be [FR Doc. 01–391 Filed 1–5–01; 8:45 am] information exchanges with planned updated as provided in the process BILLING CODE 4910±22±P

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DEPARTMENT OF TRANSPORTATION the Chief Council (202) 366–1936. The • Save design time through use of the policy is posted on the FTA website on National ITS Architecture requirements Federal Transit Administration the Internet under http:// definitions and market packages. www.fta.dot.gov. FTA has developed this policy to Federal Transit Administration Electronic Access: An electronic copy meet the TEA–21 requirement contained National ITS Architecture Policy on of this document may be downloaded in Section 5206(e) and the DOT/FTA Transit Projects using a computer, modem and suitable goal to encourage effective deployment AGENCY: Federal Transit Administration communications software from the of ITS projects. Additionally, DOT and (FTA), DOT. Government Printing Office’s Electronic FTA encourage the coordination of local ITS strategies and projects to help meet ACTION: Notice. Bulletin Board Service at (202) 512– 1661. Internet users may reach the national and local goals for mobility, SUMMARY: The Federal Transit Office of the Federal Register’s home accessibility, safety, security, economic Administration (FTA) announces the page at: http://www.nara.gov/fedreg and growth and trade, and the environment. FTA National ITS Architecture Policy the Government Printing Office’s web The National ITS Architecture on Transit Projects, which is defined in page at: http://www.access.gpo.gov/ documents were developed by the US this document. The National ITS nara. DOT, and are updated on an as-needed Architecture Policy is a product of Internet users may access all basis. Current work to update the statutory changes made by the comments received by the U.S. DOT National ITS Architecture is the Archive Transportation Equity Act for the 21st Dockets, Room PL–401, for the Request Data User Service, which provides the Century (TEA–21) (Pub. L. 105–178) for Comment that was issued on May ability to store and process data over an enacted on June 9, 1998. The National 25, 2000 which were used to clarify this extended period of time. FTA is ITS Architecture Policy is also a product Policy, by using the universal resource pursuing the addition of a Rail ITS of the Request for Comment on the locator (URL): http://dms.dot.gov. It is program for travel management, National ITS Architecture Consistency available 24 hours each day, 365 days vehicles, and users. New versions of the Policy for Project Development that was each year. Please follow the instructions documents, when they are issued, will published in the Federal Register on online for more information and help. be available from the US DOT on the May 25, 2000. Because it is highly The docket number for the Request for DOT website at www.its.dot.gov. unlikely that the entire National ITS Comment was FTA–99–6417. Version 3.0 is the latest version of the Architecture would be fully SUPPLEMENTARY INFORMATION: National ITS Architecture. implemented by any single metropolitan The first section of this policy area or State, this policy requires that I. Background contains a complete analysis of and the National ITS Architecture be used to The Federal Transit Administration response to the comments provided to develop a local implementation of the (FTA) published a Request for Comment the docket. The remainder of the Notice National ITS Architecture, which is on May 25, 2000, to implement section contains the FTA National ITS referred to as a ‘‘regional ITS 5206(e) of the Transportation Equity Act Architecture Policy for Transit Projects. architecture.’’ Therefore, conformance for the 21st Century (TEA–21) (Pub.L. II. Public Comments with the National ITS Architecture is 105–178), which was enacted on June 9, Eighteen comments were submitted to defined under this policy as 1998. development of a regional ITS Section 5206(e) of TEA–21 requires the FTA National ITS Architecture architecture within four years after the that the Secretary of the DOT must Consistency Policy for Project Development docket by the September first ITS project advancing to final Ensure that intelligent transportation design, and the subsequent adherence of 23, 2000, close of the comment period. system projects carried out using funds made Comments were submitted by transit ITS projects to the regional ITS available from the Highway Trust Fund, architecture. The regional ITS * * * conform to the national architecture, operators (3), state and local architecture is based on the National applicable standards or provisional governments (5), metropolitan planning ITS Architecture and consists of several standards, and protocols developed under organizations (4), industry associations parts including the system functional subsection(a). (3), and consultants (3). As indicated requirements and information The objectives for the FTA’s National earlier, a complete analysis and exchanges with planned and existing ITS Architecture Policy for Transit response to the docket comments is systems and subsystems and Projects are to: provided. In order to facilitate focused identification of applicable standards, • Provide requirements for ITS comments, FTA asked a series of and would be tailored to address the project development for projects questions about the policy. The public local situation and ITS investment implemented wholly or partially with comment section is organized first by needs. highway trust funds. analysis and response to the specific • Achieve system integration of ITS questions asked; second by responses to DATE: Effective Date: This policy is projects funded through the highway comments not specifically related to one effective from February 7, 2001. trust fund with other transportation of the nine questions; and finally by an ADDRESSES: For FTA staff, Federal projects planned for the region, which explanation of other changes. In general, Transit Administration, Department of will thereby enable electronic the comments received were positive. Transportation (DOT), 400 Seventh information and data sharing for Therefore, the FTA has kept the scope Street, SW., Washington, DC 20590. advanced management and operations of the policy and made appropriate FOR FURTHER INFORMATION CONTACT: For of the ITS infrastructure. clarifications to the text of the policy to Technical Information: Ron Boenau, • Engage stakeholders (state DOT’s, address concerns raised in comments. In Chief, Advanced Public Transportation transit agencies, public safety agencies, response to the many comments Systems Division (TRI–11), at (202) other transportation operating agencies) requesting it, the FTA, in association 366–0195 or Brian Cronin, Advanced in the project development and with the ITS Joint Program Office, in the Public Transportation Systems Division implementation process. Federal Highway Administration (TRI–11), at (202) 366–8841. For Legal • Facilitate future expansion (FHWA) will also provide a program of Information: Richard Wong, Office of capability of the ITS infrastructure. guidance, training, and technical

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Response: The agency will provide Architecture,’’ or is more clarification Response: As described in the guidance materials to address the needed, and if so please explain? response to question 1, the agency has comments suggested. The ITS Comments: Nine commenters removed the term ‘‘major ITS Integration Strategy, as defined in the submitted responses to this question. In investment’’ and will provide guidance NPRM, is part of the planning process general, commenters found the on the term ‘‘ITS project.’’ and as such does not satisfactorily definition confusing, and did not 4. Are the requirements for address project level requirements. understand why major ITS projects need development of a Regional ITS 6. The proposed rule allows regions to to be called out over other ITS projects. Architecture clear? If not, what is not develop a Regional Architecture as a One commenter noted that small dollar clear about the requirement? separate activity, or incrementally, as projects can have a major impact on Comment: Nine commenters provided major ITS investments are developed future development, while an expensive responses to the question. Most within a region. Do reviewers anticipate system may have no impact. Another commenters found the requirements to particular difficulties with commenter was unclear about the term be unclear and/or did not agree with the implementing and documenting either ‘‘supporting national interoperability.’’ requirements. One commenter suggested approach? Response: Of specific concern to the that a region will have different Comments: Nine commenters agency is the timing in which definitions. One commenter noted that provided responses to this question. requirements for this policy are enacted. a concept of operations and conceptual Commenters largely did not favor one As such, the terms ‘‘major ITS design are normally conducted at the approach over the other. One investment’’ and ‘‘major ITS project’’ project level. One commenter requested commenter suggested that a regional ITS were provided so as to distinguish clarification as to the appropriate place architecture with a twenty year time between projects that will require to program projects, in the regional ITS horizon is impractical and infeasible. immediate correlation to the regional architecture, or in the planning process. One commenter suggested that either ITS architecture and those that do not. Response: Of specific concern to the approach would require additional staff The term ‘‘major ITS investment’’ was agency is providing a flexible policy resources. also found to be redundant to ‘‘major that allows the transportation Response: The agency was concerned ITS project’’ and was removed from the stakeholders to define their region and about the time horizon and policy. Guidance on the classification of the roles and responsibilities of each development process needed to create a ‘‘ITS projects’’ and ‘‘major ITS projects’’ stakeholder during the development of regional ITS architecture within the will be provided upon enactment of the a regional ITS architecture. As such, the time period required and as a result policy. agency has clarified the requirements of suggested both an incremental and 2. Do reviewers understand the a regional ITS architecture and also initial comprehensive approach. Based definition of an ITS project, or is more removed the specific requirements for a on the responses, the agency has clarification needed, and if so please Concept of Operations and a Conceptual modified the policy to be silent on the explain? Design. Instead, the agency has listed approach used to develop the regional Comments: Nine commenters the specific requirements for a regional ITS architecture. Instead, the agency submitted responses to this question. ITS architecture and has left the focused on the products included in the Commenters found this term less development, documentation, and regional ITS architecture, the effective confusing than ‘‘major ITS maintenance of the regional ITS date of the requirements, and the investments,’’ but requested more architecture to the stakeholders catalyst for requiring the development clarification. Some commenters involved. Also, the region is defined as of a regional ITS architecture. proposed alternative language or asked ‘‘a geographical area that is based on 7. Do reviewers understand the for clarification on particular examples. local needs for sharing information and relationships between the Integration Response: The agency has clarified coordinating operational strategies Strategy, the Regional ITS Architecture, the definition by deleting the potentially among multiple projects.’’ A region can and the ITS Project Architecture? ambiguous examples provided and will be specified at a metropolitan, Comment: Seven commenters develop guidance material that provides Statewide, multi-State, or corridor level. provided a response to this question. In examples of projects that will be Additional guidance on this topic will general, commenters did not understand considered ITS projects and those that be provided after enactment of the the relationship between the Integration will not be considered ITS projects. In policy. Strategy, regional ITS architecture, and general, unless a technology project is 5. What additional guidance, if any, is the ITS Project Architecture. One implementing one of the ITS user required to explain how to implement commenter suggested that flexibility in services defined in the National ITS this proposed policy? application of project architecture must Architecture, it would not be considered Comments: Ten commenters provided be maintained to accommodate legacy an ITS project. responses to this question. All the systems and to take advantage of 3. Do reviewers understand the comments called for additional technological innovation, while difference between a ‘‘major ITS guidance on the specifics of maintaining the outcome of investment,’’ and an ‘‘ITS project’’, or is implementing this policy. Commenters interoperability, where applicable. more clarification needed, and if so requested guidance on the definition of Response: The Agency is concerned please explain? a ‘‘region,’’ the ownership of the with linkage between the planning Comments: Eight commenters regional ITS architecture, determination process and the project development submitted responses to this question. of stakeholders, regional ITS process. However, this policy only deals Commenters had mixed responses, as architecture maintenance, certification with the project level requirements.

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Planning level requirements, including non-compliance with agency policies and will be carried out in a coordinated the Integration Strategy, will be and regulations. FTA is using oversight fashion, as applicable under FTA and explained as the Metropolitan and funds to specifically hire contractors FHWA project management and Statewide Planning Process rulemaking with ITS experience who will monitor oversight procedures. FTA and FHWA process is advanced. This policy only and assist grantees who are at risk of planning procedures are a joint requires that the regional ITS NOT meeting the National ITS regulation and as such will be identical. architecture should be consistent with Architecture Policy requirements. FTA received some comments the transportation planning process. A Additional guidance on oversight and regarding the use of standards. Several definition for a project level ITS documentation requirements will be comments concern the premature use of architecture has been added to the provided. required standards and interoperability policy. tests, their impact on legacy systems, Additional Comments 8. What additional guidance, if any, is and confusion regarding the term required regarding phasing of this rule? One commenter suggested that the ‘‘adopted by the USDOT.’’ Comments: Six commenters proposed guidance circular requires that In response to the comments, FTA has submitted responses to this question. In all of the agencies in a region agree significantly modified the final policy to general, the commenters stated that the before a project can be implemented, eliminate reference to the use of phasing was clear. However, one thus conferring ‘‘veto’’ power over the standards and interoperability tests commenter requested a three-year project. The agency does not intend for prior to adoption through formal phase-in period. Several commenters the policy to halt ITS deployment in rulemaking. It is not the intent of the requested that existing projects be areas where agencies cannot agree on USDOT to formally adopt any standard exempt from the policy. project designs. As part of the regional before the standard is mature; also, not Response: The agency has clarified ITS Architecture development, the all ITS standards should, or will, be the policy statements that refer to the agencies can agree to disagree, however, formally adopted by the USDOT. The project status and the applicability of the regional ITS architecture should only interoperability tests that are this policy. Projects that have reached include a representation of the stand- currently contemplated by the USDOT final design by the date of this policy alone ITS deployments. are those associated with the are exempt from the policy One commenter suggests that the Commercial Vehicle Operations (CVO) requirements. The agency has extended proposal infers that existing agreements program. These tests are currently being the time period for regional ITS between agencies will now need to be used by States deploying CVO systems architecture development to four years. amended or redone, which would result and will follow a similar set of criteria Any region that is currently in a halt in operations of successful ITS for adoption as those defined for implementing ITS projects shall have a projects and prevent the completion of standards. regional architecture within four years other ITS projects. In response to the of the effective date of the final policy. comment, the agency has clarified the Other Changes All other regions not currently regional ITS architecture requirements Several commenters expressed implementing ITS projects shall have a to specify that existing agreements that concern about linkages to the planning regional ITS architecture in place within address the regional ITS architecture rule and the integration strategy. four years of the first ITS project for that requirements are sufficient and that new Comments regarding the portions of the region advancing to final design. agreements are not necessarily required. National ITS Architecture conformity 9. Are the oversight and One commenter noted that a process included in the proposed documentation requirements clear? If definition of ITS was not included in transportation planning rule will be not, what is not clear about the the policy. The commenter suggested addressed as that rule proceeds to its requirements? that the definition provided in TEA–21 issuance. The FHWA rule and the Comments: Eight commenters section 5206(e) should be included in parallel FTA policy have been submitted responses to this question. the policy. The agency agrees and has developed without direct reference to Commenters in general requested more added the definition of ITS to the list of the proposed changes to the guidance from FTA on oversight and definitions. However, the legislative transportation planning process, documentation requirements, but few definition of ITS is broad and other including no mention of the provided suggestions to clarify the commenters have suggested that if the development of an integration strategy. requirements. One commenter suggested policy is written to include every new However, the policy statement of this that checklists to verify consistency piece of electronics or hardware, then guidance notes a link to transportation requirements will be needed. Other the policy would be too limiting. As a planning processes, and fully supports commenters suggested that self- result, the policy is intended to apply those collaborative methods for certification should be allowed, but also only to projects meeting the definition establishing transportation goals and needs to be clearly defined. of an ‘‘ITS project’’ listed in the objectives. Response: The agency will continue ‘‘Definitions’’ section of the policy. to use normal existing oversight One commenter suggested that DOT Policy Contents procedures to review grantee should ensure that the Federal Highway I. Purpose compliance with FTA policies and Administration’s (FHWA’s) regulation II. Definitions regulations. Normal oversight and the FTA policy have the same III. Policy procedures include the annual risk statutory standing and that their IV. Applicability V. Regional ITS Architecture assessment of grantees performed by requirements in ITS planning and VI. Project Implementation regional office staff, triennial reviews, deployment be consistent if not VII. Project Oversight planning process reviews, and project identical. The FTA and FHWA have VIII. FTA Guidance management oversight reviews, as different processes and procedures for applicable. In TEA–21, FTA was granted project development. Therefore, the I. Purpose authority to use oversight funds to FHWA has issued a regulation, and FTA This policy provides procedures for provide technical assistance to grantees has issued the policy. The policy implementing section 5206(e) of the in which oversight activities suggested language in each document is consistent Transportation Equity Act for the 21st

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Century, Public Law 105–178, 112 Stat. merits of potential solutions but also the commensurate with the scope of ITS 547, pertaining to conformance with the costs and relative value of alternatives. investment in the region. Provision National Intelligent Transportation should be made to include participation III. Policy Systems Architecture and Standards. from the following agencies, as ITS projects shall conform to the appropriate, in the development of the II. Definitions National ITS Architecture and standards regional ITS architecture: Highway Intelligent Transportation Systems in accordance with the requirements agencies; public safety agencies (e.g., (ITS) means electronics, contained in this part. Conformance police, fire, emergency/medical); transit communications or information with the National ITS Architecture is agencies; federal lands agencies; state processing used singly or in interpreted to mean the use of the motor carrier agencies; and other combination to improve the efficiency National ITS Architecture to develop a operating agencies necessary to fully or safety of a surface transportation regional ITS architecture in support of address regional ITS integration. system. integration and the subsequent (b) Any region that is currently ITS project means any project that in adherence of all ITS projects to that implementing ITS projects shall have a whole or in part funds the acquisition regional ITS architecture. Development regional ITS architecture February 7, of technologies or systems of of the regional ITS architecture should 2005. technologies that provide or be consistent with the transportation (c) All other regions not currently significantly contribute to the provision planning process for Statewide and implementing ITS projects shall have a of one or more ITS user services as Metropolitan Transportation Planning regional ITS architecture within four defined in the National ITS (49 CFR part 613 and 621). years of the first ITS project for that region advancing to final design. Architecture. IV. Applicability Major ITS project means any ITS (d) The regional ITS architecture shall project that implements part of a (a) All ITS projects that are funded in include, at a minimum, the following: regional ITS initiative that is multi- whole or in part with the Highway Trust (1) A description of the region; jurisdictional, multi-modal, or Fund (including the mass transit (2) Identification of participating otherwise affects regional integration of account) are subject to these provisions. agencies and other stakeholders; ITS systems. (b) The Secretary may authorize (3) An operational concept that National ITS Architecture (also exceptions for: identifies the roles and responsibilities 1. Projects designed to achieve ‘‘national architecture’’) means a of participating agencies and specific research objectives outlined in common framework for ITS stakeholders in the operation and the National ITS Program Plan under interoperability. The National ITS implementation of the systems included section 5205 of the Transportation Architecture comprises the logical in the regional ITS architecture; Equity Act for the 21st Century or the architecture and physical architecture (4) Any agreements (existing or new) Surface Transportation Research and which satisfy a defined set of user required for operations, including at a Development Strategic Plan developed services. The National ITS Architecture minimum those affecting integration of under section 5208 of Title 23, United is maintained by U.S. DOT (Department ITS projects; interoperability of different States Code; or of Transportation) and is available on ITS technologies, utilization of ITS- 2. The upgrade or expansion of an ITS the DOT web site at http:// related standards, and the operation of system in existence on the date of www.its.dot.gov. the projects identified in the regional enactment of the Transportation Equity ITS architecture; Project level ITS architecture is a Act for the 21st Century if the Secretary (5) System functional requirements; framework that identifies the determines that the upgrade or (6) Interface requirements and institutional agreement and technical expansion— information exchanges with planned integration necessary to interface a a. Would not adversely affect the and existing systems and subsystems major ITS project with other ITS goals or purposes of Subtitle C (for example, subsystems and projects and systems. (Intelligent Transportation Systems) of architecture flows as defined in the Region is the geographical area that the Transportation Equity Act for the National ITS Architecture); identifies the boundaries of the regional 21st Century and (7) Identification of ITS standards ITS architecture and is defined by and b. Is carried out before the end of the supporting regional and national based on the needs of the participating useful life of such system; and interoperability; agencies and other stakeholders. A c. Is cost-effective as compared to (8) The sequence of projects required region can be specified at a alternatives that would meet the for implementation of the regional ITS metropolitan, Statewide, multi-State, or conformity requirement of this rule architecture. corridor level. In metropolitan areas, a (c) These provisions do not apply to (e) Existing regional ITS architectures region should be no less than the funds used for Operations and that meet all of the requirements of boundaries of the metropolitan planning Maintenance of an ITS system in section V(d) shall be considered to area. existence on June 9, 1998. satisfy the requirements of V(a). Regional ITS architecture means a (f) The agencies and other V. Regional ITS Architecture regional framework for ensuring stakeholders participating in the institutional agreement and technical (a) A regional ITS architecture shall development of the regional ITS integration for the implementation of be developed to guide the development architecture shall develop and ITS projects or groups of projects. of ITS projects and programs and be implement procedures and Systems engineering is a structured consistent with ITS strategies and responsibilities for maintaining the process for arriving at a final design of projects contained in applicable regional ITS architecture, as needs a system. The final design is selected transportation plans. The National ITS evolve within the region. from a number of alternatives that Architecture shall be used as a resource would accomplish the same objectives in the development of the regional ITS VI. Project Implementation and considers the total life-cycle of the architecture. The regional ITS (a) All ITS projects funded with mass project including not only the technical architecture shall be on a scale transit funds from the highway trust

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Part V

Environmental Protection Agency 40 CFR Part 82 Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2001: Allocation for Metered Dose Inhalers and the Space Shuttle and Titan Rockets; Final Rule

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ENVIRONMENTAL PROTECTION 564–9079; fax: (202) 565–2095; email: for calendar year 2001. EPA is also AGENCY [email protected]. allocating methyl chloroform for use in SUPPLEMENTARY INFORMATION: the Space Shuttle and the Titan Rocket 40 CFR Part 82 for calendar year 2001 under the Table of Contents authority of the statutory phase-out at [FRL±6929±6] I. Background section 604(a). Today’s action also RIN 2060±AJ33 II. Allocation Process for CFCs for use in amends the regulations at 40 CFR 82.12 Medical Devices for the Year 2001 to allow transfer of EUAs for CFCs Protection of Stratospheric Ozone: III. Allocation of Essential Use Allowances among MDI companies who hold Allocation of Essential Use Allowances for Calendar Year 2001 IV. Transfer of Essential Use Allowances for essential use allowances. for Calendar Year 2001: Allocation for CFCs Among Essential Use Allowance Metered Dose Inhalers and the Space Overview of the Notice of Proposed Holders Rulemaking Shuttle and Titan Rockets V. Administrative Requirements VI. Judicial Review The Notice of Proposed Rulemaking AGENCY: Environmental Protection VII. Submittal to Congress and the General (NPRM) proposing to allocate essential Agency (EPA). Accounting Office use allowances for calendar year 2001 ACTION: Final rule. I. Background was published on October 6, 2000 (65 FR 59783). In the NPRM, EPA proposed SUMMARY: With this action, EPA is The Montreal Protocol on Substances to allocate CFCs for use in metered dose allocating essential use allowances for that Deplete the Ozone Layer (Protocol) inhalers (MDIs) and methyl chloroform stratospheric ozone depleting is the international agreement to reduce for use in the Space Shuttle and Titan substances for calendar year 2001. EPA and eventually eliminate production Rocket. EPA proposed to allocate a total allocates essential use allowances to an and consumption1 of all stratospheric of 3098.67 metric tons of CFCs, which applicant for exempted production or ozone depleting substances (ODSs). As is the quantity that the Food and Drug import of a specific quantity of class I of January 1996, production and import Administration (FDA), in consultation ozone depleting substances solely for of class I ODSs (except methyl bromide) with EPA, determined to be ‘‘necessary’’ the designated essential use. Essential were phased out in all developed for use in MDIs. The total amount of use allowances permit a person to countries, including the United States. essential use authorizations for MDIs obtain controlled substances as an However, the Protocol and the Clean Air granted to the U.S. by the Parties to the exemption to the January 1, 1996 Act (CAA or Act) provide exemptions Montreal Protocol for 2001 is 3,101 regulatory phase-out of production and that allow for the continued import and/ metric tons. We explained in the NPRM import of these substances. Today, EPA or production of class I ODSs for that it would not be possible to allocate is allocating essential use allowances for specific uses. Under the Montreal CFCs in an amount higher than the production and/or import of class I Protocol, exemptions are granted for allocated to the U.S. by the Parties to the substances for use in medical devices uses that are determined by the Parties Protocol. EPA also proposed changes to for the treatment of asthma and chronic to be ‘‘essential’’ as defined by Decision the regulations at 40 CFR 82.12 that obstructive pulmonary disease, and for IV/25. The procedure set out by would allow transfer of EUAs for CFCs use in the Space Shuttle and Titan Decision IV/25 first calls for individual among essential use holders. We also Rockets for calendar year 2001. With Parties to nominate essential uses. The proposed to allocate 60.1 metric tons of today’s action, EPA is also amending the Protocol’s Technology and Economic methyl chloroform (MCF) for use in the regulations to allow essential use Assessment Panel (TEAP or the Panel) Space Shuttle and Titan Rockets. allowances for medical devices to be evaluates the nominated essential uses EPA received a total of eight transferred among essential use and makes recommendations to the comments on the NPRM. Six comments allowance holders. The essential use Protocol Parties. The Parties make the were from individual companies who exemption for class I ODSs for final decisions on essential use produce MDIs,2 one was from a laboratory and analytical applications nominations at their annual meeting. consortium group that represents MDI will be addressed in a separate EPA is responsible for allocating manufacturers,3 and one was from rulemaking. essential use allowances (EUAs) at the Friends of the Earth. Three commenters domestic level through rulemaking in expressed support for the provision to DATES: This action is effective January 8, accordance with provisions in the CAA. allow transfer of EUAs for CFCs 2001. The CAA provides a specific exemption between allowance holders. One ADDRESSES: Materials relevant to this from the phase-out of class I ODSs at commenter requested additional EUAs rulemaking are contained in Docket No. section 604(d)(2) that allows for the to meet their projected needs for MDI A–93–39. The Docket phone is (202) continued import and production of production in 2001 without utilizing 260–7548 and is located in Waterside CFCs for use in medical devices. their strategic reserves. Two companies Mall, Room M–1500, 401 M Street, SW., Today’s action allocates EUAs for CFCs requested that their EUAs be Washington, DC, 20460. The materials for use in metered dose inhalers (MDIs) reapportioned between them, but in the may be inspected from 8 a.m. until 5:30 for the treatment of asthma and chronic aggregate did not request an increase in p.m. Monday through Friday. A obstructive pulmonary disease (COPD) EUAs. One commenter stated that EPA reasonable fee may be charged by EPA and FDA had improperly interpreted the for copying docket materials. 1 ‘‘Consumption’’ is defined as the amount of a FOR FURTHER INFORMATION CONTACT: The substance produced in the United States, plus the 2 Pharmaceutical companies who commented Stratospheric Ozone Protection Hotline amount imported, minus the amount exported to were the following: Aventis Pharmaceuticals, 3M Parties to the Montreal Protocol (see section 601(6) Pharmaceuticals, Boehringer Ingelheim at 1–800–296–1996 or Erin Birgfeld, of the Clean Air Act). Stockpiles of class I ODSs Pharmaceuticals Inc., Schering Corporation, Sidmak U.S. Environmental Protection Agency, produced prior to the 1996 phase-out can continue Laboratories Inc., Glaxo Wellcome. Global Programs Division, Office of to be used for purposes not expressly banned at 40 3 The International Pharmaceutical Aerosol Atmospheric Programs, 6205J, 1200 CFR part 82, subpart C—Ban on Nonessential Consortium represents the following companies: Products Containing Class I Substances and Ban on AstraZeneca, Boehringer Ingelheim, Celltech- Pennsylvania Avenue N.W., Nonessential Products Containing or Manufactured Medeva, Cheisi Farmaceutici, Glaxo Wellcome, and Washington, DC, 20460; telephone (202) with Class II Substances. Norton Healthcare.

VerDate 112000 18:27 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR4.SGM pfrm10 PsN: 08JAR4 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1463 exemption for medical devices in the applications requested exemptions for whether a ‘‘safe and effective Act, and should not allocate CFCs for the production and import of specific alternative’’ is available for any MDI products where an alternative quantities of certain class I controlled particular CFC MDI. It should be noted propellant is available. Another substances after the phase-out, and that FDA approval of a non-CFC product commenter stated that the Act does not provided information in accordance is a determination that the product is require EPA to transfer to FDA the with the criteria in Decision IV/25 of the safe and effective, but it is not a responsibility to determine the amount Protocol and the procedures outlined in determination that the product is a ‘‘safe of the allocation for CFCs, and that the the ‘‘1997 Handbook on Essential Use and effective alternative’’ for any other FDA decision making process for Nominations.’’ EPA reviewed the CFC MDI product under the Act. FDA determining the amount of CFCs applications and nominated these uses states in their notice of proposed necessary should be more transparent. to the Protocol Secretariat for rulemaking on essential use EPA will summarize and address all consideration by the Technical and determinations that ‘‘a non-CFC product comments in the body of this preamble. Economic Assessment Panel (TEAP) and simply having the same active moiety as There were no comments on the its Technical Options Committees. MDI a CFC product is only one factor to be proposed allocation of MCF for use in producers requested a total of 3,101 considered. Other factors, such as the Space Shuttle and Titan Rockets. metric tons of CFCs for use in 2001. The whether the non-CFC product has the Parties to the Montreal Protocol same route of administration, the same How Do the Parties to the Montreal approved this amount as essential for indication, and can be used with Protocol Define an ‘‘Essential Use’’? the U.S. for 2001 at the Eleventh approximately the same level of Decision IV/25 of the Parties to the Meeting in 1999 (Decision XI/14). On convenience, are important Montreal Protocol set forth the criteria September 15, 1999, EPA issued another considerations. Additionally, FDA must for determining whether a particular use notice requesting supplemental consider whether patients who of class I ODS is ‘‘essential’’ and would applications for essential use medically need the CFC product are thus be eligible to receive EUAs for allowances for the year 2001 and adequately served by the non-CFC controlled substances. This decision beyond (64 FR 50083). No company product.’’ (September 1, 1999, 64 FR states the following: requested a supplemental amount of 47735). While FDA has approved two ‘‘(1) that a use of a controlled CFCs for the year 2001 at that time. non-CFC MDIs as of December 1, 2000, substance should qualify as ‘essential’ FDA has yet not identified any ‘‘safe only if: How Does the Clean Air Act Authorize and effective alternative’’ to any CFC (i) It is necessary for the health, safety Essential Use Allowances for MDIs? MDI as specified by section 601(8)(A). or is critical for the functioning of Section 604(d)(2) of the CAA provides Thus, part (A) of the definition of society (encompassing cultural and a standing exemption to the phase-out medical device has been met, and is intellectual aspects); and of class I ODSs for the production and consistent with today’s rulemaking. (ii) there are no available technically importation of CFCs for use in medical With respect to section 601(8)(B), EPA and economically feasible alternatives devices which reads: is relying on current FDA regulations or substitutes that are acceptable from (21 CFR 2.125) listing medical devices ‘‘Notwithstanding the termination of the standpoint of environment and production required by subsection (b), the that FDA has found to be essential. The health; Administrator, after notice and opportunity companies for which EPA is granting (2) that production and consumption, for public comment, shall, to the extent such essential use allowances produce CFC if any, of a controlled substance for action is consistent with the Montreal MDIs covered by this regulation. Thus, essential uses should be permitted only Protocol, authorize the production of limited the products for which EPA is granting if: quantities of class I substances solely for use essential use allowances are (i) all economically feasible steps in medical devices if such authorization is ‘‘determined to be essential’’ by FDA. have been taken to minimize the determined by the Commissioner, in One commenter stated that under essential use and any associated consultation with the Administrator, to be section 601(8)(A), EPA must determine emission of the controlled substance; necessary for use in medical devices.’’ that no safe and effective alternative and Section 601(8) of the Clean Air Act propellant exists for any MDI to meet (ii) the controlled substance is not defines the term ‘‘medical device’’ and the definition of ‘‘medical device.’’ EPA available in sufficient quantity and states the following: believes that the phrase ‘‘safe and quality from existing stocks of banked or [A]ny device (as defined in the Federal Food, effective alternative’’ at section recycled controlled substances, also Drug, and Cosmetic Act (21 U.S.C. 321), 608(1)(A) does not refer an alternative bearing in mind the developing diagnostic product, drug (as defined in the propellant, but refers to a ‘‘safe and countries’ need for controlled Federal Food, Drug, and Cosmetic Act), and effective alternative’’ to a CFC MDI. This substances.’’ drug delivery system— is because FDA only approves MDIs (A) if such device, product, drug, or drug under a New Drug Application (NDA) or What Was the International Procedure delivery system utilizes a class I or class an Abbreviated New Drug Application for Approving Essential Use Exemptions II substance for which no safe and effective (ANDA) as a whole unit and not by for the Year 2001? alternative has been developed, and where necessary, approved by the Commissioner approving each of its components. The international process for [of FDA]; and Therefore, it is impossible for FDA to nominating and approving essential use (B) if such device, product, drug, or drug approve an alternative to the class I or allowances for the year 2001 occurred in delivery system, has, after notice and class II substance (i.e. the propellant) the same way as in prior years. The opportunity for public comment, been alone, and it is reasonable to conclude companies in Table I submitted approved and determined to be essential that the phrase ‘‘safe and effective applications either on their own or as a by the Commissioner [of FDA] in alternative’’ refers to an adequate part of the International Pharmaceutical consultation with the Administrator [of replacement for the CFC MDI product. Aerosol Consortium (IPAC), requesting EPA]. This commenter also quoted a passage class I ODSs for essential uses in As discussed in the NPRM, EPA is from the legislative history of the 1990 response to the August 10, 1998 Federal relying on FDA regulations at 21 CFR Amendments which states that ‘‘unless Register document (63 FR 42629). Their 2.125 to provide determinations of a safe substitute exists or until a

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We do not believe drug containing a safe and effective MDI is available, EPA should deem CFC that Congress intended EPA to make alternative propellant has been MDIs with the same active moiety to be decisions involving medical judgement approved by FDA, FDA has no authority non-essential for the purposes of the and expertise. On such questions, we to continue to designate analogous CFC- CAA. As stated earlier, FDA approval of have and will continue to defer to FDA. containing products as ‘‘essential’’. In a non-CFC product is a determination The commenter states that FDA must response, we note that the term ‘‘drug that the product is safe and effective, approve and determine that the CFC- delivery system’’ indicates that Congress but it is not a determination that the containing MDI is essential after notice envisioned that FDA would need to product is a safe and effective and an opportunity for public comment, approve an entire non-CFC drug alternative for any other product under and asserts that once a drug containing delivery system, and not just the the Act. Because FDA has yet not a safe and effective alternative alternative propellant. Further, the use identified any ‘‘safe and effective propellant has been approved by FDA, of the term ‘‘substitute’’ indicates that alternative’’ for any CFC MDI, today’s FDA has no authority to continue to Congress was looking to FDA to allocation of CFCs for essential uses designate analogous CFC-containing determine whether a non-CFC MDI is a remains consistent with section products as ‘‘essential’’. Further, the safe and effective replacement for a 601(8)(A). commenter states that EPA may not wait particular CFC MDI (i.e. a ‘‘safe and The commenter’s suggestion that EPA for FDA to remove that product from its effective alternative’’). While this report make medical decisions regarding list of essential uses before finding that refers to Senate language which is whether a non-CFC MDI is an adequate it no longer qualifies as a ‘‘medical somewhat different from what appears alternative to a CFC MDI produces a device’’ under the Act. Again, EPA in the 1990 Amendments, the Senate’s result that would put asthma patient believes that this interpretation of the intent, revealed by this passage is health at risk. FDA is the appropriate Act is flawed. This is because section consistent with EPA and FDA’s agency with expertise to make 601(8)(B) refers to approval of an interpretation of the Act. independent medical decisions that alternative as occurring after ‘‘notice The commenter also states that the directly affect patients. The and opportunity for comment.’’ Because safety and efficacy of alternatives to determination that a CFC MDI is no FDA does not approve alternative CFCs is determined by EPA under longer ‘‘essential’’ is not, as the propellants, and because approval of a section 612 of the CAA, and that EPA commenter suggests, one where EPA specific MDI drug product through the had stated that it would rely upon could merely look at the active moiety New Drug Application or Abbreviated FDA’s approval of medical products of the product, read the non-CFC New Drug Application system under the containing alternative propellants under product indication, compare it to the FDCA involves unilateral action by FDA the Food Drug and Cosmetic Act (FDCA) CFC MDI product indication, and without notice-and-comment for a determination that there are no determine any CFC MDIs to be non- rulemaking or consultation with EPA, it human health effects from the use of the essential. FDA states in their notice of is reasonable to conclude that section alternative propellant. Thus, the proposed rulemaking on essential use 601(8)(B) refers to FDA’s approval of an commenter believes that when FDA determinations that ‘‘a non-CFC product essential use listing in 21 CFR 2.125 approves a non-CFC MDI as safe and simply having the same active moiety as which does involve notice and comment effective under the FDCA, EPA must a CFC product is only one factor to be rulemaking. Thus, EPA believes that by conclude that the non-CFC propellant in considered. Other factors, such as allocating CFCs for products covered by that product is safe and effective for the whether the non-CFC product has the the list of ‘‘essential’’ products at 21 purposes of the CAA. In fact, EPA has same route of administration, the same CFR 2.125, we have fulfilled the already reviewed the health risks indication, and can be used with requirements of section 601(8)(B). associated with alternative aerosol approximately the same level of Finally, the commenter states that propellants for use in non-CFC MDIs convenience, are important FDA cannot use the categorical under section 612 of the Act. considerations. Additionally, FDA must exemptions at 21 CFR 2.125 created Nevertheless, EPA disagrees with the consider whether patients who more than twenty years ago to establish assertion that a determination that an medically need the CFC product are the essentiality of particular CFC MDI alternative propellant to an ODS is adequately served by the non-CFC under the statute today, and that by acceptable under section 612 of the Act product.’’ (September 1, 1999, 64 FR doing so EPA and FDA are not relying has any bearing on the determination of 47735). Most of these factors are not on standards adopted under the Act in whether a non-CFC MDI is a ‘‘safe and addressed on the indication label of an 1990. EPA believes that our explanation effective alternative’’ to a CFC MDI as MDI. Thus the indication label alone of this issue in the interim final rule required by section 601(8)(A). cannot be used as the basis for allocating essential use allowances for The commenter states that when a determining whether a non-CFC product calendar year 2000 still stands (see 65 non-CFC MDI is approved under the is an adequate alternative for any CFC FR 716, January 6, 2000). FDCA, only CFC-based products MDI. While we are aware that FDA is containing the same active moiety, and We believe that the overall purpose of currently engaged in rulemaking to the same labeled indications would no the language in the Act regarding revise its essential use regulations, we longer qualify as ‘‘medical devices’’ medical devices is to ensure that EPA’s are relying on FDA’s current essential under the Act, and that in instances mission of environmental protection use list at 21 CFR 2.125 for purposes of where the labeled indications of a non- does not conflict with FDA’s mission of today’s action. The statute does not CFC drug do not fully duplicate those of protecting the patient health. Consistent specify a particular time at which FDA a CFC product, EPA may only authorize with this purpose, we believe that in must make such a determination or

VerDate 112000 18:27 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR4.SGM pfrm10 PsN: 08JAR4 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1465 invalidate determinations made prior to for an essential use exemption for MCF. Commissioner, in consultation with the the date of the 1990 CAA Amendments. Nevertheless, EPA believes that section Administrator, determines such Additionally, the 1990 CAA 604(d)(1) may allow for the continued authorization to be necessary for use in Amendments use language consistent limited use of methyl chloroform for medical devices.’’ We note that the with FDA’s regulations at 21 CFR 2.125. Space Shuttle and Titan Rocket through expression ‘‘such authorization’’ refers We presume that Congress was aware of 2004 under the essential use exemption back to the phrase ‘‘authorize the FDA’s regulations when it passed the as long as no substitute is available. production of limited quantities of class I substances solely for use in medical 1990 Amendments to the CAA. II. Allocation Process for CFCs for Use devices.’’ Thus, the Commissioner of Therefore, we believe that the current in Medical Devices for the Year 2001 essential use list remains valid. If FDA FDA must consider not only whether revises its regulations, we will take the As explained earlier, section 604(d)(2) any production is necessary, but what revised list into account in future of the Act provides that EPA shall quantity of production is necessary for allocation decisions. EPA further notes authorize production and import of MDIs. that both EPA and FDA are limited quantities of class I substances Further, although EPA does have implementing the more stringent for use in medical devices if FDA, in some data on CFC usage (which is provisions of the Montreal Protocol as consultation with EPA, determines such shared with FDA), only FDA personnel specified by section 614(b) of the Act 4 authorization to be ‘‘necessary.’’ Thus, are privy to confidential business by following the essentiality EPA in order to implement the information regarding annual sales and determinations of the Parties to the exemption for medical devices must distribution of MDIs. This provides FDA Montreal Protocol in allocating new receive a formal determination on the with more complete knowledge of the CFCs. amount of CFCs necessary for use in MDI market than EPA. Because of FDA’s MDIs from FDA. FDA sent EPA a letter access to additional information, and How Does the CAA Authorize the dated September 6, 2000 that provided their medical expertise which is integral Exemption for Methyl Chloroform? their determination on the amount of to making decisions that serve to protect With today’s action, EPA is allocating CFCs necessary, and explained the bases the public health, EPA believes it is methyl chloroform (MCF) for use in the for that determination. consistent with Congressional intent to Space Shuttle and Titan Rockets under One commenter stated that the CAA consult with FDA in making decisions the statutory phase-out schedule at does not delegate to FDA the authority regarding the amount of CFCs necessary section 604(a). This section provides to dictate the nomination quantity and for the production of MDIs. that MCF may be produced at up to 20 allocation of class I substances for The commenter’s second point was percent of the amount produced in 1989 medical devices. Rather, according to that EPA should ensure that the (the baseline year as specified at section the commenter, the CAA requires that rationale for adjustments made to 601(2)(B) of the Act). EPA is allocating EPA shall consult with FDA only as to allocations and the bases for FDA a total of 60.1 metric tons of MCF, an whether the authorization of class I recommendations are open and amount well below 20% of the baseline substances for medical devices is available to the public for review and year production of 315,169 metric tons necessary, which requires a yes/no comment. EPA agrees that the allocation for MCF (defined at 40 CFR 82.6). determination only. Thus, EPA should process should be as transparent as Section 604(a) of the Act requires the not transfer to the FDA the possible while accounting for the complete phase-out of production of responsibility to determine the quantity confidential nature of the data MCF after 2001. As a result, it is likely of essential use allowances allocated to employed to make the determination on that EPA will be required to rely solely companies. the amount of CFCs necessary. To this upon the exemption under section EPA has addressed the comment that end, EPA and FDA planned a process is raised here in the preamble to 604(d)(1), that may already be described in the NPRM that we felt essential use allocation for calendar year applicable, for the year 2002 and would allow this determination on the 2000 (65 FR 40524, 40530–40537). We beyond. This exemption reads as amount of CFCs necessary to occur as believe that the same interpretation and follows: openly as possible. EPA sent letters explanation provided in the previous pursuant to section 114 of the Act to (1) Essential Uses of Methyl Chloroform.— rulemaking is applicable here. Section each essential use applicant requesting Notwithstanding the termination of 604(d)(2) states the following: ‘‘The specific information such as the number production required by subsection (b), during Administrator, after notice and of units of each product produced in the period beginning on January 1, 2002, and opportunity for public comment, shall, ending on January 1, 2005, the previous years, the number of units Administrator, after notice and opportunity to the extent such action is consistent produced in the first quarter 2000, the for public comment, may, to the extent such with the Montreal Protocol authorize gross target fill weight per unit, the total action is consistent with the Montreal the production of limited quantities of amount of CFCs to be contained in the Protocol, authorize the production of limited class I substances solely for use in product in 2001, the number of units of quantities of methyl chloroform solely for use medical devices if such authorization is each product anticipated to be produced in essential applications (such as determined by the Commissioner [of in 2001, the additional amount of CFCs nondestructive testing for metal fatigue and FDA], in consultation with the necessary for production, and the total corrosion of existing airplane engines and Administrator [of EPA], to be necessary amount of CFCs requested for each airplane part susceptible to metal fatigue) for for use in medical devices.’’ (emphasis which no safe and effective substitute is product in 2001. FDA, in consultation available. added) EPA believes that it is clear that with EPA, based the determination of the authorization in question is not for necessary amounts and the allocation on EPA understands that research on an indefinite amount but for ‘‘limited this information. Thus, each company alternatives is progressing well, and that quantities.’’ It is equally clear that the knows what information it has in the year 2002 there may be no need subject of the Commissioner’s submitted as the basis for its own determination of necessity is ‘‘such allocation while protecting against 4 Section 614(b) states that ‘‘* * * in the case of conflict between [the Act] and any provisions of the authorization.’’ Thus, if the latter part of disclosure of confidential business Montreal Protocol, the more stringent provision the text quoted above were written in information to competitors. Finally, we shall govern.’’ the active voice, it would say: ‘‘if the placed all non-confidential materials in

VerDate 112000 14:26 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR4.SGM pfrm01 PsN: 08JAR4 1466 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations the docket, including the FDA letter of III. Allocation of Essential Use solely for the specified essential use. September 6, 2000 that provided EPA Allowances for Calendar Year 2001 The allocation of CFCs for use in MDIs with their recommendation on the reflects the determination on the amount of CFCs necessary for MDIs for EPA is allocating essential use amount of CFCs ‘‘necessary’’ as the year 2001. allowances for calendar year 2001 to specified under section 604(d)(2) of the entities listed in Table I for exempted Act taking into account two companies production or import of the specific requests for reapportioning EUAs among quantity of class I controlled substances them.

TABLE I.ÐESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2001

Quantity Company Chemical (metric tons)

(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease (in metric tons)

Medeva, Armstrong Pharmaceuticals Inc...... CFC±11 or CFC±12 or CFC±114 ...... 189.00 Boehringer Ingelheim Pharmaceuticals ...... CFC±11 or CFC±12 or CFC±114 ...... 338.36 Glaxo Wellcome Inc...... CFC±11 or CFC±12 or CFC±114 ...... 858.10 Aventis Pharmaceuticals ...... CFC±11 or CFC±12 or CFC±114 ...... 190.00 3M Pharmaceuticals ...... CFC±11 or CFC±12 or CFC±114 ...... 304.51 Sidmak Laboratories/Medisol Laboratories, Inc...... CFC±11 or CFC±12 or CFC±114 ...... 192.20 Schering Corporation ...... CFC±11 or CFC±12 or CFC±114 ...... 1025.20 Sciarra Laboratories, Inc...... CFC±11 or CFC±12 or CFC±114 ...... 1.30

(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets

National Aeronautics and Space Administration (NASA)/Thiokol Rocket ...... Methyl Chloroform ...... 56.7 United States Air Force/Titan Rocket ...... Methyl Chloroform ...... 3.4

Was the Allocation Listed in This would allow this transfer to occur even not been allocated EUAs, or had Proposed Rule Changed in the Final in the absence of EPA re-apportioning received an extremely low allocation, Rule? the EUAs among these two companies. opportunities due to unexpected shifts The total amount of CFCs allocated One company requested additional in the market would fall to foreign for use in MDIs is the same as in the volumes of CFCs beyond the amount manufacturers of MDIs who, the proposed rule. However, the amount of allocated to them in the NPRM. This commenter asserts, can export CFC EUAs allocated to two MDI companies company stated that it had anticipated MDIs to the U.S. and are not subject to was reapportioned between them at an earlier timing for launch of certain the same allocation requirements as U.S. their request. One commenter is the new products, and that their current MDI producers. EPA notes that New Drug Application (NDA) holder, supplier of pharmaceutical-grade CFCs companies who produce MDIs in other and the other is a contract filler for that may shut down production in the next countries are also subject to the terms of NDA holder. The NDA holder stated few years. For these reasons, they the Montreal Protocol and must receive that they had reassessed the amount of requested additional EUAs for calendar an allocation for CFCs to produce 5 MDIs the contract filler would produce year 2001 to continue MDI production ‘‘essential’’ MDIs . The major for them in 2001. The NDA holder without utilizing their strategic reserves. production of MDIs abroad is in Europe requested that a certain amount of EUAs EPA and FDA have concluded that where each company’s CFC allocated to their contract filler and the year 2001 essential use allocations requirements are also extensively earmarked for the production of the already reflect the contingencies raised reviewed before allocation. NDA holder’s products be re- by the commenter and are protective of What Was EPA’s Method for Allocating apportioned back to the NDA holder. public health. These allocations are Methyl Chloroform (MCF) for Use in The contract filler provided comments calculated to insure that the full range Solid Rocket Motors? that supported the transfer of EUAs of medical needs is met throughout the With this action, EPA is allocating from them to the NDA holder (this entire patient population. It should be 60.1 metric tons of MCF for use in solid contract filler is also an essential use noted that this company, as well as all rocket motors, the same amount allowance holder with its own essential use holders, now have the allocated in the years 1999 and 2000. allocation for production of its own opportunity to obtain additional EUAs EPA proposed to allocate MCF in an MDIs). EPA believes that in this case, it through trading, and also had the amount lower than would be consistent is not necessary for FDA to approve this opportunity to request additional CFCs with Decision X/6 taken at the Tenth adjustment to the essential use for the year 2002 in response to the meeting of the Parties to the Protocol allocations because the total amount of notice requesting essential applications because we believed, based on EUAs allocated for use in the NDA for the years 2002 and 2003 published knowledge of past MCF use, that holder’s MDI products (i.e. the MDIs to November 1, 2000 (65 FR 65311). allocating a larger amount would be be produced by the NDA holder Were There Other Comments Regarding unnecessary. EPA did not receive any themselves plus the MDI to be produced the Allocation of CFCs for Use in MDIs? comments on this issue, and is by contract filler) remains unchanged. allocating 60.1 metric tons MCF as Further, EPA is implementing One commenter who is a generic proposed in the NPRM. provisions to allow transfer of EUAs producer of MDIs stated that they were between MDI companies. This pleased with their proposed allocation. 5 EPA believes that all countries that produce provision, finalized in today’s action, However, they commented that had they MDIs are parties to the Montreal Protocol.

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When Is This Rule Effective? Another commenter requested that mechanism for addressing the inherent This final rule is effective on January EPA issue the final CFC allocations for problem in attempting to predict the 8, 2001. Section 553(d) of the APA 2001 as soon as possible so that needs for MDI manufacturers. One commenter requested a generally provides that rules may not necessary CFCs may be ordered and clarification of the proposed regulations take effect earlier than 30 days after they delivered from the supplier in Europe in time to meet MDI production needs in regarding the use of a contract filler. The are published in the Federal Register. 2001. EPA has expedited this final rule commenter took issue with the fact that However, APA section 553(d) excepts and believes that companies should EPA would have to approve the use of from this provision any action that have sufficient time to place their orders a contract filler. The commenter grants or recognizes an exemption or for CFCs for the coming year. believes it should be at the company’s relieves a restriction. Since today’s discretion as to whether it produces the action grants an exemption to the phase- What Reporting Requirements Must I product in-house or through the use of out of production and consumption of Adhere To When Using My Essential a contract filler. The new regulations CFCs, EPA is making this action Use Allocation? provide a mechanism for transfer of effective immediately to ensure the Any person obtaining class I EUAs from an NDA holder to a contract availability of CFCs for medical devices controlled substances after the phase- filler (provided they already have during calendar year 2001. out under the essential use exemptions EUAs). However, EPA must continue to Why is EPA Allocating CFC–11, CFC–12, in today’s action is subject to all the exercise strict control over the amount and CFC–114 in the Aggregate To Each restrictions and requirements in other of CFCs produced and or imported to Company? sections of 40 CFR part 82, subpart A. ensure U.S. compliance with the Holders of essential use allowances or Decisions of the Parties to the Protocol. As discussed in the proposal, EPA is persons obtaining class I controlled Thus, EPA believes that it is necessary allocating essential use allowances for substances under the essential use to approve the transfer of EUAs between CFC–11, CFC–12, and CFC–114 in the exemptions must comply with the an NDA holder and a contract filler. It aggregate in accordance with Decision recordkeeping and reporting should be noted that EPA is not X/6 of the Parties to the Montreal requirements in 40 CFR 82.13. approving or disapproving the use of a Protocol which states that ‘‘the Instructions and forms for reporting are contract filler per se, but merely quantities approved under paragraph 2 found in the Guidance Document for the ensuring that the ‘‘transferor’’ has above and all future approvals are for Stratospheric Ozone Protection Program sufficient allowances to cover the total CFC volumes with flexibility after January 1, 1996. This document transaction. between CFCs within each group.’’ can be obtained by contacting the Allocating CFCs for MDI in the Stratospheric Ozone Protection Hotline Under the New Regulations Can I aggregate instead of on a compound-by- at (800) 296–1996 between 10:00 am Transfer EUAs for CFCs To Anyone I compound basis provides MDI and 4:00 pm Eastern Standard Time. Want? producers with flexibility in obtaining Under 40 CFR 82.3 and 82.4 (63 FR No; EUAs for CFCs are only CFCs without causing additional 41626, August 4, 1998), entities transferable among those companies damage to the stratospheric ozone layer receiving essential use allowances must that have applied for and received EUAs since CFC–11, CFC–12 and CFC–114 all be the importer of record for quantities for the year 2001. In addition, have the same ozone depleting potential of CFCs brought into the United States. companies must certify in writing to of 1.0. This requires that the essential use EPA that the EUAs will only be used in Timing of This and Future Essential Use allowance holder be listed as the the production of essential medical Allocation Rules importer of record on Customs Form devices as defined in the FDCA at 21 7501. As a result, the essential use CFR 2.125 and considered essential by One commenter noted that even allowance holder who imports the Parties to the Protocol. though EPA sent letters to MDI quantities of class I controlled companies in May 2000 requesting data substances is responsible for submitting Can EUAs for CFCs Be Transferred needed to determine 2001 EUAs, the both an Importer Quarterly Report and From Year to Year? proposed allocation was not published an Essential Use Holder Quarterly No; EUAs are not transferable from until October. This commenter Report. year to year. Any EUAs for CFCs not requested that EPA make every effort to expended in 2001 will expire at the end IV. Transfer of EUAs for CFCs Among issue a proposed rule allocating EUAs of 2001. for 2002 in September of 2001, and Essential Use Allowance Holders states that as pharmaceutical-grade CFC With this action EPA is adding Is There a Cost for Transferring EUAs? production becomes increasingly essential use allowances to the list of Yes; the CAA at section 607(a) states tenuous, CFC suppliers are requiring allowances that can be transferred under that rules governing transfer of advanced notice of MDI companies’ CFC 40 CFR 82.12. This change will enable allowances for the production of class I production needs. Further, MDI companies to transfer EUAs for CFCs to and class II substances ‘‘* * * shall companies are unable to provide other essential use holders for the insure that the transactions under the suppliers with this information until production of MDIs. EPA believes that authority of this section will result in final EUA allocations are issued. Earlier allowing EUAs to be transferred among greater total reductions in the rulemakings would help to ensure that essential use allowance holders will production in each year of class I and MDI manufacturers are able to place allow MDI companies to obtain CFCs class II substances than would occur in CFC production orders, arrange for beyond their allocation without that year in the absence of such shipping, and make other administrative increasing the total amount of ODSs transactions.’’ In compliance with this arrangements in a timely manner. EPA allocated. EPA received three comments section, current regulations at 40 CFR will make every effort to issue the notice in support of the provision to allow 82.12 governing transfers of production of proposed rulemaking allocating transfer of EUAs among essential use and consumption allowances require essential use allowances for 2002 by holders. These commenters stated that one percent of the traded amount to be September of 2001. this provision provides a responsible deducted from the transferor’s

VerDate 112000 14:26 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR4.SGM pfrm01 PsN: 08JAR4 1468 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations unexpended allowances. EPA proposed to be transferred plus one tenth of one effective or least burdensome alternative to amend the regulations so that in the percent of that amount). Within three that achieves the objectives of the rule. case of EUA transfers, one tenth of one working days of receiving a complete The provisions of section 205 do not percent of the amount traded would be transfer claim, EPA will notify the apply when they are inconsistent with deducted from the transferor’s account. transferor and transferee if the transferor applicable law. Moreover, section 205 As stated in the preamble to the has sufficient unexpended allowances allows EPA to adopt an alternative other proposed rule, EPA believes that given to confer the transfer claim, and will than the least costly, most cost-effective the relatively small amount of EUAs issue a notice indicating that EPA does or least burdensome alternative if the available for use in MDIs, and that not object to the transfer. EPA will then Administrator publishes with the final providing sufficient EUAs for MDIs is reduce the transferor’s balance of rule an explanation why that alternative critically important for protecting public essential use allowances by the amount was not adopted. Section 204 of the health, deducting one percent of the to be transferred plus one tenth of one UMRA requires the Agency to develop amount of EUAs to be traded would be percent of that amount. When EPA a process to allow elected state, local, too high a penalty and may create a issues a no objection notice, the and tribal government officials to barrier against transferring EUAs freely. transferor and the transferee may provide input in the development of any Reducing the amount deducted from the proceed with the transfer. proposal containing a significant transferor’s account overcomes this If EPA’s records show that the Federal intergovernmental mandate. potential barrier. EPA received no transferor has insufficient unexpended Before EPA establishes any regulatory adverse comments on this issue, and is allowances to cover the transfer claim, requirements that may significantly or amending the regulation as described or that the transferor has failed to uniquely affect small governments, above. respond to one or more Agency requests including tribal governments, it must to supply information needed to make a have developed under section 203 of the How Can I Transfer EUAs From My determination, EPA will issue a notice UMRA a small government agency plan. Company to Another? disallowing the transfer. Within 10 The plan must provide for notifying In order to complete a transfer of working days after receipt of potentially affected small governments, EUAs for CFCs from one essential use notifications, either party may file a enabling officials of affected small allowance holder to another, the notice of appeal, with supporting governments to have meaningful and transferor would have to submit to the reasons, to EPA, in which case EPA may timely input in the development of EPA Administrator a letter with the either affirm or vacate the disallowance. regulatory proposals with significant information requested in 40 CFR If no appeal is taken by the tenth Federal intergovernmental mandates, 82.12(a)(1). Under the regulations at 40 working day after notification, the and informing, educating, and advising CFR 82.12, the transferor must submit to disallowance shall be final on that day. small governments on compliance with the Administrator a transfer claim with (The transferor and transferee will be the regulatory requirements. the following information: held liable in accordance with section Today’s rule contains no Federal 1. The identities and addresses of the 113 of the Act for any violations that mandates (under the regulatory transferor and transferee. occur as a result of an improper provisions of title II of the UMRA) for 2. The names and telephone numbers transfer.) In the event that EPA does not State, local, or tribal governments or the of contact persons for both the transferor respond to a transfer claim within three private sector. Because this rule imposes no enforceable duty on any State, local and transferee. working days of receipt of the or tribal government it is not subject to 3. The type of allowances being completed claim, the transferor and the requirements of sections 202 and transferred, which in this case would transferee may proceed with the transfer 205 of the UMRA. EPA has also always be essential use allowances. and EPA will reduce the transferor’s determined that this rule contains no 4. The group of controlled substances balance accordingly. being transferred, which would always regulatory requirements that might be Group I. V. Administrative Requirements significantly or uniquely affect small governments; therefore, EPA is not 5. The amount of allowances being A. Unfunded Mandates Reform Act transferred in kilograms. required to develop a plan with regard 6. The calendar year for which the Title II of the Unfunded Mandates to small governments under section 203. allowances are being transferred (e.g. Reform Act of 1995 (UMRA), Public Finally, because this rule does not calendar year 2001). Law 104–4, establishes requirements for contain a significant intergovernmental 7. The amount of unexpended Federal agencies to assess the effects of mandate, the Agency is not required to essential use allowances for the current their regulatory actions on State, local, develop a process to obtain input from calendar year. and tribal governments and the private elected state, local, and tribal officials 8. The amount of the 0.1% offset sector. under section 204. applied to the unweighted amount Under section 202 of the UMRA, EPA traded that will be deducted from the generally must prepare a written B. Executive Order 12866 transferor’s allowance balance. statement, including a cost-benefit Under Executive Order 12866 (58 FR A sample form that outlines the analysis, for proposed and final rules 51735, October 4, 1993), the Agency necessary information that a transferor with ‘‘Federal mandates’’ that may must determine whether this regulatory must submit to EPA will be available result in expenditures by State, local, action is Significant and therefore through the Stratospheric Ozone Hotline and tribal governments, in the aggregate, subject to OMB review and the at 1–800–296–1996. or by the private sector, of $100 million requirements of the Executive Order. As specified in 40 CFR 82.12, EPA or more in any one year. Before The Order defines Significant regulatory will determine, based on records promulgating an EPA rule for which a action as one that is likely to result in maintained by the EPA ODS tracking written statement is needed, section 205 a rule that may: system, whether the transferor possesses of the UMRA generally requires EPA to (1) Have an annual effect on the as of the date of the transfer claim, identify and consider a reasonable economy of $100 million or more, or unexpended allowances sufficient to number of regulatory alternatives and adversely affect in a material way the cover the transfer claim (i.e., the amount adopt the least costly, most cost- economy, a sector of the economy,

VerDate 112000 18:27 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR4.SGM pfrm10 PsN: 08JAR4 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1469 productivity, competition, jobs, the and systems for the purposes of determined that this action will not environment, public health or safety, or collecting, validating, and verifying have a significant economic impact on State, local, or tribal governments or information, processing and a substantial number of small entities. communities; maintaining information, and disclosing This rule does not have a significant (2) Create a serious inconsistency or and providing information; adjust the impact on a substantial number of small otherwise interfere with an action taken existing ways to comply with any entities. There are only ten entities that or planned by another agency; previously applicable instructions and are affected by this rulemaking (see (3) Materially alter the budgetary requirements; train personnel to be able table I above). This rule does not have impact of entitlement, grants, user fees, to respond to a collection of an adverse economic impact on any or loan programs or the rights and information; search data sources; entity because it grants exceptions to a obligations of recipients thereof; or complete and review the collection of pre-existing ban. (4) Raise novel legal or policy issues information; and transmit or otherwise F. Applicability of Executive Order arising out of legal mandates, the disclose the information. President’s priorities, or the principles An Agency may not conduct or 13045: Protection of Children from set forth in the Executive Order. It has sponsor, and a person is not required to Environmental Health Risks and Safety been determined by OMB and EPA that respond to a collection of information Risks this action is not a Significant regulatory unless it displays a currently valid OMB Executive Order 13045: ‘‘Protection of action under the terms of Executive control number. The OMB control Children from Environmental Health Order 12866 and is therefore not subject numbers for EPA’s regulations are listed Risks and Safety Risks’’ (62 FR 19885, to OMB review under the Executive in 40 CFR part 9 and 48 CFR chapter 15. April 23, 1997) applies to any rule that Order. (1) Is determined to be ‘‘economically D. Executive Order 13084: Consultation significant’’ as defined under Executive C. Paperwork Reduction Act and Coordination with Indian Tribal Order 12866, and (2) concerns an This action does not impose any new Governments environmental health and safety risk information collection burden as Under Executive Order 13084, EPA that EPA has reason to believe may have defined by the Paperwork Reduction may not issue a regulation that is not a disproportionate effect on children. If Act (PRA). The Office of Management required by statute, that significantly or the regulatory action meets both criteria, and Budget’s draft guidance on PRA uniquely affects the communities of the Agency must evaluate the states that a rule is exempt from OMB Indian tribal governments, and that environmental health or safety effects of review if it ‘‘explicitly applies to nine or imposes substantial direct compliance the planned rule on children, and fewer persons’’. Since the reporting costs on those communities, unless the explain why the planned regulation is requirements in this rule are not of Federal government provides the funds preferable to other potentially effective general applicability, and apply only to necessary to pay the direct compliance and reasonably feasible alternatives the eight entities receiving EUAs for costs incurred by the tribal considered by the Agency. EPA CFCs, and only if a company decides to governments, or EPA consults with interprets Executive Order 13045 as transfer EUAs to another essential use those governments. If EPA complies by applying only to those regulatory holder, we believe that this rule is consulting, Executive Order 13084 actions that are based on health or safety exempt from the requirement of requires EPA to provide to the Office of risks, such that the analysis required submitting an Information Collection Management and Budget, in a separately under section 5–501 of the Order has Request and undergoing OMB review. identified section of the preamble to the the potential to influence the regulation. However, OMB has previously rule, a description of the extent of EPA’s This rule is not subject to Executive approved the information collection prior consultation with representatives Order 13045 because it implements the requirements that are contained in the of affected tribal governments, a phase-out schedule and exemptions existing regulations at 40 CFR 82.12 that summary of the nature of their concerns, established by Congress in title VI of the set forth the process for inter-company and a statement supporting the need to Clean Air Act. transfers of consumption allowances issue the regulation. In addition, G. National Technology Transfer and under the provisions of the Paperwork Executive Order 13084 requires EPA to Advancement Act Reduction Act, 44 U.S.C. 3501 et seq. develop an effective process permitting and has assigned OMB control number elected officials and other Section 12(d) of the National 2060–0170 (EPA ICR No.1432.17). representatives of Indian tribal Technology Transfer and Advancement Copies of the ICR document(s) may be governments to provide meaningful and Act of 1995 (‘‘NTTAA’’), Public Law obtained from Sandy Farmer, by mail at timely input in the development of 104–113, section 12(d) (15 U.S.C. 272 the Office of Environmental regulatory policies on matters that note) directs EPA to use voluntary Information, Collection Strategies significantly or uniquely affect their consensus standards in this regulatory Division; U.S. Environmental Protection communities.’’ Today’s rule does not activities unless to do so would be Agency (2822); 1200 Pennsylvania Ave., significantly or uniquely affect the inconsistent with applicable law or NW, Washington, DC 20460, by email at communities of Indian tribal otherwise impractical. Voluntary [email protected], or by calling governments. Accordingly, the consensus standards are technical (202) 260–2740. A copy may also be requirements of section 3(b) of standards (e.g., materials specifications, downloaded off the internet at http:// Executive Order 13084 do not apply to test methods, sampling procedures, and www.epa.gov/icr. Include the ICR and/ this rule. business practices) that are developed or or OMB number in any correspondence. adopted by voluntary consensus Burden means the total time, effort, or E. Regulatory Flexibility standards bodies. The NTTAA directs financial resources expended by persons After considering the economic EPA to provide Congress, through OMB, to generate, maintain, retain, or disclose impacts of today’s proposed rule on explanations when the Agency decides or provide information to or for a small entities, EPA has determined that not to use available and applicable Federal agency. This includes the time it is not necessary to prepare a voluntary consensus standards. This needed to review instructions; develop, regulatory flexibility analysis in final rule does not involve technical acquire, install, and utilize technology connection with this rule. EPA has also standards. Therefore, EPA did not

VerDate 112000 14:26 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR4.SGM pfrm01 PsN: 08JAR4 1470 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations consider the use of any voluntary regulation, and a statement of the extent Fairness Act of 1996, generally provides consensus standards. to which the concerns of State and local that before a rule may take effect, the officials have been met. Also, when EPA agency promulgating the rule must H. Executive Order 13132 (Federalism) transmits a draft final rule with submit a rule report, which includes a Executive Order 13132, entitled federalism implications to OMB for copy of the rule, to each House of the ‘‘Federalism’’ (64 FR 432255, August 10, review pursuant to Executive Order Congress and to the Comptroller General 1999), requires EPA to develop an 12866, EPA must include a certification of the United States. Therefore, EPA accountable process to ensure from the agency’s Federalism Official will submit a report containing this rule ‘‘meaningful and timely input by State stating that EPA has met the and other required information to the and local officials in the development of requirements of Executive Order 13132 U.S. Senate, the U.S. House of regulatory policies that have federalism in a meaningful and timely manner. Representatives, and the Comptroller implications.’’ ‘‘Policies that have This rule will not have substantial General of the United States prior to federalism implications’’ is defined in direct effects on the States, on the publication of the rule in the Federal the Executive Order to include relationship between the national Register. This rule is not a ‘‘major rule’’ regulations that have ‘‘substantial direct government and the States, or on the as defined by 5 U.S.C. 804(2). This rule effects on the States, on the relationship distribution of power and will be effective January 8, 2001. between the national government and responsibilities among the various List of Subjects in 40 CFR Part 82 the States, or on the distribution of levels of government, as specified in power and responsibilities among the Executive Order 13132. This rule will Environmental protection, various levels of government.’’ Under affect only the ability of private entities Administrative practice and procedure, Executive Order 13132, EPA may not and the national government to request Air pollution control, Chemicals, issue a regulation that has federalism production of controlled ozone- Exports, Imports, Reporting and implications, that imposes substantial depleting substances. Thus, the recordkeeping requirements. direct compliance costs, and that is not requirements of section 6 of the Dated: December 28, 2000. required by State and local Executive Order to not apply to this Carol M. Browner, governments, or EPA consults with rule. State and local officials early in the Administrator. process of developing the proposed VI. Judicial Review 40 CFR Part 82 is amended as follows: regulation. EPA also may not issue a Under section 307(b)(1) of the Act, PART 82ÐPROTECTION OF regulation that has federalism EPA finds that these regulations are of STRATOSPHERIC OZONE implications and that preempts State national applicability. Accordingly, law unless the Agency consults with judicial review of the action is available 1. The authority citation for part 82 State and local officials early in the only by the filing of a petition for review continues to read as follows: process of developing the proposed in the United States Court of Appeals regulation. for the District of Columbia Circuit Authority: 42 U.S.C. 7414, 7601, 7671– 7671q. If EPA complies by consulting, within sixty days of publication of the Executive Order 13132 requires EPA to action in the Federal Register. Under Subpart AÐProduction and provide the Office of Management and section 307(b)(2), the requirements of Consumption Controls Budget, in a separately identified this rule may not be challenged later in section of the preamble to the rule, a the judicial proceedings brought to 2. Section 82.4 is amended by revising federalism summary impact statement enforce those requirements. the table in paragraph (t)(2) to read as (FSIS). The FSIS must include a follows: description of the extent of EPA’s prior VII. Submittal to Congress and the consultation with State and local General Accounting Office § 82.4 Prohibitions. officials, a summary of the nature of The Congressional Review Act, 5 * * * * * their concerns and the agency’s position U.S.C. 801 et seq., as added by the Small (t) * * * supporting the need to issue the Business Regulatory Enforcement (2) * * *

TABLE I.ÐESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2001

Quantity Company Chemical (metric tons)

(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease (in metric tons)

Medeva Americas, Inc...... CFC±11 or CFC±12 or CFC±114 ...... 189.00 Boehringer Ingelheim ...... CFC±11 or CFC±12 or CFC±114 ...... 338.36 Glaxo Wellcome ...... CFC±11 or CFC±12 or CFC±114 ...... 858.10 Aventis ...... CFC±11 or CFC±12 or CFC±114 ...... 190.00 3M Pharmaceuticals ...... CFC±11 or CFC±12 or CFC±114 ...... 304.51 Sidmak Laboratories, Inc...... CFC±11 or CFC±12 or CFC±114 ...... 192.20 Schering Corporation ...... CFC±11 or CFC±12 or CFC±114 ...... 1025.20 Sciarra Laboratories, Inc...... CFC±11 or CFC±12 or CFC±114 ...... 1.3

(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets

National Aeronautics and Space Administration (NASA)/Thiokol Rocket ...... Methyl Chloroform ...... 56.7 United States Air Force/Titan Rocket ...... Methyl Chloroform ...... 3.4

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* * * * * case of transferring essential use of that amount. When EPA issues a no 3. Section 82.12 is amended by allowances, the amount of one tenth of objection notice, the transferor and the revising paragraphs (a)(1) introductory one percent of the amount traded will transferee may proceed with the text, (a)(1)(i)(H), (a)(1)(ii) introductory be deducted from the transferor’s transfer. However, if EPA ultimately text, (a)(1)(ii)(A), and (a)(1)(iii) to read allowance balance. finds that the transferor did not have as follows: (ii) The Administrator will determine sufficient unexpended allowances to whether the records maintained by EPA, cover the claim, the transferor and § 82.12 Transfers. taking into account any previous transferee will be held liable for any (a) * * * transfers and any production, allowable violations of the regulations of this (1) Until January 1, 1996, for all class imports and exports of controlled subpart that occur as a result of, or in I controlled substances, except for substances reported by the transferor, conjunction with, the improper transfer. Group VI, and until January 1, 2001, for indicate that the transferor possesses, as Group VI, any person (‘‘transferor’’) may of the date the transfer claim is * * * * * transfer to any other person processed, unexpended allowances (iii) In the event that the (‘‘transferee’’) any amount of the sufficient to cover the transfer claim Administrator does not respond to a transferor’s consumption allowances or (i.e., the amount to be transferred plus, transfer claim within the three working production allowances, and effective in the case of transferors of essential use days specified in paragraph (a)(1)(ii) of January 1, 1995, for all class I controlled allowances, one tenth of one percent of this section, the transferor and substances any person (‘‘transferor’’) the transferred amount, and in the case transferee may proceed with the may transfer to any other person of transferors of production or transfer. EPA will reduce the (‘‘transferee’’) any amount of the consumption allowances, one percent of transferor’s balance of unexpended transferor’s Article 5 allowances, and the transferred amount). Within three allowances by the amount to be after January 1, 2001 any essential use working days of receiving a complete transferred plus, in the case of transfers allowance holder (‘‘transferor’’) may transfer claim, the Administrator will of production or consumption transfer essential use allowances for take action to notify the transferor and allowances, one percent of that amount, CFCs to any other essential use transferee as follows: and in the case of essential use allowance holder for CFCs (A) If EPA’s records show that the allowances, one tenth of one percent of (‘‘transferee’’) solely for the production transferor has sufficient unexpended that amount. However if EPA ultimately of essential products (defined at 21 CFR allowances to cover the transfer claim, finds that the transferor did not have 2.125) as follows: the Administrator will issue a notice sufficient unexpended allowances to (i) * * * indicating that EPA does not object to cover the claim, the transferor and (H) The amount of the one percent the transfer and will reduce the transferee will be held liable for any offset applied to the unweighted amount transferor’s balance of unexpended violations of the regulations of this traded that will be deducted from the allowances by the amount to be subpart that occur as a result of, or in transferor’s production or consumption transferred plus, in the case of transfers conjunction with, the improper transfer. allowance balance (except for trades of production or consumption from transformers and destroyers to allowances, one percent of that amount, * * * * * producers or importers for the purpose or in the case of transfers of essential [FR Doc. 01–463 Filed 1–5–01; 8:45 am] of allowance reimbursement). In the use allowances, one tenth of one percent BILLING CODE 6560±50±U

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Part VI

Department of Education 34 CFR Part 300

Assistance to States for the Education of Children With Disabilities; Final Rule

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DEPARTMENT OF EDUCATION the amount it receives that exceeds the do not address comments that are not amount it received under Part B during directly relevant to these regulations. 34 CFR Part 300 the prior year. By treating certain Comment: The comments generally RIN 1820±AB51 Federal funds as local funds, and LEA acknowledged the need for having the will be able to meet the maintenance of proposed regulation, but were varied in Assistance to States for the Education effort requirement of § 300.231 even their recommendations for change. With of Children With Disabilities though it reduces the amount of other respect to which funds under section local or local and State funds, as the 611 of the Act apply in determining the AGENCY: Office of Special Education and case may be, by an amount equal to the amount of money that will be treated as Rehabilitative Services, Department of amount of Federal funds that may be local funds, one commenter agreed with Education. treated as local funds. The fiscal year the position in the NPRM (i.e., that the ACTION: Final regulations. ending September 30, 1999 was the first funds should be limited to LEA year that the Part B appropriation subgrants under section 611(g) SUMMARY: The Secretary amends the exceeded $4.1 billion. (§ 300.712 of the regulations)). Two regulations for the Assistance to States A key question the NPRM proposed to commenters recommended that the for the Education of Children with resolve was whether only LEA subgrant provision be expanded to also include Disabilities program under Part B of the funds under section 611(g) of the Act or funds for local capacity-building and Individuals with Disabilities Education LEA subgrant funds and other Part B improvement under section 611(f) of the Act (IDEA; Part B)). This amendment is funding sources (i.e., subgrants to LEAs Act (§ 300.622 of the regulations). needed to implement the statutory for capacity-building and improvement Another commenter noted that States provision that for any fiscal year in under section 611(f), other funds the routinely flow through additional Part B which the appropriation for section 611 SEA may provide to LEAs under section (section 611) funds beyond the required ofthe IDEA exceeds $4.1 billion, a local 611(f) or preschool grant funds under LEA subgrants under section 611(g), and educational agency (LEA) may treat as section 619) would be affected by the 20 recommended that the regulations local funds up to 20 percent of the percent rule in section 613(a)(2)(C) of clarify that the 20 percent rule applies amount it receives that exceeds the the Act (§ 300.233 of the regulations). to all section 611 funds LEAs receive, amount it received during the prior In the NPRM, we proposed that the 20 including funds that are not retained by fiscal year. The amendment is intended percent rule apply only to LEA subgrant States for administrative purposes and to ensure effective implementation of funds under section 611(g) of the Act other State-level activities specified the 20 percent rule by clarifying which (§ 300.712 of the regulations), for the under section 611(f). funds under Part B of IDEA can be reasons described in the preamble to the Discussion: We believe that the included in the 20 percent calculation, NPRM. We believe that the position position taken in the NPRM—that the and, as a result, to reduce the potential taken in the NPRM is the most money that may be treated by LEAs as for audit exceptions. appropriate and reasonable position to local funds under the section 611 DATES: These regulations are effective— follow in implementing the 20 percent appropriation should be limited to February 9, 2001. rule. Therefore, we have retained statutory subgrant funds under section FOR FURTHER INFORMATION CONTACT: proposed § 300.233(a)(1), without 611(g)—is the most appropriate and JoLeta Reynolds (202) 205–5507. If you change, in these final regulations. reasonable position to follow in There are only two significant use a telecommunication device for the implementing section 613(a)(2)(C) of the differences between the NPRM and deaf (TDD), you may call the TDD Act (§ 300.233 of the regulations). There these final regulations: number at (202) 205–5465. were no compelling reasons presented • First, we have amended proposed Individuals with disabilities may by commenters to do otherwise. § 300.233(a)(3) (which provided that if obtain this document in an alternate Therefore, we have retained proposed funds are being withheld from an LEA, format (e.g., Braille, large print, § 300.233(a)(1), without change, in these those funds would not be included in audiotape, or computer diskette) on final regulations. The reasons for taking the 20 percent calculation) to clarify request to Katie Mimcey, Director of the this position were specified in the that if funds that have been withheld are Alternate Formats Center. Telephone: preamble to the NPRM (and are also subsequently released to the LEA, the (202) 205–8113. included in a new Appendix C to these LEA may apply the 20 percent rule to Part 300 regulations). We believe that SUPPLEMENTARY INFORMATION: On May those funds. 10, 2000, the Secretary published a • Second, we have added (in a new the regulations clearly indicate that, notice of proposed rulemaking (NPRM) Appendix C to the regulations for Part while States may provide additional in the Federal Register (65 FR 30314) to 300) information to assist LEAs in funds to LEAs from their section 611(f) amend the regulations governing the implementing the 20 percent rule, set-aside, only section 611(g) funds are Assistance to States for the Education of including a full, substantive description subject to the 20 percent rule. Children with Disabilities program (34 of the provision (with examples) that is Changes: None. CFR part 300). The NPRM proposed to similar to the information contained in Comment: A commenter noted that implement a statutory provision the Background section of the preamble the NPRM did not indicate at what regarding the permissive treatment of a to the NPRM. point in the year an LEA should make portion of Part B funds by LEAs in its calculation (e.g., at the beginning of certain fiscal years, as added by the Analysis of Comments and Changes the year or at another time), and added IDEA Amendments of 1997 (see section In response to the Secretary’s that the point in time when the 613(a)(2)(C) of the Act and § 300.233 of invitation in the NPRM, six parties determination is made could have an the regulations). submitted comments on the proposed impact on the LEA, especially if the Under the new statutory provision, for regulations. An analysis of the LEA has had funds withheld that are any fiscal year (FY) for which the comments and of the changes in the later restored. The commenter further appropriation for section 611 of the regulations since publication of the requested that the background section IDEA exceeds $4.1 billion, an LEA may NPRM follows. In the analysis, we from the NPRM be expanded to include treat as local funds up to 20 percent of address substantive comments, but we more complex examples for calculating

VerDate 112000 14:30 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR5.SGM pfrm01 PsN: 08JAR5 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1475 the 20 percent formula, and to specify 1997, and, therefore, it would be Comment: A commenter stated that resources in the Department that LEAs inappropriate for the regulation to § 300.233(a)(3) of the NPRM—which might turn to for assistance in this exclude the FY 1999 appropriation. provides that an LEA is not eligible to regard. Discussion: Because funds for FY receive funds that have been withheld Discussion: The LEA may make its 1999 had already been received (and, in under § 300.197 or § 300.587—is calculation—and spend the 20 percent many cases already obligated by LEAs), overbroad, and ignores the fact that of the increase in the Federal grant as we believed that it would be funds that have been withheld may local funds—at any point from the time inappropriate to apply this amendment subsequently be released when the LEA receives its grant under section to § 300.233 retroactively to FY 1999 compliance has been achieved. The 611(g) of the Act (§ 300.712 of the funds). Therefore, we proposed to apply commenter recommended that the regulations), to the end of the period the amended regulation to FY 2000 provision be deleted, noting, further, that these funds are available for funds and thereafter. In the NPRM, we that it does not coincide with section obligation. Thus, if an LEA’s Federal should have definitively stated that the 613(a)(2)(C)(ii) of the Act (§ 300.233(b) fiscal year 2001 funds were withheld at FY 1999 appropriation was not affected of the regulations), which provides that the beginning of a school year, but were by the proposed regulations, and, an SEA may prohibit an LEA from subsequently released by the SEA on therefore, States and LEAs could apply applying the 20 percent rule only if it January 1, 2002, the LEA could do the a broader interpretation of section is authorized to do so by State calculation and spend those funds any 613(a)(2)(C) of the Act (§ 300.233 of the constitution or statute. Discussion: We agree with the time between January 1, 2002 and regulations) to the funds they received commenter that proposed new September 30, 2003. from that appropriation. § 300.233(a)(3) does not appropriately We agree with the commenter’s Changes: None. request for additional examples. We also reflect the requirements of the Act. It believe that it is important to retain, on Comment: A commenter disagreed should have indicated that funds that a permanent basis, the background with the interpretation of the year by have been withheld may subsequently section from the NPRM related to the 20 year applicability of the 20 percent rule be released when compliance has been percent rule (along with the examples), in the NPRM, and stated that the achieved, and that the 20 percent rule so that school officials at both the State provision should apply throughout the may be applied to those funds during and local levels will have a technical entire period of appropriations their period of availability. This is assistance source to turn to regarding availability, including the carryover consistent with our intent in the NPRM. implementation of that provision. Thus, year authorized by the Tydings However, we continue to believe that it we have included the basic content of Amendment. The commenter further is necessary to provide guidance in this the background section in the NPRM recommended that the regulation be area. (with examples) in a new Appendix C revised to allow for the 20 percent rule Upon further review of proposed to the regulations for this part. to be applied on a cumulative basis, so § 300.233(a)(3), we believe that it needs With respect to providing technical that (for example) if there is no increase to be revised to clarify that during any assistance on the 20 percent rule at the in appropriations for FY 2002 from the period in which Part B funds are Federal level, we believe that it would prior year, an LEA that has not used the withheld from an LEA because of a be more appropriate for LEAs to seek 20 percent rule in fiscal years 1999, finding of noncompliance under advice and guidance from the SEA 2000, and 2001 would be allowed to § 300.197 or § 300.587, the LEA may not within each State regarding take advantage of the appropriations implement the 20 percent rule. implementation of the 20 percent rule, increases received in those prior years However, if the funds are subsequently rather than directly seeking assistance for local budgetary relief. released to the LEA during the grant from the Department. Because each SEA Discussion: An LEA can take award period, the LEA may spend those is responsible for monitoring an LEA’s advantage of the 20 percent rule at any funds consistent with the 20 percent compliance with the Part B point throughout the period in which rule. requirements (including the 20 percent the LEA can use its section 611(g) funds, Changes: Section 300.233(c) has been rule), it would not be appropriate for the including the carryover year under the amended, consistent with the preceding Department to provide direct assistance Tydings Amendment. (The Tydings discussion. to individual LEAs on this provision. Amendment allows States to obligate Executive Order 12866 On the other hand, if the SEA, in their grant funds for one additional year We have reviewed these final assisting an LEA to apply the 20 percent after the initial period of availability. regulations in accordance with rule, needs policy guidance regarding See General Education Provisions Act, Executive Order 12866. Under the terms the provision, it would be appropriate section 421.) However, there is no of the order, we have assessed the for the SEA to contact the Department statutory authority to allow the potential costs and benefits of this for that assistance. provision to be applied on a cumulative regulatory action. Changes: A new Appendix C has been basis. The Act makes it clear that the The potential costs associated with added to the regulations, as described in provision applies only on a year to year the final regulations are those we have the preceding discussion. basis (i.e., section 613(a)(2)(C) specifies determined as necessary for Comment: One commenter stated that that, for any fiscal year for which the administering these programs effectively the preamble to the NPRM suggests that amounts appropriated to carry out and efficiently. Elsewhere in this the 20 percent rule would be section 611 exceeds $4.1 billion, an LEA SUPPLEMENTARY INFORMATION section, we implemented beginning with fiscal year ‘‘may treat as local funds * * * up to identify and explain any burdens (FY) 2000, even though FY 1999 was the 20 percent of the amount of funds it specifically associated with the first year in which the section 611 receives under this part that exceeds the information collection requirements. appropriation exceeded $4.1 billion. amount it received under this part for See the heading Paperwork Reduction The commenter added that the statutory the previous fiscal year.’’). Emphasis Act of 1995. authority relating to this provision was added. In assessing the potential costs and established by the IDEA Amendments of Changes: None. benefits—both quantitative and

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Section 300.233 is amended by interfere with State, local, and tribal would require transmission of revising paragraph (a)(1), and by adding governments in the exercise of their information that any other agency or a new paragraph (a)(3), to read as governmental functions. authority of the United States gathers or follows: Regulatory Flexibility Act Certification makes available. § 300.233 Treatment of Federal funds in Based on the response to the NPRM The Secretary certifies that these final certain fiscal years. and on our review, we have determined (a)(1) Subject to paragraphs (a)(2), regulations will not have significant that these final regulations do not economic impact on a substantial (a)(3), and (b) of this section, for any require transmission of information that fiscal year for which amounts number of small entities. The small any other agency or authority of the entities affected will be small LEAs. The appropriated to carry out section 611 of United States gathers or makes the Act exceed $4.1 billion, an LEA may regulations will benefit the small available. entities affected by clarifying the treat as local funds up to 20 percent of statutory requirements and reducing the Electronic Access to this Document the amount of funds it is eligible to possibility of audit exceptions. By receive under § 300.712 from that You may view this document, as well ensuring consistency, the regulations appropriation that exceeds the amount as all other Department of Education will promote more effective and from funds appropriated for the documents published in the Federal efficient program administration. previous fiscal year that the LEA was Register, in text or Adobe Portable eligible to receive under § 300.712. Paperwork Reduction Act of 1995 Document Format (PDF) on the Internet * * * * * These final regulations do not contain at either of the following sites: (3) For purposes of this section: any information collection http://ocfo.ed.gov/fedreg.htm (i)(A) An LEA is not eligible to receive requirements. http://www.ed.gov/news.html funds during any period in which those funds under this part are withheld from To use the PDF you must have Adobe Intergovernmental Review the LEA because of a finding of Acrobat Reader Program, which is This program is subject to the noncompliance under § 300.197 or available free at either of the previous requirements of Executive Order 12372 § 300.587. sites. If you have questions about using and the regulations in 34 CFR part 79. (B) An LEA is eligible to receive funds the PDF, call the U.S. Government The objective of the Executive order is that have been withheld under Printing Office (GPO), toll free, at 1– to foster an intergovernmental § 300.197 or § 300.587 but are 800–293–6498; or in the Washington, partnership and a strengthened subsequently released to the LEA within DC area, at (202) 512–1530. federalism by relying on processes the period of the funds availability. developed by State and local Note: The official version of this document (ii) An LEA is not eligible to receive governments for coordination and is the document published in the Federal funds that have been reallocated to Register. Free Internet access to the official other LEAs under § 300.714. review of proposed Federal financial edition of the Federal Register and the Code assistance. of Federal Regulations is available on GPO 3. Part 300 is further amended by In accordance with the order, we Access at: adding a new Appendix C— intend this document to provide early Implementation of the 20 Percent Rule notification of our specific plans and http://www.access.gpo.gov/nara/ under § 300.233, to read as follows: actions for this program. index.html APPENDIX C TO PART 300— Federalism (Catalog of Federal Domestic Assistance Number: 84.027 Assistance to States for the IMPLEMENTATION OF THE 20 Executive Order 13132 requires us to Education of Children with Disabilities) PERCENT RULE UNDER § 300.233 ensure meaningful and timely input by List of Subjects This appendix is intended to assist States State and local elected officials in the and LEAs to implement the ‘‘20 percent rule’’ development of regulatory policies that Administrative practice and under Part B (section 613(a)(2)(C)) of the have federalism implications. procedure, Education of individuals Individuals with Disabilities Education Act ‘‘Federalism implications’’ means with disabilities, Elementary and (IDEA), and, specifically, the regulation substantial direct effects on the States, secondary education, Equal educational implementing that provision in § 300.233. The purposes of the appendix are to—(1) on the relationship between the opportunity, Grant programs— provide background information about the 20 National Government and the States, or education, Privacy, Private schools, percent rule and its intended effect, on the distribution of power and Reporting and recordkeeping including specifying which funds under Part responsibilities among the various requirements. B of the Act are covered by the provision (as described in § 300.233), and the basis for the levels of government. Dated: December 12, 2000. Since these regulations relate solely to Department’s decision regarding those funds; Richard W. Riley, implementation of the statutory 20 and (2) include examples showing how the percent rule, we do not believe these Secretary of Education. 20 percent rule would apply in several regulations have federalism For the reasons described in the situations. implications as defined in Executive preamble, the Secretary amends title 34, A. Background Order 13132. In addition, these part 300, of the Code of Federal 1. Purpose of 20 Percent Rule. The IDEA regulations do not preempt State law. Regulations as follows: Amendments of 1997 (Pub. L. 105–17) added

VerDate 112000 14:30 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\08JAR5.SGM pfrm01 PsN: 08JAR5 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1477 a provision related to the permissive (i.e., Subgrants to LEAs for capacity-building funds (i.e., $4,000 from FY–2 and $4,000 treatment of a portion of Part B funds by and improvement under section 611(f)(4) from FY–3), provided those funds are LEAs for maintenance of effort and non- (§ 300.622); other funds the SEA may provide obligated by the end of FY–3. supplanting purposes in certain fiscal years to LEAs under section 611(f) (§ 300.602); and • Example 2: An LEA from one fiscal year (see section 613(a)(2)(C) of the Act and preschool grant funds under section 619 (34 (FY–1) receives $100,000 in section 611(g) § 300.233). Under that provision, for any CFR part 301)) from the funds that could be funds and $20,000 in SEA discretionary fiscal year (FY) for which the appropriation treated as local funds. The reasons for funds under section 611(f) of the Act; and for section 611 of IDEA exceeds $4.1 billion, excluding these other Part B funds were from the following year (FY–2) receives an LEA may treat as local funds, for stated in the NPRM, as follows: $120,000 in section 611(g) funds, but does maintenance of effort and non-supplanting • If IDEA funds that States have the not receive any funds under section 611(f). purposes, up to 20 percent of the amount it authority to provide to LEAs on a The LEA may spend and treat up to 20 receives that exceeds the amount it received discretionary basis (such as those identified percent of the $20,000 in section 611(g) funds under Part B during the prior year. in the preceding paragraph) are included in it receives from FY–2 (i.e. up to $4,000), Thus, under § 300.233, an LEA is able to the 20 percent calculation, it would result in since $20,000 is the amount of section 611(g) meet the maintenance of effort requirement some LEAs receiving a proportionately funds that exceeds the amount it received of § 300.231 and the non-supplanting greater benefit from this provision than other from FY–1. requirement of § 300.230(c) even though it LEAs, based on receipt of funds that may be • Example 3: An LEA had all of its section reduces the amount it spends of other local earmarked for a specific, time-limited 611(g) funds ($100,000) withheld from one or local and State funds, as the case may be, purpose. This would lead to inequitable fiscal year (FY–1); but in the next fiscal year by an amount equal to the amount of Federal results of the § 300.233 exception across (FY–2), the LEA received a total of $220,000 funds that may be treated as local funds. LEAs in a State. in section 611(g) funds (i.e., $100,000 from 2. 20 Percent Rule Applies Only to LEA • Including section 619 formula grant FY–1, plus $120,000 from FY–2). Because the Subgrants. Following enactment of the IDEA funds (34 CFR part 301) in the calculation LEA would have been entitled to $100,000 in Amendments of 1997 (and publication of Part does not appear to be justified as the FY–1, the LEA may spend and treat as local B regulations on March 12, 1999), State and ‘‘trigger’’ appropriation amount applies only funds up to 20 percent of the $20,000 from local educational agency officials stated that with respect to the amount appropriated FY–2 that exceeded the FY–1 allotment (i.e., it is not clear from the Act and regulations under section 611. up to $4,000). whether the funds affected by the 20 percent The Department subsequently determined • Example 4: An LEA received $100,000 rule are only those that an LEA receives that the position taken in the NPRM (that the under section 611(g) from one fiscal year through statutory subgrants under section provision under § 300.233 should apply only (FY–1), and would have received $120,000 in 611(g), or whether the provision also applies to LEA subgrant funds under section 611(g) to other Part B funding sources (i.e., section 611(g) funds for the next fiscal year of the Act) is the most appropriate and (FY–2); but the LEA has had all of its section subgrants to LEAs for capacity-building and reasonable position to follow in improvement under section 611(f)(4); other 611(g) funds withheld in FY–2 because of a implementing the 20 percent rule. Therefore, finding of noncompliance under § 300.197 or funds the SEA may provide to LEAs under the proposed provision in § 300.233(a)(1) was section 611(f); or funds provided under § 300.587. The LEA would have no section retained, without change, in the final 611(g) funds that could be spent or treated as section 619 (Preschool Grants program)). regulations. Further, because section 613(a)(2)(C) refers local funds until those funds are released. • to an amount of funds that an LEA ‘‘receives’’ B. Application of the 20 percent rule Example 4–A: In example 4, the SEA in one fiscal year compared to the amount it subsequently determines that the LEA is in 1. Examples Related to Implementing the 20 ‘‘received’’ in the prior fiscal year (and compliance, and releases the FY–2 funds to percent rule because agencies may, at any one point in the LEA later in that fiscal year. The LEA time, be using funds appropriated in several The following are examples showing how could then spend and treat as local funds up Federal fiscal years), agency officials were the 20 percent provision would apply under to 20 percent of the $20,000 that exceeds the uncertain as to how to determine that an LEA several situations: amount it received in FY–1 (i.e., up to had ‘‘received’’ Federal funds. • Example 1: An LEA receives $100,000 in $4,000). Those funds could be used by the Because the statute and regulations were Federal LEA Subgrant funds under section LEA for the remainder of FY–2 and through not sufficiently clear with respect to which 611(g) of the Act from the appropriation for the end of the carry-over period for FY–2 precise funds are affected by the 20 percent one fiscal year (FY–1), and $120,000 in funding. section 611(g) funds from the appropriation rule, this could have resulted in the 2. Auditing for Compliance with § 300.231 for the following fiscal year (FY–2). The LEA provision being interpreted and applied and the 20 percent rule in § 300.233 differently from LEA to LEA. If that situation may spend and treat as local funds up to 20 were to occur, it could result in a significant percent of the $20,000 in section 611(g) funds The following provides guidance for use by increase in the number of audit exceptions it receives from FY–2 (i.e., up to $4,000), auditors in determining if LEAs are in against LEAs. since this is the amount that exceeds the compliance with the maintenance of effort Given the confusion about which funding amount it received from the prior year. requirement in § 300.231 and the 20 percent sources are affected by the 20 percent rule, • Example 1–A: In Example 1, an LEA in rule in § 300.233: there was a critical need to set out in the FY–2 is uncertain whether to exercise its a. Meeting the Maintenance of Effort regulations a clear interpretation of section option to treat as local funds during FY–2 up Requirement. In order to be eligible to receive 613(a)(2)(C) in order to support its consistent to $4,000 of its section 611(g) funds received an IDEA-Part B subgrant in any particular application across LEAs and States, and to from FY–2, and wishes to wait until the fiscal year, an LEA is required to demonstrate reduce the potential for audit exceptions. carry-over year to make a decision. If the LEA that it has budgeted an amount of State and Thus, on June 10, 2000, the Department decides to exercise its option during the local funds, or just local funds, to be spent published a notice of proposed rulemaking carry-over period regarding the $4,000 from on special education and related services that (NPRM) regarding this provision (65 FR the FY–2 appropriation, it could do so as equals or exceeds (on either an aggregate or 30314). The NPRM stated that— long as those funds are used within the carry- per capita basis) the amount of those funds In light of the statutory structure for over period for FY–2. spent by the LEA for those purposes in the distribution of Federal funds to LEAs, we • Example 1–B: An LEA receives $100,000 prior fiscal year, or in the most recent prior believe that the most reasonable in section 611(g) funds from FY–1, $120,000 fiscal year for which information is available. interpretation is to apply that provision only from FY–2 and $140,000 from FY–3. The 34 CFR 300.231. to subgrants to LEAs under section 611(g) of LEA may spend and treat as local funds up b. Auditing Compliance with § 300.231. the Act (§ 300.712 of the regulations) from to 20 percent of the $20,000 from FY–2 funds Auditors, in determining if an LEA has funds appropriated from one Federal fiscal and $20,000 of FY–3 funds (i.e., up to $4,000 complied with § 300.231 in any particular year compared to funds appropriated for the for each year). Thus, if its FY–2 funds are not fiscal year, review the actual level of prior Federal fiscal year. (Emphasis added.) used until FY–3, and the LEA so chooses, it expenditures of State and local funds, or just Thus, the NPRM proposed to exclude the may spend and treat as local funds during local funds, on special education and related other Federal funds under Part B of the Act FY–3 a total of up to $8,000 in section 611(g) services for the year in question and the prior

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Part VII

Department of Education Office of Special Education and Rehabilitative Services, National Institute on Disability and Rehabilitation Research; Inviting Applications and Pre-application for a New Disability and Rehabilitation Research Projects for Fiscal Year 2001– 2002; Final Funding Priorities for Fiscal Years 2001–2002 for a National Center on Accessible Education-Based Information Technology and the Disability and Business Technical Assistance Centers; Notices

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DEPARTMENT OF EDUCATION application meeting to discuss the may not be able to make available the funding priorities for a National Center requested auxiliary aid or service [CFDA No.: 84.133D] on Accessible Education-Based because of insufficient time to arrange Office of Special Education and Information Technology and the it. Rehabilitative Services, National Disability and Business Technical Purpose of the Program: One of the Institute on Disability and Assistance Centers and to receive purposes of the Disability and Rehabilitation Research; Notice technical assistance through individual Rehabilitation Research Projects and Inviting Applications and Pre- consultation and information about the Centers Program is to improve the application for a New Disability and funding priority. The pre-application effectiveness of services authorized Rehabilitation Research Projects for meeting will be held on Wednesday, under the Rehabilitation Act of 1973. Fiscal Year 2001±2002 February 14, 2001 at the Department of The Assistant Secretary takes this action Education, Office of Special Education to focus research attention on an area of Note to Applicants: This notice is a and Rehabilitative Services, Switzer national need. The priority is intended complete application package. Together with Building, Room 3065, 330 C St. SW, to improve rehabilitation services and the statute authorizing the programs and Washington, DC between 9:30 a.m. and outcomes for individuals with applicable regulations governing the 12:00 a.m. NIDRR staff will also be disabilities. programs including the Education available at this location from 1:30 p.m. Department General Administrative to 5:00 p.m. on that same day to provide The notice of final funding priorities Regulations (EDGAR), this notice contains technical assistance through individual for a National Center on Accessible information, application forms, and Education-Based Information instructions needed to apply for a grant consultation and information about the under these competitions. funding priority. NIDRR will make Technology and the Disability and These programs support the National alternate arrangements to accommodate Business Technical Assistance Centers Education Goal that calls for all interested parties who are unable to is published elsewhere in this issue of Americans to possess the knowledge attend the pre-application meeting in the Federal Register. and skills necessary to compete in a person. For further information contact Eligible Applicants: Parties eligible to global economy and exercise the rights Joseph DePhillips, Switzer Building, apply for grants under this program are and responsibilities of citizenship. room 3418, 330 C Street, SW, States, public or private agencies, The estimate of funding levels in this Washington, D.C. 20202. Telephone including for-profit agencies, public or notice does not bind the Department of (202) 205–8187. If you use a TTY, please private organizations, including for- Education to make awards in any of call (202) 205–4475. profit organizations, institutions of these categories, or to any specific Assistance to Individuals With higher education, and Indian tribes and number of awards or funding levels, Disabilities at the Public Meeting tribal organizations. unless otherwise specified in statute. Application Available: January 8, Requests for funding reasonable The meeting site is accessible to 2001. accommodations are not included in the individuals with disabilities, and a sign maximum award amount, per year, as language interpreter will be available. If Project Period: 60 months. listed in the table. you need an auxiliary aid or service Program Authority: 29 U.S.C. 762(g) and Reasonable Accommodation: We will other than a sign language interpreter in 764(b)(4). consider, and may grant, requests for order to participate in the meeting (e.g. additional funding as an addendum to other interpreting service such as oral, Applicable Regulations: The an application to reflect the costs of cued speech, or tactile interpreter; Education Department General reasonable accommodations necessary assistive listening device; or materials in Administrative Regulations (EDGAR), to allow individuals with disabilities to alternative format), notify the contact 34 CFR parts 74, 75, 77, 80, 81, 82, 85, be employed on the project as personnel person listed in this notice at least two and 86; the program regulations 34 CFR on project activities. weeks before the scheduled meeting part 350, and the Notice of Final Priority This notice also invites interested date. Although we will attempt to meet published elsewhere in this issue of the parties to participate in a pre- a request we receive after this date, we Federal Register.

APPLICATION NOTICE FOR FISCAL YEARS 2000±2001 DISABILITY AND REHABILITATION RESEARCH PROJECTS, CFDA NO. 84±133D

Estimated Maximum award Project Funding priority Deadline for transmittal of number of amount period applications awards (per year)* (months)

84.133D National Center on Accessible Education- March 26, 2001 ...... 1 ...... $700,000 ...... 60 Based Information Technology. 84.133±D8 Disability and Business Technical Assist- March 26, 2001 ...... see below ...... See below 60 ance Centers. (Break down by Region). Region I, DBTAC ...... March 26, 2001 ...... 1 ...... $850,000 ...... 60 Region II, DBTAC ...... March 26, 2001 ...... 1 ...... $1,100,000 ...... 60 Region III, DBTAC ...... March 26, 2001 ...... 1 ...... $1,100,000 ...... 60 Region IV, DBTAC ...... March 26, 2001 ...... 1 ...... $1,450,000 ...... 60 Region V, DBTAC ...... March 26, 2001 ...... 1 ...... $1,450,000 ...... 60 Region VI, DBTAC ...... March 26, 2001 ...... 1 ...... $1,100,000 ...... 60 Region VII, DBTAC ...... March 26, 2001 ...... 1 ...... $850,000 ...... 60 Region VIII, DBTAC ...... March 26, 2001 ...... 1 ...... $850,000 ...... 60 Region IX, DBTAC ...... March 26, 2001 ...... 1 ...... $1,450,000 ...... 60 Region X, DBTAC ...... March 26, 2001 ...... 1 ...... $850,000 ...... 60

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APPLICATION NOTICE FOR FISCAL YEARS 2000±2001 DISABILITY AND REHABILITATION RESEARCH PROJECTS, CFDA NO. 84±133DÐContinued

Estimated Maximum award Project Funding priority Deadline for transmittal of number of amount period applications awards (per year)* (months)

AIMS (optional) ...... March 26, 2001 ...... 1 ...... $80,000 ...... 60 *Note: Consistent with EDGAR 34 CFR 75.104(b), we will reject any application that proposes a project funding level for any year that ex- ceeds the stated maximum award amount for that year.

For Applications Contact: The Grants in accomplishing the objectives of the (e) Quality of the management plan (3 and Contracts Service Team (GCST), project. points total). (1) The Secretary considers Department of Education, 400 Maryland (2) In determining the extent to which the quality of the management plan for Avenue SW, Switzer Building, 3317, the design is likely to be effective in the proposed project. Washington, D.C. 20202, or call (202) accomplishing the objectives of the (2) In determining the quality of the 205–8207. Individuals who use a project, the Secretary considers the management plan for the proposed telecommunications device for the deaf following factors: project, the Secretary considers the (TDD) may call the TDD number at (202) (i) The extent to which the proposed adequacy of the management plan to 205–9860. The preferred method for training materials are likely to be achieve the objectives of the proposed requesting information is to FAX your effective, including consideration of project on time and within budget, request to (202) 205–8717. their quality, clarity, and variety (17 including clearly defined Individuals with disabilities may points). responsibilities, timelines, and obtain a copy of the application package (ii) The extent to which the proposed milestones for accomplishing project in an alternative format by contacting training methods are of sufficient tasks (3 points). the GCST. However, the Department is quality, intensity, and duration (7 (f) Adequacy and reasonableness of not able to reproduce in an alternative points). the budget (4 points total). (1) The (c) Design of dissemination activities format the standard forms included in Secretary considers the adequacy and (24 points total). the reasonableness of the proposed the application package. (1) The Secretary considers the extent budget. FOR FURTHER INFORMATION CONTACT: to which the design of dissemination (2) In determining the adequacy and Donna Nangle, U.S. Department of activities is likely to be effective in the reasonableness of the proposed Education, 400 Maryland Avenue, SW, accomplishing the objectives of the budget, the Secretary considers the room 3414, Switzer Building, project. Washington, D.C. 20202–2645. (2) In determining the extent to which following factors: Telephone: (202) 205–5880. Individuals the design is likely to be effective in (i) The extent to which the costs are who use a telecommunications device accomplishing the objectives of the reasonable in relation to the proposed for the deaf (TDD) may call the TDD project, the Secretary considers the project activities (2 points). number at (202) 205–4475. Internet: following factors: (iii) The extent to which the budget [email protected]. (i) The extent to which the materials for the project, including any Individuals with disabilities may to be disseminated are likely to be subcontracts, is adequately justified to obtain this document in an alternative effective and usable, including support the proposed project activities format (e.g., Braille, large print, consideration of their quality, clarity, (2 points). audiotape, or computer diskette) on variety, and format (17 points). (g) Quality of the project evaluation (3 request to the contact person listed in (ii) The extent to which the methods points total). the preceding paragraph. for dissemination are of sufficient (1) The Secretary considers the quality, intensity, and duration (7 quality of the evaluation to be Selection Criteria points). conducted of the proposed project. (2) In determining the quality of the National Center on Accessible (d) Design of technical assistance evaluation, the Secretary considers the Education-Based Information activities (22 points total). (1) The Secretary considers the extent to which extent to which the methods of Technology Selection Criteria: The the design of technical assistance evaluation are thorough, feasible, and Secretary uses the following selection activities is likely to be effective in appropriate to the goals, objectives, and criteria to evaluate applications for the accomplishing the objectives of the outcomes of the proposed project (3 National Center on Accessible project. points). Education-Based Information (2) In determining the extent to which (h) Project staff (13 points total). (1) Technology. the design is likely to be effective in The Secretary considers the quality of (a) Importance of the problem (3 accomplishing the objectives of the the project staff. points total). (1) The Secretary considers project, the Secretary considers the (2) In determining the quality of the the importance of the problem. following factors: project staff, the Secretary considers the (2) In determining the importance of (i) The extent to which the methods extent to which the applicant the problem, the Secretary considers the for providing technical assistance are of encourages applications for employment extent to which the proposed project sufficient quality, intensity, and from persons who are members of will have beneficial impact on the target duration (7 points). groups that have traditionally been population (3 points). (ii) The extent to which the underrepresented based on race, color, (b) Design of training activities (24 information to be provided through national origin, gender, age, or disability points total). (1) The Secretary considers technical assistance covers all of the (1 point). the extent to which the design of relevant aspects of the subject matter (15 (3) In addition, the Secretary training activities is likely to be effective points). considers the following factors:

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(i) The extent to which key personnel project, the Secretary considers the (f) Quality of project services (10 have expert knowledge on the American following factors: points total). (1) The Secretary considers with Disabilities Act (ADA) and (i) The extent to which the proposed the quality of the services to be experience with providing technical training materials are likely to be provided by the proposed project. assistance on the ADA to conduct all effective, including consideration of (2) In determining the quality of the proposed activities (3 points). their quality, clarity, and variety (7 services to be provided by the proposed (ii) The extent to which key personnel points). project, the Secretary considers the have expert knowledge about state-of- (ii) The extent to which the proposed quality and sufficiency of strategies for the-art Information Technology (IT) to training methods are of sufficient ensuring equal access and treatment for conduct all proposed activities (7 quality, intensity, and duration (7 eligible project participants who are points). points). members of groups that have (iii) The extent to which the (d) Design of dissemination activities traditionally been underrepresented commitment of staff time is adequate to (21 points total). based on race, color, national origin, accomplish all the proposed activities of (1) The Secretary considers the extent gender, age, or disability (2 points). the project (2 points). to which the design of dissemination (3) In addition, the Secretary (i) Adequacy and accessibility of activities is likely to be effective in considers the following factors: resources (4 points total). (1) The accomplishing the objectives of the (i) The extent to which the services to Secretary considers the adequacy and project. be provided by the proposed project accessibility of the applicant’s resources (2) In determining the extent to which involve the collaboration of appropriate to implement the proposed project. the design is likely to be effective in partners for maximizing the (2) In determining the adequacy and accomplishing the objectives of the effectiveness of project services (5 accessibility of resources, the Secretary project, the Secretary considers the points). considers the following factors: following factors: (ii) The extent to which the technical (i) The extent to which the materials (i) The extent to which the applicant assistance services to be provided by the to be disseminated are likely to be is committed to provide adequate proposed project involve the use of effective and usable, including facilities, equipment, other resources, efficient strategies, including the use of consideration of their quality, clarity, including administrative support, and technology, as appropriate, and the variety, and format (7 points). laboratories, if appropriate (2 points). leveraging of non-project resources (3 (ii) The extent to which the methods (ii) The extent to which the facilities, points). for dissemination are of sufficient equipment, and other resources are (g) Quality of the management plan (3 quality, intensity, and duration (7 appropriately accessible to individuals points total). (1) The Secretary considers with disabilities who may use the points). (iii) The extent to which the materials the quality of the management plan for facilities, equipment, and other the proposed project. resources of the project (2 points). and information to be disseminated and the methods for dissemination are (2) In determining the quality of the The Disability and Business Technical appropriate to the target population, management plan for the proposed Assistance Centers including consideration of the project, the Secretary considers the Selection Criteria: The Secretary uses familiarity of the target population with adequacy of the management plan to the following selection criteria to the subject matter, format of the achieve the objectives of the proposed evaluate applications for the Disability information, and subject matter (7 project on time and within budget, and Business Technical Assistance points). including clearly defined Centers. (e) Design of technical assistance responsibilities, timelines, and (a) Importance of the problem (3 activities (21 points total). (1) The milestones for accomplishing project points total). (1) The Secretary considers Secretary considers the extent to which tasks (3 points). the importance of the problem. the design of technical assistance (h) Adequacy and reasonableness of (2) In determining the importance of activities is likely to be effective in the budget (4 points total). (1) The the problem, the Secretary considers the accomplishing the objectives of the Secretary considers the adequacy and extent to which the proposed project project. the reasonableness of the proposed will have beneficial impact on the target (2) In determining the extent to which budget. population (3 points). the design is likely to be effective in (2) In determining the adequacy and (b) Significance (3 points total). (1) accomplishing the objectives of the the reasonableness of the proposed The Secretary considers the significance project, the Secretary considers the budget, the Secretary the following of the proposed project. following factors: factors: (3) In determining the significance of (i) The extent to which the methods (i) The extent to which the costs are the proposed project, the Secretary for providing technical assistance are of reasonable in relation to the proposed considers the extent to which the sufficient quality, intensity, and project activities (2 points). proposed project is likely to build local duration (7 points). (ii) The extent to which the budget for capacity to provide, improve, or expand (iii) The extent to which the the project, including any subcontracts, services that address the needs of the information to be provided through is adequately justified to support the target population (3 points). technical assistance covers all of the proposed project activities (2 points). (c) Design of training activities (14 relevant aspects of the subject matter (7 (i) Quality of the project evaluation (3 points total). (1) The Secretary considers points). points total). (1) The Secretary considers the extent to which the design of (iii) The extent to which the technical the quality of the evaluation to be training activities is likely to be effective assistance is appropriate to the target conducted of the proposed project. in accomplishing the objectives of the population, including consideration of (2) In determining the quality of the project. the knowledge level of the target evaluation, the Secretary considers the (2) In determining the extent to which population, needs of the target extent to which the methods of the design is likely to be effective in population, and format for providing evaluation are thorough, feasible, and accomplishing the objectives of the information (7 points). appropriate to the goals, objectives, and

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(1) up to a total of 10 points in addition to (c) If an application is mailed through The Secretary considers the quality of those awarded under the published the U.S. Postal Service, the Secretary the project staff. selection criteria for these priorities. does not accept either of the following (2) In determining the quality of the That is, an applicant meeting this as proof of mailing: project staff, the Secretary considers the competitive preference could earn a (1) A private metered postmark. maximum total of 110 points. extent to which the applicant (2) A mail receipt that is not dated by encourages applications for employment Instructions for Application Narrative the U.S. Postal Service. from persons who are members of Notes: (1) The U.S. Postal Service does not groups that have traditionally been The Secretary will reject without consideration or evaluation any uniformly provide a dated postmark. Before underrepresented based on race, color, relying on this method, an applicant should national origin, gender, age, or disability application that proposes a project check with its local post office. (1 point). funding level that exceeds the stated (2) An applicant wishing to know that its (3) In addition, the Secretary maximum award amount per year (See application has been received by the considers the following factors: 34 CFR 75.104(b)). Department must include with the (i) The extent to which key personnel The Secretary strongly recommends application a stamped self-addressed have expert knowledge on the ADA and the following: postcard containing the CFDA number and experience with providing technical (1) A one-page abstract; title of this program. (3) The applicant must indicate on the assistance on the ADA to conduct all (2) An Application Narrative (i.e., Part III that addresses the selection criteria envelope and—if not provided by the proposed activities (8 points). Department—in Item 10 of the Application (ii) The extent to which key personnel that will be used by reviewers in evaluating individual proposals) of no for Federal Assistance (Standard Form 424) have expert knowledge about state-of- the CFDA number—and letter, if any—of the the-art IT to conduct all proposed more 125 pages for Project applications, competition under which the application is double-spaced (no more than 3 lines per being submitted. activities (3 points). ″ ″ (iii) The extent to which the vertical inch) 8 x 11 pages (on one side Application Forms and Instructions commitment of staff time is adequate to only) with one inch margins (top, bottom, and sides). The application accomplish all the proposed activities of The appendix to this application is narrative page limit recommendation the project (2 points). divided into four parts. These parts are does not apply to: Part I—the (k) Adequacy and accessibility of organized in the same manner that the electronically scannable form; Part II— resources (4 points total). (1) The submitted application should be the budget section (including the Secretary considers the adequacy and organized. These parts are as follows: accessibility of the applicant’s resources narrative budget justification); and Part IV—the assurances and certifications; PART I: Application for Federal Assistance to implement the proposed project. (ED Form 424 (Rev. 11/12/99)) and and (2) In determining the adequacy and instructions. (3) A font no smaller than a 12-point accessibility of resources, the Secretary font and an average character density no PART II: Budget Form—Non-Construction considers the following factors: Programs (ED Form 524A) and instructions. greater than 14 characters per inch. (i) The extent to which the applicant PART III: Application Narrative. is committed to provide adequate Instructions for Transmittal of Additional Materials facilities, equipment, other resources, Applications Estimated Public Reporting Burden. including administrative support, and (a) If an applicant wants to apply for Assurances—Non-Construction Programs laboratories, if appropriate (2 points). a grant, the applicant must— (Standard Form 424B). (ii) The extent to which the facilities, (1) Mail the original and two copies Certification Regarding Lobbying, equipment, and other resources are of the application on or before the appropriately accessible to individuals Debarment, Suspension, and Other deadline date to: U.S. Department of Responsibility Matters: and Drug-Free with disabilities who may use the Education, Application Control Center, facilities, equipment, and other Work-Place Requirements (ED Form 80– Attention: (CFDA # [Applicant must 0013). resources of the project (2 points). insert number and letter] and name), Certification Regarding Debarment, Additional Selection Criterion: The Washington, DC 20202–4725, or Suspension, Ineligibility and Voluntary maximum score for all the criteria is 100 (2) Hand deliver the original and two Exclusion: Lower Tier Covered points; however, under 34 CFR copies of the application by 4:30 p.m. Transactions (ED Form 80–0014) and 75.105(c)(2)(i) we will also use the [Washington, DC time] on or before the instructions. (NOTE: ED Form GCS–014 following criterion so that up to an deadline date to: U.S. Department of is intended for the use of primary additional 10 points may be earned by Education, Application Control Center, participants and should not be an applicant for a total possible score of Attention: (CFDA # [Applicant must transmitted to the Department.) 110 points. insert number and letter] and name), Up to 10 points based on the extent Room #3633, Regional Office Building Disclosure of Lobbying Activities to which an application includes #3, 7th and D Streets, SW., Washington, (Standard Form LLL (if applicable) and effective strategies for employing and DC. instructions; and Disclosure Lobbying advancing in employment qualified (b) An applicant must show one of the Activities Continuation Sheet (Standard individuals with disabilities in projects following as proof of mailing: Form LLL–A). awarded under these absolute priorities. (1) A legibly dated U.S. Postal Service An applicant may submit information In determining the effectiveness of those postmark. on a photostatic copy of the application strategies, we will consider the (2) A legible mail receipt with the and budget forms, the assurances, and applicant’s prior success, as described date of mailing stamped by the U.S. the certifications. However, the in the application, in employing and Postal Service. application form, the assurances, and advancing in employment qualified (3) A dated shipping label, invoice, or the certifications must each have an individuals with disabilities. receipt from a commercial carrier. original signature. No grant may be

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Can NIDRR Staff Advise Me Whether My budgets for both the first year and all documents published in the Federal Project is of Interest to NIDRR or Likely to subsequent project years should be included. Register, in text or Adobe Portable be Funded? Document Format (PDF) on the Internet If collaboration with another organization is involved in the proposed activity, the No. NIDRR staff can advise you of the at either of the following sites: application should include assurances of requirements of the program in which you http://ocfo.ed.gov/fedreg.htm participation by the other parties, including propose to submit your application. http://www.ed.gov/news.html written agreements or assurances of However, staff cannot advise you of whether To use PDF you must have Adobe cooperation. It is not useful to include your subject area or proposed approach is Acrobat Reader, which is available free general letters of support or endorsement in likely to receive approval. at either of the preceding sites. If you the application. 9. How Do I Assure That My Application have questions about using PDF, call the If the applicant proposes to use unique Will be Referred to the Most Appropriate U.S. Government Printing Office (GPO), tests or other measurement instruments that Panel for Review? toll free at 1–888–293–6498; or in the are not widely known in the field, it would Applicants should be sure that their Washington, DC, area at (202) 512–1530. be helpful to include the instrument in the applications are referred to the correct application. competition by clearly including the Note: The official version of this document Many applications contain voluminous competition title and CFDA number, is the document published in the Federal appendices that are not helpful and in many including alphabetical code, on the ED Form Register. Free Internet access to the official cases cannot even be mailed to the reviewers. 424, and including a project title that edition of the Federal Register and the Code It is generally not helpful to include such describes the project. of Federal Regulations is available on GPO things as brochures, general capability Access at: 10. How Soon After Submitting My statements of collaborating organizations, Application Can I Find Out if it Will be http://www.access.gpo.gov/nara/index.html maps, copies of publications, or descriptions Funded? of other projects completed by the applicant. (Catalog of Federal Domestic Assistance The time from closing date to grant award Numbers: 84.133D, Disability and 3. What Format Should Be Used for the date varies from program to program. Rehabilitation Research Projects) Application? Generally speaking, NIDRR endeavors to Program Authority: 29 U.S.C. 762(g) and NIDRR generally advises applicants that have awards made within five to six months 764(b)(4). they may organize the application to follow of the closing date. Unsuccessful applicants the selection criteria that will be used. The generally will be notified within that time Dated: December 26, 2000. specific review criteria vary according to the frame as well. For the purpose of estimating Curtis L. Richards, specific program, and are contained in this a project start date, the applicant should Acting Assistant Secretary For Special Consolidated Application Package. estimate approximately six months from the Education and Rehabilitative Services. closing date, but no later than the following 4. May I Submit Applications to More Than September 30. Appendix One NIDRR Program Competition or More Than One Application to a Program? 11. Can I Call NIDRR to Find Out if My Application Forms and Instructions Application is Being Funded? Yes, you may submit applications to any Applicants are advised to reproduce and program for which they are responsive to the No. When NIDRR is able to release complete the application forms in this program requirements. You may submit the information on the status of grant section. Applicants are required to submit an same application to as many competitions as applications, it will notify applicants by original and two copies of each application you believe appropriate. You may also letter. The results of the peer review cannot as provided in this section. However, submit more than one application in any be released except through this formal applicants are encouraged to submit an given competition. notification. original and seven copies of each application 12. If My Application is Successful, Can I in order to facilitate the peer review process 5. What Is the Allowable Indirect Cost Rate? Assume I Will Get the Requested Budget and minimize copying errors. The limits on indirect costs vary according Amount in Subsequent Years? to the program and the type of application. Frequest Questions An applicant for a Disability and No. Funding in subsequent years is subject 1. Can I Get an Extansion of the Due Date? Rehabilitation Research Project should limit to availability of funds and project performance. No! On rare occasions the Department of indirect charges to the organization’s Education may extend a closing date for all approved indirect cost rate. If the 13. Will All Approved Applications be applicants. If that occurs, a notice of the organization does not have an approved Funded? revised due date is published in the Federal indirect cost rate, the application should No. It often happens that the peer review Register. However, there are no extensions or include an estimated actual rate. panels approve for funding more applications exceptions to the due date made for 6. Can Profitmaking Businesses Apply for than NIDRR can fund within available individual applicants. Grants? resources. Applicants who are approved but 2. What Should Be Included in the Yes. However, for-profit organizations will not funded are encouraged to consider Application? not be able to collect a fee or profit on the submitting similar applications in future competitions. The application should include a project grant, and in some programs will be required narrative, vitae of key personnel, and a to share in the costs of the project. BILLING CODE 4000±01±U

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[FR Doc. 01–85 Filed 1–4–01; 8:45 am] DEPARTMENT OF EDUCATION SUMMARY: The Assistant Secretary for BILLING CODE 4000±01±C the Office of Special Education and National Institute on Disability and Rehabilitative Services announces final Rehabilitation Research; Notice of funding priorities for a National Center Final Funding Priorities for Fiscal on Accessible Education-Based Years 2001±2002 for a National Center Information Technology and the on Accessible Education-Based Disability and Business Technical Information Technology and the Assistance Centers under the National Disability and Business Technical Institute on Disability and Assistance Centers Rehabilitation Research (NIDRR) for fiscal years 2001–2002. The Assistant AGENCY: Office of Special Education and Secretary takes this action to focus Rehabilitative Services, Department of research attention on areas of national Education. need. We intend these priorities to improve the rehabilitation services and

VerDate 112000 14:45 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4703 E:\FR\FM\08JAN4.SGM pfrm01 PsN: 08JAN4 1500 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Notices outcomes for individuals with Disability and Rehabilitation Research addresses the extent to which key disabilities. Project and Centers Program personnel have expert knowledge on the ADA and experience with providing General Comments DATES: These priorities take effect on technical assistance on the ADA. February 7, 2001. Comment: The National Center on National Center on Accessible Accessible Education-Based Information FOR FURTHER INFORMATION CONTACT: Education-Based Information Technology or one of the DBTACs Donna Nangle. Telephone: (202) 205– Technology 5880. Individuals who use a should be responsible for evaluating the Comment: The National Center telecommunications device for the deaf accessibility of nationally distributed IT should be required to coordinate with (TDD) may call the TDD number at (202) products. the Assistive Technology Act Projects 205–4475. Internet: Discussion: The scale of this activity and the Technical Assistance provider [email protected]. would rival all of the required activities in the priority. In addition, a variety of to the Assistive Technology Act Individuals with disabilities may public and private sector interests (e.g., Projects. obtain this document in an alternative manufacturers, Federal agencies, trade Discussion: The priority requires the format (e.g., Braille, large print, associations, disability organizations) National Center to coordinate with a audiotape, or computer diskette) on currently undertake this activity. The number of NIDRR grantees as well as a request to the contact person listed in National Center and the DBTACs will wide array of Federal agencies. Because the preceding paragraph. disseminate the results of these we do not believe that it is imperative for the National Center to coordinate SUPPLEMENTARY INFORMATION: This evaluations. We decline to revise the notice contains final priorities under the priority as suggested because of its scale with the Assistive Technology Act Disability and Rehabilitation Research and in order to avoid duplication of Projects and the Technical Assistance Projects and Centers Program (DRRP) for effort. provider to the Assistive Technology a National Center on Accessible Changes: None. Act Projects in order to fulfill the Education-Based Information purposes of the priority, we decline to Comment: An additional factor was require the National Center to Technology and the Disability and proposed to the selection criteria that Business Technical Assistance Centers. coordinate with these entities. However, will be used to evaluate applications for an applicant may propose to coordinate The final priorities refer to NIDRR’s the National Center and the DBTACs. with the Assistive Technology Act Long Range Plan (the Plan). The Plan This proposed factor states that in Projects and the Technical Assistance can be accessed on the World Wide Web determining the quality of the project provider to the Assistive Technology at: http://www.ed.gov/offices/OSERS/ staff, NIDRR will consider the extent to Act Projects, and the application review NIDRR/#LRP. which key personnel have expert process will evaluate the merits of the knowledge about state-of-the-art IT to National Education Goals proposal. conduct all activities. Changes: None. These final priorities will address the One commenter suggested that this factor should be revised to include the Disability and Business Technical National Education Goal that every Assistance Centers adult American will be literate and will extent to which key personnel have possess the knowledge and skills expert knowledge about the ADA and Comment: Two commenters suggested necessary to compete in a global significant experience in providing requiring the DBTACs to provide economy and exercise the rights and technical assistance about basic and technical assistance on the responsibilities of citizenship. complex ADA issues. nondiscrimination requirements of the A second commenter suggested that Workforce Investment Act to entities The authority for the program to this factor should be applied to all within the Workforce Investment establish research priorities by reserving partners and collaborators in an System such as One-Stop Centers and funds to support particular research application. local Workforce Investment Boards. activities is contained in sections 202(g) Discussion: In regard to the first Discussion: Other than educational and 204 of the Rehabilitation Act of comment, it will not be possible for the entities, the priority does not require the 1973, as amended (29 U.S.C. 762(g) and National Center and the DBTACs to DBTACs to provide technical assistance 764(b)(4)). Regulations governing this fulfill their purposes unless key and training to any specific target program are found in 34 CFR part 350. personnel have expert knowledge on the audience. In order to allow the DBTACs Note: This notice does not solicit ADA and experience with providing as much flexibility as possible to meet applications. A notice inviting applications is technical assistance on the ADA. the demands for technical assistance published in this issue of the Federal Revising the selection criteria as within their region, we decline to Register. suggested by the first commenter will require the DBTACs to provide Analysis of Comments and Changes improve the evaluation process. We technical assistance and training to agree to revise the factor as suggested. entities within the Workforce On November 7, 2000, the Assistant In regard to the second comment, the Development System. The priority Secretary published a notice of application of this factor is not allows the DBTACs the discretion to proposed priorities in the Federal restricted exclusively to the applicant. provide technical assistance to all Register (65 FR 66732). The Department The staff of an applicant’s partners or entities covered by the ADA including of Education received 10 letters collaborators will be evaluated by the those within the Workforce Investment commenting on the notice of proposed peer reviewers using this factor if their System. An applicant may propose to priorities by the deadline date. roles are considered key to the provide technical assistance and Technical and other minor changes— performance of the grant. It is not training to entities within the Workforce and suggested changes the Assistant necessary to revise the factor in order to Development System, and the Secretary is not legally authorized to address the commenter’s concern. application review process will evaluate make under statutory authority—are not Changes: The selection criteria have the merits of the proposal. addressed. been changed to include a factor that Changes: None.

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Comment: Three commenters made grantees would be more effective than Special Education Program’s Regional various suggestions to require the the DBTACs in carrying out these Resource Centers, and the application DBTACs to promote the employment activities. review process will evaluate the merits status of persons with disabilities. Two Discussion: We share the first of the proposal. commenters suggested that the DBTACs commenter’s concern that the special Changes: None. should be required to promote best emphasis should not compromise the Comment: Educational IT is unique in practices in the employment area for technical assistance and training that many respects and is developed by an business and government. One of these the DBTACs provide on the ADA. In industry that is diverse and not very commenters also suggested that an order to ensure that this does not advanced in addressing accessibility additional selection criteria factor be happen, we requested and received an standards. Providing technical added to evaluate applicants’ proposals increase of approximately five million assistance and training to schools to promote successful employer dollars in the DBTAC program’s budget. without a complementary effort targeted practices that impact hiring, retention, We believe that this additional support toward industry will minimize the and promotion of persons with will allow the DBTACs to maintain their impact of the priority. disabilities. current level of activity on the ADA and Discussion: We agree with the Two commenters suggested that the effectively carry out the additional commenter’s observations regarding the DBTACs undertake a number of activities related to accessible unique qualities of educational IT and activities to educate employers and education-based IT. the need to work with industry to employment specialists on providing In regard to the commenters who improve the accessibility of their IT accessible IT to employees with questioned whether the DBTACs were products. NIDRR has funded a disabilities and the benefits of providing the appropriate vehicle to carry out the Rehabilitation Engineering Research this accommodation. special emphasis, the DBTAC program Center (RERC) on Information Discussion: One of the primary has had a special emphasis on working Technology Access since June of 1998, purposes of the ADA is to prohibit with schools systems dating back to an Information Technology Technical discrimination against persons with 1994 and has developed a State network Assistance and Training Center in disabilities in the area of employment in structure that is well-suited to FY2000, and plans on establishing a order to improve their employment delivering training and technical new RERC on Wireless Information status. Nearly twenty-five percent of all assistance at the State and local levels. Technology in FY2001. The mission of the training and technical assistance In order to ensure that the DBTACs have both of these RERCs is to work closely that the DBTACs provide is targeted to the technological expertise on IT that with industry to assist them in the employers and businesses. The DBTACs will be necessary to successfully carry development and marketing of have the authority to undertake the out the special emphasis, we designed accessible IT products. When these types of activities submitted by the the priority and the selection criteria to centers work with the educational IT commenters. We believe that they are require the DBTACs to partner with industry, they will address the unique excellent activities to promote the organizations that are expert in IT and qualities of educational IT products. successful implementation of the ADA. maintain IT expertise on their staffs. Therefore we believe that this priority is However, in order to provide the In regard to the comment that the appropriately focused with an emphasis DBTACs with as much flexibility as Assistive Technology State grantees on education-based information possible in meeting the needs of their would be more effective than the technology. regions, we decline to revise the DBTACs in carrying out this special Changes: None. selection criteria or require these emphasis, NIDRR recognizes the Comment: Two commenters specific activities. An applicant may valuable contribution that these expressed concern about the lack of propose to undertake the activities organizations can make to this initiative. national standards and its impact on the suggested by the commenters, and the This is evidenced by the fact that the technical assistance provided by the application review process will evaluate priority specifically requires the DBTACs. One of these commenters the merits of the proposal. DBTACs to form regional partnerships suggested that NIDRR should wait for Changes: None. with the Assistive Technology Act national standards for accessibility to Comment: The priority adds a special grantees among others. We note that the computer labs to be developed before emphasis to the mission of the DBTACs, entities that administer the Assistive providing technical assistance and by requiring them to assist educational Technology State grants are eligible training to educational entities. entities in providing children, youth, applicants for the DBTAC competition. Discussion: National accessibility and adults with disabilities with access NIDRR encourages competition in all of standards, including those for computer to IT. Five commenters expressed our programs, and looks forward to labs, would simplify the work of the various concerns about these activities. receiving applications from a wide DBTACs significantly. However, Three commenters observed that these range of applicants with the capabilities educational entities need technical activities departed significantly from the to fulfill the purposes of a DBTAC. assistance now in order to improve the DBTACs’ primary mission. One of these Changes: None. accessibility of their IT. We decline to commenters suggested this activity Comment: The DBTACs should be wait to provide technical assistance and emphasis could compromise the required to utilize the personnel from training. DBTACs’ principal efforts in providing the Assistive Technology Act Project Changes: None. technical assistance and training on the and the Office of Special Education Comment: Elementary and secondary ADA. The other two commenters Program’s Regional Resource Centers. schools are accustomed to using the suggested that the DBTACs did not Discussion: We decline to specify Individuals with Disabilities Education possess the requisite experience in applicant personnel because applicants Act (IDEA) and Section 504 to working with IT and State and local should be able to tailor proposed understand their obligation to provide educational entities to be effective. personnel to the activities that will be accessible instructional technology to These latter two commenters, as well as supported. An applicant may propose to students with disabilities. It will be two additional commenters, suggested utilize personnel from the Assistive helpful to not only seek a clear legal that the Assistive Technology Act State Technology Act Project and the Office of interpretation of the ADA’s

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In order for the Background DBTACs to be able to provide the type Public Law 101–336, the Americans with Disabilities Act (ADA), enacted on IT plays a critical role in all of technical assistance identified by the educational settings. Regardless of their commenter, the priority requires the July 26, 1990, prohibits discrimination against individuals with disabilities in age, students who cannot access IT are DBTACs to be knowledgeable about a operating at a significant disadvantage wide array of disability-related or employment, public accommodations, transportation, State and local to their peers who can. Recent reports disability rights laws, including IDEA suggests that, regardless of age, and Section 504. In addition, the government, and telecommunications. In October 1991, and again in October educators and students with disabilities priority emphasizes the importance of face significant IT accessibility issues the DBTACs’ promotion of best 1996, NIDRR awarded five-year grants to establish 10 regional Disability and (‘‘Computer and Internet Use Among practices in order to encourage People with Disabilities,’’ Dr. Stephen educational entities to acquire Business Technical Assistance Centers (DBTACs). These centers provide Kaye, Disability Statistics Center, accessible IT even when they are not University of California-San Francisco, obligated to do so. Therefore, no technical assistance and training on all of the requirements of the ADA to published by NIDRR, U.S. Department changes are necessary to address the of Education, March 2000; and ‘‘What commenter’s concern regarding 504 and covered entities and individuals with responsibilities and rights under the are the Barriers to Use of Advanced IDEA because we expect the DBTACs to Telecommunications for Students with be able to assist schools to understand ADA. Currently, there is one DBTAC in each of the 10 Department of Education Disabilities in Public Schools,’’ Issue not only their ADA obligations, but also Brief published by the National Center the relationships between the ADA, regions. For FY 2001 NIDRR is funding 10 new DBTACs that will maintain the for Education Statistics, U.S. IDEA, and Section 504. Department of Education, NCES 2000– In regard to the comment of the need current level of effort on providing 42, January 2000). These issues can be for clear legal interpretation of the information and technical assistance on broken down into two types: legal and ADA’s requirements for IT, as case law the ADA as well as add a special technological. and policy guidance from responsible emphasis in the area of education-based Section 504 of the Rehabilitation Act Federal agencies develop on the subject information technology (IT). The of 1973, as amended, prohibits of the application of the ADA to IT, the purpose of this special emphasis is to discrimination on the basis of disability DBTACs will disseminate this assist covered educational entities in in any program or activity of recipients information to all interested parties. providing children, youth, and adults of Federal financial assistance. Virtually Changes: None. with disabilities with access to IT. Comment: Does education-based IT NIDRR is funding two priorities all school districts receive Federal funds include accessible textbooks and toward this end. The first will establish and have been required to comply with accessibility issues related to a national center on accessible Section 504 for many years. The ADA instructional media (e.g., captioning and education-based IT that will operate in extends this prohibition to a wider audio description of video)? collaboration with the DBTACs and will range of educational entities; however, Discussion: The final paragraph of the provide support and guidance on with some exceptions, the ADA does introduction to the two priorities education-based accessible IT technical not impose any major new requirements provides definitions of IT and assistance activities. The second priority on school districts and other education-based IT. If the textbooks and will establish 10 new DBTACs and educational entities that receive Federal instructional media contemplated by the delineates the technical assistance and funds and are covered by Section 504. commenter meet the definition of IT training activities required of them to The ADA requires virtually all cited in this paragraph, then they would promote the successful implementation educational entities to ensure that be considered education-based IT. of the ADA, including those activities persons with disabilities are not Changes: None. related to the special emphasis on excluded from participation in, or educational institutions and accessible denied the benefits of, its services, Disability and Rehabilitation Research IT. programs, and activities. This includes Project and Centers Program For the purposes of these priorities, all aspects of the instructional The authority for Disability and and consistent with the Clinger-Cohen environment, employment Rehabilitation Research Projects (DRRP) Act of 1996, information technology is relationships, and services carried out is contained in section 204 of the defined to include any equipment or by contractors. When IT is part of the Rehabilitation of 1973, as amended (29 interconnected system or subsystem of programs, services, or activities U.S.C. 762(g) and 764(b)(4)). The equipment that is used in the automatic provided by the educational entity, purpose of the Disability and acquisition, storage, manipulation, those entities have an obligation to Rehabilitation Research Project and management, movement, control, ensure that the hardware and software Centers Program is to plan and conduct display, switching, interchange, that make up those technologies are research, demonstration projects, transmission, or reception of data or accessible to all users. In some training and related activities to— information. It includes computer instances, educational entities may be (a) Develop methods, procedures, and hardware, software, networks, and unaware of their legal obligation to rehabilitation technology that peripherals as well as many electronic provide accessible IT to persons with maximizes the full inclusion and and communications devices commonly disabilities who enroll or seek to enroll integration into society, employment, used in offices. Education-based IT in their programs. Similarly, persons independent living, family support, and refers to any IT that is used by either with disabilities may be unaware that

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The audience elementary and secondary purchase accessible IT, or adapt the IT Center must: institutions, and postsecondary they have so that it is accessible to (1) Develop new materials and educational entities including, but not students or employees with disabilities. reformat or reprint existing materials to limited to, institutions of higher Both the responsible party within the assist educational entities to understand education, proprietary schools educational entity (e.g., the procurement and fulfill their legal obligations to (particularly those offering IT training), officer, related services personnel, the provide accessible IT. These materials and adult education programs; • teacher, or the computer lab director) may include, but are not limited to, the Coordinate with NIDRR’s and the student, or employee with a ADA self-evaluation guide for schools, Rehabilitation Engineering Research disability, may be unaware that Section 504 and ADA guidance for Centers (RERCs) on Information accessible IT exists and can be educational entities, technical materials Technology Access and purchased, or that adaptations may be on IT access, consumers’ guide to Telecommunications Access, and also made to the existing IT to provide accessible IT, and technical IT with NIDRR’s Information Technology accessibility. When a student or standards; Technical Assistance and Training employee with a disability uses assistive Center; (2) Conduct a national information • Coordinate with relevant Federal technology (e.g., an augmentative dissemination campaign to raise communication device), the agencies responsible for the awareness on accessible education- administration of public laws that technological problem may involve based IT and inform target audiences on identifying the proper interface between address access to and usability of the availability of technical assistance education-based IT for persons with the educational entity’s IT and the from the DBTACs and others. This student or employee’s assistive disabilities including, but not limited, to campaign may include, but is not the General Services Administration, technology. In these instances, limited to, print and electronic ads, information and technical assistance the Access Board, the Federal newsletters, presentations at national Communications Commission, the can aid the educational entity to provide conferences, and regular electronic accessible IT. Department of Justice, and offices communication with national within the Department of Education Some educational entities may also be organizations to update them on legal required to comply with the standards including the Rehabilitation Services and technological developments; Administration, the Office of Special for accessible technology to be issued by (3) Promote the procurement by the Access Board, as required by Section Education Programs, and the Office for educational entities of accessible Civil Rights; 508 of the Rehabilitation Act. Section information technology that meets the • 508 requires Federal agencies and Develop and maintain a web site to standards for section 508 or universal assist educational entities to understand departments to ensure equal access to design principles; electronic and information technology and fulfill their legal obligations related (4) Coordinate with and provide to accessible IT; and for individuals with disabilities • comparable to those who do not have training, materials, and technical Provide information and technical disabilities, unless such a requirement assistance to the DBTACs in support of assistance consistent with other IT would cause an undue burden. The their technical assistance efforts to accessibility laws, including, but not Assistive Technology Act (AT Act) educational entities on accessible IT; limited to, section 508 of the requires that States receiving assistance, (5) Provide training, materials, and Rehabilitation Act. including sub-recipients of AT Act technical assistance to the U. S. Priority 2: Disability and Business funds, under the AT State Grants Department of Education’s various IT Technical Assistance Centers program comply with the requirements initiatives including, but not limited to, of section 508, including the standards the Regional Technology in Education Background developed by the Access Board. Each Consortia, Comprehensive Regional Covered entities and individuals with State must determine whether entities Assistance Centers, the Technology responsibilities and rights under the such as colleges and universities or Literacy Challenge Fund, Community ADA continue to need technical local and intermediate school districts Technology Centers, and the Preparing assistance on the ADA. The demand for are considered part of the State and Tomorrow’s Teachers to Use technical assistance services from the therefore, must comply with Section Technology Programs in order to DBTACs has remained high since 1992 508 and the standards as published by promote accessibility by persons with (see Table 1), a trend that will likely the Access Board. disabilities; and continue indefinitely.

TABLE 1.ÐSUMMARY OF SELECTED DBTAC TECHNICAL ASSISTANCE AND TRAINING ACTIVITIES FROM FY 1992 THROUGH FY 1999

Number of Number of Number of Number of hard copy Fiscal year 800 line people technical materials calls trained assistance dissemi- efforts nated

1992 ...... 20,000 30,759 40,313 188,842 1993 ...... 61,000 63,341 79,964 539,511 1994 ...... 75,700 56,800 127,736 698,040 1995 ...... 90,400 64,870 152,395 901,878

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TABLE 1.ÐSUMMARY OF SELECTED DBTAC TECHNICAL ASSISTANCE AND TRAINING ACTIVITIES FROM FY 1992 THROUGH FY 1999ÐContinued

Number of Number of Number of Number of hard copy Fiscal year 800 line people technical materials calls trained assistance dissemi- efforts nated

1996 ...... 88,500 64,502 135,000 1,800,000 1997 ...... 91,534 70,000 180,909 785,695 1998 ...... 92,312 86,000 157,126 1,082,294 1999 ...... 90,839 74,500 170,865 1,014,057 Source: Annual Reports of NIDRR's ADA Technical Assistance Grantees FY 1992±FY 1999.

In many instances, the nature of the benefits of IT and stay current with new and web-based technical assistance and technical assistance that the DBTACs developments in the field. For example, training activities, the DBTACs’ staffs provide today is more complex than the the DBTACs use web-based programs to must have a sufficiently high level of technical assistance they provided in carry out distance learning activities in expertise on IT. the years shortly after the passage of the order to increase access to and The DBTACs provide a wide range of ADA. This is a result of covered entities participation in their information technical assistance services such as seeking to stay current with the growing dissemination efforts. In FY 1999 the referrals, consultation, and information body of legal precedents as well as DBTACs and the ADA Program dissemination. They also issue standards and policy guidance issued by Assistance Coordinator’s web sites newsletters and information briefs, and responsible Federal agencies. However, received over 870,001 visits. While participate in discussion groups on the there are still many covered entities that there will always be a need to distribute Internet. The DBTACs address the needs need information on the most hard copies of materials, the DBTACs of non-English populations by fundamental requirements of the law. receive increasing numbers of requests distributing materials that have been Subsequently, DBTACs must continue for electronic copies of these same translated into other languages and to provide basic information about the materials. They also respond to employing bilingual information ADA as well as respond to more technical questions, provide training, specialists when appropriate. Table 2 complex requests for technical and participate in cooperative efforts indicates the recipient groups of the assistance and training. related to ADA technical assistance DBTACs technical assistance, training, In order to be effective, it is virtually activities using electronic media. To and materials distribution activities in imperative that the DBTACs exploit the carry out a wide variety of electronic FY 1999.

TABLE 2.ÐSUMMARY OF PERCENTAGE OF TECHNICAL ASSISTANCE, TRAINING, AND MATERIALS DISTRIBUTED TO TARGET AUDIENCE BY DBTACSINFY 1999

Technical Materials Target audience assistance Training distributions

Disability entities ...... 50 44 45 Businesses ...... 31 24 30 Public entities ...... 14 23 18 Other ...... 5 9 7 Source: Annual Report of NIDRR's ADA Technical Assistance Grantees FY 1999.

In addition, the DBTACs carry out awareness of the ADA. The DBTACs are accessible to all individuals with public awareness activities on the ADA have established at least one affiliate in disabilities, and all of the materials they and the services provided by the every State. These affiliates carry out distribute are available in alternate DBTACs through a variety of means their activities in collaboration with formats. The DBTACs also share a including, but not limited to, radio and coalitions of organizations interested in national toll-free telephone number that television appearances, presentations at promoting the implementation of the automatically connects the caller with conferences, and the production of ADA. In addition, the DBTACs support the DBTAC serving the caller’s area materials for newspaper and magazine and collaborate with Centers for code. Further, the DBTACs meet semi- articles. When it enhances their Independent Living (CILs) to assist them annually to coordinate their activities technical assistance activities, the in implementing the ADA through the and receive briefings from Federal DBTACs also disseminate ADA research provision of technical assistance and agencies with responsibilities under the findings generated by NIDRR-sponsored training. ADA. They also evaluate their technical grantees and others. The DBTACs rely, to the maximum assistance efforts using the ADA Impact In order to tailor their efforts to State extent possible, on existing Federally- Measurement System (AIMS). AIMS and local needs and maximize their approved materials and, through a uses a follow-up telephone survey and resources, DBTACs also work to systematic process of quality control, a postcard survey to measure the impact increase the capacity of State and local ensure the legal sufficiency and that the DBTACs’ technical assistance organizations to provide technical accuracy of the information has had on its customers and their level assistance, disseminate information, disseminated by the Centers and their of satisfaction with the services that the provide training, and promote affiliates. DBTAC services and activities DBTACs provided. AIMS are currently

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Carriers Access Act, section 255 of the the application evaluation process will Each center must: Telecommunications Act, section 188 of select one successful applicant to carry (1) Provide technical assistance and the Workforce Investment Act, the Fair out this activity. training and disseminate information to Housing Act, the Family and Medical Since 1991, the DBTACs have individuals and entities with Leave Act, the AT Act, and workers’ provided technical assistance and responsibilities and rights under the compensation laws; training to educational entities on their ADA on the ADA’s requirements as well • Coordinate its activities with the responsibilities under the ADA. In 1994, as developments in case law, policy, National Center on Accessible NIDRR funded a training project on the and implementation; Education-based IT, and Federal ADA for schools and supported the U.S. (2) Increase the capacity of agencies including, but not limited to, Department of Education Office for Civil organizations, at the State and local the Department of Justice, the Equal Rights’ development and publication of level, including CILs, to provide Employment Opportunity Commission, an ADA self-evaluation guide for public technical assistance and training on, the Department of Transportation, the elementary and secondary schools. A disseminate information on, and Federal Communications Commission, toll-free ADA hotline specifically for promote awareness of the ADA; the Access Board, the Department of school systems, that originated with the (3) Promote awareness of the ADA Education’s Office for Civil Rights, the schools training project, is still in and the availability of services provided President’s Committee on Employment operation through the Region I DBTAC. by the DBTACs, other NIDRR-sponsored of Persons with Disabilities, the The special emphasis that is being ADA grantees, and other Federal National Council on Disability, and placed on the DBTACs to provide information sources on the ADA; other offices within the Department of technical assistance on accessible IT to (4) Provide technical assistance and Education including the Rehabilitation educational entities represents an training and disseminate information on Services Administration, and the Office expansion of their technical assistance legal obligations of educational entities of Special Education Programs; efforts. In those instances where the to provide accessible IT to students and • Provide performance accountability requisite assistance is a matter of employees; data on a monthly and annual basis as helping the entity to understand its legal (5) Provide technical assistance to requested by NIDRR; obligation, NIDRR expects the DBTACs educational entities to enable them to • Distribute services and resources to provide accurate information to the conduct self-evaluations on the equitably—taking into account educational entity on the requirements accessibility of their IT; of the ADA. In those instances where population and size—among each State (6) Provide technical assistance, either in its region; the requisite assistance is technical and • involves assisting the entity to procure, directly or through referral, on how to Address the needs of non-English make existing IT accessible and ensure speaking populations; and create, adapt, maintain or evaluate the • accessibility of their IT, NIDRR expects that new IT acquisitions are accessible; Include in their target audience for the DBTACs to possess the requisite (7) Promote ‘‘best practices’’ by activities (4), (5), (6) and (7): elementary technical expertise or develop encouraging educational entities to and secondary institutions, and partnerships with agencies and purchase IT consistent with the postsecondary educational entities organizations who have the necessary standards issued by the Access Board including, but not limited to, technical expertise. under Section 508 or universal design institutions of higher learning, The DBTACs routinely receive principles, regardless of whether they proprietary schools (particularly those inquiries that involve disability-related have a legal obligation to do so; offering IT training), and adult laws or disability rights laws other than (8) Provide information to education programs. the ADA. In some of these instances, the independent living centers, Parent In carrying out its evaluation inquiry concerns the interaction Training Information Centers, and the activities, a DBTAC may maintain the between the ADA and disability-related Regional Resource Centers on accessible ADA Impact Measurement System. laws such as the Family and Medical education-based IT; and (9) Form regional partnerships among Additional Selection Criterion for the Leave Act or the Worker’s DBTACs and the National Center on Compensation Act. In other instances, Assistive Technology Act grantees, RERCs, Office of Special Education Accessible Education-Based IT individuals with a disability may Priorities believe that their civil rights have been Programs’ technology grantees, and violated, but are not sure of the other pertinent educational We will use the selection criteria in controlling authority. For example, organizations and agencies to guide, 34 CFR 350.54 to evaluate applications individuals with a disability may want coordinate, and if appropriate, carry out under this program. In evaluating to know about their landlord’s technical assistance activities in each applications for the DBTACs and the responsibility to make their apartment region. National Center on Accessible accessible. In this case, in order to In carrying out these activities each Education-based IT and, we will also provide appropriate technical DBTAC must: use the following factor under the assistance, the DBTAC must be • Involve individuals with project staff criterion. In determining sufficiently familiar with not only the disabilities, parents or other family the quality of the project staff, we will ADA, but also the Fair Housing Act. members of individuals with consider the extent to which key Thus to respond directly or to refer the disabilities, in all phases of the design personnel have expert knowledge about inquirer to an expert source of technical and operation of the DBTAC to the state-of-the-art IT to conduct all assistance, the DBTACs must be maximum extent possible; proposed activities.

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Disability and Rehabilitation Research effective strategies for employing and ocfo.ed.gov/fedreg.htm http:// Project and Centers Program advancing in employment qualified www.ed.gov/news.html To use PDF you individuals with disabilities in projects The purpose of the DRRP program is must have Adobe Acrobat Reader, awarded under this absolute priority. In to plan and conduct research, which is available free at either of the determining the effectiveness of those demonstration projects, training, and preceding sites. If you have questions strategies, we will consider the related activities to: about using PDF, call the U.S. applicant’s prior success, as described Government Printing Office (GPO), toll (a) Develop methods, procedures, and in the application, in employing and free, at 1–888–293–6498; or in the rehabilitation technology that advancing in employment qualified Washington, DC, area at (202) 512–1530. maximizes the full inclusion and individuals with disabilities. Note: The official version of the document integration into society, employment, Thus, for purposes of this competitive independent living, family support, and is published in the Federal Register. Free preference, applicants can be awarded Internet access to the official edition of the economic and social self-sufficiency of up to a total of 10 points in addition to Federal Register and the Code of Federal individuals with disabilities; and those awarded under the published Regulations is available on GPO Access at: (b) Improve the effectiveness of selection criteria for these priorities. http://www.access.gpo.gov/nara/index.html services authorized under the Act. That is, an applicant meeting this (Catalog of Federal Domestic Assistance Additional Selection Criterion competitive preference could earn a Numbers 84.133D, Disability maximum total of 110 points. Rehabilitation Research Project) We will use the selection criteria in Applicable Program Regulations: 34 34 CFR 350.54 to evaluate applications CFR part 350. Program Authority: 29 U.S.C. 762(g) and under these programs. The maximum 764(b)(4). score for all the criteria is 100 points; Electronic Access to This Document however, we will also use the following You may view this document, as well Dated: December 26, 2000. criterion so that up to an additional ten as all other Department of Education Curtis L. Richards, points may be earned by an applicant documents published in the Federal Acting Assistant Secretary for Special for a total possible score of 110 points. Register, in text or Adobe Portable Education and Rehabilitative Services. Up to ten (10) points based on the Document Format (PDF) on the Internet [FR Doc. 01–86 Filed 1–4–01; 8:45 am] extent to which an application includes at either of the following sites: http:// BILLING CODE 4000±01±U

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Part VIII

Department of Health and Human Services Food and Drug Administration

21 CFR Part 1271 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement; Proposed Rule

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DEPARTMENT OF HEALTH AND regulating human cellular and tissue- regulation of human cellular and tissue- HUMAN SERVICES based products. In an earlier related based products. The agency announced rulemaking, the agency proposed to its regulatory plans in two documents: Food and Drug Administration define a human cellular or tissue-based ‘‘Reinventing the Regulation of Human product as a ‘‘product containing or Tissue’’ and ‘‘A Proposed Approach to 21 CFR Part 1271 consisting of human cells or tissues that the Regulation of Cellular and Tissue- [Docket No. 97N±484P] is intended for implantation, based Products’’ (hereinafter ‘‘proposed transplantation, infusion, or transfer approach document’’). FDA requested Current Good Tissue Practice for into a human recipient * * *’’ written comments on its proposed Manufacturers of Human Cellular and (‘‘Suitability Determination for Donors approach and, on March 17, 1997, held Tissue-Based Products; Inspection of Human Cellular and Tissue-based a public meeting to solicit information and Enforcement Products,’’ proposed rule (64 FR 52696, and views from the interested public (62 September 30, 1999), hereinafter FR 9721, March 4, 1997). AGENCY: Food and Drug Administration, ‘‘donor-suitability proposed rule’’). Since that time, the agency has HHS. ‘‘Transfer’’ is a term used with respect published two proposed rules that ACTION: Proposed rule. to reproductive cells and tissues, and would implement aspects of the has also been defined in another related proposed approach. On May 14, 1998, SUMMARY: The Food and Drug proposal (‘‘Establishment Registration the agency proposed regulations that Administration (FDA) is proposing new and Listing for Manufacturers of Human would create a new, unified system for regulations to require manufacturers to Cellular and Tissue-based Products,’’ registering establishments that follow current good tissue practice, proposed rule (63 FR 26744 at 26754, manufacture human cellular and tissue- which includes methods used in, and May 14, 1998), hereinafter ‘‘registration based products and for listing their the facilities and controls used for, the proposed rule’’). products (registration proposed rule at manufacture of human cellular and Examples of human cellular and 63 FR 26744). On September 30, 1999, tissue-based products; recordkeeping; tissue-based products include cadaveric FDA proposed regulations that would and the establishment of a quality ligaments, skin, bone, dura mater, heart require most cell and tissue donors to be program. The agency is also proposing valves, corneas, blood hematopoietic tested and screened for relevant new regulations pertaining to labeling, stem cells, manipulated autologous communicable diseases (donor- reporting, inspections, and enforcement chondrocytes, and spermatozoa. Certain suitability proposed rule at 64 FR 52696 that will apply to manufacturers of exclusions from the definition of human at 52719). those human cellular and tissue-based cellular and tissue-based products may With the present rulemaking, the products that the agency is proposing to be applicable and have been discussed agency is completing the set of regulate solely under the authority of in earlier rulemakings (registration proposals that would implement the the Public Health Service Act (PHS Act) proposed rule, 63 FR 26744 at 26748; new regulatory scheme. In the proposed and not as biological drugs or as donor-suitability proposed rule, 64 FR approach document, the agency stated devices. The agency’s actions are 52696 at 52700). that it would require that cells and intended to improve protection of the The regulations now being proposed tissues be handled according to public health while permitting would require all human cellular and procedures designed to prevent significant innovation and keeping tissue-based products to be contamination and to preserve tissue regulatory burden to a minimum. manufactured in compliance with function and integrity. Thus, the agency DATES: Submit written comments on the current good tissue practice (CGTP). The is now proposing to require that proposed rule by May 8, 2001. Submit proposal also contains provisions establishments that manufacture human written comments on the information relating to establishment inspection and cellular or tissue-based products comply collection provisions by February 7, enforcement, as well as certain labeling with CGTP, which would include, 2001. and reporting requirements, which among other things, proper handling, would be applicable to those human processing, labeling, and recordkeeping ADDRESSES: Submit written comments procedures. In addition, the proposed to the Dockets Management Branch cellular and tissue-based products that regulations would require each (HFA–305), Food and Drug the agency is proposing to regulate establishment to maintain a ‘‘quality Administration, 5630 Fishers Lane, rm. solely under the authority of section 361 of the PHS Act and not as biological program’’ to ensure compliance with 1061, Rockville, MD 20852. Submit CGTP. written comments on the information drugs or devices. The agency also requests consultation The proposed CGTP regulations collection provisions to the Office of from the States on any preemption would be contained in title 21 CFR in Information and Regulatory Affairs, issues raised by the proposed CGTP new part 1271, along with provisions OMB, New Executive Office Bldg., 725 rule, specifically with regard to: (1) the relating to establishment registration 17th St. NW., Washington, DC 20503, need for CGTP requirements to prevent and donor suitability that have been Attn: Wendy Taylor, Desk Officer for communicable disease transmission proposed previously. Subpart A of part FDA. through human cellular and tissue- 1271 would set forth scope and purpose FOR FURTHER INFORMATION CONTACT: based products; (2) alternatives that as well as definitions. Subpart B of part Paula S. McKeever, Center for Biologics would limit the scope of such national 1271 would contain registration Evaluation and Research (HFM–17), requirements or otherwise preserve procedures. Subpart C of part 1271 Food and Drug Administration, 1401 State prerogatives and authority; and (3) would set forth provisions for the Rockville Pike, suite 200N, Rockville, any other issues raised by this proposed screening and testing of donors in order MD 20852–1448, 301–827–6210. rule that could affect State laws and to determine their suitability. Subpart D SUPPLEMENTARY INFORMATION: authorities. of part 1271 would contain the provisions on CGTP now being I. Introduction A. Background proposed. Subpart E of part 1271 would FDA is in the process of establishing In February 1997, FDA proposed a contain certain labeling and reporting a comprehensive new system for new, comprehensive approach to the requirements and subpart F of part 1271

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For example, superseded by new part 1271. Group (TRG). The TRG is composed of: compliance with CGTP would require (1) Three representatives from the such precautions as cleaning of facilities B. The Tiered, Risk-Based Regulatory Center for Biologics Evaluation and and equipment, storage procedures Approach Research (CBER); (2) three designed to prevent product mix-ups, The proposed approach document set representatives from the Center for and controls over processing to prevent out a tiered regulatory scheme, under Devices and Radiological Health product contamination and impairment which human cellular and tissue-based (CDRH); (3) the product jurisdictional to function or integrity. products would be subject to an officer from each Center; and (4) a Those human cellular or tissue-based appropriate level of regulation based on liaison from the agency’s Office of the products regulated solely under the the degree of risk and the necessity for Chief Mediator and Ombudsman authority of section 361 of the PHS Act FDA review. Certain human cellular and (OCMO), a nonvoting member. Other would be subject only to the tissue-based products (e.g., tissues that FDA staff attend the TRG meetings as requirements contained in part 1271. In are more than minimally manipulated) needed to discuss issues related to contrast, human cellular or tissue-based would be regulated as biological drugs products in their area of expertise. The products regulated as devices or or medical devices under the Federal TRG provides a single reference point biological drugs would be subject not Food, Drug, and Cosmetic Act (the act) and makes recommendations to the only to the core requirements contained and/or section 351 of the PHS Act (42 center directors regarding product in subparts B, C, and D of part 1271, but U.S.C. 262), and thus would be subject jurisdiction of specific tissue. also to other applicable statutory and to premarket review procedures, among In addition, FDA recognizes that regulatory requirements. further public discussion of how the other requirements. FDA is proposing to C. Legal Authority proposed tissue regulations would be regulate other human cellular and FDA is proposing to issue these new tissue-based products solely under the applied to certain categories of human cells and tissues may be warranted due regulations under the authority of authority of section 361 of the PHS Act section 361 of the PHS Act. Under (42 U.S.C. 264), which authorizes the to the complexity or sensitivity of the issues. For example, the agency held a section 361 of the PHS Act, FDA may agency to issue regulations to prevent make and enforce regulations necessary the introduction, transmission, or public meeting to discuss how proposed definitions for ‘‘minimally to prevent the introduction, spread of communicable diseases. manipulated’’ and ‘‘homologous use’’ transmission, or spread of (These products are referred to in this should be applied to human bone communicable diseases between the document as ‘‘361 products.’’) allograft products on August 2, 2000. States or from foreign countries into the The proposed tissue regulations FDA intends to provide further States. (See sec. 1, Reorg. Plan No. 3 of would apply to a wide range of human opportunities for public discussion of 1966 at 42 U.S.C. 202 for delegation of cells and tissues. To simplify how the regulatory approach should be section 361of the PHS Act authority terminology, the proposed regulations applied to reproductive cells and tissue. from the Surgeon General to the refer generally to all human cells and FDA anticipates that there may be Secretary, Health and Human Services; tissues, including reproductive tissue, additional needs for discussion through see 21 CFR 5.10(a)(4) for delegation as ‘‘products,’’ and refer to persons who public meetings, public hearings, or from the Secretary to FDA.) Intrastate recover, screen, test, process, store, guidance as the agency implements the transactions may also be regulated label, package, or distribute human new regulations. The regulatory under section 361 of the PHS Act. (See cellular and tissue-based products as categories applicable to human cellular Louisiana v. Mathews, 427 F. Supp. 174, ‘‘manufacturers.’’ The term ‘‘product’’ is and tissue-based products are discussed 176 (E.D. La. 1977).) a term of art coined under Section 351 in greater detail in the registration and Certain diseases, such as those caused of the PHS Act, i.e., ‘‘biological donor-suitability proposed rules (63 FR by the human immunodeficiency virus product,’’ while the term 26744 at 26746; 64 FR 52696 at 52698). (HIV) and the hepatitis B and C viruses, ‘‘manufacturer’’ is used in FDA’s Under the regulatory scheme being may be transmitted through the current regulations that affect biological proposed at part 1271, all human implantation, transplantation, infusion, products, drugs, and devices. However, cellular and tissue-based products, or transfer of human cellular or tissue- Section 361 of the PHS Act, which gives regardless of the regulatory category in based products derived from infected FDA the authority to make and enforce which they belong, would be subject to donors. The agency has, in an earlier regulations to prevent the spread of certain core requirements designed to rulemaking, proposed that most cell and communicable disease, does not require address concerns common to all such tissue donors be screened and tested for use of the term ‘‘product’’ to define its products. (These core requirements will these and other relevant communicable scope. The agency has received cover registration procedures, donor diseases (donor-suitability proposed comments to the first two proposed testing and screening, and CGTP, and rule, 64 FR 52696 at 52720). However, rules to implement the proposed will be in subparts B, C, and D of part donor screening and testing, although approach objecting to the use of the 1271.) Because of their nature as crucial, are not sufficient to prevent the terms ‘‘product’’ and ‘‘manufacturer’’ as derivatives of the human body, all transmission of disease by human applied to human cells and tissues. In human cellular and tissue-based cellular and tissue-based products. finalizing these rules, the agency will products pose a potential risk of Rather, each step in the manufacturing consider whether alternative transmitting communicable diseases. process needs to be controlled. Errors in terminology to describe the scope of the Thus, the donor-suitability proposed labeling, mix-ups of testing records, regulations should be used. rule would require that most cell and failure to adequately clean work areas,

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1510 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules and faulty packaging are all examples of agency can be assured that 361 products inspection, and enforcement provisions. improper practices that could lead to a are subject to sufficient regulatory Because products regulated under the product capable of transmitting disease controls to protect the public health. act and/or section 351 of the PHS Act, to its recipient. Similarly, as noted in FDA is proposing that the CGTP are subject to similar regulation the proposed approach document, regulations would supplement, but not requirements, these provisions would improper handling of a human cellular supersede, the current good apply only to 361 products. Proposed or tissue-based product can lead to manufacturing practice (CGMP) and subpart E of part 1271 contains bacterial contamination of the product quality system (QS) regulations regulations on reporting and labeling or to cross-contamination between applicable to drugs and devices in parts pertaining to 361 products and is products. 210, 211, and 820 (21 CFR parts 210, discussed in section III of this In addition to the direct transmission 211, and 820). Under the proposed rule, document. Proposed subpart F of part of communicable disease agents by human cellular and tissue-based 1271 contains inspection and human cellular and tissue-based products regulated as biological drugs enforcement provisions also applicable products to their recipients, the agency under the act and section 351 of the only to 361 products; the relevant is also concerned about the spread of PHS Act, or as devices under the act, discussion appears in section IV of this communicable disease through the use would have to be manufactured in document. of products whose function or integrity accordance with CGTP, in addition to have been impaired. When a product existing requirements. Thus, in keeping II. Summary of the Proposed CGTP does not work in a patient because it has with the plan outlined in the proposed Regulations not been manufactured properly, the approach document, those products The regulations being proposed risk of introducing, transmitting, or regulated as biological drugs or devices would require manufacturers of human spreading a communicable disease is would be subject to more cellular and tissue-based products to increased each time a procedure is comprehensive regulation of follow CGTP, which includes proper repeated for at least two reasons: (1) manufacturing than the 361 products. handling, processing, storage, and Despite the best controls, there is a risk, In the donor-suitability proposed rule, labeling of human cellular and tissue- albeit smaller than without controls, of the agency proposed to amend the based products, recordkeeping, and the communicable disease transmission, existing CGMP regulations for drugs and establishment of a quality program. The and (2) a procedure for transfer or the QS requirements for devices to proposed CGTP regulations are designed transplant can carry an independent risk incorporate the testing and screening to address issues common to all human of communicable disease transmission. provisions of proposed part 1271, cellular and tissue-based products, and For example, use of a product whose subpart C. At that time, in order to so are intentionally broad in scope. The function or integrity may have been obviate the need for further revisions, agency anticipates that, as it implements compromised could create a the agency also proposed to amend the new regulations, there may be circumstance that increases a patient’s those sections to incorporate the current additional need for discussion, through need for an additional transfer or good tissue practice procedures of public meetings, public hearings, or transplant attempt. A repeat surgical proposed part 1271 subpart D. In guidance, of how these general procedure necessitated by the damaged amending the CGMP and QS regulations would apply to specific product would further expose the regulations, FDA is relying both on the types of products. In addition, there patient to the additional communicable authority provided by section 361 of the may be specific elements of these disease risks inherent in any such PHS Act to make regulations to prevent proposed requirements that some procedure. Moreover, a patient in a the spread of communicable disease, readers may not consider appropriate to weakened state from the first and on its authority under the act to general application. The agency unsuccessful procedure is at greater risk issue CGMP regulations (section welcomes comments that will assist it in of contracting a communicable disease 301(a)(2)(B) and (h) of the act) (21 U.S.C. achieving the proper balance between by experiencing a repeat procedure. 351(a)(2)(B) and (h)), section 520(f)(1) of generality and specificity in these Therefore, the agency considers that the act (360j(f)(1)); section 701 of the act regulations. requirements aimed at maintaining (21 U.S.C. 371)). product function and integrity are Under proposed 21 CFR 210.1(c), the A. General Provisions (Proposed necessary, and thus may be issued manufacturer of a human cellular or §§ 1271.150 and 1271.155) under section 361 of the PHS Act. tissue-based product regulated as a drug Proposed § 1271.150 contains general The proposed CGTP regulations or biological drug would be required to provisions intended to aid in the would govern the methods used in, and comply with the CGTP procedures in interpretation of the requirements the facilities and controls used for, the part 1271, subpart D (donor suitability contained in subparts C and D of part manufacture of human cellular and proposed rule, (64 FR 52696 at 52699 1271. Proposed § 1271.155 sets out the tissue-based products. CGTP and 52719)). Likewise, under proposed procedures for obtaining an exemption requirements are a fundamental 21 CFR 820.1, the manufacturer of a or variance from one or more of these component of FDA’s risk-based human cellular or tissue-based product requirements. approach to regulating human cellular regulated as a device would be required 1. Current Good Tissue Practice and tissue-based products. Products that to comply with the same procedures (Proposed § 1271.150(a)) the agency is proposing to regulate (donor suitability proposed rule (64 FR Proposed § 1271.150(a) states that solely under section 361 of the PHS Act 52696 at 52699 and 52719)). If the CGTP requirements govern the methods and proposed part 1271, would be manufacturer failed to follow the CGMP used in, and the facilities and controls subject to less rigorous agency oversight requirements, including the good tissue used for, the manufacture of human than products also regulated under the practice procedures in part 1271, the cellular and tissue-based products. act and/or section 351 of the PHS Act. product would be adulterated under CGTP requirements are intended to By requiring that 361 products be section 501(a)(2)(B) of the act. prevent the introduction, transmission, manufactured in compliance with FDA is also relying on its authority and spread of communicable disease CGTP, in combination with the other under section 361 of the PHS Act to through the use of human cellular and proposed requirements in part 1271, the propose several reporting, labeling, tissue-based products by helping to

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1511 ensure that: (1) The products do not establishments will need to make only those requirements applicable to the contain relevant communicable disease small changes in their operations to operations in which it engages. Under agents; (2) they are not contaminated achieve compliance. Other § 1271.150(b), an establishment that during the manufacturing process; and establishments may find that complying does not process cells or tissue would (3) the function and integrity of the with the new requirements entails not be obligated to establish and products are not impaired through revising certain procedures and maintain process controls under improper manufacturing, all of which recordkeeping practices, but few proposed § 1271.220. However, an could lead to circumstances that operational changes. Another group of establishment that engages another increase the risk of communicable establishments—for example, those that establishment, under a contract, disease transmission. ‘‘Manufacture’’ as have not previously been subject to agreement, or other arrangement, to defined in the registration proposed regulation and that do not belong to any perform any step in the manufacturing rule, includes, but is not limited to, any standard-setting or accrediting process, would be responsible for or all steps in the recovery, processing, organization—may need to revise their ensuring that the work is performed in storage, labeling, packaging, or procedures more completely, in order to compliance with the requirements in distribution of any human cellular or bring them into compliance with these subparts C and D of part 1271. One tissue-based product, and the screening regulations and industry practice. method of accomplishing this might be and testing of a cell or tissue donor Proposed § 1271.150(a) states that by performing periodic audits. (proposed § 1271.3(f), 63 FR 26744 at CGTP requirements are set forth in Given that the steps in manufacturing 26754.) The definition of ‘‘human subparts C and D of part 1271. The a single human cellular or tissue-based cellular or tissue-based product’’ as CGTP provisions specifically governing product may be carried out by several revised in the donor suitability donor suitability, including donor establishments, FDA considers it proposed rule, is intended to cover such testing and screening, are set out essential that additional safeguards be products at all stages of their separately in subpart C of part 1271. The established to ensure compliance with manufacture, from recovery through agency notes that § 1271.90 contains regulatory requirements throughout the distribution (see proposed § 1271.3(e) exceptions from required testing and manufacturing process. The agency has (64 FR 52696 at 52719). For a human screening for two types of human considered various ways of allocating cellular or tissue-based product to be cellular and tissue-based product: regulatory responsibilities among the manufactured properly, CGTP must be Banked cells and tissues for autologous establishments involved in followed in each step of the use, and reproductive cells or tissue manufacturing a human cellular or manufacturing process. donated by a sexually-intimate partner tissue-based product. The agency seeks The word ‘‘current’’ is included in the of the recipient for reproductive use (64 to permit establishments to maintain term ‘‘current good tissue practice’’ FR 52696 at 52723). (Donor testing and flexibility in sharing manufacturing because the agency recognizes that screening are recommended, however.) responsibilities, while ensuring that appropriate practices may change over The agency specifically notes that the products made available for release time, as research is conducted and new exceptions in § 1271.90 apply only to maintain their function and integrity, manufacturing methods are developed. subpart C of part 1271 and do not are not contaminated, and do not These regulations are not intended to extend to the provisions of subpart D of contain communicable disease agents. require that practices considered current part 1271. Because the safety concerns The agency first considered assigning at the time of issuance of the final addressed by the proposed CGTP overall responsibility for ensuring that a regulations be maintained indefinitely; requirements apply to all human human cellular and tissue-based instead, the obligation on an cellular and tissue-based products, no product is manufactured in compliance establishment is to maintain up-to-date exceptions are being proposed for any with all applicable regulations to the practices over time. Recognizing that particular category of product. Thus, establishment that determines donor improved manufacturing techniques banked cells and tissues for autologous suitability. However, the agency may be developed, the agency has use, and reproductive cells or tissue recognized that the role this generally refrained in these proposed donated by a sexually-intimate partner establishment plays in the manufacture regulations from requiring specific of the recipient for reproductive use, of a human cellular or tissue-based procedures, such as particular would be subject to the CGTP product occurs early in the sequence of processing methods or storage requirements in subpart D of part 1271. manufacturing events. As a practical temperatures. Instead, the proposed 2. Compliance With Applicable matter, the establishment that regulations set out general objectives. Requirements (Proposed § 1271.150(b)) determines donor suitability might not This approach not only allows for new FDA recognizes that several be able to ensure that later developments, but also affords establishments may be involved in the manufacturing steps, such as processing establishments flexibility in developing manufacture of a single human cellular and labeling, are performed in procedures that are both appropriate to or tissue-based product. For example, compliance with the regulations. A their particular operations and that one establishment may recover tissue more pragmatic approach would be to comply with the regulations. from a cadaver, another establishment assign responsibility to the The proposed requirements are based may make the donor-suitability establishment that makes a product on current good industry practice and determination, a third may process the available for distribution. are intended to address what the agency tissue, and a fourth may distribute the Another option would be to permit considers important minimum criteria product. The agency has taken care, in the establishments engaged in the for the manufacture of these products. designing these proposed regulations, to manufacturing process to decide among In developing these regulations, the reflect the fact that manufacturing roles themselves which party bears ultimate agency has reviewed several sets of might be divided up in a variety of responsibility for the product. However, industry standards, including those possible ways. Thus, under proposed the agency is concerned that, under this issued by the American Association of § 1271.150(b), an establishment that approach, there would be occasions Tissue Banks (AATB) and by the Eye engages in only some operations subject when no establishment would step Bank Association of America (EBAA). to the regulations in subparts C and D forward as the one ultimately The agency expects that some of part 1271 need only comply with responsible, and that as a consequence

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1512 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules compliance with certain requirements and spread of communicable disease; proposed § 1271.155, an establishment might not be accomplished. As a result, the proposed regulations are therefore could demonstrate to the agency that it products might be released that pose a less extensive in scope than the CGMP should be exempted from an otherwise risk of transmitting communicable and QS regulations. applicable regulatory requirement or disease or otherwise increasing the risk Proposed § 1271.150(c) states that, permitted to satisfy the purpose of the of disease transmission. For the same with respect to human cellular and requirement in an alternative manner. A reasons, FDA has rejected the idea that tissue-based products regulated as request for an exemption or alternative designating a responsible establishment biological drugs or as devices, the would need to be accompanied by is unnecessary. proposed CGTP procedures will supporting documentation, including all The agency has also considered a supplement, not supersede, the CGMP relevant valid scientific data. Requests ‘‘cascading’’ set of responsibilities. and QS requirements. Proposed would be made in writing or Under this approach, an establishment § 1271.150(c) states that, in the event electronically, except that in limited would be responsible for ensuring that that it is impossible to comply with all circumstances (e.g., emergencies) a its own operations comply with applicable regulations, the regulations request might be made and granted applicable requirements, and also specifically applicable to the biological orally, with a written request and would bear the burden of proof that drug or device in question shall acknowledgment of approval to follow. operations performed by other supersede the more general. Under proposed § 1271.155(c), the establishments prior to its receipt of the 4. ‘‘Where Appropriate’’ Director of the Center for Biologics cells or tissue were performed in Several of the requirements contained Evaluation and Research (CBER) could compliance with applicable in part 1271, subpart D, are qualified by grant an exemption or alternative if he requirements. the term ‘‘where appropriate,’’ which as or she found that doing so would be After considering the unique nature of explained in proposed § 1271.150(d), consistent with the goals of preventing the cell and tissue industry, and each of are considered to be appropriate, and circumstances that increase the risk of the above options, the agency has must be followed, unless an the introduction, transmission, and tentatively concluded that the best establishment can justify otherwise, and spread of communicable disease. In approach is to assign ultimate maintains documentation of that addition, an exemption or alternative responsibility for the product to the justification. Under proposed would be conditioned on a finding by establishment that is responsible for § 1271.150(d), a requirement is the Director that the information making the product available for ‘‘appropriate’’ if nonimplementation submitted justified an exemption or that distribution. This is consistent with the could reasonably be expected to result the proposed alternative satisfied the proposed approach document, which in the: (1) Product’s not meeting its purpose of the requirement. An stated that ‘‘[t]he establishment or specified requirements related to establishment that requested an person responsible for determining preventing the introduction, exemption or alternative could not suitability of release of cells or tissues transmission, and spread of begin operating under its terms until the would be responsible for ensuring that communicable disease agents and exemption or alternative had been required screening and testing had been diseases; or (2) manufacturer’s inability granted. Some exemptions or performed prior to final release of the to carry out any necessary corrective alternatives might have expiration dates, material.’’ Thus, proposed § 1271.150(b) action. in which case an extension could be states that the establishment that 5. Exemptions and Alternatives requested. An establishment operating determines that a product meets release (Proposed § 1271.155) under the terms of an exemption or criteria and makes the product available FDA recognizes the possibility that, as alternative would be required to for distribution, whether or not that technology and scientific knowledge maintain documentation that the establishment is the actual distributor, advance, new methods may be exemption or alternative had been is responsible for ensuring that the developed that could be used in the granted, and of the date on which the product has been manufactured in manufacture of human cellular and establishment began operating under the compliance with the requirements of tissue-based products, or other terms of the exemption or alternative. subpart C and D of part 1271 and any unanticipated circumstances may arise other applicable requirements. that warrant a departure from an B. Definitions (Proposed § 1271.3) The agency specifically requests approach detailed in the regulations. Definitions pertinent to part 1271 will comments on the allocation of overall Some of these technical developments be contained in subpart A, in § 1271.3. manufacturing responsibility. Examples may not be consistent with the terms of In the registration proposed rule, FDA of industry arrangements currently in the donor-suitability and CGTP set out defined terms in paragraphs (a) existence would be particularly useful regulations, although the purpose of through (h) of § 1271.3. In the donor- to the agency in evaluating the those regulations might be satisfied. In suitability proposed rule, further comments on these proposed order to provide establishments with definitions were proposed, to be regulations. flexibility, and to ensure that the agency contained in § 1271.3(i) through (ee), 3. Compliance With Parts 210, 211, may respond appropriately to improved and the proposed definition of human and 820 technologies and increased scientific cellular or tissue-based product in The proposed CGTP regulations are knowledge, the agency proposes that paragraph (e) was revised. similar to the CGMP requirements establishments may apply for Now, the agency is proposing new applicable to drugs and the QS exemptions or alternatives from the paragraphs (ff) through (tt) in § 1271.3. requirements for devices. However, the regulatory requirements contained in These new definitions are discussed CGMP and QS regulations do not subparts C and D of part 1271. below, when the requirements to which contain provisions specifically intended Proposed § 1271.155 sets out the the defined terms relate are discussed. to prevent the spread of communicable procedures for obtaining an exemption disease. In contrast, the purpose of the or alternative from a requirement in C. Quality Program (Proposed proposed CGTP regulations is limited to subpart C of part 1271, pertaining to § 1271.160) preventing circumstances that increase donor suitability, or in subpart D of part Any establishment that manufactures the risk of introduction, transmission, 1271, pertaining to CGTP. Under human cellular or tissue-based products

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1513 needs to have in place a method of established and maintained; (2) Certain product deviations in ensuring that its manufacturing ensuring the appropriate analysis and manufacturing would be required to be processes are performed properly and in sharing of information that could affect reported. The proposed requirement, compliance with applicable regulations. the integrity and function of a human applicable to distributed 361 products, For devices, such a program is called a cellular or tissue-based product, for reporting product deviations in ‘‘quality system’’ (§ 820.1 et seq.). In possible contamination of the product, manufacturing that could lead to these regulations, FDA is proposing to or the potential transmission of adverse reactions is discussed below in use ‘‘quality program’’ to refer to the set communicable disease by the product; section III of this document. Certain of activities, including management (3) ensuring that appropriate corrective product variations, referred to currently review, training, audits, and corrective actions are taken and documented; (4) as errors and accidents, involving and preventive actions, that represent a ensuring the proper training and human cellular and tissue-based commitment on the part of an education of personnel; (5) establishing products regulated as biological drugs establishment’s management to the and maintaining appropriate monitoring are required to be reported under 21 quality of its products. FDA proposes to systems; (6) establishing and CFR 600.14 (currently undergoing define ‘‘quality program’’ in § 1271.3(oo) maintaining a system for maintaining revisions; see 62 FR 49642, September as ‘‘an organization’s comprehensive records; (7) investigating and 23, 1997). In addition, each system for manufacturing and tracking documenting product deviations and establishment would be required to human cellular and tissue-based making certain required reports; and (8) perform a periodic review and analysis products. This program includes conducting evaluations, investigations, of all investigations of product preventing, detecting, and correcting audits, and other actions necessary to deviations in manufacturing, at least deficiencies that may lead to ensure compliance with the regulations. once each year, for the purpose of circumstances that increase the risk of Proposed § 1271.160(b)(2) would identifying trends and adopting the introduction, transmission, or specifically require procedures to be appropriate corrective and preventive spread of communicable disease.’’ established for sharing and receiving measures. Section 1271.160(b)(7) Proposed § 1271.160 would require an information that could affect the specifies that this analysis shall be establishment that performs any step in integrity and function of a human available for review upon inspection the manufacture of human cellular and cellular or tissue-based product, the and for submission to FDA upon tissue-based products to establish and possible contamination of the product, request. Under proposed § 1271.160(c), one or maintain a quality program that is or the potential transmission of appropriate for the specific human more designated persons shall have communicable disease by the product. cellular and tissue-based products authority over the quality program, and This would include information on manufactured and the manufacturing this person shall report to management testing or screening results that could steps performed and that meets the at least once a year on the performance make a donor unsuitable; such requirements of this part. With of the quality program. However, more information would need to be shared proposed § 1271.160, FDA intends to frequent reports may be necessary in with other establishments that are require that a quality program perform order to keep management informed of known to have recovered cells or tissue certain basic functions, but also intends the status of the program. from the same donor. An establishment to provide each establishment with Audits are an important component of would also need procedures in place in flexibility to devise a program a quality program. Under proposed appropriate to its particular activities order to respond appropriately (through § 1271.160(d), a comprehensive quality and characteristics. Thus, FDA expects investigation, evaluation, possible audit of all activities would be required that quality programs may differ from recall, reporting, etc.) if it received any at least once a year. FDA proposes to establishment to establishment, such information from another define ‘‘quality audit’’ in proposed depending on the size of the establishment. § 1271.3(nn), as ‘‘a documented, establishment and the type of Proposed § 1271.160(b)(7) would independent inspection and review of manufacturing performed, among other require establishments to investigate an establishment’s activities, including factors. A smaller company that and document all product deviations in manufacturing and tracking, performed performs limited manufacturing steps manufacturing. The term ‘‘product according to procedures, to verify, by might have a less complex quality deviation’’ is defined in proposed examination and evaluation of objective program than a larger establishment that § 1271.3(kk) as ‘‘an event that represents evidence, the degree of compliance with processes a variety of products. a deviation from current good tissue those aspects of the quality program Some establishments may currently practice, applicable standards, or under review.’’ In addition to the annual have in place quality programs that established specifications; or an quality audit, special audits would be would meet the requirements of unexpected or unforeseeable event that performed as necessary to ensure that proposed § 1271.160. An establishment may relate to the transmission or quality program objectives are achieved. that manufactures human cellular and potential transmission of a Proposed § 1271.160(e) covers the use tissue-based products regulated as communicable disease agent or disease of computers or automated data devices would likely find it unnecessary from a human cellular or tissue-based processing systems used as part of the to make major changes to its quality product to a recipient, may lead to quality program, as part of system established in compliance with product contamination, or may manufacturing, or for maintaining § 820.5 in order to comply with adversely affect the function or integrity manufacturing data or records. An proposed § 1271.160. Such an of the product.’’ Investigation would be establishment using such a computer or establishment would not need to required to include a review and automated system would be required to maintain both a QS and a separate evaluation of the product deviation in validate the computer software for its quality program. manufacturing, the efforts made to intended use according to an The functions of a quality program, as determine the cause, and the established protocol, as well as all listed in proposed § 1271.160(b), implementation of corrective action software changes. Validation and results include but are not limited to: (1) designed to address the event and would be required to be documented. Ensuring that required procedures are prevent its recurrence. The agency proposes to define

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‘‘validation’’ in proposed § 1271.3(rr) as required elsewhere in subpart D of part transplantation, it would be important ‘‘confirmation by examination and 1271, would be required to be designed to know the procedures under which provision of objective evidence that to prevent circumstances that increase the tissue was recovered or processed, particular requirements can consistently the risk of the introduction, especially if those procedures differ be fulfilled * * *’’. transmission, and spread of from the ones currently in place. communicable diseases through the use D. Organization and Personnel of human cellular and tissue-based F. Facilities, Environmental Control and (Proposed § 1271.170) products by ensuring that: (1) The Monitoring, Equipment, and Supplies Proposed § 1271.170 sets out general products do not contain relevant and Reagents requirements for the organization and communicable disease agents; (2) the 1. Facilities (Proposed § 1271.190) personnel of establishments that products do not become contaminated Under proposed § 1271.190, any manufacture human cellular and tissue- during manufacturing; and (3) the based products. Under this section, each facility used in the manufacture of function and integrity of the products human cellular or tissue-based products establishment would be required to are not impaired through improper must be of suitable size, construction, maintain an adequate organizational manufacturing. Procedures must be and location to facilitate cleaning, structure and sufficient personnel to designed to ensure compliance with the relevant maintenance, and proper ensure that the requirements of part requirements of part 1271. 1271 are met. Moreover, an The recovery of cells or tissue is an operations. A facility that, for whatever establishment would need to have example of an especially significant step reason, cannot be adequately cleaned is sufficient personnel with the necessary in the manufacture of a human cellular not appropriate for use in the education and experience, or or tissue-based product, for which manufacture of human cellular and combination thereof, to assure procedures would have to be tissue-based products, because of the competent performance of their established. Under the terms of potential risk of product contamination. assigned functions. proposed § 1271.180, such procedures ‘‘Relevant maintenance’’ refers to those Under proposed § 1271.170, would need to include the use of actions that, if not taken, could lead to personnel would only be permitted to procurement techniques designed to potentially adverse effects on product perform those activities for which they prevent the transmission of integrity or function, or to the accidental are qualified. Training of personnel to communicable disease agents and exposure of human cellular and tissue- perform their assigned responsibilities diseases by the product. In addition, based products to communicable adequately would be required, as would procedures for recovery would have to disease agents, or to contamination or any necessary retraining. Because of the be designed to ensure that the function cross-contamination with such agents. particular risks addressed by the and integrity of the procured cells or Finally, any operation undertaken by a requirements of part 1271, the agency is tissue are maintained during and after manufacturing establishment needs to proposing to require that personnel be procurement. be performed in a facility in which the educated about possible consequences All procedures shall be reviewed and operation can be performed correctly. of improperly performing their duties; approved by a responsible person prior For example, although not specifically e.g., the risk that an improperly handled to implementation. At least once in a required to do so by these regulations, product could cause harm to the 12-month period, all procedures would an establishment may need to establish product’s recipient, by transmitting a be required to be reviewed and, if gowning procedures for its employees, communicable disease or by failing to necessary, revised; such review would in order that their functions be function adequately. A record of the need to be documented. Procedures performed properly. Such an education, experience, training, and must be readily available to personnel establishment would need to provide retraining would need to be maintained in the area where relevant operations employees with a dressing room and for all personnel. are performed, unless this would be gowning area. impractical. Any deviation from a Proposed § 1271.190 would also E. Procedures (Proposed § 1271.180) procedure must be authorized by a require that a facility be maintained in Under proposed § 1271.180, each responsible person, recorded, and a good state of repair. Broken windows, establishment would be required to justified. peeling paint, uneven flooring, and establish and maintain procedures for FDA is not prescribing the contents of improper electrical wiring are all all significant steps that it performs in particular procedures, but is allowing examples of maintenance problems that the manufacture of human cellular and establishments to develop procedures could lead to product contamination or tissue-based products. The agency is that suit their particular operations. impairment of product function or proposing to define ‘‘establish and Alternatively, under proposed integrity. In addition, adequate lighting, maintain’’ in § 1271.3(ll) as ‘‘define, § 1271.180, an establishment could ventilation, plumbing, drainage, and document (in writing or electronically), adopt current standard procedures, e.g., washing and toilet facilities would all and implement, then follow, review, those in a technical manual prepared by be required. and as needed, revise on an ongoing another organization, so long as the Proposed § 1271.190(b) sets out basis.’’ FDA intends, by using the procedures are consistent with the requirements for the location of phrase ‘‘establish and maintain’’ in requirements of part 1271, at least as operations within a facility used in the these regulations, to indicate that, once stringent as those requirements, and manufacture of human cellular or established, procedures must be appropriate for the establishment’s tissue-based products. Such a facility followed on an ongoing basis. Because operations. would need to be divided into separate established procedures would, by Any procedure that becomes obsolete or defined areas of adequate size for definition, be documented in writing or would be required to be archived for at each operation that takes place in the electronically, the agency is proposing least 10 years. Since some tissues have facility. As an alternative, however, to use the term ‘‘procedures’’ as long expiration dates, they can be other control systems could be opposed to ‘‘written procedures.’’ transplanted many years after they were established and maintained to prevent Procedures required under proposed recovered or processed. Should an improper labeling, mix-ups, § 1271.180, and those specifically adverse reaction occur after contamination, cross-contamination,

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1515 and accidental exposure of human operations; and environmental performed according to established cellular and tissue-based products to monitoring for organisms. Proposed schedules. communicable disease agents. Examples § 1271.195(a) would require these Section 1271.200(d) sets out a of different types of operations that an elements to be adopted, where requirement for routine inspections of establishment might perform, and appropriate. Thus, under proposed equipment for cleanliness, sanitation, which would need to be conducted § 1271.195, an establishment would be and calibration, and to ensure either in separate locations or subject to required first to identify any compliance with maintenance other controls, include: (1) Receipt, environmental conditions that require schedules. identification, and storage of containers, monitoring and control, and then to Section 1271.200(e) contains specific labels, supplies, and reagents; (2) respond appropriately. requirements for records, to be processing, including laboratory Periodic inspections of environmental maintained in accordance with the functions; (3) storage of human cellular controls systems would be required. In general records provisions in and tissue-based products, both before addition, environmental controls and § 1271.270. All maintenance, cleaning, and after release from quarantine; (4) monitoring activities would have to be sanitizing, calibration, and other product labeling; (5) storage and documented, and records maintained. activities performed in accordance with disposal of biohazards and/or medical 3. Equipment (Proposed § 1271.200) § 1271.200 would be required to be waste; (6) irradiation; and (7) documented. Records of recent sterilization and aseptic processing. CGTP requirements for equipment are set out in proposed § 1271.200. For maintenance, cleaning, sanitizing, Proposed § 1271.190(c) contains basic calibration, and other activities must be requirements for facility cleaning and human cellular and tissue-based available at each piece of equipment; sanitation. Facilities must be products to be manufactured properly, this requirement promotes both accurate maintained in a clean, sanitary, and the equipment used in their recordkeeping and ease of reference. In orderly manner. Sewage, trash, and manufacture must be appropriate. Thus, addition, the use of each piece of other refuse must be disposed of in a § 1271.200(a) contains the general equipment must be documented, and timely, safe, and sanitary manner. requirement that equipment used in the this record of use must identify each Procedures for facility cleaning and manufacture of human cellular and human cellular or tissue-based product sanitation would be required to be tissue-based product be of appropriate manufactured using the equipment. established and maintained. These design for its use. Equipment must be This requirement is necessary to ensure procedures would need to include an suitably located and installed to assignment of responsibility for facilitate operations, including cleaning that those products manufactured with sanitation, cleaning methods to be used, and maintenance. In addition, a particular piece of equipment may be and a cleaning schedule. Finally, all equipment must not have any adverse traced for follow-up and appropriate significant cleaning and sanitation effect on the products being corrective action, in the event that a activities that are done to prevent manufactured. problem (e.g., contamination or contamination would need to be Equipment used for inspection, malfunction) is discovered after the documented, and records maintained. measuring, and testing must be capable equipment is used. of producing valid results; such 2. Environmental Control and 4. Supplies and Reagents (Proposed equipment could include automated, § 1271.210) Monitoring (Proposed § 1271.195) mechanical, electronic, computer, or Proposed § 1271.195 would require other kinds of equipment. Section Use of a contaminated or otherwise monitoring and control over 1271.200(c) would require regularly defective supply or reagent in the environmental conditions where such scheduled calibration of equipment manufacture of a human cellular or conditions (e.g., temperature, air used for inspection, measuring, and tissue-based product could adversely quality) could reasonably be expected to testing. Thus, for example, a affect the product; e.g., by introducing a have an adverse effect on the function thermometer used in a storage area disease agent or by failing to properly or integrity of human cellular and would be required to produce valid preserve the product. For this reason, tissue-based products, to cause results and would also be subject to compliance with CGTP requires that contamination or cross-contamination of regularly scheduled calibration care be taken in receiving supplies and products or equipment, or to lead to procedures. ‘‘Equipment used for reagents into an establishment, in accidental exposure of products to inspection’’ would include any determining their appropriateness for communicable disease agents. In these equipment used to inspect a human use, and in keeping track of the situations, an establishment would be cellular or tissue-based product during products in whose manufacture they are required to establish and maintain its manufacture or prior to making it used. By ‘‘supplies and reagents,’’ the procedures to adequately control and available for distribution. agency refers to all of the products that monitor environmental conditions and Under § 1271.200(b), an establishment might be used during the manufacturing to provide proper conditions for would be required to establish and process but excludes any material that operations. maintain procedures for cleaning, might be considered to become a Depending on the particular sanitizing, and maintaining equipment. component of a human cellular or environmental factors at a facility, and The purpose of these procedures is to tissue-based product. Supplies and the type of operations that take place prevent equipment malfunctions, reagents would include, but not be there, environmental controls and contamination or cross-contamination, limited to, ‘‘processing material,’’ which monitoring could include one or more accidental exposure of human cellular the agency is proposing to define at of the following: Temperature and and tissue-based products to § 1271.3(hh) as ‘‘any material or humidity controls; ventilation and air communicable disease agents, and other substance that is used in, or to facilitate, filtration; cleaning and disinfecting of events that could reasonably be processing, but which is not intended rooms and equipment to ensure aseptic expected to have an adverse effect on by the manufacturer to be included in processing operations; maintenance of product function or integrity. Cleaning, the human cellular or tissue-based equipment used to control conditions sanitizing, and maintenance of product when it is made available for necessary for aseptic processing equipment would be required to be distribution.’’

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Proposed § 1271.210 contains several 1. Process Controls (Proposed discussed in section II.A.4. of this requirements with respect to supplies § 1271.220) document, in-process monitoring would and reagents used in the manufacture of Under proposed § 1271.220(a), any be required unless the establishment human cellular and tissue-based establishment engaged in the processing can justify, and document, that it would products. An establishment would be of human cellular and tissue-based be unnecessary under the terms of required to establish and maintain products would be required to develop, § 1271.150(d). The in-process product procedures for receiving supplies and conduct, control, and monitor its would have to be controlled until the reagents. Before using a supply or manufacturing processes to ensure that completion of any required inspection, reagent, the establishment must verify each product: (1) Conforms to its tests, or other verification activities, or that the supply or reagent meets specifications, (2) is not contaminated, until any necessary approvals are specifications that are designed to (3) maintains its function and integrity, received and documented. Any prevent circumstances that increase the and (4) is manufactured so as to prevent sampling taken of the in-process risk of the introduction, transmission, transmission of communicable disease product for the purpose of testing or and spread of communicable disease by the product. By ‘‘specifications,’’ the inspection would be required to be through product contamination or the agency refers to those criteria representative of the material being impairment of product function or established by a manufacturer for a evaluated. integrity. An establishment could verify human cellular or tissue-based product 2. Process Changes (Proposed on its own that the supplies and that must be met at defined stages in the § 1271.225) reagents that it uses meet specifications; manufacturing process and before the e.g., by testing the product. product is made available for Proposed § 1271.225 would require an Alternatively, verification could be distribution. establishment to establish procedures accomplished by the vendor of the Sections 1271.220(b) governs the for making changes to a process. Any supply or reagent. ‘‘Verification’’ is removal of processing materials. In such change would have to be verified defined in proposed § 1271.3(ss) as accordance with the definition proposed or validated, to ensure that the change ‘‘confirmation by examination and in § 1271.3(hh), processing materials does not create an adverse impact provision of objective evidence that would not be intended by the elsewhere in the operation. Any change specified requirements have been manufacturer to be included in a human would also have to be approved by a fulfilled.’’ cellular or tissue-based product when it responsible person with appropriate Section 1271.210(b) would require is made available for distribution. Under knowledge and background before being that reagents used in processing and § 1271.220(b), where a processing implemented. Proposed § 1271.225(b) preservation of human cellular and material could reasonably be expected would require that records be kept of all tissue-based products be of appropriate to have an adverse effect on a human such changes, and sets out the required grade for their intended use and, if cellular or tissue-based product’s elements of such records (e.g., the appropriate, sterile. Some function or integrity, the establishment rationale for the change). would be required to establish and establishments may produce their own 3. Process Validation (Proposed in-house reagents. These establishments maintain procedures for the use and § 1271.230) would be required to validate and/or removal of the processing material to verify the procedures for producing ensure that it is removed or limited to Proposed § 1271.230 contains such reagents. an amount that does not adversely affect requirements related to the validation of Section 1271.210(c) would require the product’s function or integrity. Any processes. Process validation, under that specific records relating to the such removal or reduction would be proposed § 1271.3(rr), means receipt, verification, and use of each required to be documented. ‘‘establishing by objective evidence that supply and reagent be maintained. Section 1271.220(c) would prohibit a process consistently produces a result the pooling of human cells or tissue or product meeting its predetermined G. Processing from two or more donors during specifications.’’ Three sections of the proposed CGTP manufacturing. Pooling refers to placing Proposed § 1271.230(a) would require regulations address the processing of products in physical contact with each establishments to validate their human cellular and tissue-based other or mixing them in a single processes where verification is not products. Proposed § 1271.220 would receptacle. Such commingling of cells or feasible; e.g., where verification cannot require controls to be established over tissues from a single infected donor be performed on each and every processing. Requirements for making with cells or tissues from other donors finished product. Thus, § 1271.230(a) changes to processes are contained in can contaminate the entire pooled states that, where the results of a proposed § 1271.225. Proposed quantity, greatly increasing the risk to process cannot be fully verified by § 1271.230 would require process recipients of the pooled materials of subsequent inspection and tests, the validation in place of verification in exposure to infectious agents. The process must be validated and approved some situations and sets out certain proposed regulation is consistent with according to established procedures, specific requirements related to process recommendations made by FDA’s and the validation activities must be validation. Transmissible Spongiform documented. ‘‘Processing’’ is defined in proposed Encephalopathy Advisory Committee, at Under § 1271.230(b), any claim made § 1271.3(mm) as ‘‘any activity other than their meeting on October 6, 1997, with in labeling or promotional materials that recovery, donor screening, donor respect to the pooling of dura mater. is related to the process used to testing, storage, labeling, packaging, or Section 1271.220(d) would require manufacture a human cellular or tissue- distribution performed on a human procedures to be established for in- based product must be based on a cellular or tissue-based product, process monitoring, or monitoring of the process that has been validated. including, but not limited to, product during processing, for Validation must be documented, and preparation, sterilization, steps to compliance with specified evidence of the validation must be inactivate and remove adventitious requirements. This requirement is maintained at the establishment and agents, preservation for storage, and modified by the phrase ‘‘where made available for review on inspection. removal from storage.’’ appropriate.’’ In other words, as Examples of such process-related claims

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1517 include the claim that a product is ‘‘Applicable labeling requirements’’ for expiration date be assigned for each sterile or that it has undergone viral human cellular and tissue-based human cellular or tissue-based product. inactivation. products regulated as biological drugs Under § 1271.260(d), corrective action The agency is proposing in include the labeling regulations in parts must be taken and documented § 1271.230(c) a requirement that would 201 and 610 (21 CFR parts 201 and 610); whenever proper storage conditions are apply specifically to establishments that for products regulated as devices, they not met. process dura mater. Donor screening include those in part 801 (21 CFR part J. Receipt and Distribution (Proposed and testing requirements for donors of 801). Other labeling requirements § 1271.265) dura mater have been proposed in the appear in several sections of proposed donor-suitability proposed rule, but part 1271, and these are listed in Proposed § 1271.265 covers the additional processing safeguards are proposed § 1271.250. For example, receipt and distribution of human necessary to prevent the transmission of § 1271.90 is cross-referenced in cellular and tissue-based products. Creutzfeldt-Jakob disease (CJD) (64 FR § 1271.250; it would require that banked Section 1271.265(a) contains general 52696 at 52706). Proposed § 1271.230(c) cells and tissues for autologous use be requirements for procedures and would require that dura mater be labeled ‘‘FOR AUTOLOGOUS USE recordkeeping. Section 1271.265(b) processed using a validated procedure ONLY’’ (donor-suitability proposed rule governs receiving activities. to reduce CJD infectivity, while (64 FR 52723)). Procedures established Requirements that must be met prior to preserving the clinical utility of the in compliance with proposed § 1271.250 making a product available for product. Currently, an example of such would need to ensure that banked cells distribution are contained in a procedure would be a sodium and tissues for autologous use were § 1271.265(c). The remaining paragraphs hydroxide (NaOH) protocol that has labeled with this statement. deal with packaging, shipping been validated to reduce CJD infectivity conditions, and the return of products to (in an animal model) while preserving I. Storage (Proposed § 1271.260) inventory. Under § 1271.265(a), procedures the tissue’s clinical utility. In the future, Proposed § 1271.260 sets out storage would be required for receiving, other methods that more effectively requirements. The proposed regulation accepting or rejecting, and distributing reduce CJD infectivity may be addresses three general areas of concern: developed. human cellular and tissue-based Control of storage areas; storage products, as well as for the destruction If processes are validated, in place of temperature; and expiration date. verification, then procedures must be or other disposition of such products. Under proposed § 1271.260, each established and maintained to ensure Each of these activities, when establishment would be required to that the specified requirements continue performed, must be documented. establish and maintain procedures for to be met; this requirement appears in Required documentation would include the control of storage areas and stock proposed § 1271.230(d). Under the identification of the human cellular rooms in order to prevent mix-ups, § 1271.230(e), any change or deviation or tissue-based product, the activities commingling, deterioration, from a validated process would require performed and the results of such contamination, and cross-contamination a review and evaluation of the process activities, the date or dates of the and, where appropriate, revalidation. of human cellular and tissue-based activity, the quantity of product subject products and supplies, as well as any to the activity, and the disposition of the H. Labeling Controls (Proposed other condition that might adversely product. The disposition of the product § 1271.250) affect product function or integrity. In would include, for example, the identity Under proposed § 1271.250, an addition, controls would be required to of the consignee. Complete and accurate establishment would be required to prevent improper release for identification of a consignee would establish and maintain procedures to distribution. include not only the consignee’s name, control the labeling of human cellular Storage at a proper temperature, in but its address and telephone number. and tissue-based products. These order to preserve a product’s function Section 1271.265(b) contains specific control procedures would be designed and integrity and prevent deterioration, requirements with respect to the receipt to ensure that products are identified is an important aspect of CGTP. FDA of human cellular and tissue-based properly and to prevent mix-ups. The recognizes that appropriate products for processing, distribution, or agency is not specifying how such temperatures may differ for various any other step in the manufacturing controls should be designed, but notes types of products. Thus, § 1271.260(b) process. As part of its receiving that they would likely need to include would require an establishment to activities, an establishment would be such elements as proper storage establish acceptable temperature limits required to inspect incoming human methods to prevent deterioration of for the storage of human cellular and cellular and tissue-based products, adhesives, among other problems. In tissue-based products at each step of the according to established procedures, for addition, § 1271.250 would require manufacturing process. Monitoring of damage, contamination, deterioration, procedures to include verification of storage temperatures would be required. or any other indication that the integrity label accuracy, legibility, and integrity. Temperatures would have to be of the product had been impaired. The Thus, for example, a labeled product documented, and recorded temperatures establishment would then determine would be checked under such reviewed periodically to assure that whether to accept or reject the product. verification procedures to ensure that its temperatures remained in the Acceptance or rejection of the incoming label was affixed securely to the permissible range. product would need to be documented. container, could be read with ease, and Different products may be stored for An establishment receiving a human accurately identified the product by differing lengths of time before use. The cellular or tissue-based product would identifier and product type. maximum storage period depends on also be required to ascertain its status Proposed § 1271.250 would also such factors as product type, processing and handle the product appropriately. require that procedures be established procedures and method of preservation, For example, a product that is shipped and maintained to ensure that products storage conditions, and type of under quarantine, pending completion are labeled in accordance with all packaging. Section 1271.260(c) would of the donor-suitability determination applicable labeling requirements. require, where appropriate, that an required under subpart C of part 1271,

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1518 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules would be required to be maintained in required in subparts C and D of part management system could utilize a quarantine after its receipt until the 1271. Many, but not necessarily all, of computer to generate files and subfiles. determination was complete. Other the requirements for documenting a Section 1271.270(d) and (e) deal with issues of product status (e.g., stage in manufacturing activity are specifically methods and time frames for retaining processing, results of donor screening noted elsewhere in the regulations. For records. Under § 1271.270(d), records and testing) would dictate other example, an establishment’s receipt of could be maintained electronically, as appropriate action with respect to the tissue for processing would be a original paper records, or as true copies. product. significant step that needs to be Examples of true copies include Proposed § 1271.265(c) deals with an documented; proposed § 1271.265(a) photocopies, microfiche, and microfilm. establishment’s determination that a lists the specific documentation that Suitable equipment would be required product is ‘‘available for distribution,’’ a would be required. As noted in to be available for reading and term that the agency is proposing to proposed § 1271.270(a), any photocopying any records maintained define in proposed § 1271.3(ff). Under requirement in part 1271 that an activity on microfiche or microfilm. Records that definition, a human cellular or be documented involves the creation of stored in automated data processing tissue-based product is ‘‘available for a record, and that record would be systems must be backed up to prevent distribution’’ if it has been determined subject to the requirements of their loss. Any electronic record or to meet all release specifications and to § 1271.270. electronic signature would be subject to be suitable for distribution. Under Section 1271.270(a) would require the requirements in 21 CFR part 11. § 1271.265(c), an establishment would records to be accurate, indelible, and Under § 1271.270(e), all records be required to establish and maintain legible. Entries must be dated and the would be required to be kept for 10 procedures for making products person performing the work in question years after their creation. However, available for distribution, including must be identified. Records would have consistent with proposed § 1271.55(b) developing release criteria. These to be sufficiently detailed to provide a on records of donor-suitability procedures would be designed to complete history of the work performed determinations, records pertaining to a prevent the release of products that are and to relate the records to the particular human cellular or tissue- in quarantine, have deteriorated, or particular human cellular or tissue- based product must be retained at least otherwise have been manufactured in based product involved. In order to 10 years after the date of implantation, violation of CGTP. They must also protect the privacy of both donors and transplantation, infusion, or transfer of prevent the release of products from recipients, adequate record security the product. See donor-suitability donors who have not been determined systems would be required. proposed rule (64 FR 52721). If the date to be suitable, except as provided under Under § 1271.270(b), establishments of implantation, transplantation, proposed §§ 1271.65 and 1271.90. would have the flexibility to develop infusion, or transfer is not known, then Prior to making a human cellular or individualized systems of maintaining the records must be retained at least 10 tissue-based product available for and organizing their records, so long as years after the date of the product’s distribution, an establishment would be certain objectives were achieved. distribution, disposition, or expiration, required to review all records pertaining Records could be maintained in more whichever is latest. The establishment to the product and to verify and than one location, provided that the must make provisions for all records to document that release criteria have been records management system was be maintained for the required period in met. The determination that a product is designed to ensure prompt the event that the establishment ceases available for distribution must be identification, location, and retrieval of operation. FDA requests comment on documented and dated by a responsible all records. Further, the records whether there are specific types of person. management system would need to records for which a retention period Under § 1271.265(d), all packaging facilitate the review of a particular shorter than 10 years would be and shipping containers would be human cellular or tissue-based appropriate and would not compromise required to be designed, validated, and product’s history both prior to its the agency’s ability to prevent the constructed so as to ensure product release for distribution and, if necessary, introduction, transmission and spread function and integrity and to protect the at a later date as part of a follow-up of communicable disease. product from damage, deterioration, evaluation or investigation. In addition Section 1271.270(c) cross-references contamination, or other adverse effects to records pertaining to individual records requirements proposed in during customary conditions of products, records for product types subpart C of part 1271 that relate to processing, storage, handling, and would be required to be maintained and donor testing and screening, in order to distribution. Section 1271.265(e) would organized. Thus, for example, a make clear that records required under require that appropriate shipping manufacturer of several different types subpart C of part 1271 are subject to the conditions, to be maintained during of human cellular and tissue-based recordkeeping requirements in transit, be defined for each type of products would be required to maintain, § 1271.270. Section 1271.270(f) would product. And § 1271.265(f) would for each product type, records of require an establishment to maintain require that an establishment develop pertinent procedures, product records of contracts, agreements, and procedures for determining whether a specifications, labeling and packaging other arrangements with other product that is returned to the procedures, and equipment logs. A establishments under which any step in establishment may be returned to records management system could be as the manufacturing process is performed inventory. simple as keeping all information by the other establishment. These pertaining to the manufacture of one records would need to contain not only K. Records (Proposed § 1271.270) product in one file folder, and keeping the name and address of the other Proposed § 1271.270 contains general all file folders for one product type, e.g., establishment, but also a description of requirements for recordkeeping under tendons, in one drawer of the file each party’s responsibilities. part 1271. Section 1271.270(a) would cabinet. This drawer, labeled require establishments to maintain ‘‘Tendons’’, would also contain a folder L. Tracking (Proposed § 1271.290) records concurrently with the for ‘‘generic’’ procedures common to all FDA considers product tracking to be performance of each significant step tendons. A more elaborate records an essential component of its proposed

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1519 regulatory system for human cellular the donor to the recipient or final requirements. For example, a statement and tissue-based products. Should the disposition and conversely from the might be included in the materials recipient of such a product contract a recipient or final disposition to the accompanying the consigned human communicable disease, tracking would donor. FDA recognizes, however, that cellular or tissue-based product that permit appropriate follow-up, such as some establishments may be better would describe applicable regulations an investigation to determine whether equipped than others to establish an and the establishment’s tracking the human cellular or tissue-based effective tracking system. For this method. The establishment would be product transmitted the disease agent reason, the agency proposes to permit required to document that the consignee and, if so, would permit steps to be an establishment that performs some, agreed to participate in its tracking taken to prevent the distribution of but not all, of the steps in the method and to take all necessary steps other similarly infected products. manufacturing process to participate in to ensure compliance with the Similarly, if a donor is discovered, post- a method of product tracking that has requirements of § 1271.290; this donation, to have had a communicable been established by another agreement would need to be obtained disease, tracking would permit an establishment responsible for other and documented upon initial establishment to locate products from steps in the manufacturing process, distribution of human cellular or tissue- that donor. Thus, a tracking system is provided that the tracking method meets based products to a consignee and closely linked to the agency’s regulatory all the requirements of § 1271.290. One would not need to be obtained for each objective of preventing the spread of possible method of tracking would be to subsequent consignment. communicable disease. collect information about recipients on As with other components of these cards that are returned to the tracking Proposed § 1271.290(g) contains a CGTP regulations, FDA is proposing establishment. requirement specific to donors of dura certain basic requirements, but is Section 1271.290(c) would require mater, intended to address the allowing establishments flexibility in that each human cellular or tissue-based particular communicable-disease designing tracking programs that suit product be assigned and labeled with a concerns associated with that type of their particular activities. Auditing of an distinct identification code (e.g., product. Appropriate specimens from establishment’s tracking method to alphanumeric) that relates the product the dura mater donor would be required ensure its effectiveness would be to the donor and to all records to be archived, under appropriate required under the quality program pertaining to the product. Except in the storage conditions, and for the (proposed § 1271.160(b)(8) and (d)). case of autologous or directed appropriate duration, to enable future FDA recognizes that some donations, such a code must be created testing of the archived material for establishments have already developed specifically for tracking and may not evidence of transmissible spongiform and implemented tracking systems and include an individual’s name, social encephalopathy (TSE) and appropriate requests comments from those security or medical record number. An disposition of any affected dura mater establishments on the success or failure establishment that receives a human tissue, if necessary. Although archiving of particular tracking methods. cellular or tissue-based product for samples may not immediately increase Part 821 (21 CFR part 821) of FDA’s further manufacturing might use the the assurance of safety for a dura mater regulations contains the medical device code already assigned or might assign a graft, it would permit later testing for tracking requirements. Except for dura new identifier to the product. The TSE-induced changes using improved or mater, human cellular and tissue-based regulation specifies, however, that an new methods as they become available. products regulated as devices generally establishment that assigns a new In the event that a dura graft recipient have not been subject to tracking under identifier to a product shall establish became ill with CJD, such testing of part 821; thus, there will be little or no and maintain procedures for relating the archival donor material would be duplication of tracking requirements. new identifier to the old identifier. needed to confirm whether the dura When a human cellular or tissue-based Section 1271.290(d) would require graft was the source of infection, so that product is designated as a ‘‘tracked establishments to ensure, through no additional grafts from the affected lot device,’’ and subject to the device agreements with consignees or through would be distributed. At this time, tracking regulations, the manufacturer other measures, that the code and type based on currently available would be required to satisfy both sets of of each human cellular or tissue-base information, FDA recommends that tracking requirements. However, given product that is implanted, transplanted, samples of donor brain and dura mater the variety of methods that could be infused, or transferred into a recipient tissues be archived at a temperature devised to satisfy the tracking be recorded in the recipient’s medical equal to or less than minus 70 1⁄2C for requirements proposed in § 1271.290, it records, or in other pertinent records, to 16 years beyond the product’s is foreseeable that a single tracking enable tracking from the recipient to the expiration date. method could be adopted that conforms donor. Section 1271.290(e) would with the requirements of both require an establishment to document Ideally, archived samples should be § 1271.290 and part 821. and maintain records of the disposition retained for the lifetime of the graft Proposed § 1271.290 would require of each of its human cellular or tissue- recipient, because the maximum each human cellular or tissue-based based products to enable tracking from incubation period is not certain. To product to be tracked. Section the donor to the recipient or final date, the longest known incubation 1271.290(a) would place the tracking disposition. The information to be period is 16 years (Ref. 1). FDA believes obligation on each establishment that maintained must permit the prompt that it may be unrealistic to expect a performs any step in the manufacture of identification of the recipient of the manufacturer to maintain an archive for a human cellular or tissue-based product. such a long time. FDA suggests that product. Under § 1271.290(f), an establishment establishment of a nationally supported Proposed § 1271.290(b) would require would be required to inform its archive be considered for prolonged the establishment to establish and consignees in writing of the storage of these materials, in order to maintain a method of product tracking requirements in § 1271.290 and of the further the study of iatrogenic that enables the tracking of all human tracking method that the establishment transmission of spongiform cellular and tissue-based products from is using to comply with those encephalopathies.

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M. Complaint Files (Proposed have a systemic effect. The agency See ‘‘Expedited Safety Reporting § 1271.320) proposes to regulate such products Requirements for Human Drug and Proposed § 1271.320 would require solely under the authority of section 361 Biological Products,’’ final rule (62 FR establishments to maintain records of, of the PHS Act and not as biological 52237, October 7, 1997). In order to and review, all complaints. drugs or devices. Thus the heading of achieve a degree of uniformity ‘‘Complaint’’ is defined in proposed subpart E of part 1271 is ‘‘Additional throughout the agency and to simplify § 1271.3(ii) as: Requirements for Establishments reporting requirements for firms, FDA Described in § 1271.10.’’ Human cellular has modeled the procedures in any written, oral, or electronic and tissue-based products regulated as § 1271.350(a) on the reporting communication that alleges: (1) that a biological drugs or as medical devices requirements for other regulated human cellular or tissue-based product will continue to be subject to reporting products (i.e., drugs, devices, and has transmitted or may have transmitted and labeling requirements that are biological products) and is proposing to a communicable disease to the recipient currently in place. require use of the same standard of the product; (2) that the function or Although the title of proposed subpart reporting form that is already in use integrity of a human cellular or tissue- E of part 1271 refers to ‘‘additional’’ (FDA Form-3500A). based product may have been impaired; requirements for establishments Proposed § 1271.3(gg) would define or (3) any other problem with a human described in § 1271.10, the proposed an adverse reaction as ‘‘a noxious and cellular or tissue-based product that reporting and labeling requirements are unintended response to any human could result from the failure to comply designed to be less extensive and cellular or tissue-based product for with current good tissue practice. burdensome than the current which there is a reasonable possibility A communication from a physician requirements applicable to products that the response may have been caused expressing concern about possible regulated as biological drugs or as by the product (i.e., the relationship product contamination would be a devices. This approach is in keeping cannot be ruled out).’’ This definition ‘‘complaint.’’ with the agency’s expressed plans to put reflects the agency’s intention to shift The proposed regulation would in place a tiered regulatory scheme, from adverse experience reporting to require establishments to establish and under which human cellular and tissue- adverse reaction reporting, consistent maintain procedures for the prompt based products would be subject to an with ICH guidelines (62 FR 52237 at review, evaluation, and documentation appropriate level of regulation based on 52238), and is consistent with the ICH of all complaints. Records of each the degree of risk. At the same time, the E2A guideline’s definitions of ‘‘adverse complaint that the establishment proposed reporting and labeling drug reaction,’’ International Conference receives would be required to be requirements for 361 products have on Harmonisation; Guideline on maintained in a file designated for been drafted to be generally consistent Clinical Safety Data Management; complaints. The complaint file would with existing biological drug and device Definitions and Standards for Expedited be required to contain sufficient regulations. Reporting, availability (60 FR 11284 at information about each complaint for 11285, March 1, 1995). Under the A. Reporting Requirements (Proposed proper review and evaluation of the proposed definition, not all § 1271.350) complaint, including the identifier of unsuccessful outcomes would be the human cellular or tissue-based In order to stay informed of potential considered ‘‘adverse reactions.’’ For product that is the subject of the problems with human cellular and example, the agency recognizes that a complaint. For example, the complaint tissue-based products related to recipient may reject a human cellular or file should include the date of each communicable-disease transmission, tissue-based product, or that there may report, the unique product identifier, and to be able to take appropriate steps be a failure to engraft (e.g., of and the name of the person or in response, FDA needs to receive hematopoietic stem cells), for reasons establishment that submitted the information from establishments on that are unrelated to the product itself. complaint. Proposed § 1271.320 would adverse reactions and certain product Or a procedure may fail for reasons that, require that the complaint file be made deviations that could result in adverse whether or not specifically identified, available for review and copying upon reactions. For this reason, FDA is are known not to be product-related. On request from an authorized employee of proposing to require two different kinds the other hand, if the relationship FDA. Section 1271.320(c) sets out of reports from establishments that between the product and the noxious requirements for the review and manufacture human cellular and tissue- and unintended response cannot be evaluation of complaints. based products regulated solely under ruled out, the response would be section 361 of the PHS Act: the considered an adverse reaction under III. Additional Requirements With reporting of adverse reactions, and the the proposed definition. Respect to 361 Products reporting of product deviations. The phrase ‘‘the relationship cannot Proposed subpart E of part 1271 be ruled out’’ is included in the contains reporting and labeling 1. Adverse Reactions proposed definition to clarify which requirements that would apply only to Under proposed § 1271.350(a), individual cases should be reported to those establishments that manufacture establishments would be required to FDA. Instances of probable, possible, human cellular and tissue-based report adverse reactions to CBER. The remote, or unlikely relationships would products as described in proposed agency is engaged in an ongoing effort all be considered adverse reactions, § 1271.10 (registration proposed rule (63 to enhance agency-wide consistency in because there would be at least a FR 26754)). Such products would be the collection of safety data and, where reasonable possibility that the noxious products that: (1) Are minimally possible, consistency with the and unintended response may have manipulated, (2) are not promoted or definitions, reporting periods, formats, been caused by the human cellular or labeled for any use other than a and standards recommended by the tissue-based product, even though homologous use, (3) are not combined International Conference on causality has not been established. with or modified by the addition of any Harmonisation of Technical Under proposed § 1271.350(a), only nontissue or noncellular component Requirements of Registration of those adverse reactions that involved that is a drug or a device, and (4) do not Pharmaceuticals for Human Use (ICH). the transmission of a communicable

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1521 disease, product contamination, or the deviations: those that are of the type 1. Labeling Information failure of a human cellular or tissue- that could reasonably be expected to Proposed § 1271.370(a) would require based product’s function or integrity lead to a reportable adverse reaction. In each human cellular or tissue-based would be required to be reported. addition, required reporting would be product made available for distribution Moreover, reporting would be limited to limited to product deviations involving to be labeled clearly and accurately. In those adverse reactions that are fatal or human cellular or tissue-based products addition, certain basic information life-threatening, that result in that have been distributed. The agency would be required to appear on the permanent impairment of a body considers that these limitations on the product label: (1) The name and address function or permanent damage to body reporting obligation will lessen the of the establishment that determined structure, or that necessitate medical or burden on establishments and on the that the product met release criteria and surgical intervention. agency, making it possible for the made the product available for In order to determine which adverse agency to receive meaningful distribution, (2) a description of the type reactions are required to be reported, information and respond appropriately each establishment would be required to of product, and (3) the product’s (e.g., by monitoring recalls and assisting expiration date, if any. The agency review all adverse reaction reports. The in their implementation as necessary source of the information is not considers each of these items to be of and appropriate). sufficient importance that they warrant relevant; all reports, regardless of Proposed § 1271.350(b) sets out the source, would have to be considered. placement on the product label itself requirements for reporting product instead of in materials that accompany The procedures proposed for deviations that could give rise to an reporting adverse reactions are modeled the product. The first two items are adverse reaction and provides the crucial for accurately identifying the on those used for other products address to be used. Reports of such regulated by the agency. Reports to the product and responsible establishment product deviations would be expected in the event of any necessary follow-up agency would be required within 15 as soon as possible. Although no calendar days of initial receipt of the action (e.g., adverse reaction reports). particular reporting form would be Requiring products to be labeled with information, with a possible follow-up required, § 1271.350(b)(2) states that report. Reports would be submitted to their expiration dates helps to ensure each report shall contain a description that they maintain their function and CBER. The proposed regulation of the product deviation and provides addresses and information on integrity at the time of use. information on all corrective actions Recognizing that space on the product obtaining forms. that have been or will be taken in With respect to human cellular and label may be limited, the agency response to the product deviation, such tissue-based products regulated as proposes to require that the following as recalls. biological drugs, the reporting information appear either on the requirements in 21 CFR 600.80 continue B. Labeling and Claims product label or in a package insert: (1) to apply. For those products regulated Storage temperature, (2) warnings, Proposed § 1271.370 contains as devices, the medical device reporting where appropriate, and (3) instructions requirements for product labeling and requirements in 21 CFR part 803 apply. for use. Information on storage would govern promotional claims made The agency notes that the transmission temperature will help prevent errors in for human cellular and tissue-based of a serious communicable disease handling and help ensure that the products regulated solely under the would constitute an event that is product maintains its integrity and authority of section 361 of the PHS Act. required to be reported under current functions properly in the recipient. Section 1271.370(a) describes the regulations. Warnings and instructions for use will required contents of product labels and inform the physician of the proper use 2. Product Deviations accompanying materials. The types of of the product and would increase the FDA is proposing to require, in claims that may be made for human probability of a successful procedure. § 1271.350(b), that those product cellular and tissue-based products are 2. Claims deviations that could reasonably be addressed in § 1271.370(b). expected to lead to a reportable adverse The agency considers regulation of Section 1271.370(b) deals with claims reaction be reported to CBER, along labeling and promotion to be an for human cellular and tissue-based with information on corrective actions. essential part of its proposed tiered, products in labeling, advertising, and A definition of the term ‘‘product risk-based regulatory system for human promotional materials. Consistent with deviation’’ is proposed in § 1271.3(kk) cellular and tissue-based products. the agency’s plans outlined in the and has been discussed at section II.C of Labeling and promotional materials proposed approach document, this this document. which contain incomplete, unclear, provision would require that any such In the proposed approach document, inaccurate, unbalanced, or misleading claim be clear, truthful, balanced, and FDA indicated that establishments information can increase the risk of the not misleading. A ‘‘balanced’’ claim for would be required to maintain records introduction, transmission, or spread of a product would, for example, reflect an of errors and accidents, a term that is communicable disease by misleading objective, unbiased view of the product, incorporated in this proposal within the the public into inappropriate or unsafe including not only claims for the meaning of ‘‘product deviation’’ (see practices regarding these products (e.g., product’s benefits but also explanations proposed § 1271.3(kk)), and to make storing a product at an incorrect of any hazards. A claim may be them available for inspection, but that temperature) or by hindering corrective considered to be misleading if it omits no reports to the agency would be action which might become necessary important information. required. The General Accounting (e.g., by delaying identification of the Proposed § 1271.370(b)(2) is intended Office, in its report on human tissue establishment distributing an unsafe to clarify one of the four criteria that banks, criticized the agency for not product). must be met for a human cellular or requiring that such records be reported For these reasons, the agency tissue-based product to be regulated (Ref. 2). considers that section 361 of the PHS solely under the authority of section 361 The agency is now proposing to Act provides the agency with sufficient of the PHS Act. Under proposed require the reporting of certain product authority to issue these requirements. § 1271.10, a 361 product is one that, in

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1522 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules addition to meeting other criteria, is not §§ 610.60(a)(2), 610.61(b), and 610.63 interpret as including any appropriate promoted or labeled for any use other require the name, address, and license warnings. than a homologous use (registration number of the manufacturer or, in the f. Instructions for use. For biological proposed rule (63 FR 26744 at 26754)). case of divided manufacturing drugs, § 610.61(i), (j), and (k), as well as Section 1271.370(b)(2) explains that a responsibilities, all manufacturers. § 201.57(c), requires instructions for use. labeling claim or promotional materials Section 610.64 permits the name of the For devices, instructions for use are regarding the therapeutic or clinical distributor to appear. For human required in § 801.109(b)(2) and (c). outcome of a human cellular or tissue- cellular and tissue-based products, FDA IV. Inspection and Enforcement based product (other than for considers the establishment that Provisions reconstruction, replacement, repair, or determines that the product meets supplementation of cells or tissue) release criteria and makes the product Proposed subpart F of part 1271 would be considered a claim for a use available for distribution to be a contains provisions on inspections; other than a homologous use. A product manufacturer and will expect that human cellular and tissue-based for which such a claim was made would manufacturer’s name and address to products offered for import; and orders be subject, along with its labeling, to appear on the product label. of retention, recall, destruction, and regulation under the act and/or section Section 801.1(a) requires the label of cessation of manufacturing. Subpart F of 351 of the PHS Act. a device to specify the name and place part 1271 would apply only to those of business of the manufacturer, packer, establishments described in proposed 3. Labeling of Biological Drugs and or distributor. FDA proposes to interpret § 1271.10; i.e., those establishments that Devices this requirement, with respect to human manufacture human cellular and tissue- Proposed § 1271.370 applies only to cellular and tissue-based products based products regulated under the 361 products; human cellular and regulated as devices, as requiring the authority of section 361 of the PHS Act tissue-based products regulated as name of the establishment that and proposed part 1271, but not as biological drugs or as devices will determines that the product meets biological drugs or as devices. Products continue to be subject to labeling release criteria and makes the product that the agency is regulating as devices requirements currently in place. Parts available for distribution. or biological drugs will be subject to the 201 and 610 (21 CFR parts 201 and 610) b. Description of the type of product. enforcement provisions of the act and will apply to human cellular or tissue- For biological drugs, §§ 610.60(a)(1) and applicable regulations. based products regulated as biological 610.61(a) require the proper name of the The proposed inspection and drugs, as will relevant statutory product to appear on the container and enforcement provisions are based on provisions and any conditions of package label. The product’s proper those contained in part 1270, subpart D, product licensure. Human cellular and name will serve as an adequate which are currently applicable to tissue-based products regulated as description of the type of product. For human tissue intended for devices will be subject to the labeling devices, section 502(e)(2) and (e)(4) of transplantation. These provisions were requirements in part 801, in addition to the act (21 U.S.C. 352(e)(2) and (e)(4)) fully discussed in the rulemaking on the provisions of the act and any requires products to be labeled with part 1270 (‘‘Human Tissue Intended for applicable conditions of approval or their established name, or if there is no Transplantation,’’ interim rule (58 FR clearance. established name, then with the 65514 and 65517 to 65518, December In order to ensure that all human common or usual name of the device; 14, 1993); ‘‘Human Tissue Intended for cellular and tissue-based products, either will suffice, so long as it Transplantation,’’ final rule (62 FR regardless of regulatory category, bear adequately describes the type of 40429 and 40439 to 40440, July 29, certain basic relevant information, FDA product. 1997). proposes to interpret several current c. Expiration date. For biological Authority for the enforcement of regulations as encompassing the drugs, §§ 610.60(a)(4) and 610.61(d) section 361 of the PHS Act is provided information set out in proposed require products to be labeled with their for in part under section 368 of the PHS § 1271.370(a). The agency would expect expiration dates. For devices, Act (42 U.S.C. 271). Under section the information listed in proposed § 801.109(c) requires products to be 368(a) of the PHS Act, any person who § 1271.370(a) to appear on the label or labeled with information on ‘‘any violates a regulation prescribed under package insert of those products relevant * * * precautions’’; FDA section 361 of the PHS Act may be regulated as biological drugs or devices. proposes to interpret this provision as punished by imprisonment for up to 1 The paragraphs below set out each requiring a product’s expiration date, if year (42 U.S.C. 271(a)). Individuals may item listed in proposed § 1271.370(a), the product has one, because the also be punished for violating such a along with the parallel regulation expiration date is effectively a regulation by a fine of up to $100,000 applicable to biological drugs or precaution against use of an out-of-date if death has not resulted from the devices. The agency expects that few if product. violation or up to $250,000 if death has any changes will need to be made to d. Storage temperature. For biological resulted (18 U.S.C. 3559, 3571(b)). current labeling to ensure that the drugs, § 610.61(h) requires the Organizations may be fined up to information listed in proposed recommended storage temperature to $200,000 per violation not resulting in § 1271.370(a) is provided. Where there appear on the package label. For death and $500,000 per violation is a difference in required placement of devices, FDA proposes to interpret resulting in death (18 U.S.C. 3559, the information (e.g., on the label or in § 801.109(c), which requires information 3571(c)). In addition, Federal District a package insert), the placement for use, including precautions, to Courts have jurisdiction to enjoin required in the biological drug or device include the proper storage temperature. individuals and organizations from regulation will apply. e. Warnings, where appropriate. For violating regulations implementing a. Name and address of the biological drugs, § 210.57(e) requires section 361 of the PHS Act. establishment that determines that the warnings. For devices, § 801.109(c) product meets release criteria and requires information on hazards, A. Inspections (Proposed § 1271.400) makes the product available for contraindications, side effects, and Proposed § 1271.400 addresses the distribution. For biological drugs, precautions, which FDA proposes to inspectional process. In large part,

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1523 inspections of establishments that describing the observations of the accordance with the records manufacture human cellular and tissue- representative that represent an requirements proposed in the donor- based products would be conducted in observed or potential problem with the suitability proposed rule. the same manner as inspections of firms facility or with the human cellular and As with other imports, when a human dealing in other FDA-regulated tissue-based products. After the report cellular or tissue-based product is commodities. of the FDA representative is reviewed, offered for entry, the importer of record Establishments subject to inspection FDA may issue additional must notify the director of the FDA include those that perform any step in correspondence to the establishment district having jurisdiction over the port the manufacture of human cellular and describing the violations to the of entry through which the product is tissue-based products, including regulations and requesting appropriate imported or offered for import. recovery, donor screening, donor follow-up action. ‘‘Importer of record’’ is defined in testing, processing, storage, labeling, The public disclosure of records proposed § 1271.3(tt). The human packaging, and distribution. All of these containing the name or other positive cellular or tissue-based product offered establishments, including any location identification of donors or recipients of for import must be held intact, under performing contract services, would be human cellular or tissue-based products conditions necessary to maintain required to permit inspections by an would be handled in accordance with product function and integrity, prevent authorized FDA representative at any FDA’s procedures on disclosure of contamination, and prevent reasonable time and in a reasonable information as set forth in 21 CFR part transmission of communicable disease, manner. The FDA representative would 20. Under these procedures, FDA takes until it is released by FDA. determine which areas of the necessary precautions to protect the Human cellular and tissue-based establishment to inspect in order to privacy of names of donors and products that are offered for import and determine compliance with the recipients prior to public disclosure of found to be in violation of part 1271 provisions of part 1271; these might records containing identifiers of the would be subject to recall and include, but would not necessarily be donor and recipients. FDA recognizes destruction in accordance with limited to, the establishment’s facilities, the sensitive nature of information that § 1271.440. equipment, processes, products, would identify a human tissue donor or C. Orders of Retention, Recall, procedures, labeling, and records. recipient. FDA may copy records Destruction, and Cessation of Inspections would be made with or containing identification of the donors Manufacturing (Proposed § 1271.440) without prior notification and would or recipients if such records are needed; ordinarily occur during regular business for example, to document the Proposed § 1271.440 describes the hours. The frequency of inspection distribution of potentially infectious procedures for the retention, recall, and would be at the agency’s discretion. human cellular and tissue-based destruction of human cellular and The FDA representative would call products. tissue-based products and for the upon the most responsible person The agency invites additional cessation of manufacturing operations, available at the time of inspection of the comments on possible alternative and is derived in large part from establishment and could question the inspection and enforcement provisions § 1270.43. Section 1271.440(a) states personnel of the establishment as the that would leverage agency resources, that, upon a finding that a human representative deems necessary. The be cost-effective, and achieve the public cellular or tissue-based product or an FDA representative could review and health goals of the proposed rule. The establishment is in violation of the copy any records required to be kept agency welcomes comments on the regulations in this part (and thus poses under part 1271, and could take advantages and disadvantages of various a risk of spreading a communicable photographs or make video tapes. The types of programs, such as joint agency- disease), the agency may issue an order agency notes that, under the policy third party inspectional programs and that the product be recalled and/or expressed in Compliance Policy Guide joint Federal-State inspectional and destroyed, as appropriate, or that it be 7151.02, ‘‘FDA Access to Results of enforcement programs, as well as any retained until it is recalled by the Quality Assurance Program Audits and other alternative approach that would distributor, destroyed, or disposed of as Inspections,’’ the FDA representative help ensure compliance with the agreed by FDA, or until the safety of the would not ordinarily review or copy an proposed rule. product is confirmed. Alternatively, the establishment’s records and reports that agency may take possession of and/or B. Imports (Proposed § 1271.420) result from audits of the establishment’s destroy the violative product. quality program established under Proposed § 1271.420, which is Section 1271.440(c) describes in proposed § 1271.160, when such audits derived from § 1270.42, is intended to further detail the order of retention, are conducted according to the clarify the administrative steps for the recall, or destruction, and describes establishment’s written quality program. importation of human cellular and possible alternatives to destruction. This policy is intended to encourage the tissue-based products into the United Section 1271.440(e) provides an establishment to conduct quality States. Human cellular and tissue-based opportunity for a hearing under 21 CFR program audits that are candid and products that have been recovered from part 16 and states that, if such a hearing meaningful. The agency would continue sources outside the United States can is requested, any possible destruction of to have access to all information enter the country, and products that human cellular and tissue-based required to be maintained under have been recovered from sources in the products would be held in abeyance proposed part 1271, such as complaint United States and then sent outside the pending resolution of the hearing files, information on product deviations, United States for processing can reenter request. and information on corrective actions. the country, consistent with the Proposed § 1271.440(a)(3) contains a At the end of the inspection, if provisions of part 1271. All imported provision not found in § 1270.43: an possible violations of the regulations are human cellular and tissue-based ‘‘order to cease manufacturing until found, the FDA representative would products would be required to be compliance with the regulations of this issue to the most responsible person at accompanied by appropriate records part has been achieved.’’ This type of the establishment a list of ‘‘Inspectional identifying the donor and the status of order would bar an establishment from Observations’’ (Form FDA–483), donor testing and screening in continuing its manufacturing operations

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1524 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules until the agency has determined that V. Proposed Revocation of Part 1270 one year (adjusted annually for compliance has been achieved. The Part 1270 contains regulations inflation). order will specify the regulations at governing infectious disease testing, The agency believes that this final issue, and will ordinarily specify the donor screening, recordkeeping, and rule is consistent with the principles particular operations covered by the enforcement for human tissue intended identified in Executive Order 12866. order (e.g., distribution, labeling, etc.). for transplantation. Products currently The Office of Management and Budget Operations may not resume without subject to the provisions in part 1270 (OMB) has determined that the final prior authorization of FDA. would be considered human cellular rule is a significant regulatory action as defined by the Executive Order and so Authority for this new provision and tissue-based products under the is subject to review. Because the rule derives from section 361 of the PHS Act, definition in § 1271.3(e) and would be does not impose mandates on State, which states that, ‘‘[f]or purposes of regulated under proposed part 1271. local, or tribal governments, or the carrying out and enforcing such The agency has previously announced private sector, that will result in an regulations, the Surgeon General may its intention that proposed part 1271 expenditure in any one year of $100 provide for such inspection, * * * would supersede the regulations in part million or more, FDA is not required to destruction * * *, and other measures, 1270 (donor suitability proposed rule perform a cost-benefit analysis as in his judgment may be necessary.’’ (64 FR 52696)). After the regulations in according to the Unfunded Mandates The agency considers these new part 1271 go into effect, the regulations Reform Act. Many of the establishments measures to be a necessary component in part 1270 will be unnecessary, confusing, and duplicative. For these within the tissue industry would be of its new comprehensive approach to classified as small business entities, and cell and tissue regulation, which reasons, the agency now proposes to revoke part 1270. a number of these facilities will incur includes the proposed establishment new costs. Because of the limits of registration and product listing and the VI. Proposed Effective Date information to characterize the current proposed CGTP requirements. FDA proposes that any final rule that quality management practices at many The agency recognizes that an order to may issue based on this proposal of these facilities, and thus the retain particular human cellular and become effective 180 days after the date increased effort required to meet the tissue-based products suspected of of its publication in the Federal standards of CGTP, the cost impact on being in violation of the regulations may Register. small business entities is uncertain. The be appropriate in some instances, and FDA has therefore prepared an Initial intends to continue to issue such orders VII. Environmental Impact Regulatory Flexibility Analysis. as necessary. However, such a limited The agency has determined under 21 A. Estimated Cost Impact action against a product or products CFR 25.30(h) that this action is of a type may be an inadequate enforcement tool that does not individually or With the proposed CGTP rule, the in some instances; e.g., when an cumulatively have a significant effect on FDA is furthering completion of the set establishment fails to comply with the human environment. Therefore, of proposals that represent a CGTP. In that situation, it may be more neither an environmental assessment comprehensive new system of appropriate to take action directly nor an environmental impact statement regulating human cellular and tissue- against the establishment, rather than is required. based products. Manufacturers of tissue against the products of the products may need to make certain VIII. Analysis of Economic Impacts establishment. changes to their operations to comply FDA has examined the impacts of the with the rule, such as creating new For example, an order to cease proposed rule under Executive Order procedures and providing additional operations would be appropriate in the 12866 and the Regulatory Flexibility Act documentation. The proposed rule case of an establishment that failed to (5 U.S.C. 601–612), and under the affects several industries involved in the establish and maintain proper Unfunded Mandates Reform Act (Public manufacture of human cellular and procedures under proposed Law 104–4). Executive Order 12866 tissue-based products. These include: § 1271.260(a) for storage of human directs agencies to assess all costs and Eye banks, conventional tissue banks, cellular and tissue-based products in benefits of available regulatory hematopoietic stem cell facilities, and such a way as to prevent their cross- alternatives and, when regulation is reproductive tissue facilities. contamination. Such a failure to comply necessary, to select regulatory FDA estimates are based on available with CGTP would cause potential approaches that maximize net benefits administrative data on the number of serious communicable-disease risk from (including potential economic, facilities within each industry sector all of the establishment’s products. An environmental, public health and safety, and the number accredited by various order to retain or destroy particular and other advantages; distributive industry associations. Where good products would not prevent the impacts; and equity). The Regulatory statistical data are not available, FDA’s establishment from continuing its faulty Flexibility Act requires agencies to cost impact estimates have incorporated practices and could therefore be analyze whether a rule may have a the quantified judgments of individual inadequate. significant impact on a substantial experts identified through contacts with The agency expects that, typically, an number of small entities and, if it does, the industry associations. Because of the order of cessation may be directed only to analyze regulatory options that would lack of comprehensive data to at the distribution of human cellular or minimize the impact. The Unfunded characterize patterns of current practice tissue-based products and would not Mandates Reform Act requires that within each affected industry sector, affect the rest of an establishment’s agencies prepare a written statement and the importance of this data in operations. However, in some cases, the under section 202 (a) of anticipated development of an accurate assessment order might cover a particular step in costs and benefits before proposing any of cost impact, FDA requests detailed the manufacturing process. And in rule that may result in an annual industry comment on the number of egregious cases involving serious CGTP expenditure by State, local and tribal facilities involved in the manufacture of deficiencies, the order might cover all of governments, in the aggregate, or by the cellular and tissue products, and the net a firm’s operations. private sector, of $100 million in any change in quality assurance efforts

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1525 needed for those facilities to comply umbilical cord blood would also be believed to follow industry standards with the proposed rule. affected by the proposed rule. FDA finds that are comparable to the CGTP. 1. The Number and Type of Entities that available data to estimate the According to industry consultants, Affected number of peripheral blood stem cell approximately one-third of the 20 The economic impact of the proposed (PBSC) facilities and current practices largest sperm banks are accredited by rule is organized around four subgroups: are quite limited. The actual number of the AATB, and the remaining two-thirds eye banks, conventional tissue banks, PBSC facilities may range from 200 to are licensed by State health agencies, stem cell facilities, and reproductive 400. Of the estimated total involved in including the California Department of tissue facilities. The number of facilities peripheral blood stem cell production, Health and the New York Department of and the percent of facilities that follow approximately 150 are currently Health. Sperm banks are also regulated current industry standards are accredited by the AABB and an under the Clinical Laboratory summarized in table 1 of this document. estimated 130 have applied for In estimating net new costs for facilities, accreditation by the Foundation for the Improvement Amendment (CLIA) of it is critical to account for facility Accreditation of Hematopoietic Cell 1988. adherence to current industry standards. Therapy (FAHCT). Industry sources Andrology laboratories at ART In a number of tissue manufacturing estimate that approximately 80 of these facilities are also subject to CLIA 1988. sectors the industry standards for many facilities are seeking dual AABB/ The Committee on Laboratory manufacturing operations meet or FAHCT accreditation, indicating an Accreditation (COLA) and the Joint exceed the specifications in the unduplicated count of approximately Commission on Accreditation of Health proposed rule. Facilities following those 200 PBSC facilities assumed to be Care Organization (JCAHO), also inspect standards should experience very little accredited by AABB and/or FAHCT. embryo laboratories for accreditation. impact in complying with FDA- However, the manufacturing practices of The requirements for accreditation by proposed standards. non-accredited facilities are unknown. the College of American Pathologists As presented in table 1 of this The International Bone Marrow document, FDA estimates that there are (CAP), which also accredits ART Transplant Registry/Autologous Blood facilities, closely resemble those in the 114 eye banks currently operating in the and Marrow Transplant Registry proposed CGTP rule, with a few United States, although the EBAA (IBMTR/ABMTR) estimates that the believes that the number of banks is total number of peripheral blood or exceptions. Consultants estimate that as declining and may currently be closer to bone marrow facilities may be as high many as 80 percent of ART facilities 100. According to EBAA, virtually all as 4001 (i.e., 200 more than the number may currently comply with the CAP operating eye banks currently comply estimated to be accredited by AABB or requirements. with the industry (EBAA) medical and FAHCT), but the number of IBMTR/ procedural standards for quality control. ABMTR-estimated facilities that TABLE 1.ÐESTIMATED NUMBER OF FA- For eye banks, the costs associated with actually process peripheral blood (as CILITIES THAT FOLLOW INDUSTRY following the proposed rule result from opposed to bone marrow) is uncertain. STANDARDS additional quality assurance steps and In addition, the proposed rule would process documentation as specified apply to facilities involved with Percent of under the CGTP. reproductive tissue, primarily sperm Affected Relevant Firms FDA estimates that 110 tissue banks banks and Assisted Reproduction Industry Industry Following are involved in the manufacture of other Standards Industry Technology (ART) facilities. For Standards conventional tissue, e.g., pericardium, purposes of this discussion, references dura mater, heart valves, skin allografts, to ART facilities include infertility Eye Tissue: EBAA1 100% facili- bone allografts, fascia, tendon, and clinics, and andrology and embryology 100±114 ties esti- ligaments (hereafter referred to as laboratories. The American Society of facilities mated com- ‘‘conventional tissue banks’’). Industry Reproductive Medicine (ASRM) has a pliant sources report that approximately 75 to membership of approximately 330 ART Conventional AATB2 75±80% facili- 80 percent of these facilities currently facilities. The ASRM also has a 1996 list follow the standards for tissue banking Tissue: ties esti- of approximately 110 sperm banks (e.g., peri- mated com- established by the AATB. For these operating in the United States. Based on facilities, there will be some additional cardium, pliant conversations with consultants, most dura cost associated with review of the commercial sperm banking and most mater, proposed FDA rule and with alignment ART facilities currently adhere to heart of their current procedures to FDA’s industry standards similar to those in valves, requirements. There may also be some the proposed rule. The 20 largest sperm skin additional recurring cost, where banks are estimated to handle 95 allograft, documentation and quality control bone percent of the total volume of product allograft) required under the proposed rule extend for the industry, and these facilities are beyond current practice. For the 110 facili- ties remaining 20 to 25 percent of facilities 1Based on the National Inpatient Sample of not following the industry standard, the hospital discharge data collected by the Agency for Stem Cells AABB or 85% accred- cost of compliance would be somewhat Health Care Policy Research (AHCPR) in the Health Peripheral FAHCT3 ited facili- higher. These facilities may need to Care Utilization Project (HCUP), a total of 7,300 stem cell transplants were performed in 1994, the Blood ties esti- establish more formal procedures and most recent year reported. With the number of stem (PB): 400 FAHCT mated com- quality control steps, and may need to cell facilities ranging from 400 to 200, this would facilities pliant devote added staff hours to performing translate to a range of 18 to 37 transplants per [uncertain] these procedures and processing facility per year. Based on the implied volume of Cord Blood 100% CB controls. product per facility per year, a total of as many as (CB): 25 facilities 400 facilities would seem unlikely if the number of facilities compliant Facilities that produce stem cell transplants in 1994 were representative of the products from peripheral blood or from current volume of demand for stem cell products.

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TABLE 1.ÐESTIMATED NUMBER OF FA- TABLE 1.ÐESTIMATED NUMBER OF FA- 4College of American Pathologists 5Clinical Laboratory Improvement Amend- CILITIES THAT FOLLOW INDUSTRY CILITIES THAT FOLLOW INDUSTRY ments of 1988 STANDARDSÐContinued STANDARDSÐContinued 6Assisted Reproductive Technology 7American Society for Reproductive Percent of Percent of Medicine Relevant Firms Affected Relevant Firms Affected 2. Estimated Impact on Industry Industry Following Industry Industry Following Industry Standards Industry Standards Industry Facilities Standards Standards In the sections that follow, the agency considers each of the provisions of the Reproductive AATB; CAP4 20% facilities Reproductive CAP accredi- approximately proposed rule its estimated impact on Tissue accredita- estimated Tissue tation; State 80% facili- facilities in the identified sectors of the ART6 Fa- licensed ties esti- Sperm tion; State compliant tissue industry. The impact analysis Banks: 110 Licensed (accounting cilities: 330 (e.g., mated com- facilities (e.g., for 95% of facilities NY,CA); pliant distinguishes expected cost impacts NY,CA); all produc- ASRM7 based on both facility size and estimated CLIA5-cer- tion) guidelines current adherence with industry tified standards. As defined by the U.S. Small 1Eye Bank Association of America 2American Association of Tissue Banks Business Administration, a small 3Foundation for the Accreditation of facility has revenues less that $5.0 Hematopoietic Cell Therapy million.

TABLE 2.ÐESTIMATED COST PER FACILITY AND ESTIMATED PERCENTAGE OF FACILITIES THAT WOULD BE AFFECTED BY PROPOSED CURRENT GOOD TISSUE PRACTICES1

Stem Cell Facili- 2 Section Title Eye Banks Conventional Tis- ties (Compliant/ Sperm Banks ART Facilities sue (Small/Large) noncompliant) (Small/Large)

1271.150 CURRENT GOOD TISSUE ± ± ± ± ± ± ± ± ± ± PRACTICE: GENERAL

1271.155 EXEMPTIONS AND ALTER- ± ± ± ± ± ± ± ± ± ± NATIVES

1271.160 ESTABLISHMENT AND MAIN- TENANCE OF A QUALITY PROGRAM (b)(2) FunctionsÐProcedures $349 (95%) $698/ $2,004 $0/ $698 (0%/ $698 (5%) $698/ $0 (5%/ 0%) for sharing information (23%) 80%) (b)(3) FunctionsÐCorrective ac- $414 (95%) $828 (23%) $0/ $828 (0%/ $828 (5%) $828/ $0 (5%/ 0%) tions 80%) (b)(7) FunctionsÐInvestigations $2,022 (95%) $2,022 (23%) $0/ $2,022 (0%/ $2,022 (5%) $2,022 /$0 (5%/ 80%) 0%) (d)(1) AuditsÐAnnual $414 (95%) $828/ $1,656 $0/ $828 (0%/ $828 (5%) $828/ $1,656 (50%) (23%) 80%) (d)(3) AuditsÐReport $138 (95%) $276 /$552 (23%) $207 (95%) $207 (5%) $207/ $414 (50%) (e) ComputersÐValidate cus- $2,040 (10%) $2,040 (10%) $2,040 (10%) $2,040 (5%) $2,040 (5%) tomized software (f) ProceduresÐQuality pro- gram ÐFacility with minor defi- $449 (95%) $449/ $1,159 $449 (80%) $449 (80%) $449/ $1,159 (80%) ciencies (23%) ÐFacility with major defi- $2,191 (5%) $2,191/ $4,359 $0/ $2191 (0%/ $2,191 (5%) $2,191/$4,359 (5%) ciencies (5%) 5%) ÐCost for additional qual- $1,236 (95%) $1,236 (23%) $1,236 (80%) $1,236 (80%) $1,236 (80%) ity control work

1271.170 ORGANIZATION AND PER- SONNEL (b) Competent performance ± ± $15,560 (23%) $0/ $15,560 (0%/ $15,560 (5%) $15,560 (5%) of functionsÐSufficient 95%) personnel (c) Training ± ± $2,348/ $3,104 $0/ $2,348 (0%/ $2,348 (5%) $2,348/ $0 (5%/ (23%) 95%) 0%)) (d) RecordsÐPersonnel ± ± ± ±- ± ± ± ± ± ±

1271.180 PROCEDURESÐGENERAL $8,280 (5%) $8,280 (23%) $0/ $8,280 (0%/ $8,280 (50%) $8,280 (50%) REQUIREMENTS 95%)

1271.190 FACILITIES (a) General ± ± ± ± ± ± $14,000 (5%) $14,000/$28,000 (5%/ 5%) (b) Operation-Separation ± ± ± ± $0/$14,000 (0%/ 14,000 (5%) $14,000/$28,000 of Operations 95%) (5%/ 15%) (b) General-Separation ± ± ± ±

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TABLE 2.ÐESTIMATED COST PER FACILITY AND ESTIMATED PERCENTAGE OF FACILITIES THAT WOULD BE AFFECTED BY PROPOSED CURRENT GOOD TISSUE PRACTICES1ÐContinued

Stem Cell Facili- 2 Section Title Eye Banks Conventional Tis- ties (Compliant/ Sperm Banks ART Facilities sue (Small/Large) noncompliant) (Small/Large)

(c)(3) Facility cleaning and sani- $299 (5%) $299/ $471 (23%) $299 (95%) $299 (5%) $299/ $471 (5%) tationÐProcedures (c)(4) Facility cleaning and sani- ± ± ± ± ± ± ± ± ± ± tationÐRecords

1271.195 ENVIRONMENTAL CONTROL AND MONITORING (a) GeneralÐProcedures for ± ± $299/ $471 (23%) $299 (95%) $299 (80%) $299/ $471 (80%) ventilation and air filtra- tion (b) InspectionsÐEnviron- $1,000 (5%) ± ± $1,000 ( 50%/ $1,000 (20%) $1,000/$2,000 mental control systems 95%) (20%) (c) RecordsÐEnvironmental $162 (95%) $162/ $324 (23%) $162 ( 95%) $162 (80%) $162/ $324 (80%) control and monitoring activities

1271.200 EQUIPMENT (b) Procedures and sched- ± ± $1,254/ $2,638 $0/ $1,254 (0%/ $1,343 (90%) $1,343/$2,261 ulesÐCleaning, sani- (23%) 95%) (90%) tizing, and maintenance (c) Calibration of equipment ± ± $1,254/ $2,638 $1,254 (95%) $1,343 (5%) $1,343/ (23%) $2,261(50%) (d) InspectionsÐRoutine $204 (95%) $408/ $816 (23%) $204 (95%) $204 (5%) $204/ $408 (5%) (e) RecordsÐMaintenance, cleaning, sanitizing, and calibrating activities ÐKeeping records of $162 (95%) $324/ $648 (23%) $162 (95%) $162 (5%) $162/ $324 (5%) cleaning and calibration activities ÐKeeping records of the $648 (95%) $1,296/ $2,592 $1,296 (95%) $1,296 (100%) $1,296/$2,592 use of each piece of (23%) (100%) equipment

1271.210 SUPPLIES AND REAGENTS (a) Receipt and verificationÐ $100 (95%) $299/ $471 (23%) $100/ $299 (95%/ $299 (5%) $299/ $471 (80%) Procedures 95%) (b) ReagentsÐProcedures in- ± ± $299/ $471 (23%) $299 (95%) house (c)(1) RecordsÐReceipt of sup- $162 (95%) $162 / $324 (23%) $0 / $162 (0%/ $162 (5%) $162 / $324 (5%) ply or reagent 95%)

1271.220 PROCESS CONTROLS (b) Processing materialÐPro- $299 (95%) $299/ $471 (23%) $299 (95%) $299 (90%) $299/ $471 (90%) cedures for the use and removal of damaging processing materials (d) In-process monitoringÐ $349 (95%) $349/ $1,002 $698 (95%) $349 (5%) $349/ $1,002 (5%) Procedures (23%)

1271.225 PROCESS CHANGES (a) ProceduresÐProcess $698 (95%) $698/ $2,004 $0 /$698 (0%/ $698 (5%) $698/ $2,004 (90%) changes (23%) 95%) (b) Change records $414 (95%) $414/ $828 (95%) $414 (95%) $414 (90%) $414/ $828 (90%)

1271.230 PROCESS VALIDATION (a) General $1,570 (95%) $1,570 (95%) $1,570 (95%) ± ± ± ± (d) Procedures $1,396 (95%) $698 / $2004 $698/ $1,396 (95%) (95%/ 95%) (e) Changes and deviationsÐ $785 (95%) $1,570 (95%) $1,055 (95%) Revalidation

1271.250 LABELING CONTROLSÐ $349 (5%) $349 / $1,002 $349 (5%) $349 (5%) $349 / $1,002 (5%) PROCEDURES (5%)

1271.260 STORAGE ± ± ± ± ± ± ± ± ± ±

1271.265 RECEIPT AND DISTRIBUTION (a)(1) GeneralÐDocument iden- $816 (5%) $1,632/ $3,264 $1,632/ $3,264 $1,632 (5%) $1,632/ $3,264 tification of product (5%) (5%) (5%)

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TABLE 2.ÐESTIMATED COST PER FACILITY AND ESTIMATED PERCENTAGE OF FACILITIES THAT WOULD BE AFFECTED BY PROPOSED CURRENT GOOD TISSUE PRACTICES1ÐContinued

Stem Cell Facili- 2 Section Title Eye Banks Conventional Tis- ties (Compliant/ Sperm Banks ART Facilities sue (Small/Large) noncompliant) (Small/Large)

(b) Receiving activitiesÐPro- ± ± $349/ $1,002 $698 (95%) $698 (5%) $698/ $2,004 (5%) cedures (23%) (c) Availability for distribu- ± ± $349/ $1,002 $349/ $698 (95%) $698 (5%) $698/ $2,004 (5%) tionÐProcedures (23%) (d) PackagingÐValidation $1,296 (95%) $1,296 (95%) $544 (95%) $544 (100%) $544 (100%) (f) Return to inventoryÐPro- ± ± $299/ $471 (23%) $0/$399 (0%/ $299 (5%) $299/$471 (100%) cedures 95%)

1271.270 RECORDS (a) General $648 (95%) $0/ $648 (0%/ $648 (95%) ± ± ± ± 95%) (b) Records management $2,760 (95%) $0/ $2,760 (0%/ $2,760 (95%) $2,760 (5%) $2,760/$5,520 systems 95%) (50%) (e) Length of retention $18 (5%) $18 (50%/ 95%) $18 (95%) $18 (5%) $18/$36 (5%)

1271.290 TRACKING (b)(1) Method of product track- $698 (5%) $0/ $349 (0%/ $349 (95%) $349 (80%) $349/ $1,002 (80%) ing-General method 95%) (e) Recipient information $1,632 (5%) $0/ $3,264 (0%/ $3,264 (95%) ± ± ± ± 95%) (f) Consignees $1,380 (5%) $1,380 (23%) $1,380 (95%) $1,380 (80%) $1,380 (80%)

1271.320 COMPLAINT FILE (a) Procedures $100 (95%) $299/ $471 (23%) $299 (95%) $299 (5%) $299/ $471 (5%) (b) Complaint file ± ± ± ± ± ± ± ± ± ± (c) Review and evaluation of $552 (95%) $552 / $1,104 $552 (95%) $552 (5%) $552 / $1,104 (5%) complaints (23%) EÐADDITIONAL REQUIREMENTS FOR ESTABLISHMENTS DESCRIBED IN 1271.10

1271.350 REPORTING ± ± ± ± ± ± ± ± ± ±

1271.370 LABELING AND CLAIMS ± ± ± ± ± ± ± ± ± ±

FÐINSPECTION AND ENFORCEMENT OF ESTABLISHMENTS DESCRIBED IN 1271.10

1271.400 INSPECTIONS (a) InspectionsÐGeneral $708 (100%) $708 (100%) $708 (100%) $708 (100%) $708 (100%)

1271.420 HUMAN CELLULAR AND TIS- ± ± ± ± ± ± ± ± ± ± SUE-BASED PRODUCTS OFFERED FOR IMPORT

1271.440 ORDERS OF RETENTION, ± ± ± ± ± ± ± ± ± ± RECALL, DESTRUCTION, AND CESSATION OF MAN- UFACTURING 1Only sections estimated to have compliance costs for these industries are shown. No cost is estimated for a section (indicated by a double dash``Ð'') if the background analysis (see a detailed presentation of cost assumptions provided in FDA's Cost Impacts of the Proposed Current Good Tissue Practices Rule on Eye Banks, Conventional Tissue Banks and Stem Cell Facilities: Background Paper, April 1999, and in Cost Im- pacts of the Proposed Current Good Tissue Practice Rule on Sperm Banks and ART Facilities, February 1999, prepared by Eastern Research Group, Inc. ) shows that the requirements: (1) Do not apply, (2) have no new cost impact, or (3) are met by another section of the proposed rule. 2Assisted Reproductive Technology

As indicated by the information in revision of existing procedures. The the agency’s analysis relies on table 2, the impact of the proposed rule scope and degree of complexity may standardized estimates of the level of varies, depending upon the sector of the vary. FDA expects that the staff effort and cost for establishing tissue industry and the particular typically involved in the development procedures. Table 3 summarizes the provisions of the proposed rule. For and finalization of facility procedures agency’s assumptions, based on input many of the proposed provisions, the will include technicians, clerical staff, from industry consultants.2 facility level impact will entail lab supervisors, and the lab director. For development of new procedures, or purposes of industry-wide estimation,

2A detailed presentation of level of effort and cost Cell Facilities: Background Paper,’’ April 1999, and Research Group, Inc. These documents will be assumptions are provided in FDA’s ‘‘Cost Impacts in ‘‘Cost Impacts of the Proposed Current Good available on the CBER website. of the Proposed Current Good Tissue Practices Rule Tissue Practice Rule on Sperm Banks and ART on Eye Banks, Conventional Tissue Banks and Stem Facilities,’’ February 1999, prepared by Eastern

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TABLE 3.ÐESTIMATED LEVEL OF EFFORT AND COST PER PROCEDURE REVISED OR PREPARED TO COMPLY WITH THE PROPOSED CURRENT GOOD TISSUE PRACTICE1

Size Category Minor Procedures Major Procedures

Small Facility Revise Existing Prepare New Revise Existing Prepare New Staff level of effort 2.0 hrs. 6.0 hrs. 8.0 hrs. 16.0 hrs. Cost $99.50 $298.50 $349.0 $698.00 Large Facility Staff level of effort 4.0 hrs. 12.0 hrs. 27.0 hrs. 54.0 hrs. Cost $157.00 $471.00 $1,002.00 $2,004.00 1Small facilities are those with revenues less than $5.0 million. The distinction between major and minor procedures is described in the report by Eastern Research Group, Inc.

The analysis of impact is summarized would include: Procedures for each step standards would need to prepare a below through a discussion of the in the manufacturing process, major procedure; and 5 percent of sperm proposed rule provisions and expected procedures for exchanging information banks and 5 percent of ART facilities type and extent of industry impact. The with other establishments known to would need to prepare a major pertinent section of the proposed rule is have recovered cells from the same procedure to address this requirement. noted to facilitate reference to the donor, corrective action and Although FDA anticipates that most related estimates in table 2. documentation, training and education industry facilities take steps to a. Section 1271.150—current good of personnel, appropriate monitoring administer corrective actions and tissue practice: general. The proposed systems, maintenance of records, conduct investigations, some may rule would require manufacturers of investigation and documentation of all currently do so only when major human cellular and tissue-based product deviations, other actions deviations arise. products to follow CGTP. Section necessary to assure compliance with the FDA estimates that 95 percent of eye 1271.150(a) gives an overview of CGTP quality program; assignment of banks, 23 percent of conventional tissue but does not present specific authority over the quality control banks, 80 percent of stem cell facilities, compliance requirements. The specific program, audits, computer software and 5 percent of sperm banks and ART requirements are addressed in validation, and other procedures facilities, would need to invest subsequent sections. Section specific to the quality program. A additional time. The incremental time 1271.150(b) would require that number of these functions are further for the laboratory director to administer manufacturers ensure compliance on specified in subsequent provisions of corrective actions and document these the part of contractors and proposes the the rule, and the impact is estimated in activities is estimated to be an establishment that should be the context of those provisions. additional half-hour per month of responsible for compliance. FDA In general, FDA anticipates that laboratory director time at eye banks expects that facilities would use almost all of the establishments in the that already perform this activity to a accredited referral laboratories to ensure affected industries have the appropriate lesser extent, and an additional hour per compliance with the CGTP rule, and facilities, equipment, and systems to month at all other facilities that will be therefore new costs would be associated support comprehensive quality newly affected by this provision. As with § 1271.150(b). Section1271.150(c) management, but only those already shown in table 2 in § 1271.160(b)(7) of explains the relationship of the estimated to be following industry the background papers prepared by FDA proposed rule to regulations specifically standards are expected to have and Eastern Research Group Inc., (ERG) applicable to biological drugs or devices comprehensive quality programs in for newly required investigations in and paragraph (d) defines the term place. Some facilities may need to tissue facilities, FDA estimates an ‘‘where appropriate’’ in relation to the upgrade their quality program for additional cost per year of $2,022 for an rule. Neither § 1271.150(c) nor (d) several of the proposed requirements. additional 2 hours per month for the would generate any costs for this These include: Procedures for sharing laboratory director to investigate and industry because no compliance information, corrective actions, and document deviations, and an additional requirements are specified. investigations. Further, some facilities half hour each for the laboratory b. Section 1271.155—exemptions and may need to take additional steps to supervisor and technician to participate alternatives. The proposed rule would administer corrective actions and in the investigations. allow establishments to request an conduct investigations, if they currently A number of facilities would also exemption or alternative from FDA for do so only when major deviations arise. institute other requirements of the any of the requirements of the rule. Although sharing of information is an quality program, including audits, There is currently no basis for industry-wide practice, some small computer software validation, and predicting industry requests for facilities, particularly those not procedures specific to the quality exemptions or alternatives, or for following current industry standards, program. Audits are part of the industry predicting the effect of these actions on may not have written procedures and standards published by the AATB, the compliance costs. FDA anticipates that reporting forms for this task. FDA EBAA, by FAHCT and the AABB. very few facilities will consider it estimates that 95 percent of industry eye However, some facilities following these appropriate to be exempted from the banks would need to revise a major standards may need to do some quality standards specified in the procedure; 23 percent of other additional recordkeeping, and facilities proposed rule. conventional tissue banks, not following not following standards would begin to c. Section 1271.160—establishment the current AATB standard, would need conduct audits. Referring to table 2, and maintenance of a quality program. to write a major procedure to comply FDA assumes that up to 95 percent of The proposed rule would require that with this requirement; 80 percent of the eye banks would increase their audit facilities establish and maintain a peripheral blood stem cell facilities not efforts, including additional lab director quality program. The quality program following the FAHCT or AABB time to perform the audit and additional

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The cost of hours at larger facilities, to prepare 2.4.3 of the background reports by FDA of this staffing effort is estimated to be for, and to conduct the audit. For stem and ERG. approximately $15,560 per affected cell facilities, FDA estimates that there The last requirement for the quality facility. would be no additional auditing control program is for procedures that FDA anticipates that the 23 percent of required at facilities following FAHCT stipulate how the quality program conventional tissue facilities, 95 percent or AABB standards, but an estimated 80 should be operated. Industry of industry-noncompliant stem cell percent of facilities not following consultants indicate that facilities have facilities, 5 percent of sperm banks, and industry standards would need to spend quality systems in place, but that most 5 percent of small ART facilities would additional time to prepare for and to facilities are not aware of some minor incur new training costs in complying conduct an audit each year. It is also elements that should be included in the with the proposed rule. For a small assumed that approximately 5 percent procedures. Consequently, inspectors tissue establishment, these costs are of sperm banks would allocate for accreditation groups often find a few estimated to average $2,348. The additional staff hours for these audit- deficiencies during initial visits. FDA proposed CGTP would also require that related activities. estimates that about 95 percent of eye records of personnel qualifications and In addition to performing the annual banks, 23 percent of conventional training be maintained, but because the audit, the proposed rule would require tissue, and up to 80 percent of stem cell incremental record keeping is minimal, preparation of an annual audit report. facilities, sperm banks and ART FDA assumes that the cost to comply Facilities following current industry facilities will have minor deficiencies with this requirement would be standards may need to increase the time that would require them to revise one negligible. Detailed presentations of for reporting. minor and one major procedure. In these assumptions are provided in FDA estimates that 95 percent of addition, FDA estimates that 5 percent section 2.4.4 of the background reports industry eye banks will experience an of all eye banks, conventional tissue, by FDA and ERG. increase of approximately 2 hours per reproductive tissue facilities, and e. Section 1271.180—procedures: year of lab director time for preparing industry non-compliant stem cell general requirements. The proposed rule the audit report. The 23 percent of facilities, may identify major would require establishments to keep conventional tissue facilities not deficiencies, and would need to prepare written procedures for all steps following AATB standards are estimated five minor procedures and one major performed during manufacturing of to devote 4 hours of lab director time, procedure to address those problems. human cellular or tissue-based in the case of small facilities, and 8 The agency further assumes that products, and to perform an annual additional hours of lab director time at facilities may generally need to do some review. FDA anticipates a negligible large facilities for the preparation of an additional quality control work to incremental cost for most facilities annual audit report. Laboratory comply with the quality control following industry standards, and an directors of 95 percent of the stem cell program requirements in the CGTP rule. additional 120 hours by the laboratory facilities, 5 percent of sperm banks, and Although some tasks would not take any director for facilities not following the 33 percent of ART facilities, would additional time to perform, FDA current industry standards. FDA spend an estimated additional 3 hours estimates that one additional hour per estimates that 5 percent of eye banks to prepare the annual audit report. month each for the laboratory director would need to expand their current Approximately 17 percent of ART and supervisor may be needed. FDA review efforts, and that 23 percent of facilities would also be affected, with an estimates that 95 percent of all eye conventional tissue banks, 95 percent of increase of approximately 6 hours per banks, 23 percent of conventional tissue stem cell facilities, and 50 percent of year of staff time for audit report banks and approximately 80 percent of reproductive tissue facilities would preparation. stem cell facilities and reproductive incur new costs for an annual review. Section 1271.160 of the proposed rule tissue facilities would allocate this f. Section 1271.190—facilities. The further stipulates that facilities would additional staff time. proposed rule stipulates a number of be required to validate the computer d. Section 1271.170—organization requirements regarding the construction software used in their operations. The and personnel. The proposed rule of facilities, covering size, location, FDA assumes that off-the-shelf would require facilities to employ lighting, ventilation, plumbing, commercial software packages for sufficient personnel with the necessary drainage, and toilet and washing particular applications are already education and experience to complete facilities. The facility would also be validated by the software vendor, but their tasks. Personnel would be trained required to have properly divided areas that a facility’s custom software would to perform their work adequately. The for appropriate quality control. Cleaning require complete software validation. EBAA, AATB, FAHCT, and AABB requirements are also outlined, FDA assumes that none of the affected standards for quality assurance all including requirements for written facilities currently validate their custom include provisions for appropriate procedures and schedules for cleaning software and that approximately 10 personnel qualifications and training, and documentation of cleaning percent of eye, conventional tissue and and recordkeeping related to this activities. Based on discussions with stem cell facilities, and approximately 5 requirement. It is expected that most industry experts, FDA estimates that percent of reproductive tissue facilities facilities for eye banking, conventional nearly all facilities that follow industry have developed custom software that tissue banking, and stem cell production standards would not incur new costs would require full software validation already follow these practices as under the proposed CGTP rule. under the proposed rule. While the proposed. The fraction of facilities in However, some establishments that scope of such work can vary, FDA conventional tissue and stem cell generally adhere to cleaning standards estimates that the custom software in manufacturing that do not follow do not have written procedures. FDA

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FDA equipment, an additional 2 hours per provision of the CGTP also would estimates that 80 percent of all sperm month of technician time to record require that records of cleaning be banks and ART facilities would incur cleaning and calibration activities, and maintained. This proposed requirement costs to comply with this provision of an additional 8 hours of technician time is currently practiced by most facilities, the proposed rule. FDA also estimates per month to record each use of each and is expected to have a negligible that 20 percent of ART facilities would piece of equipment. It is anticipated that impact on facilities not following increase ventilation systems inspection the facilities simultaneously preparing industry standards. activities. Table 2 provides estimates of multiple procedures related to g. Section 1271.195—environmental cost per facility associated with these equipment would realize some control and monitoring. The proposed efforts. economies of scale because of rule would require that procedures be h. Section 1271.200—equipment. The similarities across procedures. This is written for environmental control and proposed rule stipulates that expected to result in a savings of 30 monitoring activities or systems where appropriate equipment be used and any percent in the total amount of staff time an environmental condition could have equipment used be validated. Cleaning, to prepare six to eight equipment an adverse effect on the human cellular maintenance, and calibration of maintenance procedures at one time. equipment would be performed or tissue-based product. The rule also Stem cell facilities also would be according to established schedules and would require that environmental expected to perform some additional procedures; equipment would be control systems be regularly inspected work to align current practice with the regularly inspected for adherence to and that control and monitoring proposed CGTP requirements. Current applicable procedures and schedules; activities be documented. The impact of FAHCT procedures provide for routine and all such activities would be this provision of the CGTP varies by maintenance and calibration of documented. In addition, facilities industry sector. For eye banking, the equipment. In addition, the AABB would be required to keep records of standards recommend that standard EBAA standards already contain each use of each piece of equipment, operating procedures (SOP’s) be relevant provisions, however, some including the identification of each established for proper equipment additional costs may be incurred for human cellular or tissue-based product maintenance and monitoring. To further annual inspection of the environmental manufactured with that piece of develop procedures to address routine control systems and for keeping records equipment. maintenance and recordkeeping under of environmental control and The standards related to equipment, the proposed CGTP, FDA estimates that monitoring activities. It is estimated that as specified by AATB, EBAA, FAHCT, 95 percent of all stem cell facilities 5 percent of eye banks may incur new and AABB generally address would prepare a minor procedure for costs for inspection and certification of maintenance procedures, and calibration of each of six pieces of equipment. FDA anticipates that the recordkeeping related to maintenance. equipment. In addition to the conventional tissue facilities following However, the proposed rule extends preparation of procedures, lab personnel AATB standards would experience no beyond the industry standard for EBAA, would carry out the maintenance work, new costs, but that the remaining 23 FAHCT and AABB in the areas of estimated to require an additional half percent of facilities would need to equipment inspection and hour of supervisor time per month in prepare a minor procedure to control recordkeeping. FDA therefore estimates routine inspection of equipment, an and monitor ventilation and air that 95 percent of all eye banks would additional half hour per month for filtration. allocate an additional half-hour per technicians to document cleaning and The current FAHCT and AABB month for the laboratory supervisor to calibration work, and an added 4 hours standards do not provide for written inspect equipment, an additional half per month of technician time to record procedures for environmental control hour per month of technician time to each use of equipment. In addition, and monitoring. FDA therefore documenting equipment cleaning and most stem cell facilities that do not estimates that 95 percent of all stem cell calibration, and two additional hours of currently follow FAHCT or AABB facilities would need to develop a minor technician time per month in recording standards would incur the cost of procedure to control and monitor each use of the equipment. preparing a minor procedure for ventilation and air filtration to comply The estimated 23 percent of cleaning, for sanitizing and for routine with the CGTP. However, because the conventional tissue facilities that maintenance of six pieces of equipment. industry standards provides for currently do not follow AATB standards In the reproductive tissue industry, appropriate environmental controls, would also incur new costs related to the agency estimates that all facilities FDA assumes that some facilities are equipment quality control. FDA have the appropriate equipment to currently performing control activities. estimates that small facilities would process the tissue products, but that The agency estimates that as many as prepare one minor procedure for only a small percentage currently half of the facilities currently following calibration, and for cleaning and other conduct recordkeeping and have written standards may already be conducting maintenance for each of six pieces of procedures related to maintenance, routine inspections of their equipment. In addition, small facilities calibration and other activities as environmental control equipment. It is will allocate an additional hour per specified under the proposed CGTP. assumed that the remaining 50 percent month of lab supervisor time for routine The agency estimates that 90 percent of of those facilities, and 95 percent of inspection of equipment, an additional sperm banks and ART facilities would facilities assumed not to be following hour per month of technician time for develop additional procedures, and that industry standards, would incur documentation of cleaning and 100 percent of these facilities would additional costs to inspect equipment calibration, and 4 hours per month need to perform additional

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1532 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules recordkeeping related to equipment use. Based on consultant estimates that 95 FDA anticipates that conventional In addition, an estimated 5 percent of percent of commercial sperm banks tissue banks not following the AATB sperm banks, and 50 percent of ART follow AATB guidelines, the agency standard would need to prepare a major facilities would devote additional estimates that only 5 percent of sperm procedure related to process changes, resources to routine calibration of banks and 80 percent of ART facilities and nearly all tissue banks would equipment. An estimated 5 percent of would need to take new steps to comply increase related recordkeeping. The facilities would need to also increase with this proposed CGTP provision. For agency estimates that small efforts in routine inspection, and record these facilities, the agency anticipates conventional tissue banks would spend keeping related to equipment cleaning that each facility would need to prepare an additional half hour per month of lab and maintenance. The costs per facility new procedures for receipt and director time to document process associated with each of these areas of verification of supplies and reagents, changes, and large facilities would activity are presented in table 2. Section and each will devote additional staff allocate an additional hour of lab 2.4.8 of the ERG background paper time to recording the receipt of these director time for this. FDA anticipates provides a detailed presentation of these materials. The estimated costs per that almost all stem cell facilities that do assumptions. facility are presented in table 2. not follow FAHCT or AABB standards i. Section 1271.210—supplies and j. Section 1271.220—process controls. would need to prepare a major reagents. The proposed rule would The proposed rule would require procedure to address process changes. require that procedures be established facilities to monitor manufacturing In addition, FDA estimates that 95 for receipt of supplies and reagents used processes to ensure that specified percent of all stem cell facilities would in the manufacture of human cellular requirements for the product are met. allocate an additional half hour of and tissue-based products. In particular, This includes having written procedures laboratory director time to document manufacturers would be required to for the use and removal of processing process changes. verify that supplies and reagents meet material that can damage products, and According to industry contacts, most specifications designed to prevent procedures for in-process monitoring. sperm banks already have established transmission of communicable disease The standards for tissue banking written procedures for process changes, and impairment of product function and specified by the AATB include activities and would therefore be in compliance integrity. Verification of supply or to address these process controls, but with this proposed provision. FDA is reagent quality could be accomplished the EBAA, FAHCT, and AABB also informed that ART facilities follow standards for process changes, but the with a certificate of analysis. The standards do not include specific procedures may not be in writing. In proposed rule would also require requirements for monitoring and addition, industry consultants estimate documentation of receipt, verification, removal of processing material that may that many reproductive tissue facilities and each use of a supply or reagent in damage the product. FDA estimates that may not keep written records of their product processing. 95 percent of eye banks, 23 percent of process changes. Based on these conventional tissue banks, 95 percent of The existing industry standards characterizations, FDA estimates that stem cell facilities, and 90 percent of address some or all of these activities, approximately 5 percent of sperm banks sperm banks and ART facilities would and the estimated impact per facility and 90 percent of ART facilities would need to prepare a minor procedure varies accordingly. EBAA standards need to develop a written procedure for specify that sterilized supplies and related to monitoring and removal of process changes. In addition, the agency reagents should contain sterilization damaging processing material. estimates that 90 percent of sperm banks dates, method or appropriate expiration Consultants estimate that most and ART facilities would need to dates. However, the agency estimates reproductive tissue facilities have allocate additional staff time (an that up to 95 percent of eye banks procedures for in-process monitoring, estimated one half-hour per month at would be required to develop additional and in these industries, an estimated 5 small facilities and one hour per month procedures related to receipt and percent of reproductive tissue facilities at large facilities) to record changes. The verification, and would devote would need to prepare procedures to associated costs per facility are additional staff time to recording the address this activity. presented in table 2. receipt of supplies and reagents. k. Section 1271.225—process l. Section 1271.230—process Similarly, FAHCT and AABB standards changes. The proposed regulation validation. The proposed rule would contain provisions for quality control in would require establishments to require facilities to validate processes the storage, handling and use of institute process change procedures that that cannot be verified through supplies and reagents, including will govern modifications to established subsequent inspection and testing. maintenance of records. However, FDA operations. Changes to processes would Current EBAA standards do not require expects that approximately 95 percent be documented with the date of the process validation. Although current of stem cell facilities may be required to change, the date of implementation, the AATB, FAHCT, and AABB standards expand on their current SOP’s and rationale for the change, and include provisions for process recordkeeping in order to comply with appropriate approval signatures. The validation and related recordkeeping, the CGTP provisions. current standards for AATB, FAHCT industry experts indicate that additional The current AATB standards address and the AABB provide for SOP’s for validation work would be required at most of the requirements for supplies process changes, although nearly all facilities under the proposed and reagents included in the proposed recordkeeping procedures are not rule. FDA therefore estimates that 95 rule. FDA assumes that the estimated 23 specified. Current EBAA standards do percent of all eye banks, of all percent of facilities that follow these not provide for SOP’s for process conventional tissue banks and all stem standards would be required to prepare changes. FDA therefore estimates that cell facilities, not compliant with AABB additional procedures for in-house nearly all eye banks would be required or FAHCT, would need to prepare two reagent verification, for receipt and to prepare a major procedure for process major procedures related to process verification, and would devote changes, and would allocate an validation, and 95 percent of additional staff time to keeping records additional half hour of lab director time conventional tissue banks and AABB/ of the receipt of supplies and reagents. to document process changes. FAHCT-compliant stem cell facilities

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1533 would need to revise two major for facilities in eye banking, percent of facilities do not currently procedures. FDA estimates that 95 conventional tissue banking, stem cell follow industry standards for product percent of all facilities in the tissue processing, and reproductive tissue. documentation. The agency estimates industry would devote additional staff o. Section 1271.265—receipt and that an additional 4 to 8 hours of staff time for process validation. distribution. The proposed rule would time per month would be required by In addition to the initial validation require that procedures be established those facilities, for documentation work, CGTP would require revalidation and maintained for receiving, rejecting, activities. Industry consultants indicate of procedures. The agency estimates that distributing, and disposing of human that although most reproductive tissue 95 percent of eye banks, conventional cellular or tissue-based products. facilities utilize ‘‘dry shippers’’ for tissue banks and stem cell facilities Documentation of each of those shipped products, most do not perform would need to allocate an additional activities, when performed, would also formal packaging validation. FDA amount (on the order of 20 to 40 hours) be required. Packaging and shipping therefore estimates that all facilities of laboratory staff time for annual containers would be validated and would be required to perform packaging revalidation. appropriate shipping conditions must validation, in compliance with the Reproductive tissue industry be defined. Procedures would also be proposed CGTP. Experts in the consultants considered that the process established to determine whether reproductive tissue industry also validation requirement would have products returned to an establishment consider it unusual for a product to be limited application to this industry are suitable to be returned to inventory. returned to inventory; given the because the tissues involved in Agency review of current industry potential risk of product deterioration or laboratory processes (e.g., sperm and standards indicates that provisions damage. It is expected that most sperm ova) are not uniform in quality. related to this area of quality control, banks already have a formal procedure However, quality control through in- except for package validation, are for handling returned product, and that process monitoring (under § 1271.220) included in each of the relevant ART facilities generally have an would be applicable to these tissues. standards. established protocol, but not a written m. Section 1271.250—labeling The primary impact of the proposed procedure. The agency estimates that controls: procedures. The proposed rule CGTP provisions for product receipt and approximately 5 percent of sperm banks would require facilities to establish and distribution thus involves packaging and 100 percent of ART facilities maintain written procedures for validation for most facilities, and therefore would be required to write a controlling the labeling of products. The procedures development for facilities minor procedure to comply with this procedures would ensure proper that do not currently follow industry proposed CGTP requirement. The costs identification of products and include standards. FDA estimates that 95 per facility for these activities are various checks and verifications. Each percent of eye banks, conventional presented in table 2. product would also be accompanied by tissue banks and stem cell facilities p. Section 1271.270—records. The donor suitability information, if would allocate approximately 4 extra proposed rule would require that applicable. Other labeling requirements hours per month for a laboratory records be maintained for any would also be met, such as labeling technician to validate packaging, significant step in the manufacturing products appropriately with the particularly packaging changes. In process. A records management system required information. addition, an estimated 5 percent of eye would need to be in place and According to consultants and industry banks, conventional tissue banks, and procedures would need to be contacts, labeling controls are usual and stem cell facilities would increase lab established for keeping records customary practice in the industry. FDA supervisor time to document receipt of associated with donor suitability record anticipates that only about 5 percent of products. keeping requirements. Records would all facilities in eye banking, in The agency estimates that be maintained for at least 10 years. The conventional tissue banking, in stem conventional tissue banks not following proposed rule would also require that cell processing and in the reproductive AATB standards would need to revise records be kept of any contracts or tissue industries would need to do one major procedure for receiving agreements. Although many additional work to comply with the products, revise one major procedure components of the required proposed labeling controls. FDA related to distribution of products, and recordkeeping system are addressed estimates that such facility would need prepare a minor procedure for return of under separate provisions of the to revise a major procedure for proper products to inventory. FDA estimates proposed CGTP, there may be a few identification of products. that 95 percent of stem cell facilities minor gaps in the records system of a n. Section 1271.260—storage. The would need to write one major facility that would be addressed under proposed rule would require that procedure addressing receiving this general provision. FDA therefore storage areas be controlled to prevent activities. Facilities following FAHCT or estimates that approximately 95 percent mix-ups and contamination. AABB standards would also need to of all eye banks, conventional tissue Temperature should be monitored and revise a major procedure for product banks, and stem cell facilities that limits established, including expiration distribution, while all other facilities follow FAHCT or AABB standards, dating where appropriate. Each of the would need to prepare a new major would be required to write at least one relevant industry standards contains procedure for product distribution as minor procedure, and revise one major provisions regarding storage practices. well as a minor procedure for handling procedure related to recordkeeping. Based on agency review of current of products returned to inventory. The agency also estimates that industry standards, and conversations According to industry contacts, most additional lab director time would be with experts about current practices at sperm banks and ART facilities have a allocated (estimated 40 hours at small facilities, FDA anticipates that virtually protocol for receiving and distributing facilities and 80 at large facilities) to set all facilities follow industry standards reproductive tissue products, however, up enhanced recordkeeping where a that would comply with this provision an estimated 5 percent of facilities system is already in place. System of the proposed CGTP. These provisions would need to write a major procedure enhancement would be performed at an of the proposed rule are therefore for receiving activities and one for estimated 95 percent of eye banks, 23 expected to produce no new cost impact distribution. Similarly, an estimated 5 percent of conventional tissue facilities,

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95 percent of stem cell facilities, 5 more than the 10-year period specified laboratory director time (on a one-time percent of sperm banks, and 50 percent in the proposed rule. It is estimated that basis) to institute formal contracts with of the ART facilities. only 5 percent of sperm banks and ART consignees. The FAHCT and AABB Various industry standards specify facilities would need to extend record standards for product tracking in stem record retention, although the time retention by an estimated 5 years. The cell facilities recommend that the periods vary somewhat. Of those additional cost of storing these files is facility be able to trace products to final facilities following industry standards, based on an assumption of 5 boxes (each distribution or disposition, but do not approximately 95 percent of eye banks approximately 2 cubic feet) specify that formal agreements be and the 77 percent of conventional accumulated per year at small facilities, established with consignees to assure tissue banks retain records for at least 10 and 10 boxes per year at large facilities, timely tracking of products. FDA years, and the remainder retain records for an additional 5 years, at a cost of 30 therefore estimates that 95 percent of for a minimum of 5 years. For these cents per cubic foot per year. The stem cell facilities would, on a one-time facilities, and the stem cell facilities that estimated costs per affected facility are basis, allocate an additional 20 hours of do not currently follow industry summarized in table 2. laboratory supervisor time to institute standards, FDA estimates increased q. Section 1271.290—tracking. The agreements for information sharing with record retention costs based on the cost proposed rule stipulates the steps the consignees who will receive of storing an additional 5 boxes (2.4 needed to properly track a product from products. In addition, FDA estimates cubic feet each) of records per year for donor to recipient and vice versa. The that 95 percent of stem cell facilities 5 years. The retention standards of proposed CGTP would require that that are not following FAHCT or AABB FAHCT and AABB for records related to facilities maintain a method for product standards would need to revise a major products are different from those tracking and that each product be procedure related to product tracking, concerned with facility and equipment assigned and labeled with a unique and would need to allocate additional maintenance and personnel training. All identifier. If a new identifier is assigned staff hours each month for recipient records related to the product should be during the manufacturing process, identification and documentation. retained indefinitely and records related procedures would be required for Consultants for the reproductive to facility and equipment maintenance relating the new identifier to the old tissue industry indicate that although and personnel training should be identifier. Records of product transfers sperm banks and ART facilities retained for only 5 years. would be kept in the recipient’s medical generally perform product tracking and FDA estimates that a half of the records. The facility that manufactured adhere to the practice of documenting records at stem cell facilities following the product would also keep track of the recipient information for products, industry standards would need to be disposition of each product, so that the current practices in assigning and retained for an additional 5 years, and recipient of the product can be easily documenting products with unique the annual cost will be comparable to identified. Facilities would be required identifiers throughout tissue processing that of other small tissue facilities. The to inform consignees of the established may widely vary, and there may be little agency also estimates that nearly all tracking method and would be required documentation of tracking agreements stem cell facilities that are not following to document that consignees agreed to with consignees. Most reproductive industry standards will increase record participate in their tracking method. tissue facilities therefore would need to retention. Almost all stem cell facilities Product ‘‘traceability’’ is a familiar review current systems and perform that do not follow industry standards concept and common practice in eye some enhancements. It is estimated that would be required to prepare at least banking, in conventional tissue banking, 80 percent of reproductive tissue one minor procedure and to revise a and in the stem cell processing industry. facilities would need to revise a major major procedure related to record Eye banks following EBAA standards procedure related to product tracking, keeping. The laboratory director at these maintain records with information that and would allocate additional staff facilities would be expected to allocate permits tracing of product from the hours each month for recipient 40 hours of time to improving the donor source to the patient recipient, identification and documentation. In facility’s current recordkeeping system. working through the surgeon who addition, approximately 80 percent of Consultants estimate that within the performed the procedure. FDA facilities would need to allocate lab reproductive tissue industries all anticipates that only 5 percent of eye supervisor time to institute agreements facilities have some record management facilities would need to enhance current for information sharing with the system, and many facilities have tracking, and would be required to consignees who will receive products. systems that meet the requirements of prepare one major procedure related to The estimated cost per facility to the proposed rule. Consultants estimate product tracking, spend additional staff perform these activities are presented in that most sperm banks and the currently time each month to identify and table 2. accredited ART facilities have adequate document recipient information, and Hospitals generally handle all records management systems in place, would allocate additional laboratory categories of cellular and tissue-based but that approximately 5 percent of director time to institute agreements for products. For accreditation by the Joint sperm banks, and about 50 percent of information sharing with the consignees Commission on Accreditation of the ART facilities would need to who will receive products. Healthcare Organizations (JCAHO), allocate additional laboratory staff time Conventional tissue facilities organizations that store tissue must keep (i.e., 40 hours at small facilities and 80 following AATB standards are able to records that permit tracing of any tissue hours at larger facilities) to enhance trace all products from donation source from the donor or source facility to all their current recordkeeping system in to product recipient. Conventional recipients or other final dispositions. compliance with the proposed rule. tissue facilities not following AATB The records must include In addition, FDA is informed that the requirements would be required to documentation of tissue use in the usual and customary practice in most revise a major procedure to address patient’s clinical record. Most hospitals ART facilities is to retain donor records product tracking, allocate additional are accredited and, therefore, are for an indefinite period. Usual and staff time each month to obtain and presumed to be tracking tissue to customary practice in sperm banks is to record information about product recipient. We believe that hospitals not retain records for at least 15 years, thus recipients, and allocate some additional accredited tend to be specialized

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FDA expect hospitals to incur no additional records be maintained of both donor assumes, therefore, that the industry costs as a result of this regulation. and recipient complaints, the proposed would be in compliance with this However, as some of our sources (Ref. rule requires that facilities also have provision of the proposed CGTP rule, 45) lack conclusive data on the written procedures for complaint and estimates that the cost impact adequacy of hospital recordkeeping, we review. FDA therefore estimates that 95 would be negligible. welcome comment on this matter. percent of all stem cell facilities would u. Section 1271.400—inspections. The proposed rule would also require be required to write a minor procedure FDA could conduct inspections of any that specimens of dura mater be to handle complaints, and that 95 facility subject to the proposed CGTP archived for the appropriate duration percent of all facilities would also be rule. FDA would interact primarily with under appropriate conditions to enable required to allocate additional time for one responsible person for each future testing for evidence of TSE. FDA yearly review and handling of establishment, but other personnel may recommends that the specimens be complaints. also be involved in the inspection. FDA archived for 16 years beyond the Consultants assessing the impact of could inspect facilities, equipment, expiration date. As CDRH guidance the proposed rule on the reproductive processes, products, procedures, already recommends that such tissue industry estimate that about 95 labeling, and records, and could review specimens be archived for 10 years, this percent of sperm banks and ART and copy any records required to be requirement would not impose an facilities already have written kept under the proposed rule. The additional tracking burden. FDA procedures for dealing with complaints, agency estimates that all industry assumes the incremental cost of the and that 5 percent of facilities would facilities would be subject to this longer storage time to be extremely need to prepare a minor procedure for provision of the proposed CGTP, and small and the overall cost impact to be complaint handling, and would allocate that inspections would occur annually. negligible. additional laboratory director time each FDA estimates that up to 16 hours of r. Section 1271.320—complaint file. year to review complaints that are laboratory technician time could be The proposed rule would require received. The estimated costs per necessary, to accompany the FDA facilities to maintain procedures for affected facility are presented in table 2. inspector through the facility and to reviewing and evaluating complaints s. Section 1271.350—reporting. The support the inspector’s information and to maintain a file for these proposed rule would require facilities to needs, and that up to 4 hours of complaints. Facilities would be required review adverse reaction reports and laboratory director time would be to review and evaluate complaints and report any adverse reactions, or product needed for activities related to the to determine whether each complaint deviations, involving transmission of inspection. This is expected to yield a represents an event that should be disease, or of the failure of a product cost of approximately $702 per facility. reported to FDA. Documentation of the that is fatal, life-threatening, results in review and evaluation would be permanent impairment of the body, or v. Section 1271.420—human cellular required, even if no investigation is requires surgical intervention. Based on and tissue-based products offered for made. FDA finds that the AATB, expert assessments of current industry import. The proposed rule would FAHCT, and AABB standards explicitly practices, and the inclusion of adverse require importers of human cellular and address procedures or recordkeeping event reporting in current industry tissue-based products to notify the FDA related to complaints. Based on standards, the agency expects that this district director having jurisdiction over discussions with industry experts, the requirement, within the proposed CGTP the port of entry through which the agency assumes that nearly all facilities framework for quality management, product is imported or offered for currently track, albeit informally, the would impose a negligible cost on import. The product would be held complaints received from consignees facilities in the industry. intact until it is inspected and released and recipients. Facilities that would be t. Section 1271.370—labeling and by FDA. required to prepare written procedures claims. The proposed rule would In the cellular and tissue-based for handling complaints, and to review require that products be labeled clearly product industries there is currently complaints on a yearly basis, would and accurately, with information very little use of imported tissue that incur additional costs. The agency including name and address of the would trigger activities for facility estimates that additional costs for manufacturer, a description of the compliance with this provision of the facilities to maintain a complaint file product, and product expiration date. proposed CGTP. FDA therefore would be negligible. The storage temperature, warnings, and estimates the current cost for industry To fully comply with provisions in instructions would be required on the compliance with this proposed the proposed rule, FDA estimates that label or on a package insert. The rule requirement would be negligible. 95 percent of all eye banks would revise would also require that any claims on w. Section 1271.440—orders of a minor procedure to include the labeling be truthful and that any retention, recall, and cessation of required handling of complaints, and therapeutic claim or claim of a clinical manufacturing. Industry firms could would allocate some additional staff outcome of a product would be subject incur costs to comply with orders under time each year to review complaints. to regulation under section 351 of the this proposed provision. There is little FDA assumes that conventional tissue PHS Act and/or the act. available data on which to base facilities following AATB standards Industry consultants inform FDA that estimates of the future frequency and would already perform the necessary such elements are typically present on scope of tissue industry conditions and activities, but the estimated 23 percent the labels of products manufactured by practices that would necessitate such of facilities not following AATB eye banks, conventional tissue banks, actions on the part of FDA. The agency standards would need to prepare a stem cell facilities, sperm banks and anticipates that product orders under minor procedure for complaint ART facilities. Proper labeling is this provision would be rare. FDA handling, and would allocate additional considered very important to these estimates that the yearly costs to

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TABLE 4.ÐAGGREGATE COMPLIANCE COSTS FOR EYE BANKS

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.150 Current good tissue practice: general $0 $0 $0 1271.155 Exemptions and alternatives $0 $0 $0 1271.160 Establishment and mainte- nance of a quality program $122,111 $457,459 $474,845 1271.170 Organization and personnel $0 $0 $0 1271.180 ProceduresÐGeneral require- ments $0 $47,196 $47,196 1271.190 Facilities $1,701 $0 $242 1271.195 Environmental control and monitoring $0 $23,245 $23,245 1271.200 Equipment $0 $109,816 $109,816 1271.210 Supplies and reagents $10,776 $17,545 $19,079 1271.220 Process Controls $70,124 $0 $9,984 1271.225 Process changes $75,593 $44,836 $55,599 1271.230 Process validation $321,218 $85,016 $130,750 1271.250 Labelling ControlsÐProce- dures $1,989 $0 $283 1271.260 Storage $0 $0 $0 1271.265 Receipt and distribution $0 $145,008 $145,008 1271.270 Records $369,032 $103 $52,644 1271.290 Tracking $11,845 $9,302 $10,989 1271.320 Complaint file $10,776 $59,782 $61,316 1271.350 Reporting $0 $0 $0 1271.370 Labelling and claims $0 $0 $0 1271.400 Inspections $0 $80,712 $80,712 1271.420 Human cellular and tissue- based products offered for import $0 $0 $0 1271.440 Orders of retention, recall, de- struction, and cessation of manufacturing $0 $0 $0 Total $995,165 $1,080,020 $1,221,708

TABLE 5.ÐAGGREGATE COMPLIANCE COSTS FOR CONVENTIONAL TISSUE FACILITIES

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.150 Current good tissue practice: general $0 $0 $0 1271.155 Exemptions and alternatives $0 $0 $0 1271.160 Establishment and mainte- nance of a quality program $77,800 $137,655 $148,732 1271.170 Organization and personnel $393,668 $63,751 $119,801 1271.180 ProceduresÐGeneral require- ments $0 $209,484 $209,484 1271.190 Facilities $8,544 $0 $1,216 1271.195 Environmental control and monitoring $8,544 $5,030 $6,247 1271.200 Equipment $79,352 $62,969 $74,267 1271.210 Supplies and reagents $17,088 $5,030 $7,463 1271.220 Process Controls $21,128 $0 $3,008 1271.225 Process changes $25,169 $53,096 $56,679 1271.230 Process validation $268,024 $164,065 $202,226 1271.250 Labelling ControlsÐProce- dures $2,736 $0 $390 1271.260 Storage $0 $0 $0 1271.265 Receipt and distribution $33,713 $146,448 $151,248 1271.270 Records $172,967 $455 $25,082 1271.290 Tracking $47,498 $101,347 $108,110 1271.320 Complaint file $8,544 $17,140 $18,356

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TABLE 5.ÐAGGREGATE COMPLIANCE COSTS FOR CONVENTIONAL TISSUE FACILITIESÐContinued

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.350 Reporting $0 $0 $0 1271.370 Labelling and claims $0 $0 $0 1271.400 Inspections $0 $77,880 $77,880 1271.420 Human cellular and tissue- based products offered for import $0 $0 $0 1271.440 Orders of retention, recall, de- struction, and cessation of manufacturing $0 $0 $0 Total $1,164,775 $1,044,350 $1,210,189

TABLE 6.ÐAGGREGATE COMPLIANCE COSTS FOR STEM CELL INDUSTRIES

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.150 Current good tissue practice: general $0 $0 $0 1271.155 Exemptions and alternatives $0 $0 $0 1271.160 Establishment and mainte- nance of a quality program $188,166 $473,119 $499,909 1271.170 Organization and personnel $739,100 $111,530 $216,761 1271.180 ProcedureÐGeneral require- ments $0 $393,300 $393,300 1271.190 Facilities 77,983 $665,000 $676,103 1271.195 Environmental control and monitoring $77,983 $202,323 $213,426 1271.200 Equipment $387,080 $434,198 $489,309 1271.210 Supplies and reagents $113,430 $7,695 $23,845 1271.220 Process Controls $260,336 $0 $37,066 1271.225 Process changes $33,155 $108,158 $112,878 1271.230 Process validation $625,670 $275,619 $364,700 1271.250 Labeling ControlsÐProcedures $4,799 $0 $683 1271.260 Storage $0 $0 $0 1271.265 Receipt and distribution $446,405 $26,520 $90,078 1271.270 Records $161,856 $2,880 $25,925 1271.290 Tracking $377,103 $155,040 $208,731 1271.320 Complaint file $77,983 $144,210 $155,313 1271.350 Reporting $0 $0 $0 1271.370 Labeling and claims $0 $0 $0 1271.400 Inspections $0 $194,700 $194,700 1271.420 Human cellular and tissue- based products offered for import $0 $0 $0 1271.440 Orders of retention, recall, de- struction, and cessation of manufacturing $0 $0 $0 Total $3,571,049 $3,194,292 $3,702,727

TABLE 7.ÐAGGREGATE COMPLIANCE COSTS FOR ART1 FACILITIES

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.150 Current good tissue practice: general $0 $0 $0 1271.155 Exemptions and alternatives $0 $0 $0 1271.160 Establishment and mainte- nance of a quality program $272,904 $586,854 $625,709 1271.170 Organization and personnel $256,740 $25,358 $61,912 1271.180 ProceduresÐGeneral require- ments $0 $1,366,200 $1,366,200 1271.190 Facilities $5,909 $621,600 $622,441 1271.195 Environmental control and monitoring $94,536 $146,342 $159,802 1271.200 Equipment $767,022 $583,549 $692,756 1271.210 Supplies and reagents $94,536 $3,596 $17,056 1271.220 Process Controls $115,834 $0 $16,492 1271.225 Process changes $341,302 $165,434 $214,028 1271.230 Process validation $0 $0 $0 1271.250 Labeling Controls-Procedures $9,481 $0 $1,350 1271.260 Storage $0 $0 $0

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TABLE 7.ÐAGGREGATE COMPLIANCE COSTS FOR ART1 FACILITIESÐContinued

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.265 Receipt and distribution $335,612 $36,230 $84,014 1271.270 Records $612,720 $400 $87,637 1271.290 Tracking $516,010 $0 $73,468 1271.320 Complaint file $5,909 $12,254 $13,096 1271.350 Reporting $0 $0 $0 1271.370 Labeling and claims $0 $0 $0 1271.400 Inspections $0 $233,640 $233,640 1271.420 Human cellular and tissue- based products offered for import $0 $0 $0 1271.440 Orders of retention, recall, de- struction, and cessation of manufacturing $0 $0 $0 Total $3,428,515 $3,781,457 $4,269,601 1Assisted Reproductive Technology

TABLE 8.ÐAGGREGATE COMPLIANCE COSTS FOR SPERM BANKS

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.150 Current good tissue practice: general $0 $0 $0 1271.155 Exemptions and alternatives $0 $0 $0 1271.160 Establishment and mainte- nance of a quality program $12,105 $23,661 $25,384 1271.170 Organization and personnel $15,560 $2,348 $4,563 1271.180 Procedures-General require- ments $0 $82,800 $82,800 1271.190 Facilities $299 $28,000 $28,042 1271.195 Environmental control and monitoring $4,776 $6,592 $7,272 1271.200 Equipment $25,522 $26,286 $29,920 1271.210 Supplies and reagents $299 $162 $204 1271.220 Process Controls $5,722 $0 $815 1271.225 Process changes $698 $7,452 $7,551 1271.230 Process validation $0 $0 $0 1271.250 Labeling Controls-Procedures $349 $0 $50 1271.260 Storage $0 $0 $0 1271.265 Receipt and distribution $12,575 $1,632 $3,422 1271.270 Records $2,760 $18 $411 1271.290 Tracking $27,664 $0 $3,939 1271.320 Complaint file $299 $552 $594 1271.350 Reporting $0 $0 $0 1271.370 Labeling and claims $0 $0 $0 1271.400 Inspections $0 $14,160 $14,160 1271.420 Human cellular and tissue- based products offered for import $0 $0 $0 1271.440 Orders of retention, recall, de- struction, and cessation of manufacturing $0 $0 $0 Total $108,628 $193,663 $209,127

TABLE 9.ÐSUMMARY OF AGGREGATE COMPLIANCE COSTS FOR ALL TISSUE INDUSTRIES

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.150 Current good tissue practice: general $0 $0 $0 1271.155 Exemptions and alternatives $0 $0 $0 1271.160 Establishment and mainte- nance of a quality program $673,085 $1,678,748 $1,774,580 1271.170 Organization and personnel $1,405,068 $202,987 $403,038 1271.180 ProceduresÐGeneral require- ments $0 $2,098,980 $2,098,980 1271.190 Facilities $94,435 $1,314,600 $1,328,046 1271.195 Environmental control and monitoring $185,839 $383,532 $409,991 1271.200 Equipment $1,258,976 $1,216,819 $1,396,069 1271.210 Supplies and reagents $236,129 $34,028 $67,648

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TABLE 9.ÐSUMMARY OF AGGREGATE COMPLIANCE COSTS FOR ALL TISSUE INDUSTRIESÐContinued

Section Title One-Time Costs Annual Costs Total Annualized Costs

1271.220 Process Controls $473,145 $0 $67,365 1271.225 Process changes $475,917 $378,976 $446,735 1271.230 Process validation $1,214,911 $524,700 $697,675 1271.250 Labelling ControlsÐProce- dures $19,354 $0 $2,756 1271.260 Storage $0 $0 $0 1271.265 Receipt and distribution $828,305 $355,838 $473,770 1271.270 Records $1,319,336 $3,856 $191,700 1271.290 Tracking 980,120 265,690 405,237 1271.320 Complaint file $103,510 $233,937 $248,675 1271.350 Reporting $0 $0 $0 1271.370 Labelling and claims $0 $0 $0 1271.400 Inspections $0 $601,092 $601,092 1271.420 Human cellular and tissue- based products offered for import $0 $0 $0 1271.440 Orders of retention, recall, de- struction, and cessation of manufacturing $0 $0 $0 Total $9,268,130 $9,293,783 $10,613,357

B. Estimated Benefits of the Proposed patients would result from the reduced considered, in order to gauge the Rule risk of communicable disease by potential magnitude of the benefits The overall purpose of the CGTP rule avoiding product contamination or associated with improved quality in is to prevent the introduction, product failure through CGTP. The manufacturing. The discussion is transmission, or spread of discussion that follows considers the organized by types of tissue product. potential benefit of avoided problems communicable disease through the use 1. Eye Tissue Products of human cellular and tissue-based with tissue products, based on a survey products. Although industry quality of the clinical literature. Primary corneal graft failure is a key standards exist for most of the affected Recent clinical literature indicates adverse outcome of concern following products, not all members of the that each type of tissue product corneal tissue transplant. Such failures industry follow these standards. FDA considered in the proposed rule has result in additional graft attempts. Each finds that public safety cannot be documented contamination or other attempt increases the risk of assured or effectively protected through product problems resulting from communicable disease transmission by reliance on this less formal and processing, or other steps in exposing the recipient to another tissue voluntary mechanism for quality manufacturing. These reported quality product and to another surgical assurance. The existing industry problems provide a basis for assessing procedure. Although primary corneal standards vary to some extent in their the magnitude of the potential benefit graft failure is relatively uncommon, its comprehensiveness. Moreover, there are from further reducing events that occurrence has been attributed to variations in the extent to which the increase the risk of communicable several factors related to tissue industry follows these standards. disease transmission. In cases involving collection, processing and product For example, most industry eye tissue, conventional tissue, or stem distribution. These factors include consultants for the cost analysis agree cell products, problems have required donor characteristics such as age (Ref. that quality standards, such as those medical intervention to treat infection, 3), donor infectivity (e.g., with Herpes proposed by the FDA, and similar or to replace an implanted defective Simplex Virus) (Ref. 4) length of standards recommended by industry, product. In some clinical applications, product storage, storage medium, and could substantially reduce the risk of product failures have increased the risk shipping distance from the eye bank to product contamination and product of patient mortality. In other the recipient site. In a recent analysis of failure. However, most experts also applications, such as embryo factors contributing to primary corneal opined that, because additional costs are processing, poor product quality is graft failure, Wilhelmus et al. found that associated with maintaining higher associated with lower success rates (i.e., ‘‘[T]he duration of donor corneal quality standards, and because there is pregnancy rates) among treated patients, preservation may have a significant no explicit patient demand for higher which results in an increase in transfer effect on endothelial vitality,’’ citing quality standards to prevent attempts. In general, FDA anticipates studies that demonstrate endothelial contamination risks, some facilities are that the risk of communicable disease cell loss in chondroitin-supplemented not currently following adequate quality transmission from product quality storage media after 7 to 10 days of control standards. A regulatory problems will decline as a result of storage. The authors suggest that, with requirement for quality systems would compliance with the proposed CGTP. modern eye bank screening and provide the incentive needed to bring The sections that follow describe preservation procedures, a donor all facilities to a more uniform and product-related problems associated corneal storage time greater than 1 week appropriately high standard of quality. with communicable disease increases the risk of primary failure by The primary beneficiaries of the transmission that are at least partly more than twofold. proposed CGTP rule would be the attributable to a lack of uniform quality Wilhelmus et al. include in their patients who receive the cellular and standards in manufacturing. The costs analysis a summary of selected findings tissue-based products. Benefits to related to correcting these problems are of studies published between 1971 and

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1994 reporting primary graft failure for graft failure prior to hospitalization4 presents a different potential for product corneal transplants using 4 °C (Ref. 6), and initial and follow-up failure and thus different kinds of preservation, and using a variety of physician visits during patient benefits from improved quality preservation methods. The rates of hospitalization5 (Ref. 6) for the repeated assurance in product manufacture. The primary graft failure ranged from 0.9 to corneal transplant. It also includes one discussion that follows considers three 3.1 percent, and a combined rate of 2.1 follow-up physician office visit to assess distinct areas of benefit. percent was estimated across all the outcome of the second transplant. a. Bone allograft products. An preservation methods. In their analysis The patient is estimated to further incur analysis of the incidence, nature, and of factors associated with corneal graft at least one week of time lost from work treatment of infection in bone allograft failures reported to the EBAA for 1991 for the doctor visits, hospitalization and (Ref. 7) by Lord et al. demonstrates the to 1993, the findings of Wilhelmus et al. recovery of visual function after surgery. importance of quality standards and illustrate the importance of The cost of $772 for this patient time process requirements to prevent tissue documentation of the receipt of supplies loss is estimated based on a 40-hour contamination. Of the 283 patients in and reagents used in tissue processing. work week and average hourly their analysis who had received a The authors found the identical compensation of $19.30.6 Thus, the massive allograft of bone, infection manufacturer’s lot number for the current cost impact of corneal graft developed in 33 cases (11.7 percent). preservation medium among 2 media in failure may range from $61,292 [7 × The final outcome for those 33 patients 34 cases, among 3 media in 36 cases, ($7,530 + $454 + $772)] to $1,365,936 was poor compared to the 250 and among 4 media in 16 cases. Thus, [156 × ($7,530 + $454 + $772)]. uninfected patients. About 82 percent 86 cases (approximately 59 percent of These estimates provide an indication (27 of the 33) of the infected allograft cases) with primary graft failure shared of the potential cost savings from were considered failures of treatment preservation media from the same lots. avoided eye tissue product failures, because amputation or resection of the The lot number was unique in 45 cases based on corneal transplants. Tissue graft was required to control the (31 percent) and was not recorded in 16 quality would improve through the infection. Potential sources of cases (10 percent of cases) involving institution of multiple good quality contamination cited in the study product failure. These findings also practices, including the validation of include donor infection or underline the importance of the processing methods, the verification of contamination introduced during proposed CGTP-required verification of processes quality control, and improved processing (estimated to occur in as quality and documentation of each documentation. Since these events many as 7 percent of the grafts), in particular lot of processing media used represent only one type of eye tissue addition to factors such as the duration in the manufacture of a uniquely labeled product, the potential for benefit across of the operation, loss of blood, injury to and traceable product. all products in the eye tissue industry soft tissue, and skin sloughing during Primary corneal graft failure typically may be greater. The estimated benefits the operation. These risk factors requires repeat surgery to replace the of CGTP applied to eye tissue, measured highlight the critical need for tissue failed graft. According to the Agency for in terms of avoided corneal graft products that are both sterile and viable. Health Care Policy Research (AHCPR)3 failures, therefore provide a lower- The importance of processing (Ref. 5), an estimated 7,443 corneal bound estimate of the potential benefits validation is implied by Hardin (Ref. 8) transplants were performed in 1994, of the proposed rule. Based on just this in a review of banked bone allograft with a mean hospital length of stay one type of eye tissue product, the cost processes. In describing methods for (LOS) of 2 days, and a mean total of graft failures that may be avoidable sterilization, Hardin lists ethylene oxide hospital charge equal to $7,530. The through a universal application of good as one of the most commonly used estimated rate of primary graft failure tissue practices ranges from $61,292 per chemicals, but indicates that its resulting from one or more aspects of year, with the lower estimated failure effectiveness may nonetheless be product collection, processing, or rate, to $1,365,936 per year, based on questionable, because of reports of graft distribution ranges from 0.1 percent (the the higher rate of primary graft failure failures in which residues of ethylene number of cases officially reported to reported in the clinical literature. oxide have been blamed, and some EBAA for the period 1991 to 1993) to as 2. Conventional Tissue Products experimental evidence indicating much as 2.1 percent (combined failure Conventional tissue includes a wide toxicity of ethylene oxide in human rate reported in the literature, across the range of products including bone tissues. range of preservation media currently allograft, skin allograft, heart valves, and Based on an average rate of 0.057 for used in eye tissue processing, cited in other products. FDA’s survey of the bone allograft failure due to Wilhelmus et al.). Based on the AHCPR- clinical literature indicates that bone, contamination (based on an estimated reported 1994 volume of corneal skin and heart valve allograft each allograft infection rate of 0.07 and an transplants, the estimated cases of estimated 0.82 failure rate for infected primary graft failure may range from 7 4 An estimated submitted charge of $76 per office bone allograft), and the assumption that cases [0.001 × 7,443] to 156 cases [0.021 visit for ophthalmology care is based on HFCA all failures would be treatable through × 7,443]. The total cost of replacement allowed payments for Medicare beneficiaries in the repeat surgery to replace the bone graft, of a failed corneal graft is estimated to Health Care Financing Review 1997 Statistical the associated costs could be on the include $454 of physician services, Supplement Table 62, adjusted to estimate order of $33 million per year submitted charges. × × including an office visit to diagnose the 5 An estimated initial hospital visit charge of $214 [$33,069,348 = 0.057 39,000 and subsequent visit charge of $88, based on HFCA ($13,538 + $1,338)]. This is based on a 3 These AHCPR estimates are based on data from allowed payments for Medicare beneficiaries in the national estimate of 39,000 bone the Healthcare Cost and Utilization Project (HCUP– Health Care Financing Review 1997 Statistical allograft per year7 (Ref. 9), and an 3) National Inpatient Sample. This is a Federal- Supplement Table 62, adjusted to estimate State-industry partnership to assemble health care submitted charges. estimated $13,538 per hospitalization data, based on a nationwide inpatient sample of 6 This estimate is based on the 1994 average total hospital discharge records for 1994, from 20 percent compensation of $36,834 adjusted by 2.9 percent 7 Detailed Diagnoses and Procedures, National of U.S. community hospitals from 17 States. The annual increase between 1994 and 1997, per the Hospital Discharge Survey 1995, Series 13: Data HCUP–3 estimated hospital charges do not include U.S. Statistical Abstract. ($36,834 × 1,0293/2080) = from the National Health Survey, No. 13, November physician payments. $19.3 1997, table 4, p. 131.

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1541 for repeat surgery (AHCPR HCUP–3 contaminated or defective products. The tissue disinfection regimen is not NIS). Physician costs per hospitalization clinical literature reports cases of effective in eradicating fungal are estimated to be $1,338 including cytomegalovirus (CMV) transmission contamination. $135 for each of two specialty physician through skin donor infection (Ref. 10), Fungal endocarditis is a rare but office visits: one prior to, and one and HIV contamination from infected potentially fatal complication of following hospitalization8 (Ref. 6); and donor tissue and subsequent skin tissue allograft valve replacement. According $1,068 for surgeon services while handling (Ref. 11). CMV infections are to Kuehnert et al., the incidence of hospitalized, based on HCFA-reported usually not life-threatening in healthy fungal endocarditis following surgery average submitted charges per person individuals, but present grave risks to for heart valve replacement with served for orthopedic surgery9 (Ref. 6). the types of patients who typically allograft is estimated to range from 0.3 The reported average length of stay for require skin grafts. In general, patients percent to 1.4 percent (midpoint bone surgery is approximately 5 days. who have suffered severe burns and estimate of 0.0085). In one reported The estimated cost of patient time lost require skin grafts are case, the infected patient needed assumes that repeat surgery would immunosuppressed as a result of their subsequent surgery to replace the valve require at least 1 week of time from injury and are therefore susceptible to and required intravenous amphotericin work, at an estimated value of $772, potentially life-threatening CMV B for the following 8 weeks. In many based on a 40-hour work week and infections. These include pneumonitis, cases, treatment is not successful and average hourly compensation of $19.30 retinitis, gastroenteritis, hepatitis, and death results. In one review, cited by (see footnote 6). This yields a total neurological complications (Ref. 10). Kuehnert et al., over 40 percent of the estimated patient time cost of Contamination of skin allograft can patients who had acquired fungal $1,716,156 [0.057 × 39,000 × $772]. The significantly affect burn patient endocarditis after valve allograft total annual cost of bone allograft failure survival. Because the clinical literature implantation died within 2 weeks of due to contamination is therefore does not provide summary estimates of diagnosis. estimated to be nearly $35 million the risk of contamination of skin In their study, Kuehnert et al. describe [$34,785,504 = $33,069,348 + allografts, the agency is unable to the process controls used by AATB- $1,716,156]. quantify overall risk. The agency affiliated facilities, including the If bone allograft failures result in welcomes comment on the rate and establishment, validation, and amputation, the direct and indirect costs severity of skin tissue contamination. documentation of decontamination would be significantly higher. For c. Heart valve allograft. Heart valve protocols. Because these regimens have example, the cost per hospitalization for allograft, another conventional tissue not been found effective against fungal lower extremity amputation is estimated product, provide another compelling contamination, AATB-affiliated to be $24,178, based on the AHCPR case for process validation and quality facilities routinely discard tissue with HCUP–3 data. Moreover, permanent control. Valve tissue contaminants not documented fungal contamination. disability following amputation imposes effectively removed in tissue processing However, according to Kuehnert et al., extremely high costs on the patient, and have resulted in serious infections that, the supplier of over 85 percent of all on society. at minimum, require valve replacement heart valve allograft does not follow FDA is uncertain about the extent to and that may also result in patient AATB standards, but instead follows a which the estimated cost impact will be death. decontamination protocol that is reduced through CGTP for two reasons. Sources of contamination of a valve reported to be proprietary. This protocol First, some tissue graft failures may allograft include the donor, the apparently includes efforts to disinfect result from the transplant procedures environment during harvesting and rather than discard tissue with fungal rather than the bone allograft processing, and the operating room contamination. However, efforts to manufacture. Second, some facilities during implantation. Microbial eradicate fungal contamination may have already developed new bone contamination of valve tissue is identified in processing can be processing methods that may greatly common at tissue harvesting, with unsuccessful, and in this case, a false- reduce infection risk. If as much as 75 reports of over 50 percent negative culture following processing to 80 percent of the estimated risk is contamination among valves retrieved resulted in the tissue being distributed actually attributable to other factors, or in open mortuary areas. According to a for patient use. The proposed rule would require that has already been addressed through study by Kuehnert et al. (Ref. 12) all facilities validate the effectiveness of better manufacturing procedures at common contaminants found before disinfection consist of gastrointestinal each step in processing, and would many facilities, the net benefit from the and skin flora, including coliforms, require that contaminated tissue that proposed CGTP rule applied to the viridans group streptococci, cannot be effectively disinfected be remainder of bone tissue processes and Staphylococcus aureus, Staphylococcus discarded or otherwise removed from facilities would be approximately $8 × epidermidis, and Bacillus species. In processing for distribution. Based on the million [$34,785,504 0.23] per year. rates of infection and mortality risk b. Skin allograft products. Skin general, bacterial contamination can be effectively removed through standard reported by Kuehnert et al., and a total allograft represent another type of tissue disinfection procedures used in most of 61,000 heart valve allografts reported product that is critically dependent on tissue banks. However, tissue that per year by the National Hospital quality controls to prevent the remains contaminated with these Discharge Survey (Ref. 13), there may be manufacture and distribution of pathogens, particularly Staphylococcus an estimated 519 cases per year [0.0085 and Streptococcus species, can cause × 61,000] of heart valve contamination 8 An estimated cost of $135 per service based on average submitted charges per service for‘‘All early onset allograft valve endocarditis. causing fungal endocarditis. These Other Physician’’ specialty groups is used to In contrast to bacterial contamination, contaminated valves may further cause estimate specialist office visit charges. This cost per reported rates of fungal contamination an estimated 207 deaths per year service is reported in the Health Care Financing are relatively low. However, Kuehnert et [0.0085 x 0.40 x 61,000]. Changes in Review 1997 Statistical Supplement Table 59. 9 See Health Care Financing Review 1997 al. report that rates vary widely (1.7 processing based on the proposed CGTP Statistical Supplement Table 59, Submitted percent to 28.0 percent), and that the requirements would help to avoid these Charges, for Orthopedic Surgery. inclusion of anti-fungal drugs in the deaths. Substantial health care cost

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Survival rates for potential of seven avoided stem cell per case, including repeat surgery and hematopoietic stem cell transplantation patient deaths per year, due to infection. patient care during the average 13-day are significantly reduced for patients This number reflects the excess hospital stay. If the CGTP requirements that become critically ill. In a study of mortality risk reported for stem cell avoided 80 percent of these valve survival rates among stem cell recipients with infection versus those infections, this might result in health recipients admitted to an intensive care without infection. It is based on the care cost savings of up to $29 million following: (8,000 transplant procedures unit, Price et al. (Ref. 15) found that × [0.8 x 519 x $63,096 + $6,796)]. patients with probable infection had a per year) (58 percent of procedures with PBSC) × (2.41 percent PBSC significantly higher death rate (57 3. Stem Cell Products patients receiving contaminated percent) compared to patients with no According to the National Center for product) × (13.7 percent patients probable infection (13 percent). Health Statistics National Hospital receiving contaminated product develop Discharge Survey, approximately 8,000 Multiple regression analyses by Price et infection) × (57 percent to 13 percent) stem cell transplant procedures were al., to predict probability of death excess rate of death for stem cell performed in 1994. Based on the controlling for other risk factors such as recipients given presence of infection. AHCPR HCUP–3 NIS data for 1994 (Ref. patient intubation, type of transplant, As bacterial contamination has also 5), the average length of hospital stay for source of stem cells, human leukocyte been documented in a study of cord bone marrow transplant procedures was antigen compatibility, type of blood processing, the proposed CGTP 35 days, with an average cost per stay malignancy and patient age, also found requirements for staff training and of $168,573. infection to be a significant predictor of process validation would support Promising outcomes from use of mortality. similar risk reduction efforts across peripheral blood stem cells (PBSC) and An estimated 15 patients per year CBSC facilities. For example, a study by cord blood-derived stem cells (CBSC) in could suffer infection following receipt Kogler et al. (Ref. 17) found that during lieu of bone marrow have resulted in of contaminated PBSC, based on the the initial 6 months of an unrelated CB increased collection and use of these reported rates of 2.4 percent of patients collection program, the median bacterial products in stem cell transplants. For receiving contaminated PBSC, 13.7 contamination rate was 18 percent. example, recent studies have percent of those patients subsequently After extensive training in sterile respectively reported use of PBSC developing infection, and 8,000 stem procedures for the staff who collect cord (rather than bone marrow) in 54 percent cell transplants reported for 1994, and blood, the contamination rate was (Ref. 14) and 62 percent (Ref. 15) of reduced to 1 percent. cases. However, studies of stem cell assuming that 58 percent of stem cell products indicate that products transplants (the average of the two 4. Reproductive Tissue Products manufactured by this industry can reported rates of PBSC transplant cited Most aspects of cellular and tissue become contaminated during collection above) involve PBSC. Costs of treating product manufacturing in the and processing. Moreover, the therapy- patients who become infected after reproductive tissue industry would induced immunosuppression of the receiving contaminated stem cell become newly regulated under the oncology patients who receive these product are based on an average proposed CGTP rule. The affected products places them at particular risk AHCPR-reported hospital charge10 (Ref. establishments within this industry for serious infection and subsequent 5) of $17,981 per 9-day patient stay for include sperm banks and ART facilities. mortality. Manufacturing methods treatment of bacterial infection. Reports of the sensitivity of product conforming to good tissue practice are Estimated health care costs also include quality to variations in tissue collection, necessary to prevent this threat to the physician costs of $918 assuming one technician skill, processing methods, safety and effectiveness of stem cell initial hospital visit, and daily follow- environmental conditions, and other therapies. For example, earlier up visits during the patient stay11 (Ref. factors (Ref. 22), indicate that the risk of investigations of PBSC reported that the 6). Patient time loss during the communicable disease transmission large quantity of blood that must be hospitalization is valued at $1,387, would be reduced by improving the processed to obtain adequate numbers based on estimated hourly proposed overall product quality, and of stem cells resulted in large volumes compensation of $19.30 (see footnote 4) economic benefits would be seen of cryopreserved cells received by and a 9-day hospital stay. Thus, the total through improved patient outcomes patients. This process posed the risk of annual cost impact of patient infection from facility compliance with the increased toxicity, because of the following transplant of contaminated proposed CGTP requirements. amount of dimethyl sulfoxide used for PBSC products is estimated to be The tissue used in commercial sperm cryopreservation (Ref. 16). banks is washed, processed, and Another quality concern with PBSC 10 Based on AHCPR HCUP–3 National Inpatient cryopreserved donor sperm used for involves the maintenance of sterile Survey for 1994 hospital charges by principal therapeutic donor insemination (TDI). integrity of the apheresis catheter and diagnosis, ‘‘bacterial infection, unspecified site’’ The sperm are obtained generally from component throughout the period of ($17,891), http://www.ahcpr.gov/data/ paid donors who have been screened 94dcchpr.htm. 1998. leukopheresis, cryopreservation, 11 Physician charges are based on estimates of and tested for infectious disease and thawing, and transfusion (Espinosa et physician submitted charges using data reported in certain genetic disease risks. al., 1996). Webb et al. (Ref. 14) reported the Health Care Financing Review Statistical The tissues used in ART facilities a 2.41 percent rate of bacterial Supplement, 1997, table 62. Initial inpatient visit include fresh or cryopreserved oocytes, charge is estimated to be $214, and daily follow-up contamination in PBSC products, and a visits in the hospital are estimated to be $88 per sperm, zygotes, and embryos. The 13.7 percent rate of infection of patients visit. Thus total physician charges for care during handling of tissues include but are not receiving contaminated products. the 9-day hospital stay are estimated to be $918. limited to: Retrieval of oocytes from a

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The success of in vitro validation and quality controls that washing, they found that some agents fertilization, measured as the number of would be required under the proposed produced severe adverse effects on deliveries per IVF cycle, has gradually rule is expected to substantially reduce sperm motility and actually decreased increased over the past decade or so, or eliminate detrimental variations, and sperm fertilizing capacity. The from 11 percent in 1985 to 18 percent thereby improve product quality. importance of product quality in this in 1994 (Ref. 18). More recently, the Sperm processing occurs in both step of processing offers another Centers for Disease Control and commercial sperm banks and ART example of the value of process Prevention (CDC) have reported average facilities. Commercial sperm banks validation in ensuring sperm product live birth pregnancy rates for ART generally screen, wash, and viability and thus successful fertility clinics to be as high as 19.6 percent per cryopreserve donor sperm. ART treatment for patients. cycle in 1995 and 22.6 percent per cycle facilities typically include an andrology Environmental controls present in 1996 (Refs. 19 and 20). laboratory that performs semen analysis another area with a demonstrated need Despite the increasing effectiveness of and conducts IVF. Variations in for quality control in reproductive tissue infertility treatment through ART, methods and technician skills at various processing. Environmental problems can occur in tissue processing. stages of sperm processing have been contamination may come from many Adverse outcomes owing to problems associated with variations in quality. sources, including the air, water or with product quality can result from Poor sperm quality increases the laboratory supplies. A study of contamination that produces infection probability that additional tissue laboratory air quality in ART facilities (e.g., HIV transmission) in the infertility transfer procedures will be necessary. by Cohen et al. (Ref. 36) found that over patient (Ref. 21). Problems with ART For example, in a study conducted to 300 volatile organic compounds were facility processing of sperm or oocytes establish quality controls in semen detectable in spite of the use of can also lead to reduced rates of analysis, Yeung et al. found that the centralized high efficiency particulate fertilization, and unsuccessful IVF subjective thresholds for judging sperm air (HEPA) filtration, generic but attempts, which would ultimately motility (a key measure of sperm centralized carbon and pre-filtration, increase the number of transfer function for diagnosis and treatment) and numerous ionization units placed at attempts. Each additional transfer differed for each technician performing strategic points in the laboratory. attempt increases the risk of the analysis (Ref. 30). The establishment Potential sources of contaminants communicable disease with each of values for threshold velocities, and included vehicle and industrial attempt. standards for technician training were emissions in outside air, use of plastics Where quality problems in tissue identified as methods to improve and disposable plasticware in the processing result in reduced embryo consistency in technician assessments. laboratory, equipment (e.g., freon quality and lower probability of A study by Mahmoud et al. (Ref. 31) leakage from refrigeration units), pregnancy, the patient, on average, compared 10 different methods for cleaning agents and equipment needs to undergo more cycles of IVF to estimation of sperm concentration lubricants, and air flows from activities achieve a pregnancy that produces a live (another key indicator of sperm quality) in adjacent areas of the building. birth. The estimated patient cost per and reported substantial differences in A more detailed study of these factors cycle ranges from $8,000 to $10,000 the accuracy of laboratory assessments, by Cohen et al. was prompted in part by (Refs. 24 to 26). depending upon the type of pipette and the sudden and significant declines in The number of Americans who would the method used. They found that clinical pregnancy and implantation potentially benefit from improved although a few devices and methods rates that occurred at two points in time reproductive tissue processing is produced accurate, low-variability at an ART facility. In those instances, substantial. According to the 1995 estimates, others had a tendency to the pregnancy rate had declined by National Survey of Family Growth overestimate or to underestimate sperm about 50 percent and subsequent (NSFG), (Ref. 28) 15.4 percent of concentration. These findings strongly implantation rates also declined. Their American women 15 to 44 years of age, support the need for equipment investigation revealed that, in the first approximately 9.3 million women, have calibration and laboratory method instance of decline, a fumigation with reported receiving infertility services. validation. pesticides had taken place in areas of Approximately 600,000 women report In addition to processing steps related the building adjacent to the ART receiving ART’s, defined in NSFG to to the sperm quantity and quality, facility, without notification given to the include artificial insemination and IVF sperm processing for IVF typically ART facility. The second episode of services. The number of ART requires that sperm be purified, sudden decline corresponded to the procedures annually has been removing semen fluid, cellular debris, installation of a redesigned air filter in increasing in recent years. According to white blood cells, and other the facility. Further air sampling also the CDC (Ref. 29) a total of over 64,000 contaminants that may interfere with revealed that chemical contaminants cycles of ART were performed by U.S. fertilization. Many sperm separation produced in another area of the facilities in 1996, compared to methods have been developed and are building, which was used as an approximately 60,000 cycles in 1995. in use in ART programs, including basic outpatient surgery center and was not The proposed CGTP rule, therefore, has sperm washing, swim-down and swim- part of the ART clinic, could be detected the potential to benefit thousands of up techniques, refrigeration/heparin in the embryo laboratory when more infertile couples. techniques, separation with Sephadex sensitive monitoring equipment was Processes that affect product quality. and Ficoll columns, separation with used. Cohen et al. proposed various Recent clinical literature reports a glass wool and Percoll gradient measures to counter these potential number of factors in the manufacturing centrifugation (Refs. 32 to 34). No single sources of chemical air contamination process that could affect tissue quality. method has become the standard, in both the laboratory and the embryo

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1544 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules incubators. Laboratories without costs associated with a reduction in the achieved through improvement in staff adequate environmental monitoring and number of IVF attempts per live birth. training and skill, processing validation, controls would not be able to detect FDA cannot predict the precise and quality control throughout the such degradations in air quality. impact from implementation of the facility in accordance with the proposed An earlier study of mouse embryos by proposed CGTP rule. To obtain an CGTP rule. Under this scenario, the Francis et al. reported that some brands estimate of benefits and to capture a affected 150 facilities would reduce the of nonpowdered surgical gloves appear level of uncertainty, this analysis number of IVF attempts from a reported to be embryotoxic (Ref. 37). considers three potential scenarios and 10,414 cycles to an estimated 7,662 Temperature fluctuations during cell presents the results a range of possible treatment cycles, to achieve the same culture, and to a lesser extent, the time outcomes. In general, it is assumed that number of successful treatments. This between retrieval and transfer, may also the rule will affect the facilities with the would yield an estimated cost savings of affect tissue quality and thus increase lowest success rates and that these $24.8 million for patients and other the probability of additional transfer facilities would improve to some payers. This is based on an estimated attempts (Ref. 39). minimal level of performance from the 2,752 avoided cycles of treatment The lack of experience and training of implementation of good practices. In [10,414¥7,662] and assumed average laboratory personnel also could increase one scenario, benefits are assumed to be cost of $9,000 per cycle of IVF the need for additional transfer attempts limited to the worst-performing quarter treatment. due to poor tissue quality. One study of all facilities. These facilities would At the other end of the spectrum, found that new embryologists needed improve to the level of the facility just Scenario 3 provides for the possibility several months to gain the experience to better than the bottom one-fourth. In that this proposed rule would have no consistently predict nuclear maturity another scenario, the half of all facilities effect on success rates at ART facilities from cumulus-coronal morphology. with the lowest success rates would or the number of IVF attempts per live Moreover, even when a stable improve to where they would be as good birth. In such a case, there would be no prediction rate was reached, it rarely as the median facility. In a third additional economic benefit beyond the exceeded 72 percent accuracy (Ref. 40). scenario, implementation of the rule benefits previously discussed, including Yet consistent assessments of product would not change ART facility success an anticipated decrease in quality and transfer of high quality rates. communicable disease transmission. The scenarios consider only the embryos to the patient are critical to Couples seeking infertility care incur cycles of treatment for younger women increasing the overall success of IVF an indirect cost of time lost (e.g., work (age less than 35) for whom patient age treatment and to minimizing transfer time) while undergoing treatment. Using is not likely to be a confounding factor an average hourly wage of $19.3012 and attempts. affecting oocyte quality. Of the 22,811 assuming 6 hours of time (e.g., 4 hours Although there has been some Federal fresh nondonor cycles of treatment for for the female and 2 hours for the male and some private sector standard setting these patients at the 300 ART facilities patient) per couple per cycle of IVF and oversight in the reproductive tissue reporting data for 1996, the average treatment, the estimated value of the industry, existing standards do not success rate was 28.65 live births per lost time would be as follows. Under provide the level of quality management 100 cycles, and the median live birth Scenario 1, the estimated 1,665 avoided and process quality assurance that pregnancy rate was 26.3 percent per would be required under the proposed treatment cycles would yield a time gain cycle. × × CGTP rule for all tissue establishments. Scenario 1 assumes that the facilities valued at $192,807 [1,665 $19.30 6]. A voluntary accreditation program currently achieving the lowest success Under Scenario 2, the 2,752 potentially jointly offered by the CAP and the rates (i.e., the lowest quartile of success avoided treatment cycles would yield a ASRM has been available to ART time gain valued at $318,682 [2,752 × rates reported for ART establishments) × laboratories since 1992 (Refs. 41 and are able to increase their average success $19.30 6]. Under Scenario 3, there 42), and the number of facilities seeking rate to the rate corresponding to the would be no avoided treatment cycles accreditation has been increasing in 25th percentile rate. This would and, thus, no quantifiable benefits. recent years. The problems with product represent a first step and as technology C. Summary of Potential Benefits processing cited in recent clinical and techniques continue to improve, so Resulting From Avoided Quality literature, however, suggest that would success rates. In the 1996 report, Problems in Processing of Cellular and although there is increasing interest in the 25th percentile rate was 19.7 live Tissue Based Products quality assurance, there are still births per 100 cycles. FDA finds that substantial gains that could be made in raising the bottom quartile of 75 This analysis of benefits of the tissue facilities, by implementing the facilities, to 19.7 live births per 100 proposed CGTP rule has considered its proposed CGTP rule. cycles, would reduce the IVF attempts impact on major sectors of the tissue In addition to the benefits that would from a reported 4,756 to an estimated industry by focusing on product quality accrue directly from implementation of 3,591 treatment cycles. This problems cited in the literature. This this proposed rule, individuals may improvement would decrease transfer review suggests that industry standards reap ancillary benefits that could arise attempts and yield an estimated savings are not applied uniformly resulting in indirectly from the rule. Although the of $10.5 million for patients and other uneven product quality. proposed rule would provide a direct payers, based on an estimated average Table 10 provides a summary of the benefit from the decreased risk of cost of $9,000 per cycle, and an particular products and problems communicable disease transmission, the estimated 1,165 avoided cycles identified in the agency’s survey of public, particularly couples seeking [4,756¥3,591]. literature. FDA estimated the potential assistance in beginning a pregnancy, Scenario 2 assumes that facilities in benefits of avoiding quality problems could receive an indirect economic the lower half of the industry based on reported risks and national benefit. Such ancillary economic distribution are able to bring their 12 Estimated hourly compensation of $19.30 is benefit, although not certain, would be success rates up to the median rate of based on the 1994 average total compensation of seen as an increase in ART facility 26.3 live births per 100 cycles. The $36,834, adjusted by 2.9 percent annual increase success rates and a decrease in health increased success rate is assumed to be reported in the 1997 U.S. Statistical Abstract.

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TABLE 10.ÐSUMMARY OF POTENTIAL BENEFITS OF PROPOSED CURRENT GOOD TISSUE PRACTICE BASED ON TISSUE PROBLEMS CITED IN REVIEWED LITERATURE

Avoided Problems with Avoided Treatment or Potential Cost Savings/ Tissue Industry Sector Tissue(s) Considered Tissue Outcome Year

Eye Tissue corneal graft graft failure repeat surgery; increased $61,000 to $1.4 million graft attempts Conventional Tissue bone allograft bone infection; graft failure repeat surgery/amputation; $8 million increased graft attempts Conventional Tissue heart valve allograft fungal endocarditis repeat surgery/patient $29.6 million death; increased 176 excess deaths transplant attempts Peripheral Blood and Cord stem cell transplant infection in cancer patients hospitalization/patient $304,000 Blood Stem Cells death 7 excess deaths Reproductive Tissue sperm, oocytes, zygotes, IVF1 failure additional IVF treatment $0 to 24.8 million embryos cycles Total Potential Cost Sav- $41.9 to $68.0 million ings/Year 1 In vitro fertilization

Uncertainties affecting the true level annual revenues less than $5.0 million the industry EBAA standards. The of benefit include: The actual extent of is considered small by the U.S. Small average annual revenue per eye bank is current CGTP compliance in each of the Business Administration. In every sector estimated at $1.2 million (Ref. 44). If an affected industries, the lack of more of the cell and tissue product industry, eye bank were to incur every new cost complete information about the the majority of establishments are estimated for facilities in that industry, incidence and severity of problems from estimated to be classified as small the total cost impact, including total processing of tissue products, the net entities. However, because of the high one-time costs and the yearly cost, impact of those quality problems on level of current compliance with would be $36,738, which represents an patient outcomes, and the size of the industry standards, the increase in costs estimated 3 percent (0.03) of estimated affected patient population. Because of is expected to be limited primarily to annual revenues. Average annualized the limits of available data, the facilities that do not comply with compliance costs per eye bank are foregoing analysis has focused on a industry standards. To measure the estimated to be $10,717, or 0.89 percent limited set of tissue products. It is not impact of CGTP on small businesses, of annual revenue per firm. certain how well these data represent FDA calculated the ratio of industry In the conventional tissue industry, the most critical areas or actual scale of compliance costs to industry revenues, an estimated 75 to 80 percent of the risks in the tissue industry. For some assuming that all facilities incurred the total of 110 facilities would be classified products, such as demineralized bone, same cost. The small entity impacts as small entities. Industry experts also the industry has achieved important estimated below focus on the facilities estimate that 75 to 80 percent of those advances in processing that have that will be newly compliant under the facilities currently comply with the improved the safety and effectiveness of proposed CGTP, and thus will AATB standards, which generally meet its products. Thus, the analysis of experience the highest potential new or exceed the requirements of the benefits based on problem reports from costs. In addition, although current proposed CGTP rule. Based on the several years ago may overstate the quality management practices at non- assumed levels of increased effort and potential for improvements in the accredited or less-than-fully compliant costs shown in table 2, the remaining 23 current best industry practice. In other facilities may vary, and not every percent of small facilities that do not cases, the publication of the recent facility will incur every new cost comply with AATB standards would problem reports suggests that estimated in table 2, the analysis that incur up to $62,662 in total new costs, deficiencies still exist within current follows considers a high-cost scenario including both the total one-time cost practices. These areas present important where every estimated cost is incurred, and the yearly cost, assuming that every opportunities to avoid unnecessary in order to produce a conservative potential area of new quality patient risks and health care costs. estimate of the potential impact on management effort would be needed at small entities. While some firms may every one of these facilities. The average D. Small Entity Impacts have lower than average revenues, annual revenue per small conventional The Regulatory Flexibility Act (RFA) making them potentially more sensitive tissue bank is estimated at $1.2 million requires agencies to determine whether to cost increases, FDA does not know (Ref. 44). The estimated total new costs a proposed rule may have a significant the distribution of firms by revenues. would represent approximately 5 effect on a substantial number of small FDA welcomes comments on this issue. percent of this annual revenue figure. entities. Tissue and blood banks are Within the eye banking industry, The average annualized compliance cost classified in North American Industry experts estimate that virtually all for a small conventional tissue bank is Classification System (NAICS) 621991. facilities would be classified as small, estimated to be $10,310, representing In this industry category, any firm with and believe all are to be compliant with 0.86 percent of firm revenues.

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The agency anticipates that all stem estimated 95 percent of that total prefer to discontinue banking, and refer cell facilities would be classified as production is handled by the largest 20 their patients to a commercial bank for small entities, and estimates that these facilities. Nineteen of the largest 20 this service. establishments have annual revenue facilities are estimated to have average In summary, the majority of facilities averaging $1.2 million (Ref. 44). annual revenues of approximately $2 within each sector of the tissue industry Establishments that comply with the million, and only 1 of the 20 is are expected to qualify as small entities. current FAHCT or AABB standards estimated to have revenues greater than The actual cost impact on each facility would incur some additional costs. If $5 million per year. The remaining 5 is uncertain because of the limited each of these facilities were to incur percent of industry production, or 5,000 information available to describe the new costs for every provision identified TDI units, are processed by very small current practices and compliance with in table 2, the total cost per facility, banks described by an industry expert industry standards at each of these including total one-time and yearly as typically functioning within a facilities and within each distinct costs, would be approximately $20,270. physician office practice (e.g., that of an industry sector. Based on the limited This figure represents approximately 2 obstetrician (ob) or a gynecologist (gyn)). available data and expert opinions, the percent of estimated annual revenues. The sperm banking in these facilities is agency estimates impacts that would Stem cell facilities that do not currently generally offered as an additional result in an average annualized cost per comply with AABB or FAHCT service to patients receiving fertility facility ranging from $ 7,000 to $11,000 standards would incur greater costs, as treatment, and is not the primary line of for facilities that currently comply with shown in table 2. If each of these business of these establishments. The an industry standard, to over $40,000 in facilities were assumed to incur every annual revenue for these individual average annualized costs for facilities new cost identified in the cost analysis, physician practices is estimated to be that do not currently comply with most the total one-time cost plus annual cost $252,000 per year, based on the mean industry quality standards. These would be approximately $79,337. This physician income of $215,000 after annualized costs represent 0.45 to 3.39 figure is equal to approximately 7 expenses and before taxes for the ob/gyn percent of the estimated total average percent of estimated annual revenues. specialty category, reported in the 1992 annual revenues. The average annualized compliance American Medical Association (AMA) The agency is uncertain about the costs incurred by stem cell facilities survey (Ref. 45), adjusted to 1998 accuracy of these estimates, however, would similarly vary depending on assuming an average annual wage because of the lack of good data on current facility practices and inflation of 2.7 percent, based on yearly revenues for these facilities. Because of compliance with AABB or FAHCT rates reported by the Bureau of Labor the importance of this information in standards. If a facility is currently Statistics. Thus the majority of sperm accurately assessing the impact on small entities, the agency requests that compliant with these industry banks would be considered small industry provide detailed comment on standards, the average annualized cost entities. of compliance with the proposed rule is the percentage of facilities that qualify If each of the small sperm banks were estimated to be about $7,407, as small entities in the eye tissue, to incur every potential new cost of representing 0.62 percent of the yearly conventional tissue, stem cell, and revenue of these firms. However, if a compliance with the proposed CGTP reproductive tissue industries; the facility is not currently compliant with rule, as shown in table 2, the total one- percentage of those facilities that fully the requirements of the current industry time cost plus annual cost would equal comply with current industry standards; standards, a greater level of new effort $83,302, which would be approximately and the specific areas where industry would be required for quality assurance 4 percent of the $2 million in annual anticipates substantial differences and quality management. The average revenues for the ‘‘larger’’ small facilities. between current manufacturing annualized cost per facility is estimated The average annualized cost to these practices and the quality assurance to be $40,721, which would represent banks is estimated to be $11,007, elements specified under the proposed 3.39 percent of an average annual representing approximately 0.55 percent rule. For those areas of identified revenue of $1.2 million. of annual revenues. Although these cost difference, the agency further requests Consultants estimate that figures would account for a much larger estimates of the resources and costs that approximately two-thirds of all ART percentage of individual physician will be required for facility compliance. facilities (approximately 200) would be practice income, the sperm banking Although the proposed rule would classified as small entities, and have provided by these establishments is impose some costs on small entities average annual revenues of $2.5 million. considered to represent a small and involved in the manufacture of cellular Based on the project levels of generally nonessential part of their and tissue-based products, the agency compliance with various provisions of business. For the smallest banks, the believes that the proposed approach CGTP, as described in the cost analysis, estimated 5,000 TDI units supplied by represents an effective means of if a facility were to incur every potential the estimated 90 facilities translates to protecting patient safety and public new cost, as shown in table 2, the total an average volume of 55 units per health in the manufacture of human one-time plus annual cost to the facility facility per year. With an estimated cellular and tissue-based products. The would be $83,302. This total would price of $95 to $145 per TDI unit (Ref. less burdensome alternative to the represent approximately 3 percent of 46) and an estimated profit of 15 proposed approach, i.e., continue with average annual revenues. The average percent, the banks would realize a net the use of trade organizational standards annualized compliance cost per facility income of $12.40 to $19.00 per unit, or by industry, involve fewer requirements is estimated to be $11,342, representing average net income of $682 to $1,045 for for small entities (the vast majority of approximately 0.45 percent of annual 55 units. This income would represent facilities in this industry), but fail to revenues. only 0.3 percent (0.0027) to 0.4 percent provide fundamental aspects of product According to recent estimates by a (0.0041) of the estimated $252,000 in safety. Reliance on trade organization sperm banking industry expert, annual net income for the ob/gyn voluntary standards for good tissue approximately 100,000 TDI units are physician practice. Thus, it seems likely practice, rather than establishing a produced each year from collected and that physician practices that currently regulatory requirement, would not processed sperm donations. An operate small-scale sperm banking may ensure uniform or consistent

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1547 compliance and would preclude the 11. Gala, J., A. Vandenbroucke, B. Lu, ‘‘Maximizing Pregnancy Rates and agency’s ability to effectively monitor Vandercam, J. Pirnay, N. Delferriere, and G. Limiting Higher-order Multiple Conceptions tissue products to ensure public health Burronboy, ‘‘Human Immunodeficiency by Determining the Optimal Number of Virus in Fresh or Cryopreserved Postmortem Embryos to Transfer Based on Quality,’’ and safety. While each trade Skin: Potential Implications for Skin Fertility and Sterility, vol. 69, No. 4, pp. 650– organization varies in their standards or Handling and Allografting,’’ Journal of 657, 1998. guidelines, regulatory requirements for Clinical Pathology, vol. 50, pp. 481–484, 24. Van Voorhis, B. J., D. W. Stovall, B. D. good tissue practice would help ensure 1997. Allen, and C. H. Syrop, and ‘‘Cost-effective consistency among manufacturers. FDA 12. Kuehnert, M. J., E. Clark, S. R. Treatment of the Infertile Couple,’’ Fertility finds that this proposed rulemaking Lockhart, D. R. Soll, J. Chia, and W. R. Jarvis, and Sterility, vol. 70, No. 6, pp. 995–1004. would enhance both public health and ‘‘Candida Albicans Endocarditis Associated 1998. public confidence in the safety and with a Contaminated Aortic Valve Allograft: 25. Griffin, M., and W. F. Panak, ‘‘The Implications for Regulation of Allograft Economic Cost of Infertility-related Services: quality of cellular and tissue-based Processing,’’ Clinical Infectious Diseases, vol. An Examination of the Massachusetts products, while imposing only a 27, pp. 688–91, October 1998. Infertility Insurance Mandate,’’ Fertility and minimum burden on the affected 13. National Center for Health Statistics, Sterility, vol. 70, No. 1, pp. 22–29, 1999. industry sectors. Detailed Diagnosis and Procedures, National 26. Neumann, P. J., ‘‘Should Health Hospital Discharge Survey (ICD–9–CM 35.2) Insurance Cover IVF? Issues and Options,’’ IX. References Series 13: Data from the National Health Journal of Health Politics, Policy and Law, The following references have been Survey No. 130, November 1997. vol. 22, No. 5, pp. 1215–1236, 1997. placed on display in the Dockets 14. Webb, I. J., F. S. Coral, J. W. Andersen, 27. Steinberg, E. P., P. M. Holtz, E. M. Management Branch (address above) A. D. Elias, R. W. Finberg, L. M. Nadler, J. Sullivan, and C. P. Villar, ‘‘Profiling Assisted Ritz, and K. C. Anderson, ‘‘Sources and Reproductive Technology Outcomes and and may be seen by interested persons Sequelae of Bacterial Contamination of Quality of Infertility Management,’’ Fertility between 9 a.m. and 4 p.m., Monday Hematopoietic Stem Cell Components: and Sterility, vol. 69, No. 4, pp. 617–623, through Friday. Implications for the Safety of Hematotherapy 1998. 1. Centers for Disease Control and and Graft Engineering,’’ Transfusion, vol. 36, 28. National Center for Health Statistics, Prevention, ‘‘Creutzfeldt-Jakob Disease pp. 782–788, 1996. Centers for Disease Control and Prevention, Associated with Cadaveric Dura Mater 15. Price, K. J., P. F. Thall, S. K. Kish, V. U. S. DHHS, Fertility, Family Planning and Grafts—Japan, January 1979–May 1996,’’ R. Shannon, and B. S. Andersson, Women’s Health: New Data From the 1995 Morbidity and Mortality Weekly Report; vol. ‘‘Prognostic Indicators for Blood and Marrow National Survey of Family Growth, Series 23, 46; pp. 1066–1069, 1997. Transplant Patients Admitted to an Intensive No. 19, table 55, May 1997. 2. General Accounting Office, ‘‘Human Care Unit,’’ American Journal of Respiratory 29. National Center for Chronic Disease Tissue Banks; FDA Taking Steps to Improve Critical Care Medicine, vol. 158, pp. 876– Prevention and Health Promotion, Centers for Safety, but Some Concerns Remain,’’ 884, 1998. Disease Control and Prevention, U.S. DHHS, December 1997. 16. Espinosa, M. T. F., R. Fox, R. J. Creger, 1996 Assisted Reproductive Technology 3. Wilhelmus, K. R., R. D. Stulting, J. Sugar, and H. M. Lazarus, ‘‘Microbiologic Success Rates: National Summary and and M. M. Khan, ‘‘Primary Corneal Graft Contamination of Peripheral Blood Fertility Clinic Reports, December 1998. Failure,’’ Archives of Ophthalmology, vol. Progenitor Cells Collected for Hematopoietic 30. Yeung, C. H., T. G. Cooper, and E. 113, pp. 1497–1502, December 1995. Cell Transplantation,’’ Transfusion, vol. 36, Nieschlag, ‘‘A Technique for Standardization 4. Remeijer, L., P. Doornenbal, A. J. M. pp. 789–793, 1996. and Quality Control of Subjective Sperm Geerards, W. A. Rijneveld, and W. H. 17. Kogler, G., J. Callejas, P. Hakenberg, J. Motility Assessments in Semen Analysis,’’ Beekhuis, ‘‘Newly Acquired Herpes Simplex Enczmann, O. Adams, W. Daubener, C. Fertility and Sterility, vol. 67, No. 6, pp. Virus Keratitis After Penetrating Krempe, U. Gobel, T. Somville, and P. 1156–1158, 1997. Keratoplasty,’’ Ophthamology, vol. 104, No. Wernet, ‘‘Hematopoietic Transplant Potential 31. Mahmoud, A. M. A., B. Depoorter, N. 4, pp. 648–652, April 1997. of Unrelated Cord Blood: Critical Issues,’’ Piens, and F. H. Comhaire, ‘‘The Performance 5. Statistics From the HCUP–3 Nationwide Journal of Hematotherapy, vol. 5, pp. 105– of 10 Different Methods for the Estimation of Inpatient Sample for 1994: Principal 116, 1996. Sperm Concentration,’’ Fertility and Sterility, Procedures, http://www.ahcpr.gov/data/ 18. Van Voorhis, B. J. et al, ‘‘Cost-effective vol. 68, No. 2, pp. 340–345, 1997. 94pcchpr.htm, current as of September 1997, Treatment of the Infertile Couple,’’ Fertility 32. Ziebe, S. and C. Y. Andersen, ‘‘Isolation AHCPR Pub. No. 97–0057. and Sterility, vol. 70, pp. 995–1005, 1998. of Motile Spermatozoa: Comparison of 6. Health Care Finance Review 1997 19. U.S. Department of Health and Human Percoll Centrifugation, SpermPrep Filtration Statistical Supplement, U.S. Department of Services, Centers for Disease Control and and Swim-Up Techniques,’’ Journal of Health and Human Services, Health Care Prevention, American Society for Assisted Reproduction and Genetics vol. 10, Financing Administration, Office of Research Reproductive Medicine and RESOLVE, 1997, No. 7, pp. 485–487, 1993. and Demonstrations, Baltimore, MD, 1995 Assisted Reproductive Technology 33. Carrell, D.T. et al., ‘‘A Randomized, November 1997. Success Rates: National Summary and Prospective Analysis of Five Sperm 7. Lord, C. F., M. C. Gebhardt, W. W. Fertility Clinic Reports. Preparation Techniques Before Intrauterine Tomford, and H. J. Mankin, ‘‘Infection in 20. U.S. Department of Health and Human Insemination of Husband Sperm,’’ Fertility Bone Allograft: Incidence, Nature and Services, Centers for Disease Control and and Sterility, vol. 69, No. 1, pp. 122–126, Treatment,’’ The Journal of Bone and Joint Prevention, American Society for 1998. Surgery, vol. 70–A, No. 3, pp. 369–376, Reproductive Medicine and RESOLVE. 34. Ozornek, M. H., P. Bielfeld, and R. S. March 1988. 1998.1996 Assisted Reproductive Technology Jeyendran, ‘‘Increase Recovery of Viable 8. Hardin, C. K., ‘‘Banked Bone,’’ Success Rates: National Summary and Spermatozoa Through Oscillating Otolaryngologic Clinics of North America, Fertility Clinic Reports. Centrifugation,’’ Fertility and Sterility vol. 70, vol. 27, No. 5, pp. 911–925, October 1994. 21. Wortley, P. M., T. A. Hammett, and P. No. 4, pp. 712–714, 1998. 9. Vital and Health Statistics, Detailed L. Fleming, ‘‘Donor Insemination and Human 35. King, K., ‘‘Antibiotics: Effect on Diagnoses and Procedures, National Hospital Immunodeficiency Virus Transmission,’’ Cryopreserved-thawed Human Sperm Discharge Survey, 1995, U.S. Department of Obstetrics and Gynecology, vol. 91, No. 4, Motility In Vitro,’’ Fertility and Sterility, vol. Health and Human Services, Centers for 1998. 67, No. 6, pp. 1146–1151, 1997. Disease Control and Prevention, National 22. VanKooij, R. J., M. F. Peeters, and E. 36. Cohen, J., A. Gilligan, W. Esposity, T. Center for Health Statistics, Series 13, No. R. Velde, ‘‘Twins of Mixed Races: Schimmel, and B. Dale, ‘‘Ambient Air and its 130, PHS–98–1791, November 1997. Consequences for Dutch IVF Laboratories,’’ Potential Effects on Conception in Vitro,’’ 10. Abecassis, M. M., ‘‘Transmission of Human Reproduction, vol. 12, No. 12, pp. Human Reproduction, vol. 12, No. 8, pp. Cytomegalovirus by Skin Allograft,’’ Tissue 2585–2587, 1997. 1742–1749, 1997. and Cell Report, vol. 2, No. 1, pp. 14–17, 23. Hu, Yunxia, W. S. Maxson, D. I. 37. Francis, M. M. et al., ‘‘Embryo toxicity 1995. Hoffman, S. J. Ory, S. Eager, J. Dupre, and C. of three commercially available powderless

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1548 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules surgical gloves,’’ Journal of Assisted including the validity of the described in proposed § 1271.10 would Reproduction and Genetics, vol. 9, No. 3, pp. methodology and assumptions used; (3) be required under proposed 283–357, 1992. ways to enhance the quality, utility, and § 1271.350(a) and (b) to report to the 38. Munne, S. et al., ‘‘Treatment-related clarity of the information to be agency any adverse reaction or any error Chromosome Abnormalities in Human Embryos,’’ Human Reproduction, vol. 12, No. collected; and (4) ways to minimize the or accident that may reasonably be 4, pp. 780–784, 1997. burden of the collection of information expected to lead to a reportable adverse 39. Brinsden, P. R. and P. A. Rainsbury, on respondents, including through the reaction as defined in proposed eds., A Textbook of In Vitro Fertilization and use of automated collection techniques, § 1271.3(ee). Section 1271.370(a)(2) and Assisted Reproduction, Park Ridge, NJ: The when appropriate, and other forms of (a)(3) would require establishments to Parthenon Publishing Group, 1992. information technology. include specific information on the 40. Hammitt, D. G. et al., ‘‘Prediction of Title: Reporting and Recordkeeping product label and package insert. Nuclear Maturity from Cumulus-coronal Requirements in Current Good Tissue Table 12 lists recordkeeping Morphology: Influence of Embryologist Experience,’’ Journal of Assisted Practice. provisions under the proposed rule, Reproduction and Genetics, vol. 9, No. 5, pp. Description: Under the authority of establishments would be required to 439–467, 1992. section 361 of the PHS Act, FDA is prepare and maintain written SOP’s for 41. Wilcox, L. S. and J. S. Marks, proposing new regulations to require all significant steps performed in the ‘‘Regulating assisted reproductive manufacturers of human cellular and manufacturing and tracking of human technologies: public health, consumer tissue-based products to follow CGTP, cellular and tissue-based products. As protection, and public resources,’’ Women’s which would include information calculated in table 12, the preparation of Health Issues, vol. 6, No. 3, pp. 175–180, collection provisions such as the the SOP’s would result in a one-time 1996. establishment and maintenance of impact on establishments rather than 42. Pool, T. B. ‘‘Practices Contributing to SOP’s, recordkeeping, reporting, and Quality Performance in the Embryo the year to year maintenance of the Laboratory and the Status of Laboratory labeling of the products. The CGTP SOP’s because, once composed, SOP’s Regulation in the U.S.,’’ Human information collection provisions would would only be reviewed annually and Reproduction, vol. 12, No. 12, pp. 2591– provide: (1) additional measures for updated as necessary. 2593, 1997. preventing the introduction, The SOP provisions proposed under 43. Callahan, T. L., J. E. Hall, S. L. Ettner, transmission, or spread of part 1271 in the combined maintenance C. L. Christiansen, M. F. Greene, and W. F. communicable diseases; (2) step-by-step estimate include: (1) § 1271.160(b)(2) Crowley, ‘‘The Economic Impact of Multiple- consistency in the manufacturing of the (receiving, investigation, evaluating, and Gestation Pregnancies and the Contribution product; (3) necessary information to documenting information received from of Assisted Reproductive Techniques to FDA for the purpose of protecting other sources); (2) § 1271.160(f) (quality Their Incidence,’’ The New England Journal of Medicine, vol. 331, No. 4, pp. 244–249, public health and safety; (4) program); (3) § 1271.180 (all significant 1994. accountability in the manufacturing of steps performed in the manufacture of 44. Prottas, Jeffrey, ‘‘A Study of the Tissue cellular and tissue-based products; (5) human cellular and tissue-based Procurement and Distribution System of the information for meaningful FDA products); (4) § 1271.190(c)(3) (facility United States,’’ Brandeis University, FDA/ inspections; (6) information facilitating cleaning and sanitization); (5) HRSA Contract No. 240–090–0048, October the tracking of a product back to its § 1271.195(a) (control and monitoring of 1995. original source or to a recipient; (7) environmental conditions); (6) 45. American Medical Association, information to FDA of any adverse § 1271.200(b) (cleaning, sanitizing, and Socioeconomics Characteristics of Medical reaction; and (8) information that would maintenance of equipment); (7) Practice, table 47, p. 150, 1994. 46. Fee Schedule 1/98, Donor Semen 0.5cc aid in the investigation of any § 1271.200(c) (calibration of equipment); and Donor Semen 0.8cc-1.0cc, The Sperm introduction, transmission, or spread of (8) § 1271.210(a) (receipt and Bank of California, at a communicable disease. verification of supplies and reagents); www.thespermbankofca.org/fees96.htm Table 11 lists provisions that would (9) § 1271.210(b) (validation and/or require reporting or disclosure of verification of in-house reagents); (10) X. The Paperwork Reduction Act of information to third parties, the Federal § 1271.220(b) (use and removal of 1995 government, or the public. Section processing material); (11) § 1271.220(d) This proposed rule contains 1271.155(a) would require the (control of in-process product); (12) information collection provisions that submission of a request for FDA § 1271.225(a) (verification or validation are subject to review by OMB under the approval of an exemption or an of changes to a process); (13) Paperwork Reduction Act of 1995 (44 alternative from any requirement in § 1271.230(d) (maintenance and control U.S.C. 350193520). A description of subpart C or D of part 1271 of the of validated processes); (14) § 1271.250 these provisions is shown below with proposed rule. When documentation on (labeling of human cellular and tissue- an estimate of the annual reporting and the determination of donor suitability is based products); (15) § 1271.265(a) to (c) recordkeeping burden. Included in the translated into English, § 1271.270(c) (receipt, acceptance or rejection, estimate is the time for reviewing the would require a statement of distribution, and destruction or other instructions, searching existing data authenticity by the translator. Section disposition of human cellular or tissue- sources, gathering and maintaining the 1271.290(c) would require a unique based products); (16) § 1271.265(f) data needed, and completing and identifier be affixed to each cellular or (suitable for return to inventory); (17) reviewing each collection of tissue-based product to relate the § 1271.270(b) (records management information. product to the donor and all records system); (18) § 1271.290(b) (method of FDA invites comments on: (1) pertaining to the product. Whenever an product tracking); and, (19) Whether the proposed collection of establishment initially distributes § 1271.320(a) (review, evaluation, and information is necessary for the proper product to a consignee, § 1271.290(f) documentation of all complaints). performance of FDA’s functions, would require the establishment to Proposed part 1271 would require the including whether the information will inform the consignee, in writing, of the following additional recordkeeping have practical utility; (2) the accuracy of product tracking requirements and the provisions listed under table 12. Section FDA’s estimate of the burden of the methods the establishment uses to fulfill 1271.155(f) would require an proposed collection of information, the requirements. Establishments establishment operating under the terms

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In addition, advances in would require documentation of all documentation of the review and medical technology have created product deviations in manufacturing evaluation of a process and revalidation opportunities for diagnosis and therapy cellular or tissue-based products. of the process, if necessary, when any for up to 10 years after recipient Section 1271.160(d)(3) would require changes to or deviations from a exposure to a donor later determined to documentation of the results of all validated process occur. Section be at risk for communicable disease audits and reaudits of the quality 1271.260(b)(3) and (d) would require agents or diseases. program. Section 1271.160(e) would documentation of the storage Section 1271.270(f) would require require documentation of computer temperature of human cellular and documentation of any contract, validation activities and results when tissue-based products and any agreement, or other arrangement with computers are used as part of the quality corrective action taken when acceptable another establishment under which any program, as part of manufacturing, or for storage conditions are not met. Section step in the manufacturing process is maintaining data or records. Section 1271.265(a) and (b) would require performed by the other establishment. 1271.170(d) would require the documentation of the receipt, Section 1271.290(e) would require maintenance of records of education, acceptance or rejection, distribution, documentation of the disposition of experience, training, and retraining of and destruction or other disposition of each of its human cellular or tissue- all personnel. Section 1271.190(c)(4) a human cellular or tissue-based based product as part of its tracking would require documentation of all product. Section 1271.270(a) and (c) method. Section 1271.290(f) would significant facility cleaning and would require documentation of each require an establishment to document sanitation. Section 1271.195(c) would significant step in manufacturing that a consignee agreed to participate in require documentation of environmental required in subparts C and D of part its tracking method and will take all control and monitoring activities. 1271, the results and interpretation of necessary steps to ensure compliance Section 1271.200(e) would require all testing and screening for relevant with the requirements of the regulation. documentation of all equipment communicable disease agents and Section 1271.320(b) would require an maintenance, cleaning, sanitizing, diseases, and the determination of establishment to maintain a record of calibration, and other activities. Section donor suitability. each complaint that it receives, 1271.210(c) would require Section 1271.180 would require the including a review and evaluation. documentation of the receipt, retention of obsolete procedures for 10 Section 1271.350(c) would require the verification, and use of each supply or years. Section 1271.270(e) would documentation of adverse reaction reagent. Section 1271.220(b) and (d) require the retention of all records for a reports, errors and accidents in would require documentation of the period of 10 years after their creation. manufacturing that may lead to product adequate removal of processing material Records pertaining to a particular deviation reports, and the investigation and the verification activities for in- human cellular or tissue-based product of these reports. process product. Section 1271.225(b) would be required to be retained at least would require documentation of all 10 years after the date of implantation, Description of Respondents: changes to established processes, transplantation, infusion, or transfer of Manufacturers of cellular and tissue- including rationale and the date of the product. If the date of implantation, based products. implementation. Section 1271.230(a) transplantation, infusion, or transfer is FDA estimates the burden of this would require documentation of not known, then records would be collection of information as follows:

TABLE 11.ÐESTIMATED ANNUAL REPORTING BURDEN 1

No. of Annual Frequency Total Annual 21 CFR Section Respondents per Response Responses Hours per Response Total Hours

1271.155(a) 1,065 1 1,065 3 3,195 1271.270(c) 1,065 1 1,065 1 1,065 1271.290(c) 791 250 198,215 0.08 15,857 1271.290(f) 1,065 1 1,065 1 1,065 1271.350(a) 1,065 6 6,390 0.5 3,195 1271.350(b) 1,065 2 2,130 0.5 1,065 1271.370(a)(2) and (a)(3) 633 207 131,005 0.25 32,751 Total 58,193 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 12.ÐESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper

One-time Burden (Creation of SOP's 2) 1,065 9 9,585 16 153,360 One-time Burden (Review of existing SOP's for compliance) 1,065 19 20,235 5 101,175

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TABLE 12.ÐESTIMATED ANNUAL RECORDKEEPING BURDEN 1ÐContinued

Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper

SOP Maintenance (See previous list of 19 SOP's) 1,065 19 20,235 1 20,235 1271.155(f) 1,065 1 1,065 0.25 266 1271.160(b)(3) 483 2 966 6 5,796 1271.160(b)(7) 597 15 8,955 0.5 4,478 1271.160(d)(3) 558 1 558 13 7,254 1271.160(e) 597 5 2,985 0.25 746 1271.170(d) 483 1 483 1 483 1271.180 483 1 483 120 57,960 1271.190(c)(4) 558 12 6,696 1 6,696 1271.195(c) 822 12 9,864 1 9,864 1271.200(e) 483 12 5,796 1 5,796 1271.210(c) 597 12 7,164 1 7,164 1271.220(b) and (d) 91 781 71,070 0.08 5,686 1271.225(b) 1,065 2 2,130 1 2,130 1271.230(a) 755 1 755 1 755 1271.230(b) 980 1 980 1 980 1271.230(e) 1,065 1 1,065 1 1,065 1271.260(b)(3) 597 356 212,532 0.08 17,003 1271.260(d) 747 12 8,964 0.25 2,241 1271.265(a) 597 360 214,920 0.08 17,194 1271.265(b) 822 407 334,554 0.08 26,764 1271.270(a) and (c) 597 360 214,920 0.1 21,492 1271.270(f) 755 2 1,510 0.25 378 1271.290(e) 641 306 196,146 0.3 58,844 1271.290(f) 1,065 57 60,705 0.35 21,247 1271.320(b) 830 5 4,150 1 4,150 1271.350(c) 726 6 4,356 0.5 2,178 Total 563,380 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Standard operating procedures.

Under this proposed rule, 19 SOP’s number of industry organizations, such The agency has estimated that there would be required as previously as, AATB, EBAA, AABB, FAHCT, and are approximately 1,065 manufacturers described. FDA is assuming that CAP, and the guidelines provided by of cellular and tissue-based products approximately 1,065 manufacturers ASRM. In those cases where a voluntary (approximately 110 manufacturers of would have to create up to 9 SOP’s for industry standard appears to be conventional tissue, 114 manufacturers a total of 9,585 records, and the agency equivalent to a proposed regulation, of eye tissue, 425 manufacturers of estimates that it would take 16 hours FDA has assumed that any reporting or peripheral and cord blood stem cells, per record to create 9 new SOP’s for a recordkeeping burden is a customary 350 manufacturers of reproductive total of 153,360 hours as a one-time and usual business practice of tissue, and 66 manufacturers of cellular burden. The agency estimates that up to establishments who are members of or tissue-based licensed biological 19 SOP’s would already exist as a result those organizations and no additional products or devices). FDA obtained of complying with current applicable burden is calculated here. In some cases these estimates of manufacturers regulations or following industry establishments affected by this proposed (including percentage of members and organizational standards. rule may already be required to comply nonmembers) from the various trade Approximately 1,065 manufacturers with regulations for manufacturers of organizations and the agency’s would have to review these 19 SOP’s for human drugs or biological products, registration systems for biological compliance with the regulations, which e.g., parts 210, 211, 312, 314, and 606 product and device manufacturers. The would expend approximately 5 hours (21 CFR parts 312, 314, and 606). total number of respondents and per SOP as a one-time burden. Annual FDA has estimated the reporting recordkeepers, 1,065, in the tables is SOP maintenance of existing SOP’s is (table 11) and recordkeeping (table 12) decreased for each provision by the estimated to involve 1 hour annually burdens based upon the agency’s number of establishments that follow, as per SOP, totaling 19 hours annually per institutional experience with usual and customary practice, the recordkeeper. comparable recordkeeping and reporting applicable established trade In some cases, the estimated burden provisions applicable to the human drug organizational standards comparable to may appear to be lower or higher than and biological product industries, recent the CGTP requirements, i.e., AATB, the burden experienced by individual information from trade organizations EBAA, FAHCT, AABB, or CAP. FDA establishments. The estimated burden in related to the manufacturing of products based the estimated numbers for these charts is an estimated average utilizing cells and tissues, and data ‘‘Number of Respondents’’ and burden, taking into account the range of provided by the Eastern Research Group ‘‘Number of Recordkeepers’’ on impact each proposed regulation may (ERG), a consulting firm hired by FDA information provided by the trade have. In estimating the burden, FDA to prepare an economic analysis of the organizations. compared the proposed regulations with potential economic impact on sperm FDA based the estimated numbers for the current voluntary standards of a banks and ART facilities. ‘‘Annual Frequency per Response,’’

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‘‘Total Annual Responses,’’ ‘‘Annual except that individuals may submit one (1) That a human cellular or tissue- Frequency per Recordkeeping,’’ and copy. Comments are to be identified based product has transmitted or may ‘‘Total Annual Records’’ on information with the docket number found in have transmitted a communicable received from the trade organizations, brackets in the heading of this disease to the recipient of the product; institutional experience with similar document. Received comments may be (2) That the function or integrity of a requirements (good manufacturing seen in the Dockets Management Branch human cellular or tissue-based product practice), general information provided between 9 a.m. and 4 p.m., Monday may have been impaired; or to FDA during inspections of through Friday. Comments received in (3) Any other problem with a human manufacturers of human tissue intended response to the proposed GTP rule cellular or tissue-based product that for transplantation, and information could support a change that will affect could result from the failure to comply gathered by ERG. language in previously published with current good tissue practice. The estimates for ‘‘Hours per proposed tissue rules. In the event that (jj) Distribution means any Response’’ or ‘‘Hours per Recordkeeper’’ any tissue rule becomes effective before conveyance or shipment of human were calculated using comparable either or both of the remaining tissue cellular or tissue-based products burdens under drug GMP regulations, rules become effective, FDA intends to (including importation and exportation), part 211, and GMP for blood and blood make conforming amendments to those whether or not such conveyance or components, part 606, or by using the final rules at the same time the shipment is entirely intrastate and information provided by ERG, e.g., time remaining tissue rules become effective. whether or not possession of the spent on §§ 1271.190(c)(4) product is taken. (documentation of cleaning and List of Subjects in 21 CFR Part 1271 (kk) Product deviation means an event sanitation) and 1271.195(c) Human cellular and tissue-based that represents a deviation from current (documentation of environmental products, Communicable diseases, HIV/ good tissue practice, applicable control and monitoring activities) was AIDS, Reporting and recordkeeping standards, or established specifications; an estimate provided by ERG. requirements. or an unexpected or unforeseeable event In compliance with the Paperwork Therefore, under the Public Health that may relate to the transmission or Reduction Act of 1995 (44 U.S.C. Service Act, and under the authority potential transmission of a 3507(d), the agency has submitted the delegated to the commissioner of Food communicable disease agent or disease information collection provisions of this and Drugs, it is proposed to amend 21 from a human cellular or tissue-based proposed rule to OMB for review. CFR Chapter I as follows: product to a recipient, or may lead to Interested persons are requested to send Part 1271 as proposed in the Federal product contamination, or may comments regarding information Register of May 14, 1998 (63 FR 26744) adversely affect the function or integrity collection by February 7, 2001 to the and September 30, 1999 (64 FR 52696) of the product. Office of Information and Regulatory is amended as follows: (ll) Establish and maintain means Affairs, OMB, New Executive Office define, document (in writing or Bldg., 725 17th St. NW., rm. 10235, PART 1271ÐHUMAN CELLULAR AND electronically), and implement, then Washington, DC 20503, Attn: Wendy TISSUE-BASED PRODUCTS follow, review, and as needed, revise on Taylor, Desk Officer for FDA. an ongoing basis. 1. The authority citation for 21 CFR (mm) Processing means any activity XI. Federalism part 1271 is revised to read as follows: other than recovery, donor screening, FDA has analyzed this proposed rule Authority: 42 U.S.C. 216, 243, 263a, donor testing, storage, labeling, in accordance with the principles set 264, 271. packaging, or distribution performed on forth in Executive Order 13132. FDA 2. Section 1271.3 is amended by a human cellular or tissue-based has concluded that the proposed rule adding paragraphs (ff) through (tt) to product, including but not limited to raises Federalism implications because read as follows: preparation, sterilization, steps to it could preempt some States’ laws inactivate and remove adventitious regarding donated human cells and § 1271.3 Definitions. agents, preservation for storage, and tissues. FDA currently is seeking * * * * * removal from storage. comments from elected State and local (ff) Available for distribution means (nn) Quality audit means a government officials under Executive that the human cellular or tissue-based documented, independent inspection Order 13132 on: (1) The need for the product has been determined to meet all and review of an establishment’s proposed good tissue practice rule to release specifications and to be suitable activities, including manufacturing and prevent communicable disease for distribution. tracking, performed according to transmission through human cellular (gg) Adverse reaction means a noxious procedures, to verify, by examination and tissue-based products; (2) and unintended response to any human and evaluation of objective evidence, alternatives that would limit the scope cellular or tissue-based product for the degree of compliance with those of such national requirements or which there is a reasonable possibility aspects of the quality program under otherwise preserve State prerogatives that the response may have been caused review. and authority; (3) the proposed good by the product (i.e., the relationship (oo) Quality program means an tissue practice provisions; and (4) any cannot be ruled out). organization’s comprehensive system other issues raised by this proposed rule (hh) Processing material means any for manufacturing and tracking human possibly affecting State laws and material or substance that is used in, or cellular and tissue-based products. This authorities. to facilitate, processing, but which is not program includes preventing, detecting, intended by the manufacturer to be and correcting deficiencies that may XII. Request For Comments included in the human cellular or lead to circumstances that increase the Interested persons may submit to the tissue-based product when it is made risk of introduction, transmission, or Dockets Management Branch (address available for distribution. spread of communicable disease. above) written comments on this (ii) Complaint means any written, (pp) Recovery means the process of proposal by May 8, 2001. Two copies of oral, or electronic communication that obtaining from a donor cells or tissues any comments are to be submitted, alleges: that are intended for use in human

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1552 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules implantation, transplantation, infusion, through the use of human cellular and related to prevention of introduction, or transfer. tissue-based products by helping to transmission, or spread of (qq) Storage means holding human ensure that the products do not contain communicable disease agents and cellular or tissue-based products for communicable disease agents; that the diseases, or in the establishment’s future processing and/or distribution. products do not become contaminated inability to carry out any necessary (rr) Validation means confirmation by during manufacturing; and that the corrective action. examination and provision of objective function and integrity of the products evidence that particular requirements are not impaired through improper § 1271.155 Exemptions and alternatives. can consistently be fulfilled. Validation manufacturing. The CGTP provisions (a) General. An establishment may of a process, or process validation, specifically governing determinations of request an exemption or alternative means establishing by objective donor suitability, including donor from any requirement in subpart C or D evidence that a process consistently screening and testing, are set out of this part regarding a human cellular produces a result or product meeting its separately in subpart C of this part. or tissue-based product. predetermined specifications. (b) Compliance with applicable (b) Request for exemption or (ss) Verification means confirmation requirements. (1) If an establishment alternative. A request under this section by examination and provision of engages in only some operations subject shall be submitted to the Director, objective evidence that specified to the regulations in this subpart and Center for Biologics Evaluation and requirements have been fulfilled. subpart C of this part, and not others, Research (the Director). The request (tt) Importer of record means the that establishment need only comply shall be accompanied by supporting person, establishment, or its with those requirements applicable to documentation, including all relevant representative responsible for making the operations in which it engages. valid scientific data. A request for an entry of imported goods in accordance However, an establishment that engages exemption shall contain information with all laws affecting such importation. another establishment under a contract, justifying the exemption. A request for 3. Subpart D, consisting of agreement, or other arrangement, to an alternative shall contain a §§ 1271.150 through 1271.320, is added perform any step in the manufacturing description of an alternative that to part 1271 to read as follows: process, is responsible for ensuring that satisfies the purpose of the requirement. the work is performed in compliance (c) Criteria for granting exemption or Subpart DÐCurrent Good Tissue with the requirements in this subpart alternative. The Director may grant an Practice and subpart C of this part. exemption or alternative if he or she finds that such action is consistent with Sec. (2) The establishment that determines that a product meets release criteria and the goals of preventing the introduction, 1271.150 Current good tissue practice: transmission, and spread of general. makes the product available for 1271.155 Exemptions and alternatives. distribution, whether or not that communicable disease and that: 1271.160 Establishment and maintenance of establishment is the actual distributor, (1) The information submitted a quality program. is responsible for ensuring that the justifies an exemption; or 1271.170 Organization and personnel. product has been manufactured in (2) The proposed alternative satisfies 1271.180 Procedures. compliance with the requirements of the purpose of the requirement. (d) Form of request. A request for an 1271.190 Facilities. subparts C and D of this part and any 1271.195 Environmental control and exemption or alternative shall ordinarily other applicable requirements. monitoring. be made in writing or electronically. 1271.200 Equipment. (c) Compliance with parts 210, 211, and 820 of this chapter. With respect to However, in limited circumstances such 1271.210 Supplies and reagents. a request may be made orally, and an 1271.220 Process controls. human cellular or tissue-based products regulated as biological drugs or devices exemption or alternative may be granted 1271.225 Process changes. orally by the Director. An oral request 1271.230 Process validation. under section 351 of the Public Health 1271.250 Labeling controls. Service Act and/or the Federal Food, and approval shall be followed by an 1271.260 Storage. Drug, and Cosmetic Act, the procedures immediate written request and written 1271.265 Receipt and distribution. contained in this subpart and in subpart acknowledgment of approval. (e) Operation under exemption or 1271.270 Records. C of this part and the current good alternative. An establishment shall not 1271.290 Tracking. manufacturing practice regulations in 1271.320 Complaint file. begin operating under the terms of a parts 210 and 211 of this chapter and requested exemption or alternative until the quality system regulations in part Subpart DÐCurrent Good Tissue the exemption or alternative has been Practice 820 of this chapter, shall be considered to supplement, not supersede, each granted in writing. An establishment § 1271.150 Current good tissue practice: other unless the regulations explicitly may apply for an extension of an general. provide otherwise. In the event that it is exemption or alternative beyond its (a) General. Current good tissue impossible to comply with all expiration date, if any. (f) Documentation. An establishment practice (CGTP) requirements are set applicable regulations in these parts, the operating under the terms of an forth in this subpart and in subpart C of regulations specifically applicable to the exemption or alternative shall maintain this part. CGTP requirements govern the biological drug or device in question methods used in, and the facilities and documentation of: shall supersede any other requirements. (1) FDA’s granting of the exemption or controls used for, the manufacture of (d) Where appropriate. When a alternative, and human cellular and tissue-based requirement is qualified by ‘‘where (2) The date on which it began products, including but not limited to appropriate,’’ it is deemed to be operating under the terms of the all steps in recovery, donor screening, ‘‘appropriate’’ unless the establishment exemption or alternative. donor testing, processing, storage, can document justification otherwise. A labeling, packaging, and distribution. requirement is ‘‘appropriate’’ if § 1271.160 Establishment and The CGTP requirements are intended to nonimplementation could reasonably be maintenance of a quality program. prevent the introduction, transmission, expected to result in the product’s not (a) General. An establishment that and spread of communicable disease meeting its specified requirements performs any step in the manufacture of

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1553 human cellular and tissue-based (6) Establishing and maintaining a establishment shall validate computer products shall establish and maintain a system for the maintenance of records in software for its intended use according quality program that is appropriate for compliance with § 1271.270; to an established protocol. All software the specific human cellular and tissue- (7) Investigating and documenting all changes shall be validated before based products manufactured and the product deviations and making reports approval and issuance. These validation manufacturing steps performed and that if required under § 1271.350(b) or other activities and results shall be meets the requirements of this subpart. applicable regulations. Each documented. (b) Functions. Functions of the quality investigation shall include a review and (f) Procedures. Procedures shall be program shall include, but not be evaluation of the product deviation, the established and maintained for a quality limited to: efforts made to determine the cause, and program, including quality audits. (1) Ensuring that appropriate the implementation of corrective procedures are established and action(s) designed to address the § 1271.170 Organization and personnel. maintained, and ensuring compliance product deviation and prevent (a) General. Each establishment shall with the requirements of § 1271.180 recurrence. Each establishment shall maintain an adequate organizational with respect to procedures, including also perform a periodic review and structure and sufficient personnel to review, approval, revision, and analysis of all product deviations, at ensure that the requirements of this part archiving; least once each year, for the purpose of are met. (2) Ensuring that procedures exist for identifying trends and adopting (b) Competent performance of receiving, investigating, evaluating, and appropriate preventive measures. This functions. Each establishment shall documenting information received from analysis shall be available for review have sufficient personnel with the other sources and for sharing with upon inspection and for submission to necessary education and experience to consignees and other establishments FDA upon request; and assure competent performance of their that are known to have recovered cells (8) Conducting evaluations, assigned functions. Personnel shall or tissue from the same donor any investigations, audits, and other actions perform only those activities for which information pertaining to the integrity necessary to ensure compliance with the they are qualified. and function of a human cellular or requirements of this subpart. (c) Training. All personnel shall be tissue-based product, possible (c) Authority over program. One or trained, and retrained as necessary, to contamination of the product, or the more designated persons shall have perform their assigned responsibilities potential transmission of communicable authority over and responsibility for adequately. Personnel shall be made disease by the product. In the case of ensuring that the quality program is aware of possible consequences of information received after the product is effectively established and effectively improper performance of their duties; made available for distribution or maintained. This person shall report to e.g., the risk of transmission of shipped to the consignee, procedures management on the performance of the communicable disease agents and shall include provisions for evaluating quality program on no less than an diseases, and the hazards associated the effect this information has on the annual basis. If this person also with those disease agents and diseases, product and for the notification of all performs other tasks in the and the risk of adversely affecting entities to whom affected product was establishment, he or she shall not have function and integrity of human cellular distributed, the quarantine and recall of final oversight over his or her own and tissue-based products. the product, and/or reporting to FDA, as work. (d) Records. A record of the necessary. (d) Audits. (1) A comprehensive education, experience, training, and (3) Ensuring that appropriate quality audit, as defined in § 1271.3(nn), retraining shall be maintained for all corrective actions, including reaudits of shall be performed no less than once in personnel. a 12-month period. Special audits shall deficiencies, are taken and documented, § 1271.180 Procedures. as necessary. Corrective actions shall be be performed as necessary. All audits Each establishment shall establish verified to ensure that such actions are shall be conducted in accordance with and maintain procedures for all effective and do not adversely affect the procedures to assure that the quality significant steps that it performs in the finished product. Where appropriate, program is operating effectively and to manufacture of human cellular and corrective actions shall include both identify trends or recurring problems. tissue-based products. These procedures short-term action to address the (2) Quality audits shall be conducted shall be designed to prevent immediate problem and long-term by individuals with sufficient circumstances that increase the risk of action to prevent the problem’s knowledge, training, and experience to the introduction, transmission, and recurrence. Documentation of corrective identify problems in the specific spread of communicable disease actions shall include where appropriate: processes under review, but who do not (i) Identification of the human cellular have direct responsibility for the through the use of human cellular and or tissue-based product affected and a processes being audited. tissue-based products by ensuring that description of its disposition; (3) A documented report of the results the products do not contain relevant (ii) The nature of the problem of the audits and reaudits, where taken, communicable disease agents; that the requiring corrective action; shall be retained. Such reports shall be products do not become contaminated (iii) A description of the corrective reviewed by management having during manufacturing; and that the action taken; and responsibility for the matters audited, function and integrity of the products (iv) The date(s) of the corrective and this management review shall be are not impaired through improper action. documented. manufacturing. Procedures shall be (4) Ensuring the proper training and (e) Computers. If computers or designed to ensure compliance with the education of personnel; automated data processing systems are requirements of this part. Prior to (5) Establishing and maintaining used as part of the quality program, as implementation, all procedures shall be appropriate monitoring systems as part of manufacture or tracking, or for reviewed and approved by a responsible necessary to comply with the maintaining data or records related to person. At least once in a 12-month requirements of this subpart (e.g., the manufacture or tracking of human period, all procedures shall be reviewed environmental monitoring); cellular or tissue-based products, the and, if necessary, revised, and the

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1554 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules review shall be documented. Procedures the function or integrity of human be routinely calibrated according to shall be readily available to the cellular and tissue-based products, or to established procedures and schedules. personnel in the area where the cause contamination or cross- Calibration procedures shall include operations to which they relate are contamination of products or equipment specific directions and, where performed, unless this is impractical. or accidental exposure of products to applicable, shall include limits for Any deviation from a procedure shall be communicable disease agents, accuracy and precision. When accuracy authorized in advance by a responsible procedures shall be established and and precision limits are not met, there person, recorded, and justified. An maintained to adequately control and shall be provisions for corrective action establishment may adopt current monitor environmental conditions and to reestablish the limits and to evaluate standard procedures, such as those in a to provide proper conditions for whether there were any adverse effects technical manual prepared by another operations. Where appropriate, these on any human cellular or tissue-based organization, provided the procedures procedures shall provide for the product. are consistent with and at least as following control and monitoring (d) Inspections. Equipment shall be stringent as the requirements of this part activities or systems: routinely inspected for cleanliness, and appropriate for the operations (1) Temperature and humidity sanitation, and calibration, and to assure conducted at the establishment. controls; adherence to applicable equipment Obsolete procedures shall be archived (2) Ventilation and air filtration; maintenance schedules. for at least 10 years. (3) Cleaning and disinfecting of rooms (e) Records. All maintenance, and equipment to ensure aseptic cleaning, sanitizing, calibration, and § 1271.190 Facilities. processing operations; other activities performed in accordance (a) General. Any facility used in the (4) Maintenance of equipment used to with this section shall be documented manufacture of human cellular or control conditions necessary for aseptic and maintained. Records of recent tissue-based products shall be of processing operations; and maintenance, cleaning, sanitizing, suitable size, construction, and location (5) Environmental monitoring for calibration, and other activities shall be to facilitate cleaning, relevant organisms. available at each piece of equipment. (b) Inspections. Each environmental maintenance, and proper operations. Records of the use of each piece of control system shall be inspected The facility shall be maintained in a equipment, which shall include the periodically to verify that the system, good state of repair. Adequate lighting, identification of each human cellular or including necessary equipment, is ventilation, plumbing, drainage, and tissue-based product manufactured with adequate and functioning properly. washing and toilet facilities shall be that equipment, shall be maintained. provided. Appropriate corrective action shall be (b) Operations. A facility used in the taken as necessary. § 1271.210 Supplies and reagents. manufacture of human cellular or (c) Records. Environmental control (a) Receipt and verification. tissue-based products shall be divided and monitoring activities shall be Procedures shall be established and into separate or defined areas of documented, and records shall be maintained for receiving supplies and adequate size for each operation that maintained. reagents used in the manufacture of takes place in the facility, or other § 1271.200 Equipment. human cellular and tissue-based control systems shall be established and products. Supplies and reagents shall be maintained to prevent improper (a) General. Equipment used in the manufacture of human cellular and verified to meet specifications designed labeling, mix-ups, contamination, cross- to prevent circumstances that increase contamination, and accidental exposure tissue-based products shall be of appropriate design for its use, shall be the risk of the introduction, of human cellular and tissue-based transmission, or spread of products to communicable disease suitably located and installed to facilitate operations, including cleaning communicable disease through product agents. contamination or the impairment of (c) Facility cleaning and sanitation. and maintenance, and shall not have any adverse effect on the products. Any product function or integrity, and shall (1) Any facility used in the manufacture not be used until such verification is of human cellular and tissue-based automated, mechanical, electronic, computer, or other equipment used for completed. Verification may be products shall be maintained in a clean, accomplished by the establishment that sanitary, and orderly manner. inspection, measuring, and testing shall be capable of producing valid results. uses the supply or reagent, or by the (2) Sewage, trash, and other refuse vendor of the supply or reagent. shall be disposed of in a timely, safe, (b) Procedures and schedules. Procedures shall be established and (b) Reagents. Reagents used in and sanitary manner. processing and preservation of human (3) Procedures for facility cleaning maintained for cleaning, sanitizing, and cellular and tissue-based products shall and sanitation shall be established and maintaining equipment to prevent be of appropriate grade for the intended maintained. These procedures shall malfunctions, contamination or cross- use and shall be sterile, if appropriate. assign responsibility for sanitation and contamination, accidental exposure of Procedures for production of in-house shall describe in sufficient detail the human cellular and tissue-based reagents shall be validated and/or cleaning methods to be used and the products to communicable disease verified. schedule for cleaning the facility. agents, and other events that could (4) All significant cleaning and reasonably be expected to have an (c) Records. The following records sanitation activities shall be adverse effect on product function or pertaining to supplies and reagents shall documented, and records shall be integrity. Cleaning, sanitizing, and be maintained: maintained. maintenance of equipment shall be (1) Records of the receipt of each performed according to established supply or reagent, including the type, § 1271.195 Environmental control and schedules. manufacturer, lot number, date of monitoring. (c) Calibration of equipment. All receipt, and expiration date; (a) General. Where environmental automated, mechanical, electronic, (2) Records of the verification of each conditions could reasonably be computer, or other equipment used for supply or reagent, including test results expected to have an adverse effect on inspection, measuring, and testing shall or, in the case of vendor verification, a

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1555 certificate of analysis from the vendor; include a description of the change, § 1271.260 Storage. and identification of the affected documents, (a) Control of storage areas. Each (3) Records of the use of each supply the signature of the approving establishment shall control its storage or reagent, which shall include the individual(s), approval date, and when areas and stock rooms to prevent mix- identification of each human cellular or the change becomes effective. Approved ups, commingling, deterioration, tissue-based product manufactured with changes shall be communicated to the contamination, and cross- the supply or reagent. appropriate personnel in a timely contamination, of human cellular and manner. tissue-based products and supplies, and § 1271.220 Process controls. any other condition that may adversely (a) General. Each establishment § 1271.230 Process validation. affect product function or integrity, and engaged in the processing of human (a) General. Where the results of a to prevent improper release for cellular or tissue-based products shall distribution. develop, conduct, control, and monitor process cannot be fully verified by subsequent inspection and tests, the (b) Temperature. (1) Each its manufacturing processes to ensure establishment shall store human cellular process shall be validated and approved that each human cellular or tissue-based and tissue-based products at an according to established procedures. product conforms to specifications, is appropriate temperature and for no The validation activities and results, not contaminated, maintains its longer than the maximum storage period including the date and signature of the function and integrity, and is for the product. manufactured so as to prevent individual(s) approving the validation, (2) Acceptable temperature limits for transmission of communicable disease shall be documented. storage of human cellular and tissue- by the product. (b) Claims. Any process-related claim based products at each step of the (b) Processing material. Where a in labeling or promotional materials for manufacturing process shall be processing material could reasonably be a human cellular or tissue-based established to ensure product function expected to have an adverse effect on a product, e.g., a claim for sterility or viral and integrity, to prevent product human cellular or tissue-based inactivation, shall be based on a deterioration, and to inhibit the growth product’s function or integrity, the validated process. Validation shall be of infectious agents. establishment shall establish and documented, and the documentation (3) Storage temperatures for human maintain procedures for the use and shall be maintained at the establishment cellular and tissue-based products shall removal of such processing material to and made available for review on be maintained and recorded. Recorded ensure that it is removed or limited to inspection. temperatures shall be reviewed an amount that does not adversely affect periodically to assure that temperatures (c) Dura mater. Dura mater shall be the product’s function or integrity. The have not exceeded acceptable limits. processed using a validated procedure removal or reduction of such processing (c) Expiration date. Where that reduces transmissible spongiform material shall be documented. appropriate, an expiration date shall be encephalopathy, while preserving the (c) Pooling. Human cells or tissue assigned to each human cellular or from two or more donors shall not be clinical utility of the product. tissue-based product based on the pooled (placed in physical contact or (d) Procedures. Procedures shall be following factors: mixed in a single receptacle) during established and maintained for (1) Product type; manufacturing. monitoring and control of validated (2) Processing procedures, including (d) In-process monitoring. Procedures processes to ensure that the specified the method of preservation; shall be established and maintained, requirements continue to be met. (3) Storage conditions; and where appropriate, to ensure that (4) Packaging. (e) Changes and deviations. When (d) Corrective action. Corrective specified requirements of in-process changes to or deviations from a action shall be taken and documented product are met. Such procedures shall validated process occur, the whenever proper storage conditions are ensure that in-process product is establishment shall review and evaluate not met. controlled until the required inspection the process and perform revalidation and tests or other verification activities where appropriate. These activities shall § 1271.265 Receipt and distribution. have been completed or necessary be documented. (a) General. Procedures shall be approvals are received and documented. established and maintained for the Sampling of in-process products shall § 1271.250 Labeling controls. following activities: receipt, acceptance be representative of the material to be or rejection, distribution, and evaluated. Procedures shall be established and maintained to control the labeling of destruction or other disposition of § 1271.225 Process changes. human cellular and tissue-based human cellular or tissue-based products. These procedures shall be products, and these activities shall be (a) Procedures. Procedures shall be documented. Documentation shall established and maintained for making designed to ensure proper product identification and to prevent mix-ups. include: changes to a process. Any such change (1) Identification of the human Procedures shall include verification of shall be verified or validated, to ensure cellular or tissue-based product; that the change does not create an label accuracy, legibility, and integrity. (2) Activities performed and the adverse impact elsewhere in the Procedures shall ensure that each results of such activities; operation, and shall be approved before product is labeled in accordance with (3) Date(s) of activity; implementation by a responsible person all applicable labeling requirements, (4) Quantity of human cellular or with appropriate knowledge and including those in §§ 1271.55, 1271.65, tissue-based product subject to the background. 1271.75, 1271.90, 1271.290, and activity; and (b) Change records. All changes to 1271.370, and that each product made (5) Disposition of the human cellular established processes shall be available for distribution is or tissue-based product (e.g., identity of documented, including the rationale for accompanied by documentation of the consignee). the change and the date of donor suitability determination as (b) Receiving activities. Procedures implementation. Change records shall required under § 1271.55. shall be established and maintained for

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 1556 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules receiving and accepting or rejecting performance of each significant step and accompanied by a statement of human cellular or tissue-based products required in this subpart and subpart C authenticity by the translator that for processing, distribution, or any other of this part. Any requirement in this specifically identifies the translated step in the manufacturing process. The part that an action be documented document. status of each incoming human cellular involves the creation of a record, which (d) Methods of retention. Records or tissue-based product (e.g., with record is subject to the requirements of required under this subpart may be respect to quarantine, donor screening this section. All records shall be maintained electronically, as original and testing, and processing) shall be accurate, indelible, and legible. The paper records, or as true copies such as determined and identified promptly records shall identify the person photocopies, microfiche, or microfilm, after receipt, and each product shall be performing the work, the dates of the in which case suitable reader and handled in a manner appropriate to its various entries, and shall be as detailed photocopying equipment shall be status. Each incoming human cellular or as necessary to provide a complete readily available. Records stored in tissue-based product shall be inspected history of the work performed and to automated data processing systems shall according to established procedures for relate the records to the particular be backed up. Electronic records and damage, contamination, deterioration, human cellular or tissue-based product electronic signatures are subject to the or other indications that the integrity of involved. Record security systems shall requirements in part 11 of this chapter. the product has been impaired. be adequate to ensure the (e) Length of retention. All records Acceptance or rejection of incoming confidentiality of donors and recipients shall be retained 10 years after their products shall be documented. of human cellular and tissue-based creation. However, records pertaining to (c) Availability for distribution. products. a particular human cellular or tissue- Procedures shall be established and (b) Records management system. A based product shall be retained at least maintained for making human cellular records management system shall be 10 years after the date of implantation, and tissue-based products available for established and maintained. Under this transplantation, infusion, or transfer of distribution. These procedures, which system, records pertaining to a the product, or if the date of shall include release criteria, shall be particular human cellular or tissue- implantation, transplantation, infusion , designed to prevent the release of based product manufactured shall be or transfer is not known, then records products that are in quarantine, are maintained in such a way as to facilitate shall be retained at least 10 years after contaminated, have deteriorated, or review of the product’s history prior to the date of the product’s distribution, otherwise have been manufactured in making it available for distribution and, disposition, or expiration, whichever is violation of current good tissue practice if necessary, subsequent to the product’s latest. Records for archived specimens and, except as provided under release as part of a follow-up evaluation of dura mater shall be retained 10 years §§ 1271.65 and 1271.90, products from or investigation. Records pertinent to after the appropriate disposition of the donors who have been determined to be the manufacture of each type of human specimens. The establishment shall unsuitable or for whom a donor- cellular or tissue-based product (e.g., make provisions for all records to be suitability determination has not been procedures, specifications, labeling and maintained for the required period in completed. Prior to making a human packaging procedures, equipment logs) the event that the establishment ceases cellular or tissue-based product shall also be maintained and organized operation. available for distribution, the under the records management system. (f) Contracts and agreements. Each establishment shall verify and If records are maintained in more than establishment shall maintain records of document that the release criteria have one location, then the records any contract, agreement, or other been met and shall review all records management system shall be designed to arrangement with another establishment pertaining to the product. The ensure prompt identification, location, under which any step in the determination that a human cellular or and retrieval of all records. manufacturing process is performed by tissue-based product is available for (c) Other recordkeeping requirements. the other establishment. These records distribution shall be documented and Procedures shall be established and shall include the name and address of dated by a responsible person. maintained to ensure compliance with the other establishment and the (d) Packaging. Packaging and the recordkeeping requirements in responsibilities of each party to the shipping containers shall be designed, § 1271.55. Documentation of results and contract, agreement, or other validated, and constructed to ensure interpretation of all testing for relevant arrangement. product function and integrity and communicable disease agents in protect the product from damage, compliance with §§ 1271.80 and § 1271.290 Tracking. deterioration, contamination, or other 1271.85 shall be maintained, as well as (a) General. Each establishment that adverse effects during customary the name and address of the testing performs any step in the manufacture of conditions of processing, storage, laboratory or laboratories. a human cellular or tissue-based handling, and distribution. Documentation of the results and product shall track each such product in (e) Shipping conditions. Appropriate interpretation of all donor screening for accordance with this section. shipping conditions shall be defined for relevant communicable disease in (b) Method of product tracking. (1) each type of human cellular or tissue- compliance with § 1271.75 shall be Each establishment shall establish and based product to be maintained during maintained in accordance with maintain a method of product tracking transit. § 1271.270. Documentation of the that enables the tracking of all human (f) Return to inventory. Procedures donor-suitability determination, cellular and tissue-based products from: shall be established and maintained to including the name of the responsible (i) The donor to the recipient or final determine if a product that is returned person who made the determination and disposition; and to an establishment is suitable to be the date of the determination, shall also (ii) The recipient or final disposition returned to inventory. be maintained. Information on the to the donor. identity and relevant medical records of (2) Alternatively, an establishment § 1271.270 Records. the donor, as defined in § 1271.3(v), that performs some but not all of the (a) General. Records shall be shall be in English or, if in another steps in the manufacture of a human maintained concurrently with the language, shall be translated to English cellular or tissue-based product may

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1557 participate in a method of product archived, under appropriate storage Subpart EÐAdditional Requirements tracking that has been established and is conditions, and for the appropriate for Establishments Described in maintained by another establishment duration, to enable testing of the § 1271.10 responsible for other steps in the archived material for evidence of manufacture of the same product, transmissible sponiform § 1271.330 Applicability provided that the tracking method encephalopathy, and appropriate The provisions set forth in this complies with all the requirements of disposition of any affected dura mater subpart are applicable only to human this section. tissue, if necessary. cellular and tissue-based products (c) Distinct identification code. As described in § 1271.10 and regulated part of its tracking method, an § 1271.320 Complaint file. solely under section 361 of the Public establishment shall ensure that each (a) Procedures. Each establishment Health Service Act (the PHS Act) and human cellular and tissue-based shall establish and maintain procedures the regulations in this part, and to the product that it manufactures is assigned for the prompt review, evaluation, and establishments that manufacture those and labeled with a distinct documentation of all complaints, as products. Human cellular and tissue- identification code, e.g., alphanumeric, defined in § 1271.3(ii), and the based products described in § 1271.15 that relates the product to the donor and investigation of complaints as and regulated as drugs, devices, and/or to all records pertaining to the product. appropriate. biological products under the act and/or Except in the case of autologous or section 351 of the PHS Act, and the directed donations, such a code must be (b) Complaint file. Each establishment establishments that manufacture those created specifically for tracking and may shall maintain a record of each products, are not subject to the not include an individual’s name, social complaint that it receives in a file regulations set forth in this subpart. security or medical record number. An designated for complaints. The establishment may adopt a distinct complaint file shall contain sufficient § 1271.350 Reporting. identification code assigned by another information about each complaint for (a) Adverse reaction reports. (1) Any establishment engaged in the proper review and evaluation of the establishment that receives information manufacturing process, or may assign a complaint, including the identifier of about an adverse reaction, regardless of new code. An establishment that assigns the human cellular or tissue-based source, shall review the information to a new code to a product shall establish product that is the subject of the determine whether the adverse reaction and maintain procedures for relating the complaint. The complaint file shall be is required to be reported. The new code to the old code. made available for review and copying establishment shall report any adverse (d) Product information. As part of its upon request from an authorized reaction involving the transmission of a tracking method, an establishment shall employee of the Food and Drug communicable disease, product ensure that the identifier and type of Administration. contamination, or failure of the each human cellular or tissue-based (c) Review and evaluation of product’s function or integrity if the product that is implanted, transplanted, complaints. Each complaint shall be adverse reaction: infused, or transferred into a recipient is reviewed and evaluated to determine if (i) Is fatal; recorded in the recipient’s medical the complaint is related to a product (ii) Is life-threatening; records, or in other pertinent records, to deviation of a human cellular or tissue- (iii) Results in permanent impairment enable tracking from the recipient to the based product or to an adverse reaction, of a body function or permanent damage donor. and to determine if a report under to body structure; or (e) Recipient information. As part of § 1271.350 or another applicable (iv) Necessitates medical or surgical its tracking method, an establishment regulation is required. Each complaint intervention. Each report shall be shall document, and maintain records that represents an event required to be submitted on an FDA Form-3500A to of, the disposition of each of its human reported to FDA shall be promptly the address in paragraph (a)(4) of this cellular or tissue-based products, to reviewed, evaluated, and investigated. A section within 15 calendar days of enable tracking from the donor to the complaint that does not represent an initial receipt of the information. recipient or final disposition. The event required to be reported shall be (2) The establishment shall promptly information to be maintained shall reviewed and evaluated to determine investigate all adverse reactions that are permit the prompt identification of the whether investigation is necessary; subject of these 15-day reports and shall recipient of the product, if any. investigation may include referring a submit follow-up reports within 15 (f) Consignees. At or before the time copy of the complaint to another calendar days of the receipt of new of distribution of a human cellular or establishment that performed information or as requested by FDA. If tissue-based product to a consignee, an manufacturing steps pertinent to the additional information is not obtainable, establishment shall inform the complaint. When no investigation is a follow-up report may be required that consignee in writing of the requirements made, the establishment shall maintain describes briefly the steps taken to seek in this section and of the tracking a record that includes the reason no additional information and the reasons method that the establishment has investigation was made, and the name why it could not be obtained. established and is maintaining to of the individual responsible for the (3) Copies of the reporting form (FDA- comply with these requirements. Upon decision not to investigate. 3500A) may be obtained from the Center initial distribution of product to the for Biologics Evaluation and Research consignee, the establishment shall 4. Subpart E, consisting of (see address in paragraph (a)(4) of this document that the consignee agreed to §§ 1271.330 through 1271.370, is added section). Additional supplies of the form participate in its tracking method and to to part 1271 to read as follow: may be obtained from the Consolidated take all necessary steps to ensure Subpart EÐAdditional Requirements for Forms and Publications Distribution compliance with the requirements of Establishments Described in § 1271.10 Center, 3222 Hubbard Rd., Landover, this section. Sec. MD 20785. (g) Requirements specific to dura 1271.330 Applicability. (4) The establishment shall submit mater donors. Appropriate specimens 1271.350 Reporting. two copies of each report described in from each donor of dura mater shall be 1271.370 Labeling and claims. this paragraph to the Center for

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Biologics Evaluation and Research reconstruction, replacement, repair, or personnel of the establishment as the (HFM-210), Food and Drug supplementation of cells or tissue) is representative deems necessary. Administration, 1401 Rockville Pike, considered a claim for a use other than (d) FDA’s representative may review suite 200N, Rockville, MD 20852–1448. a homologous use, as defined in and copy any records required to be FDA may waive the requirement for the § 1271.3(d), and the product, including kept under this part and may take second copy in appropriate labeling, shall be regulated under photographs or make videotapes. circumstances. section 351 of the PHS Act and/or the (e) The public disclosure of records (b) Reports of product deviations. (1) Federal Food, Drug, and Cosmetic Act. containing the name or other positive Any establishment that becomes aware 5. Subpart F, consisting of identification of donors or recipients of of a product deviation in the §§ 1271.390 through 1271.440, is added human cellular or tissue-based products manufacture of a distributed human to part 1271 to read as follows: will be handled in accordance with cellular or tissue-based product shall Subpart FÐInspection and Enforcement of FDA’s procedures on disclosure of immediately determine whether the Establishments Described in § 1271.10 information as set forth in part 20 of this product deviation is of the type that chapter. could reasonably be expected to lead to Sec. 1271.390 Applicability. a reportable adverse reaction and, if it § 1271.420 Human cellular and tissue- 1271.400 Inspections. based products offered for import. is, shall report the product deviation to 1271.420 Human cellular and tissue-based (a) When a human cellular or tissue- the address in paragraph (b)(3) of this products offered for import. section as soon as possible. 1271.440 Orders of retention, recall, based product is offered for entry, the (2) Each report shall contain a destruction, and cessation of importer of record shall notify the description of the product deviation and manufacturing. director of the district of the Food and information on all corrective actions Drug Administration (FDA) having that have been or will be taken in Subpart FÐInspection and jurisdiction over the port of entry response to the product deviation (e.g., Enforcement of Establishments through which the product is imported recalls). Described in § 1271.10 or offered for import, or such officer of the district as the director may designate (3) Each report of a product deviation § 1271.390 Applicability. shall be reported to the Director, Office to act in his or her behalf in The provisions set forth in this of Compliance and Biologics Quality, administering and enforcing this part. subpart are applicable only to human Center for Biologics Evaluation and (b) A human cellular or tissue-based cellular and tissue-based products Research (HFM-600), 1401 Rockville product offered for import shall be held described in § 1271.10 and regulated Pike, suite 200N, Rockville, MD 20852– intact, under conditions necessary to solely under section 361 of the Public 1448. maintain product function and integrity (c) Records. Reports and Health Service Act (the PHS Act) and and prevent transmission of investigations required under this the regulations in this part, and to the communicable disease, until it is section shall be documented and establishments that manufacture those released by FDA. records shall be maintained. products. Human cellular and tissue- based products described in § 1271.15 § 1271.440 Orders of retention, recall, § 1271.370 Labeling and claims. and regulated as drugs, devices, and/or destruction, and cessation of manufacturing. (a) Label information and biological products under the act and/or accompanying materials. (1) Each section 351 of the PHS Act, and the (a) Upon an agency finding that a human cellular or tissue-based product establishments that manufacture those human cellular or tissue-based product made available for distribution shall be products, are not subject to the or an establishment is in violation of the labeled clearly and accurately. regulations set forth in this subpart. regulations in this part, an authorized Food and Drug Administration (FDA) (2) The following information shall § 1271.400 Inspections. appear on the product label: representative may take one or more of (i) Name and address of the (a) An establishment subject to this the following actions: establishment that determines that the part as described in § 1271.10, including (1) Serve upon the person who product meets release criteria and any location performing contract distributed the human cellular or tissue- makes the product available for services, shall permit an authorized based product a written order that the distribution; representative of the Food and Drug product be recalled and/or destroyed, as (ii) Description of the type of product; Administration (FDA) to make at any appropriate, and upon persons in and reasonable time and in a reasonable possession of the product that the (iii) Expiration date, if any. manner such inspection of the product shall be retained until it is (3) The following information shall establishment, including but not limited recalled by the distributor, destroyed, or appear either on the product label or to its facilities, equipment, processes, disposed of as agreed by FDA, or the package insert: products, procedures, labeling, and safety of the product is confirmed; (i) Storage temperature; records, as may be necessary in the (2) Take possession of and/or destroy (ii) Warnings, where appropriate; and judgment of such representative to the violative human cellular or tissue- (iii) Instructions for use. determine compliance with the based product; or (b) Claims. (1) All labeling, provisions of this part. Such inspection (3) Serve upon the establishment an advertising, and promotional materials may be made with or without notice and order to cease manufacturing until for a human cellular or tissue-based will ordinarily be made during regular compliance with the regulations of this product shall be clear, truthful, and business hours. part has been achieved. balanced in all respects, and may not be (b) The frequency of inspection will (b) A written order issued under false or misleading in any particular. be at the agency’s discretion. paragraph (a) of this section will state (2) A labeling claim or promotional (c) FDA’s representative will call with particularity the facts that justify materials regarding the therapeutic or upon the most responsible person the order. clinical outcome of a human cellular or available at the time of the inspection of (c)(1) A written order issued under tissue-based product (other than the establishment and may question the paragraph (a)(1) of this section will

VerDate 112000 18:20 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 E:\FR\FM\08JAP3.SGM pfrm10 PsN: 08JAP3 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1559 ordinarily provide that the human with records or other written (e) Within 5 working days of receipt cellular or tissue-based product be information that adequately assure that of a written order for retention, recall, recalled and/or destroyed within 5 the human cellular or tissue-based destruction, and/or cessation (or within working days from the date of receipt of product has been recovered, processed, 5 working days of the agency’s the order. After receipt of an order stored, and distributed in conformance possession of a human cellular or tissue- issued under paragraph (a)(1) of this with this part, and that, except as based product under paragraph (a)(2) of section, the establishment in possession provided under §§ 1271.65 and 1271.90, this section), the recipient of the written of the human cellular or tissue-based the donor of the cells or tissue for the order or prior possessor of such product product shall not distribute or dispose product has been determined to be may request a hearing on the matter in of the product in any manner except to suitable. accordance with part 16 of this chapter. recall and/or destroy the product An order of destruction will be held in consistent with the provisions of the (d) A written order issued under abeyance pending resolution of the order, under the supervision of an paragraph (a)(3) of this section will hearing request. authorized FDA representative. specify the regulations with which (2) In lieu of paragraph (c)(1) of this compliance shall be achieved and will Dated: August 29, 2000. section, other arrangements for assuring ordinarily specify the particular Jane E. Henney, the proper disposition of the human operations covered by the order. After Commissioner of Food and Drugs. cellular or tissue-based product may be receipt of an order issued under agreed upon by the person receiving the paragraph (a)(3) of this section, an Donna E. Shalala, written order and an authorized official establishment shall not resume Secretary of Health and Human Services. of FDA. Such arrangements may operations without prior authorization [FR Doc. 01–447 Filed 1–5–01; 8:45 am] include, among others, providing FDA of an authorized official of FDA. BILLING CODE 4160±01±F

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Reader Aids Federal Register Vol. 66, No. 5 Monday, January 8, 2001

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING JANUARY

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202±523±5227 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since the revision date of each title. Laws 523±5227 267, 1031, 1253, 1255 3 CFR 71...... 1033 Presidential Documents Executive Orders: 91...... 1002 Executive orders and proclamations 523±5227 13184...... 697 93...... 1002 The United States Government Manual 523±5227 13185...... 701 121...... 1002 EO 12543 (continued 135...... 1002 by Notice of January Other Services Proposed Rules: 4, 2001)...... 1251 39...57, 59, 61, 64, 1054, 1057, Electronic and on-line services (voice) 523±4534 EO 12544 (continued 1271, 1273 Privacy Act Compilation 523±3187 by Notice of January Public Laws Update Service (numbers, dates, etc.) 523±6641 4, 2001)...... 1251 17 CFR TTY for the deaf-and-hard-of-hearing 523±5229 Proclamations: 1...... 1375 7389...... 703 20 CFR ELECTRONIC RESEARCH Administrative Orders Presidential Determinations: 655...... 1375 World Wide Web No. 2001±05 of Proposed Rules: December 15, 369...... 314 Full text of the daily Federal Register, CFR and other 404...... 1059 publications: 2000 ...... 223 No. 2001±06 of 416...... 1059 http://www.access.gpo.gov/nara December 15, 21 CFR Federal Register information and research tools, including Public 2000 ...... 225 Inspection List, indexes, and links to GPO Access: No. 2001±07 ...... 1013 14...... 1257 522...... 711 Notices: http://www.nara.gov/fedreg 524...... 712 January 4, 2001...... 1251 E-mail Proposed Rules: 5 CFR 14...... 1276 PENS (Public Law Electronic Notification Service) is an E-mail 1271...... 1508 service for notification of recently enacted Public Laws. To 792...... 705 subscribe, send E-mail to 22 CFR 7 CFR [email protected] 41...... 1033 54...... 1190 with the text message: 302...... 1015 Proposed Rules: 41...... 1064 subscribe PUBLAWS-L your name 905...... 227 930...... 229, 232 23 CFR Use [email protected] only to subscribe or unsubscribe to 944...... 227 655...... 1446 PENS. We cannot respond to specific inquiries. 989...... 705 Reference questions. Send questions and comments about the 940...... 1446 Federal Register system to: 8 CFR 24 CFR [email protected] 212...... 235, 1017 888...... 162 The Federal Register staff cannot interpret specific documents or Proposed Rules: Proposed Rules: 212...... 1053 regulations. 941...... 1008 9 CFR 26 CFR FEDERAL REGISTER PAGES AND DATE, JANUARY 2...... 236 1 ...... 268, 279, 280, 713, 715, 3...... 239 1±226...... 2 723, 1034, 1038, 1040 20...... 1040 227±704...... 3 10 CFR 25...... 1040 705±1012...... 4 5...... 708 54...... 1378 1013±1252...... 5 301...... 725 1253±1560...... 8 12 CFR 602...... 280 225...... 257, 400 Proposed Rules: 303...... 1018 1.....66, 76, 315, 319, 747, 748, 337...... 1018 1066 362...... 1018 54 ...... 1421, 1435, 1437 1501...... 257 301...... 77, 749 1780...... 709 Proposed Rules: 28 CFR 225...... 307 Ch. VIII...... 1259 1501...... 307 29 CFR 14 CFR 2590...... 1378 25...... 261 Proposed Rules: 39...... 1, 2, 5, 7, 263, 264, 265, 2590...... 1421

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30 CFR 40 CFR 42 CFR 5...... 1283 Proposed Rules: 52 ...... 8, 586, 634, 666, 730, 411...... 856 90...... 86 256...... 1277 1046 424...... 856 948...... 335 63...... 1263 49 CFR 45 CFR 32 CFR 70...... 16 1247...... 1051 81...... 1268 146...... 1378 Proposed Rules: Proposed Rules: Proposed Rules: 326...... 1280 82...... 1462 10...... 1294 180 ...... 296, 298, 1242 146...... 1421 229...... 136 33 CFR 271 ...... 22, 23, 28, 33, 733 46 CFR 567...... 90 66...... 8 745...... 1206 571...... 968 100...... 1044 1610...... 1050 Proposed Rules: 591...... 90 117...... 1045, 1262 110...... 1283 592...... 90 Proposed Rules: 111...... 1283 Proposed Rules: 70...... 84, 85 594...... 90 117...... 1281 271...... 85, 86 47 CFR 34 CFR 413...... 424 1...... 33 50 CFR 433...... 424 300...... 1474 73...... 737 20...... 737, 1052 606...... 1262 438...... 424 90...... 33 635...... 55 463...... 424 Proposed Rules: 679...... 742, 1375 36 CFR 464...... 424 1...... 86, 341 Proposed Rules: Proposed Rules: 467...... 424 2...... 341 17...... 345, 1295 7...... 1069 471...... 424 3...... 1283 648...... 91

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REMINDERS HEALTH AND HUMAN AGRICULTURE Atlantic coastal fisheriesÐ The items in this list were SERVICES DEPARTMENT DEPARTMENT American lobster; editorially compiled as an aid Food and Drug Animal and Plant Health comments due by 1-9- to Federal Register users. Administration Inspection Service 01; published 11-28-00 Inclusion or exclusion from Animal drugs, feeds, and Exportation and importation of Atlantic highly migratory this list has no legal related products: animals and animal speciesÐ significance. Animal Drug Availability Act; products: Atlantic bluefin tuna; veterinary feed directive Horses from contagious comments due by 1-16- implementation; published equine meritis (CEM)- 01; published 12-21-00 RULES GOING INTO 12-8-00 affected countriesÐ EFFECT JANUARY 8, Pelagic longline fishery; Oregon; receipt 2001 HOUSING AND URBAN sea turtle protection DEVELOPMENT authorization; comments measures; comments DEPARTMENT due by 1-17-01; due by 1-8-01; COMMERCE DEPARTMENT Housing programs: published 12-18-00 published 10-13-00 National Oceanic and Uniform physical condition Horses, ruminants, swine, Northeastern United States Atmospheric Administration standards and physical and dogs; inspection and fisheriesÐ Ocean and coastal resource inspection requirements; treatment for screwworm; Atlantic herring; comments management: insured and assisted comments due by 1-12- due by 1-10-01; Coastal Zone Management properties assessment; 01; published 11-13-00 published 12-11-00 Act Federal consistency administrative process; Spain; Spanish Pure Breed Ocean and coastal resource regulations; published 12- published 12-8-00 horses; comments due by management: 8-00 INTERIOR DEPARTMENT 1-16-01; published 11-16- 00 Marine sanctuariesÐ COURT SERVICES AND Minerals Management OFFENDER SUPERVISION User fees: Florida Keys National Service Marine Sanctuary, FL; AGENCY FOR THE Veterinary servicesÐ DISTRICT OF COLUMBIA Outer Continental Shelf; oil, boundary expansion; gas, and sulphur operations: Permit applications; comments due by 1-8- Organization and general Documents incorporated by comments due by 1-12- 01; published 11-22-00 functions; published 1-8-01 01; published 11-13-00 reference; update DEFENSE DEPARTMENT ENERGY DEPARTMENT AGRICULTURE API Specification 14A, Civilian health and medical Energy Efficiency and Tenth Edition DEPARTMENT Renewable Energy Office program of uniformed (subsurface safety valve Food and Nutrition Service services (CHAMPUS): Energy conservation: equipment); published Child nutrition programs: Enuretic devices, breast Weatherization assistance 12-8-00 National school lunch and program for low-income reconstruction surgery, NUCLEAR REGULATORY child and adult care food Persons with Disabilities persons; published 12-8- COMMISSION programs, State 00 Program valid Radiation protection standards: administrative expense authorization period, and ENVIRONMENTAL New dosimetry technology; funds, and free and early intervention services; PROTECTION AGENCY licensee use of personnel reduced price meals and comments due by 1-16- Air pollutants, hazardous; dosimeters requiring free milk in schools- 01; published 11-15-00 national emission standards: processing by accredited Afterschool care Federal Acquisition Regulation Off-site waste and recovery processors; published 10- programs; snacks (FAR): reimbursement; operations; technical 24-00 Preference for U.S.-flag corrections; published 1-8- comments due by 1-9- TRANSPORTATION vessels; comments due 01 01; published 10-11-00 DEPARTMENT by 1-8-01; published 11-7- Air programs: Coast Guard COMMERCE DEPARTMENT 00 Stratospheric ozone Drawbridge operations: National Institute of ENERGY DEPARTMENT protectionÐ Standards and Technology Louisiana; published 12-28- Acquisition regulations: Essential use allowances; National Voluntary Laboratory 00 Management and operating allocation; published 1- Accreditation Program; contracts; patent 8-01 TRANSPORTATION operating procedures; regulations; revision; Air quality implementation DEPARTMENT comments due by 1-8-01; comments due by 1-16- plans; approval and Federal Aviation published 11-7-00 Administration 01; published 11-15-00 promulgation; various COMMERCE DEPARTMENT States: Airworthiness directives: ENERGY DEPARTMENT National Oceanic and California; published 12-7-00 Airbus; published 12-4-00 Atmospheric Administration Energy Efficiency and Superfund program: Renewable Energy Office Boeing; published 12-4-00 Fishery conservation and National oil and hazardous Dornier; published 12-4-00 management: Consumer products; energy substances contingency conservation program: McDonnell Douglas; Alaska; fisheries of planÐ published 12-4-00 Exclusive Economic Electric distribution National priorities list ZoneÐ transformers; efficiency update; published 11-9- standards; comments due Alaska Commercial 00 COMMENTS DUE NEXT by 1-16-01; published 12- WEEK Operator's Annual 1-00 FEDERAL Report; reporting and COMMUNICATIONS recordkeeping ENVIRONMENTAL COMMISSION AGRICULTURE requirements; comments PROTECTION AGENCY Radio and television DEPARTMENT due by 1-16-01; Acquisition regulations: broadcasting: Agricultural Marketing published 12-14-00 Contract quality Broadcast and cable EEO Service Pacific halibut and requirements removed, rules and policies Raisins grown inÐ sablefish; comments and technical amendment; Clarification; published 12- California; comments due by due by 1-16-01; comments due by 1-19- 8-00 1-19-01; published 1-4-01 published 12-14-00 01; published 12-20-00

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Air pollutants, hazardous; National oil and hazardous Wisconsin; comments due Grants management national emission standards: substances contingency by 1-8-01; published 11- regulations; amendments; Municipal solid waste planÐ 30-00 comments due by 1-16- landfills; comments due National priorities list FEDERAL DEPOSIT 01; published 11-15-00 by 1-8-01; published 11-7- update; comments due INSURANCE CORPORATION HOUSING AND URBAN 00 by 1-8-01; published Risk-based capital: DEVELOPMENT Air pollution control: 12-8-00 Market risk measure; DEPARTMENT Operating permits programs; FEDERAL securities borrowing Fair housing: interim approval expiration COMMUNICATIONS transactions; comments Fair Housing Act violations; dates; revision; comments COMMISSION due by 1-19-01; published sexual harassment cases; due by 1-19-01; published Common carrier services: 12-5-00 comments due by 1-12- 12-20-00 Access chargesÐ FEDERAL HOUSING 01; published 11-13-00 Air programs: Competitive local FINANCE BOARD INTERIOR DEPARTMENT Outer Continental Shelf exchange carriers; tariff Practice and procedure: Fish and Wildlife Service regulationsÐ charge reform; Administrative enforcement Endangered and threatened comments due by 1-11- actions; hearings on species California; consistency 01; published 12-27-00 update; comments due record; comments due by Critical habitat Federal-State Joint Board by 1-10-01; published 1-17-01; published 12-18- designationsÐ on Universal ServiceÐ 00 12-11-00 Various plants from Kauai Non-rural carriers; Air quality implementation FEDERAL RESERVE and Niihau, HI; telephone exchange SYSTEM comments due by 1-8- plans; approval and transfers; interim hold- promulgation; various Risk-based capital: 01; published 11-7-00 harmless support Market risk measure; States: phase-down; comments Various plants from Kauai Alabama; comments due by securities borrowing and Niihau, HI; due by 1-17-01; transactions; comments 1-8-01; published 12-8-00 published 12-18-00 correction; comments due by 1-19-01; published due by 1-8-01; Arizona; comments due by Mandatory FCC Registration 12-5-00 published 11-13-00 1-17-01; published 12-18- Number; adoption; GENERAL SERVICES 00 comments due by 1-16- Endangered and threatened ADMINISTRATION species: California; comments due by 01; published 12-15-00 Federal Acquisition Regulation 1-16-01; published 12-15- Satellite communicationsÐ Scotts Valley polygonum; (FAR): comments due by 1-8-01; 00 Fixed-Satellite Service Preference for U.S.-flag published 11-9-00 Colorado; comments due by (FSS) earth stations vessels; comments due Migratory bird permits: 1-19-01; published 12-20- and terrestrial fixed by 1-8-01; published 11-7- 00 service stations; efficient Falconry education permits; 00 review; comments due by Georgia; comments due by use and sharing of HEALTH AND HUMAN 1-19-01; published 11-20- 1-17-01; published 12-18- radio spectrum; SERVICES DEPARTMENT 00 00 comments due by 1-8- 01; published 11-24-00 Food and Drug INTERIOR DEPARTMENT Pennsylvania; comments Administration Telecommunications service Minerals Management due by 1-16-01; published Food for human consumption: 12-15-00 quality reporting Service requirements; biennial Food labelingÐ Rhode Island; comments Royalty management: regulatory review; Trans fatty acids in Rate relief or reduction; due by 1-17-01; published comments due by 1-12- nutrition labeling, 12-18-00 deep water royalty relief 01; published 12-4-00 nutrient content claims, for post-2000 OCS oil and Texas; comments due by 1- Digital television stations; table and health claims; 19-01; published 12-20-00 gas leases; comments of assignments: comments due by 1-19- due by 1-9-01; published Hazardous waste program Florida; comments due by 01; published 12-5-00 12-15-00 authorizations: Medical devices: 1-16-01; published 12-1- INTERIOR DEPARTMENT Alabama; comments due by 00 Menstrual tampons labeling; National Park Service 1-19-01; published 12-20- Nevada; comments due by change from junior to light 00 1-16-01; published 11-29- absorbency; comments Special regulations: Hazardous waste: 00 due by 1-16-01; published Yellowstone National Park, 10-18-00 John D. Rockefeller, Jr., Identification and listingÐ South Dakota; comments due by 1-16-01; published HEALTH AND HUMAN Parkway, and Grand Exclusions; comments due 11-29-00 SERVICES DEPARTMENT Teton National Park; by 1-18-01; published snowmobile and Virginia; comments due by Health Care Financing 12-4-00 snowplane use; limitations 1-19-01; published 11-30- Administration Exclusions; comments due and prohibitions; 00 Medicare and Medicaid: by 1-19-01; published comments due by 1-17- 12-5-00 Wisconsin; comments due Hospital conditions of 01; published 12-18-00 by 1-16-01; published 11- participation; laboratory Exclusions; correction; 30-00 services; comments due JUSTICE DEPARTMENT comments due by 1-19- Radio stations; table of by 1-16-01; published 11- Prisons Bureau 01; published 12-11-00 assignments: 16-00 Inmate control, custody, care, Superfund program: Arizona; comments due by Medicare: etc.: National oil and hazardous 1-8-01; published 11-29- Hospital outpatient services; Suicide prevention program; substances contingency 00 prospective payment comments due by 1-12- planÐ Colorado; comments due by system; comments due by 01; published 11-13-00 National priorities list 1-8-01; published 12-18- 1-12-01; published 11-13- LEGAL SERVICES update; comments due 00 00 CORPORATION by 1-8-01; published Oregon; comments due by HEALTH AND HUMAN Regulations review; comment 12-8-00 1-8-01; published 11-29- SERVICES DEPARTMENT request; comments due by Superrfund program: 00 Grants: 1-8-01; published 11-24-00

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NATIONAL AERONAUTICS 8(a) business development/ flammability standards; Market risk measure; AND SPACE small disadvantaged comments due by 1-18- securities borrowing ADMINISTRATION business status 01; published 9-20-00 transactions; comments Federal Acquisition Regulation determinations; comments Airworthiness standards: due by 1-19-01; published (FAR): due by 1-8-01; published Special conditionsÐ 12-5-00 11-8-00 Preference for U.S.-flag Eurocopter France Model TREASURY DEPARTMENT vessels; comments due TRANSPORTATION EC-155 helicopters; Fiscal Service by 1-8-01; published 11-7- DEPARTMENT comments due by 1-12- 00 Coast Guard 01; published 11-28-00 Financial management services: INTERIOR DEPARTMENT Drawbridge operations: Class D airspace; comments Federal-State funds Massachussetts; comments due by 1-12-01; published National Indian Gaming transfers; rules and due by 1-8-01; published 11-28-00 Commission procedures; comments Indian Gaming Regulatory Act: 11-8-00 Class D and Class E airspace; comments due by due by 1-10-01; published Environment and public TRANSPORTATION 1-12-01; published 11-28-00 10-12-00 health and safety; DEPARTMENT Class E airspace; comments TREASURY DEPARTMENT comments due by 1-19- Federal Aviation due by 1-15-01; published 01; published 12-5-00 Administration Internal Revenue Service 11-20-00 NUCLEAR REGULATORY Air traffic operating and flight Estate and gift taxes: TRANSPORTATION COMMISSION rules, etc.: Estate tax return (Form DEPARTMENT Spent nuclear fuel and high- Temporary flight restrictions; 706); automatic 6-month Maritime Administration level radioactive waste; comments due by 1-16- extension to file; independent storage; 01; published 11-16-00 Practice and procedure: comments due by 1-18- licensing requirements: Airworthiness directives: Audit appeals; policy and 01; published 10-20-00 procedure; comments due Approved spent fuel storage Bell; comments due by 1- Income taxes, etc.: by 1-16-01; published 11- casks; list; comments due 16-01; published 11-15-00 16-00 Information reporting by 1-8-01; published 12-7- Boeing; comments due by requirementsÐ 00 1-8-01; published 11-7-00 TRANSPORTATION DEPARTMENT Payments made on behalf PERSONNEL MANAGEMENT Empresa Brasileira de of another person, National Highway Traffic OFFICE Aeronautica S.A.; payments to joint Safety Administration Excepted service, and career comments due by 1-8-01; payees, and payments and career-conditional published 12-8-00 Motor vehicle safety of gross proceeds from standards: employment: Fairchild; comments due by sales involving Federal Career Intern 1-11-01; published 12-5- Fuel system integrity; investment advisers; Program; staffing 00 comments due by 1-12- comments due by 1-17- 01; published 11-13-00 provisions; comments due Groupe Aerospatiale; 01; published 10-17-00 by 1-16-01; published 12- comments due by 1-19- Occupant crash protectionÐ Income Taxes: 14-00 01; published 12-14-00 Anthropomorphic test Corporations; liability Prevailing rate systems; McDonnell Douglas; dummy; comments due assumptions in certain comments due by 1-18-01; comments due by 1-11- by 1-16-01; published corporate transactions; published 12-19-00 01; published 11-27-00 11-29-00 hearing; comments due POSTAL SERVICE Robinson Helicopter Co.; TREASURY DEPARTMENT by 1-10-01; published 1-4- International Mail Manual: comments due by 1-8-01; Alcohol, Tobacco and 01 Global Express Guaranteed published 11-7-00 Firearms Bureau Income taxes: services; postal rate Special conditionsÐ Firearms: Principal residence sale or changes; comments due Sikorsky Aircraft Corp. Commerce in explosivesÐ exchange; exclusion of by 1-6-01; published 12- Model S-92 helicopters; Imported explosive gain; comments due by 1- 11-00 comments due by 1-12- materials; identification 8-01; published 10-10-00 Correction; comments due 01; published 11-28-00 markings; comments Procedure and administration: by 1-6-01; published due by 1-12-01; Airworthiness standards, etc.: Pension and employee 12-28-00 published 11-13-00 Transport category benefit trusts, and other SMALL BUSINESS airplanesÐ TREASURY DEPARTMENT trusts; classification; ADMINISTRATION Thermal/acoustic Comptroller of the Currency comments due by 1-10- Small business size standards: insulation materials; Risk-based capital: 01; published 10-12-00

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H.R. 5528/P.L. 106±568 lands in the Lake Tahoe Establishment Act (Dec. 29, Omnibus Indian Advancement Basin to the Washoe County 2000; 114 Stat. 3088) LIST OF PUBLIC LAWS Act (Dec. 27, 2000; 114 Stat. School District for use as an 2868) elementary school site. (Dec. Last List December 29, 2000 This completes the listing of 28, 2000; 114 Stat. 3063) public laws enacted during the H.R. 5640/P.L. 106±569 second session of the 106th American Homeownership and S. 1761/P.L. 106±576 Economic Opportunity Act of Congress. It may be used in Lower Rio Grande Valley 2000 (Dec. 27, 2000; 114 Public Laws Electronic conjunction with ``PLUS'' Water Resources Conservation Notification Service (Public Laws Update Service) Stat. 2944) and Improvement Act of 2000 (PENS) on 202±523±6641. This list is S. 2943/P.L. 106±570 (Dec. 28, 2000; 114 Stat. also available online at http:// Assistance for International 3065) www.nara.gov/fedreg. Malaria Control Act (Dec. 27, S. 2749/P.L. 106±577 2000; 114 Stat. 3038) PENS is a free electronic mail The text of laws is not To establish the California published in the Federal H.R. 207/P.L. 106±571 notification service of newly Federal Physicians Trail Interpretive Center in enacted public laws. To Register but may be ordered Elko, Nevada, to facilitate the in ``slip law'' (individual Comparability Allowance subscribe, go to http:// Amendments of 2000 (Dec. interpretation of the history of hydra.gsa.gov/archives/ pamphlet) form from the development and use of trails Superintendent of Documents, 28, 2000; 114 Stat. 3054) publaws-l.html or send E-mail H.R. 2816/P.L. 106±572 in the settling of the western to [email protected] U.S. Government Printing portion of the United States, Office, Washington, DC 20402 Computer Crime Enforcement with the following text Act (Dec. 28, 2000; 114 Stat. and for other purposes. (Dec. message: (phone, 202±512±1808). The 28, 2000; 114 Stat. 3068) text will also be made 3058) S. 2924/P.L. 106±578 SUBSCRIBE PUBLAWS-L available on the Internet from H.R. 3594/P.L. 106±573 Your Name. GPO Access at http:// Installment Tax Correction Act Internet False Identification www.access.gpo.gov/nara/ of 2000 (Dec. 28, 2000; 114 Prevention Act of 2000 (Dec. Note: PENS will resume index.html. Some laws may Stat. 3061) 28, 2000; 114 Stat. 3075) service when bills are enacted not yet be available. H.R. 4020/P.L. 106±574 S. 3181/P.L. 106±579 into law during the next To authorize the addition of The list will resume when bills National Moment of session of Congress. This land to Sequoia National Park, are enacted into public law Remembrance Act (Dec. 28, service is strictly for E-mail and for other purposes. (Dec. during the next session of 2000; 114 Stat. 3078) notification of new laws. The Congress. A cumulative list of 28, 2000; 114 Stat. 3062) text of laws is not available Public Laws will be published H.R. 4656/P.L. 106±575 H.R. 1795/P.L. 106±580 through this service. PENS in the Federal Register on To authorize the Forest National Institute of Biomedical cannot respond to specific Tuesday, January 16, 2001. Service to convey certain Imaging and Bioengineering inquiries sent to this address.

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CFR CHECKLIST Title Stock Number Price Revision Date 14 Parts: 1–59 ...... (869–042–00037–4) ...... 58.00 Jan. 1, 2000 This checklist, prepared by the Office of the Federal Register, is 60–139 ...... (869–042–00038–2) ...... 46.00 Jan. 1, 2000 published weekly. It is arranged in the order of CFR titles, stock 140–199 ...... (869–038–00039–1) ...... 17.00 4Jan. 1, 2000 numbers, prices, and revision dates. 200–1199 ...... (869–042–00040–4) ...... 29.00 Jan. 1, 2000 An asterisk (*) precedes each entry that has been issued since last 1200–End ...... (869–042–00041–2) ...... 25.00 Jan. 1, 2000 week and which is now available for sale at the Government Printing 15 Parts: Office. 0–299 ...... (869–042–00042–1) ...... 28.00 Jan. 1, 2000 A checklist of current CFR volumes comprising a complete CFR set, 300–799 ...... (869–042–00043–9) ...... 45.00 Jan. 1, 2000 also appears in the latest issue of the LSA (List of CFR Sections 800–End ...... (869–042–00044–7) ...... 26.00 Jan. 1, 2000 Affected), which is revised monthly. 16 Parts: The CFR is available free on-line through the Government Printing 0–999 ...... (869–042–00045–5) ...... 33.00 Jan. 1, 2000 Office's GPO Access Service at http://www.access.gpo.gov/nara/cfr/ 1000–End ...... (869–042–00046–3) ...... 43.00 Jan. 1, 2000 index.html. For information about GPO Access call the GPO User Support Team at 1-888-293-6498 (toll free) or 202-512-1530. 17 Parts: 1–199 ...... (869–042–00048–0) ...... 32.00 Apr. 1, 2000 The annual rate for subscription to all revised paper volumes is 200–239 ...... (869–042–00049–8) ...... 38.00 Apr. 1, 2000 $951.00 domestic, $237.75 additional for foreign mailing. 240–End ...... (869–042–00050–1) ...... 49.00 Apr. 1, 2000 Mail orders to the Superintendent of Documents, Attn: New Orders, 18 Parts: P.O. Box 371954, Pittsburgh, PA 15250±7954. All orders must be 1–399 ...... (869–042–00051–0) ...... 54.00 Apr. 1, 2000 accompanied by remittance (check, money order, GPO Deposit 400–End ...... (869–042–00052–8) ...... 15.00 Apr. 1, 2000 Account, VISA, Master Card, or Discover). Charge orders may be telephoned to the GPO Order Desk, Monday through Friday, at (202) 19 Parts: 512±1800 from 8:00 a.m. to 4:00 p.m. eastern time, or FAX your 1–140 ...... (869–042–00053–6) ...... 40.00 Apr. 1, 2000 charge orders to (202) 512-2250. 141–199 ...... (869–042–00054–4) ...... 40.00 Apr. 1, 2000 200–End ...... (869–042–00055–2) ...... 20.00 Apr. 1, 2000 Title Stock Number Price Revision Date 20 Parts: 1, 2 (2 Reserved) ...... (869–038–00001–3) ...... 6.50 Apr. 1, 2000 1–399 ...... (869–042–00056–1) ...... 33.00 Apr. 1, 2000 3 (1997 Compilation 400–499 ...... (869–042–00057–9) ...... 56.00 Apr. 1, 2000 and Parts 100 and 500–End ...... (869–042–00058–7) ...... 58.00 Apr. 1, 2000 1 101) ...... (869–042–00002–1) ...... 22.00 Jan. 1, 2000 21 Parts: 4 ...... (869–042–00003–0) ...... 8.50 Jan. 1, 2000 1–99 ...... (869–042–00059–5) ...... 26.00 Apr. 1, 2000 100–169 ...... (869–042–00060–9) ...... 30.00 Apr. 1, 2000 5 Parts: 170–199 ...... (869–042–00061–7) ...... 29.00 Apr. 1, 2000 1–699 ...... (869–042–00004–8) ...... 43.00 Jan. 1, 2000 200–299 ...... (869–042–00062–5) ...... 13.00 Apr. 1, 2000 700–1199 ...... (869–042–00005–6) ...... 31.00 Jan. 1, 2000 300–499 ...... (869–042–00063–3) ...... 20.00 Apr. 1, 2000 1200–End, 6 (6 500–599 ...... (869–042–00064–1) ...... 31.00 Apr. 1, 2000 Reserved) ...... (869–042–00006–4) ...... 48.00 Jan. 1, 2000 600–799 ...... (869–038–00065–0) ...... 10.00 Apr. 1, 2000 7 Parts: 800–1299 ...... (869–042–00066–8) ...... 38.00 Apr. 1, 2000 1–26 ...... (869–042–00007–2) ...... 28.00 Jan. 1, 2000 1300–End ...... (869–042–00067–6) ...... 15.00 Apr. 1, 2000 27–52 ...... (869–042–00008–1) ...... 35.00 Jan. 1, 2000 22 Parts: 53–209 ...... (869–042–00009–9) ...... 22.00 Jan. 1, 2000 1–299 ...... (869–042–00068–4) ...... 54.00 Apr. 1, 2000 210–299 ...... (869–042–00010–2) ...... 54.00 Jan. 1, 2000 300–End ...... (869–042–00069–2) ...... 31.00 Apr. 1, 2000 300–399 ...... (869–042–00011–1) ...... 29.00 Jan. 1, 2000 400–699 ...... (869–042–00012–9) ...... 41.00 Jan. 1, 2000 23 ...... (869–042–00070–6) ...... 29.00 Apr. 1, 2000 700–899 ...... (869–042–00013–7) ...... 37.00 Jan. 1, 2000 24 Parts: 900–999 ...... (869–042–00014–5) ...... 46.00 Jan. 1, 2000 0–199 ...... (869–042–00071–4) ...... 40.00 Apr. 1, 2000 1000–1199 ...... (869–042–00015–3) ...... 18.00 Jan. 1, 2000 200–499 ...... (869–042–00072–2) ...... 37.00 Apr. 1, 2000 1200–1599 ...... (869–042–00016–1) ...... 44.00 Jan. 1, 2000 500–699 ...... (869–042–00073–1) ...... 20.00 Apr. 1, 2000 1600–1899 ...... (869–042–00017–0) ...... 61.00 Jan. 1, 2000 700–1699 ...... (869–042–00074–9) ...... 46.00 Apr. 1, 2000 1900–1939 ...... (869–042–00018–8) ...... 21.00 Jan. 1, 2000 1700–End ...... (869–042–00075–7) ...... 18.00 5Apr. 1, 2000 1940–1949 ...... (869–042–00019–6) ...... 37.00 Jan. 1, 2000 25 ...... (869–042–00076–5) ...... 52.00 Apr. 1, 2000 1950–1999 ...... (869–042–00020–0) ...... 38.00 Jan. 1, 2000 2000–End ...... (869–042–00021–8) ...... 31.00 Jan. 1, 2000 26 Parts: §§ 1.0-1–1.60 ...... (869–042–00077–3) ...... 31.00 Apr. 1, 2000 8 ...... (869–042–00022–6) ...... 41.00 Jan. 1, 2000 §§ 1.61–1.169 ...... (869–042–00078–1) ...... 56.00 Apr. 1, 2000 9 Parts: §§ 1.170–1.300 ...... (869–042–00079–0) ...... 38.00 Apr. 1, 2000 1–199 ...... (869–042–00023–4) ...... 46.00 Jan. 1, 2000 §§ 1.301–1.400 ...... (869–042–00080–3) ...... 29.00 Apr. 1, 2000 200–End ...... (869–042–00024–2) ...... 44.00 Jan. 1, 2000 §§ 1.401–1.440 ...... (869–042–00081–1) ...... 47.00 Apr. 1, 2000 §§ 1.441-1.500 ...... (869-042-00082-0) ...... 36.00 Apr. 1, 2000 10 Parts: §§ 1.501–1.640 ...... (869–042–00083–8) ...... 32.00 Apr. 1, 2000 1–50 ...... (869–042–00025–1) ...... 46.00 Jan. 1, 2000 §§ 1.641–1.850 ...... (869–042–00084–6) ...... 41.00 Apr. 1, 2000 51–199 ...... (869–042–00026–9) ...... 38.00 Jan. 1, 2000 §§ 1.851–1.907 ...... (869–042–00085–4) ...... 43.00 Apr. 1, 2000 200–499 ...... (869–042–00027–7) ...... 38.00 Jan. 1, 2000 §§ 1.908–1.1000 ...... (869–042–00086–2) ...... 41.00 Apr. 1, 2000 500–End ...... (869–042–00028–5) ...... 48.00 Jan. 1, 2000 §§ 1.1001–1.1400 ...... (869–042–00087–1) ...... 45.00 Apr. 1, 2000 11 ...... (869–042–00029–3) ...... 23.00 Jan. 1, 2000 §§ 1.1401–End ...... (869–042–00088–9) ...... 66.00 Apr. 1, 2000 2–29 ...... (869–042–00089–7) ...... 45.00 Apr. 1, 2000 12 Parts: 30–39 ...... (869–042–00090–1) ...... 31.00 Apr. 1, 2000 1–199 ...... (869–042–00030–7) ...... 18.00 Jan. 1, 2000 40–49 ...... (869–042–00091–9) ...... 18.00 Apr. 1, 2000 200–219 ...... (869–042–00031–5) ...... 22.00 Jan. 1, 2000 50–299 ...... (869–042–00092–7) ...... 23.00 Apr. 1, 2000 220–299 ...... (869–042–00032–3) ...... 45.00 Jan. 1, 2000 300–499 ...... (869–042–00093–5) ...... 43.00 Apr. 1, 2000 300–499 ...... (869–042–00033–1) ...... 29.00 Jan. 1, 2000 500–599 ...... (869–042–00094–3) ...... 12.00 Apr. 1, 2000 500–599 ...... (869–042–00034–0) ...... 26.00 Jan. 1, 2000 600–End ...... (869–042–00095–1) ...... 12.00 Apr. 1, 2000 600–End ...... (869–042–00035–8) ...... 53.00 Jan. 1, 2000 27 Parts: 13 ...... (869–042–00036–6) ...... 35.00 Jan. 1, 2000 1–199 ...... (869–042–00096–0) ...... 59.00 Apr. 1, 2000

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Title Stock Number Price Revision Date Title Stock Number Price Revision Date 200–End ...... (869–042–00097–8) ...... 18.00 Apr. 1, 2000 260–265 ...... (869–042–00151–6) ...... 36.00 July 1, 2000 ...... 28 Parts: ...... 266–299 (869–042–00152–4) 35.00 July 1, 2000 300–399 ...... (869–042–00153–2) ...... 29.00 July 1, 2000 0-42 ...... (869–042–00098–6) ...... 43.00 July 1, 2000 400–424 ...... (869–042–00154–1) ...... 37.00 July 1, 2000 43-end ...... (869-042-00099-4) ...... 36.00 July 1, 2000 425–699 ...... (869–042–00155–9) ...... 48.00 July 1, 2000 29 Parts: 700–789 ...... (869–042–00156–7) ...... 46.00 July 1, 2000 0–99 ...... (869–042–00100–1) ...... 33.00 July 1, 2000 790–End ...... (869–042–00157–5) ...... 23.00 6July 1, 2000 100–499 ...... (869–042–00101–0) ...... 14.00 July 1, 2000 41 Chapters: 500–899 ...... (869–042–00102–8) ...... 47.00 July 1, 2000 1, 1–1 to 1–10 ...... 13.00 3 July 1, 1984 900–1899 ...... (869–042–00103–6) ...... 24.00 July 1, 2000 1, 1–11 to Appendix, 2 (2 Reserved) ...... 13.00 3 July 1, 1984 1900–1910 (§§ 1900 to 3–6 ...... 14.00 3 July 1, 1984 6 1910.999) ...... (869–042–00104–4) ...... 46.00 July 1, 2000 7 ...... 6.00 3 July 1, 1984 1910 (§§ 1910.1000 to 8 ...... 4.50 3 July 1, 1984 6 end) ...... (869–042–00105–2) ...... 28.00 July 1, 2000 9 ...... 13.00 3 July 1, 1984 1911–1925 ...... (869–042–00106–1) ...... 20.00 July 1, 2000 10–17 ...... 9.50 3 July 1, 1984 6 1926 ...... (869–042–00107–9) ...... 30.00 July 1, 2000 18, Vol. I, Parts 1–5 ...... 13.00 3 July 1, 1984 1927–End ...... (869–042–00108–7) ...... 49.00 July 1, 2000 18, Vol. II, Parts 6–19 ...... 13.00 3 July 1, 1984 30 Parts: 18, Vol. III, Parts 20–52 ...... 13.00 3 July 1, 1984 1–199 ...... (869–042–00109–5) ...... 38.00 July 1, 2000 19–100 ...... 13.00 3 July 1, 1984 200–699 ...... (869–042–00110–9) ...... 33.00 July 1, 2000 1–100 ...... (869–042–00158–3) ...... 15.00 July 1, 2000 700–End ...... (869–042–00111–7) ...... 39.00 July 1, 2000 101 ...... (869–042–00159–1) ...... 37.00 July 1, 2000 102–200 ...... (869–042–00160–5) ...... 21.00 July 1, 2000 31 Parts: 201–End ...... (869–042–00161–3) ...... 16.00 July 1, 2000 0–199 ...... (869–042–00112–5) ...... 23.00 July 1, 2000 200–End ...... (869–042–00113–3) ...... 53.00 July 1, 2000 42 Parts: 1–399 ...... (869–038–00162–4) ...... 36.00 Oct. 1, 1999 32 Parts: 400–429 ...... (869–038–00163–2) ...... 44.00 Oct. 1, 1999 1–39, Vol. I ...... 15.00 2 July 1, 1984 430–End ...... (869–038–00164–1) ...... 54.00 Oct. 1, 1999 1–39, Vol. II ...... 19.00 2 July 1, 1984 1–39, Vol. III ...... 18.00 2 July 1, 1984 43 Parts: 1–190 ...... (869–042–00114–1) ...... 51.00 July 1, 2000 1–999 ...... (869–042–00165–6) ...... 45.00 Oct. 1, 2000 191–399 ...... (869–042–00115–0) ...... 62.00 July 1, 2000 1000–end ...... (869–038–00166–7) ...... 47.00 Oct. 1, 1999 400–629 ...... (869–042–00116–8) ...... 35.00 July 1, 2000 44 ...... (869–038–00167–5) ...... 28.00 Oct. 1, 1999 630–699 ...... (869–042–00117–6) ...... 25.00 July 1, 2000 700–799 ...... (869–042–00118–4) ...... 31.00 July 1, 2000 45 Parts: 800–End ...... (869–042–00119–2) ...... 32.00 July 1, 2000 1–199 ...... (869–042–00168–1) ...... 50.00 Oct. 1, 2000 200–499 ...... (869–038–00169–1) ...... 16.00 Oct. 1, 1999 33 Parts: 500–1199 ...... (869–042–00170–2) ...... 45.00 Oct. 1, 2000 1–124 ...... (869–042–00120–6) ...... 35.00 July 1, 2000 1200–End ...... (869–038–00171–3) ...... 40.00 Oct. 1, 1999 125–199 ...... (869–042–00121–4) ...... 45.00 July 1, 2000 200–End ...... (869–042–00122–5) ...... 36.00 July 1, 2000 46 Parts: 1–40 ...... (869–038–00172–1) ...... 27.00 Oct. 1, 1999 34 Parts: 41–69 ...... (869–038–00173–0) ...... 23.00 Oct. 1, 1999 1–299 ...... (869–042–00123–1) ...... 31.00 July 1, 2000 70–89 ...... (869–038–00174–8) ...... 8.00 Oct. 1, 1999 300–399 ...... (869–042–00124–9) ...... 28.00 July 1, 2000 90–139 ...... (869–042–00175–3) ...... 41.00 Oct. 1, 2000 400–End ...... (869–042–00125–7) ...... 54.00 July 1, 2000 140–155 ...... (869–038–00176–4) ...... 15.00 Oct. 1, 1999 35 ...... (869–042–00126–5) ...... 10.00 July 1, 2000 156–165 ...... (869–038–00177–2) ...... 21.00 Oct. 1, 1999 166–199 ...... (869–038–00178–1) ...... 27.00 Oct. 1, 1999 36 Parts 200–499 ...... (869–038–00179–9) ...... 23.00 Oct. 1, 1999 1–199 ...... (869–042–00127–3) ...... 24.00 July 1, 2000 500–End ...... (869–042–00180–0) ...... 23.00 Oct. 1, 2000 200–299 ...... (869–042–00128–1) ...... 24.00 July 1, 2000 300–End ...... (869–042–00129–0) ...... 43.00 July 1, 2000 47 Parts: 0–19 ...... (869–038–00181–1) ...... 39.00 Oct. 1, 1999 37 (869–042–00130–3) ...... 32.00 July 1, 2000 20–39 ...... (869–042–00182–6) ...... 41.00 Oct. 1, 2000 38 Parts: 40–69 ...... (869–038–00183–7) ...... 26.00 Oct. 1, 1999 0–17 ...... (869–042–00131–1) ...... 40.00 July 1, 2000 70–79 ...... (869–038–00184–5) ...... 39.00 Oct. 1, 1999 18–End ...... (869–042–00132–0) ...... 47.00 July 1, 2000 80–End ...... (869–042–00185–1) ...... 54.00 Oct. 1, 2000 39 ...... (869–042–00133–8) ...... 28.00 July 1, 2000 48 Chapters: 1 (Parts 1–51) ...... (869–038–00186–1) ...... 55.00 Oct. 1, 1999 40 Parts: 1 (Parts 52–99) ...... (869–038–00187–0) ...... 30.00 Oct. 1, 1999 1–49 ...... (869–042–00134–6) ...... 37.00 July 1, 2000 2 (Parts 201–299) ...... (869–038–00188–8) ...... 36.00 Oct. 1, 1999 50–51 ...... (869–042–00135–4) ...... 28.00 July 1, 2000 3–6 ...... (869–038–00189–3) ...... 40.00 Oct. 1, 2000 52 (52.01–52.1018) ...... (869–042–00136–2) ...... 36.00 July 1, 2000 7–14 ...... (869–038–00190–0) ...... 35.00 Oct. 1, 1999 52 (52.1019–End) ...... (869–042–00137–1) ...... 44.00 July 1, 2000 15–28 ...... (869–038–00191–8) ...... 36.00 Oct. 1, 1999 53–59 ...... (869–042–00138–9) ...... 21.00 July 1, 2000 29–End ...... (869–038–00192–6) ...... 25.00 Oct. 1, 1999 60 ...... (869–042–00139–7) ...... 66.00 July 1, 2000 61–62 ...... (869–042–00140–1) ...... 23.00 July 1, 2000 49 Parts: 63 (63.1–63.1119) ...... (869–042–00141–9) ...... 66.00 July 1, 2000 1–99 ...... (869–038–00193–4) ...... 34.00 Oct. 1, 1999 63 (63.1200–End) ...... (869–042–00142–7) ...... 49.00 July 1, 2000 100–185 ...... (869–038–00194–2) ...... 53.00 Oct. 1, 1999 64–71 ...... (869–042–00143–5) ...... 12.00 July 1, 2000 186–199 ...... (869–038–00195–1) ...... 13.00 Oct. 1, 1999 72–80 ...... (869–042–00144–3) ...... 47.00 July 1, 2000 200–399 ...... (869–038–00196–9) ...... 53.00 Oct. 1, 1999 81–85 ...... (869–042–00145–1) ...... 36.00 July 1, 2000 400–999 ...... (869–038–00197–7) ...... 57.00 Oct. 1, 1999 86 ...... (869–042–00146–0) ...... 66.00 July 1, 2000 1000–1199 ...... (869–042–00198–2) ...... 25.00 Oct. 1, 2000 87-135 ...... (869–042–00146–8) ...... 66.00 July 1, 2000 1200–End ...... (869–042–00199–1) ...... 21.00 Oct. 1, 2000 136–149 ...... (869–042–00148–6) ...... 42.00 July 1, 2000 50 Parts: 150–189 ...... (869–042–00149–4) ...... 38.00 July 1, 2000 1–199 ...... (869–038–00200–1) ...... 43.00 Oct. 1, 1999 190–259 ...... (869–042–00150–8) ...... 25.00 July 1, 2000 200–599 ...... (869–042–00201–6) ...... 35.00 Oct. 1, 2000

VerDate 11-MAY-2000 19:26 Jan 05, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4721 Sfmt 4721 E:\FR\FM\08JACL.LOC pfrm10 PsN: 08JACL Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Reader Aids ix

Title Stock Number Price Revision Date 600–End ...... (869–038–00202–7) ...... 37.00 Oct. 1, 1999 CFR Index and Findings Aids ...... (869–042–00047–1) ...... 53.00 Jan. 1, 2000 Complete 1999 CFR set ...... 951.00 1999 Microfiche CFR Edition: Subscription (mailed as issued) ...... 290.00 1999 Individual copies ...... 1.00 1999 Complete set (one-time mailing) ...... 247.00 1997 Complete set (one-time mailing) ...... 264.00 1996 1 Because Title 3 is an annual compilation, this volume and all previous volumes should be retained as a permanent reference source. 2 The July 1, 1985 edition of 32 CFR Parts 1–189 contains a note only for Parts 1–39 inclusive. For the full text of the Defense Acquisition Regulations in Parts 1–39, consult the three CFR volumes issued as of July 1, 1984, containing those parts. 3 The July 1, 1985 edition of 41 CFR Chapters 1–100 contains a note only for Chapters 1 to 49 inclusive. For the full text of procurement regulations in Chapters 1 to 49, consult the eleven CFR volumes issued as of July 1, 1984 containing those chapters. 4 No amendments to this volume were promulgated during the period January 1, 1999, through January 1, 2000. The CFR volume issued as of January 1, 1999 should be retained. 5 No amendments to this volume were promulgated during the period April 1, 1999, through April 1, 2000. The CFR volume issued as of April 1, 1999 should be retained. 6 No amendments to this volume were promulgated during the period July 1, 1999, through July 1, 2000. The CFR volume issued as of July 1, 1999 should be retained..

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