Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules 32159

No. 11–2A which describes the Authority: 49 U.S.C. 106(g), 40103, 40113, yeast derived form of the application procedure. 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– , used for the treatment of 1963 Comp., p. 389. congenital sucrase-isomaltase The Proposal § 71.1 [Amended] deficiency. The Commission proposes The FAA proposes to amend 14 CFR 2. The incorporation by reference in this exemption because human part 71 by revising the Class E airspace 14 CFR 71.1 of Federal Aviation experience has shown no evidence of at Unalakleet, AK, due the Administration Order 7400.9E, Airspace serious toxicity. establishment of a GPS instrument Designations and Reporting Points, DATES: Comments on the proposal approach to RWY 14. The intended dated September 10, 1997, and effective should be submitted no later than effect of this proposal is to provide September 16, 1997, is to be amended August 26, 1998. adequate controlled airspace for as follows: ADDRESSES: Comments should be Instrument Flight Rules (IFR) operations mailed to the Office of the Secretary, at Unalakleet, AK. Paragraph 6005 Class E airspace extending upward from 700 feet or more above the Consumer Product Safety Commission, The area would be depicted on Washington, D.C. 20207, or delivered to aeronautical charts for pilot reference. surface of the earth. * * * * * the Office of the Secretary, Consumer The coordinates for this airspace docket Product Safety Commission, Room 502, are based on North American Datum 83. AAL AK E5 Unalakleet, AK 4330 East-West Highway, Bethesda, The Class E airspace areas designated as Unalakleet Airport, AK Maryland 20814–4408, telephone (301) an 700/1200 foot transition area are (Lat. 63°53′18′′N., long. 160°47′56′′W.) 504–0800. Comments may also be filed published in paragraph 6005 in FAA Unalakleet VORTAC by telefacsimile to (301) 504–0127 or by ° ′ ′′ ° ′ ′′ Order 7400.9E, Airspace Designations (Lat. 63 53 31 N., long. 160 41 04 W.) email to [email protected]. and Reporting Points, dated September Unalakleet Localizer 10, 1997, and effective September 16, (Lat. 63°52′52′′N., long. 160°47′42′′W.) FOR FURTHER INFORMATION CONTACT: 1997, which is incorporated by That airspace extending upward from 700 Jacqueline Ferrante, Ph.D., Division of reference in 14 CFR 71.1 (62 FR 52491; feet above the surface within a 6.7-mile Health Sciences, Directorate for radius of the Unalakleet Airport and within Epidemiology and Health Sciences, October 8, 1997). The Class E airspace ° listed in this document would be 2 miles each side of the 289 radial of the Consumer Product Safety Commission, Unalakleet VORTAC extending from the 6.7- revised and published in the Order. Washington, D.C. 20207; telephone mile radius to 14.1 miles west of the (301) 504–0477 ext. 1199. The FAA has determined that these VORTAC and within 3 miles east and 3 miles SUPPLEMENTARY INFORMATION: proposed regulations only involve an west of the Unalakleet Localizer front course established body of technical extending from the 6.7-mile radius to 12.9 A. Background regulations for which frequent and miles north of the airport; and that airspace routine amendments are necessary to extending upward from 1,200 feet above the The Poison Prevention Packaging Act keep them operationally current. It, surface within a 22-mile radius of the of 1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476, Unalakleet VORTAC extending clockwise provides the Commission with authority therefore—(1) is not a ‘‘significant ° ° regulatory action’’ under Executive from the 165 radial to the 322 radial and to establish standards for the ‘‘special within 4 miles east and 8 miles west of the packaging’’ of household substances, Order 12866; (2) is not a ‘‘significant Unalakleet Localizer front course extending rule’’ under DOT Regulatory Policies such as drugs, when child resistant from the Localizer to 22 miles north of the packaging is necessary to protect and Procedures (44 FR 11034; February airport and within 4 miles north and 8 miles 26, 1979); and (3) does not warrant south of the Unalakleet VORTAC 289° radial children from serious personal injury or preparation of a regulatory evaluation as extending from the VORTAC to 27 miles west illness due to the substance and the the anticipated impact is so minimal. of the VORTAC. special packaging is technically feasible, Since this is a routine matter that will * * * * * practicable, and appropriate for such only affect air traffic procedures and air Issued in Anchorage, AK, on June 4, 1998. substance. Accordingly, the navigation, it is certified that this rule, Willis C. Nelson, Commission requires that oral prescription drugs be in child resistant when promulgated, will not have a Manager, Air Traffic Division, Alaskan significant economic impact on a Region. (‘‘CR’’) packaging. 16 CFR 1700.14(a)(10). substantial number of small entities [FR Doc. 98–15714 Filed 6–11–98; 8:45 am] The Commission’s regulations allow under the criteria of the Regulatory BILLING CODE 4910±13±U Flexibility Act. companies to petition the Commission for exemption from CR requirements. 16 List of Subjects in 14 CFR Part 71 CFR Part 1702. Possible grounds for CONSUMER PRODUCT SAFETY granting the exemption are that: Airspace, Incorporation by reference, COMMISSION Navigation (air). (a) The degree or nature of the hazard to 16 CFR Part 1700 children in the availability of the substance, The Proposed Amendment by reason of its packaging, is such that In consideration of the foregoing, the Poison Prevention Packaging special packaging is not required to protect Federal Aviation Administration Requirements; Proposed Exemption of children from serious personal injury or proposes to amend 14 CFR part 71 as Sucraid serious illness resulting from handling, using or ingesting the substance, or follows: AGENCY: Consumer Product Safety (b) Special packaging is not technically PART 71ÐDESIGNATION OF CLASS A, Commission. feasible, practicable, or appropriate for the subject substance, or CLASS B, CLASS C, CLASS D, AND ACTION: Proposed rule. (c) Special packaging is incompatible with CLASS E AIRSPACE AREAS; the particular substance.16 CFR 1702.17. AIRWAYS; ROUTES; AND REPORTING SUMMARY: The Commission is proposing POINTS to exempt from its child-resistant On July 10, 1997, Orphan Medical, packaging requirements the oral Inc. (‘‘Orphan Medical’’) petitioned the 1. The authority citation for 14 CFR prescription drug Sucraid. Sucraid is a Commission to exempt its product, part 71 continues to read as follows: new liquid formulation of sacrosidase, a Sucraid, from the special packaging 32160 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules requirements for oral prescription drugs. indicates that glycerol is only mildly illness resulting from handling, using, The petitioner stated that the exemption toxic by ingestion. In addition, the or ingesting the substance. Therefore, is justified because of lack of toxicity Handbook of Common Poisonings in the Commission voted to grant the and lack of adverse human experience Children characterizes glycerol as a petition and begin a rulemaking with the drug. The petitioner also stated laxative, stating that ‘‘acute exposure to proceeding to exempt Sucraid from the that CR packaging is not technically most laxatives produces nausea, special packaging requirements for oral feasible, practicable and appropriate for vomiting, and diarrhea, which are prescription drugs. Sucraid. Because, as explained below, usually mild and self-limiting.’’ the Commission concludes that Sucraid The CPSC staff found three cases in E. Regulatory Flexibility Act lacks sufficient toxicity to justify special the National Electronic Injury Certification packaging, the Commission did not Surveillance System (‘‘NEISS’’) of Under the Regulatory Flexibility Act, consider the technical feasibility, children under five years old ingesting 5 U.S.C. 601 et seq., an agency that practicability, and appropriateness of products containing glycerol. The engages in rulemaking generally must special packaging for Sucraid. products involved were a glycerol prepare proposed and final regulatory Sucraid is a liquid formulation of suppository, a baby enema preparation, flexibility analyses describing the sacrosidase, a yeast derived form of the and an ear solution. In all three cases impact of the rule on small businesses sucrase enzyme. It is used to treat the child was treated and released or and other small entities. Section 605 of patients with congenital sucrase- examined and released without the Act provides that an agency is not isomaltase deficiency (‘‘CSID’’). The treatment. required to prepare a regulatory petitioner estimates that there are Thus, based on the information flexibility analysis if the head of an approximately 3000 to 10,000 cases of discussed above, the glycerol agency certifies that the rule will not CSID in the United States. CSID is a component of Sucraid is not likely to have a significant economic impact on condition characterized by absent or cause significant toxicity to children. a substantial number of small entities. low levels of sucrase and isomaltase, C. Human Experience Data The Commission’s Directorate for two in the small intestine. Economic Analysis prepared a According to the petitioner, there Sucrase breaks down (table preliminary assessment of the impact of have been three clinical trials of sugar) so that it can be absorbed. a rule to exempt Sucraid from special Sucraid, two of which are complete. The Persons with CSID have such symptoms packaging requirements. The staff clinical investigators conducting the as diarrhea, abdominal pain, bloating, reports that because of the small number trials did not rate any of the adverse and gas. Patients with severe CSID may of cases of CSID (3,000 to 10,000 in the effects encountered as probably or require hospitalization for diarrhea, U.S.), the market for Sucraid is expected definitely related to the drug. Some dehydration, malnutrition, weakness to be small. The petitioner, Orphan effects were considered to be possibly and muscle wasting. Sacrosidase is an Medical, is a small manufacturer based enzyme replacement therapy that related to the drug. on its employment and sales. Orphan reduces the symptoms of CSID. The investigators considered most of the adverse effects to be unrelated to Medical has marketing exclusivity for B. Toxicity Data Sucraid and due to illnesses common to Sucraid for seven years. The exemption Sacrosidase is derived from bakers children (e.g., flu, ear infection and from special packaging requirements yeast. It is Generally Recognized as Safe strep throat). Unrelated effects included will allow the company to avoid costs (‘‘GRAS’’) for use in food by the Food sore throat, fever, cough, runny nose, associated with obtaining CR packaging. and Drug Administration (‘‘FDA’’). 21 diarrhea, cramping and abdominal pain. Based on this assessment, the CFR 170.30. Sucraid contains about 1.5 The clinical investigator did rate some Commission preliminarily concludes milligrams per milliliter of the enzyme adverse events in the second trial as that the proposed amendment in a 50:50 solution of glycerol and possibly related to Sucraid. These exempting Sucraid from special water. symptoms included abdominal pain, packaging requirements would not have One bottle of Sucraid contains 150 mg diarrhea, nausea, vomiting, a significant impact on a substantial of protein, 59 ml of water and 59 ml of constipation, dehydration, cramps, number of small businesses or other glycerol. Similar to dietary proteins, the headache, insomnia, nervousness, and small entities. protein component of Sucraid is wheezing. The petitioner noted that F. Environmental Considerations digested to amino acids which are used many of these were gastrointestinal to make new protein and are not symptoms typical of CSID. Thus, the Pursuant to the National expected to cause toxicity. Glycerol is a dose of Sucraid given may not have Environmental Policy Act, and in sweet liquid used as a solvent, been adequate to alleviate all symptoms accordance with the Council on preservative, and moisturizer. FDA of the disease. An asthmatic child had Environmental Quality regulations and recognizes glycerol as GRAS for use as an acute hypersensitivity reaction CPSC procedures for environmental a food. 21 CFR 182.1320. It is also used (wheezing) to Sucraid that resolved review, the Commission has assessed as a drug, for example, to reduce without sequelae. This patient was the possible environmental effects intraocular and intracranial pressure. It withdrawn from the trial. associated with the proposed PPPA also can be used as a laxative. amendment. Possible adverse effects associated D. Action on the Petition The Commission’s regulations state with glycerol include nausea, vomiting, After considering the information that rules requiring special packaging headache, and dehydration. Less provided by the petitioner and other for consumer products normally have commonly reported effects include available toxicity and human experience little or no potential for affecting the diarrhea, thirst, dizziness, and mental data, the Commission preliminarily human environment. 16 CFR confusion. Some more serious effects concludes that the degree and nature of 1021.5(c)(3). Nothing in this proposed have been reported with intravenous the hazard to children presented by the rule alters that expectation. (3) administration of glycerol and with availability of Sucraid do not require Therefore, because the rule would have certain high risk patients. However, the special packaging to protect children no adverse effect on the environment, Hazardous Chemicals Desk Reference from serious personal injury or serious neither an environmental assessment Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Proposed Rules 32161 nor an environmental impact statement 2. Section 1700.14 is amended by ACTION: Proposed rules. is required. republishing paragraph (a) introductory text and paragraph (a)(10) introductory SUMMARY: These proposed regulations G. Executive Orders text, and by adding new paragraph would change our rules to reflect an According to Executive Order 12988 (a)(10)(xx) to read as follows: amendment to the Social Security Act (February 5, 1996), agencies must state (the Act) made by Public Law 104–193, in clear language the preemptive effect, § 1700.14 Substances requiring special the Personal Responsibility and Work if any, of new regulations. packaging. Opportunity Reconciliation Act of 1996. The PPPA provides that, generally, (a) Substances. The Commission has The amendment prohibits payment of when a special packaging standard determined that the degree or nature of Supplemental Security Income (SSI) issued under the PPPA is in effect, ‘‘no the hazard to children in the availability benefits to certain fugitives and State or political subdivision thereof of the following substances, by reason of probation and parole violators. shall have any authority either to their packaging, is such that special DATES: To be sure that your comments establish or continue in effect, with packaging meeting the requirements of are considered, we must receive them respect to such household substance, § 1700.20(a) is required to protect no later than August 11, 1998. any standard for special packaging (and children from serious personal injury or any exemption therefrom and serious illness resulting from handling, ADDRESSES: Comments should be requirement related thereto) which is using, or ingesting such substances, and submitted in writing to the not identical to the [PPPA] standard.’’ the special packaging herein required is Commissioner of Social Security, P.O. 15 U.S.C. 1476(a). A State or local technically feasible, practicable, and Box 1585, Baltimore, MD 21235; sent by standard may be excepted from this appropriate for these substances: telefax to (410) 966–2830; sent by E-mail preemptive effect if (1) the State or local * * * * * to ‘‘[email protected]’’; or delivered standard provides a higher degree of (10) Prescription Drugs. Any drug for to the Office of Process and Innovation protection from the risk of injury or human use that is in a dosage form Management, Social Security illness than the PPPA standard; and (2) intended for oral administration and Administration, L2109 West Low Rise, the State or political subdivision applies that is required by Federal law to be 6401 Security Boulevard, Baltimore, MD to the Commission for an exemption dispensed only by or upon an oral or 21235, between 8:00 A.M. and 4:30 P.M. from the PPPA’s preemption clause and written prescription of a practitioner on regular business days. Comments the Commission grants the exemption licensed by law to administer such drug may be inspected during these same through a process specified at 16 CFR shall be packaged in accordance with hours by making arrangements with the Part 1061. 15 U.S.C. 1476(c)(1). In the provisions of § 1700.15 (a), (b), and contact person shown below. addition, the Federal government, or a (c), except for the following: FOR FURTHER INFORMATION CONTACT: State or local government, may establish * * * * * Teresa Robinson, Policy Analyst, Office and continue in effect a non-identical (xx) Sacrosidase (sucrase) of Program Benefits Policy, Social special packaging requirement that preparations in a solution of glycerol Security Administration, 6401 Security provides a higher degree of protection and water. Boulevard, Baltimore, MD 21235, (410) than the PPPA requirement for a 965–7960 for information about these household substance for the Federal, Dated: June 4, 1998. Sadye E. Dunn, rules. For information on eligibility or State or local government’s own use. 15 claiming benefits, call our national toll- Secretary, Consumer Product Safety U.S.C. 1476(b). free number, 1–800–772–1213. Thus, with the exceptions noted Commission. SUPPLEMENTARY INFORMATION: above, the proposed rule exempting List of Relevant Documents Sucraid from special packaging 1. Briefing memorandum from Jaqueline Background requirements would preempt non- Ferrante, Ph.D., EH, to the Commission, Section 202(a) of Public Law 104–193 identical state or local special packaging ‘‘Petition (PP 97–1) to Exempt Sucraid from standards for the substance. the Special Packaging Requirements for Oral added section 1611(e)(5) of the Act to In accordance with Executive Order Prescription Drugs,’’ May 20, 1998. preclude eligibility for SSI benefits for 12612 (October 26, 1987), the 2. Memorandum from Jaqueline Ferrante, certain fugitives and probation and Commission certifies that the proposed Ph.D., EH, to Mary Ann Danello, Ph.D., parole violators. In general, section rule does not have sufficient Associate Executive Director, EH, ‘‘Sucraid 1611(e)(5) of the Act provides that a implications for federalism to warrant a Review’’ April 1, 1998. person shall not be considered an 3. Memorandum from Marcia P. Robins, eligible individual or eligible spouse for Federalism Assessment. EC, to Jacqueline Ferrante, Ph.D., EH, purposes of the SSI program for any List of Subjects in 16 CFR Part 1700 ‘‘Economic Considerations: Petition for Exemption from PPPA Requirements for Oral month during which the person is— Consumer protection, Drugs, Infants Prescription Drug Sucraid,’’ April 2, 1998. • Fleeing to avoid prosecution for a and children, Packaging and containers, [FR Doc. 98–15493 Filed 6–11–98; 8:45 am] crime, or an attempt to commit a crime, Poison prevention, Toxic substances. which is a felony under the laws of the BILLING CODE 6355±01±P For the reasons given above, the place from which the person flees (or Commission proposes to amend 16 CFR which, in the case of the State of New part 1700 as follows: Jersey, is a high misdemeanor under the SOCIAL SECURITY ADMINISTRATION laws of that State); PART 1700Ð[AMENDED] 20 CFR Part 416 • Fleeing to avoid custody or 1. The authority citation for part 1700 confinement after conviction for a RIN 0960±AE77 continues to read as follows: crime, or an attempt to commit a crime, which is a felony under the laws of the Authority: Pub. L. 91–601, secs. 1–9, 84 Denial of Supplemental Security Stat. 1670–74, 15 U.S.C. 1471–76. Secs Income Benefits for Fugitive Felons place from which the person flees (or 1700.1 and 1700.14 also issued under Pub. L. and Probation and Parole Violators which, in the case of the State of New 92–573, sec. 30(a), 88 Stat. 1231. 15 U.S.C. Jersey, is a high misdemeanor under the 2079(a). AGENCY: Social Security Administration. laws of that State); or