Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Rules and Regulations 55737

gynecological biopsy forceps that is a § 886.4670 Phacofragmentation system. with the vibro penetration testing. reprocessed single use device (SUD) as * * * * * Unauthorized persons or vessels are defined in § 807.3(u) of this chapter, the (b) Classification. Class II (special prohibited from entering into, transiting exemption from premarket notification controls). If the device is a through, or remaining in the safety zone does not apply and the manufacturer phacoemulsification needle that is a without permission of the Captain of the must submit a premarket notification reprocessed single use device (SUD) as Port or his designated representative. that includes validation data as defined in § 807.3(u) of this chapter, a DATES: This rule is effective from described in § 807.3(v). premarket notification submission for September 25, 2006 through December I 60. Section 884.6100 is amended by the device must include validation data 31, 2006. revising paragraph (b) to read as follows: as described in § 807.3(v). ADDRESSES: Documents indicated in this preamble as being available in the PART 892—RADIOLOGY DEVICES § 884.6100 Assisted reproduction needles. docket are part of docket COTP San * * * * * I 65. The authority citation for 21 CFR Francisco Bay 06–022 and are available (b) Classification. Class II (special part 892 continues to read as follows: for inspection or copying at the controls) (mouse embryo assay Waterways Safety Branch of Sector San information, endotoxin testing, Authority: 21 U.S.C. 351, 360, 360c, 360e, Francisco, Yerba Buena Island, Bldg. 360j, 371. sterilization validation, design 278, San Francisco, California, 94130, I specifications, labeling requirements, 66. Section 892.5730 is amended by between 9 a.m. and 4 p.m., Monday biocompatibility testing, and clinical revising paragraph (b) to read as follows: through Friday, except Federal holidays. testing). If the device is a reprocessed § 892.5730 Radionuclide brachytherapy FOR FURTHER INFORMATION CONTACT: single use device (SUD) as defined in source. Ensign Erin Bastick, U.S. Coast Guard § 807.3(u) of this chapter, the exemption * * * * * Sector San Francisco, at (415) 556–2950 from premarket notification does not (b) Classification. Class II (special or Sector San Francisco 24 hour apply and the manufacturer must controls). If the device is an isotope Command Center at (415) 399–3547. submit a premarket notification that needle that is a reprocessed single use SUPPLEMENTARY INFORMATION: includes validation data as described in device (SUD) as defined in § 807.3(u) of Regulatory Information § 807.3(v). this chapter, a premarket notification submission for the device must include We did not publish a notice of PART 886—OPTHALMIC DEVICES validation data as described in proposed rulemaking (NPRM) for this § 807.3(v). regulation. Under 5 U.S.C. 553(b)(B), the I 61. The authority citation for 21 CFR Coast Guard finds that good cause exists Dated: September 6, 2006. part 886 continues to read as follows: for not publishing an NPRM. The dates Jeffrey Shuren, Authority: 21 U.S.C. 351, 360, 360c, 360e, for the vibro penetration testing along 360j, 371. Assistant Commissioner for Policy. the Transbay tube were not finalized [FR Doc. 06–8166 Filed 9–22–06; 8:45 am] I 62. Section 886.4350 is amended by and presented to the Coast Guard in revising paragraph (b) to read as follows: BILLING CODE 4160–01–S time to draft and publish an NPRM. As such, the testing would commence § 886.4350 Manual ophthalmic surgical before the rulemaking process could be instrument . DEPARTMENT OF HOMELAND completed. Any delay in implementing * * * * * SECURITY this rule is contrary to the public (b) Classification. Class I (general interest since immediate action is controls). The device is exempt from the Coast Guard necessary in order to protect the premarket notification procedures in maritime public from the hazards subpart E of part 807 of this chapter, 33 CFR Part 165 associated with the vibro penetration subject to the limitations in § 886.9. If [COTP San Francisco Bay 06–022] testing. the device is an ophthalmic knife that Under 5 U.S.C. 553(d)(3), the Coast RIN 1625–AA00 is a reprocessed single use device (SUD) Guard finds that good cause exists for as defined in § 807.3(u) of this chapter, Safety Zone; BART Transbay Tube making this rule effective less than 30 the exemption from premarket Seismic Upgrade, San Francisco, CA days after publication in the Federal notification does not apply and the Register. The dates for the vibro manufacturer must submit a premarket AGENCY: Coast Guard, DHS. penetration testing along the Transbay notification that includes validation ACTION: Temporary final rule. tube were not finalized and presented to data as described in § 807.3(v). the Coast Guard in time to publish this SUMMARY: The Coast Guard is rule 30 days prior to its effective date. I 63. Section 886.4370 is amended by establishing a moving temporary safety As such, the testing would commence revising paragraph (b) to read as follows: zone in the navigable waters of San before the rulemaking process could be § 886.4370 Keratome. Francisco Bay, California during vibro completed. Delay in the effective date of penetration testing for a seismic upgrade * * * * * this rule would expose the mariners and of the Bay Area Rapid Transit (BART) waterways users to undue hazards (b) Classification. Class I (general Transbay tube. The testing will require associated with the vibro penetration controls). If the device is a reprocessed placement of a barge at test sites along testing. single use device (SUD) as defined in the BART Transbay tube. The safety § 807.3(u) of this chapter, a premarket zone will surround the barge and move Background and Purpose notification submission for the device with the barge as it conducts the tests Bay Area Rapid Transit has contracted must include validation data as at seven sites along the BART Transbay Hayward Baker, Soletanche, Traylor, A described in § 807.3(v). tube. This safety zone is necessary to Joint Venture, to conduct BART marine I 64. Section 886.4670 is amended by protect persons and vessels from demonstration tests in support of their revising paragraph (b) to read as follows: hazards, injury, and damage associated earthquake safety efforts. They will be

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conducting vibro penetration tests for Regulatory Evaluation able to pass through the zone on a case- future seismic upgrade of the BART This rule is not a ‘‘significant by-case basis. Therefore, the economic Transbay tube. The scope of work regulatory action’’ under section 3(f) of impact of this waterway closure is not involves four primary activities carried Executive Order 12866, Regulatory expected to be significant. out on the water. These activities Planning and Review, and does not Assistance for Small Entities include vibro penetration tests, vibro require an assessment of potential costs ground improvement, drilling, sampling and benefits under section 6(a)(3) of that Under section 213(a) of the Small and sonic borings. Order. The Office of Management and Business Regulatory Enforcement The Joint Venture’s work will involve Budget has not reviewed it under that Fairness Act of 1996 (Pub. L. 104–121), outfitting the barge DOGBONE with a Order. we offered to assist small entities in crane and vibratory densification Although this rule restricts access to understanding the rule so that they equipment and locating it over the tube the waters encompassed by the safety could better evaluate its effects on them alignment to perform the ground and participate in the rulemaking improvement with in the test areas. At zone, the effect of this rule will not be significant because the local waterway process. times there will be an additional barge Small businesses may send comments lashed to the barge DOGBONE for users have been contacted to ensure the closure will result in minimum impact. on the actions of Federal employees material handling. Approximately ten 5- who enforce, or otherwise determine foot tall tripods with acoustic The entities most likely to be affected are pleasure craft engaged in compliance with, Federal regulations to transponders will be deployed on the the Small Business and Agriculture bay bottom to determine specific test recreational activities. Not only is the safety zone small in size, but there will Regulatory Enforcement Ombudsman locations along the BART Transbay. At and the Regional Small Business each specified location the crane be ample space to navigate around the safety zone as well. Regulatory Fairness Boards. The suspended vibrator will be lowered into Ombudsman evaluates these actions the bay floor and then proceed to Small Entities annually and rates each agency’s densify the granular backfill placed responsiveness to small business. If you around the tubes shortly after they were Under the Regulatory Flexibility Act wish to comment on actions by originally placed into position. (5 U.S.C. 601–612), we have considered whether this rule would have a employees of the Coast Guard, call 1– Discussion of Rule significant economic impact on a 888–REG–FAIR (1–888–734–3247). This safety zone will encompass the substantial number of small entities. Collection of Information navigable waters from the surface to the The term ‘‘small entities’’ comprises sea floor, located in the San Francisco small businesses, not-for-profit This rule calls for no new collection Bay, encompassing a circular safety organizations that are independently of information under the Paperwork zone with a 750-foot radius extending owned and operated and are not Reduction Act of 1995 (44 U.S.C. 3501– from the Crane Barge DOGBONE. The dominant in their fields, and 3520). Barge DOGBONE will transit and governmental jurisdictions with Federalism conduct testing along the BART populations of less than 50,000. Transbay tube between two points: The Coast Guard certifies under 5 A rule has implications for federalism 37°47′50.97″ N Latitude by U.S.C. 605(b) that this rule will not have under Executive Order 13132, 122°23′17.01″ W Longitude at the a significant economic impact on a Federalism, if it has a substantial direct western extreme and 37°48′25.65″ N substantial number of small entities. effect on State or local governments and Latitude by 122°21′03.59″ W Longitude This rule will affect the following would either preempt State law or on the eastern extreme. This area entities, some of which may be small impose a substantial direct cost of between the two points will be used to entities: the owners or operators of compliance on them. We have analyzed maneuver and anchor the Barge vessels intending to transit or anchor in this rule under that Order and have DOGBONE as it conducts the vibro a portion of the San Francisco Bay from determined that it does not have penetration tests from September 25, September 25, 2006 through December implications for federalism. 31, 2006. 2006 through December 31, 2006. The Unfunded Mandates Reform Act BART Project manager coordinated the We expect this rule may affect owners test locations with the local Bar Pilots and operators of vessels, some of which The Unfunded Mandates Reform Act and the Vessel Traffic Service to ensure may be small entities, intending to fish, of 1995 (2 U.S.C. 1531–1538) requires the testing would result in minimum sightsee, transit, or anchor in the waters Federal agencies to assess the effects of impact to vessel traffic. This moving affected by this safety zone. This safety their discretionary regulatory actions. In safety zone around the Barge DOGBONE zone will not have a significant particular, the Act addresses actions is necessary to protect persons and economic impact on a substantial that may result in the expenditure by a vessels from hazards, injury, and number of small entities for several State, local, or tribal government, in the damage associated with the vibro reasons: small vessel traffic will be able aggregate, or by the private sector of penetration testing. to pass safely around the area and $100,000,000 or more in any one year. U.S. Coast Guard personnel will vessels engaged in recreational Though this rule will not result in such enforce this safety zone. Other Federal, activities, sightseeing and commercial expenditure, we do discuss the effects of State, or local agencies may assist the fishing have ample space outside of the this rule elsewhere in this preamble. Coast Guard, including the Coast Guard safety zone to engage in these activities. Taking of Private Property Auxiliary. Section 165.53 of Title 33, The entities most likely to be affected Code of Federal Regulations, prohibits are pleasure craft engaged in This rule will not affect a taking of any unauthorized person or vessel from recreational activities and sightseeing. private property or otherwise have entering or remaining in a safety zone. Small entities and the maritime taking implications under Executive Vessels or persons violating this section public will also be advised of this safety Order 12630, Governmental Actions and may be subject to both criminal and zone via public broadcast notice to Interference with Constitutionally civil penalties. mariners. In addition, vessels will be Protected Property Rights.

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Civil Justice Reform This rule does not use technical 122°21′03.59″W Longitude at the eastern This rule meets applicable standards standards. Therefore, we did not extreme. (b) Effective Dates.This rule is in sections 3(a) and 3(b)(2) of Executive consider the use of voluntary consensus effective from September 25, 2006 Order 12988, Civil Justice Reform, to standards. through December 31, 2006. If the need minimize litigation, eliminate Environment for the safety zone ends prior to the ambiguity, and reduce burden. We have analyzed this rule under scheduled termination time, the Captain Protection of Children Commandant Instruction M16475.lD of the Port (COTP) will cease We have analyzed this rule under and Department of Homeland Security enforcement of the safety zone. (c) Regulations. In accordance with Executive Order 13045, Protection of Management Directive 5100.1, which the general regulations in § 165.23 of Children from Environmental Health guide the Coast Guard in complying this part, entry into, transit through, or Risks and Safety Risks. This rule is not with the National Environmental Policy anchoring within this safety zone by all an economically significant rule and Act of 1969 (NEPA) (42 U.S.C. 4321– vessels and persons is prohibited, does not create an environmental risk to 4370f), and have concluded that there unless specifically authorized by the health or risk to safety that may are no factors in this case that would COTP San Francisco, or his designated disproportionately affect children. limit the use of a categorical exclusion under section 2.B.2 of the Instruction. representative. Indian Tribal Governments Therefore, this rule is categorically (d) Enforcement. All persons and This rule does not have tribal excluded, under figure 2–1, paragraph vessels shall comply with the implications under Executive Order (34)(g), of the Instruction, from further instructions of the Coast Guard COTP or 13175, Consultation and Coordination environmental documentation. his designated representative. The with Indian Tribal Governments, Paragraph (34)(g) is applicable because COTP’s designated representative can be because it does not have a substantial this rule establishes a safety zone. comprised of commissioned, warrant, direct effect on one or more Indian A final ‘‘Environmental Analysis and petty officers of the Coast Guard tribes, on the relationship between the Check List’’ and a final ‘‘Categorical onboard Coast Guard, Coast Guard Federal Government and Indian tribes, Exclusion Determination’’ will be Auxiliary, local, State, and Federal law or on the distribution of power and available in the docket where indicated enforcement vessels. Upon being hailed responsibilities between the Federal under ADDRESSES. by U.S. Coast Guard patrol personnel by Government and Indian tribes. siren, radio, flashing light, or other List of Subjects in 33 CFR Part 165 means, the operator of a vessel shall Energy Effects Harbors, Marine safety, Navigation proceed as directed. We have analyzed this rule under (water), Reporting and recordkeeping The U.S. Coast Guard may be assisted Executive Order 13211, Actions requirements, Security measures, in the patrol and enforcement of these Concerning Regulations That Waterways. two safety zones by local law enforcement as necessary. Significantly Affect Energy Supply, I For the reasons discussed in the Distribution, or Use. We have preamble, the Coast Guard amends 33 Dated: September 8, 2006. determined that it is not a ‘‘significant CFR part 165 as follows: W.J. Uberti, energy action’’ under that order because Captain, U.S. Coast Guard, Captain of the it is not a ‘‘significant regulatory action’’ PART 165—REGULATED NAVIGATION Port, San Francisco, California. under Executive Order 12866 and is not AREAS AND LIMITED ACCESS AREAS [FR Doc. 06–8132 Filed 9–22–06; 8:45 am] likely to have a significant adverse effect I BILLING CODE 4910–15–P on the supply, distribution, or use of 1. The authority citation for part 165 energy. The Administrator of the Office continues to read as follows: of Information and Regulatory Affairs Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. DEPARTMENT OF HOMELAND has not designated it as a significant Chapter 701; 50 U.S.C. 191; 33 CFR 1.05–1(g), SECURITY energy action. Therefore, it does not 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, require a Statement of Energy Effects 116 Stat. 2064; Department of Homeland Coast Guard under Executive Order 13211. Security Delegation No. 0170.1. 33 CFR Part 165 Technical Standards I 2. Add § 165.T11–146, to read as follows: [COTP Western Alaska 06–003] The National Technology Transfer and Advancement Act (NTTAA) (15 § 165.T11–110 Safety Zone; San Francisco RIN 1625–AA00 U.S.C. 272 note) directs agencies to use Bay, California. Safety Zone; Gulf of Alaska, Narrow voluntary consensus standards in their (a) Location. This safety zone will Cape, Kodiak Island, AK regulatory activities unless the agency encompass the navigable waters from provides Congress, through the Office of the surface to the sea floor, in the San AGENCY: Coast Guard, DHS. Management and Budget, with an Francisco Bay, and its limits will ACTION: Temporary final rule. explanation of why using these encompass a circular safety zone with a standards would be inconsistent with radius of 750-feet extending from and SUMMARY: The Coast Guard is applicable law or otherwise impractical. around the Crane Barge DOGBONE. establishing a temporary safety zone in Voluntary consensus standards are This safety zone will move and continue the Gulf of Alaska, encompassing the technical standards (e.g., specifications to extend 750-feet from the Barge navigable waters in the vicinity of of materials, performance, design, or DOGBONE while it operates along the Narrow Cape and Ugak Island. The zone operation; test methods; sampling charted BART Transbay tube between is needed to protect persons and vessels procedures; and related management the following two points: 37°47′50.97″ N operating in the vicinity of the safety systems practices) that are developed or Latitude, by 122°23′17.01″W Longitude zone during a rocket launch from the adopted by voluntary consensus at the western extreme, and Alaska Aerospace Development standards bodies. 37°48′25.65″N Latitude by Corporation, Narrow Cape, Kodiak

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