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PART 270—RULES AND DEPARTMENT OF HEALTH AND also delayed the effective date of the REGULATIONS, INVESTMENT HUMAN SERVICES final rule 60 days, until November 30, COMPANY ACT OF 1940 2008. Food and Drug Administration The agency received many ■ 1. The authority citation for Part 270 substantive comments on the order of is amended by adding the following 21 CFR Part 530 prohibition. Therefore, to allow more citation to read as follows: [Docket No. FDA–2008–N–0326] time to fully consider the comments, FDA has decided to revoke the order so Authority: 15 U.S.C. 80a–1 et seq., 80a– New Animal Drugs; Cephalosporin that it does not take effect November 30, 34(d), 80a–37, and 80a–39, unless otherwise 2008. This means that neither the order noted. Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; nor the change to § 530.41 that would * * * * * Withdrawal have listed cephalosporins as prohibited Section 270.22e–3T is also issued under 15 from extralabel use will take effect on U.S.C. 80a–6(c) and 80a–37(a). AGENCY: Food and Drug Administration, November 30, 2008. If, after considering * * * * * HHS. the comments and other relevant ACTION: Final rule; withdrawal. ■ information, FDA decides to issue 2. Section 270.22e–3T is added to another order of prohibition addressing read as follows: SUMMARY: The Food and Drug this matter, FDA will follow the Administration (FDA) is revoking the procedures in 21 CFR 530.25 that § 270.22e–3T Temporary exemption for order prohibiting the extralabel use of liquidation of certain money market funds. provide for a public comment period cephalosporin antimicrobial drugs in prior to implementing the order. (a) A registered investment company, food-producing animals. FDA received We note that, insofar as withdrawal of or a series thereof (‘‘fund’’), is exempt many substantive comments on the the amendment to § 530.41 might be from the requirements of section 22(e) of order of prohibition. The agency is considered a rule subject to 5 U.S.C. the Act (15 U.S.C. 80a–22(e)) if: taking this action so that it may fully 553(b), the agency for good cause finds consider these comments. (1) The fund has a currently effective that prior notice and comment agreement (‘‘Agreement’’) with the U.S. DATES: Effective November 26, 2008, the procedures are unnecessary because Department of the Treasury final rule published July 3, 2008 (73 FR there is no need to amend § 530.41 since 38110), for which the effective date was (‘‘Treasury’’) to participate in the the order is being revoked. delayed until November 30, 2008, in a Temporary Guaranty Program for Money Dated: November 21, 2008. document published August 18, 2008 Market Funds (‘‘Program’’); (73 FR 48127), is withdrawn. William T. Flynn, (2) The fund has delivered to Treasury Acting Director, Center for Veterinary FOR FURTHER INFORMATION CONTACT: Neal Medicine. a notice indicating that it has Bataller, Center for Veterinary Medicine [FR Doc. E8–28093 Filed 11–25–08; 8:45 am] experienced a guarantee event, and will (HFV–230), Food and Drug promptly commence liquidation of the Administration, 7519 Standish Pl., BILLING CODE 4160–01–S fund under the terms of the Agreement; Rockville, MD, 20855, 240–276–9200, e- and mail: [email protected]. (3) The fund has not cured the SUPPLEMENTARY INFORMATION: In the DEPARTMENT OF HOMELAND guarantee event as provided under the Federal Register of July 3, 2008 (73 FR SECURITY terms of the Agreement. 38110), FDA published an order Coast Guard (b) For the protection of security prohibiting the extralabel use of cephalosporin antimicrobial drugs in holders of a fund, the Commission may 33 CFR Part 165 food-producing animals, with a 60-day issue an order to rescind or modify the comment period and a 90-day effective [Docket No. USCG–2008–0984] exemption provided by this section as to date for the final order. The order, that that fund, after appropriate notice and was to take effect on November 30, RIN 1625–AA00 opportunity for hearing in accordance 2008, would have resulted in a change with section 40 of the Act (15 U.S.C. Safety Zone, Bayfront Park New Year’s to § 530.41 (21 CFR 530.41) to list Eve Celebration, Biscayne Bay, FL 80a–39). cephalosporins as prohibited from (c) This section will expire on October extralabel use in food-producing AGENCY: Coast Guard, DHS. 18, 2009, unless the Commission animals as provided for in 21 CFR ACTION: Temporary final rule. publishes a notice in the Federal 530.25(f). Register announcing an earlier In response to publication of this SUMMARY: The Coast Guard is termination date in connection with order, the agency received requests for establishing a Safety Zone east of the termination of the Guaranty Program. a 60-day extension of the comment Intracoastal Waterway at the Port of period. The requests conveyed concern Miami, Florida for the Bayfront Park Dated: November 20, 2008. that the original 60-day comment period New Year’s Eve Ceremony. This By the Commission. would not allow the requesters temporary zone is intended to restrict Florence E. Harmon, sufficient time to examine the available vessels from entering waters within the Acting Secretary. evidence, consider the impact of the zone unless specifically authorized by [FR Doc. E8–28050 Filed 11–25–08; 8:45 am] order, and provide constructive the Captain of the Port Miami, Florida, comment. or a designated representative. This rule BILLING CODE 8011–01–P FDA considered the requests and, in is necessary to provide for the safety of the Federal Register of August 18, 2008 life on the navigable waters of the (73 FR 48127), extended the comment United States, and protect participants, period for the order for 60 days, until spectators, and mariner traffic from November 1, 2008. Accordingly, FDA potential hazards associated with

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launching fireworks over the navigable Background and Purpose Small Entities waters of the United States. Firepower Displays Unlimited will be Under the Regulatory Flexibility Act DATES: This rule is effective from 11:59 sponsoring the Bayfront Park New (5 U.S.C. 601–612), we have considered p.m. on December 31, 2008 to 1 a.m. on Year’s Eve Celebration. The event will whether this rule would have a January 1, 2009. be held from 11:59 p.m. on December significant economic impact on a ADDRESSES: Documents indicated in this 31, 2008 to 1 a.m. on January 1, 2009. substantial number of small entities. preamble as being available in the The public is invited to attend. The high The term ‘‘small entities’’ comprises docket are part of docket USCG–2008– concentration of event participants, small businesses, not-for-profit 0984 and are available online at spectators, and the general boating organizations that are independently www.regulations.gov. They are also public presents an extra hazard to the owned and operated and are not available for inspection or copying at safety of life on the navigable waters of dominant in their fields, and two locations: The Docket Management the United States. A regulated area east governmental jurisdictions with Facility (M–30), U.S. Department of of the Intracoastal Waterways of the Port populations of less than 50,000. The Coast Guard certifies under 5 Transportation, West Building Ground of Miami, Florida is necessary to protect U.S.C. 605(b) that this rule will not have Floor, Room W12–140, 1200 New Jersey participants as well as spectators from a significant economic impact on a Avenue, SE., Washington, DC 20590, hazards associated with the event. between 9 a.m. and 5 p.m., Monday substantial number of small entities. through Friday, except Federal holidays, Discussion of Rule This rule will affect the following and at Sector Miami, 100 MacArthur entities, some of which may be small This rule establishes a temporary Causeway, Miami Beach, FL 33139 entities: the owners or operators of safety zone surrounding the fireworks between 8 a.m. and 3 p.m., Monday vessels intending to transit this zone barge east of the Intracoastal Waterways through Friday, except Federal holidays. between 11:59 p.m. on December 31, of Miami, Florida. A 375 yard radius FOR FURTHER INFORMATION CONTACT: If 2008 and 1 a.m. on January 1, 2009. safety zone encompassing the waters This safety zone will not have a you have questions on this temporary surrounding the fireworks barge east of rule, call Lieutenant Paul Steiner, Coast significant economic impact on a the Intracoastal Waterway is necessary substantial number of small entities for Guard Sector Miami, Florida at (305) to protect participants as well as 535–8724. If you have questions on the following reasons: This rule will spectators from hazards associated with only be in effect for a short period of viewing the docket, call Renee V. the fireworks display. The fireworks Wright, Program Manager, Docket time and the impact on routine barge will be located in position navigation is expected to be minimal. Operations, telephone 202–366–9826. 25°46′23″ N, 080°10′57″ W. All vessels SUPPLEMENTARY INFORMATION: and persons are prohibited from Assistance for Small Entities Regulatory Information anchoring, mooring, or transiting within Under section 213(a) of the Small this zone unless authorized by the Business Regulatory Enforcement The Coast Guard is issuing this Captain of the Port Miami, Florida or a Fairness Act of 1996 (Pub. L. 104–121), temporary final rule without prior designated representative. The we offer to assist small entities in notice and opportunity to comment temporary safety zone will protect the understanding the rule so that they can pursuant to authority under section 4(a) participants and the public from the better evaluate its effects on them and of the Administrative Procedure Act dangers associated with the event. This participate in the rulemaking process. (APA) (5 U.S.C. 553(b)). This provision regulation will be effective from 11:59 Small businesses may send comments authorizes an agency to issue a rule p.m. on Wednesday, December 31, 2008 on the actions of Federal employees without prior notice and opportunity to to 1 a.m. on Thursday, January 01, 2009. who enforce, or otherwise determine comment when the agency for good compliance with, Federal regulations to cause finds that those procedures are Regulatory Analyses the Small Business and Agriculture ‘‘impracticable, unnecessary, or contrary Regulatory Enforcement Ombudsman to the public interest.’’ Under 5 U.S.C. We developed this rule after considering numerous statutes and and the Regional Small Business 553(b)(B), the Coast Guard finds that Regulatory Fairness Boards. The good cause exists for not publishing a executive orders related to rulemaking. Below we summarize our analyses Ombudsman evaluates these actions notice of proposed rulemaking (NPRM) annually and rates each agency’s with respect to this rule because based on 13 of these statutes or executive orders. responsiveness to small business. If you immediate action is necessary to ensure wish to comment on actions by the safety of commercial and Regulatory Planning and Review employees of the Coast Guard, call 1– recreational vessels in the vicinity of the 888–REG–FAIR (1–888–734–3247). The fireworks display on the dates and times This rule is not a significant regulatory action under section 3(f) of Coast Guard will not retaliate against this rule will be in effect and delay small entities that question or complain would be contrary to the public interest. Executive Order 12866, Regulatory Planning and Review, and does not about this rule or any policy or action A Coast Guard Patrol Commander will of the Coast Guard. be available and the Coast Guard will require an assessment of potential costs also issue a Broadcast Notice to and benefits under section 6(a)(3) of that Collection of Information Mariners. This temporary rule is Order. The Office of Management and This rule calls for no new collection necessary to ensure the safety of Budget has not reviewed it under that of information under the Paperwork participants, spectators, and the general Order. Reduction Act of 1995 (44 U.S.C. 3501– public on the navigable waters of the This expectation is based on the fact 3520). United States. that this regulation will only be in effect For the same reasons above, under 5 for a short period of time and the impact Federalism U.S.C. 553(d)(3), the Coast Guard finds on routine navigation is expected to be A rule has implications for federalism that good cause exists for making this minimal. For the above reasons, the under Executive Order 13132, rule effective less than 30 days after Coast Guard does not anticipate any Federalism, if it has a substantial direct publication in the Federal Register. significant economic impact. effect on State or local governments and

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would either preempt State law or under Executive Order 12866 and is not PART 165—REGULATED NAVIGATION impose a substantial direct cost of likely to have a significant adverse effect AREAS AND LIMITED ACCESS AREAS compliance on them. We have analyzed on the supply, distribution, or use of this rule under that Order and have energy. The Administrator of the Office ■ 1. The authority citation for part 165 determined that it does not have of Information and Regulatory Affairs continues to read as follows: implications for federalism. has not designated it as a significant Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Unfunded Mandates Reform Act energy action. Therefore, it does not Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; require a Statement of Energy Effects 33 CFR 1.05–1, 6.04–1, 6.04–6 and 160.5; The Unfunded Mandates Reform Act under Executive Order 13211. of 1995 (2 U.S.C. 1531–1538) requires Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. Federal agencies to assess the effects of Technical Standards their discretionary regulatory actions. In ■ 2. A new temporary § 165.T08–0984 is particular, the Act addresses actions The National Technology Transfer added to read as follows: that may result in the expenditure by a and Advancement Act (NTTAA) (15 State, local, or tribal government, in the U.S.C. 272 note) directs agencies to use § 165.T08–0984 Safety Zone, Bayfront Park aggregate, or by the private sector of voluntary consensus standards in their New Year’s Eve Celebration, Biscayne Bay, $100,000,000 or more in any one year. regulatory activities unless the agency Florida. Though this rule will not result in such provides Congress, through the Office of (a) Regulated areas. The Coast Guard an expenditure, we do discuss the Management and Budget, with an effects of this rule elsewhere in this explanation of why using these is establishing a temporary safety zone preamble. standards would be inconsistent with on the waters of the Intracoastal applicable law or otherwise impractical. Waterway, in the Port of Miami, Florida, Taking of Private Property Voluntary consensus standards are that encompasses the area within a 375 This rule will not effect a taking of technical standards (e.g., specifications yard radius of the fireworks barge private property or otherwise have of materials, performance, design, or located in approximate position: ° ′ ″ ° ′ ″ taking implications under Executive operation; test methods; sampling 25 46 23 N, 080 10 57 W. The safety Order 12630, Governmental Actions and procedures; and related management zone is within the boundaries of the Interference with Constitutionally systems practices) that are developed or Intracoastal Waterway in the Port of Protected Property Rights. adopted by voluntary consensus Miami, Florida. All coordinates referenced use datum: NAD 83. Civil Justice Reform standards bodies. This rule does not use technical (b) Definitions. The following This rule meets applicable standards definitions apply to this section: in sections 3(a) and 3(b)(2) of Executive standards. Therefore, we did not Order 12988, Civil Justice Reform, to consider the use of voluntary consensus Designated representative means minimize litigation, eliminate standards. Coast Guard Patrol Commanders, ambiguity, and reduce burden. including Coast Guard coxswains, petty Environment officers and other officers operating Protection of Children We have analyzed this rule under Coast Guard vessels, and federal, state, We have analyzed this rule under Department of Homeland Security and local officers designated by or Executive Order 13045, Protection of Management Directive 5100.1 and assisting the Captain of the Port Miami, Children from Environmental Health Commandant Instruction M16475.lD, Florida (COTP) in the enforcement of Risks and Safety Risks. This rule is not which guide the Coast Guard in regulated navigation areas, safety zones, an economically significant rule and complying with the National and security zones. does not create an environmental risk to Environmental Policy Act of 1969 (c) Regulations. (1) In accordance with health or risk to safety that may (NEPA) (42 U.S.C. 4321–4370f), and the general regulations in § 165.23 of disproportionately affect children. have concluded under the Instruction this part, no person or vessel may Indian Tribal Governments that there are no factors in this case that anchor, moor or transit a safety zone This rule does not have tribal would limit the use of a categorical without permission of the Captain of the implications under Executive Order exclusion under section 2.B.2 of the Port Miami, Florida or a designated 13175, Consultation and Coordination Instruction. Therefore, this rule is representative. To request permission to with Indian Tribal Governments, categorically excluded, under figure 2– enter into a safety zone, the Captain of because it does not have a substantial 1, paragraph (34)(g.), of the Instruction, the Port’s designated representative may direct effect on one or more Indian from further environmental be contacted on VHF channel 16. tribes, on the relationship between the documentation. An environmental (2) At the completion of scheduled Federal Government and Indian tribes, analysis checklist and a categorical event, and departure of participants or on the distribution of power and exclusion determination will be from the regulated area, the Coast Guard responsibilities between the Federal available in the docket where indicated Patrol Commander may permit traffic to Government and Indian tribes. under ADDRESSES. resume normal operations. Energy Effects List of Subjects in 33 CFR Part 165 (3) The public will be informed of this regulation by a Coast Guard Patrol We have analyzed this rule under Harbors, Marine safety, Navigation Executive Order 13211, Actions Commander on scene and through a (water), Reporting and recordkeeping Broadcast Notice to Mariners. Concerning Regulations That requirements, Security measures, and (d) Enforcement Period. This Significantly Affect Energy Supply, Waterways. Distribution, or Use. We have temporary safety zone will be effective determined that it is not a ‘‘significant ■ For the reasons discussed in the between the hours of 11:59 p.m., energy action’’ under that order because preamble, the Coast Guard amends 33 Wednesday, December 31, 2008 and 1 it is not a ‘‘significant regulatory action’’ CFR part 165 as follows: a.m., Thursday, January 1, 2009.

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Dated: October 30, 2008. P.O. Box 8079, Philadelphia, Further, because TSGLI is intended to J.O. Fitton, Pennsylvania 19101, (215) 842–2000, provide a source of income for expenses Captain, U.S. Coast Guard, Captain of the ext. 4839. (This is not a toll-free during periods of treatment and Port Miami, FL. number.) convalescence following a loss due to [FR Doc. E8–28150 Filed 11–25–08; 8:45 am] SUPPLEMENTARY INFORMATION: TSGLI traumatic injury, we believe the BILLING CODE 4910–15–P was established by Congress in May application of these regulations is more 2005 to provide monetary assistance to directly connected to those persistent severely injured service members who circumstances than to the past date on DEPARTMENT OF VETERANS suffer a loss, such as the loss of a hand, which an injury or loss was incurred or AFFAIRS as a direct result of a serious traumatic a claim was filed. Id. We also note that injury in order to help the member and these regulatory amendments would not 38 CFR Part 9 the member’s family through an often have affected conduct prior to the date of publication, nor would the long and arduous treatment and RIN 2900–AN00 regulations upset any settled rehabilitation period. VA codified expectations in any meaningful way. Servicemembers’ Group Life Insurance regulations to implement TSGLI at 38 See Landgraf v. USI Film Prods., 511 Traumatic Injury Protection Program CFR 9.1(k)–(q) and 9.20. See 70 FR U.S. 244, 280 (1994); Princess Cruises, 75940 (Dec. 22, 2005); 72 FR 10362 AGENCY: Department of Veterans Affairs. Inc. v. United States, 397 F.3d 1358, (Mar. 8, 2007). ACTION: Interim final rule. VA conducted an extensive review of 1362–63 (Fed. Cir. 2005). The service member’s traumatic injury, the the TSGLI program at the end of the first SUMMARY: The Department of Veterans scheduled loss due to the injury, and year of the program’s operation (‘‘Year- Affairs (VA) is issuing this interim final the resulting economic burdens on the One Review’’) to ensure that the rule to amend the Servicemembers’ service member were not within any program was operating effectively and Group Life Insurance traumatic injury party’s control and obviously actions that it was meeting the intent of protection program (TSGLI) regulations were not taken in reliance on prior Congress. The report was published on in order to add losses that would be regulations. Although application of the the VA Web site on July 17, 2008. covered under the program and to regulations will increase the http://www.insurance.va.gov/ define terms relevant to these new Government’s economic burden, we miscellaneous/index.htm. Many of the losses. This rulemaking also clarifies believe the additional burden is language in and reorganizes existing amendments made by this interim final countered in this instance by the other provisions. rule, particularly the losses that we considerations discussed above. propose to add to the Schedule of We are amending 38 CFR 9.1(b) to DATES: This interim final rule is Losses in § 9.20, are derived from the effective November 26, 2008. Comments provide the current address of the Office recommendations and findings of the of Servicemembers’ Group Life must be received on or before December TSGLI Year-One Review. 26, 2008. Insurance (OSGLI), which is 80 Congress has expressed its intent to Livingston Avenue, Roseland, New Applicability Date: VA will apply this provide TSGLI benefits retroactively. rule to injuries incurred in Operation Jersey 07068. Section 1032(c)(1) of the ‘‘Emergency We are moving the definitions from Enduring Freedom or Operation Iraqi Supplemental Appropriations Act for Freedom on or after October 7, 2001, 38 CFR 9.1(k)–(q), which pertain only to Defense, the Global War on Terror, and TSGLI, to 38 CFR 9.20(e)(6)(vi)–(xii) for through and including November 30, Tsunami Relief, 2005,’’ Public Law 109– purposes of administrative convenience 2005, and to all qualifying injuries 13, which established the TSGLI and to make it easier for the public to incurred on or after December 1, 2005. program effective December 1, 2005, locate the rules. We are expanding the ADDRESSES: Written comments may be also provided for the payment of TSGLI definition of ‘‘medical professional’’ at submitted through http:// benefits to service members who § 9.20(e)(6)(xii) to include a ‘‘licensed www.Regulations.gov; by mail or hand- experienced a traumatic injury between practitioner of the healing arts acting delivery to Director, Regulations October 7, 2001, when Operation within the scope of his or her practice.’’ Management (02REG), Department of Enduring Freedom began, and December We have broadened the definition in Veterans Affairs, 810 Vermont Ave., 1, 2005, the effective date of section order to encompass a wider range of NW., Room 1068, Washington, DC 1032 of Public Law 109–13, if the loss licensed medical professionals who are 20420; or by fax to (202) 273–9026. was a direct result of injuries incurred qualified to certify eligibility for TSGLI. Comments should indicate that they are in Operation Enduring Freedom or We are revising 38 CFR 9.20(b)(3) to submitted in response to ‘‘RIN 2900– Operation Iraqi Freedom. VA as well state that the term ‘‘traumatic event’’ AN00.’’ Copies of comments received has made its regulations implementing does not include a medical procedure or will be available for public inspection in the TSGLI program retroactive. In 2007, a surgical procedure in and of itself. the Office of Regulation Policy and VA applied changes to the TSGLI Current § 9.20(b)(3) only refers to a Management, Room 1063B, between the program made by the Veterans’ Housing surgical procedure. The revision makes hours of 8 a.m. and 4:30 p.m., Monday Opportunity and Benefits Improvement the regulation consistent with VA’s through Friday (except holidays). Please Act of 2006, Public Law 109–233, current practice of not providing TSGLI call (202) 461–4902 for an appointment. section 501(a)(3), 120 Stat. 397, 413, to payments for an injury that directly (This is not a toll-free number.) In claims filed or injuries suffered prior to results from either a medical or surgical addition, during the comment period, the date of the change in the law procedure. The publication of this comments are available online through because it was consistent with the revision to the current rule will not the Federal Docket Management System objectives of the TSGLI provisions result in any deviation from already (FDMS) at http://www.Regulations.gov. authorizing payments based on injuries established guidelines or processes. FOR FURTHER INFORMATION CONTACT: preceding the program’s creation. 72 FR Further, the revised definition is Jeanne King, Attorney-Advisor, 10362, 10363 (2007). We believe that the consistent with current 38 CFR Department of Veterans Affairs Regional same holds true with regard to the 9.20(e)(3)(i)(C), which excludes Office and Insurance Center (310/290B), changes made by this rulemaking. payment for a scheduled loss due to a

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