Proposed Rules. Notice of proposed rulemaking

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4910-13-M DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-283P] Schedules of Controlled Substances: Placement of Indiplon Into Schedule IV AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. SUMMARY: This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration

(DEA)to place the substance indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-a]pyrimidin-7- yl]phenyl]acetamide), including its salts, and all products containing indiplon into schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services

(DHHS)and an evaluation of the relevant data by DEA. This scheduling of indiplon in schedule IV will not be finalized until a New Drug Application

(NDA)for an indiplon product is approved by the Food and Drug Administration (FDA). If finalized, this action will impose the regulatory controls and criminal sanctions applicable to schedule IV non-narcotics on those who handle indiplon and products containing indiplon. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before March 3, 2008. ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-283” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to *dea.diversion.policy@usdoj.gov.* Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided on that site. However, persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. DEA will accept electronic comments containing MS Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here. *Posting of Public Comments:* Please note that all comments received are considered part of the public record and made available for public inspection online at *http://www.regulations.gov* and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION paragraph. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537,

(202)307-7183. SUPPLEMENTARY INFORMATION: Note Regarding This Proposed Scheduling Action In accordance with the provisions of the Controlled Substances Act (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557). Interested persons are invited to submit their comments, objections or requests for a hearing with regard to this proposal. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. Requests for a hearing should be made in accordance with 21 CFR 1308.44 and should state, with particularity, the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the DEA using the address information provided above. Background Indiplon acts as an agonist at benzodiazepine sites of the GABA A receptor-channel complex. It has comparable sedative/hypnotic action to that of the benzodiazepines, diazepam and triazolam, and non-benzodiazepines that bind to the GABA A complex, such as zolpidem, zaleplon and zopiclone, all of which are controlled as depressants in schedule IV of the CSA. Indiplon has a similar pharmacological profile as these substances in addition to a short plasma half-life and short duration of action. In a human abuse-liability study in individuals with known histories of sedative abuse, oral administration of indiplon (30 mg, 50 mg and 80 mg) produced dose-dependent increases in drug-liking and decreases in psychomotor and cognitive functioning comparable to those produced by the schedule IV benzodiazepine, triazolam. Indiplon is likely to be diverted and abused in the same manner as other schedule IV depressants. The FDA has received two NDAs for indiplon products, Somposure® and Somposure® MR. These products are currently under review for the treatment of insomnia, as characterized by difficulty in sleep onset or sleep maintenance. Indiplon is a new chemical entity and has not been marketed in the United States or in other countries. On January 23, 2006, the Assistant Secretary for Health of the DHHS sent the Administrator of the DEA a scientific and medical evaluation and a letter recommending that indiplon be placed into schedule IV of the CSA. Enclosed with the January 23, 2006, letter was a document prepared by the FDA entitled, “Basis for the Recommendation for Control of Indiplon in Schedule IV of the Controlled Substances Act (CSA).” The document contained a review of the factors which the CSA requires the Secretary to consider (21 U.S.C. 811(b)). The factors considered by the Assistant Secretary of Health and DEA with respect to Indiplon were:

(1)Its actual or relative potential for abuse;

(2)Scientific evidence of its pharmacological effects;

(3)The state of current scientific knowledge regarding the drug;

(4)Its history and current pattern of abuse;

(5)The scope, duration, and significance of abuse;

(6)What, if any, risk there is to the public health;

(7)Its psychic or physiological dependence liability; and

(8)Whether the substance is an immediate precursor of a substance already controlled under this subchapter (21 U.S.C. 811(c)). Based on the recommendation of the Assistant Secretary for Health, received in accordance with section 201(b) of the Act (21 U.S.C. 811(b)), and the independent review of the available data by the DEA, the Deputy Administrator of the DEA, pursuant to section 201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:

(1)Based on information now available, indiplon has a low potential for abuse relative to the drugs or other substances in schedule III;

(2)Once approved for marketing, indiplon will have a currently accepted medical use in treatment in the United States; and

(3)Abuse of indiplon may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. Based on these findings, the Deputy Administrator of the DEA concludes that indiplon, including its salts, and all products containing indiplon, warrant control in schedule IV of the CSA, if and when a NDA for indiplon is approved. Interested persons are invited to submit their comments, objections or requests for a hearing with regard to this proposal. Requests for a hearing should state, with particularity, the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the Drug Enforcement Administration using the address information provided above. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. In the event that comments, objections, or requests for a hearing raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the **Federal Register** , summarizing the issues to be heard and setting the time for the hearing. Requirements for Handling Indiplon If this rule is finalized as proposed, indiplon and all products containing indiplon would be subject to the Controlled Substances Act and the Controlled Substances Import and Export Act regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a schedule IV controlled substance, including the following: *Registration* . Any person who manufactures, distributes, dispenses, imports, exports, engages in research or conducts instructional activities with indiplon, or who desires to manufacture, distribute, dispense, import, export, engage in instructional activities or conduct research with indiplon, would need to register with the DEA to conduct such activities in accordance with part 1301 of Title 21 of the Code of Federal Regulations. *Security* . Indiplon would be subject to schedule III-V security requirements and must be manufactured, distributed and stored in accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76, and 1301.77. *Labeling and Packaging* . All labels and labeling for commercial containers of indiplon which are distributed on or after finalization of this rule would need to comply with requirements of 21 CFR 1302.03-1302.07. *Inventory* . Every registrant required to keep records and who possesses any quantity of indiplon would be required to keep an inventory of all stocks of indiplon on hand pursuant to 21 CFR 1304.03, 1304.04 and 1304.11. Every registrant who desires registration in schedule IV for indiplon would be required to conduct an inventory of all stocks of the substance on hand at the time of registration. *Records* . All registrants would be required to keep records pursuant to 21 CFR 1304.03, 1304.04, 1304.05, 1304.21, 1304.22, and 1304.23. *Prescriptions* . All prescriptions for indiplon or prescriptions for products containing indiplon would be required to be issued pursuant to 21 CFR 1306.03-1306.06, 1306.21-1306.27. *Importation and Exportation* . All importation and exportation of indiplon would need to be in compliance with 21 CFR Part 1312. *Criminal Liability* . Any activity with indiplon not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after finalization of this proposed rule would be unlawful. Regulatory Certifications Executive Order 12866 In accordance with the provisions of the CSA (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive Order 12866, section 3(d)(1). Regulatory Flexibility Act The Deputy Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. Indiplon products will be prescription drugs used for the treatment of insomnia. Handlers of indiplon often handle other controlled substances which are already subject to the regulatory requirements of the CSA. Executive Order 12988 This regulation meets the applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by state, local and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or, significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and export markets. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Under the authority vested in the Attorney General by § 201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of DEA by Department of Justice regulations (28 CFR 0.100), and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes that 21 CFR part 1308 be amended as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted. 2. Section 1308.14 is amended by redesignating paragraphs (c)(25) through (c)(51) as (c)(26) through (c)(52) and adding a new paragraph (c)(25) to read as follows: § 1308.14 Schedule IV.

(c)* * *

(25)indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-a]pyrimidin-7-yl]phenyl]-acetamide)—2726 Dated: January 22, 2008. Michele M. Leonhart, Deputy Administrator. [FR Doc. E8-1692 Filed 1-30-08; 8:45 am] BILLING CODE 4410-09-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2007-1139; FRL-8523-4] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Control of Volatile Organic Compound

(VOCs)Emissions From the Kraft Foods Global, Inc.—Richmond Bakery located in Henrico County, VA AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a State Implementation Plan

(SIP)revision submitted by the Commonwealth of Virginia on October 29, 2007. This revision pertains to a federally enforceable state operating permit containing terms and conditions for the control of emissions of volatile organic compounds

(VOCs)from the Kraft Foods Global, Inc.—Richmond Bakery located in Henrico County, Virginia. The submittal is for the purpose of meeting the requirements for reasonably available control technology

(RACT)in order to implement the maintenance plan for the Richmond 8-hour ozone maintenance area. EPA is proposing to approve the revision to the Virginia SIP in accordance with the requirements of the Clean Air Act (CAA). DATES: Written comments must be received on or before March 3, 2008. ADDRESSES: Submit your comments, identified by Docket ID Number EPA-R03-OAR-2007-1139, by one of the following methods: A. *www.regulations.gov* . Follow the on-line instructions for submitting comments. B. *E-mail: fernandez.cristina@epa.gov* . C. *Mail:* EPA-R03-OAR-2007-1139, Cristina Fernandez, Chief, Air Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. D. *Hand Delivery:* At the previously-listed EPA Region III address. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R03-OAR-2007-10139. EPA's policy is that all comments received will be included in the public docket without change, and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the electronic docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Virginia Department of Environmental Quality, 629 East Main Street, Richmond, Virginia 23219. FOR FURTHER INFORMATION CONTACT: Irene Shandruk,

(215)814-2166, or by e-mail at *shandruk.irene@epa.gov* . SUPPLEMENTARY INFORMATION: On October 29, 2007, the Commonwealth of Virginia submitted a revision to its State Implementation Plan

(SIP)for the control of emissions of VOCs from the Kraft Foods Global, Inc.—Richmond Bakery located in Henrico County, Virginia. The submittal is for the purpose of meeting the requirements for Reasonably Available Control Technology

(RACT)in order to implement the maintenance plan for the Richmond 8-hour ozone maintenance area. I. Background RACT is the lowest emission limit that a particular source is capable of meeting by the application of control technology that is reasonably available with the consideration of technological and economic feasibility. When the Richmond area was originally designated as an ozone nonattainment area under the 1-hour standard, it was classified as moderate and thereby had to meet the non-CTG RACT requirements of section 182 of the CAA. As part of the 1-hour ozone attainment plan, one of the sources located in the area identified as being subject to non-CTG RACT was Nabisco Brands (now Kraft Foods). Cookies, crackers, and pretzels are produced at this plant. The sources of VOC emissions at this plant are proof-room, ovens for baking the dough, and oil treatment facilities. The Kraft Foods Global, Inc. in Henrico County, Virginia underwent RACT analysis, and a federally-enforceable state operating permit was issued to the facility, which became effective on April 24, 1991. The permit was then submitted to EPA as a SIP revision, and approved into the Commonwealth's SIP on March 6, 1992 (57 FR 8080). On September 22, 2004, under the new 8-hour ozone standard, the Richmond area was classified as a marginal nonattainment area. On September 20, 2006, the Virginia Department of Environmental Quality (VADEQ) formally submitted a request to redesignate the Richmond area from nonattainment to attainment for the 8-hour ozone NAAQS. On September 25, 2006, the VADEQ submitted a maintenance plan for the Richmond area as a SIP revision to ensure continued attainment. The redesignation request and maintenance plan were approved on June 1, 2007 (72 FR 30485). Section 107(d)(3)(E) of the CAA stipulates that for an area to be redesignated, EPA must approve a maintenance plan that meets the requirements of section 175A. All applicable nonattainment area requirements remain in place. The plan includes a demonstration that emissions will remain within the 2005 levels for a 10-year period by keeping in place key elements of the current federal and state regulatory programs, including case-by-case RACT requirements for the area. Because the Richmond area in which this facility is located has continuously been classified as either a nonattainment or a maintenance area, the RACT requirements remain in effect. II. Summary of SIP Revision In 2006, Kraft made modifications to its process that necessitated the following revisions to its RACT permit:

(1)Kraft will demonstrate compliance with RACT for oven #1 by testing the catalyst annually to demonstrate that it is functioning properly; and

(2)Compliance with the exhaust gas flow through the catalytic oxidizer will be achieved by installing and operating the fan model with a rated capacity no less than 3,500 scfm. III. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information

(1)that are generated or developed before the commencement of a voluntary environmental assessment;

(2)that are prepared independently of the assessment process;

(3)that demonstrate a clear, imminent and substantial danger to the public health or environment; or

(4)that are required by law. On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. * * *” The opinion concludes that “[r]egarding (§ 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.” Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law. IV. Proposed Action EPA's review of this material indicates that Virginia has met the requirements for submitting a SIP revision concerning a federally enforceable state operating permit containing terms and conditions for the control of emissions of VOCs from the Kraft bakery in Henrico County, Virginia. This revision request is for the purpose of meeting the requirements for RACT in order to implement the maintenance plan for the Richmond 8-hour ozone maintenance area. EPA is proposing to approve Virginia's SIP revision concerning this state operating permit, which was submitted on October 29, 2007. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action. V. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). This action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, *et seq.* ). Because this rule proposes to approve pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This proposed rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely proposes to approve a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This proposed rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This action proposing approval of Virginia's SIP revision concerning a federally enforceable State operating permit containing terms and conditions for the control of emissions of VOCs from the Kraft Foods Global, Inc.—Richmond Bakery does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, *et seq.* ). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Authority: 42 U.S.C. 7401, *et seq.* Dated: January 23, 2008. William T. Wisniewski, Acting Regional Administrator, Region III. [FR Doc. E8-1777 Filed 1-30-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA-R01-RCRA-2007-1171; FRL-8521-7] Massachusetts: Final Authorization of State Hazardous Waste Management Program Revisions AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: The Commonwealth of Massachusetts has applied to EPA for final authorization of changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to Massachusetts. EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through an immediate final action. DATES: Comments must be received on or before March 3, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-RCRA-2007-1171, by one of the following methods: • *www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: biscaia.robin@epa.gov* . • *Fax:*

(617)918-0642, to the attention of Robin Biscaia • *Mail:* Robin Biscaia, Hazardous Waste Unit, EPA New England—Region 1, One Congress Street, Suite 1100 (CHW), Boston, MA 02114-2023 • *Hand Delivery or Courier:* Deliver your comments to: Robin Biscaia, Hazardous Waste Unit, Office of Ecosystem Protection, EPA New England—Region 1, One Congress Street, 11th Floor, (CHW), Boston, MA 02114-2023. Such deliveries are only accepted during the Office's normal hours of operation, and special arrangements should be made for deliveries of boxed information. For further information on how to submit comments, please see today's immediate final rule published in the “Rules and Regulations” section of this **Federal Register** . FOR FURTHER INFORMATION CONTACT: Robin Biscaia, Hazardous Waste Unit, EPA New England—Region 1, One Congress Street, Suite 1100 (CHW), Boston, MA 02114-2023, telephone number:

(617)918-1642; fax number:

(617)918-0642, e-mail address: *biscaia.robin@epa.gov.* SUPPLEMENTARY INFORMATION: In the “Rules and Regulations” section of this **Federal Register** , EPA is authorizing these changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect adverse comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written adverse comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we get comments that oppose this action, we will withdraw the immediate final rule and it will not take immediate effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you should do so at this time. Dated: December 17, 2007. Robert W. Varney, Regional Administrator, EPA New England. [FR Doc. E8-1313 Filed 1-30-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Part 6 [FAR Case 2007-008; Docket 2007-0001; Sequence 14] RIN 9000-AK90 Federal Acquisition Regulation; FAR Case 2007-008, Limiting Length of Noncompetitive Contracts in “Unusual and Compelling Urgency” Circumstances AGENCIES: Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA). ACTION: Proposed rule. SUMMARY: The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) are proposing to amend the Federal Acquisition Regulation

(FAR)to limit the length of contracts awarded noncompetitively under unusual and compelling urgency circumstances to the minimum contract period necessary to meet the requirements, and no longer than one year, unless approved by the head of the contracting activity. DATES: Interested parties should submit comments in writing on or before March 31, 2008 to be considered in the formulation of a final rule. ADDRESSES: Submit comments identified by FAR Case 2007-008 by any of the following methods: • Regulations.gov: *http://www.regulations.gov* . Submit comments via the Federal eRulemaking portal by inputting “FAR Case 2007-008” under the heading “Comment or Submission”. Select the link “Send a Comment or Submission” that corresponds with FAR Case 2007-008. Follow the instructions provided to complete the “Public Comment and Submission Form”. Please include your name, company name (if any), and “FAR Case 2007-008” on your attached document. • Fax: 202-501-4067. • Mail: General Services Administration, Regulatory Secretariat (VPR), 1800 F Street, NW., Room 4035, ATTN: Diedra Wingate, Washington, DC 20405. *Instructions* : Please submit comments only and cite FAR Case 2007-008 in all correspondence related to this case. All comments received will be posted without change to *http://www.regulations.gov* , including any personal and/or business confidential information provided. FOR FURTHER INFORMATION CONTACT: Mr. Ernest Woodson, Procurement Analyst, at

(202)501-3775, for clarification of content. For information pertaining to status or publication schedules, contact the FAR Secretariat at

(202)501-4755. Please cite FAR Case 2007-008. SUPPLEMENTARY INFORMATION: A. Background The Administrator of the Office of Federal Procurement Policy

(OFPP)issued a memorandum on enhancing competition in Federal acquisition, dated May 31, 2007, to executive agency chief acquisition officers and senior procurement executives. One of the initiatives identified by the Administrator for strengthening competitive policies was limiting the length of contracts awarded noncompetitively under the authority in FAR Part 6.302-2, unusual and compelling urgency, to the minimum period necessary for meeting the requirements, and no longer than one year unless approved by the head of the contracting activity. This rule implements a contract period limitation under FAR Part 6.302-2. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804. B. Regulatory Flexibility Act The Councils do not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, *et seq.* , because the rule addresses internal agency procedures and will benefit small entities by encouraging competition after a one year contract period, except when a longer contract period is properly approved. Therefore, an Initial Regulatory Flexibility Analysis has not been performed. The Councils will consider comments from small entities concerning the affected FAR Part 6.303-2 in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 601, *et seq.* (FAR case 2007-008), in correspondence. C. Paperwork Reduction Act The Paperwork Reduction Act (Pub. L. 96-511) does not apply because the changes to the FAR do not contain any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, *et seq.* List of Subjects in 48 CFR Part 6 Government procurement. Dated: January 15, 2008. Al Matera, Director, Office of Acquisition Policy. Therefore, DoD, GSA, and NASA propose amending 48 CFR part 6 as set forth below: PART 6—COMPETITION REQUIREMENTS 1. The authority citation for 48 CFR part 6 continues to read as follows: Authority: 40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 42 U.S.C. 2473(c). 2. Amend section 6.302-2 by adding paragraph

(d)to read as follows: 6.302-2 Unusual and compelling urgency.

(d)*Period of Performance* . The total period of performance of a contract awarded using this authority shall not exceed the minimum period necessary for meeting the unusual and compelling urgency requirements, but no longer than one year unless a longer period of performance is approved by the head of the contracting activity. Approval of a longer contract period of performance is in addition to the justification approval of requirements in 6.304. [FR Doc. E8-1681 Filed 1-30-08; 8:45 am] BILLING CODE 6820-EP-S DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 16 [FWS-R9-FHC-2008-0015; 94410-1342-0000-N3] RIN 1018-AV68 Injurious Wildlife Species; Review of Information Concerning Constrictor Snakes From Python, Boa, and Eunectes genera AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of inquiry. SUMMARY: We, the U.S. Fish and Wildlife Service (Service or We), are reviewing available biological and economic information on constrictor snakes in the *Python, Boa* and *Eunectes* genera for possible addition to the list of injurious wildlife under the Lacey Act. The importation and introduction of constrictor snakes into the natural ecosystems of the United States may pose a threat to the interests of agriculture, horticulture, forestry; to the health and welfare of human beings; and to the welfare and survival of wildlife and wildlife resources in the United States. An injurious wildlife listing would prohibit the importation into, or transportation between, States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States by any means, without a permit. Permits may be issued for scientific, medical, educational, or zoological purposes. This document seeks comments from the public to aid in determining if a proposed rule is warranted. DATES: We will accept comments received or postmarked on or before April 30, 2008. ADDRESSES: You may submit comments by one of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *U.S. mail or hand-delivery:* Public Comments Processing, Attn: RIN 1018-AV68, Division of Policy and Directives Management, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Suite 222, Arlington, VA 22203. *Instructions:* We will not accept e-mail or faxes. We will post all comments on *http://www.regulations.gov.* This generally means that we will post any personal information you provide us (see the Public Comments section below for more information). FOR FURTHER INFORMATION CONTACT: Erin Williams, Branch of Invasive Species at

(703)358-2034 or *erin_williams@fws.gov* . SUPPLEMENTARY INFORMATION: On September 21, 2006, we received a petition from the South Florida Water Management District (SFWMD) requesting that Burmese pythons be considered for inclusion in the injurious wildlife regulations pursuant to the Lacey Act (18 U.S.C. 42). SFWMD is concerned about the number of Burmese pythons found in Florida, particularly in the Everglades National Park. We are looking at obtaining information on constrictor species in the *Python, Boa* and *Eunectes* genera for possible addition to the injurious wildlife list under the Lacey Act. The regulations contained in 50 CFR part 16 implement the Lacey Act, as amended. Under the terms of the injurious wildlife provisions of the Lacey Act, the Secretary of the Interior is authorized to prohibit the importation and interstate transportation of species designated by the Secretary as injurious. Injurious wildlife are those species, offspring, and eggs that are injurious or potentially injurious to wildlife and wildlife resources, to human beings, and to the interests of forestry, horticulture, or agriculture of the United States. Wild mammals, wild birds, fish, mollusks, crustaceans, amphibians, and reptiles are the only organisms that can be added to the injurious wildlife list. The lists of injurious wildlife are at 50 CFR 16.11-16.15. If the process initiated by this notice results in the addition of a species to the list of injurious wildlife contained in 50 CFR part 16, their importation into or transportation between States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States would be prohibited, except by permit for zoological, educational, medical, or scientific purposes (in accordance with permit regulations at 50 CFR 16.22), or by Federal agencies without a permit solely for their own use. Public Comments This notice of inquiry solicits biological, economic, or other data on adding species in the *Python, Boa* and *Eunectes* genera to the list of injurious wildlife. This information, along with other sources of data, will be used to determine if these species are a threat, or potential threat, to those interests of the United States delineated above, and thus warrant addition to the list of injurious reptiles in 50 CFR 16.15. You may submit your comments and materials concerning this notice of inquiry by one of the methods listed in the ADDRESSES section. We will not accept comments sent by e-mail or fax or to an address not listed in the ADDRESSES section. We will not accept anonymous comments; your comment must include your first and last name, city, State, country, and postal

(zip)code. Finally, we will not consider hand-delivered comments that we do not receive, or mailed comments that are not postmarked, by the date specified in the DATES section. We will post your entire comment—including your personal identifying information—on *http://www.regulations.gov.* If you provide personal identifying information in addition to the required items specified in the previous paragraph, such as your street address, phone number, or e-mail address, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Comments and materials we receive, as well as supporting documentation we used in preparing this notice of inquiry, will be available for public inspection on *http://www.regulations.gov,* or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Arlington, VA 22203. We are soliciting public comments and supporting data to gain additional information and specifically seek comment on the following questions:

(1)What regulations does your State have pertaining to the use, transport, or production of *Python, Boa* and *Eunectes* genera?

(2)How many species in the *Python, Boa* and *Eunectes* genera are currently in production for wholesale or retail sale, and in how many and which States?

(3)How many businesses sell *Python, Boa* or *Eunectes* species?

(4)How many businesses breed *Python, Boa* or *Eunectes* species?

(5)What are the annual sales for *Python, Boa* or *Eunectes* species?

(6)Please provide the number of *Python, Boa* or *Eunectes* species, if any, permitted within each State.

(7)What would it cost to eradicate *Python, Boa* or *Eunectes* individuals or populations, or similar species, if found?

(8)What are the costs of implementing propagation, recovery, and restoration programs for native species that are affected by *Python, Boa* or *Eunectes* species, or similar snake species?

(9)What State-listed species would be impacted by the introduction of *Python, Boa* or *Eunectes* species?

(10)What species have been impacted, and how, by *Python, Boa* or *Eunectes* species? Dated: January 11, 2008. Lyle Laverty, Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. E8-1770 Filed 1-30-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 216 [Docket No. 071105649-8028-01] RIN 0648-AW22 Marine Mammals: Advanced Notice of Proposed Rulemaking AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Advance notice of proposed rulemaking; request for comments. SUMMARY: NMFS is considering proposing changes to its implementing regulations governing the taking of stranded marine mammals under section 109(h), section 112(c), and Title IV of the Marine Mammal Protection Act (MMPA), and is soliciting public comment to better inform the process. The taking of stranded marine mammals and release of rehabilitated marine mammals to the wild is governed by the MMPA and NMFS implementing regulations. NMFS intends to clarify requirements and procedures for responding to stranded marine mammals and for determining the disposition of rehabilitated marine mammals, which includes procedures for the placement of non-releasable animals and for authorizing the retention of releasable rehabilitated marine mammals for scientific research, enhancement, or public display. Any other recommendations received in response to this Advanced Notice of Proposed Rulemaking

(ANPR)(see DATES and ADDRESSES ) will be considered prior to proposed rulemaking. DATES: Written comments must be received at the appropriate address or facsimile

(fax)number (see ADDRESSES ) no later than 5 p.m. local time on March 31, 2008. ADDRESSES: You may submit comments, identified by “RIN 0648-AW22,” by any one of the following methods: • Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal *http://www.regulations.gov* ; • Fax:

(301)427-2525, Attn: Stranding Regulations ANPR • Mail: Chief, Marine Mammal and Sea Turtle Division, Attn: Stranding Regulations ANPR, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13635, Silver Spring, MD 20910. Instructions: All comments received are a part of the public record and will generally be posted to *http://www.regulations.gov* without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only. FOR FURTHER INFORMATION CONTACT: Sarah Howlett, Fishery Biologist, Office of Protected Resources, NMFS, at

(301)713-2322, ext. 202. SUPPLEMENTARY INFORMATION: NMFS has the authority, delegated from the Secretary of Commerce, to take stranded marine mammals under section 109(h) of the MMPA (16 U.S.C. 1379) and to establish and manage the Marine Mammal Health and Stranding Response Program (MMHSRP) under Title IV of the MMPA (16 U.S.C. 1421 *et seq.* ). Title IV of the MMPA charges the Secretary of Commerce to develop and maintain a marine mammal health and stranding response program with three goals:

(1)Facilitate the collection and dissemination of reference data on the health of marine mammals and health trends of marine mammal populations in the wild;

(2)correlate the health of marine mammals and marine mammal populations, in the wild, with available data on physical, chemical, and biological environmental parameters; and

(3)coordinate effective responses to unusual mortality events by establishing a process in the Department of Commerce in accordance with section 404 of the MMPA. Under the MMHSRP, NMFS has the authority to: enter into agreements with persons to take marine mammals in response to a stranding (in accordance with section 112(c) of the MMPA); collect information on procedures and practices for rescue and rehabilitation of stranded marine mammals; develop criteria and provide guidance for determining the releasability of a rehabilitated marine mammal to the wild; and collect information on strandings, life history, and reference level data. The National Marine Mammal Stranding Network (Network) is a major component of the MMHSRP. The Network consists of organizations nationwide that respond to stranded cetaceans and pinnipeds (except walrus) on land and within U.S. waters. These organizations are authorized through Stranding Agreements issued by NMFS under section 112(c) of the MMPA or through section 109(h), which authorizes Federal, state, and local government employees to take marine mammals in the course of their official duties. Organizations involved in the Network include academic institutions, museums, government agencies, Native American tribes and Alaska Native communities, non-profit and for-profit organizations, and individuals. The regulations in 50 CFR 216.22 implement MMPA sections 109(h)(1)(A) and (B); and 109(h)(3) (16 U.S.C. 1379- Federal Cooperation With States) and were last updated in 1991. NMFS is considering updating § 216.22 to be consistent with the 1994 Amendments to the MMPA, and broadening the scope to include other authorized activities including: MMPA sections 109(h)(1)(C) and 109(h)(2) (16 U.S.C. 1379); section 112(c) (16 U.S.C. 1382- Regulations and Administration); section 403 (16 U.S.C. 1421b—Stranding Response Agreements), and possibly other aspects of Title IV—Marine Mammal Health and Stranding Response, of the MMPA (16 U.S.C. 1421). The regulations in 50 CFR 216.27 implement MMPA section 402(a) (16 U.S.C. 1421a—Determination; Data Collection and Dissemination) and were last updated in 1996. NMFS is considering updating § 216.27 to clarify procedures and requirements for: rehabilitated marine mammal release determinations, which are defined in the draft *Policies and Best Practices for Marine Mammal Stranding Response, Rehabilitation, and Release* (Policies and Best Practices), disposition of non-releasable animals; data and sample collection; euthanasia of stranded marine mammals; and public viewing of marine mammals in rehabilitation. The MMHSRP is currently undergoing a programmatic National Environmental Policy Act review, which includes the finalization and issuance of the Policies and Best Practices. The notice of availability for the Draft Programmatic Environmental Impact Statement

(PEIS)was published in the **Federal Register** on March 16, 2007 (72 FR 12610). The Draft PEIS, Policies and Best Practices, and other supporting documents are available on the MMHSRP website: *http://www.nmfs.noaa.gov/pr/health/eis.htm* . The Final PEIS is anticipated in early 2008. The following paragraphs contain potential regulatory changes being considered by NMFS. The regulatory sections under consideration can be found at 50 CFR 216.3, 216.22, 216.26, and 216.27. The specific parts and subparts are identified below and are either followed by recommendations from NMFS on possible alternatives or changes to the current language, or a general solicitation by NMFS for public comments pertaining to that section. In § 216.3, a number of new terms have been introduced into the implementing guidelines, protocols, and policies, and terms may currently be used differently than when they were first defined. New definitions may need to be included or current definitions may need to be revised in order to reflect these changes. For example, the definition of a “stranded marine mammal” may be clarified or expanded. Are there existing definitions relevant to marine mammal strandings that need clarification or expansion? Are there any new definitions pertaining to stranded marine mammals that need to be added to these regulations? In § 216.22 (a), we are considering expanding this paragraph to include all persons authorized to respond to stranded marine mammals, including Federal, state, and local government employees (government employees) (MMPA section 109(h)(1)) and any non-governmental persons designated under MMPA section 112(c). Should regulations for government employees and 112(c) designated responders be combined in the same section or in separate sections? Should all stranding responders, regardless of whether they are a government employee or a designated responder (authorized by a Stranding Agreement), be required to follow the same procedures for taking stranded marine mammals, including following the same animal handling and treatment, data collection, and reporting requirements? If so, should these regulations provide specific policies or procedures that government employees must follow and specify what these government stranding responders operating under section 109(h) of the MMPA should and should not do, similar to those established in Stranding Agreements for responders designated under MMPA section 112(c)? NMFS may also clarify that “taking” includes euthanasia, as specified in MMPA section 109(h)(1), and add paragraph § 216.22(a)(4) to further address euthanasia. NMFS proposes to list acceptable humane methods of euthanasia in the regulations, as defined in the draft Policies and Best Practices. Should euthanasia methods be part of NMFS policy and referred to in regulations or should they be specifically included in regulations? Should NMFS add criteria regarding qualifications necessary to obtain authorization to perform euthanasia of a stranded marine mammal and criteria for the use of firearms to accomplish euthanasia? Any recommendations on the subject of euthanasia will be considered. In § 216.22(a)(3), NMFS is planning to publish the minimum requirements for stranding responders, defined in the Policies and Best Practices, including:

(1)criteria for receiving designation under MMPA section 112(c);

(2)criteria for maintaining good standing under section 112(c) designation;

(3)standards for maintaining marine mammals in rehabilitation;

(4)data collection required under MMPA sections 402(b)(3) (stranding information by NMFS region), 402(b)(4) (other life history and reference level data), and 402(c) (availability of collected stranding data and information); and

(5)carcass disposal (acceptable methods and protocols; Federal, state, and local environmental laws and jurisdiction; private land owner considerations, etc.). NMFS may also add provisions for taking and transporting samples from live stranded animals for diagnostic analysis and/or archiving, and criteria and procedures for revoking MMPA section 112(c) agreements. In § 216.22(b), NMFS may also change the reporting requirements (i.e., information required and frequency of reporting) for government officials and employees to be the same as the reporting requirements for stranding network participants designated under MMPA section 112(c). Section 112(c) agreement holders are required to submit Level A data within 30 days of a stranding event per their Stranding Agreement; NMFS proposes to include this as a regulatory requirement. Level A data includes, but is not limited to, location information, animal disposition, morphological data, whether or not the animal was necropsied, and carcass/specimen disposition. The complete required Level A data can be found on the following website: *http://www.nmfs.noaa.gov/pr/pdfs/health/levela.pdf* . Given the increased number of disease outbreaks observed in marine mammals that have population level effects and the potential for transmission of diseases from marine mammals to humans, NMFS is proposing to incorporate language in this paragraph to require disease reporting or sample submission for specific diseases from all stranding responders (those designated under MMPA sections 109(h) and 112(c)). In § 216.22 (c), NMFS is considering deleting the word “salvage” and utilizing a term relevant to taking samples from both live and dead stranded animals. In § 216.22(c)(1), NMFS is considering expanding the purposes of sample collection to include diagnostic purposes, in addition to research, curation, and educational purposes. In § 216.22(c)(2), NMFS intends to expand the scope of this paragraph to include live animals and modify reporting requirements, including Level A data collection and submission. Is the 30-day reporting requirement and information required adequate? Should special reporting provisions for die-off or disease outbreak events be required? In § 216.22(c)(3), NMFS recognizes a significant need for a standard method of identifying an animal so that each animal is recorded only once (to avoid “double-counting”) and so that NMFS can ensure that parts and samples will be traced back to the original stranding (or other legal take) for scientific, diagnostic, and management purposes. NMFS intends to develop a specific numbering system that allows responders to assign a unique number in the field which would be used in the Marine Mammal National Database. This numbering system would not replace organizational/institutional numbering systems, but may require responders to add a field to their databases. In § 216.22(c)(4), Is it acceptable, for example, to use marine mammal tissues in research to develop a commercial vaccine that can be sold, where the vaccine itself is not composed in part or whole of any marine mammal? NMFS intends to clarify the language regarding reimbursement from recipients for services and transportation costs associated with transferring stranded animal samples or parts. In § 216.22(c)(5), NMFS is considering combining regulations governing the transfer of parts taken under this paragraph with § 216.37 Marine Mammal Parts (May 10, 1996; 61 FR 21937) and having one section of the regulations covering transfers of any marine mammal part legally taken (during scientific research, subsistence harvest, stranding, etc.). NMFS is also considering establishing criteria under which cell cultures and cell lines of tissues collected from stranded marine mammals may be developed, used, or transferred for research, diagnostic, treatment, or archival purposes. In § 216.22(c)(7), NMFS is proposing to include a provision for allowing Regional Administrators and Office Directors, as well as the Assistant Administrator, to authorize export and re-import of stranded animal parts for diagnostic testing, research, education, and curatorial purposes under these regulations, and combine this paragraph with parts transfer procedures under § 216.37. § 216.22(c)(8), Are there any other exceptions that should be considered (e.g., transferring carcasses for necropsy training workshops)? § 216.26, NMFS intends to clarify the scope and procedures within this paragraph, including whether they apply to ESA-listed species and/or how to properly manage parts from endangered species under these circumstances. Should NMFS consolidate § 216.26 with other parts sections to simplify the information and procedures? Is there any other clarification required in this section, such as whether this section would be applicable to a hard part with soft tissue still attached? In § 216.27, in paragraph

(a)Release requirements, NMFS intends to publish regulatory requirements and/or standards for releasing rehabilitated marine mammals to the wild based on the draft Policies and Best Practices. Do any of the administrative procedures need to be clarified or modified, and if so, in what way? NMFS proposes these regulatory requirements to include a standardized health certificate for rehabilitated marine mammals to be completed prior to their release to the wild and retention of these records. What are the necessary components of this health certificate and the appropriate retention time for records? In § 216.27(b), NMFS may clarify the procedures for making a non-releasable or postponed release determination and provide further guidance on procedures in paragraphs (b)(3)(i) and

(ii)regarding making a request to retain or transfer custody of a non-releasable marine mammal, and when euthanasia is appropriate. Any comments on these sections would be appreciated. In § 216.27(c), NMFS may develop a standardized method for making disposition decisions, including procedures for the placement of non-releasable animals for public display, research, or enhancement purposes and for informing facilities of the availability of non-releasable marine mammals. How should facilities be notified of the availability of non-releasable animals? How should NMFS determine the placement of marine mammals? This would include decisions on which facility receives the animal and what purpose the animal would be used for (scientific research or public display). Should NMFS have standard criteria to use to determine where to place an animal (e.g., pool size, availability of suitable conspecifics, distance of transport, etc.)? How much flexibility is necessary for these criteria? NMFS may clarify this paragraph to state that a special exemption permit is required to retain a stranded marine mammal that was determined to be releasable to the wild following rehabilitation for scientific research, enhancement, or public display. Any recommendations on how these processes should be implemented and what concerns there are associated with disposition determinations would be appreciated. In § 216.27(c)(5), Should marine mammals undergoing rehabilitation or pending disposition determination be subject to public viewing? If not, provide justification. If so, under what circumstances and why? And, if so, does NMFS need to clarify the definition of public viewing for animals undergoing rehabilitation to differentiate this from permanently captive animals on public display? Would public viewing of rehabilitating marine mammals have an effect on their chances for survival post-release? NMFS understands the significant public interest in animals undergoing rehabilitation, however public access to sick or injured animals does carry some risks to the animals and public health. NMFS proposes to provide guidelines or regulations on public access to marine mammals undergoing rehabilitation. What should NMFS include in these guidelines or regulations and how should they be implemented? In § 216.27(c)(6), Does NMFS need to further define or clarify what activities would qualify as intrusive research on a marine mammal undergoing rehabilitation, based on the definition in § 216.3, or qualify the procedures for making this determination for animals undergoing rehabilitation? Should NMFS require Institutional Animal Care and Use Committee (IACUC) review before intrusive research occurs on animals in rehabilitation? Public Involvement NMFS invites the public to submit written comments (see DATES and ADDRESSES ) on the current regulations, recommended changes to the current regulations and any relevant issues pertaining to stranding response activities for consideration during the future proposed rulemaking. Be as specific as possible when providing draft language. NMFS does not intend to convene public meetings associated with this ANPR. Comments and recommendations received in response to this ANPR will be reviewed as part of a proposed rulemaking, which may be the next step in this regulatory process. Dated: January 24, 2008. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. [FR Doc. E8-1666 Filed 1-30-08; 8:45 am] BILLING CODE 3510-22-S 73 21 Thursday, January 31, 2008 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Docket No. AMS-LS-07-0131] United States Standards for Livestock and Meat Marketing Claims, Naturally Raised Claim for Livestock and the Meat and Meat Products Derived From Such Livestock AGENCY: Agricultural Marketing Service, USDA. ACTION: Reopening and Extension of the Comment Period. SUMMARY: The Agricultural Marketing Service

(AMS)is reopening and extending the comment period for the proposed voluntary standard for a naturally raised marketing claim that was published in the **Federal Register** on November 28, 2007 (72 FR 67266). DATES: Comments must be received by March 3, 2008 to be assured of consideration. ADDRESSES: Interested persons are invited to submit written comments concerning this proposal. Comments should be submitted through the Web site at *http://www.regulations.gov.* Send written comments to: Naturally Raised Marketing Claim, Room 2607-S, AMS, USDA, 1400 Independence Avenue, SW., Washington, DC 20250-0254, or by facsimile to

(202)720-1112. All comments should reference the docket number. Comments received will be posted on the Web site at *http://www.regulations.gov* and will be made available for public inspection at the above physical address during regular business hours. FOR FURTHER INFORMATION CONTACT: Martin E. O'Connor, Chief, Standards, Analysis, and Technology Branch, Livestock and Seed Program, AMS, USDA, Room 2607-S, 1400 Independence Avenue, SW., Washington, DC 20250-0254; facsimile:

(202)720-1112; telephone:

(202)720-4486; or e-mail: *Martin.OConnor@usda.gov.* Additional information can also be found by accessing the Web site at *http://www.ams.usda.gov/lsg/stand/naturalclaim.htm.* SUPPLEMENTARY INFORMATION: Section 203(c) of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1622), directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” USDA is committed to carrying out this authority in a manner that facilitates the marketing of agricultural products. One way of achieving this objective is through the development and maintenance of voluntary standards by AMS. AMS is seeking comments on a proposed voluntary U.S. Standard for Livestock and Meat Marketing Claims, Naturally Raised Claim for Livestock and the Meat and Meat Products Derived from such Livestock, in accordance with procedures that are contained in Title 7 Part 36 of the Code of Federal Regulations. On November 28, 2007, AMS published a notice (72 FR 67266) with request for comments for the proposed voluntary standard for a naturally raised marketing claim. The comment period closed on January 28, 2008. However, a number of interested producers, processors, and marketers have requested additional time to evaluate the full impact of the requirements of the proposed standard in order to provide more meaningful and substantive comments. Therefore, AMS has determined that there is sufficient justification to reopen and extend the comment period. Authority: 7 U.S.C. 1621-1627. Dated: January 25, 2008. Kenneth C. Clayton, Acting Administrator, Agricultural Marketing Service. [FR Doc. E8-1722 Filed 1-30-08; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Forest Service San Juan National Forest; Columbine Ranger District; Colorado; Hermosa Landscape Grazing Analysis; Correction AGENCY: Forest Service, USDA. ACTION: Notice of intent to prepare an environmental impact statement; correction. SUMMARY: The San Juan National Forest published a document in the **Federal Register** of January 17, 2008, giving notice of intent to prepare an Environmental Impact Statement. The document contained incorrect location information in the Summary. FOR FURTHER INFORMATION CONTACT: Cam Hooley, 970-884-1414, *chooley@fs.fed.us.* Correction In the **Federal Register** of January 17, 2008, in FR Doc. E8-749, on page 3234, in the third column, correct the “Summary” caption to read: SUMMARY: The San Juan National Forest proposes to continue to authorize livestock grazing on all or portions of the Hermosa Landscape in a manner that moves resource conditions toward desired on-the-ground conditions and is consistent with Forest Plan standards and guidelines. The analysis area encompasses approximately 122,000 acres on three active cattle allotments (Elbert Creek, Dutch Creek, and Upper Hermosa) and four vacant cattle allotments (Cascade, Forebay, Hope Creek, and South Fork). The area is located north of Durango, Colorado, in San Juan and La Plata Counties, in Townships 37-40 North, Ranges 8-11 West, N.M.P.M. and is within the Columbine Ranger District, San Juan National Forest, Colorado. The proposed action is designed to increase the flexibility of livestock grazing systems through adaptive management, which will allow quicker and more effective response to problems areas when they are revealed. Problems will be revealed through the use of short and long term monitoring. Application of adaptive management practices should result in healthier soil, watershed, and vegetative conditions. Dated: January 25, 2008. Pauline E. Ellis, District Ranger/Field Office Manager. [FR Doc. E8-1728 Filed 1-30-08; 8:45 am] BILLING CODE 3410-11-P COMMISSION ON CIVIL RIGHTS Sunshine Act Notice AGENCY: United States Commission on Civil Rights. ACTION: Notice of meeting and briefing. Date and Time: Friday, February 8; 9 a.m. Place: U.S. Commission on Civil Rights, 624 Ninth Street, NW., Rm. 540, Washington, DC 20425. Meeting Agenda I. Approval of Agenda II. Approval of Minutes of January 11 Meeting III. Management and Operations • Transition Issues IV. Adjourn Meeting Briefing Agenda Topic: Religious Discrimination in Prisons I. Introductory Remarks by Chairman II. Speakers' Presentations III. Questions by Commissioners and Staff Director IV. Adjourn Briefing Contact Person for Further Information: Sock-Foon MacDougall, Acting Chief, Public Affairs Unit

(202)376-8582. Dated: January 29, 2008. David Blackwood, General Counsel. [FR Doc. 08-461 Filed 1-29-08; 2:27 pm]

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