        DEPARTMENT OF TRANSPORTATION
        Federal Railroad Administration
        49 CFR Part 236
        [Docket No. FRA-2011-0028, Notice No. 2]
        RIN 2130-AC27
        Positive Train Control Systems

          AGENCY:
          Federal Railroad Administration (FRA), Department of Transportation (DOT).

          ACTION:
          Notice of public hearing and extension of comment period.

          SUMMARY:

          On August 24, 2011, FRA published a notice of proposed rulemaking that would remove regulatory provisions requiring railroads to either conduct further analyses or meet certain risk-based criteria in order to avoid positive train control (PTC) system implementation on track segments that do not transport poison- or toxic-by-inhalation (PIH) hazardous materials traffic and are not used for intercity or commuter rail passenger transportation as of December 31, 2015. FRA is announcing a public hearing to provide interested persons an opportunity to provide comments on the proposal and to discuss further development of the regulation. The Rail Safety Improvement Act of 2008 requires the implementation of PTC systems. FRA is also extending the comment period for this proceeding to allow time for interested parties to submit comments after the public hearing.

          DATES:
          A public hearing will be held on November 10, 2011, in Washington, DC and will commence at 9 a.m. The comment period in this proceeding is extended to November 25, 2011.

          ADDRESSES:

            Public Hearing. The public hearing will be held at the Washington Plaza Hotel, 10 Thomas Circle, NW., Washington, DC 20005.

            Attendance: Any persons wishing to make a statement at the hearing should notify Michelle Silva in FRA's Office of Chief Counsel by telephone, e-mail, or in writing, at least five business days before the date of the hearing. Ms. Silva's contact information is as follows: FRA, Office of Chief Counsel, Mail Stop 10, 1200 New Jersey Avenue, SE., Washington, DC 20590; telephone: 202-493-6030; e-mail: michelle.silva@dot.gov. For information on facilities or services for persons with disabilities or to request special assistance at the meeting, please contact by telephone or e-mail as soon as possible, Larry Woolverton at 202-493-6212 or larry.woolverton@dot.gov.

          FOR FURTHER INFORMATION CONTACT:

          Thomas McFarlin, Office of Safety Assurance and Compliance, Staff Director, Signal & Train Control Division, Federal Railroad Administration, Mail Stop 25, West Building 3rd Floor West, Room W35-332, 1200 New Jersey Avenue, SE., Washington, DC 20590 (telephone: 202-493-6203); or Jason Schlosberg, Trial Attorney, Office of Chief Counsel, RCC-10, Mail Stop 10, West Building 3rd Floor, Room W31-207, 1200 New Jersey Avenue, SE., Washington, DC 20590 (telephone: 202-493-6032).

        SUPPLEMENTARY INFORMATION:

        The purpose of the hearing is to receive oral comments in response to a notice of proposed rulemaking (NPRM) proposing amendment of the regulations requiring certain railroads to implement PTC systems. See 76 FR 52918 (Aug. 24, 2011). Interested parties are invited to present oral statements and to proffer information and views at the hearing. The hearing will be informal and will be conducted by a representative designated by FRA in accordance with FRA's Rules of Practice (49 CFR 211.25). The hearing will be a non-adversarial proceeding; therefore, there will be no cross examination of persons presenting statements or proffering evidence. An FRA representative will make an opening statement outlining the scope of the hearing. After all initial statements have been completed; those persons wishing to make a brief rebuttal will be given the opportunity to do so in the same order in which the initial statements were made. Additional procedures, as necessary for the conduct of the hearing, will be announced at the hearing. A transcript of the discussions will be made part of the public docket in this proceeding.

          Public Participation Procedures. Any person wishing to participate in the public hearing should notify FRA by mail or at the address or fax number provided in the Attendance section of this notice at least five working days prior to the date of the hearing and submit three copies of the oral statement that he or she intends to make at the proceeding. The notification should identify the party the person represents, the particular subject(s) the person plans to address, and the time requested. The notification should also provide the Docket Clerk with the participant's mailing address and other contact information. FRA reserves the right to limit participation in the hearing of persons who fail to provide such notification. FRA reserves the right to limit the duration of presentations if necessary to afford all persons with the opportunity to speak.

          Extension of Comment Period. A public hearing has been scheduled after the close of the comment period specifically provided for in the notice of proposed rulemaking. To accommodate the public hearing and to afford interested parties the opportunity to submit comments in response to views or information provided at the public hearing, FRA is extending the comment period in this proceeding to November 25, 2011.

          Issued in Washington, DC, on October 11, 2011.
          Jo Strang,
          Associate Administrator for Railroad Safety/Chief Safety Officer, Federal Railroad Administration.

      [FR Doc. 2011-26594 Filed 10-13-11; 8:45 am]
      BILLING CODE 4910-06-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 82
        [EPA-HQ-OAR-2006-0158; FRL-8157-3]
        RIN 2060-AN29
        Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2006

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          EPA is proposing to allocate essential use allowances for import and production of class I stratospheric ozone depleting substances (ODSs) for calendar year 2006. Essential use allowances enable a person to obtain controlled class I ODSs as part of an exemption to the regulatory ban on the production and import of these chemicals which became effective as of January 1, 1996. EPA allocates essential use allowances for exempted production or import of a specific quantity of class I ODS solely for the designated essential purpose. The proposed allocations total 1,002.40 metric tons of chlorofluorocarbons (CFCs) for use in metered dose inhalers for 2006.

          DATES:

          Written comments on this proposed rule must be received by the EPA Docket on or before May 11, 2006, unless a public hearing is requested. Comments must then be received on or before May 22, 2006. Any party requesting a public hearing must notify the contact listed below under FOR FURTHER INFORMATION CONTACT by 5 p.m. Eastern Standard Time on April 17, 2006. If a hearing is held, it will take place on April 21, 2006 at EPA headquarters in Washington DC. EPA will post a notice on our Web site http://www.epa.gov/ozone announcing further information on the hearing if it is requested.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2006-0158, by one of the following methods:
          • http://www.regulations.gov: Follow the on-line instructions for submitting comments.
          • E-mail: A-and-R-docket@epa.gov

          • Fax: 202-343-2337, attn: Hodayah Finman
          • Mail: Air Docket, Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
          • Hand Delivery or Courier. Deliver your comments to: EPA Air Docket, EPA West 1301 Constitution Avenue, NW., Room B108, Mail Code 6102T, Washington, D.C. 20460. 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-HQ-OAR-2006-0158. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://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 http://www.regulations.gov or e-mail. The http://www.regulations.gov website 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 http://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. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

            Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the Air Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Air Docket is (202) 566-1742.

          FOR FURTHER INFORMATION CONTACT:

          Hodayah Finman, Team Leader, by regular mail: U.S. Environmental Protection Agency, Stratospheric Protection Division (6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; by courier service or overnight express: 1301 L Street, NW., Room 827M Washington DC 20005, by telephone: 202-343-9246; or by e-mail: finman.hodayah@epa.gov.

        SUPPLEMENTARY INFORMATION:

          Table of Contents
          I. General Information
          A. What Should I Consider When Preparing My Comments?
          II. Basis for Allocating Essential Use Allowances
          A. What are essential use allowances?
          B. Under what authority does EPA allocate essential use allowances?
          C. What is the process for allocating essential use allowances?
          III. Essential Use Allowances for Medical Devices
          IV. Proposed Allocation of Essential Use Allowances for Calendar Year 2006
          V. Statutory and Executive Order Reviews
          A. Executive Order 12866: Regulatory Planning and Review
          B. Paperwork Reduction Act
          C. Regulatory Flexibility Act
          D. Unfunded Mandates Reform Act
          E. Executive Order 13132: Federalism
          F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
          G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

          H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

          I. National Technology Transfer and Advancement Act

        I. General Information
        A. What Should I Consider When Preparing My Comments?
        1. Confidential Business Information
        Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
        2. Tips for Preparing Your Comments
        When submitting comments, remember to:

        • Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).
        • Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
        • Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
        • Describe any assumptions and provide any technical information and/or data that you used.
        • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
        • Provide specific examples to illustrate your concerns, and suggest alternatives.
        • Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
        • Make sure to submit your comments by the comment period deadline identified.
        II. Basis for Allocating Essential Use Allowances
        A. What are essential use allowances?
        Essential use allowances are allowances to produce or import certain ozone-depleting chemicals in the U.S. for purposes that have been deemed “essential” by the Parties to the Montreal Protocol and the U.S. Government.
        The Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol) is the international agreement aimed at reducing and eliminating the production and consumption of stratospheric ozone-depleting substances. The elimination of production and consumption of class I ODSs is accomplished through adherence to phase-out schedules for specific class I ODSs 1
          , including: chlorofluorocarbons (CFCs), halons, carbon tetrachloride, and methyl chloroform. As of January 1, 1996, production and import of most class I ODSs were phased out in developed countries, including the United States.

            1 Class I ozone-depleting substances are listed at 40 CFR Part 82 subpart A, appendix A.

        However, the Protocol and the Clean Air Act (Act) provide exemptions that allow for the continued import and/or production of class I ODS for specific uses. Under the Protocol, exemptions may be granted for uses that are determined by the Parties to be “essential.” Decision IV/25, taken by the Parties to the Protocol in 1992, established criteria for determining whether a specific use should be approved as essential, and set forth the international process for making determinations of essentiality. The criteria for an essential use, as set forth in paragraph 1 of Decision IV/25, are the following:

          “(a) that a use of a controlled substance should qualify as ‘essential’ only if:
          (i) it is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects); and
          (ii) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;
          (b) that production and consumption, if any, of a controlled substance for essential uses should be permitted only if:
          (i) all economically feasible steps have been taken to minimize the essential use and any associated emission of the controlled substance; and
          (ii) the controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, also bearing in mind the developing countries' need for controlled substances.”

        B. Under what authority does EPA allocate essential use allowances?
        Title VI of the Act implements the Protocol for the United States.2
           Section 604(d) of the Act authorizes EPA to allow the production of limited quantities of class I ODSs after the phase out date for the following essential uses:

            2 According to Section 614(b) of the Act, Title VI “shall be construed, interpreted, and applied as a supplement to the terms and conditions of the Montreal Protocol * * * and shall not be construed, interpreted, or applied to abrogate the responsibilities or obligations of the United States to implement fully the provisions of the Montreal Protocol. In the case of conflict between any provision of this title and any provision of the Montreal Protocol, the more stringent provision shall govern.” EPA's regulations implementing the essential use provisions of the Act and the Protocol are located in 40 CFR part 82.

        (1) Methyl Chloroform, “solely for use in essential applications (such as nondestructive testing for metal fatigue and corrosion of existing airplane engines and airplane parts susceptible to metal fatigue) for which no safe and effective substitute is available.” Under section 604(d)(1) of the Act, this exemption was available only until January 1, 2005.
        (2) Medical Devices (as defined in section 601(8) of the Act), “if such authorization is determined by the Commissioner [of the Food and Drug Administration], in consultation with the Administrator [of EPA] to be necessary for use in medical devices.” EPA issues allowances to manufacturers of metered-dose inhalers, which use CFCs as propellant for the treatment of asthma and chronic obstructive pulmonary diseases.
        (3) Aviation Safety, for which limited quantities of halon-1211, halon-1301, and halon-2402 may be produced “if the Administrator of the Federal Aviation Administration, in consultation with the Administrator [of EPA] determines that no safe and effective substitute has been developed and that such authorization is necessary for aviation safety purposes.” Neither EPA nor the Parties have ever granted a request for essential use allowances for halon, because alternatives are available or because existing quantities of this substance are large enough to provide for any needs for which alternatives have not yet been developed.

        The Protocol, under Decision X/19, additionally allows a general exemption for laboratory and analytical uses. This exemption is reflected in EPA's regulations at 40 CFR part 82, subpart A. While the Act does not specifically provide for this exemption, EPA has determined that an exemption for essential laboratory and analytical uses is allowable under the Act as a de minimis exemption. The de minimis exemption is addressed in EPA's final rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol subsequently agreed (Decision XI/15) that the general exemption does not apply to the following uses: testing of oil and grease, and total petroleum hydrocarbons in water; testing of tar in road-paving materials; and forensic finger-printing. EPA incorporated this exclusion at Appendix G to Subpart A of 40 CFR part 82 on February 11, 2002 (67 FR 6352). In a December 29, 2005 final rule, EPA extended the general exemption for laboratory and analytical uses through December 31, 2007 (70 FR 77048), in accordance with Decision XV/8 of the Parties to the Protocol.
        C. What Is the Process for Allocating Essential Use Allowances?
        Before EPA may allocate essential use allowances, the Parties to the Protocol must first approve the United States' request to produce or import essential class I ODSs. The procedure set out by Decision IV/25 calls for individual Parties to nominate essential uses and the total amount of ODSs needed for those essential uses on an annual basis. The Protocol's Technology and Economic Assessment Panel evaluates the nominated essential uses and makes recommendations to the Protocol Parties. The Parties make the final decisions on whether to approve a Party's essential use nomination at their annual meeting. This nomination cycle occurs approximately two years before the year in which the allowances would be in effect. The allowances allocated through today's action were first nominated by the United States in January 2004.
        Once the U.S. nomination is approved by the Parties, EPA allocates essential use exemptions to specific entities through notice-and-comment rulemaking in a manner consistent with the Act. For medical devices, EPA requests information from manufacturers about the number and type of devices they plan to produce, as well as the amount of CFCs necessary for production. EPA then forwards the information to the Food and Drug Administration (FDA), which determines the amount of CFCs necessary for metered-dose inhalers in the coming calendar year. Based on FDA's assessment, EPA proposes allocations to each eligible entity. Under the Act and the Protocol, EPA may allocate essential use allowances in quantities that together are below or equal to the total amount approved by the Parties. EPA may not allocate essential use allowances in amounts higher than the total approved by the Parties. For 2006, the Parties authorized the United States to allocate up to 1,100 metric tons of CFCs for essential uses.
        III. Essential Use Allowances for Medical Devices
        The following is a step-by-step list of actions EPA and FDA have taken thus far to implement the exemption for medical devices found at section 604(d)(2) of the Act for the 2006 control period.
        1. On March 24, 2005, EPA sent letters to MDI manufacturers requesting the following information under section 114 of the Act (“114 letters”):
        a. The MDI product where CFCs will be used.
        b. The number of units of each MDI product produced from 1/1/04 to 12/31/04.
        c. The number of units anticipated to be produced in 2005.
        d. The gross target fill weight per unit (grams).
        e. Total amount of CFCs to be contained in the MDI product for 2006.
        f. The additional amount of CFCs necessary for production.
        g. The total CFC request per MDI product for 2006.
        The 114 letters are available for review in the Air Docket ID No. EPA-HQ-OAR-2006-0158. The companies requested that their responses be treated as confidential business information; for this reason, EPA has not placed the responses in the docket.
        2. On July 5, 2005, EPA sent FDA the information MDI manufacturers provided in response to the 114 letters with a letter requesting that FDA make a determination regarding the amount of CFCs necessary for MDIs for calendar year 2006. This letter is available for review in Air Docket ID No. EPA-HQ-OAR-2006-0158.
        3. On October 12, 2005, FDA sent a letter to EPA stating the amount of CFCs determined by the Commissioner to be necessary for each MDI company in 2006. This letter is available for review in the Air Docket ID No. EPA-HQ-OAR-2006-0158. In their letter, FDA informed EPA that they had determined that 1,002.40 metric tons of CFCs were necessary for use in medical devices in 2006. The letter stated: “Our recommendation for the allocation of CFCs is lower than the total amount requested by sponsors. In reaching this estimate, we took into account the sponsors' production of MDIs that used CFCs as a propellant in 2004, their estimated production in 2005, their estimated production in 2006, their current stockpile levels, and the presence on the market of two albuterol MDIs that do not use CFCs. We have also based our recommendation for 2006 on an estimate of the quantity of MDIs using CFCs as a propellant that would be necessary for sponsors to maintain a 12-month stockpile, consistent with paragraph 3 of Decision XVI/12.” EPA has confirmed with FDA that this determination is consistent with Decision XVII/5, including new language on stocks that states that “Parties shall take into account pre- and post-1996 stocks of controlled substances as described in paragraph 1 (b) of decision IV/25, such that no more than a one-year operational supply is maintained by that manufacturer.”
        In accordance with the determination made by FDA, today's action proposes to allocate essential use allowances for a total of 1,002.40 metric tons of CFCs for use in MDIs for calendar year 2006.
        The amounts listed in this proposal are subject to additional review by EPA and FDA if new information demonstrates that the proposed allocations are either too high or too low. Commentors requesting increases or decreases of essential use allowances should provide detailed information supporting their claim for additional or fewer CFCs. Any company that needs less than the full amount listed in this proposal should notify EPA of the actual amount needed.
        IV. Proposed Allocation of Essential Use Allowances for Calendar Year 2006

          Table I.—Essential Use Allocation for Calendar Year 2006

            Company
            Chemical
            2006 Quantity (metric tons)

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

            Armstrong Pharmaceuticals
            CFC-11 or CFC-12 or CFC-114
            147.50

            Boehringer Ingelheim Pharmaceuticals
            CFC-11 or CFC-12 or CFC-114
            116.50

            Inyx (Aventis)
            CFC-11 or CFC-12 or CFC-114
            106.40

            Schering-Plough Corporation
            CFC-11 or CFC-12 or CFC-114
            556.00

            3M Pharmaceuticals
            CFC-11 or CFC-12 or CFC-114
            0.0

            Wyeth
            CFC-11 or CFC-12 or CFC-114
            76.0

        EPA proposes to allocate essential use allowances for calendar year 2006 to the entities listed in Table 1. These allowances are for the production or import of the specified quantity of class I controlled substances solely for the specified essential use.
        V. Statutory and Executive Order Reviews
        A. Executive Order 12866: Regulatory Planning and Review
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether this regulatory action is “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:
        (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
        (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
        (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
        (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
        It has been determined by OMB and EPA that this proposed action is not a “significant regulatory action” under the terms of Executive Order 12866, and is therefore not subject to OMB review under the Executive Order.
        Under Section 6(a)(3)(B)(ii) of Executive Order 12866, the Agency must provide to OMB's Office of Information and Regulatory Affairs an ”assessment of the potential costs and benefits of the regulatory action, including an explanation of the manner in which the regulatory action is consistent with a statutory mandate and, to the extent permitted by law, promotes the President's priorities and avoids undue interference with State, local, and tribal governments in the exercise of their governmental functions.”
        EPA is undertaking today's proposed action under the mandate established by Section 604(d) of the Clean Air Act Amendments of 1990, which directs the Administrator to authorize the production of limited quantities of class I substances solely for use in medical devices, if the Commissioner of FDA determines that the authorization is necessary. The proposed allocations in today's rule are the amounts determined by FDA to be necessary for calendar year 2006. EPA has not assessed the costs and benefits specific to today's proposed action. The Agency examined the costs and benefits associated with a related regulation. The Agency's Regulatory Impact Analysis (RIA) for the entire Title VI phaseout program examined the projected economic costs of a complete phaseout of consumption of ozone-depleting substances, as well as the projected benefits of phased reductions in total emissions of CFCs and other ozone-depleting substances, including essential-use CFCs used for metered dose inhalers (U.S. Environmental Protection Agency, “Regulatory Impact Analysis: Compliance with Section 604 of the Clean Air Act for the Phaseout of Ozone Depleting Chemicals,” July 1992).
        B. Paperwork Reduction Act

        This proposed action does not add any information collection requirements or increase burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. OMB previously approved the information collection requirements contained in the final rule promulgated on May 10, 1995, and assigned OMB control number 2060-0170 (EPA ICR No. 1432.21).
        Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 1.
        C. Regulatory Flexibility Act
        The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
        For purposes of assessing the impact of today's rule on small entities, small entity is defined as: (1) Pharmaceutical preparations manufacturing businesses (NAICS code 325412) that have less than 750 employees; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

        After considering the economic impacts of today's proposed rule on small entities, EPA certifies that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.
        This proposed rule provides an otherwise unavailable benefit to those companies that are receiving essential use allowances by creating an exemption to the regulatory phaseout of chlorofluorocarbons. We have therefore concluded that today's proposed rule will relieve regulatory burden for all small entities. We continue to be interested in the potential impact of the proposed rule on small entities and welcome comments on issues related to such impacts.
        D. Unfunded Mandates Reform Act
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year.
        Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative, if the Administrator publishes with the final rule an explanation why that alternative was not adopted.
        Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed a small government agency plan under section 203 of the UMRA. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
        Today's proposed rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector, since it merely provides exemptions from the 1996 phase out of class I ODSs. Similarly, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments, because this rule merely allocates essential use exemptions to entities as an exemption to the ban on production and import of class I ODSs.
        E. Executive Order 13132: Federalism
        Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that 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.”
        This proposed rule does not have federalism implications. It will not 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. Thus, Executive Order 13132 does not apply to this rule.
        F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
        Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This proposed rule does not have tribal implications, as specified in Executive Order 13175. Today's rule affects only the companies that requested essential use allowances. Thus, Executive Order 13175 does not apply to this rule.
        G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
        Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) is determined to be “economically significant” under E.O. 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.
        EPA interprets E.O. 13045 as applying only to those regulatory actions that are based on health or safety risks, such as the analysis required under section 5-501 of the Order has the potential to influence the regulation. This proposed rule is not subject to E.O. 13045 because it implements a mandatory requirement as per Section 604(d)(2) of the Clean Air Act which compels the Agency to allocate essential use exemptions should the Food and Drug Administration finds that the exemption is necessary.
        H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use
        This proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The rule affects only the pharmaceutical companies that requested essential use allowances.
        I. National Technology Transfer and Advancement Act

        Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rule does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

          List of Subjects in 40 CFR Part 82
          Administrative practice and procedure, Air pollution control, Chemicals, Chlorofluorocarbons, Environmental protection, Imports, Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

          Dated: April 5, 2006.
          Stephen L. Johnson,
          Administrator.

        40 CFR Part 82 is proposed to be amended as follows:

          PART 82—PROTECTION OF STRATOSPHERIC OZONE
          1. The authority citation for part 82 continues to read as follows:

            Authority:
            42 U.S.C. 7414, 7601,7671-7671q.

            Subpart A—Production and Consumption Controls

          2. Section 82.8 is amended by revising the table in paragraph (a) to read as follows:

            § 82.8
            Grants of essential use allowances and critical use allowances.
            (a) * * *

              Table I.—Essential Use Allocation for Calendar Year 2006

                Company
                Chemical
                2006 Quantity (metric tons)

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

                Armstrong Pharmaceuticals
                CFC-11 or CFC-12 or CFC-114
                147.50

                Boehringer Ingelheim Pharmaceuticals
                CFC-11 or CFC-12 or CFC-114
                116.50

                Inyx (Aventis)
                CFC-11 or CFC-12 or CFC-114
                106.4

                Schering-Plough Corporation
                CFC-11 or CFC-12 or CFC-114
                556.00

                3M Pharmaceuticals
                CFC-11 or CFC-12 or CFC-114
                0.0

                Wyeth
                CFC-11 or CFC-12 or CFC-114
                76.0

       [FR Doc. E6-5329 Filed 4-10-06; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 648
        [Docket No. 030225045-3045-01; I.D. 020603A]
        RIN 0648-AQ29
        Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Monkfish Fishery; Framework Adjustment 2

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments.

          SUMMARY:
          NMFS proposes regulations to implement Framework Adjustment 2 to the Monkfish Fishery Management Plan (FMP) developed by the New England and Mid-Atlantic Fishery Management Councils (Councils).  Pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the FMP, this proposed rule would modify the monkfish overfishing definition reference points and optimum yield (OY) target control rule to be consistent with the most recent stock assessment and other scientific information.  This rule also proposes an expedited process for setting annual target total allowable catch (TAC) and a method for adjusting monkfish trip limits and days-at-sea (DAS) allocations to achieve the annual target TACs.  Based on this method, this proposed rule would establish a target TAC and corresponding trip limits and DAS allocations for fishing year (FY) 2003.  In addition, this proposed rule would eliminate the default measures adopted in the original FMP that would result in elimination of  the directed monkfish fishery and reduce incidental catch limits.  Finally, this proposed rule would clarify the regulations pertaining to the monkfish area declaration requirements by specifying that vessels intending to fish under either a monkfish, multispecies, or scallop DAS, under the less restrictive measures of the Northern Fishery Management Area (NFMA), declare their intent to fish in the NFMA for a minimum of 30 days.

          DATES:
          Public comments must be received on or before March 24, 2003.

          ADDRESSES:
          Comments on the proposed rule should be sent to Patricia A. Kurkul, Regional Administrator (RA), Northeast Region, NMFS, One Blackburn Drive, Gloucester, MA  01930-2298.  Mark the outside of the envelope “Comments on Monkfish Framework 2.”  Comments may also be submitted via facsimile (fax) to 978-281-9135.  Comments will not be accepted if submitted via e-mail or the Internet.

          Copies of Framework Adjustment 2 to the FMP, including the Environmental Assessment (EA), Regulatory Impact Review (RIR), and the Initial Regulatory Flexibility Analysis (IRFA) are available upon request from Paul Howard, Executive Director, New England Fishery Management Council (NEFMC), 50 Water Street, Newburyport, MA, 01950.  Copies of the Framework 2 EA/RIR/IRFA are also available online at www.nefmc.org under “Plans and Reports.”

          FOR FURTHER INFORMATION CONTACT:

          Allison Ferreira, Fishery Policy Analyst, (978) 281-9103, fax (978) 281-9135, e-mail Allison.Ferreira@noaa.gov.

        SUPPLEMENTARY INFORMATION:

        The monkfish fishery is jointly managed by the Councils.  The FMP contains default measures that would eliminate the directed monkfish fishery by allocating zero monkfish DAS.  These measures were scheduled to take effect during Year 4 (May 1, 2002) of the FMP's 10-year rebuilding schedule, but were delayed until May 1, 2003, as a result of the implementation of an emergency interim rule (67 FR 35928; May 22, 2002) and its extension (67 FR 67568; November 6, 2002).  The emergency interim rule temporarily amended the fishing mortality rate (F) criteria in the FMP to be consistent with the most recent stock assessment.  The emergency rule also implemented the measures contained in Framework Adjustment 1 to the FMP (which was disapproved by NMFS in conjunction with the implementation of the emergency rule) since these measures were deemed to be consistent with the revised F criteria.
        The purpose of the proposed action is to continue the 10-year stock rebuilding program started in 1999 under the original FMP, consistent with updated scientific information.  As noted above, the FMP contains default measures that, unless eliminated or delayed, will end the directed fishery (no allocation of monkfish DAS) and reduce several of the incidental catch limits starting May 1, 2003.  The default measures were developed in the original FMP based on scientific analysis and projections done in 1997.  More recent analyses and stock assessments have indicated that the scientific basis for the default measures is no longer valid, and the measures are not appropriate.  Furthermore, the most recent stock assessment (SAW 34; January 2002) has invalidated the lower F reference points contained in the FMP, and suggested alternative reference points for the monkfish overfishing definition and control rules.  In addition to revising the overfishing definitions in the FMP to make them consistent with the best available science and the provisions of the Magnuson-Stevens Act, this action proposes to establish an expedited process for setting annual target TACs, and the necessary trip limits and/or DAS allocations to meet such target TACs.  Furthermore, this proposed rule would establish target TACs and corresponding trip limits for FY 2003 utilizing the proposed method.
        Monkfish Overfishing Definition Reference Points
        The threshold fishing mortality rate (Fthreshold) is the criterion by which the overfishing status is determined.  Framework 2 would revise the Fthreshold reference point by setting Fthreshold equal to Fmax=0.2, as recommended by the 34th Stock Assessment Workshop.  Fmax is the proxy for the fishing mortality rate that will achieve maximum sustainable yield (MSY) from a rebuilt stock.
        The minimum biomass threshold (Bthreshold) is the criterion by which a stock is determined to be overfished.  The biomass target (Btarget) is a proxy for the expected biomass at MSY (Bmsy).  The National Standard Guidelines prescribe that Bthreshold be set at whichever of the following is greater: At one-half the Btarget, or the minimum stock size at which rebuilding to Btarget would be expected to occur within 10 years, if the stock were exploited at Fthreshold.  The existing Bthresholds in the FMP were established based on the 33rd percentile of NMFS' fall trawl survey biomass index values for the years 1963-1994; Bthreshold = 1.46 kg/tow for the NFMA and Bthreshold = 0.75 kg/tow for the Southern Fishery Management Area (SFMA).  At the time the FMP was implemented, the Councils believed that this was an acceptable proxy for a risk adverse Bthreshold.  Language in the FMP, however, indicates that it is unclear how this Bthreshold relates to rebuilding because of the inability to model monkfish stock dynamics and predict rebuilding potential due to a lack of biological data on the monkfish resource.  Although a recent cooperative industry survey provided valuable biological information on the monkfish resource, there continues to be a lack of sufficient information necessary to conduct reliable projections for monkfish rebuilding, or to produce a reliable estimate of F.  As a result, it is currently not possible for NMFS to determine the minimum stock size at which rebuilding to Btarget would be expected to occur within 10 years if the stock were exploited at Fthreshold.  Because a Bthreshold of one-half the Btarget is consistent with National Standard 1, and because there are no other suitable proxies for Bthreshold given the data-poor situation, the proposed action would revise the Bthreshold values contained in the FMP to be equivalent to one-half the Btarget established for each management area.  This would establish a Bthreshold = 1.25 for the NFMA, and Bthreshold = 0.93  for the SFMA.  Under the proposed action, the Btargets established in the FMP would remain unchanged.

        The results of the 2002 NMFS fall trawl survey indicate that the 3-year average biomass index is 2.23 kg/tow for the NFMA and 0.813 kg/tow for the SFMA.  Applying the new Bthreshold criteria that would be established by this rule, the stock in the NFMA remains not overfished.  However, the stock in the SFMA, which is currently considered not overfished, would be considered overfished under the proposed revision.
        Setting Annual Target TACs and Associated Management Measures

        Framework 2 would require the Monkfish Monitoring Committee (MFMC) to submit to the Council and Regional Administrator the target TACs for the upcoming year by December 1 based on a formulaic index- and landings-based method.  This method would compare the current 3-year average biomass index (observed biomass index) values to annual biomass index targets, which are based on 10 equal increments between the 1999 biomass index (the start of the rebuilding program) and the 2009 biomass index target (Btarget), a proxy for the monkfish biomass level at MSY.  Annual target TACs would be set based on the ratio of the observed biomass index to the annual index target applied to the monkfish landings for the previous fishing year.  Once the annual target TACs are established and submitted to the RA, the RA would adjust trip limits and/or DAS, if necessary, through rulemaking consistent with the Administrative Procedures Act (APA) based on the methodology established in this framework.  If the TAC resulting from the application of the TAC setting procedures described herein does not require a change to existing management measures, then the RA would not required to take any regulatory action under the procedures established in Framework 2.
        The MFMC is currently required to meet on or before November 15 each year to review the status of the monkfish resource and develop TACs for the upcoming fishing year.  If the results of the most recent NMFS fall trawl survey are available at that time, the MFMC would incorporate these results into the formulaic method as described in this framework to establish target TACs for the upcoming fishing year.

        Under the target TAC setting method contained in Framework 2, if the observed biomass index is below the annual index target, the target TAC would be set proportionally below the previous year's landings.  If the observed biomass index is above the annual index target, the target TAC would be increased from the previous year's landings by 1/2 of the ratio of the biomass index to the index target, with certain limitations as described below.  In cases where F can be determined, the annual target TAC would always be set at a value that would not exceed Fthreshold (F=0.2).  For example, if F for the previous fishing year exceeded Fthreshold, but a reduction in the target TAC is not required under the index-based method, the target TAC would be reduced proportionally from the previous year's landings to end overfishing. When F cannot be determined and the observed biomass index is above the annual index target, the target TAC for the previous year would be increased by the method described above, but not by more than 20 percent of the previous year's landings.

        Once the stock in a management area is rebuilt (the observed biomass index is at or above Btarget),  the target TAC would be adjusted based on the ratio of current F to Fthreshold, allowing for an increase in the target TAC if F is below Fthreshold.  This would set the OY target reference point at Fthreshold.  However, if F cannot be determined and the observed biomass index is above Btarget, the target TAC would be set at no more than 20 percent above the previous year's landings.
        In the situation where landings decline from the previous fishing year and the observed biomass index is above the annual index target, the MFMC would review the circumstances surrounding the landings decline and recommend to the Councils a target TAC equivalent to either the previous year's landings or target TAC.  The Councils, after considering the MFMC's recommendation, would then recommend a target TAC to the RA regarding whether the target TAC should be set at the previous year's landings or target TAC.  If the RA concurs with this recommendation, the target TAC and associated trip limits would be promulgated through rulemaking and consistent with the requirements of the APA.  Otherwise, the RA would notify the Councils in writing of his or her reasons for non-concurrence.
        The intent of the Councils in establishing a formulaic method for setting annual target TACs, described above, was to enable the RA to set future TACs and associated management measures outside of the framework adjustment process established in the FMP.  In this proposed rule, NMFS is clarifying that the expedited process for setting annual TACs contained in the Framework 2 document is to be done through the rulemaking process specified under the APA.
        The Framework 2 document analyzes a range of target TAC alternatives for FY 2004.  The intent of this analysis is to facilitate the expedited process for annual adjustments and to provide the public with ample notice of the possible impacts of such adjustments.  The expedited annual adjustment process to be established in this framework would not preclude the Councils from initiating a framework adjustment at anytime to implement other measures deemed necessary to meet the objectives of the FMP.
        FY 2003 TACs and Possession Limits
        For FY 2003, the TACs under the proposed action would be 10,211 mt in the SFMA and 17,708 mt in the NFMA.  As a result, trip limits for monkfish limited access vessels in the SFMA would be increased from FY 2002 (May 1, 2002 - April 30, 2003) levels (550 lb (249.5 kg) tail weight per DAS for Category A and C vessels, and 450 lb (204.1 kg) tail weight per DAS for Category B and D vessels), to 1,250 lb (567 kg) tail weight per DAS for Category A and C vessels, and 1,000 lb (453.6 kg) tail weight per DAS for Category B and D vessels.  In the NFMA, there is currently no trip limit for monkfish limited access vessels while fishing under either a monkfish or Northeast (NE) multispecies DAS, and no change is proposed.  However, monkfish open-access Category E vessels fishing exclusively in the NFMA on a NE multispecies DAS would have their monkfish incidental catch limits increased from 300 lb (136.1 kg) tail weight per DAS or 25 percent of the total weight of fish on board to the lesser of 400 lb (181.4 kg) tail weight per DAS or 50 percent of total weight of fish on board.
        Revision to the Area Declaration Regulations
        Regulations implementing the FMP (64 FR 54732; October 7, 1999) specify that a vessel intending to fish for or catch monkfish under a monkfish DAS only in the NFMA must declare into the NFMA for a minimum of 30 days in order to fish under the less restrictive size and trip limits of this management area.  However, the FMP also requires vessels fishing under a multispecies or scallop DAS to declare into the NFMA in order to fish under the less restrictive measures of this area.  Because NMFS inadvertently referenced only limited access monkfish DAS vessels in the regulations implementing the FMP, Framework 2 proposes to correct the area declaration provision by requiring vessels with limited access multispecies and scallop DAS permits, in addition to vessels possessing limited access monkfish DAS permits, to declare into the NFMA for a minimum of 30 days in order to fish under the less restrictive size and trip limits of this management area.
        Revisions to Prohibitions
        Since they are ambiguous and do not contain the appropriate cross-references to the monkfish regulations specified under 50 CFR Part 648 Subpart F, this action also proposes to clarify the monkfish prohibitions found at § 648.14(y).
        Classification
        This proposed rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866 because it does not have an annual effect on the economy of 100 million dollars or more, or adversely effect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities.  The proposed action also does not raise any novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

        The Council prepared an initial regulatory flexibility analysis (IRFA) that describes the economic impact this proposed rule, if adopted, would have on small entities.  The IRFA prepared for this action by the NEFMC follows NMFS' “Guidelines for Economic Analysis of Fishery Management Actions” (NMFS' guidelines).  A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY.  A summary of the analysis follows:
        There are approximately 714 limited access monkfish permit holders, of which about 85 percent record some monkfish activity.  Of the approximately 1,900 open-access Category E permits, only about 25 percent have recorded landing monkfish.  Vessels range in size from less than 30 ft (9.14 m) to over 90 ft (27.43 m), with the median being less than 50 ft (15.24 m) in overall length.  Most of the inactive vessels (those not landing monkfish or not landing any species) are in the smaller size classes, while 70 percent of the limited access vessels over 50 ft  (15.24 m) have recorded monkfish landings.  In achieving OY from the fishery on an annual basis while rebuilding the resource to levels that will sustain MSY, the proposed action strikes a reasonable balance between biological requirements and uncertainties, and the financial requirements of small entities.

        NMFS' guidelines specify two criteria to be used for evaluating whether a proposed action is significant:  Disproportionality and profitability.  Disproportionality relates to the effect on small entities compared to large entities.  Since all entities engaged in the fishery fall under the Small Business Administration approved definition of “small entity,” this evaluation standard is not relevant to the fishery.  According to the analysis of the impact on vessels in the SFMA, relative to performance during calendar years 1998-2000, net return on monkfish-only trips would improve by 23 percent for the median and range from no change to an improvement of 78 percent at the proposed FY 2003 quota level.  Given these levels of expected change in profitability, the proposed trip limits may have a significant positive impact on limited access monkfish vessels that fish in the SFMA.  At other quota levels, median vessel performance would be reduced by 63 percent at a 5,000-mt quota, but would increase by 29 percent at a 13,000-mt quota.  In either of these two scenarios, the change in profitability would be significant; negative for the former, and positive for the latter.
        In the NFMA, the only change in management measures would be an increase in the incidental catch limit for open access Category E monkfish vessels.  During FY 2001 (May 1, 2001 - April 30, 2002), 255 Category E vessels caught monkfish in the NFMA.  Average monkfish catch by these vessels (62 lb (28.1 kg) per NE multispecies DAS) is well below the current and proposed incidental catch limits.  Therefore, in terms of improvements to participating vessels' annual profit, the proposed change is not likely to have a significant impact.  While the current trip limit does not constrain the majority of the 255 Category E vessels catching monkfish in the NFMA, the proposed increase could allow those vessels that are constrained by the current trip limit to increase their monkfish landings by as much as 33 percent without jeopardizing the stock rebuilding program.
        NMFS' guidelines state that “a rule may be determined to affect a substantial number of small entities if the rule is controversial, impacts more than just a few entities, or affects the structure of the regulated industry even though only a small number of entities may be impacted.” The proposed action may affect a substantial number of small entities because it will impact approximately 700 limited access monkfish permit holders, although not in an adverse way, by means of an increase to the trip limits for the SFMA.  An analysis of projected change in fishing performance under the proposed TACs and trip limits for FY 2003, as compared to FY 2002, indicates that the median vessel will realize a 23-percent increase in net returns on monkfish-only trips.  According to this analysis, the change in net returns resulting from the proposed trip limit increase ranged from no change to an improvement of 78 percent.  A vessel would realize no change in net revenues under the proposed trip limit increase if the vessel was not constrained by the 2002 trip limits; in other words, the vessel did not fish at a level exceeding the trip limits established for FY 2002.  Under future TACs that could range from 5,000 mt to 13,000 mt, the median vessel would realize gross revenue impacts ranging from a loss of 49 percent to a gain of 17 percent in net income.  In the NFMA, approximately 255 vessels out of approximately 1,500 limited access multispecies permit holders landed monkfish under the open-access Category E (incidental catch) permit. These vessels will mostly be unaffected by the proposed incidental catch limit increase since they land, on average, only about 20 percent of the current limit.
        Combining the two evaluation criteria, the proposed regulations would likely have a considerable positive impact on a substantial number of vessels that participate in the SFMA on monkfish-only DAS.  The incidental catch trip limit change in the NFMA would impact a substantial number of participating small entities, but the overall impact on vessel profitability is not expected to be significant.
        A copy of this analysis is available from the NEFMC (see ADDRESSES).

        This proposed rule does not duplicate, overlap or conflict with other Federal rules, and does not contain new reporting or recordkeeping requirements.  However this action makes a correction to the regulatory language referencing area declaration procedures.  This collection-of-information requirement that is subject to the Paperwork Reduction Act (PRA) has previously been approved by OMB under control number 0648-0202.  Public reporting burden for this collection of information is estimated to average 3 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington DC 20503 (Attention: NOAA Desk Officer).
        Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

          List of Subjects in 50 CFR Part 648

        Fisheries, Fishing, Reporting and recordkeeping requirements.

          Dated:  February 28, 2003.
          William T. Hogarth,
          Assistant Administrator for Fisheries, National Marine Fisheries Service.

          For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:

            PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES

          1.  The authority citation for part 648 continues to read as follows:

            Authority:
            16 U.S.C. 1801 et seq.

          2.  In § 648.14, paragraphs (y) introductory text, (y)(1), (y)(4), (y)(6), (y)(9) through (y)(11), (y)(13), and (y)(17) through (y)(21) are revised to read as follows:

            § 648.14
            Prohibitions.

            (y) In addition to the general prohibitions specified in § 600.725 of this chapter and in paragraph (a) of this section, it is unlawful for any person owning or operating a vessel that engages in fishing for monkfish to do any of the following:
            (1) Fish for, possess, retain or land monkfish, unless:
            (i) The monkfish are being fished for, or were harvested, in or from the EEZ by a vessel issued a valid monkfish permit under § 648.4(a)(9); or
            (ii) The monkfish were harvested by a vessel not issued a Federal monkfish permit that fishes for or possesses monkfish exclusively in state waters; or
            (iii) The monkfish were harvested in or from the EEZ by a vessel not issued a Federal monkfish permit that engaged in recreational fishing.

            (4) Operate or act as an operator of a vessel fishing for, possessing, retaining, or landing monkfish in or from the EEZ without having been issued and possessing a valid operator permit pursuant to § 648.5, and this permit is onboard the vessel.

            (6) Violate any provision of the monkfish incidental catch permit restrictions as provided in §§ 648.4(a)(9)(ii) or 648.94(c).

            (9) Fail to comply with the monkfish size limit restrictions of § 648.93 when issued a valid monkfish permit under § 648.4(a)(9).
            (10) Fail to comply with the monkfish possession limits and landing restrictions, including liver landing restrictions, specified under § 648.94 when issued a valid monkfish permit under § 648.4(a)(9).
            (11) Fail to comply with the monkfish DAS provisions specified at § 648.92 when issued a valid limited access monkfish permit, and fishing for, possessing, or landing monkfish in excess of the incidental catch limits specified at § 648.94 (c).

            (13) Combine, transfer, or consolidate monkfish DAS allocations.

            (17) If the vessel has been issued a valid limited access monkfish permit, and fishes under a monkfish DAS, fail to comply with gillnet requirements and restrictions specified in § 648.92(b)(8).
            (18) Fail to produce gillnet tags when requested by an authorized officer.
            (19) Tagging a gillnet with or otherwise using or possessing a gillnet tag that has been reported lost, missing, destroyed, or issued to another vessel, or using or possessing a false gillnet tag.
            (20) Selling, transferring, or giving away gillnet tags that have been reported lost, missing, destroyed, or issued to another vessel.
            (21) Fail to comply with the area declaration requirements specified at § § 648.93(b)(2) and 648.94(f) when fishing under a scallop, multispecies or monkfish DAS exclusively in the NFMA under the less restrictive monkfish size and possession limits of that area.

          3.  In § 648.92, paragraph (b)(1) is revised to read as follows:

            § 648.92
            Effort control program for monkfish limited access vessels.

            (b) *  *  *
            (1) Limited access monkfish permit holders.  All limited access monkfish permit holders shall be allocated 40 monkfish DAS for each fishing year, unless modified according to the provisions specified at § 648.96(b)(3).  Limited access multispecies and limited access scallop permit holders who also possess a valid limited access monkfish permit must use a multispecies or scallop DAS concurrently with their monkfish DAS, except as provided in paragraph (b)(2) of this section.

          4.  In § 648.93, the introductory heading for paragraph (a), and paragraphs (a)(1) and (b) are revised to read as follows:

            § 648.93
            Monkfish minimum fish sizes.
            (a) General provisions. (1) All monkfish caught by vessels issued a valid Federal monkfish permit must meet the minimum fish size requirements established in this section.

            (b) Minimum fish sizes. (1) The minimum fish size for vessels fishing in the SFMA, or for vessels not declared into the NFMA as specified in paragraph (b)(2) of this section, is 21 inches (53.3 cm) total length/14 inches (35.6 cm) tail length.
            (2) Vessels fishing exclusively in the NFMA.  The minimum fish size for vessels fishing exclusively in the NFMA is 17 inches (43.2 cm) total length/11 inches (27.9 cm) tail length.  In order for this size limit to be applicable, a vessel intending to fish for monkfish under a scallop, multispecies, or monkfish DAS exclusively in the NFMA must declare into the NFMA for a period of not less than 30 days pursuant to the provisions specified at § 648.94(f).  A vessel that has not declared into the NFMA under this paragraph shall be presumed to have fished in the SFMA and shall be subject to the more restrictive requirements of that area.  A vessel that has declared into the NFMA may transit the SFMA providing that it complies with the transiting and gear storage provisions described in § 648.94(e) and provided that it does not fish for or catch monkfish, or any other fish, in the SFMA.

          5.  In § 648.94, paragraph (b)(7) is removed and reserved; and paragraphs (b)(1), (b)(2), introductory heading of paragraph (b)(3), (b)(4) through (b)(6), (c)(1)(i), (c)(2), (c)(3)(i) and (f) are revised to read as follows:

            § 648.94
            Monkfish possession and landing restrictions.

            (b) *  *  *
            (1) Vessels fishing under the monkfish DAS program in the NFMA.  There is no monkfish trip limit for vessels issued a limited access Category A, B, C, or D permit that are fishing under a monkfish DAS exclusively in the NFMA.
            (2) Vessels fishing under the monkfish DAS program in the SFMA—(i) Category A and C vessels.  Category A and C vessels fishing under the monkfish DAS program in the SFMA may land up to 1,250 lb (567 kg) tail-weight or 4,150 lb (1,882 kg) whole weight of monkfish per monkfish DAS (or any prorated combination of tail-weight and whole weight based on the conversion factor for tail-weight to whole weight of 3.32).
            (ii) Category B and D vessels.  Category B and D vessels fishing under the monkfish DAS program in the SFMA may land up to  1,000 lb (454 kg) tail-weight or 3,320 lb (1,506 kg) whole weight of monkfish per monkfish DAS (or any prorated combination of tail-weight and whole weight based on the conversion factor for tail-weight to whole weight of 3.32).
            (iii) Administration of landing limits.  A vessel owner or operator may not exceed the monkfish trip limits as specified in paragraphs (b)(2)(i) and (ii) of this section per monkfish DAS fished, or any part of a monkfish DAS fished.
            (3) Category C and D vessels fishing under the multispecies DAS program. * * *

            (4) Category C and D vessels fishing under the scallop DAS program.  A Category C or D vessel fishing under a scallop DAS may land up to 300 lb (136 kg) tail-weight or 996 lb (452 kg) whole weight of monkfish per DAS (or any prorated combination of tail-weight and whole weight based on the conversion factor for tail-weight to whole weight of 3.32).  All monkfish permitted vessels are prohibited from fishing for, landing, or possessing monkfish while in possession of dredge gear unless fishing under a scallop DAS.
            (5) Category C and D scallop vessels declared into the monkfish DAS program without a dredge on board, or not under the net exemption provision.  Category C and D vessels that have declared into the monkfish DAS program and that do not fish with or have a dredge on board, or are not fishing with a net under the net exemption provision specified in § 648.51(f), are subject to the same landing limits as specified in paragraphs (b)(1) and (b)(2) of this section.  Such vessels are also subject to provisions applicable to Category A and B vessels fishing only under a monkfish DAS, consistent with the provisions of this part.
            (6) Vessels not fishing under a multispecies, scallop or monkfish DAS.  The possession limits for all limited access monkfish vessels when not fishing under a multispecies, scallop, or monkfish DAS are the same as the possession limits for a vessel issued a monkfish incidental catch permit specified under paragraph (c)(3) of this section.

            (c) *  *  *
            (1) *  *  *
            (i) NFMA.  Vessels issued a monkfish incidental catch permit fishing under a multispecies DAS exclusively in the NFMA may land up to 400 lb (181 kg) tail weight or 1,328 lb (602 kg) whole weight of monkfish per DAS, or  50 percent (where the weight of all monkfish is converted to tail weight) of the total weight of fish on board, whichever is less.  For the purposes of converting whole weight to tail weight, the amount of whole weight possessed or landed is divided by 3.32.

            (2) Scallop dredge vessels fishing under a scallop DAS.  A scallop dredge vessel issued a monkfish incidental catch permit fishing under a scallop DAS may land up to 300 lb (136 kg) tail-weight or 996 lb (452 kg) whole weight of monkfish per DAS (or any prorated combination of tail-weight and whole weight based on the conversion factor).
            (3) * * *
            (i) Vessels fishing with large mesh.  A vessel issued a valid monkfish incidental catch permit and fishing in the GOM, GB, SNE, or MA RMAs with mesh no smaller than specified at § 648.80(a)(3)(i), (a)(4)(i), (b)(2)(i), and § 648.104(a)(1), respectively, while not on a monkfish, multispecies, or scallop DAS, may possess, retain, and land monkfish (whole or tails) only up to 5 percent (where the weight of all monkfish is converted to tail weight) of the total weight of fish on board.  For the purposes of converting whole weight to tail weight, the amount of whole weight possessed or landed is divided by 3.32.

            (f) Area declaration requirement for vessels fishing exclusively in the NFMA.  Vessels fishing under a multispecies, scallop, or monkfish DAS under the less restrictive management measures of the NFMA, must fish for monkfish exclusively in the NFMA and declare into the NFMA for a period of not less than 30 days by obtaining a letter of authorization from the Regional Administrator.  A vessel that has not declared into the NFMA under this paragraph shall be presumed to have fished in the SFMA and shall be subject to the more restrictive requirements of that area.  A vessel that has declared into the NFMA may transit the SFMA providing that it complies with the transiting and gear storage provisions described in § 648.94(e) and provided that it does not fish for or catch monkfish, or any other fish, in the SFMA.

          6.  In § 648.96, the section heading and paragraphs (a), (b) and (c) are revised to read as follows:

            § 648.96
            Monkfish annual adjustment process and framework specifications.
            (a) General.  The Monkfish Monitoring Committee (MFMC) shall meet on or before November 15 of each year to develop target TACs for the upcoming fishing year in accordance with § 648.96(b)(1), and options for NEFMC and MAFMC consideration on any changes, adjustment, or additions to DAS allocations, trip limits, size limits, or other measures necessary to achieve the Monkfish FMP's goals and objectives.  The MFMC shall review available data pertaining to discards and landings, DAS, and other measures of fishing effort; stock status and fishing mortality rates; enforcement of and compliance with management measures; and any other relevant information.
            (b) Annual adjustment procedures—(1) Setting annual target TACs.  (i) The MFMC shall submit to the Councils and Regional Administrator the target monkfish TACs for the upcoming fishing year by December 1 based on the control rule formula described in paragraph (b)(1)(ii) of this section.  The Regional Administrator shall then promulgate any changes to existing management measures, pursuant to the methods specified in paragraphs (b)(2) and (3) of this section, resulting from the updated target TAC through rulemaking consistent with the Administrative Procedures Act.  If the annual target TAC generated through the control rule formula described in paragraph (b)(1)(ii) of this section does not require any changes to existing  management measures, then no action is required by the Regional Administrator.
            (ii) Control rule method for setting annual targets TACs.  The current 3-year running average of the NMFS fall trawl survey index of monkfish biomass will be compared to the established annual biomass index target, and target annual TACs will be set in accordance with paragraphs (b)(1)(ii)(A) through (F) of this section.  The annual biomass index targets established in Framework Adjustment 2 to the FMP  are provided in the following table (kg/tow).

                FY 2003
                FY 2004
                FY 2005
                FY 2006
                FY 2007
                FY 2007
                FY 2008
                FY 2009

                NFMA
                1.33
                1.49
                1.66
                1.83
                2.00
                2.16
                2.33
                2.50

                SFMA
                0.88
                1.02
                1.15
                1.29
                1.43
                1.57
                1.71
                1.85

            (A) Unless the provisions of paragraphs (b)(1)(ii)(C) or (D) of this section apply, if the current 3-year running average of the NMFS fall trawl survey biomass index is below the annual index target, the target TAC for the subsequent fishing year will be set equivalent to the monkfish landings for the previous fishing year minus the percentage difference between the 3-year average biomass index and the annual index target.

            (B) If the 3-year running average of the NMFS fall trawl survey biomass index is above the annual index target, and the current estimate of F is below Fthreshold=Fmax=0.2, the target TAC for the subsequent fishing year shall be set equivalent to the previous year's landings plus one-half the percentage difference between the 3-year average biomass index and the annual index target, but not to exceed an amount calculated to generate an F in excess of Fthreshold.  If current F cannot be determined, the target TAC shall be set at not more than 20 percent above the previous year's landings.
            (C) If the current estimate of F exceeds Fthreshold, the target TAC shall be reduced proportionally to stop overfishing, even if a reduction is not called for based on biomass index status as described in paragraph (b)(1)(ii)(A) of this section.  For example, if F=0.24, and Fthreshold=0.2, then the target TAC shall be reduced to 20 percent below the previous year's landings.

            (D) If the 3-year average biomass index is below the annual index target, and F is above Fthreshold, the method (F-based or biomass index based) that shall result in the greater reduction from the previous year's landings will determine the target TAC for the subsequent fishing year.
            (E) If the observed index is above the 2009 index targets, the target TAC for the subsequent fishing year shall be based on the ratio of current F to F=0.2 applied to the previous year's landings.  If current F cannot be determined, the target TAC shall be set at not more than 20 percent above previous year's landings.

            (F) If landings decline from the previous year and the current 3-year average biomass index is above the annual index target, whether or not F can be determined, the MFMC shall include in its report, prepared under paragraph (a) of this section, after taking into account circumstances surrounding the landings decline, a recommendation to the Councils on whether the target TAC should be set at the previous year's landings or previous year's target TAC.  The Councils shall consider the MFMC recommendation, and then recommend to the Regional Administrator whether the target TAC should be set at the previous year's landings or previous year's target TAC.  If such a recommendation is made, the Regional Administrator must decide whether to promulgate measures consistent with the recommendation as provided for in paragraph (b)(4) of this section.
            (2) Setting trip limits for the SFMA.  (i) Under the method described in paragraph (b)(1)(ii) of this section, if the SFMA target TAC is set at 8,000 mt or higher, the Regional Administrator shall adjust the trip limits according to the method described in paragraph (b)(2)(ii) of this section.
            (ii) Trip limit analysis procedures.  Trip limits shall be determined annually using information from the mandatory fishing vessel trip reports (FVTR).  The 1999 fishing year shall be used as the baseline year for this analysis.  The most recent fishing year for which there is complete FVTR information shall be utilized to establish the level of landings and fishing effort under current regulations.  For example, the determination of trip limits for the 2004 fishing year would be based on the ratio of landings and effort obtained from the FVTRs for the 2002 fishing year, the most recent fishing year for which complete FVTR information would be available.  Using the relationship between the fishing patterns for these two years, ratios shall be calculated for each permit category.  These ratios shall be used to determine landings goals for each permit category based on the proposed TAC for the SFMA.  A simulation process will then be used to estimate the landings per DAS for each permit category that would achieve the established landings goals.
            (3) Setting DAS allocations for the SFMA.  Under the method described in paragraph (b)(1)(ii) of this section, if the SFMA target TAC is set below 8,000 mt, the Regional Administrator shall set the trip limits as specified in paragraphs (b)(3)(i) and (ii) of this section, and adjust the DAS allocations according to the method described in paragraph (b)(3)(iii) of this section.
            (i) Category A and C vessels. Category A and C vessels fishing under the monkfish DAS program in the SFMA may land up to 550 lb (249 kg) tail-weight or 1,826 lb (828 kg) whole weight of monkfish per DAS (or any prorated combination of tail-weight and whole weight based on the conversion factor for tail-weight to whole weight of 3.32).
            (ii)Category B and D vessels.  Category B and D vessels fishing under the monkfish DAS program in the SFMA may land up to 450 lb (204 kg) tail-weight or 1,494 lb (678 kg) whole weight of monkfish per DAS (or any prorated combination of tail-weight and whole weight based on the conversion factor for tail-weight to whole weight of 3.32).
            (iii) DAS analysis.  This procedure involves setting a maximum DAS usage for all permit holders of 40 DAS; proportionally adjusting the landings to a given DAS value based on the trip limits specified under paragraphs (b)(3)(i) and (ii) of this section; and adjusting the landings according to the same methodology used in the trip limit analysis described in paragraph (b)(2)(ii) of this section.
            (A) Limited access monkfish permit holders are allowed to carry over up to 10 DAS from the previous fishing year to the current fishing year.  For this procedure, adjustments to DAS usage are made by first reducing the landings for all permit holders who used more than 40 DAS by the proportion of DAS exceeding 40, and then resetting the upperlimit of DAS usage to 40.
            (B) The expected landings at the adjusted DAS are calculated by adding the landings of all permit holders who used less than the proposed DAS limit to the landings of those who used more than the proposed DAS limit, where landings are reduced by the proportion of the proposed DAS limit to the actual DAS used by vessels during the baseline fishing year, 1999.
            (C)  Landings are prorated between permit categories in the same manner used in the trip limit analysis procedures described under paragraph (b)(2)(iii) of this section.
            (4) Council TAC recommendations.  As described in paragraph (b)(1)(ii)(F) of this section, if the Councils recommend a target TAC to the Regional Administrator, and the Regional Administrator concurs with this recommendation, the Regional Administrator shall then promulgate the target TAC and associated management measures through rulemaking consistent with the APA.  If the Regional Administrator does not concur with the Councils' recommendation, then the Councils shall be notified in writing of the reasons for the non-concurrence.
            (c)Annual and in-season framework adjustments to management measures—(1) Annual framework process.  (i)  Based on their annual review, the MFMC may develop and recommend, in addition to the target TACs and management measures established under paragraph (b) of this section, options necessary to achieve the Monkfish FMP's goals and objectives, which may include a preferred option.  The MFMC must demonstrate through analysis and documentation that the options it develops are expected to meet the Monkfish FMP goals and objectives.  The MFMC may review the performance of different user groups or fleet sectors in developing options.  The range of options developed by the MFMC may include any of the management measures in the Monkfish FMP, including, but not limited to: closed seasons or closed areas; minimum size limits; mesh size limits; net limits; liver to monkfish landings ratios; annual monkfish DAS allocations and monitoring; trip or possession limits; blocks of time out of the fishery; gear restrictions; transferability of permits and permit rights or administration of vessel upgrades, vessel replacement, or permit assignment; and other frameworkable measures included in § § 648.55 and 648.90.
            (ii)  The Councils shall review the options developed by the MFMC and other relevant information, consider public comment, and submit a recommendation to the Regional Administrator that meets the Monkfish FMP's objectives, consistent with other applicable law.  The Councils' recommendation to the Regional Administrator shall include supporting documents, as appropriate, concerning the environmental and economic impacts of the proposed action and the other options considered by the Councils.  Management adjustments made to the Monkfish FMP require majority approval of each Council for submission to the Secretary.
            (A)  The Councils may delegate authority to the Joint Monkfish Oversight Committee to conduct an initial review of the options developed by the MFMC.  The oversight committee would review the options developed by the MFMC and any other relevant information, consider public comment, and make a recommendation to the Councils.
            (B)  If the Councils do not submit a recommendation that meets the Monkfish FMP's goals and objectives, and is consistent with other applicable law, the Regional Administrator may adopt any option developed by the MFMC unless rejected by either Council, provided such option meets the Monkfish FMP's goals and objectives, and is consistent with other applicable law.  If either the NEFMC or MAFMC has rejected all options, then the Regional Administrator may select any measure that has not been rejected by both Councils.

            (iii)  If the Councils submit, on or before January 7 of each year, a recommendation to the Regional Administrator after one framework meeting, and the Regional Administrator concurs with the recommendation, the recommendation shall be published in the Federal Register as a proposed rule.  The Federal Register notification of the proposed action shall provide a 30-day public comment period.  The Councils may instead submit their recommendation on or before February 1 if they choose to follow the framework process outlined in paragraph (c)(3) of this section and request that the Regional Administrator publish the recommendation as a final rule.  If the Regional Administrator concurs that the Councils' recommendation meets the Monkfish FMP's goals and objectives, and is consistent with other applicable law, and determines that the recommended management measures should be published as a final rule, the action shall be published as a final rule in the Federal Register.  If the Regional Administrator concurs that the recommendation meets the Monkfish FMP's goals and objectives, is consistent with other applicable law, and determines that a proposed rule is warranted, and, as a result, the effective date of a final rule falls after the start of the fishing year, fishing may continue.  However, DAS used by a vessel on or after the start of a fishing year shall be counted against any DAS allocation the vessel ultimately receives for that year.

            (iv)  Following publication of a proposed rule and after receiving public comment,  if the Regional Administrator concurs in the Councils' recommendation, a final rule will be published in the Federal Register prior to the start of the next fishing year.  If the Councils fail to submit a recommendation to the Regional Administrator by February 1 that meets the goals and objectives of the Monkfish FMP, the Regional Administrator may publish as a proposed rule one of the MFMC options reviewed and not rejected by either Council, provided the option meets the goals and objectives of the Monkfish FMP, and is consistent with other applicable law.
            (2) In-season action.  At any time, the Councils or the Joint Monkfish Oversight Committee (subject to the approval of the Councils' chairmen) may initiate action to add or adjust management measures if it is determined that action is necessary to meet or be consistent with the goals and objectives of the Monkfish FMP.  Recommended adjustments to management measures must come from the categories specified under paragraph (c)(1)(i) of this section.  In addition, the procedures for framework adjustments specified under paragraph (c)(3) of this section must be followed.
            (3) Framework adjustment procedures.  Framework adjustments shall require at least one initial meeting of the Monkfish Oversight Committee or one of the Councils (the agenda must include notification of the framework adjustment proposal) and at least two Council meetings, one at each Council.  The Councils shall provide the public with advance notice of the availability of both the proposals and the analysis, and opportunity to comment on them prior to the first of the two final Council meetings.  Framework adjustments and amendments to the Monkfish FMP require majority approval of each Council for submission to the Secretary.
            (i) Councils' recommendation.  After developing management actions and receiving public testimony, the Councils shall make a recommendation to the Regional Administrator.  The Councils' recommendation must include supporting rationale and, if management measures are recommended, an analysis of impacts and a recommendation to the Regional Administrator on whether to issue the management measures as a final rule.  If the Councils recommend that the management measures should be issued as a final rule, the Councils must consider at least the following four factors and provide support and analysis for each factor considered:
            (A) Whether the availability of data on which the recommended management measures are based allows for adequate time to publish a proposed rule, and whether regulations have to be in place for an entire harvest/fishing season;
            (B) Whether there has been adequate notice and opportunity for participation by the public and members of the affected industry in the development of the Councils' recommended management measures;
            (C) Whether there is an immediate need to protect the resource or to impose management measures to resolve gear conflicts; and
            (D) Whether there will be a continuing evaluation of management measures adopted following their implementation as a final rule.
            (ii) Action by NMFS. (A)  If the Regional Administrator approves the Councils' recommended management measures and determines that the recommended management measures should be issued as a final rule based on the factors specified in paragraph (c)(3)(i) of this section, the Secretary may, for good cause found under the standard of the Administrative Procedure Act, waive the requirement for a proposed rule and opportunity for public comment in the Federal Register.   The Secretary, in so doing, shall publish only the final rule.  Submission of the recommendations does not preclude the Secretary from deciding to provide additional opportunity for prior notice and comment in the Federal Register.

            (B)  If the Regional Administrator concurs with the Councils' recommendation and determines that the recommended management measures should be published first as a proposed rule, then the measures shall be published as a proposed rule in the Federal Register.  After additional public comment, if NMFS concurs with the Councils' recommendation, then the measures shall be issued as a final rule in the Federal Register.
            (C)  If the Regional Administrator does not concur, then the Councils shall be notified in writing of the reasons for the non-concurrence.
            (iii)  Adjustments for gear conflicts.  The Councils may develop a recommendation on measures to address gear conflict as defined under § 600.10 of this chapter, in accordance with the procedure specified in § 648.55(d) and (e).

      [FR Doc. 03-5172 Filed 3-3-03; 3:17 pm]
      BILLING CODE 3510-22-S