        DEPARTMENT OF TRANSPORTATION
        National Highway Traffic Safety Administration
        49 CFR Parts 571, 580, 581, 582, 583, 584, 585, 586, 587, and 588
        [Docket No. NHTSA-02-13206]
        Federal Motor Vehicle Safety Standards (FMVSS); Small Business Impacts of Motor Vehicle Safety

          AGENCY:
          National Highway Traffic Safety Administration (NHTSA), DOT.

          ACTION:
          Notice of regulatory review; request for comments.

          SUMMARY:
          The National Highway Traffic Safety Administration (NHTSA) seeks comments on the economic impact of its regulations on small entities. As required by Section 610 of the Regulatory Flexibility Act, we are attempting to identify rules that may have a significant economic impact on a substantial number of small entities. We also request comments on ways to make these regulations easier to read and understand. The focus of this notice is rules that specifically relate to passenger cars, multipurpose passenger vehicles, trucks, buses, trailers, incomplete vehicles, motorcycles, and motor vehicle equipment.

          DATES:
          Comments must be received on or before September 20, 2002.

          ADDRESSES:
          You should mention the docket number of this document in your comments and submit your comments in writing to: Docket Management System, U.S. Department of Transportation, Room PL-401, 400 Seventh Street, SW., Washington, DC, 20590. You may call Docket Management at: (202) 366-9324. You may visit the Docket from 10 am to 5 pm Monday through Friday.

          FOR FURTHER INFORMATION CONTACT:
          Nita Kavalauskas, Office of Regulatory Analysis, Office of Planning, Evaluation and Budget, National Highway Traffic Safety Administration, U.S. Department of Transportation, 400 Seventh Street, SW., Facsimile (fax): (202) 366-2559.

        SUPPLEMENTARY INFORMATION:
        I. Section 610 of the Regulatory Flexibility Act
        A. Background and Purpose
        Section 610 of the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), requires agencies to conduct periodic reviews of final rules that have a significant economic impact on a substantial number of small business entities. The purpose of the reviews is to determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the objectives of applicable statutes, to minimize any significant economic impact of the rules on a substantial number of such small entities.
        B. Review Schedule
        The Department of Transportation (DOT) published its Semiannual Regulatory Agenda on November 22, 1999, listing in Appendix D (64 FR 64684) those regulations that each operating administration will review under section 610 during the next 12 months. Appendix D also contains DOT's 10-year review plan for all of its existing regulations.
        The National Highway Traffic Safety Administration (NHTSA, “we”) has divided its rules into 10 groups by subject area. Each group will be reviewed once every 10 years, undergoing a two-stage process—an Analysis Year and a Review Year. For purposes of these reviews, a year will coincide with the fall-to-fall publication schedule of the Semiannual Regulatory Agenda. Thus, Year 1 (1998) began in the fall of 1998 and ended in the fall of 1999; Year 2 (1999) began in the fall of 1999 and ended in the fall of 2000; and so on.
        During the Analysis Year, we will request public comment on and analyze each of the rules in a given year's group to determine whether any rule has a significant impact on a substantial number of small entities and, thus, requires review in accordance with section 610 of the Regulatory Flexibility Act. In each fall's Regulatory Agenda, we will publish the results of the analyses we completed during the previous year. For rules that have subparts, or other discrete sections of rules that do have a significant impact on a substantial number of small entities, we will announce that we will be conducting a formal section 610 review during the following 12 months.

        The section 610 review will determine whether a specific rule should be revised or revoked to lessen its impact on small entities. We will consider: (1) The continued need for the rule; (2) the nature of complaints or comments received from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other federal rules or with state or local government rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. At the end of the Review Year, we will publish the results of our review.
        The schedule has been revised from its listing in the Semiannual Regulatory Agenda on November 22, 1999. A major revision to Parts 591 through 594 has been proposed. Thus, we deemed it appropriate to delay our small business impact review of these parts from year 3 to year 8, and move the other regulations forward one year.
        The following table shows the 10-year analysis and review schedule:

          NHTSA Section 610 Review Plan1

            Year
            Regulations to be reviewed
            Analysis year
            Review year

            1
            49 CFR parts 501 through 526 and 571.213
            1998
            1999

            2
            49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222
            1999
            2000

            3
            49 CFR 571.101 through 571.110 and 571.135
            2000
            2001

            4
            49 CFR parts 529 through 579, except part 571
            2001
            2002

            5
            49 CFR 571.111 through 571.129 and parts 580 through 590
            2002
            2003

            6
            49 CFR 571.201 through 571.212
            2003
            2004

            7
            49 CFR 571.214 through 571.219, except 571.217
            2004
            2005

            8
            49 CFR parts 591 through 594
            2005
            2006

            9
            49 CFR 571.223 through 571.304, part 500 and new parts and subparts under 49 CFR
            2006
            2007

            10
            23 CFR parts 1200 and 1300 and new parts and subparts under 23 CFR
            2007
            2008

            1 Revised schedule.

        C. Regulations Under Analysis
        During Year 5 (2002), the Analysis Year, we will conduct a preliminary assessment of the following sections of 49 CFR parts 571 and 580 through 588:

            Section
            Title

            571.111
            Rearview mirrors.

            571.112
            [Reserved].

            571.113
            Hood latch system.

            571.114
            Theft protection.

            571.115
            [Reserved].

            571.116
            Motor vehicle brake fluids.

            571.117
            Retreaded pneumatic tires.

            571.118
            Power-operated window, partition, and roof panel systems.

            571.119
            New pneumatic tires for vehicles other than passenger cars.

            571.120
            Tire selection and rims for motor vehicles other than passenger cars.

            571.121
            Air brake systems.

            571.122
            Motorcycle brake systems.

            571.123
            Motorcycle controls and displays.

            571.124
            Accelerator control systems.

            571.125
            Warning devices.

            571.126
            [Reserved].

            571.127
            [Reserved].

            571.128
            [Reserved].

            571.129
            New non-pneumatic tires for passenger cars.

            580
            Odometer disclosure requirements.

            581
            Bumper standard.

            582
            Insurance cost information regulation.

            583
            Automobile parts content labeling.

            585
            Advanced air bag phase-in reporting requirements.

            586
            Side impact phase-in reporting requirements.

            587
            Deformable barriers.

            588
            Child restraint systems recordkeeping requirements.

        We are seeking comments on whether any requirements in parts 571 and 580 through 588 have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. Business entities are generally defined as small businesses by Standard Industrial Classification (SIC) code, for the purposes of receiving Small Business Administration (SBA) assistance. Size standards established by SBA in 13 CFR 121.201 are expressed either in number of employees or annual receipts in millions of dollars, unless otherwise specified. The number of employees or annual receipts indicates the maximum allowed for a concern and its affiliates to be considered small. If your business or organization is a small entity and if any of the requirements in parts 571 and 580 through 588 have a significant economic impact on your business or organization, please submit a comment to explain how and to what degree these rules affect you, the extent of the economic impact on your business or organization, and why you believe the economic impact is significant.
        If the agency determines that there is a significant economic impact on a substantial number of small entities, it will ask for comment in a subsequent notice during the Review Year on how these impacts could be reduced without reducing safety.
        II. Plain Language
        A. Background and Purpose
        Executive Order 12866 and the President's memorandum of June 1, 1998, require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
        • Have we organized the material to suit the public's needs?
        • Are the requirements in the rule clearly stated?
        • Does the rule contain technical language or jargon that is not clear?
        • Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
        • Would more (but shorter) sections be better?
        • Could we improve clarity by adding tables, lists, or diagrams?
        • What else could we do to make the rule easier to understand?
        If you have any responses to these questions, please include them in your comments on this document.
        B. Review Schedule

        In conjunction with our section 610 reviews, we will be performing plain language reviews over a ten-year period on a schedule consistent with the section 610 review schedule. We will review parts 571 and 580 through 588 to determine if these regulations can be reorganized and/or rewritten to make them easier to read, understand, and use. We encourage interested persons to submit draft regulatory language that clearly and simply communicates regulatory requirements, and other recommendations, such as for putting information in tables that may make the regulations easier to use.

        Comments
        How Do I Prepare and Submit Comments?
        Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.
        Your comments must not be more than 15 pages long. (49 CFR 553.21.) We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.

        Please submit two copies of your comments, including the attachments, to Docket Management at the address given above under ADDRESSES.

        Comments may also be submitted to the docket electronically by logging onto the Docket Management System Web site at http://dms.dot.gov. Click on “Help & Information” or “Help/Info” to obtain instructions for filing your comments electronically.
        How Can I Be Sure That My Comments Were Received?
        If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
        How Do I Submit Confidential Business Information?

        If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, U.S. Department of Transportation, 400 Seventh Street, SW, Washington, DC 20590. In addition, you should submit two copies, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under ADDRESSES. When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation. (49 CFR part 512.)
        Will the Agency Consider Late Comments?

        We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under DATES. To the extent possible, we will also consider comments that Docket Management receives after that date.
        How Can I Read the Comments Submitted by Other People?

        You may read the comments received by Docket Management at the address given above under ADDRESSES. The hours of the Docket are indicated above in the same location.
        You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:

        (1) Go to the Docket Management System (DMS) Web page of the Department of Transportation (http://dms.dot.gov/).
        (2) On that page, click on “search.”
        (3) On the next page (http://dms.dot.gov/search/), type in the four-digit docket number shown at the beginning of this document. Example: If the docket number were “NHTSA-1998-1234,” you would type “1234.” After typing the docket number, click on “search.”
        (4) On the next page, which contains docket summary information for the docket you selected, click on the desired comments. You may download the comments. However, since the comments are imaged documents, instead of word processing documents, the “pdf” versions of the documents are word searchable.
        Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.

          Rose A. McMurray,
          Associate Administrator for Planning, Evaluation and Budget.

      [FR Doc. 02-22703 Filed 9-5-02; 8:45 am]
      BILLING CODE 4910-59-P


        DEPARTMENT OF TRANSPORTATION
        Federal Motor Carrier Safety Administration
        49 CFR Chapter III, Subchapter B
        [Docket No. FMCSA-2018-0037]
        RIN 2126-AC17
        Safe Integration of Automated Driving Systems-Equipped Commercial Motor Vehicles; Correction

          AGENCY:
          Federal Motor Carrier Safety Administration (FMCSA), DOT.

          ACTION:
          Advance notice of proposed rulemaking (ANPRM); correction.

          SUMMARY:

          FMCSA is correcting an advanced notice of proposed rulemaking (NPRM) that published in the Federal Register on May 28, 2019. The document requests public comment about Federal Motor Carrier Safety Regulations (FMCSRs) that may need to be amended, revised, or eliminated to facilitate the safe introduction of automated driving systems (ADS) equipped commercial motor vehicles (CMVs) onto our Nation's roadways. The ANPRM contained an erroneous date for closure of the comment period.

          DATES:
          The comments due date for the ANPRM published on May 28, 2019 (84 FR 24449), is corrected as of May 28, 2019. Comments on the ANPRM must be received on or before July 29, 2019.

          ADDRESSES:
          You may submit comments identified by Docket Number FMCSA-2018-0037 using any of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
          • Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001.
          • Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.
          • Fax: 202-493-2251.

          • Submissions Containing Confidential Business Information (CBI): Mr. Brian Dahlin, Chief, Regulatory Evaluation Division, 1200 New Jersey Avenue SE, Washington, DC 20590.

          To avoid duplication, please use only one of these methods. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for instructions on submitting comments, including collection of information comments for the Office of Information and Regulatory Affairs, OMB.

          FOR FURTHER INFORMATION CONTACT:

          Michael Huntley, Division Chief, Vehicle and Roadside Operations, Office of Carrier, Driver, and Vehicle Safety, MC-PSV, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 by telephone at (202) 366-9209 or by email, michael.huntley@dot.gov. If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

        SUPPLEMENTARY INFORMATION:
        In FR Doc. 2019-11038 appearing on page 24449 in the Federal Register of Tuesday, May 28, 2019, in the first column, the DATES section is corrected to read as follows:

          DATES: Comments on this document must be received on or before July 29, 2019.

          Issued on: May 28, 2019.
          Larry W. Minor,
          Associate Administrator for Policy.

      [FR Doc. 2019-11387 Filed 5-28-19; 4:15 pm]
      BILLING CODE 4910-EX-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 82
        [FRL-7579-7]
        Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2004

          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 2004. Essential use allowances enable a person to obtain controlled class I ODSs as an exemption to the regulatory ban of production and import of these chemicals, which became effective on 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 2077.91 metric tons of chlorofluorocarbons for use in metered dose inhalers. EPA is also proposing to allocate the remaining allowances for methyl chloroform (141.877 metric tons) to the U.S. Space Shuttle Program.

          DATES:

          Written comments on this proposed rule must be received by the EPA Docket on or before November 28, 2003, unless a public hearing is requested. Comments must then be received on or before 30 days following the public hearing. 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 November 7, 2003. If a hearing is held, EPA will publish a document in the Federal Register announcing the hearing information.

          ADDRESSES:

          Comments on this proposed rulemaking should be submitted to Air and Radiation Docket, Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460, Attention: Docket ID No. OAR-2003-0202. Comments also may be submitted electronically, by facsimile, or through hand deliver or courier service, as described in SUPPLEMENTARY INFORMATION below. Comments will be filed in EPA Air Docket ID No. OAR-2003-0202. Written comments or other materials also may be submitted in duplicate to the Essential Use Program Manager as identified in FOR FURTHER INFORMATION CONTACT below.
          Materials related to previous EPA actions on the essential use program are contained in EPA Air Docket No. A-93-39. Docket A-93-39 is located at EPA West Building, Room B102, 1301 Constitution Avenue, NW., Washington, DC, 20460. The Air Docket is open from 8:30 a.m. until 4:30 p.m. Monday through Friday.

          FOR FURTHER INFORMATION CONTACT:

          Scott Monroe, Essential Use Program Manager, by regular mail: U.S. Environmental Protection Agency, Global Programs Division (6205J), 1200 Pennsylvania Avenue, NW., Washington, DC, 20460; by courier service or overnight express: 1301 L Street, NW., Washington DC, 20005, by telephone: 202-564-9712; or by email: monroe.scott@epa.gov.

        SUPPLEMENTARY INFORMATION:

          Table of Contents
          I. General Information
          A. How can I get copies of related information?
          B. How and to whom do I submit comments?
          C. How should I submit confidential business information to EPA?
          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. Exemption for Methyl Chloroform for Use in the Space Shuttle and Titan Rockets
          V. Proposed Allocation of Essential Use Allowances for Calendar Year 2004
          VI. Correction to 40 CFR Part 82, Sections 3 and 4(k)
          VII. 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. How Can I Get Copies of Related Information?
        1. Docket
        EPA has established an official public docket for this action at Air Docket ID No. OAR-2003-0202. The official public docket consists of the documents specifically referenced in this action and other information related to this action. Hard copies of documents related to previous essential use allocation rulemakings and other actions may be found in EPA Air Docket ID No. A-93-39. The public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute, although this information is part of EPA's official docket. The public docket is available for viewing at the Air and Radiation Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1742, and the telephone number for the Air and Radiation Docket is (202) 566-1742. EPA may charge a reasonable fee for copying docket materials.
        2. Electronic Access

        An electronic version of the public docket is available through EPA's electronic public docket and comment system, “EPA Dockets.” You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number.
        Certain types of information will not be placed in EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in section I.A.1 above.
        For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
        Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
        B. How and to Whom Do I Submit Comments?
        You may submit comments electronically, by mail, by facsimile, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in section I.C below. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
        1. Electronically

        Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. To access EPA's electronic public docket from the EPA Internet Home Page, select “Information Sources,” “Dockets,” and “EPA Dockets.” Once in the system, select “search,” and then key in Docket ID No. OAR-2003-0202. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.
        If you submit a comment electronically, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. 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.
        Comments also may be sent by electronic mail (e-mail) to A-And-R-Docket@epa.gov, Attention Docket ID No. OAR-2003-0202. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.
        You may submit comments on a disk or CD ROM that you mail to the mailing address identified below. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.
        2. By Mail
        Send two copies of your comments to: Air and Radiation Docket, Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460, Attention: Docket ID No. OAR-2003-0202.
        3. By Hand Delivery or Courier
        Deliver your comments to: EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC, Attention Docket ID No. OAR-2003-0202. Such deliveries are only accepted during the Docket's normal hours of operation as identified in section I.A.1.
        4. By Facsimile
        Fax your comments to: 202-566-1741, Attention: Docket ID No. OAR-2003-0202.
        C. How Should I Submit Confidential Business Information to EPA?
        Comments that contain confidential business information should be submitted in two versions, one clearly marked “Public”, to be filed in the public docket, and the other clearly marked “Confidential” to be reviewed by authorized government personnel only. If the comments are not marked, EPA will assume they do not contain confidential business information and will docket them.
        Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. Send or deliver information identified as CBI only to the Essential Use Program Manager. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR Part 2.

        In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.
        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 to reduce and eventually eliminate the production and consumption 1
           of all stratospheric ozone depleting substances (ODSs). The elimination of production and consumption of class I ODSs is accomplished through adherence to phase-out schedules for specific class I ODSs,2
           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 “Consumption” is defined as the amount of a substance produced in the United States, plus the amount imported into the United States, minus the amount exported to Parties to the Montreal Protocol (see Section 601(6) of the Clean Air Act). Stockpiles of class I ODSs produced or imported prior to the 1996 phase out may be used for purposes not expressly banned at 40 CFR part 82.

            2 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.3
           Section 604(d) of the Act authorizes EPA to allow the production of limited quantities of class I ODSs after the phaseout date for the following essential uses:

            3 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.” EPA issues methyl chloroform allowances to the U.S. Space Shuttle and Titan Rocket programs.
        (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 through December 31, 2005. 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 allowance 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).
        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 2001.
        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 2004, the Parties authorized the United States to allocate up to 2,975 metric tons of CFCs for essential uses.
        For methyl chloroform, Decision X/6 by the Parties to the Protocol established that “* * * the remaining quantity of methyl chloroform authorized for the United States at previous meetings of the Parties [will] be made available for use in manufacturing solid rocket motors until such time as the 1999-2001 quantity of 176.4 tons (17.6 ODP-weighted tons) allowance is depleted, or until such time as safe alternatives are implemented for remaining essential uses.” Section 604(d)(1) of the Act terminates the exemption period for methyl chloroform on January 1, 2005. Therefore, between 1999 and 2004 EPA may allow production or import up to a total of 176.4 metric tonnes of methyl chloroform for authorized 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 2004 control period.
        1. On March 10, 2003, 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 1/1/02 to 12/31/02.
        c. The number of units anticipated to be produced in 2003.
        d. The gross target fill weight per unit (grams).
        e. Total amount of CFCs to be contained in the MDI product for 2004.
        f. The additional amount of CFCs necessary for production.

        g. The total CFC request per MDI product for 2004. The 114 letters are available for review in the Air Docket ID No. OAR-2003-0202. 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 April 17, 2003, 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 2003. This letter is available for review in Air Docket ID No. OAR-2003-0202.
        3. On August 25, 2003, FDA sent a letter to EPA stating the amount of CFCs necessary for each MDI company in 2004. This letter is available for review in the Air Docket ID No. OAR-2003-0202.
        In their letter, FDA informed EPA that they had determined that 2,077.91 metric tons of CFCs were necessary for use in medical devices in 2004. The letter stated, “Our recommendation for the allocation for CFCs is lower than the total amount requested by sponsors. In the past, we have based our recommendations on estimates that 60 million albuterol MDIs using CFCs as a propellant would be necessary each year. However, we have based the recommendation for 2004 on an estimate that 55 million will be necessary. In reaching this estimate, we took into account the sponsors' production of albuterol MDIs that used CFCs as a propellant in 2002, their estimates for production in 2003, and the presence on the market of two albuterol MDIs that do not use CFCs. Three firms have requested CFCs sufficient to manufacture a total of over 65 million albuterol MDIs. Our allocation decision is based on a need to limit CFC allocations to quantities needed for the manufacture of 55 million albuterol MDIs and ensure the public health.”
        In accordance with the determination made by FDA, today's action proposes to allocate essential use allowances for a total of 2,077.91 metric tons of CFCs for use in MDIs for calendar year 2004. 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. Exemption for Methyl Chloroform for Use in the Space Shuttle and Titan Rockets
        As discussed in Section I.C above, before the start of calendar year 2005; EPA may allocate up to 176.4 tons of methyl chloroform for authorized essential uses. According to reporting submitted to the EPA tracking system for ozone-depleting substances, the total amount of methyl chloroform produced or imported by essential use allowance holders (the U.S. Air Force (USAF) for Titan Rockets, and the National Aeronautics and Space Administration (NASA) for the Space Shuttle) from 1999 through the second quarter of 2003 was 34.523 metric tons. USAF and NASA have notified EPA that they do not intend to use their 2003 allowances to obtain methyl chloroform during the last two quarters of 2003. Therefore, EPA finds that 141.877 tons of methyl chloroform allowances are available for 2004. In addition, USAF has notified EPA that they have no need for 2004 allowances. For this reason, we propose to make the remaining balance of allowances (141.877 metric tons) available to NASA.
        V. Proposed Allocation of Essential Use Allowances for Calendar Year 2004
        EPA proposes to allocate essential use allowances for calendar year 2004 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.

          Table I.—Essential Use Allocation for Calendar Year 2004

            Company
            Chemical
            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
            390.60

            Aventis Pharmaceutical Products
            CFC-11 or CFC-12 or CFC-114
            48.40

            Boehringer Ingelheim Pharmaceuticals
            CFC-11 or CFC-12 or CFC-114
            500.20

            PLIVA Inc.
            CFC-11 or CFC-12 or CFC-114
            136.00

            Schering-Plough Corporation
            CFC-11 or CFC-12 or CFC-114
            918.00

            3M Pharmaceuticals
            CFC-11 or CFC-12 or CFC-114
            84.71

              (ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets

            National Aeronautics and Space Administration (NASA)/Thiokol Rocket
            Methyl Chloroform
            141.877

        VI. Correction to 40 CFR Part 82, Sections 3 and 4(k)
        On January 2, 2003, EPA published a final rule (68 FR 237) regarding quarantine and preshipment applications of methyl bromide, which is an ozone-depleting substance. This final rule removed paragraphs (n) through (s) of 40 CFR Part 82, Section 4, and redesignated paragraphs (t) through (w) as (n) through (q). However, the final rule did not also change the definition of “essential-use allowances” in § 82.3 to be consistent with the reordering of paragraphs in § 82.4. The definition of essential use allowances in § 82.3 reads, “Essential-Use Allowances means the privileges granted by § 82.4(t) to produce class I substances, as determined by allocation decisions made by the Parties to the Montreal Protocol and in accordance with the restrictions delineated in the Clean Air Act Amendments of 1990.” Therefore, for consistency with the reordered regulations, we are correcting the definition of essential use allowances to refer to § 82.4(n).

        In addition, the final rule revised section 4(k) of 40 CFR Part 82 to include paragraph 4(k)(1), which states that “* * * only essential-use allowances or exemptions are required to import class I controlled substances, with the exception of transhipments, heels, and used controlled substances.” In undertaking this revision, EPA inadvertently deleted a phrase that had appeared in the prior version of this statement. EPA proposes to restore the deleted phrase by correcting the statement in question to read, “* * * only essential use allowances or exemptions are required to import class I controlled substances, with the exception of transhipments, heels, used controlled substances, and essential use CFCs.” This correction clarifies that the import restriction does not apply to CFCs produced by non-U.S. entities under the authority of privileges granted by the Parties and the national authority of another country for use in essential metered dose inhalers. See 67 FR 6351 (February 11, 2002).
        VII. 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 that this action is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.
        B. Paperwork Reduction Act

        This 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 instruction; 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, the term small entities 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 its field.
        After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This rule provides an otherwise unavailable benefit to those companies that are receiving essential use allowances.
        Although this proposed rule will not have significant economic impact on a substantial number of small entities, we continue to be interested in the potential impact of the proposed rule on small entities and welcome comments related to these issues.
        D. Unfunded Mandates Reform Act
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 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 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” as defined under E.O. 12866, and (2) concerns an environmental health and 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 that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to E.O. 13045 because it implements the phase-out schedule and exemptions established by Congress in Title VI of the Clean Air Act.
        H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use
        This 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 a significant regulatory action under Executive Order 12866.
        I. National Technology Transfer and Advancement Act

        Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA), Public Law 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, Exports, Environmental protection, Imports, Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

          Dated: October 22, 2003.
          Marianne L. Horinko,
          Acting 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 82.3 is amended by revising the definition of Essential Use Allowances to read as follows:

            § 82.3
            Definitions for class I and class II controlled substances.

              Essential-Use Allowances means the privileges granted by § 82.4(n) to produce class I substances, as determined by allocation decisions made by the Parties to the Montreal Protocol and in accordance with the restrictions delineated in the Clean Air Act Amendments of 1990.

            3. Section 82.4 is amended by revising paragraph (k)(1) and the table in paragraph (n)(2) to read as follows:

            § 82.4
            Prohibitions for class I controlled substances.

            (k)(1) Prior to January 1, 1996, for all Groups of class I controlled substances, and prior to January 1, 2005, for class I, Group VI controlled substances, a person may not use production allowances to produce a quantity of a class I controlled substance unless that person holds under the authority of this subpart at the same time consumption allowances sufficient to cover that quantity of class I controlled substances nor may a person use consumption allowances to produce a quantity of class I controlled substances unless the person holds under authority of this subpart at the same time production allowances sufficient to cover that quantity of class I controlled substances. However, prior to January 1, 1996, for all class I controlled substances, and prior to January 1, 2005, for class I, Group VI controlled substances, only consumption allowances are required to import, with the exception of transhipments, heels, and used controlled substances. Effective January 1, 1996, for all Groups of class I controlled substances, except Group VI, only essential use allowances or exemptions are required to import class I controlled substances, with the exception of transhipments, heels, used controlled substances, and essential use CFCs.

            (n) * * *
            (2) * * *

              Table I.—Essential Use Allocation for Calendar Year 2004

                Company
                Chemical
                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
                390.60

                Aventis Pharmaceutical Products
                CFC-11 or CFC-12 or CFC-114
                48.40

                Boehringer Ingelheim Pharmaceuticals
                CFC-11 or CFC-12 or CFC-114
                500.20

                PLIVA Inc.
                CFC-11 or CFC-12 or CFC-114
                136.00

                Schering-Plough Corporation
                CFC-11 or CFC-12 or CFC-114
                918.00

                3M Pharmaceuticals
                CFC-11 or CFC-12 or CFC-114
                84.71

                  (ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets

                National Aeronautics and Space Administration (NASA)/Thiokol Rocket
                Methyl Chloroform
                141.877

      [FR Doc. 03-27160 Filed 10-27-03; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF JUSTICE
        28 CFR Part 16
        [CPCLO Order No. 005-2013]
        Exemption of Records Systems Under the Privacy Act

          AGENCY:
          Executive Office for Organized Crime Drug Enforcement Task Forces (OCDETF), Department of Justice.

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:

          The Department of Justice (the Department or DOJ) proposes to amend its Privacy Act regulations for two systems of records entitled the “Drug Enforcement Task Force Evaluation and Reporting System, JUSTICE/DAG-003,” last published, March 10, 1992 in the Federal Register, and the “Organized Crime Drug Enforcement Task Force Fusion Center and International Organized Crime Intelligence and Operations Center System, JUSTICE/CRM-028,” last published, June 3, 2009 in the Federal Register. These Privacy Act regulations are being amended to reflect a recent reorganization of the Department establishing the Executive Office for OCDETF as a separate DOJ component, and transferring responsibility for these systems from the Office of the Deputy Attorney General (ODAG) and the Criminal Division to this component. In light of this departmental reorganization, JUSTICE/DAG-003 is being renumbered to JUSTICE/OCDETF-001 and will be renamed as the “Organized Crime Drug Enforcement Task Forces Management Information System (OCDETF MIS).” JUSTICE/CRM-028 is being renumbered to JUSTICE/OCDETF-002 but will retain its system name. When under the responsibility of ODAG and the Criminal Division, these systems were exempted from certain provisions of the Privacy Act of 1974 by exemptions placed in the Code of Federal Regulations (CFR) sections containing exemptions for ODAG's and the Criminal Division's Privacy Act systems. These proposed amendments will remove references to these systems from the CFR sections for ODAG and Criminal Division exemptions and add a new section for OCDETF exemptions. Public comment is invited.

          DATES:
          Comments must be received by October 16, 2013.

          ADDRESSES:

          Address all comments to Privacy Analyst, Office of Privacy and Civil Liberties, National Place Building, 1331 Pennsylvania Avenue NW., Suite 1000, Washington, DC 20530, or by facsimile to 202-307-0693. To ensure proper handling, please reference the CPCLO Order Number on your correspondence. You may review an electronic version of the proposed rule at http://www.regulations.gov, and you may also comment by using that Web site's comment form for this regulation. Please include the CPCLO Order Number in the subject box.

          Please note that the Department is requesting that electronic comments be submitted before midnight Eastern Time on the day the comment period closes because this is when http://www.regulations.gov terminates the public's ability to submit comments. Commenters in time zones other than Eastern Time may want to consider this so that their electronic comments are received. All comments sent via regular or express mail will be considered timely if postmarked on or before the day the comment period closes.

            Posting of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the Department's public docket. Such information includes personally identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.
          If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONALLY IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personally identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
          If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.

          Personally identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Department's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

          FOR FURTHER INFORMATION CONTACT:
          Jill Aronica, Chief Information Systems Section, Executive Office for OCDETF, U.S. Department of Justice, 1331 Pennsylvania Avenue NW., Suite 1060, Washington, DC 20530, phone 202-514-1860.

        SUPPLEMENTARY INFORMATION:
        In the Notices section of today's Federal Register, the Department has published two modified systems of records notices for the “Organized Crime Drug Enforcement Task Force Fusion Center and International Organized Crime Intelligence and Operations Center System” (last published at 74 FR 26733 (June 3, 2009)) and the “Organized Crime Drug Enforcement Task Forces Management Information System” (last published at 57 FR 8473 (March 10, 1992)). Previously, when these systems were under the purview of ODAG and of the Criminal Division, these systems of records were exempted from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(j) and (k). These exemptions were promulgated in the sections of the CFR for exemptions of ODAG systems (28 CFR 16.71) and of Criminal Division systems (28 CFR 16.91). The Department is now proposing to establish a new section for exemptions of OCDETF systems (28 CFR 16.135); to delete references to the exemptions for the Drug Enforcement Task Force Evaluation and Reporting System, JUSTICE/DAG-003 in 28 CFR 16.71; and to delete references to the Organized Crime Drug Enforcement Task Force Fusion Center and International Organized Crime Intelligence and Operations Center System, JUSTICE/CRM-028 in 28 CFR 16.91. The Department intends that the exemptions previously established under 28 CFR 16.71 and 28 CFR 16.91 will continue to apply to these systems and all their records until the effective date of 28 CFR 16.135.
        Regulatory Flexibility Act
        This proposed rule relates to individuals, as opposed to small business entities. Nevertheless, pursuant to the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601-612, the proposed rule will not have a significant economic impact on a substantial number of small entities.
        Small Entity Inquiries

        The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 801 et seq., requires the Executive Office for OCDETF to comply with small entity requests for information and advice about compliance with statutes and regulations within the Executive Office for OCDETF's jurisdiction. Any small entity that has a question regarding this document may contact the person listed in FOR FURTHER INFORMATION CONTACT. Persons can obtain further information regarding SBREFA on the Small Business Administration's Web page at http://www.sba.gov/advocacy/825.

        Paperwork Reduction Act
        The Paperwork Reduction Act of 1995, 44 U.S.C. 3507(d), requires that the Executive Office for OCDETF consider the impact of paperwork and other information collection burdens imposed on the public. There are no current or new information collection requirements associated with this proposed rule. The records that are contributed to this system would be created in any event by law enforcement entities and their sharing of this information electronically will not increase the paperwork burden on these entities.
        Analysis of Regulatory Impacts
        This proposed rule is not a “significant regulatory action” within the meaning of Executive Order 12866 and therefore further regulatory evaluation is not necessary. This proposed rule will not have a significant economic impact on a substantial number of small entities, because it applies only to information about individuals.
        Unfunded Mandates

        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, 109 Stat. 48, requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for proposed and final rules that contain Federal mandates. A “Federal mandate” is a new or additional enforceable duty imposed on any State, local, or tribal government or the private sector. If any Federal mandate causes those entities to spend, in aggregate, $100 million or more in any one year, the UMRA analysis is required. This proposed rule would not impose Federal mandates on any State, local, or tribal government or the private sector.

          List of Subjects in 28 CFR Part 16
          Administrative practice and procedure, Courts, Freedom of information, Privacy, Sunshine Act.

        Pursuant to the authority vested in the Attorney General by 5 U.S.C. 552a and delegated to me by Attorney General Order 2940-2008, the Department of Justice proposes to amend 28 CFR part 16 as follows:

          PART 16—[AMENDED]

        1. The authority citation for part 16 continues to read as follows:

          Authority:
           5 U.S.C. 301, 552, 552a, 552b(g), 553; 18 U.S.C. 4203(a)(1); 28 U.S.C. 509, 510, 534; 31 U.S.C. 3717, 9701.

          Subpart E—Exemption of Records Systems Under the Privacy Act

            § 16.71
            [Amended]

        2. Amend § 16.71 as follows:
        a. Remove the existing paragraphs (c)(1) and (c)(2) and amend paragraph (c) to read as follows: “The General Files System of the Office of the Deputy Attorney General (JUSTICE/DAG-013) is exempt from 5 U.S.C. 552a(c)(3) and (4); (d); (e)(1), (2), (3) and (5); and (g).”
        b. Remove the first two sentences of paragraph (d);
        c. Remove existing paragraph (e)(7); and
        d. Redesignate paragraph (e)(8) as paragraph (e)(7).

          § 16.91
          [Amended]

        3. Amend § 16.91 by removing paragraphs (u) and (v)

          § 16.135
          [Added]

        4. Add § 16.135 to subpart E to read as follows:

          § 16.135
          Exemptions of Executive Office for Organized Crime Drug Enforcement Task Forces Systems.
          (a) The following systems of records are exempt from 5 U.S.C. 552a(c)(3) and (4); (d)(1), (2), (3), and (4); (e)(1), (2), (3), (4)(G), (H), and (I), (5), and (8); (f); and (g):
          (1) The Organized Crime Drug Enforcement Task Forces Management Information System (OCDETF MIS) (JUSTICE/OCDETF-001); and
          (2) The Organized Crime Drug Enforcement Task Force Fusion Center and International Organized Crime Intelligence and Operations Center System (JUSTICE/OCDETF-002).
          (b) These exemptions apply only to the extent that information is subject to exemption under 5 U.S.C. 552a(j) and/or (k).
          (c) Exemptions from the particular subsections are justified for the following reasons:
          (1) From subsection (c)(3) because to provide the subject with an accounting of disclosures of records in these systems could inform that individual of the existence, nature, or scope of an actual or potential law enforcement or counterintelligence investigation by the Organized Crime Drug Enforcement Task Forces, the Organized Crime Drug Enforcement Task Force Fusion Center, the International Organized Crime Intelligence and Operations Center, or the recipient agency, and could permit that individual to take measures to avoid detection or apprehension, to learn of the identity of witnesses and informants, or to destroy evidence, and would therefore present a serious impediment to law enforcement or counterintelligence efforts. In addition, disclosure of the accounting would amount to notice to the individual of the existence of a record. Moreover, release of an accounting may reveal information that is properly classified pursuant to Executive Order.
          (2) From subsection (c)(4) because this subsection is inapplicable to the extent that an exemption is being claimed for subsections (d)(1), (2), (3), and (4).
          (3) From subsection (d)(1) because disclosure of records in the system could alert the subject of an actual or potential criminal, civil, or regulatory violation of the existence of that investigation, of the nature and scope of the information and evidence obtained as to his or her activities, of the identity of confidential witnesses and informants, of the investigative interest of the Organized Crime Drug Enforcement Task Forces, the Organized Crime Drug Enforcement Task Force Fusion Center, the International Organized Crime Intelligence and Operations Center, and other intelligence or law enforcement agencies (including those responsible for civil proceedings related to laws against drug trafficking or related financial crimes or international organized crime); could lead to the destruction of evidence, improper influencing of witnesses, fabrication of testimony, and/or flight of the subject; could reveal the details of a sensitive investigative or intelligence technique, or the identity of a confidential source; or could otherwise impede, compromise, or interfere with investigative efforts and other related law enforcement and/or intelligence activities. In addition, disclosure could invade the privacy of third parties and/or endanger the life, health, and physical safety of law enforcement personnel, confidential informants, witnesses, and potential crime victims. Access to records could also result in the release of information properly classified pursuant to Executive Order.
          (4) From subsection (d)(2) because amendment of the records thought to be inaccurate, irrelevant, incomplete, or untimely would also interfere with ongoing investigations, criminal or civil law enforcement proceedings, and other law enforcement activities; would impose an impossible administrative burden by requiring investigations, analyses, and reports to be continuously reinvestigated and revised; and may impact information properly classified pursuant to Executive Order.
          (5) From subsections (d)(3) and (4) because these subsections are inapplicable to the extent that exemption is claimed from subsections (d)(1) and (2) and for the reasons stated in paragraphs (b)(3) and (b)(4), above.

          (6) From subsection (e)(1) because, in the course of their acquisition, collation, and analysis of information under the statutory authority granted, the Organized Crime Drug Enforcement Task Forces, the Organized Crime Drug Enforcement Task Force Fusion Center, and the International Organized Crime Intelligence and Operations Center will occasionally obtain information, including information properly classified pursuant to Executive Order, that concerns actual or potential violations of law that are not strictly within their statutory or other authority or may compile and maintain information which may not be relevant to a specific investigation or prosecution. This is because it is impossible to determine in advance what information collected during an investigation or in support of these mission activities will be important or crucial to an investigation. In the interests of effective law enforcement, it is necessary to retain such information in this system of records because it can aid in establishing patterns of criminal activity of a suspect and can provide valuable leads for federal and other law enforcement agencies. This consideration applies equally to information acquired from, or collated or analyzed for, both law enforcement agencies and agencies of the U.S. foreign intelligence community and military community.
          (7) From subsection (e)(2) because in a criminal, civil, or regulatory investigation, prosecution, or proceeding, the requirement that information be collected to the greatest extent practicable from the subject individual would present a serious impediment to law enforcement because the subject of the investigation, prosecution, or proceeding would be placed on notice as to the existence and nature of the investigation, prosecution, or proceeding and would therefore be able to avoid detection or apprehension, to influence witnesses improperly, to destroy evidence, or to fabricate testimony. Moreover, thorough and effective investigation and prosecution may require seeking information from a number of different sources.
          (8) From subsection (e)(3) because to comply with the requirements of this subsection during the course of an investigation could impede the information-gathering process, thus hampering the investigation or intelligence gathering. Disclosure to an individual of investigative interest would put the subject on notice of that fact and allow the subject an opportunity to engage in conduct intended to impede that activity or avoid apprehension. Disclosure to other individuals would likewise put them on notice of what might still be a sensitive law enforcement interest and could result in the further intentional or accidental disclosure to the subject or other inappropriate recipients, convey information that might constitute unwarranted invasions of the personal privacy of other persons, unnecessarily burden law enforcement personnel in information-collection activities, and chill the willingness of witnesses to cooperate.
          (9) From subsections (e)(4)(G) and (H) because this system is exempt from the access and amendment provisions of subsection (d).

          (10) From subsection (e)(4)(I) to the extent that this subsection could be interpreted to require more detail regarding system record sources than has been published in the Federal Register. Should this subsection be so interpreted, exemption from this provision is necessary to protect the sources of law enforcement and intelligence information and to protect the privacy and safety of witnesses and informants and other information sources. Further, greater specificity could compromise other sensitive law enforcement information, techniques, and processes.
          (11) From subsection (e)(5) because the acquisition, collation, and analysis of information for law enforcement purposes from various agencies does not permit a determination in advance or a prediction of what information will be matched with other information and thus whether it is accurate, relevant, timely, and complete. With the passage of time, seemingly irrelevant or untimely information may acquire new significance as further investigation brings new details to light, and the accuracy of such information can often only be determined in a court of law. The restrictions imposed by subsection (e)(5) would restrict the ability of trained investigators, intelligence analysts, and government attorneys to exercise their judgment in collating and analyzing information and would impede the development of criminal or other intelligence necessary for effective law enforcement.
          (12) From subsection (e)(8) because the individual notice requirements could present a serious impediment to law enforcement by revealing investigative techniques, procedures, evidence, or interest, and by interfering with the ability to issue warrants or subpoenas; could give persons sufficient warning to evade investigative efforts; and would pose an unacceptable administrative burden on the maintenance of these records and the conduct of the underlying investigations.
          (13) From subsections (f) and (g) because these subsections are inapplicable to the extent that the system is exempt from other specific subsections of the Privacy Act.

          Dated: August 21, 2013.
          Joo Y. Chung,
          Acting Chief Privacy and Civil Liberties Officer, United States Department of Justice.

      [FR Doc. 2013-22370 Filed 9-13-13; 8:45 am]
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