96-21456. Viruses, Serums, Toxins, and Analogous Products; Biologics Establishment Licenses and Biological Product Licenses and Permits  

  • [Federal Register Volume 61, Number 164 (Thursday, August 22, 1996)]
    [Proposed Rules]
    [Pages 43316-43317]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-21456]
    
    
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    Proposed Rules
                                                    Federal Register
    ________________________________________________________________________
    
    This section of the FEDERAL REGISTER contains notices to the public of 
    the proposed issuance of rules and regulations. The purpose of these 
    notices is to give interested persons an opportunity to participate in 
    the rule making prior to the adoption of the final rules.
    
    ========================================================================
    
    
    Federal Register / Vol. 61, No. 164 / Thursday, August 22, 1996 / 
    Proposed Rules
    
    [[Page 43316]]
    
    
    
    DEPARTMENT OF AGRICULTURE
    
    Animal and Plant Health Inspection Service
    
    9 CFR Parts 102 and 104
    
    [Docket No. 96-055-1]
    
    
    Viruses, Serums, Toxins, and Analogous Products; Biologics 
    Establishment Licenses and Biological Product Licenses and Permits
    
    AGENCY: Animal and Plant Health Inspection Service, USDA.
    
    ACTION: Proposed rule.
    
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    SUMMARY: We are proposing to amend the regulations regarding veterinary 
    biological products to remove the examples of the Animal and Plant 
    Health Inspection Service (APHIS) forms for U.S. Veterinary Biologics 
    Establishment Licenses and U.S. Veterinary Biological Product Licenses 
    and Permits. This action resulted from a review of APHIS regulations in 
    response to President's Regulatory Reform Initiative. The proposed 
    amendments have the effect of removing unnecessary material from the 
    regulations. The APHIS forms for product licenses and permits would 
    still be used and provided by the agency--only the examples would be 
    removed from the regulations.
    
    DATES: Consideration will be given only to comments received on or 
    before October 7, 1996.
    
    ADDRESSES: Please send an original and three copies of your comments to 
    Docket No. 96-055-1, Regulatory Analysis and Development, PPD, APHIS, 
    Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
    state that your comments refer to Docket No. 96-055-1. Comments 
    received may be inspected at USDA, room 1141, South Building, 14th 
    Street and Independence Avenue, SW., Washington, DC, between 8 a.m. and 
    4:30 p.m., Monday through Friday except holidays. Persons wishing to 
    inspect comments are requested to call ahead at (202) 690-2817 to 
    facilitate entry into the comment reading room.
    
    FOR FURTHER INFORMATION CONTACT:
    Dr. David Espeseth, Deputy Director, Veterinary Biologics, BBEP, APHIS, 
    4700 River Road Unit 148, Riverdale, MD 20737-1237, (515) 734-8245.
    
    SUPPLEMENTARY INFORMATION: 
    
    Background
    
        The Animal and Plant Health Inspection Service (APHIS) conducted a 
    review of the regulations under 9 CFR 101-118 pertaining to veterinary 
    biologics initiated under the President's Regulatory Reform Initiative 
    to remove unnecessary material from the regulations. As part of this 
    initiative, we are proposing to amend the regulations to remove the 
    examples of U.S. Veterinary Biologics Establishment Licenses and U.S. 
    Veterinary Biological Product Licenses and Permits under Secs. 102.4, 
    102.5, and 104.7. The APHIS forms for establishment and product 
    licenses and permits would still be used and provided by the agency--
    only the examples would be removed from the regulations. It is not 
    necessary to include examples of the APHIS forms in the regulations.
    
    Executive Order 12866 and Regulatory Flexibility Act
    
        This proposed rule has been reviewed under Executive Order 12866. 
    The rule has been determined to be not significant for the purposes of 
    Executive Order 12866 and, therefore, has not been reviewed by the 
    Office of Management and Budget.
        The proposed rule would remove unnecessary material from the 
    regulations. The APHIS forms for a U.S. Veterinary Biologics 
    Establishment License and U.S. Veterinary Biological Product License 
    and Permit would still be used. Only the examples of the forms would be 
    removed from the regulations. The proposed amendment would not have any 
    adverse economic effect on producers as the APHIS forms are produced by 
    the agency and provided to all qualifying license and permit 
    applicants.
        Under these circumstances, the Administrator of the Animal and 
    Plant Health Inspection service has determined that this action would 
    not have a significant economic impact on a substantial number of small 
    entities.
    
    Executive Order 12372
    
        This program/activity is listed in the Catalog of Federal Domestic 
    Assistance under No. 10.025 and is subject to Executive Order 12372, 
    which requires intergovernmental consultation with State and local 
    officials (see 7 CFR part 3015, subpart V).
    
    Paperwork Reduction Act
    
        This proposed rule contains no new information collection or 
    recordkeeping requirements under the Paperwork Reduction Act of 1995 
    (44 U.S.C. 3501 et seq.).
    
    Executive Order 12988
    
        This proposed rule has been reviewed under Executive Order 12988, 
    Civil Justice Reform. It is not intended to have retroactive effect. 
    This rule would not preempt any State or local laws, regulations, or 
    policies, unless they present an irreconcilable conflict with this 
    rule. There are no administrative procedures which must be exhausted 
    prior to a judicial challenge to the provisions of this rule.
    
    Regulatory Reform
    
        This action is part of the President's Regulatory Reform 
    Initiative, which, among other things, directs agencies to remove 
    obsolete and unnecessary regulations and to find less burdensome ways 
    to achieve regulatory goals.
    
    List of Subjects
    
    9 CFR Part 102
    
        Animal biologics, Reporting and recordkeeping requirements.
    
    9 CFR Part 104
    
        Animal biologics, Imports, Reporting and recordkeeping 
    requirements, Transportation.
    
        Accordingly, 9 CFR parts 102 and 104 would be amended to read as 
    follows:
    
    PART 102--LICENSES FOR BIOLOGICAL PRODUCTS
    
        1. The authority citation for part 102 would continue to read as 
    follows:
    
        Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
    
        2. Section 102.4, paragraph (c) would be revised to read as 
    follows:
    
    
    Sec. 102.4  U.S. Veterinary Biologics Establishment License.
    
    * * * * *
    
    [[Page 43317]]
    
        (c) U.S. Veterinary Biologics Establishment Licenses shall be 
    numbered.
    * * * * *
        3. Section 102.5, paragraph (c) would be removed and paragraphs 
    (d), (e), and (f) would be redesignated as paragraphs (c), (d), and 
    (e).
    
    PART 104--PERMITS FOR BIOLOGICAL PRODUCTS
    
        4. The authority citation for part 104 would continue to read as 
    follows:
    
        Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
    
        5. Section 104.7, paragraph (a) would be revised to read as 
    follows:
    
    
    Sec. 104.7  Product permit.
    
        (a) A permit shall be numbered and dated.
    * * * * *
        Done in Washington, DC this 16th day of August 1996.
    A. Strating,
    Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 96-21456 Filed 8-21-96; 8:45 am]
    BILLING CODE 3410-34-M
    
    
    

Document Information

Published:
08/22/1996
Department:
Animal and Plant Health Inspection Service
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
96-21456
Dates:
Consideration will be given only to comments received on or before October 7, 1996.
Pages:
43316-43317 (2 pages)
Docket Numbers:
Docket No. 96-055-1
PDF File:
96-21456.pdf
CFR: (2)
9 CFR 102.4
9 CFR 104.7