[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
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 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.
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  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