[Federal Register Volume 62, Number 54 (Thursday, March 20, 1997)]
[Rules and Regulations]
[Pages 13293-13294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7013]


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DEPARTMENT OF AGRICULTURE
9 CFR Parts 102 and 104

[Docket No. 96-055-2]


Viruses, Serums, Toxins, and Analogous Products; Biologics 
Establishment Licenses and Biological Product Licenses and Permits

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending 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 the President's Regulatory Reform Initiative. The 
amendments have the effect of removing unnecessary material from the 
regulations. The APHIS forms for product licenses and permits will 
still be used and provided by the agency--only the examples are removed 
from the regulations.

EFFECTIVE DATE: April 21, 1997.

FOR FURTHER INFORMATION CONTACT: Dr. David Espeseth, Director, 
Licensing and Policy Development, Center for Veterinary Biologics, VS, 
APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1237, (301) 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, on August 22, 1996, we published in the Federal Register 
(61 FR 43316-43317, Docket No. 96-055-1) a proposal to amend the 
regulations regarding veterinary biological products by removing the 
examples of APHIS forms for U.S. Veterinary Biologics Establishment 
Licenses and U.S. Veterinary Biological Product Licenses and Permits. 
We stated that the APHIS forms for establishment and product

[[Page 13294]]

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.
    We solicited comments concerning our proposal for 45 days ending 
October 7, 1996. We did not receive any comments by that date.
    Therefore, based on the rationale set forth in the proposed rule, 
we are adopting the provisions of the proposal as a final rule without 
change.

Executive Order 12866 and Regulatory Flexibility Act

    This rule is a nonsubstantive change related to agency management 
and is therefore not subject to review by the Office of Management and 
Budget under Executive Order 12866.
    This rule removes 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 will still be 
used. Only the examples of the forms are removed from the regulations. 
This amendment will 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 will 
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).

Executive Order 12988

    This final 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.

Paperwork Reduction Act

    This rule contains no new information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

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 are amended as follows:

PART 102--LICENSES FOR BIOLOGICAL PRODUCTS

    1. The authority citation for part 102 continues 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) is revised to read as follows:


Sec. 102.4  U.S. Veterinary Biologics Establishment License.

* * * * *
    (c) U.S. Veterinary Biologics Establishment Licenses shall be 
numbered.
* * * * * *


Sec. 102.5  [Amended]

    3. In Sec. 102.5, paragraph (c) is removed and paragraphs (d), (e), 
and (f) are redesignated as paragraphs (c), (d), and (e).

PART 104--PERMITS FOR BIOLOGICAL PRODUCTS

    4. The authority citation for part 104 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    5. In Sec. 104.7, paragraph (a) is revised to read as follows:


Sec. 104.7  Product permit.

    (a) A permit shall be numbered and dated.
* * * * *
    Done in Washington, DC, this 14th day of March 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-7013 Filed 3-19-97; 8:45 am]
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