[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]
BILLING CODE 3410-34-P
