[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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