This PDF is the current document as it appeared on Public Inspection on 09/17/2014 at 08:45 am.
Animal and Plant Health Inspection Service, USDA.
We are amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.
Effective Date: October 20, 2014.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737-1231; (301) 851-3426.End Further Info End Preamble Start Supplemental Information
The Animal and Plant Health Inspection Service (APHIS) administers and enforces the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.). Under the Virus-Serum-Toxin Act, a veterinary biological product must be shown to be pure, safe, potent, and efficacious before a veterinary biological product license may be issued. The regulations in 9 CFR part 113, “Standard Requirements” (referred to below as the regulations), prohibit the release of biological products prior to the completion of tests identified in the regulations and in the Outline of Production, a document submitted by the licensee that explains how a serial of product is formulated, tested, packaged, dated, and recommended for use.
On May 30, 2014, we published in the Federal Register (79 FR 31054-31056, Docket No. APHIS-2013-0034) a proposal  to amend the regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. We proposed to add definitions of the terms used to designate test results, “satisfactory,” “unsatisfactory,” and “inconclusive,” to § 101.5(l) and to revise the definition of “No Test” currently in that section in order to align the regulations in 9 CFR part 113 with current industry standards and practices. We also proposed to remove §§ 113.201, 113.202, 113.203, 113.211, 113.213, and 113.214 from the regulations. These standards, which involve testing on live animals, are no longer used by the industry because newer testing methods are available.
We solicited comments concerning our proposal for 60 days ending July 29, 2014. We did not receive any comments. Therefore, for the reasons given in the proposed rule, we are adopting the proposed rule as a final rule, without change.
Executive Order 12866 and Regulatory Flexibility Act
This final 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.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.
APHIS is amending the regulations in order to better define the terminology used when reporting the results of tests performed on veterinary biological products, thereby bringing the regulations up to date with current industry standards.
The changes will clarify when the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or can be designated as a No Test. The definitional changes will improve communication between APHIS and the regulated industry, and enable APHIS to more efficiently process the release of a tested product using current industry standards for reporting of test results.
There are about 330 firms in the United States that manufacture biological products. It is not known how many of these firms are engaged in manufacturing biologic products specifically for veterinary purposes. The Small Business Administration (SBA) standard for a small business in this industry is a firm with not more than 500 employees; the average firm in this industry has 93 employees. While most firms that would be affected by this rule are small, the changes will not impose a financial burden on them, but rather help make the product approval process timelier.
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 Start Printed Page 55969intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies where they are necessary to address local disease conditions or eradication programs. However, where safety, efficacy, purity, and potency of biological products are concerned, it is the Agency's intent to occupy the field. This includes, but is not limited to, the regulation of labeling. Under the Act, Congress clearly intended that there be national uniformity in the regulation of these products. There are no administrative proceedings which must be exhausted prior to a judicial challenge to the regulations under this rule.
Paperwork Reduction Act
This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).Start List of Subjects
List of Subjects
- Animal biologics
- Animal biologics
- Reporting and recordkeeping requirements
Accordingly, we are amending 9 CFR parts 101 and 113 as follows:Start Part
PART 101—DEFINITIONSEnd Part Start Amendment Part
1. The authority citation for part 101 continues to read as follows:End Amendment Part Start Amendment Part
2. In § 101.5, paragraph (l) is revised to read as follows:End Amendment Part
(l) Test results. Terms used to designate testing results are as follows:
(1) No Test. Designation used when a deficiency in the test system has rendered a test unsuitable for drawing a valid conclusion.
(2) Satisfactory. Designation is a final conclusion given to a valid test with results that meet the release criteria stated in the filed Outline of Production or Standard Requirement.
(3) Unsatisfactory. Designation is a final conclusion given to a valid test with results that do not meet the release criteria stated in the filed Outline of Production or Standard Requirement.
(4) Inconclusive. Designation used for an initial test when a sequential test design established in the filed Outline of Production or Standard Requirement allows further testing if a valid initial test is not satisfactory.
PART 113—STANDARD REQUIREMENTSEnd Part Start Amendment Part
3. The authority citation for part 113 continues to read as follows:End Amendment Part Start Amendment Part
4. In § 113.5, paragraph (d) is revised to read as follows:End Amendment Part
(d) When the initial or any subsequent test is declared a No Test, the reasons shall be reported in the test records, the results shall not be considered as final, and the test may be repeated. When a test is declared satisfactory, the test designation is considered to be a final conclusion. When a test is declared unsatisfactory, the test designation is considered to be a final conclusion. When the initial or any subsequent test is declared inconclusive, the reasons shall be reported in the test records, the result shall not be considered as final, and the test may be repeated as established in the filed Outline of Production or Standard Requirement. If a test is designated inconclusive or No Test and the biological product is not further tested, the test designation of unsatisfactory is the final conclusion.
5. Sections 113.33, 113.36, 113.38, 113.39, 113.40, 113.41, 113.44, 113.45, 113.47, 113.67, 113.70, 113.71, 113.108, 113.109, 113.111, 113.112, 113.116, 113.117, 113.118, 113.204, 113.205, 113.207, 113.208, 113.210, 113.215, 113.216, 113.301, 113.302, 113.303, 113.304, 113.305, 113.306, 113.310, 113.311, 113.313, 113.314, 113.315, 113.316, 113.317, 113.318, 113.326, 113.327, 113.328, 113.329, 113.330, 113.331, 113.332, 113.406, 113.450, 113.454, and 113.455 are amended by removing the word “inconclusive” each time it occurs and by adding the words “a No Test” in its place.End Amendment Part
6. Sections 113.109, 113.111, and 113.112 are amended by removing the word “invalid” each time it occurs and adding the words “a No Test” in its place.End Amendment Part
7. Sections 113.201, 113.202, 113.203, and 113.211 are removed and reserved.End Amendment Part
8. In § 113.212, paragraphs (b) and (d)(1) are amended by removing the word “inconclusive” each time it occurs and replacing it with the words “a No Test”.End Amendment Part
9. Sections 113.213 and 113.214 are removed and reserved.End Amendment Part Start Amendment Part
10. Section 113.325 is amended as follows:End Amendment Part Start Amendment Part
a. By revising paragraph (b); andEnd Amendment Part Start Amendment Part
b. In paragraphs (c)(4), (d)(1), and (d)(2)(ii), by removing the word “inconclusive” each time it occurs and replacing it with the words “a No Test”.End Amendment Part
The revision reads as follows:
(b) Each lot of Master Seed Virus shall be tested for pathogens by the chicken embryo inoculation test prescribed in § 113.37, except that, if the test is a No Test because of a vaccine virus override, the test may be repeated and if the repeat test is inconclusive for the same reason, the chicken inoculation test prescribed in § 113.36 may be conducted and the virus judged accordingly.
Done in Washington, DC, this 12th day of September 2014.
Administrator, Animal and Plant Health Inspection Service.
1. To view the proposed rule and supporting documentation, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0034.Back to Citation
[FR Doc. 2014-22294 Filed 9-17-14; 8:45 am]
BILLING CODE 3410-34-P