Source: https://www.federalregister.gov/documents/2014/05/30/2014-12551/viruses-serums-toxins-and-analogous-products-standard-requirements-addition-of-terminology-to-define
Timestamp: 2018-04-24 05:51:24
Document Index: 201043381

Matched Legal Cases: ['ART 101', 'art 113', 'art 116', '§\u2009116', '§\u2009101', 'art 113', '§\u2009113', '§\u2009113', 'art 113', 'art 113', '§\u2009113', '§\u2009101', '§\u2009101', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113', '§\u2009113']

Federal Register :: Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results
A Proposed Rule by the Animal and Plant Health Inspection Service on 05/30/2014
79 FR 31054
31054-31056 (3 pages)
0579-AD86
2014-12551
APHIS-2013-0034
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology to Define Test Results
Economic Analysis in Support of Certification that the Rule...
Economic Analysis: Viruses, Toxins, and Analogous Products;...
PART 101—DEFINITIONS
https://www.federalregister.gov/d/2014-12551 https://www.federalregister.gov/d/2014-12551
Start Preamble Start Printed Page 31054
Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2013-0034.
Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2013-0034, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.
Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2013-0034 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.
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.
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.
The results of these tests must be reported in accordance with 9 CFR part 116. Specifically, § 116.7 requires veterinary biologics licensees to submit summaries of all tests conducted on each serial and subserial of product using APHIS Form 2008 or an acceptable equivalent form prior to release of each serial or subserial. This form lists four terms to designate test results: “Satisfactory,” “unsatisfactory,” “inconclusive,” and “No Test.” The terms “satisfactory,” “unsatisfactory,” and “inconclusive” are not defined in the regulations. Section 101.5(l) of the regulations currently defines the term “No Test” as a test that produces inconclusive or invalid results and, therefore, cannot be used to evaluate a biological product. Section 113.5(d) of the regulations indicates that when an initial or subsequent test is declared a No Test, the reasons must be reported in the test records, the results will not be considered as final, and the test may be repeated.
We are proposing 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. Defining these testing terms will align the regulations in 9 CFR part 113 with current industry standards and practices.
We propose to revise paragraph (l) in section 101.5 to define the testing terms in new subparagraphs (1) through (4). Paragraph (l)(1) will provide a revised definition of “No Test.” The term “No Test” would now be defined as the test designation used when a deficiency in the test system has rendered a test unsuitable for drawing a valid conclusion. For example, the deficiency can be the result of a failure to meet the test's internal validity requirements established in the filed Outline of Production or standard requirements, or be caused by an uncontrollable occurrence such as a power outage affecting incubators or other equipment. A No Test is considered an intermediate designation and cannot be used to evaluate a biological product. A further process is then required to determine a final test conclusion of satisfactory or unsatisfactory, which will be based on the filed Outline of Production or standard requirements.
Paragraph (l)(2) would define the term “satisfactory” as the final, conclusive designation given to a valid test with results that meet the release criteria stated in the filed Outline of Production or Standard Requirement.
Paragraph (l)(3) would define the term “unsatisfactory” as the final, conclusive designation given to a valid test with results that do not meet the release criteria stated in the filed Outline of Production or Standard Requirement.
Paragraph (l)(4) would define the term “inconclusive” as the test designation used for an initial test when a sequential test design established in the filed Outline of Production or Standard Start Printed Page 31055Requirement allows further testing if a valid initial test is not satisfactory.
We are also proposing to revise § 113.5(d), which indicates that, when the initial or any subsequent test is declared a No Test, the reasons must be reported in the test records, the results will not be considered as final, and the test may be repeated. We would explain to licensees and permittees what the status of the product serial or subserial would be when the result of the test is designated as satisfactory, unsatisfactory, or inconclusive. When a test is declared satisfactory or unsatisfactory, the test designation would be considered a final conclusion. When the initial or any subsequent test is declared inconclusive, the reasons would have to be reported in the test records, the result would not be considered as a final conclusion, and the test could be repeated. If a test designated inconclusive is not performed again, it would be considered concluded and the final result reported as unsatisfactory.
The definitions we propose are intended to clarify the circumstances under which the results of prescribed tests can be reported as satisfactory, unsatisfactory, inconclusive, or No Test. In some cases, the proposed definitions would change how the test results are reported by licensees and permittees on APHIS Form 2008. We have identified more than 50 specific instances of tests in the regulations in which results designated as inconclusive would be redesignated as No Test based on the proposed definition. As one example, § 113.44(b) outlines the swine safety test procedure and interpretation of the test results:
As a result of our proposed changes to this and other tests in part 113, the term “inconclusive” in the paragraph above would be replaced by the term “No Test.” The procedural steps in many part 113 tests differ depending on whether the test is initially reported as a No Test or is inconclusive. A No Test indicates an invalid test that can be repeated without regard to the initial test. On the other hand, an inconclusive initial test result cannot be disregarded. The interpretation of any subsequent testing outcomes takes into account the initial inconclusive test result, for example by averaging its results with subsequent tests and using the average to complete subsequent tests.
We are also proposing 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.
2. In § 101.5, paragraph (l) is revised to read as follows:
§ 101.5
(l) Test results. Terms used to designate testing results are as follows:Start Printed Page 31056
4. In § 113.5, paragraph (d) is revised to read as follows:
§ 113.5
§§ 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, 113.215, 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
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, 113.215, 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.
§§ 113.109, 113.111, and 113.112
6. Section 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.
§§ 113.201, 113.202, 113.203, 113.210, 113.211, 113.213, and 113.214
§ 113.210
8. In § 113.210, paragraphs (d)(1) and (d)(2) are amended by removing the word “inconclusive” each time it occurs and replacing it with the words “a No Test”.
§ 113.212
a. In paragraph (b), by removing the word “inconclusive” and replacing it with the words “a No Test”; and
b. In paragraph (d)(1), by removing the word “inconclusive” and replacing it with the words “a No Test”.
§ 113.325
a. By revising paragraph (b); and
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”.
Avian Encephalomyelitis Vaccine.
(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.
[FR Doc. 2014-12551 Filed 5-29-14; 8:45 am]