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[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Rules and Regulations]
[Pages 55968-55969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22294]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 101 and 113

[Docket No. APHIS-2013-0034]
RIN 0579-AD86

Viruses, Serums, Toxins, and Analogous Products; Standard 
Requirements; Addition of Terminology To Define Veterinary Biologics 
Test Results

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: 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.

DATES: Effective Date: October 20, 2014.

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.

SUPPLEMENTARY INFORMATION:

Background

    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 \1\ 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 Sec.  
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 
Sec. Sec.  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.
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    \1\ To view the proposed rule and supporting documentation, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0034.
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    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

[[Page 55969]]

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 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.).

List of Subjects

9 CFR Part 101

    Animal biologics.

9 CFR Part 113

    Animal biologics, Exports, Imports, Reporting and recordkeeping 
requirements.

    Accordingly, we are amending 9 CFR parts 101 and 113 as follows:

PART 101--DEFINITIONS

0
1. The authority citation for part 101 continues to read as follows:

    Authority:  21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

0
2. In Sec.  101.5, paragraph (l) is revised to read as follows:

Sec.  101.5  Testing terminology.

* * * * *
    (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 REQUIREMENTS

0
3. The authority citation for part 113 continues to read as follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

0
4. In Sec.  113.5, paragraph (d) is revised to read as follows:

Sec.  113.5  General testing.

* * * * *
    (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.
* * * * *

Sec. Sec.  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  [Amended]

0
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.

Sec. Sec.  113.109, 113.111, and 113.112  [Amended]

0
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.

Sec. Sec.  113.201, 113.202, 113.203, and 113.211  [Removed and 
Reserved]

0
7. Sections 113.201, 113.202, 113.203, and 113.211 are removed and 
reserved.

Sec.  113.212  [Amended]

0
8. In Sec.  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''.

Sec. Sec.  113.213 and 113.214  [Removed and Reserved]

0
9. Sections 113.213 and 113.214 are removed and reserved.

0
10. Section 113.325 is amended as follows:
0
a. By revising paragraph (b); and
0
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''.
    The revision reads as follows:

Sec.  113.325  Avian Encephalomyelitis Vaccine.

* * * * *
    (b) Each lot of Master Seed Virus shall be tested for pathogens by 
the chicken embryo inoculation test prescribed in Sec.  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 Sec.  113.36 
may be conducted and the virus judged accordingly.
* * * * *

    Done in Washington, DC, this 12th day of September 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-22294 Filed 9-17-14; 8:45 am]
BILLING CODE 3410-34-P
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