[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Proposed Rules]
[Pages 31054-31056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12551]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Proposed
Rules
[[Page 31054]]
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: Proposed rule.
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SUMMARY: We are proposing to amend 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 would 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 proposing to
remove several obsolete testing standard requirements from part 113.
These changes would update our regulations and improve communication
between regulators and product licensees and permittees with respect to
reporting test results.
DATES: We will consider all comments that we receive on or before July
29, 2014.
ADDRESSES: You may submit comments by either of the following methods:
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.
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.
The results of these tests must be reported in accordance with 9
CFR part 116. Specifically, Sec. 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 Sec. 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
[[Page 31055]]
Requirement allows further testing if a valid initial test is not
satisfactory.
We are also proposing to revise Sec. 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, Sec. 113.44(b)
outlines the swine safety test procedure and interpretation of the test
results:
(b) Interpretation. If unfavorable reactions attributable to the
product occur in either of the swine during the observation period, the
serial or subserial is unsatisfactory. If unfavorable reactions which
are not attributable to the product occur, the test shall be declared
inconclusive and may be repeated; Provided, That, if the test is not
repeated, the serial or subserial shall be declared unsatisfactory.
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.
For a list of instances where we are proposing to redesignate test
outcomes from inconclusive to No Test, please see the proposed
amendatory text below.
We are also proposing 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.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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
by contacting the person listed under FOR FURTHER INFORMATION CONTACT
or on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov).
APHIS is proposing to amend 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 proposed changes would 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 would 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 proposed changes
would 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 would
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 proposed 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 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 proposed 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 propose to amend 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:
[[Page 31056]]
(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,
113.215, 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. 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.
Sec. Sec. 113.201, 113.202, 113.203, 113.210, 113.211, 113.213, and
113.214 [Removed and Reserved]
0
7. Sections 113.201, 113.202, 113.203, 113.211, 113.213, and 113.214
are removed and reserved.
Sec. 113.210 [Amended]
0
8. In Sec. 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''.
Sec. 113.212 [Amended]
0
9. Section 113.212 is amended as follows:
0
a. In paragraph (b), by removing the word ``inconclusive'' and
replacing it with the words ``a No Test''; and
0
b. In paragraph (d)(1), by removing the word ``inconclusive'' and
replacing it with the words ``a No Test''.
Sec. 113.325 [Amended]
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 23rd day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-12551 Filed 5-29-14; 8:45 am]
BILLING CODE 3410-34-P