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[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Proposed Rules]
[Pages 31054-31056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12551]

========================================================================
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.

========================================================================


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
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