Viruses, Serums, Toxins, and Analogous Products; Standard Requirements; Addition of Terminology To Define Veterinary Biologics Test Results, 55968-55969 [2014-22294]
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55968
Federal Register / Vol. 79, No. 181 / Thursday, September 18, 2014 / Rules and Regulations
sentence of paragraph D.6. introductory
text and the third sentences of
paragraph D.6.d. to read as follows:
§ 1980.452 FmHA or its successor agency
under Public Law 103–354 evaluation of
application.
*
*
*
*
*
D. * * *
6. * * * Notice of approval to lender
will be accomplished by providing or
sending the lender the signed copy of
Form FmHA or its successor agency
under Public Law 103–354 1940–3 and
Form FmHA or its successor agency
under Public Law 103–354 449–14 six
working days from the date funds are
reserved, unless an exception is granted
by the National Office. * * *
*
*
*
*
*
(d) * * * The obligation date will be
the date of the request for reservation of
authority which is being processed in
the Finance Office. * * *
*
*
*
*
*
Dated: August 7, 2014.
Doug O’Brien,
Under Secretary, Rural Development.
Dated: September 3, 2014.
Michael Scuse,
Under Secretary, Farm and Foreign
Agricultural Services.
[FR Doc. 2014–21704 Filed 9–17–14; 8:45 am]
BILLING CODE 3410–XT–P
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
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
asabaliauskas on DSK5VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:55 Sep 17, 2014
Jkt 232001
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 VirusSerum-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
§ 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
1 To
view the proposed rule and supporting
documentation, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2013-0034.
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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
E:\FR\FM\18SER1.SGM
18SER1
Federal Register / Vol. 79, No. 181 / Thursday, September 18, 2014 / Rules and Regulations
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
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.
2. In § 101.5, paragraph (l) is revised
to read as follows:
■
§ 101.5
Testing terminology.
asabaliauskas on DSK5VPTVN1PROD with RULES
*
*
*
*
*
(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
VerDate Sep<11>2014
16:12 Sep 17, 2014
Jkt 232001
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
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.
4. In § 113.5, paragraph (d) is revised
to read as follows:
■
§ 113.5
*
*
*
*
*
(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.
*
*
*
*
*
§§ 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]
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
PO 00000
Frm 00007
Fmt 4700
Sfmt 9990
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
[Amended]
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.
■
§§ 113.201, 113.202, 113.203, and 113.211
[Removed and Reserved]
7. Sections 113.201, 113.202, 113.203,
and 113.211 are removed and reserved.
■
§ 113.212
[Amended]
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’’.
■
General testing.
■
55969
§§ 113.213 and 113.214
Reserved]
[Removed and
9. Sections 113.213 and 113.214 are
removed and reserved.
■
10. Section 113.325 is amended as
follows:
■ 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’’.
The revision reads as follows:
■
§ 113.325
Vaccine.
Avian Encephalomyelitis
*
*
*
*
*
(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.
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
E:\FR\FM\18SER1.SGM
18SER1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ To view the proposed rule and supporting documentation, go
to https://www.regulations.gov/#!docketDetail;D=APHIS-2013-0034.
---------------------------------------------------------------------------
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
