[Federal Register: December 21, 2007 (Volume 72, Number 245)]
[Rules and Regulations]
[Page 72563-72564]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de07-1]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
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[[Page 72563]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 113
[Docket No. APHIS-2006-0079]
RIN 0579-AC30
Viruses, Serums, Toxins, and Analogous Products; Standard
Requirements for Live Vaccines
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the Virus-Serum-Toxin Act regulations for
certain live bacterial and viral vaccines by removing the requirement
to retest the Master Seeds for immunogenicity 3 years after the initial
qualifying immunogenicity test. In addition, we are amending the
requirement concerning mouse safety tests prescribed for a biological
product recommended for animals other than poultry. These changes
update the standard requirements by eliminating unnecessary testing of
Master Seed bacteria and viruses and other forms of bulk or completed
biological product.
DATES: Effective Date: January 22, 2008.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff
Officer, Operational Support Section, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing, APHIS, USDA, 4700 River Road, Unit
148, Riverdale, MD 20737-1228; (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred
to below as the regulations) contain standard procedures and
requirements that are used to establish the purity, safety, potency,
and efficacy of veterinary biological products. Current standard
requirements for certain live bacterial and viral vaccines require that
each Master Seed be retested for immunogenicity 3 years after the
initial immunogenicity test.
The requirement to confirm the immunogenicity of a Master Seed at 3
years has been in place since the master seed concept for vaccine
production was established, and had been considered necessary until
such time that an accumulation of data derived from such confirmatory
testing established the antigenic stability of Master Seed bacteria and
viruses over extended periods of storage. Data accumulated by
veterinary biologics licensees over several years have shown that the
immunogenicity of the Master Seed is not adversely affected over
extended periods of storage.
On January 31, 2007, we published in the Federal Register (72 FR
4470-4472, Docket No. APHIS-2006-0079) a proposal\1\ to amend the
Virus-Serum-Toxin Act regulations for certain live bacterial and viral
vaccines by removing the requirement to retest the Master Seeds for
immunogenicity 3 years after the initial qualifying immunogenicity
test. We also proposed to amend the requirement concerning mouse safety
tests prescribed for biological products recommended for animals other
than poultry.
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\1\ To view the proposed rule and the comments we received, go
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0079
.
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We solicited comments concerning our proposal for 60 days ending
April 2, 2007. We received two comments by that date, from a trade
association representing veterinary biologics manufacturers and a
representative of a State animal health commission.
One commenter supported the elimination of unnecessary testing/
retesting from the regulations and noted that such action would
decrease duplicative testing in animals. With regard to using the
subcutaneous route of inoculation when conducting the mouse safety
test, that same commenter recommended that proposed Sec. 113.33(a)(1)
should provide the option to split the injection volume among more than
one injection site. The commenter pointed out that this recommendation
was consistent with the ``good practice'' guidelines for subcutaneous
injections recommended by the Association for Assessment and
Accreditation of Laboratory Animal Care.
We agree with the commenter's recommendation and have amended Sec.
113.33(a)(1) in this final rule to allow the option of dividing the 0.5
mL inoculation volume among more than one injection site.
The second commenter expressed concern that adverse local reactions
may be missed if intraperitoneal inoculation is the only route used for
the mouse safety test, and suggested that such test be conducted by
inoculating mice using both the subcutaneous and intraperitoneal routes
instead of by only one route as had been proposed.
In response to the commenter's concern that adverse local reactions
may be missed if only one route is used, we wish to point out that
Sec. 113.300(b) of the regulations requires final container samples
from each serial of product to be tested for safety in at least one
species for which the vaccine is intended; the purpose of such test is
to ensure freedom from undue adverse local reactions. Accordingly, we
are not making any changes in this final rule in response to the
comment.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The 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.
We are amending the regulations for certain live bacterial and
viral vaccines to eliminate the requirement to retest the Master Seed
for immunogenicity 3 years after the initial qualifying immunogenicity
test. In addition, this amendment updates the regulations concerning
mouse safety tests by requiring either intraperitoneal or subcutaneous
inoculation of mice, but not both, in such tests. The primary effect of
this rule will be to update the standard requirements by eliminating
unnecessary testing of Master Seed bacteria and viruses and other forms
of bulk or completed product in animals.
[[Page 72564]]
There are approximately 125 veterinary biologics establishments,
including licensees and permittees that may be affected by this rule.
According to the standards of the Small Business Administration, most
veterinary biologics establishments would be classified as small
entities.
It is anticipated that no increased recordkeeping burden will be
added to licensees or permittees since the amended regulations actually
will mean that fewer tests will be needed and fewer reports required to
be submitted. We further anticipate that licensees and permittees may
benefit economically from the cost savings associated with the
reduction in the amount of required animal testing. The overall effect
of this amendment will be to reduce the costs associated with producing
and testing veterinary biological products.
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 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, unless they present an irreconcilable conflict with this
rule. The Virus-Serum-Toxin Act does not provide administrative
procedures which must be exhausted prior to a judicial challenge to the
provisions of this rule.
Paperwork Reduction Act
This rule contains no new information or recordkeeping requirements
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 113
Animal biologics, Exports, Imports, Reporting and recordkeeping
requirements.
0
Accordingly, we are amending 9 CFR part 113 as follows:
PART 113--STANDARD REQUIREMENTS
0
1. 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.
Sec. 113.8 [Amended]
0
2. In Sec. 113.8, paragraph (d) is amended as follows:
0
a. In the heading by removing the words ``Repeat immunogenicity tests''
and adding the words ``Extending the dating of a reference'' in their
place.
0
b. By removing paragraph (d)(1).
0
c. By removing the paragraph designation ``(2)''.
0
3. In Sec. 113.33, paragraphs (a)(1) and (a)(2) are revised to read as
follows:
Sec. 113.33 Mouse safety tests.
* * * * *
(a) * * *
(1) Vaccine prepared for use as recommended on the label shall be
tested by inoculating eight mice intraperitoneally or subcutaneously
with 0.5 mL (the inoculation volume may be divided among more than one
injection site), and the animals observed for 7 days.
(2) If unfavorable reactions attributable to the product occur in
any of the mice 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.
* * * * *
Sec. Sec. 113.66, 113.68, and 113.69 [Amended]
0
4. In Sec. Sec. 113.66, 113.68, and 113.69, paragraph (b)(6) is
removed and paragraph (b)(7) is redesignated as paragraph (b)(6).
Sec. 113.67 [Amended]
0
5. In Sec. 113.67, paragraph (b)(7) is removed and paragraph (b)(8) is
redesignated as paragraph (b)(7).
Sec. 113.70 [Amended]
0
6. In Sec. 113.70, paragraph (b)(5) is removed.
Sec. Sec. 113.71, 113.306, and 113.318 [Amended]
0
7. In Sec. Sec. 113.71, 113.306, and 113.318, paragraph (b)(4) is
removed and paragraph (b)(5) is redesignated as paragraph (b)(4).
Sec. 113.303 [Amended]
0
8. In Sec. 113.303, paragraph (c)(6) is removed.
Sec. 113.302, 113.304, 113.314, 113.315, 113.317, 113.327, 113.331,
and 113.332 [Amended]
0
9. In Sec. Sec. 113.302, 113.304, 113.314, 113.315, 113.317, 113.327,
113.331, and 113.332, paragraph (c)(4) is removed and paragraph (c)(5)
is redesignated as paragraph (c)(4).
Sec. 113.305 [Amended]
0
10. In Sec. 113.305, paragraphs (b)(1)(iii) and (b)(2)(iii) are
removed and paragraph (b)(2)(iv) is redesignated as paragraph
(b)(2)(iii).
Sec. Sec. 113.308 and 113.316 [Amended]
0
11. In Sec. Sec. 113.308 and 113.316, paragraph (b)(5) is removed and
paragraph (b)(6) is redesignated as paragraph (b)(5).
Sec. 113.309 [Amended]
0
12. In Sec. 113.309, paragraph (c)(9) is removed and paragraph (c)(10)
is redesignated as paragraph (c)(9).
Sec. 113.310 [Amended]
0
13. In Sec. 113.310, paragraph (c)(8) is removed and paragraph (c)(9)
is redesignated as paragraph (c)(8).
Sec. 113.311 [Amended]
0
14. In Sec. 113.311, paragraph (c)(7) is removed and paragraph (c)(8)
is redesignated as paragraph (c)(7).
Sec. 113.312 [Amended]
0
15. In Sec. 113.312, paragraphs (b)(5) and(b)(6) are removed and
paragraph (b)(7) is redesignated as paragraph (b)(5).
Sec. Sec. 113.313 and 113.328 [Amended]
0
16. In Sec. Sec. 113.313 and 113.328, paragraph (c)(6) is removed and
paragraph (c)(7) is redesignated as paragraph (c)(6).
Sec. Sec. 113.325 and 113.326 [Amended]
0
17. In Sec. Sec. 113.325 and 113.326, paragraph (c)(5) is removed and
paragraph (c)(6) is redesignated as paragraph (c)(5).
Sec. 113.329 [Amended]
0
18. In Sec. 113.329, paragraph (c)(5) is removed and paragraphs (c)(6)
and (c)(7) are redesignated as paragraphs (c)(5) and (c)(6),
respectively.
Done in Washington, DC, this 13th day of December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-24649 Filed 12-20-07; 8:45 am]
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