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Rules and Regulations Federal Register

Vol. 72, No. 245

Friday, December 21, 2007

This section of the FEDERAL REGISTER veterinary biological products. Current subcutaneous injections recommended
contains regulatory documents having general standard requirements for certain live by the Association for Assessment and
applicability and legal effect, most of which bacterial and viral vaccines require that Accreditation of Laboratory Animal
are keyed to and codified in the Code of each Master Seed be retested for Care.
Federal Regulations, which is published under immunogenicity 3 years after the initial We agree with the commenter’s
50 titles pursuant to 44 U.S.C. 1510. recommendation and have amended
immunogenicity test.
The Code of Federal Regulations is sold by The requirement to confirm the § 113.33(a)(1) in this final rule to allow
the Superintendent of Documents. Prices of immunogenicity of a Master Seed at 3 the option of dividing the 0.5 mL
new books are listed in the first FEDERAL years has been in place since the master inoculation volume among more than
REGISTER issue of each week. seed concept for vaccine production one injection site.
was established, and had been The second commenter expressed
considered necessary until such time concern that adverse local reactions may
DEPARTMENT OF AGRICULTURE that an accumulation of data derived be missed if intraperitoneal inoculation
from such confirmatory testing is the only route used for the mouse
Animal and Plant Health Inspection established the antigenic stability of safety test, and suggested that such test
Service Master Seed bacteria and viruses over be conducted by inoculating mice using
extended periods of storage. Data both the subcutaneous and
9 CFR Part 113 accumulated by veterinary biologics intraperitoneal routes instead of by only
[Docket No. APHIS–2006–0079] licensees over several years have shown one route as had been proposed.
that the immunogenicity of the Master In response to the commenter’s
RIN 0579–AC30 concern that adverse local reactions may
Seed is not adversely affected over
extended periods of storage. be missed if only one route is used, we
Viruses, Serums, Toxins, and wish to point out that § 113.300(b) of the
On January 31, 2007, we published in
Analogous Products; Standard regulations requires final container
the Federal Register (72 FR 4470–4472,
Requirements for Live Vaccines samples from each serial of product to
Docket No. APHIS–2006–0079) a
AGENCY: Animal and Plant Health proposal1 to amend the Virus-Serum- be tested for safety in at least one
Inspection Service, USDA. Toxin Act regulations for certain live species for which the vaccine is
bacterial and viral vaccines by removing intended; the purpose of such test is to
ACTION: Final rule.
the requirement to retest the Master ensure freedom from undue adverse
SUMMARY: We are amending the Virus- Seeds for immunogenicity 3 years after local reactions. Accordingly, we are not
Serum-Toxin Act regulations for certain the initial qualifying immunogenicity making any changes in this final rule in
live bacterial and viral vaccines by test. We also proposed to amend the response to the comment.
removing the requirement to retest the requirement concerning mouse safety Therefore, for the reasons given in the
Master Seeds for immunogenicity 3 tests prescribed for biological products proposed rule and in this document, we
years after the initial qualifying recommended for animals other than are adopting the proposed rule as a final
immunogenicity test. In addition, we are poultry. rule, with the changes discussed in this
amending the requirement concerning We solicited comments concerning document.
mouse safety tests prescribed for a our proposal for 60 days ending April 2, Executive Order 12866 and Regulatory
biological product recommended for 2007. We received two comments by Flexibility Act
animals other than poultry. These that date, from a trade association This proposed rule has been reviewed
changes update the standard representing veterinary biologics under Executive Order 12866. The rule
requirements by eliminating manufacturers and a representative of a has been determined to be not
unnecessary testing of Master Seed State animal health commission. significant for the purposes of Executive
bacteria and viruses and other forms of One commenter supported the
Order 12866 and, therefore, has not
bulk or completed biological product. elimination of unnecessary testing/ been reviewed by the Office of
DATES: Effective Date: January 22, 2008. retesting from the regulations and noted Management and Budget.
FOR FURTHER INFORMATION CONTACT: Dr. that such action would decrease We are amending the regulations for
Albert P. Morgan, Chief Staff Officer, duplicative testing in animals. With certain live bacterial and viral vaccines
Operational Support Section, Center for regard to using the subcutaneous route to eliminate the requirement to retest
Veterinary Biologics, Policy, Evaluation, of inoculation when conducting the the Master Seed for immunogenicity 3
and Licensing, APHIS, USDA, 4700 mouse safety test, that same commenter years after the initial qualifying
River Road, Unit 148, Riverdale, MD recommended that proposed immunogenicity test. In addition, this
20737–1228; (301) 734–8245. § 113.33(a)(1) should provide the option amendment updates the regulations
to split the injection volume among concerning mouse safety tests by
more than one injection site. The requiring either intraperitoneal or
Background commenter pointed out that this subcutaneous inoculation of mice, but
The Virus-Serum-Toxin Act recommendation was consistent with not both, in such tests. The primary
the ‘‘good practice’’ guidelines for
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regulations in 9 CFR part 113 (referred effect of this rule will be to update the
to below as the regulations) contain 1 To view the proposed rule and the comments
standard requirements by eliminating
standard procedures and requirements we received, go to
unnecessary testing of Master Seed
that are used to establish the purity, fdmspublic/component/main?main=Docket bacteria and viruses and other forms of
safety, potency, and efficacy of Detail&d=APHIS-2006-0079. bulk or completed product in animals.

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72564 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations

There are approximately 125 PART 113—STANDARD § 113.302, 113.304, 113.314, 113.315,
veterinary biologics establishments, REQUIREMENTS 113.317, 113.327, 113.331, and 113.332
including licensees and permittees that [Amended]
may be affected by this rule. According ■ 1. The authority citation for part 113
continues to read as follows: ■ 9. In §§ 113.302, 113.304, 113.314,
to the standards of the Small Business 113.315, 113.317, 113.327, 113.331, and
Administration, most veterinary Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 113.332, paragraph (c)(4) is removed
biologics establishments would be 2.80, and 371.4.
and paragraph (c)(5) is redesignated as
classified as small entities. § 113.8 [Amended] paragraph (c)(4).
It is anticipated that no increased ■ 2. In § 113.8, paragraph (d) is § 113.305 [Amended]
recordkeeping burden will be added to amended as follows:
licensees or permittees since the ■ a. In the heading by removing the ■ 10. In § 113.305, paragraphs (b)(1)(iii)
amended regulations actually will mean words ‘‘Repeat immunogenicity tests’’ and (b)(2)(iii) are removed and
that fewer tests will be needed and and adding the words ‘‘Extending the paragraph (b)(2)(iv) is redesignated as
fewer reports required to be submitted. dating of a reference’’ in their place. paragraph (b)(2)(iii).
We further anticipate that licensees and ■ b. By removing paragraph (d)(1).
§§ 113.308 and 113.316 [Amended]
permittees may benefit economically ■ c. By removing the paragraph
from the cost savings associated with designation ‘‘(2)’’. ■ 11. In §§ 113.308 and 113.316,
the reduction in the amount of required ■ 3. In § 113.33, paragraphs (a)(1) and paragraph (b)(5) is removed and
animal testing. The overall effect of this (a)(2) are revised to read as follows: paragraph (b)(6) is redesignated as
amendment will be to reduce the costs paragraph (b)(5).
§ 113.33 Mouse safety tests.
associated with producing and testing
* * * * * § 113.309 [Amended]
veterinary biological products.
(a) * * *
Under these circumstances, the ■ 12. In § 113.309, paragraph (c)(9) is
(1) Vaccine prepared for use as
Administrator of the Animal and Plant removed and paragraph (c)(10) is
recommended on the label shall be
Health Inspection Service has redesignated as paragraph (c)(9).
tested by inoculating eight mice
determined that this action will not intraperitoneally or subcutaneously § 113.310 [Amended]
have a significant economic impact on with 0.5 mL (the inoculation volume
a substantial number of small entities. may be divided among more than one ■ 13. In § 113.310, paragraph (c)(8) is
injection site), and the animals observed removed and paragraph (c)(9) is
Executive Order 12372 redesignated as paragraph (c)(8).
for 7 days.
This program/activity is listed in the (2) If unfavorable reactions § 113.311 [Amended]
Catalog of Federal Domestic Assistance attributable to the product occur in any
under No. 10.025 and is subject to of the mice during the observation ■ 14. In § 113.311, paragraph (c)(7) is
Executive Order 12372, which requires period, the serial or subserial is removed and paragraph (c)(8) is
intergovernmental consultation with unsatisfactory. If unfavorable reactions redesignated as paragraph (c)(7).
State and local officials. (See 7 CFR part which are not attributable to the product
occur, the test shall be declared § 113.312 [Amended]
3015, subpart V.)
inconclusive and may be repeated: ■ 15. In § 113.312, paragraphs (b)(5)
Executive Order 12988 Provided, That, if the test is not and(b)(6) are removed and paragraph
repeated, the serial or subserial shall be (b)(7) is redesignated as paragraph
This final rule has been reviewed declared unsatisfactory.
under Executive Order 12988, Civil (b)(5).
Justice Reform. It is not intended to * * * * *
§§ 113.313 and 113.328 [Amended]
have retroactive effect. This rule will §§ 113.66, 113.68, and 113.69 [Amended]
not preempt any State or local laws, ■ 16. In §§ 113.313 and 113.328,
■ 4. In §§ 113.66, 113.68, and 113.69, paragraph (c)(6) is removed and
regulations, or policies, unless they
paragraph (b)(6) is removed and paragraph (c)(7) is redesignated as
present an irreconcilable conflict with
paragraph (b)(7) is redesignated as paragraph (c)(6).
this rule. The Virus-Serum-Toxin Act
paragraph (b)(6).
does not provide administrative §§ 113.325 and 113.326 [Amended]
procedures which must be exhausted § 113.67 [Amended]
prior to a judicial challenge to the ■ 17. In §§ 113.325 and 113.326,
■ 5. In § 113.67, paragraph (b)(7) is paragraph (c)(5) is removed and
provisions of this rule. removed and paragraph (b)(8) is paragraph (c)(6) is redesignated as
Paperwork Reduction Act redesignated as paragraph (b)(7). paragraph (c)(5).
This rule contains no new § 113.70 [Amended] § 113.329 [Amended]
information or recordkeeping ■ 6. In § 113.70, paragraph (b)(5) is ■ 18. In § 113.329, paragraph (c)(5) is
requirements under the Paperwork removed. removed and paragraphs (c)(6) and (c)(7)
Reduction Act of 1995 (44 U.S.C. 3501 are redesignated as paragraphs (c)(5)
§§ 113.71, 113.306, and 113.318 [Amended]
et seq.). and (c)(6), respectively.
■ 7. In §§ 113.71, 113.306, and 113.318,
List of Subjects in 9 CFR Part 113 paragraph (b)(4) is removed and Done in Washington, DC, this 13th day of
paragraph (b)(5) is redesignated as December 2007.
Animal biologics, Exports, Imports,
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paragraph (b)(4). Kevin Shea,

Reporting and recordkeeping Acting Administrator, Animal and Plant
requirements. § 113.303 [Amended] Health Inspection Service.
■ Accordingly, we are amending 9 CFR ■ 8. In § 113.303, paragraph (c)(6) is [FR Doc. E7–24649 Filed 12–20–07; 8:45 am]
part 113 as follows: removed. BILLING CODE 3410–34–P

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