[Federal Register Volume 64, Number 161 (Friday, August 20, 1999)]
[Rules and Regulations]
[Pages 45419-45421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21595]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 113
[Docket No. 97-103-2]
Viruses, Serums, Toxins, and Analogous Products; Update of
Incorporation by Reference for Rabies Vaccine
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations pertaining to the standard
requirements for rabies vaccine, killed virus, so that they incorporate
the latest edition of a guide to laboratory techniques. The regulations
currently refer to the previous edition of that guide, which was
published in 1973. This action will ensure that the latest edition of
the guide is incorporated by reference and used in conducting potency
tests during the production of inactivated (killed) veterinary rabies
vaccines.
EFFECTIVE DATES: September 20, 1999. The incorporation by reference
provided for by this rule is approved by the Director of the Federal
Register as of September 20, 1999.
FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Special
Assistant to the Deputy Administrator, Veterinary Services, Center for
Veterinary Biologics, Licensing and Policy Development, VS, APHIS, 4700
River Road Unit 148, Riverdale, MD 20737-1231; (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 113 pertain to standard requirements
for the preparation of veterinary biological products. A standard
requirement consists of test methods, procedures, and criteria
established by the Animal and Plant Health Inspection Service (APHIS)
to determine that a veterinary biological product is pure, safe,
potent, and efficacious and not worthless, dangerous, contaminated, or
harmful.
``Laboratory Techniques in Rabies,'' which is a guide to laboratory
[[Page 45420]]
techniques for rabies research and diagnosis and for the production of
vaccine and immunoglobulin and which is published by the World Health
Organization (WHO), is incorporated by reference into the Code of
Federal Regulations at 9 CFR 113.209(b)(1). In 1996, the WHO published
a fourth edition of ``Laboratory Techniques in Rabies'' (edited by F.X.
Meslin, M.M. Kaplan, and H. Koprowski), but the incorporation by
reference in Sec. 113.209(b)(1) still refers to the 1973 third edition
of that guide.
On March 4, 1999, we published in the Federal Register (64 FR
10400-10402, Docket No. 97-103-1) a proposed rule to amend the
regulations in Sec. 113.209(b)(1) so that they refer to the fourth
edition of ``Laboratory Techniques in Rabies'' in order for the latest
version to be incorporated by reference and used. In that document, we
also proposed to update several provisions of the regulations to make
them consistent with the guidelines contained in the fourth edition and
to ensure that the regulations met the requirements of the Office of
the Federal Register regarding the proper language of incorporation.
We solicited comments concerning our proposal for 60 days ending
May 3, 1999. 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 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.
In accordance with the Regulatory Flexibility Act, we have
considered the potential effects of this action on small entities. We
have identified four producers of rabies vaccine as the entities
potentially affected by this rule. Those producers fall into one of two
standard industrial classification (SIC) categories, either SIC 2836
(Biological Products, Except Diagnostic Substances) or SIC 2834
(Pharmaceutical Preparations). According to Small Business
Administration (SBA) criteria, a business in SIC 2836 is considered to
be a small entity if it has 500 or fewer employees, and a business in
SIC 2834 is considered to be a small entity if it has 750 or fewer
employees. Under those criteria, none of the four producers identified
are small entities.
``Laboratory Techniques in Rabies'' is a guide to laboratory
techniques for rabies research and diagnosis and for the production of
vaccine and immunoglobulin that is incorporated by reference into the
standard requirements regulations in 9 CFR 113.209(b)(1). This rule
amends those regulations so that the language used in the guide's
incorporation by reference is correct and ensures that the current
edition of the guide is incorporated by reference and used.
The testing required under Sec. 113.209(b)(1) will remain the same.
However, some retesting may be required due to change in the
international standard for the LD50 of the challenge dose.
We expect that the cost of a retest, which is estimated to be
approximately $2,400 for the mice and animal care, will have minimal
economic effect on the producers of rabies vaccines, none of which are
small entities under SBA criteria.
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 collection 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, Incorporation by reference,
Reporting and recordkeeping requirements.
Accordingly, we are amending 9 CFR part 113 as follows:
PART 113--STANDARD REQUIREMENTS
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 371.2(d).
2. In Sec. 113.209, paragraphs (b)(1) and (d)(3) are revised to
read as follows:
Sec. 113.209 Rabies Vaccine, Killed Virus.
* * * * *
(b) * * *
(1) The preinactivation virus titer must be established as soon as
possible after harvest by at least five separate virus titrations. A
mean relative potency value of the vaccine to be used in the host
animal potency test must be established by at least five replicate
potency tests conducted in accordance with the standard NIH test for
potency in chapter 37 of ``Laboratory Techniques in Rabies,'' Fourth
Edition (1996), edited by F.X. Meslin, M.M. Kaplan, and H. Koprowski,
World Health Organization, Geneva, Switzerland (ISBN 92 4 154479 1).
The provisions of chapter 37 of ``Laboratory Techniques in Rabies,''
Fourth Edition (1996), are the minimum standards for achieving
compliance with this section and are incorporated by reference. These
provisions state that the challenge virus standard to be used as the
challenge in the NIH test and the reference vaccine for the test are
available from the national control authority. In the United States,
that authority is the Animal and Plant Health Inspection Service's
Center for Veterinary Biologics Laboratory, located at 1800 Dayton
Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 239-8331; fax (515)
239-8673. This incorporation by reference was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the World Health Organization
Publications Center USA, 49 Sheridan Avenue, Albany, NY 12210. Copies
may be inspected at the Animal and Plant Health Inspection Service,
Center for Veterinary Biologics, Licensing and Policy Development, 4700
River Road, Riverdale, MD, or at the Office of the Federal Register,
800 North Capitol Street, NW., suite 700, Washington, DC.
* * * * *
(d) * * *
(3) Potency test. Bulk or final container samples of completed
product from each serial must be tested for potency by tests conducted
in accordance with the standard NIH test for potency in Chapter 37 of
``Laboratory Techniques in Rabies,'' Fourth Edition
[[Page 45421]]
(1996), which is incorporated by reference at paragraph (b)(1) of this
section. The relative potency of each serial must be at least equal to
that used in an approved host animal immunogenicity test.
Done in Washington, DC, this 13th day of August, 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-21595 Filed 8-19-99; 8:45 am]
BILLING CODE 3410-34-P