[Federal Register Volume 59, Number 57 (Thursday, March 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6947]
[[Page Unknown]]
[Federal Register: March 24, 1994]
VOL. 59, NO. 57
Thursday, March 24, 1994
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 113
[Docket No. 93-057-1]
Viruses, Serums, Toxins, and Analogous Products; Sampling of
Biological Products
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations regarding the number
of samples that a firm would need to submit to the Animal and Plant
Health Inspection Service for testing at the National Veterinary
Services Laboratories (NVSL), Ames, Iowa. The effect of the proposed
amendment would be to specify the number of samples that NVSL would
need for diagnostic test kits and for Master Seeds and Cells. The
proposed amendment is necessary to provide criteria to licensees
regarding diagnostic test kits and Master Seeds and Cells because no
criteria are currently included in the regulations.
DATES: Consideration will be given only to comments received on or
before May 23, 1994.
ADDRESSES: Please send an original and three copies of your comments to
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804,
Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please
state that your comments refer to Docket No. 93-057-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and
4:30 p.m., Monday through Friday, except holidays. Persons wishing to
inspect comments are requested to call ahead (202) 690-2817 to
facilitate entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT: Dr. Richard E. Pacer, Senior Staff
Veterinarian, Veterinary Biologics, BBEP, APHIS, USDA, room 838,
Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-
8245.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 113 contain Standard Requirements for
evaluating veterinary biological products that are licensed by the
Animal and Plant Health Inspection Service (APHIS), U.S. Department of
Agriculture, under the Virus-Serum-Toxin Act of 1913, as amended by the
Food Security Act of 1985. Veterinary biological products are defined
as all viruses, serums, toxins, and analogous products of natural or
synthetic origin, such as diagnostics, antitoxins, vaccines, live
microorganisms, killed microorganisms and antigenic or immunizing
components of microorganisms intended for the use in the diagnosis,
treatment, or prevention of diseases of animals. In order to be
licensed, veterinary biological products must be demonstrated to be
pure, safe, potent, and efficacious.
Purity and identity tests are performed by the licensee and the
National Veterinary Services Laboratories (NVSL) on the Master Seed(s)
and Master Cell Stock(s) used in the production of veterinary
biological products. The licensee is also required to perform tests on
the veterinary biological product following complete formulation for
purity, safety, and potency as prescribed in a filed Outline of
Production or Standard Requirements for the product in accordance with
Sec. 113.5. The manufacturer's test results may be checked by NVSL
personnel on biological product samples that the manufacturer is
required to submit to NVSL in accordance with Sec. 113.3.
Section 113.3 currently provides licensees with criteria for
selection and submission of veterinary biological products, such as
vaccines, bacterins, antiserums, and toxoids to NVSL; however, it does
not state the number of samples of diagnostic test kits and Master
Seeds and Cells needed by NVSL for evaluation. The proposed amendments
would specify that a minimum of 1 diagnostic test kit, 10 samples of
Bacterial Master Seeds, 13 samples of Viral Master Seeds, and 36
milliliters of Master Cell Stocks would be needed for evaluation by
NVSL.
Minor editorial changes would also be made in Sec. 113.309 to
reflect organizational changes within APHIS.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been determined to be not significant for purposes of
Executive Order 12866 and therefore has not been reviewed by the Office
of Management and Budget.
There are currently no criteria in the regulations which specify
the number of samples needed by NVSL to evaluate diagnostic test kits
and Master Seeds and Cells. However, almost all of the 114 currently
licensed veterinary biologics companies submit samples of Master Seeds
and Cells to NVSL for testing. In addition, at least 25 of these
companies produce veterinary diagnostic test kits and submit samples of
them to NVSL for testing. Many of these companies would be considered
small entities. This proposed amendment would benefit these entities.
This proposed rule, if adopted, would reduce the licensees' time
and expense in submitting samples to the NVSL by clearly stating the
number of samples required to be submitted, by increasing the
uniformity of sample submissions, and by allowing for more efficient
handling of samples by licensees and APHIS personnel. In addition, this
amendment could potentially increase revenues for manufacturers of
veterinary diagnostic test kits by allowing them to return unrequested
samples to inventory for sale.
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 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1980
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR part 113
Animal biologics, Exports, Imports, Reporting and recordkeeping
requirements.
Accordingly, 9 CFR part 113 would be amended as follows:
PART 113--STANDARD REQUIREMENTS
1. The authority citation for part 113 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
2. In Sec. 113.3, paragraphs (b)(7), (b)(8) and (b)(9) would be
revised, paragraph (b)(10) would be removed, paragraph (c) would be
revised, and new paragraphs (d) and (e) would be added to read as
follows:
Sec. 113.3 Sampling of biological products.
* * * * *
(b) * * *
(7) Diagnostic test kits: Two samples of diagnostic test kits. The
licensee or permittee will hold one of these selected samples at the
storage temperature recommended on the label while awaiting a request
by the Animal and Plant Health Inspection Service to submit the
additional sample. If submissions are not requested by the Animal and
Plant Health Inspection Service, the additional sample may be returned
to the serial inventory after the serial is released.
(8) Autogenous biologics: Ten samples shall be selected from each
serial of autogenous biologic that exceeds 50 containers. No samples,
other than those required by paragraph (e) of this section, are
required for a serial of autogenous biologic with 50 or fewer
containers.
(9) Miscellaneous: The number of samples from products not in the
categories provided for in paragraphs (b)(1) through (b)(8) of this
section shall be prescribed in the filed Outline of Production for the
product.
(c) Prelicensing and Outline of Production changes: Samples needed
to support a license application or a change in the Outline of
Production for a licensed product shall be submitted only upon request
from the Animal and Plant Health Inspection Service. Except for
miscellaneous products specified in paragraph (b)(9) of this section,
the number of such samples shall be at least one and one-half times the
number prescribed for such product in paragraph (b) of this section.
Samples of Master Seeds and Master Cell Stocks with a minimum
individual volume of 1 ml shall be submitted as follows:
(1) Ten samples of Bacterial Master Seeds.
(2) Thirteen samples of Viral Master Seeds or Nonviral Master Seeds
requiring cell culture propagation. For Master Seeds isolated or passed
in a cell line different from the species of intended use, an
additional 2 samples are required for each additional species. For
Master Seeds grown in cell culture and intended for use in more than
one species, an additional 2 samples are required for each additional
species.
(3) Thirty-six 1 ml samples or six 1 ml samples plus one 20 ml
sample and one 10 ml sample of Master Cell Stocks. In the case of
Master Cell Stocks which are persistently infected with a virus, an
additional four 1 ml samples are required. If these persistently
infected cell stocks are intended for use in more than one species, an
additional two 1 ml samples are required for each additional species.
(4) Four samples of the Master Cell Stock + n (highest passage)
cells.
(d) Sterile diluent: A sample of Sterile Diluent shall accompany
each sample of product, other than Marek's Disease Vaccine, if such
diluent is required to rehydrate or dilute the product before use. The
volume of diluent shall be an appropriate amount to rehydrate or dilute
the product. Samples of Sterile Diluent prepared for use with Marek's
Disease Vaccine shall be submitted upon request from the Animal and
Plant Health Inspection Service.
(e) Reserve samples shall be selected from each serial and
subserial of biological product. Such samples shall be selected at
random from final containers of completed product by an employee of the
Department, of the licensee, or of the permittee, as designated by the
Administrator.
Each sample shall: (1) Consist of 5 single-dose packages, 2
multiple-dose packages, or 2 diagnostic test kits, as the case may be;
(2) Be adequate in quantity for appropriate examination and
testing;
(3) Be truly representative and in final containers;
(4) Be held in a special compartment set aside by the licensee or
permittee for holding these samples under refrigeration at the storage
temperature recommended on the labels for 6 months after the expiration
date stated on the labels. The samples that are stored in this manner
shall be delivered to the Animal and Plant Health Inspection Service
upon request.
(Approved by the Office of Management and Budget under control
number 0579-0013)
3. In Sec. 113.309, paragraph (c)(4), the words ``Veterinary
Services'' are removed and the words ``Animal and Plant Health
Inspection Service'' are added in their place.
Done in Washington, DC, this 17th day of March 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-6947 Filed 3-23-94; 8:45 am]
BILLING CODE 3410-34-P
