[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Proposed Rules]
[Pages 12151-12153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5596]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 113

[Docket No. 95-066-1]


Viruses, Serums, Toxins, and Analogous Products; Autogenous 
Biologics

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act 
regulations for autogenous biologics. The number of test summaries that 
autogenous biologics manufacturers must submit to the Animal and Plant 
Health Inspection Service would be reduced. In addition, we are 
proposing to amend the requirement concerning the submission to the 
Animal and Plant Health Inspection Service of containers selected from 
each serial of autogenous biologic that exceeds 50 containers. 
Manufacturers would be required to hold these containers and submission 
would not be required unless requested by the Animal and Plant Health 
Inspection Service. These actions would result in savings in time and 
resources for autogenous biologics manufacturers and the Animal and 
Plant Health Inspection Service without a significant reduction in 
regulatory oversight.

DATES: We will consider all comments that we receive by May 8, 2000.

ADDRESSES: Please send your comment and three copies to:
    Docket No. 95-066-1, Regulatory Analysis and Development, PPD, 
APHIS Suite 3C03, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. 
Please state that your comment refers to Docket No. 95-066-1.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, Center for Veterinary Biologics, 
Licensing and Policy Development, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1231; (301) 734-8245.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in title 9, Code of Federal Regulations (9 CFR), 
part 113 contain standard requirements for the preparation of 
veterinary biological products. Section 113.113 of the regulations sets 
forth the requirements for autogenous biologics. Autogenous biologics 
are prepared from cultures of microorganisms that are isolated from 
sick or dead animals of a particular flock or herd. The cultures are 
used to produce an autogenous veterinary biological product that is 
administered to other animals of the originating flock or herd to 
prevent them from being affected by the same disease. Autogenous 
biologics may also be used in adjacent and nonadjacent herds under 
certain conditions, if approved by the Administrator of the Animal and 
Plant Health Inspection Service (APHIS).
    Autogenous biologics are intended for use in isolated cases of 
diseases of animals when licensed products are not available or such 
products are unable to protect the vaccinated animals (e.g., the strain 
of microorganism in the licensed product differs from the strain 
associated with the disease outbreak). Autogenous biologics can also be 
used to respond to emergency outbreaks of diseases of animals when the 
immediate need for the product is such that it precludes the usual 
route of vaccine development.
    Given the special circumstances pertaining to the preparation and 
use of autogenous biologics, including the need for a rapid response to 
emergencies, special testing and serial release reporting requirements 
have been applied. In Sec. 113.113, paragraph (c)(1)(ii) allows first 
serials or subserials of an autogenous biologic that are satisfactory 
after the third day of observation of purity test cultures and safety 
test animals to be released for shipment to the customer while the 
purity and safety tests are continued through the required period. 
Paragraph(c)(1)(iii) of Sec. 113.113 provides that such serials must be 
immediately recalled if evidence of contamination occurs in the purity 
test cultures or if any of the test animals used to demonstrate product 
safety get sick or die during the observation period. However, because 
autogenous biologic products can be shipped prior to completion of 
testing, the products, in most cases, have been used in animals prior 
to the completion of testing. In addition, Sec. 113.113(c)(1)(iv) 
requires autogenous biologics manufacturers to submit to APHIS the test 
summaries of the first serial or subserial within 4 days of the 
completion of the purity and safety tests. The test summaries must be 
submitted to APHIS in accordance with Sec. 116.7 of 9 CFR part 116, 
``Records and Reports.'' (Section 116.7, in short, provides the 
requirements for maintenance of detailed records of all tests conducted 
on each serial and subserial and the preparation and submission of 
summaries of such tests using APHIS Form 2008 or an equivalent prior to 
release of the serial or subserial.)
    In 1993, the last year for which full data are available, 
veterinary biologics manufacturers submitted approximately 11,400 
autogenous biologics first serial test summaries to APHIS for 
processing, and the number of reports has increased in succeeding 
years. However, we believe that the requirement to submit test 
summaries from the first serial or subserial of an autogenous biologic 
within 4 days of completion of purity and safety tests for serials that 
may have already been used in animals is unnecessary. We believe that 
these reports can be submitted on a quarterly basis without reducing 
our regulatory oversight. Therefore, we are proposing to revise 
Sec. 113.113(c)(iv) to provide that test summaries must be submitted on 
a quarterly basis as summary reports by the 21st day of January, April, 
July, and October, or more often as required by the Administrator.
    Because we would allow the submission of test summaries on a 
quarterly basis, we would no longer refer to Sec. 116.7.

Reserve Samples

    Manufacturers of autogenous biologics are required by Sec. 113.3 to 
submit to APHIS samples from each serial or subserial of an autogenous 
biologic for confirmatory purity and safety testing. In Sec. 113.3, 
paragraph (b)(8) states that, in the case of

[[Page 12152]]

autogenous biologics, 10 samples for submission to APHIS must be 
selected from each serial that exceeds 50 containers. Samples from 
serials containing 50 or fewer containers are required to be held and 
need not be submitted unless requested. Because purity testing can be 
conducted on any serial of comparable product, we do not believe that 
10 samples from serials of autogenous biologics that exceed 50 
containers need to be submitted to APHIS to maintain our current 
regulatory oversight. We believe that autogenous biologics 
manufacturers should maintain samples of the first serial or subserial 
in reserve and, if requested, submit them to APHIS when testing is 
necessary. However, samples of second serials and subsequent serials 
that exceed 50 containers will still be required to be submitted.
    Therefore, we are proposing to revise Sec. 113.3(b)(8) to provide 
that, with the exception of the first serial or subserial, 10 samples 
must be selected for submission to APHIS from each serial or subserial 
of autogenous biologic that exceeds 50 containers. For first serials or 
subserials with more than 50 containers, 10 samples would need to be 
selected and held in reserve for submission to APHIS upon request. For 
all serials or subserials with 50 or fewer containers, reserve samples 
would be handled as prescribed in Sec. 113.3(e) of the regulations.

Miscellaneous

    We are also proposing minor nonsubstantive and editorial changes to 
the regulations, as set out in the rule portion of this document. The 
main change would be in the APHIS address appearing in 
Sec. 113.113(a)(2).

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 purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    We are proposing to amend the Virus-Serum-Toxin Act regulations for 
autogenous biologics. We are proposing to reduce the number of test 
summaries that autogenous biologics manufacturers must submit to APHIS. 
In addition, we are proposing to amend the requirement for the 
submission of samples of any autogenous biologic that exceeds 50 
containers by requiring autogenous biologics manufacturers to hold 
samples of the first serial or subserial of the autogenous biologic in 
reserve. These actions would result in savings in time and resources 
for autogenous biologics manufacturers and APHIS without a significant 
reduction in regulatory oversight.
    This proposed rule would affect all licensed veterinary biologics 
establishments that produce autogenous biologics. Currently, there are 
approximately 150 veterinary biologics establishments, and 
approximately 35 of these establishments produce autogenous biologics. 
According to the standards of the Small Business Administration, most 
veterinary biologics establishments would be classified as small 
entities.
    By creating a system that allows the quarterly reporting of test 
results for first serials and subserials of autogenous biologics, APHIS 
would reduce paperwork submissions from autogenous biologics 
manufacturers by approximately 25 percent or more. This would reduce 
the industry's annual reporting burden by approximately 6,018 hours.
    In addition, this proposed rule would allow autogenous biologics 
manufacturers to hold in reserve 10 samples from the first serial or 
subserial of any serial or subserial of an autogenous biologic with 
more than 50 containers. These manufacturers would no longer need to 
submit samples of the first serial or subserial to APHIS unless 
requested to do so. Allowing autogenous biologics manufacturers to hold 
these samples in reserve would save them the time and resources 
previously invested in shipping samples to APHIS.
    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 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. It is not intended to have retroactive effect. 
This rule would not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
rule. The 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 proposed rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). This action would, in fact, reduce paperwork 
submissions from autogenous biologics manufacturers by approximately 25 
percent or more. This would reduce the industry's annual reporting 
burden by approximately 6,018 hours.

List of Subjects 9 CFR Part 113

    Animal biologics, Exports, Imports, Reporting and recordkeeping 
requirements.
    Accordingly, we propose to amend 9 CFR part 113 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 2.22, 2.80, and 371.2(d).

    2. In Sec. 113.3, paragraph (b)(8) would be revised to read as 
follows:


Sec. 113.3  Sampling of biological products.

* * * * *
    (b) * * *
    (8) Autogenous biologics. With the exception of the first serial or 
subserial, 10 samples must be selected from each serial or subserial of 
an autogenous biologic that consists of more than 50 containers. For 
first serials or subserials with more than 50 containers, 10 samples 
from each serial or subserial must be selected and held in reserve for 
submission to the Animal and Plant Health Inspection Service upon 
request in accordance with paragraph (e)(4) of this section. For all 
serials or subserials with 50 or fewer containers, reserve samples must 
be selected and held as prescribed in paragraph (e) of this section.
* * * * *
    3. In Sec. 113.113, paragraphs (a)(2) introductory text and 
(c)(1)(iv) would be revised to read as follows:


Sec. 113.113  Autogenous biologics.

    (a) * * *
    (2) Under normal circumstances, microorganisms from one herd must 
not be used to prepare an autogenous biologic for another herd. The 
Administrator, however, may authorize preparation of an autogenous 
biologic for use in herds adjacent to the herd of origin, when adjacent 
herds are considered to be at risk. To request authorization to prepare 
a product for use in herds adjacent to the herd of origin, the 
establishment seeking

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authorization must submit to the Administrator (in c/o the Director, 
Center for Veterinary Biologics, Inspection and Compliance, 510 South 
17th Street, Suite 104, Ames, IA 50010-8197) the following information. 
(If any of the data are unavailable, the applicant for authorization 
should indicate that such data are unavailable and why.)
* * * * *
    (c) * * *
    (1) * * *
    (iv) Test summaries must be submitted to the Administrator (in c/o 
the Director, Center for Veterinary Biologics, Inspection and 
Compliance, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) on a 
quarterly basis by the 21st day of January, April, July, and October, 
or more often as required by the Administrator.
* * * * *

    Done in Washington, DC, this 1st day of March, 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-5596 Filed 3-7-00; 8:45 am]
BILLING CODE 3410-34-P