[Federal Register Volume 67, Number 64 (Wednesday, April 3, 2002)]
[Rules and Regulations]
[Pages 15711-15714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8058]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 113

[Docket No. 95-066-2]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the Virus-Serum-Toxin Act regulations for 
autogenous biologics by reducing the number of test summaries that 
manufacturers must submit to the Animal and Plant Health Inspection 
Service. In addition, we are amending the requirement concerning the 
submission of containers selected from each serial of autogenous 
biologic that exceeds 50 containers. Manufacturers will hold these 
containers, and submission is not required unless requested by the 
Animal and Plant Health Inspection Service. These actions will 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.

EFFECTIVE DATE: May 3, 2002.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, 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 (referred to below as the 
regulations) 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 from a particular flock or herd. The cultures are 
used to produce an autogenous veterinary

[[Page 15712]]

biological product that is administered to other animals of the 
originating flock or herd to prevent them from being infected 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 in 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 animal diseases 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, 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 the 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 or if any of the test animals 
used to demonstrate product safety become sick or die during the 
observation period. However, because autogenous biological products can 
be shipped prior to the 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 
acceptable equivalent form 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.
    On March 8, 2000, we published in the Federal Register (65 FR 
12151-12153, Docket No. 95-066-1) a proposal to amend the regulations 
for autogenous biologics. We proposed to reduce the number of test 
summaries that autogenous biologics manufacturers must submit to APHIS, 
and to amend the requirement concerning the submission to APHIS of 
containers selected from each serial of autogenous biologic that 
exceeds 50 containers. Manufacturers would hold these containers and 
submit them to APHIS when requested.
    We solicited comments concerning our proposal for 60 days ending 
May 8, 2000. We received four comments by that date. They were from two 
veterinary biologics manufacturers and two trade associations 
representing veterinary biologics manufacturers. We carefully 
considered these before reaching a final decision concerning our 
proposal. Two comments were received after the close of the comment 
period. However, the issues they raised were not materially different 
from those contained in the timely comments.
    Of the four comments that were received by the May 8, 2000, close 
of the comment period, three expressed support for the changes set 
forth in the proposed rule, but suggested additional changes or 
requested that we clarify points related to reserve samples. Two 
commenters observed that first serials or subserials of autogenous 
biologics are frequently not shipped due to contamination, an 
unsatisfactory test, or for other reasons. Both suggested wording for 
Sec. 113.3(b)(8) that would make the requirement to select samples for 
submitting to APHIS applicable to the ``first serial or subserial of 
autogenous biologic eligible for shipment.'' We agree with the 
commenters regarding the need to make it clear that this provision is 
only applicable to the first serials or subserials of autogenous 
biologics eligible to be shipped and, therefore, in the final rule each 
reference to first serial or subserial is changed to ``first serial or 
subserial of autogenous biologic eligible for shipment.''
    With regard to reserve samples, one commenter questioned whether 
the proposed wording of Sec. 113.3(b)(8) requires 10 containers of 
autogenous biologic selected for submission upon request by APHIS to be 
held in reserve until 6 months beyond the expiration date. It appears 
that our use of the term ``reserve'' in Sec. 113.3(b)(8) in the 
proposed rule could be interpreted as requiring that 10 containers be 
held in reserve until 6 months beyond the expiration date. Because it 
was not our intent to change the requirements of Sec. 113.3(e) for 
reserve samples, the term ``reserve'' has been deleted in this final 
rule. The second sentence of Sec. 113.3(b)(8) now reads: ``For first 
serials or subserials of autogenous biologic eligible for shipment with 
more than 50 containers, 10 samples from each serial or subserial must 
be selected and held for submission to the Animal and Plant Health 
Inspection Service upon request in accordance with paragraph (e)(4) of 
this section.''
    In addition, one of the commenters suggested that Sec. 113.3(b)(8) 
be modified to provide that samples not selected for testing by APHIS 
could be restocked by the manufacturer and become eligible for 
distribution. We believe that the disposition of samples not selected 
for testing by APHIS is beyond the scope of the proposed rule; thus, we 
are making no changes in this final rule as a result of that comment.
    One commenter was opposed to the provisions set forth in the 
proposed rule. The commenter stated that the proposed changes would 
result in a weakening of the regulatory oversight that APHIS is 
expected to provide concerning the regulation of autogenous biologics. 
We believe that the changes to the regulations contained in the 
proposed rule and this final rule will not weaken our regulatory 
oversight. The regulations that we are amending have required samples 
to be submitted to APHIS when selected and test summaries to be 
submitted within 4 days of test completion, whereas under this final 
rule, manufacturers will be required to hold samples for submission 
when requested by APHIS and to submit test summaries on a quarterly 
basis. Confirmatory testing of autogenous samples will remain at 
current levels, and quarterly test summaries will be monitored to 
ensure that tests are completed satisfactorily and accurately reported. 
Therefore, we have made no change to this final rule in response to 
this comment.
    The same commenter stated that the proposed special testing and 
serial

[[Page 15713]]

release reporting requirements pertaining to the preparation and use of 
autogenous biologics would result in preferential treatment for firms 
producing autogenous biologics that is unavailable to firms that do not 
prepare those products. The commenter requested that the special 
testing and serial release reporting requirements proposed for 
autogenous biologics be extended to all products and all manufacturers. 
We agree that the regulations, as amended by this final rule, will 
provide for different treatment of autogenous biologics under certain 
special circumstances, but we would like to emphasize that this 
different treatment only applies to the first serial or subserial of 
autogenous biologic that is produced from an isolate. Thereafter, the 
preparation of autogenous biologics is subject to the same treatment as 
other biologics; each serial or subserial of autogenous biologic other 
than the first serial or subserial prepared from that same isolate must 
be prepared in accordance with the applicable general requirements for 
bacterial or viral products specified in the regulations, and any 
serial or subserial found unsatisfactory by any prescribed test shall 
not be released. In addition, the preparation of autogenous biologics 
is not restricted and that all manufacturers may, at their option, 
choose to produce autogenous biologics and take advantage of the 
special testing and serial release reporting requirements applicable to 
first serials or subserials of autogenous biologics. We have made no 
change in this final rule in response to that comment.
    Some comments regarding the regulation of autogenous biologics were 
not specific to the provisions in the proposal. These comments stated 
that the preparation and distribution of such products are not in 
keeping with the intent for autogenous biologics as cited in the 
preamble to the proposed rule. These commenters were concerned that 
autogenous biologics may be more widely distributed than should be 
allowed; may not be adequately evaluated for extraneous agents; may not 
be effective under certain circumstances; and may not be evaluated 
adequately for safety. We have also made no changes in this final rule 
in response to those comments.
    One change that had been proposed was an address correction in 
Sec. 113.113(a)(2). This change does not appear in this final rule 
because the address in that section is correct.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule, with the changes discussed in this document.

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.
    This rule amends the Virus-Serum-Toxin Act regulations for 
autogenous biologics by reducing the number of test summaries that 
manufacturers of autogenous veterinary biologics must submit to APHIS. 
This rule also amends the requirements concerning the submission of 
containers selected from each serial of autogenous biologic that 
exceeds 50 containers to provide that manufacturers will hold these 
containers and not submit them unless requested by APHIS. These actions 
will result in savings in time and resources for autogenous biologics 
manufacturers and APHIS without a significant reduction in regulatory 
oversight.
    The entities expected to be affected by this rule are veterinary 
biologics establishments that produce autogenous biologics. There are 
currently approximately 135 veterinary biologics establishments that 
may fit that category. According to the Small Business Administration's 
criteria, many of those establishments would be classified as small 
entities.
    This rule provides that 10 samples must be selected for submission 
when requested by APHIS from each serial or subserial of autogenous 
biologics, with the exception of first serials or subserials, that 
exceeds 50 containers, and that test summaries of autogenous biologics 
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. These changes to the regulations are not expected to 
have any adverse economic effects on firms and may provide a benefit, 
since the amount of time and resources required to complete reports 
and/or package samples for submission to APHIS should be reduced.
    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 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.). It actually reduces the information 
collection without a disruption to program services.

List of Subjects in 9 CFR Part 113

    Animal biologics, Exports, Imports, 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 371.4.

    2. In Sec. 113.3, paragraph (b)(8) is 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 and submitted to the Animal and 
Plant Health Inspection Service from each serial or subserial of an 
autogenous biologic eligible to be shipped that consists of more than 
50 containers. For first serials or subserials eligible for shipment 
consisting of more than 50 containers, 10 samples from each serial or 
subserial must be selected and held for submission to the Animal and 
Plant Health Inspection Service upon request in accordance with 
paragraph (e)(4) of this section. For serials or subserials of 
autogenous biologic with 50 or fewer containers, no samples, other than 
those required by paragraph (e) of this section, are required.
* * * * *

[[Page 15714]]


    3. In Sec. 113.113, the introductory text of paragraph (a)(2) and 
paragraph (c)(1)(iv) are 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 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 28th day of March, 2002.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-8058 Filed 4-2-02; 8:45 am]
BILLING CODE 3410-34-P