[Federal Register Volume 60, Number 180 (Monday, September 18, 1995)]
[Rules and Regulations]
[Pages 48020-48022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23032]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 102 and 114
[Docket No. 93-136-2]
Viruses, Serums, Toxins, and Analogous Products; State-Federal
Licensure of Veterinary Biologics
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations concerning State-Federal
licensing of veterinary biological products. The effect of the
amendment is that a Federally licensed establishment will not be
allowed to produce the same veterinary biological product under both a
State and Federal product license. Autogenous biologics will not be
subject to the same requirement in that a Federally licensed
establishment may hold both State and Federal product licenses for
autogenous biologics, but must choose to produce each specific serial
of such biologic under either a State or Federal product license. No
autogenous biologic may be produced at the same time under both a
Federal and State license. The amendment is necessary in order to
ensure the integrity of the Federal licensing system and the safety of
biological products produced in Federally licensed establishments.
We are also removing outdated sections from the regulations
referring to interim establishment licenses and exemption procedures
that were permitted during the 5-year transition period to attain
Federal licensure under the 1985 amendments to the Virus-Serum-Toxin
Act.
EFFECTIVE DATE: October 18, 1995.
FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy
Director, Veterinary Biologics, BBEP, APHIS, USDA, 4700 River Road Unit
148, Riverdale, MD 20737-1237, (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS), U.S.
Department of Agriculture (USDA), licenses veterinary biological
products under the Virus-Serum-Toxin Act (21 U.S.C. 151-159,
hereinafter, the Act), as amended by the Food Security Act of 1985.
Veterinary biologics licensed by APHIS include products such as
vaccines, antitoxins, viruses, diagnostics, and autogenous biologics
(vaccines, bacterins, and toxoids) which are normally used in the herd
of origin (the herd from which the disease causing microorganism is
derived) to immunize animals against infectious disease.
Under the Act, veterinary biological products are licensed on the
basis of their purity, safety, potency, and efficacy. The 1985
amendments to the Act exempt certain products from the requirement that
they be produced pursuant to an unsuspended and unrevoked Federal
license. Such products include those which are prepared solely for
distribution within the State of production pursuant to a license
granted by such State under a program approved by the Administrator of
APHIS.
The regulations in 9 CFR part 102 contain Federal licensing
provisions for biological products. The regulations in 9 CFR part 114
prescribe conditions under which an unlicensed product may be prepared
in a USDA-licensed establishment.
On March 6, 1995, we published in the Federal Register (60 FR
12162-12165, Docket No. 93-136-1) a proposal to amend parts 102 and
114.
We proposed to amend part 102 by removing the outdated reference to
Federal interim licenses in Sec. 102.1 and by removing Sec. 102.4(h),
which refers to outdated provisions. We also proposed minor editorial
changes to Sec. 102.4(b)(3) and Sec. 102.6 (introductory paragraph and
paragraph (a)) to reflect organizational changes within APHIS.
We also proposed to amend part 114 by removing outdated provisions
for interim licenses and certain exemption procedures that were used in
implementing the 5-year transition to Federal licensure under the 1985
amendments to the Virus-Serum-Toxin Act. In addition, we proposed to
amend part 114 to establish the conditions that must be maintained when
a State-licensed veterinary biological product is produced in an
establishment holding a U.S. Veterinary Biologics Establishment
License.
Under the proposed amendments, a Federally licensed establishment
would not be allowed to produce the same veterinary biological product
under both a State and Federal product license. Autogenous biologics
would not be subject to the same requirement in that a Federally
licensed establishment could hold both State and Federal product
licenses for autogenous biologics, but would have to choose to produce
each specific serial of such biologic under either a State or Federal
product license. No autogenous biologic
[[Page 48021]]
could be produced at the same time under both a Federal and State
license.
We solicited comments concerning our proposal for 60 days ending
May 5, 1995. We did not receive any comments. The proposed rule
provides the basis for this final rule.
Therefore, based on the rationale set forth in the proposed rule,
we are adopting the provisions of the proposal 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 purposes of Executive
Order 12866, and, therefore, has not been reviewed by the Office of
Management and Budget.
This rule removes outdated sections from the regulations in
Secs. 102.1 and 102.4(h) and Sec. 114.2 (b) and (d). These sections
refer to outdated provisions related to the implementation of the 1985
amendments to the Virus-Serum-Toxin Act. These provisions expired on
June 30, 1991.
This rule also establishes conditions applicable to some 100
producers to prepare a biological product under either a State or USDA
product license in a USDA licensed establishment. An exception is
provided for autogenous biologics. The amendment will not have an
adverse economic impact on these producers of biologics since it still
allows the production of both State and Federally licensed products in
Federally-licensed establishments. Therefore, it is not anticipated
that the amendment will have an economic impact on producers or small
businesses.
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 12778
This final rule has been reviewed under Executive Order 12778,
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. There are no administrative procedures which must be exhausted
prior to a judicial challenge to the provisions of this rule.
Paperwork Reduction Act
This document 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
9 CFR Part 102
Animal biologics, Reporting and recordkeeping requirements.
9 CFR Part 114
Animal biologics, Reporting and recordkeeping requirements.
Accordingly, 9 CFR parts 102 and 114 are amended as follows:
PART 102--LICENSES FOR BIOLOGICAL PRODUCTS
1. The authority citation for part 102 continues to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
2. Section 102.1 is revised to read as follows:
Sec. 102.1 Licenses issued by the Administrator.
Each establishment qualified to prepare biological products under
the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S.
Veterinary Biologics Establishment License issued by the Administrator
and a U.S. Veterinary Biological Product License for each product
prepared in such establishment unless the product is subject to the
provisions of 9 CFR parts 103 or 106 of this subchapter.
Sec. 102.4 [Amended]
3. In Sec. 102.4, paragraph (b)(3), the words ``Veterinary
Services'' are removed and the words ``Animal and Plant Health
Inspection Service'' are added in their place.
4. In Sec. 102.4, paragraph (h) is removed.
Sec. 102.6 [Amended]
5. In Sec. 102.6, in the introductory paragraph and paragraph (a),
the term ``Deputy'' is removed.
PART 114--PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS
6. The authority citation for part 114 is revised to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
7. In Sec. 114.2, paragraphs (b) and (d) are removed; paragraph (c)
is redesignated as paragraph (b) and revised; and a new paragraph (c)
is added to read as follows:
Sec. 114.2 Products not prepared under license.
* * * * *
(b) Except as provided in 9 CFR part 103, a biological product
shall not be prepared in a licensed establishment unless the person to
whom the establishment license is issued holds an unexpired,
unsuspended, and unrevoked product license issued by the Administrator
to prepare such biological product, or unless the products prepared are
subject to the provisions of Sec. 107.2 of this subchapter.
(c) A biological product produced in a USDA-licensed establishment
shall be produced under a U.S. Veterinary Biological Product License or
a license granted by a State under Sec. 107.2 (referred to as a State
biological product license and the products prepared pursuant thereto
as State-licensed biological products, including autogenous biologics),
but not under both a U.S. Veterinary Biological Product License and a
State biological product license. Before a U.S. Veterinary Biological
Product License (including a conditional license) is issued, the
licensee shall relinquish its State license for that product: Provided,
That autogenous biologics shall not be subject to this provision when
they are prepared in accordance with the provisions of paragraph (c)(5)
of this section.
(1) State-licensed biological products (including autogenous
biologics) shall only be distributed or shipped intrastate, must not
bear a U.S. Veterinary Biologics Establishment License Number, and must
not otherwise be represented in any manner as having met the
requirements for a U.S. Veterinary Biological Product license. Labeling
of State- and USDA-licensed biological products produced in the same
establishment must be distinctly different in color and design.
(2) All biological products in USDA-licensed establishments,
whether licensed by USDA or by the State, shall be prepared only in
locations indicated in legends filed in accordance with 9 CFR part 108.
A description of each State-licensed product must be filed with the
Animal and Plant Health Inspection Service as part of the blueprint
legends and must be sufficient for Animal and Plant Health Inspection
Service to determine any risk to the production of other products in
the licensed establishment and to determine that adequate procedures
are followed
[[Page 48022]]
to prevent contamination during production.
(3) Records in such establishments must be maintained in accordance
with Secs. 116.1 and 116.2 of this subchapter and shall include all
products licensed by the State or USDA.
(4) Reports prescribed in Sec. 116.5 of this subchapter for USDA-
licensed establishments shall be submitted for all veterinary
biological products in the establishment.
(5) Under the following conditions, an autogenous biologic may be
produced in a USDA-licensed establishment under either a State or U.S.
Veterinary Biological Product License:
(i) When a culture of microorganisms, isolated from a herd in a
State, is received at a USDA-licensed establishment that is in the same
State but that holds both a State and a U.S. Veterinary Biological
Products License for autogenous biologics, the isolate shall be
designated by the licensee for use in the production of an autogenous
biological product under either the State product license, or the U.S.
Veterinary Biological Product License: Provided, That the isolate meets
the requirements of the respective regulatory authority for an
autogenous biologic. If, after producing the product pursuant to one
license, the licensee elects to produce an autogenous biologic from the
same isolate under provisions of the other license, the licensee may do
so only with the approval of the other licensing authority.
(ii) The true name of a State-licensed autogenous biologic shall
specify the State of licensure: e.g.
`` __________ Autogenous Bacterin'' -------------------------------
(State)
or __________ Autogenous Vaccine''. ---------------------------------
(State)
Done in Washington, DC, this 11th day of September 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-23032 Filed 9-15-95; 8:45 am]
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