[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Proposed Rules]
[Pages 12159-12162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5406]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 102, 104, 105, and 116
[Docket No. 93-072-1]
Viruses, Serums, Toxins, and Analogous Products; Licenses,
Inspections, Records, and Reports
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations under the Virus-
Serum-Toxin Act to clarify certain provisions concerning licenses,
inspections, records, and reports. The effect of the rule is to ensure
that licensees are aware of the fact that licenses are issued on the
condition that the licensee permit inspection of establishments,
products, and records, and that a licensee must have at least one
product license in order to maintain a valid establishment license.
Failure to permit inspection would make the license subject to
suspension or revocation. We are also proposing amendments concerning
the content of records and reports and their availability for
inspection. The proposed rule is necessary to clarify and simplify
certain provisions of the regulations.
DATES: Consideration will be given only to comments received on or
before May 5, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 93-072-1, Animal and Plant Health Inspection Service,
Regulatory Analysis and Development, Program and Policy Development,
4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that
your comments refer to Docket No. 93-072-1. 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
[[Page 12160]] inspect comments are requested to call ahead on (202)
690-2817 to facilitate entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT:
Dr. Anne Goodman, Chief Staff Microbiologist, Veterinary Biologics,
BBEP, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 20737-1237.
301-734-8245.
SUPPLEMENTARY INFORMATION: The Virus-Serum-Toxin Act of 1913 (21 U.S.C.
151-159), as amended, is intended to ensure that veterinary biological
products shipped in or from the United States are not worthless,
contaminated, dangerous, or harmful. To achieve that purpose, the Act
requires that such products be prepared in compliance with USDA
regulations at an establishment holding an unsuspended and unrevoked
USDA establishment license. No such products may be imported into the
United States without a permit issued by the Administrator. Provisions
regarding veterinary biological product licenses, license suspensions,
and inspections appear in the regulations. See for example, 9 CFR Parts
102, 105, and 116.
The regulations currently provide in Sec. 102.4(f) that when a
licensee holding an establishment license no longer holds an unexpired,
unsuspended, or unrevoked product license authorizing preparation of a
product in the licensed establishment, the establishment license shall
be submitted to the Administrator for termination.
Pursuant to Sec. 102.2 of the regulations, licensees producing
biological products in the United States are required to hold at least
one unexpired, unsuspended, and unrevoked product license in addition
to an establishment license. Therefore, and establishment license
without a product license would not be valid. Section 102.2 would be
amended to make this clear.
Section 102.4 would also be amended by revising paragraph (f) and
by adding new paragraph (g). Paragraph (f) would be revised to provide
that an establishment license is not valid unless the licensee also
holds a product license, or is in the process of obtaining one. This
would include activities such as requesting or filing a product license
application or being involved in the development of a product.
Paragraph (g) would provide that licenses for establishments where
biological products are prepared shall be issued on condition that the
licensee shall permit the inspection by USDA inspectors of such
establishments and of products prepared in these establishments.
Failure to permit such inspection could result in license suspension or
revocation. This proposed change simply reflects the language in
Sec. 157 of the Virus-Serum-Toxin Act.
In Sec. 104.6(b), editorial changes would be made to reflect
organizational changes within the Animal and Plant Health Inspection
Service. The words ``Veterinary Services'' would be removed and the
words ``Animal and Plant Health Inspection Service'' would be added in
their place.
Amendments would also be made to two sections of part 105 of the
regulations which deal with suspension, revocation, or termination of
biological product licenses or permits. In Sec. 105.1, current
paragraphs (a)(4) and (5) would be redesignated paragraphs (a)(5) and
(6). New Sec. 105.1(a)(4) would be added to assure that licensees,
permittees, or foreign manufacturers of products that are imported
under permit, maintain and make available for inspection all records
relevant to the development and preparation of a product. Records and
reports would be required to be complete and accurate.
Otherwise a license or permit could be subject to suspension or
revocation under Sec. 105.1. This proposed amendment to clarify the
regulations is necessary because of recent incidence of noncompliance
and refusal by licensees or permittees to produce requested records and
reports. Since recordkeeping is already required under current
Sec. 116.8, no new paperwork burden would be imposed.
The second amendment which would be made in Part 105 is to
Sec. 105.4 concerning termination of licenses for inactivity. Proposed
Sec. 105.4(a) would specify that a product license or a permit would be
terminated for inactivity unless intent to resume activity is
demonstrated. Proposed Sec. 105.4(b) would also specify that certain
records be completed and retained in accordance with provisions in
Sec. 116.8. The proposed amendment would help to make the section
clearer and easier to administer.
The proposed rule would also amend several sections of Part 116
which deal with records and reports. First Sec. 116.1 would be amended
to provide that detailed records and reports concerning biological
products must be maintained at the establishment in which the products
are produced, unless otherwise authorized (See proposed Sec. 116.1(c)).
This proposed change is necessary because of problems which have arisen
during inspections involving records which were not available at the
producing establishment. Since such records and reports are already
required under current Secs. 116.5 and 116.8, no new reporting or
recordkeeping burden would be imposed.
Proposed Sec. 116.1(b) would also be added to provide for
appropriate records at the permittee's place of business. Proposed
Sec. 116.1(c) would be added to provide for maintenance of records at
an alternate location. Such an alternate location would have to be
confirmed by filing an addendum to the plot plan legend. The proposed
amendment would provide for archiving of records, maintenance of
distribution records, and compilation of consumer reports in off-
premise facilities and other locations. Such archiving of records and
reports should not result in paperwork burden that is greater than that
already required under current Secs. 116.5 and 116.8.
Section 116.5 would be amended to clarify that producers and
importers of biological products may be required to submit reports
containing information related to production activities or the purity,
safety, potency, and efficacy of a product. The proposed amendment
would clarify that APHIS be notified when a consumer report raises a
question regarding purity, safety, potency, and efficacy of a product
or a product is found to be unsatisfactory, or prepared, tested, or
distributed in violation of the act or regulations. Again, the
amendment is necessary to clarify for licensees, permittees, and
foreign manufacturers the type of information that must be provided to
APHIS. Since product purity, safety, potency, and efficacy remain the
responsibility of licensees and permittees, no new paperwork burden
would be imposed by these amendments over what is required in current
part 116.
Section 116.7 would be amended to state that test summaries
prepared from reports must be submitted to APHIS on Form 2008 or its
equivalent prior to serial or subserial release.
Finally Sec. 116.8, which deals with records and their retention,
would be amended by including permittees in the requirement that
records concerning biological products (other than disposition records)
be completed prior to product marketing or export. In addition,
permittees would be required to retain all records at a designated
establishment or place of business for a specified period of time after
the expiration date of the product. Since the permittee is normally a
licensee or a representative of a foreign manufacturer, who already has
recordkeeping requirements under current Sec. 116.8, no new
recordkeeping requirements would be imposed by this
amendment. [[Page 12161]]
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.
The proposed rule would amend the regulations in 9 CFR parts 102,
104, 105, and 116 to clarify existing provisions concerning licenses,
inspections, records, and reports. Licenses are issued on condition
that the licensee permit inspection of establishments, products, and
records. The proposed rule would provide that the failure to permit
such inspection would make the license subject to suspension or
revocation. In order to hold a valid establishment license, licenses
are required to have at least one unexpired, unsuspended, and unrevoked
product license. Otherwise, the establishment license would be invalid.
We are also proposing amendments concerning the content of records and
reports and the availability of their inspection.
The proposed rule would make clear and unambiguous certain
regulatory provisions. No new requirements are added in the proposed
rule. Therefore, no adverse economic impact would result from the rule.
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
In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this proposed rule have been approved by the Office of
Management and Budget (OMB), and there are no new requirements. The
assigned OMB control number is 0579-0013.
List of Subjects
9 CFR Part 102
Animal biologics, Reporting and recordkeeping requirements.
9 CFR Part 104
Animal biologics, Imports, Reporting and recordkeeping
requirements, Transportation.
9 CFR Part 105
Animal biologics.
9 CFR Part 116
Animal biologics, Reporting and recordkeeping requirements.
Accordingly, 9 CFR parts 102, 104, 105, and 116 would be revised as
follows:
PART 102--LICENSES FOR BIOLOGICAL PRODUCTS
1. The authority citation for part 102 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. 102.2, the introductory paragraph would be designated as
paragraph (a) and a new paragraph (b) would be added to read as
follows:
Sec. 102.2 Licenses required.
* * * * *
(b) An applicant who applies for an establishment license must also
apply for at least one product license. An establishment license will
not be issued without a license authorizing the production of a
biological product in the establishment.
3. In Sec. 102.4, paragraph (f) would be revised, paragraphs (g)
and (h) would be redesignated as paragraphs (h) and (i), respectively,
and new paragraph (g) would be added to read as follows:
Sec. 102.4 U.S. Veterinary Biologics Establishment License.
* * * * *
(f) When a licensee no longer holds at least one unexpired,
unsuspended, or unrevoked product license authorizing the preparation
of a biological product, or is in the process of obtaining a product
license, the establishment license shall no longer be valid and shall
be returned to the Administrator. In the case where an establishment
license expires or is suspended or revoked, any product license
authorizing preparation of a product at such establishment shall be
invalid indefinitely or for as long as the suspension is in effect.
(g) Any license issued under this Part to establishments in which
biological products are prepared shall be issued on condition that the
licensee permit the inspection of such establishments, products,
product preparation, and all relevant records as provided in Part 115.
Failure to permit inspection may result in the license being suspended
or revoked.
* * * * *
PART 104--PERMITS FOR BIOLOGICAL PRODUCTS
4. The authority citation for part 104 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
Sec. 104.6 [Amended]
5. In Sec. 104.6, paragraph (b), the words ``Veterinary Services''
would be removed and the words ``Animal and Plant Health Inspection
Service'' would be added in their place.
6. In 9 CFR part 105, the heading for the part would be revised to
read as follows:
PART 105--SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL
LICENSES OR PERMITS
7. The authority citation for part 105 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
8. In Sec. 105.1, paragraphs (a)(4) and (a)(5) would be
redesignated paragraphs (a)(5) and (a)(6), new paragraph (a)(4) would
be added, and redesignated paragraph (a)(5) would be revised to read as
follows:
Sec. 105.1 Suspension or revocation.
* * * * *
(a) * * *
(4) The licensee, permittee, or the foreign manufacturer has failed
to maintain and make available for inspection records in connection
with the development and preparation of product, has failed to provide
complete and accurate information when requested, or has failed to
provide complete and accurate information in the Outline of Production
or in reports and records;
(5) The licensee or permittee has violated or failed to comply with
any provision of the Virus-Serum-Toxin Act or the regulations in this
subchapter;
* * * * *
9. Section 105.4 would be revised to read as
follows: [[Page 12162]]
Sec. 105.4 Termination of licenses and permits for inactivity.
(a) If a biological product has not been prepared by a licensee, or
imported by a permittee for a period of five years or more, the
Administrator may require the licensee to show intent to resume
production, or the permittee to show intent to resume importation,
within six months of notification. If the licensee does not resume
preparation, or the permittee does not resume importation, within six
months of notification, or within a mutually agreeable period, the
product license, or permit, may be terminated by the Administrator.
(b) When a license or permit is terminated, the licensee or
permittee shall continue to be subject to applicable records provisions
of Sec. 116.8.
10. In 9 CFR part 116, the heading for the part would be revised to
read as follows:
PART 116--RECORDS AND REPORTS
11. The authority citation for part 116 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
12. In Sec. 116.1, paragraphs (a), (b) and (c) would be
redesignated as paragraphs (a)(1), (a)(2), and (a)(3), respectively;
redesignated paragraph (a)(1) would be revised; the introductory
paragraph would be designated as paragraph (a) and would be revised;
and new paragraphs (b) and (c) would be added to read as follows:
Sec. 116.1 Applicability and general considerations.
(a) Each licensee, permittee, and foreign manufacturer of
biological products imported into the United States shall maintain, at
the licensed or foreign establishment in which the products are
prepared, detailed records of information necessary to give a complete
accounting of all the activities within such establishment. Such
records shall include, but shall not be limited to, the items
enumerated in this part.
(1) Records shall be made concurrently with the performance of
successive steps in the development and preparation of biological
products, including new products under development. Such records shall
include the date and where critical, the time that each essential step
was taken, the identity and quantity of ingredients added or removed at
each step, and any gain or loss of product from the beginning to the
end of product preparation.
* * * * *
(b) In the case of imported products, each permittee shall maintain
at the permittee's place of business detailed and accurate records that
are relevant to each imported product and that include, but are not
limited to, importation documents, sampling records, tests summaries,
shipping records, and inventory and disposition records as required in
Sec. 116.2.
(c) When authorized by the Administrator, the licensee, permittee,
or foreign manufacturer may maintain and retain records required under
part 116 at an alternative location. Such authorization shall be
confirmed by the filing of an addendum to the plot plan legend. The
addendum shall list the location of the records and the condition of
their storage and shall permit the inspection of the records by APHIS
inspectors, or foreign inspectors acting on behalf of APHIS.
(Approved by the Office of Management and Budget under control
number 0579-0013)
Secs. 116.2, 116.3, 116.4, and 116.6 [Amended]
13. At the end of Secs. 116.2, 116.3, 116.4, and 116.6, the
reference to OMB control number ``0579-0059'' would be removed and the
number ``0579-0013'' would be added in its place.
14. Section 116.5 would be revised to read as follows:
Sec. 116.5 Reports.
(a) When required by the Administrator, reports containing accurate
and complete information concerning biological products, including but
not limited to, product development and preparation, consumer reports,
and market suspensions and recalls, shall be prepared and submitted to
the Animal and Plant Health Inspection Service by the licensee,
permittee, or foreign manufacturer whose products are being imported or
offered for importation. Unless otherwise authorized by the
Administrator, records necessary to make such reports shall be
maintained in each establishment.
(b) If, at any time, consumer reports concerning the use of
products raise questions regarding purity, safety, potency, or efficacy
of the products; or a biological product appears to be unsatisfactory
or is found to have been prepared, tested, or distributed in violation
of the Virus-Serum-Toxin Act or the regulations; the licensee,
permittee, or foreign manufacturer shall immediately report the
circumstances and the action taken, if any, to the Animal and Plant
Health Inspection Service.
(Approved by the Office of Management and Budget under control
number 0579-0013)
15. In Sec. 116.7, the second sentence would be revised to read as
follows:
Sec. 116.7 Test records.
* * * Summaries of such tests shall be prepared from such records
and submitted to the Animal and Plant Health Inspection Service using
APHIS Form 2008 or an acceptable equivalent form prior to release of
the serial or subserial. * * *
* * * * *
16. Section 116.8 would be revised to read as follows:
Sec. 116.8 Completion and retention of records.
All records (other than disposition records) required by this part
shall be completed by the licensee, permittee, or foreign manufacturer
before any portion of a serial of any product may be marketed in the
United States or exported. All records shall be retained at the
licensed or foreign establishment or permittee's place of business for
a period of two years after the expiration date of a product, or for
such longer period as may be required by the Administrator.
(Approved by the Office of Management and Budget under control
number 0579-0013)
Done in Washington, DC, this 28th day of February 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-5406 Filed 3-3-95; 8:45 am]
BILLING CODE 3410-34-M
