[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]
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