[Federal Register Volume 61, Number 197 (Wednesday, October 9, 1996)]
[Rules and Regulations]
[Pages 52871-52875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25931]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 61, No. 197 / Wednesday, October 9, 1996 /
Rules and Regulations
[[Page 52871]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 102, 104, 105, and 116
[Docket No. 93-072-2]
Viruses, Serums, Toxins, and Analogous Products; Licenses,
Inspections, Records, and Reports
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending 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 will make the license subject to
suspension or revocation. We are also amending the regulations to
specify the types of records and reports that must be available for
inspection including records describing product development and
preparation and market suspensions and recalls. Finally, we are
amending the regulations to require that APHIS receive notification
immediately if there are indications which raise questions regarding
purity, safety, potency, or efficacy of a product, or if it appears
there may be a problem regarding the preparation, testing, or
distribution of a product. The rule is necessary to clarify and
simplify certain provisions of the regulations and to describe required
records with greater specificity.
EFFECTIVE DATE: November 8, 1996.
FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy
Director, Veterinary Biologics, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737 1237; 301-734-8245.
SUPPLEMENTARY INFORMATION:
Background
The Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151-159, hereinafter
the Act), 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 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 at 9 CFR parts 102, 105, and
116.
On March 6, 1995, we published in the Federal Register (60 FR
12159-12162, Docket No. 93-072-1) a proposal to amend parts 102, 104,
105, and 116. We proposed to amend the regulations to clarify 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 will make the
license subject to suspension or revocation. We also proposed to amend
the regulations to broaden the scope of records and reports to include
records describing product development and preparation, market
suspensions, and recalls, which must be available for inspection.
Finally, we proposed to amend the regulations to require that APHIS be
notified immediately if there are indications which raise questions
regarding purity, safety, potency, or efficacy of products, or if a
biological product appears to be unsatisfactory or is found to have
been prepared, tested, or distributed in violation of the Act and
regulations. The rule is necessary to clarify and simplify certain
provisions of the regulations.
We solicited comments concerning our proposal for 60 days ending
May 5, 1995. We received nine comments by that date. They were from
biologics producers, a biologics consultant, and a national trade
association. We carefully considered all of the comments we received.
They are discussed below.
One commenter expressed general approval of the rule as proposed.
The commenter, however, requested definitions of ``raw data,'' ``data
collection,'' ``method for changing raw data,'' and ``manufacturing
records'' under proposed Sec. 105.1 and ``unsatisfactory'' and
``immediately'' under proposed Sec. 116.5(b).
In response to this comment, APHIS notes that the terms ``raw
data,'' ``data collection,'' ``methods for changing raw data,'' and
``manufacturing records'' were not included in the proposed rule.
Therefore, APHIS believes that it would be inappropriate for the agency
to define these terms. APHIS believes that the use of the phrase ``to
be unsatisfactory'' is redundant with the phrase ``to have been
prepared, tested, or distributed in violation of the VSTA and
regulations'' which appears in the same sentence and has therefore
deleted it from the regulations to improve clarity and avoid confusion
as to its meaning when used in this context. Similarly, APHIS is
removing the reference to violation of the Act or regulations and
changing the language regarding preparation, testing, and distribution
to more accurately reflect the intent of paragraph (b) of Sec. 116.5.
The term ``immediately'' is self-explanatory in that notification
should occur without delay at the time a question regarding product
purity, safety, potency, or efficacy is raised. Therefore, APHIS is not
adding definitions of these terms in response to this comment.
One commenter requested that the rule for license termination after
5 years of inactivity be withdrawn and replaced with a provision for
recertification of the master seed to save the expense of relicensure.
The commenter explained that there are situations in which a vaccine
for which there has been no need suddenly comes into demand because of
a disease condition. The example presented was an erysipelothrix
vaccine in turkeys, the need for which is apparently resurfacing after
a lapse of 10 years. Other examples of resurfacing vaccines were given,
including variant chicken pox in the midwest and California, and
Newcastle Disease Bronchitis Vaccine B1 Type B1 Strain. The
commenter indicated that the latter vaccine has not been made for
[[Page 52872]]
17 years, but now has a significant international market.
In response to this commenter, the current regulation provides for
the producer to show intent to resume production within 6 months of
notification or have the product license or permit terminated. APHIS
proposed to amend the regulation to provide the opportunity for the
producer to resume production within 6 months of notification or
``within a mutually agreeable period'' should the producer have
evidence that the vaccine might be needed in the near future. The
proposed amendment allows the licensee to present a case to support a
mutually agreeable period of longer than 6 months before production is
resumed, if desired. If production is not resumed, the product license
would be terminated without prejudice and could be reissued at a later
date if master seed and master stocks are maintained and a market
develops for the product. The original Outline of Production and
licensing data could be resubmitted to support such applications and
should only require updating to meet new licensing requirements not
addressed when the product was originally licensed. The license
applicant should consult with APHIS for guidance prior to applying for
reissuance of such licenses. APHIS does not believe that a product
license should be maintained when no product is produced or no
establishment is maintained to support continuation of licensure. No
change to the regulations is made in response to this comment.
One commenter felt that the language in Sec. 116.1 lacked
specificity. Another commenter stated that the types of records
required for product development and manufacture should be specified.
In response to these commenters, APHIS notes that the proposed
amendment to Sec. 116.1 adds permittees under the regulations and
specifies the types of records that are to be maintained at the
permittees place of business. No change to the regulations is made in
response to these commenters.
Eight commenters raised concerns about the lack of clear criteria
in the proposal for the reporting of production data and consumer
complaints. One of the commenters raised the issue of how the firms'
submissions of consumer reports will be handled under the Freedom of
Information Act (FOIA). Another commenter indicated that many consumer
reports may deal with problems related to consumer misuse that is
beyond the control of the manufacturer. Consumer reports relevant to
this regulation would only be those where there is a valid product-
related complaint. The commenter also inquired into how complaints will
be resolved by the agency and what the relationship was between
consumer reports and the agency's proposed post-licensing monitoring
program. One commenter stated that records related to consumer reports
are already available for inspection at licensed establishments and
questioned whether the submission of additional reports was necessary.
Finally, several commenters suggested that the additional reporting
requirements would increase the level of paperwork required of both
APHIS and the manufacturer. These commenters expressed general concerns
about the need to reduce paperwork submissions in order to reduce
agency burden and to facilitate agency review of and response to
license applications.
In response to these comments, APHIS believes that its intent with
regard to reporting of certain consumer complaint reports was
misunderstood. The proposed rule was not intended to require the
implementation of a comprehensive postlicensing monitoring program but
was only intended to ensure that licensees inform APHIS when it appears
that a licensed product that has been released for marketing is
involved in an unusually high number of consumer complaints or appears
or has been found to be in violation of the Act or regulations.
Informing APHIS under such situations provides an early warning of
possible emerging product-related problems and ensures prompt action if
there is a problem. Open communication between licensees and APHIS is
essential for accurate responses to consumer inquiries and a rapid
resolution of such situations. In response to the comment regarding
access to consumer complaints under FOIA, all confidential business
information would be protected. APHIS is currently working on
regulations regarding FOIA requests related to the monitoring of
products.
Based on the comments, APHIS is revising proposed Sec. 116.5
concerning the submission of consumer reports with a more general
statement to clarify our intent that APHIS be notified when there are
indications which raise questions regarding the purity, safety,
potency, or efficacy of a product, or if it appears that there may be a
problem regarding the preparation, testing, or distribution of a
product.
Some examples of when APHIS should be informed include when there
are product-related data, information, or reports to show that a serial
is contaminated, that use of a product is associated with a high
incidence of adverse reactions, or that a product is associated with
the failure to protect against disease. It would be necessary to
provide available information describing circumstances surrounding
these situations such as contributory factors and plausible options to
help resolve the problem. Other examples of such circumstances when
notification would be warranted are when consumer reports suggest that
the use of a product may pose a risk to the public health, interest, or
safety.
APHIS is removing the reference to consumer reports from paragraph
(b) of Sec. 116.5 of the proposed rule by removing the phrase
``consumer reports concerning the use of products'' and substituting
the phrase ``there are indications which.'' This revision is intended
to remove concerns about the reporting of all claims, including those
which might be considered frivolous or invalid. The reference to
``immediately report'' has also been revised to read ``immediately
notify APHIS concerning'' to provide greater flexibility in the manner
in which information is provided to APHIS including telephone, E-mail,
facsimile, or letter rather than by ``report'' which suggests a more
formal communication. We have included in the regulations for
convenience purposes the addresses and phone numbers for these
alternative methods of notification. These changes should make it clear
that this rule codifies current program practice and does not result in
a net increase of the paperwork burden imposed on the manufacturer and
the agency.
One commenter objected to use of the term, ``When requested by the
Administrator,'' in Sec. 116.5, paragraph (a). The same commenter
believed that APHIS should define the rationale for submission more
specifically. Another commenter objected to the use of terms,
``complete information'' and ``including but not limited to'' for being
ambiguous.
In response to these comments, APHIS notes that these terms are
currently used in the regulations in part 116 without further
definition. In addition, APHIS believes that the rationale of proposed
Sec. 116.5, paragraph (a), is not intended to be significantly
different from that of current Secs. 116.1 and 116.5. These regulations
were last amended in 1974 (39 FR 16853-16873, Docket No. 74-10880, May
10, 1974). Current Sec. 116.1 reads in relevant part as follows:
Each licensee * * * shall maintain detailed records of
information necessary to give a complete accounting of the
activities within each establishment. Such activities shall include,
but shall not be limited to the items enumerated in this part.
[[Page 52873]]
(a) Records shall be made concurrently with the performance of
successive steps in the preparation of a biological product. 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 loss or gain from
start to finish in such preparation.
Current Sec. 116.5 reads in relevant part as follows:
When required by the Administrator, reports containing accurate
information of production activities in each establishment * * *
shall be prepared and forwarded to APHIS. Records necessary to make
such reports shall be maintained in each establishment.
The proposed amendment to Sec. 116.5, paragraph (a), merely
specifies in greater detail the type of information that should be
maintained or submitted to APHIS. As a commenter stated previously,
licensed establishments already make available records of consumer
reports for inspection. Therefore, much, if not all, of this
information should already be available or should already have been
made available to APHIS. No change to the regulations is made in
response to these comments.
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 purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
The rule amends 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 rule provides that the failure to permit such inspection will make
the license subject to suspension or revocation. In order to hold a
valid establishment license, licensees are required to have at least
one unexpired, unsuspended, and unrevoked product license. Otherwise,
the establishment license will be invalid. We are also making
amendments concerning the content of records and reports and the
availability of their inspection.
The rule will make clear and unambiguous certain regulatory
provisions. No new requirements are added in the rule. Therefore, no
adverse economic impact is anticipated to result from the rule.
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 would 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
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this 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.
Regulatory Reform
This action is part of the President's Regulatory Reform
Initiative, which, among other things, directs agencies to remove
obsolete and unnecessary regulations and to find less burdensome ways
to achieve regulatory goals.
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 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 2.22, 2.80, and 371.2(d).
2. In Sec. 102.2, the text is designated as paragraph (a) and a new
paragraph (b) is 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) is revised, paragraph (g) is
redesignated as paragraph (h), and new paragraph (g) is 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
of this subchapter. 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 continues to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
5. In Sec. 104.6, paragraph (b), the words ``Veterinary Services''
are removed and the words ``Animal and Plant Health Inspection
Service'' are added in their place.
6. In part 105, the heading for the part is revised to read as
follows:
[[Page 52874]]
PART 105--SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL
LICENSES OR PERMITS
7. The authority citation for part 105 continues to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
8. In Sec. 105.1, paragraphs (a)(4) and (a)(5) are redesignated
paragraphs (a)(5) and (a)(6), new paragraph (a)(4) is added, and
redesignated paragraph (a)(5) is 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 is revised to read as follows:
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 5 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 6 months of notification. If the licensee does not resume
preparation, or the permittee does not resume importation, within 6
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 the applicable records
provisions of Sec. 116.8.
10. In part 116, the heading for the part is revised to read as
follows:
PART 116--RECORDS AND REPORTS
11. The authority citation for part 116 continues to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
12. In Sec. 116.1, paragraphs (a), (b), and (c) are redesignated as
paragraphs (a)(1), (a)(2), and (a)(3), respectively; redesignated
paragraph (a)(1) is revised; the introductory paragraph is designated
as paragraph (a) and is revised; and new paragraphs (b) and (c) are
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 each 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, test 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
this part 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'' is removed and the number
``0579-0013'' is added in its place.
14. Section 116.5 is 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, 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, there are indications which raise questions
regarding purity, safety, potency, or efficacy of a product, or if it
appears that there may be a problem regarding preparation, testing, or
distribution of a product, the licensee, permittee, or foreign
manufacturer shall immediately notify Veterinary Biologics Field
Operations, APHIS, 223 South Walnut Avenue, Ames, Iowa 50010,
concerning the circumstances and the action taken, if any. Notification
may be either by mail, electronic mail, facsimile, or telephone. If by
electronic mail, [email protected]. If by facsimile, Area Code (515)
232-7120. If by telephone, Area Code (515) 232-5785.
(Approved by the Office of Management and Budget under control
number 0579-0013)
15. In Sec. 116.7, the second sentence is 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 is 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.
[[Page 52875]]
(Approved by the Office of Management and Budget under control
number 0579-0013)
Done in Washington, DC, this 4th day of October 1996.
A. Strating,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-25931 Filed 10-8-96; 8:45 am]
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