[Federal Register Volume 68, Number 96 (Monday, May 19, 2003)]
[Notices]
[Pages 27094-27096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12369]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03D-0167]
Draft Guidance for Industry on Dispute Resolution Procedures for
Science-based Decisions on Products Regulated by the Center for
Veterinary Medicine; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance for industry ([numsign]79) entitled
``Dispute Resolution Procedures for Science-Based Decisions on Products
Regulated by the Center for Veterinary Medicine (CVM).'' This draft
guidance document describes dispute resolution procedures by which
sponsors, applicants, or manufacturers of FDA regulated products for
animals may request review of science-based decisions. This draft
guidance does not address procedures for handling issues associated
with FDA's new initiative to enhance pharmaceutical good manufacturing
practices (GMP's).
DATES: Submit written or electronic comments on this draft guidance by
August 4, 2003 to ensure their adequate consideration in preparation of
the final document. General comments on agency guidance documents are
welcome at any time.
Written comments on the information collection requirements must be
received by July 18, 2003.
ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your requests.
Submit written comments on the draft guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments. Comments should be identified
with the full title of the draft guidance document and the docket
number found in the heading of this document. See the SUPPLEMENTARY
INFORMATION section of this document for electronic access to the draft
guidance document.
Submit written comments on the collection of information
requirements to the Dockets Management Branch (address above). Comments
should be identified with the docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Marcia Larkins, Center for Veterinary
Medicine (HFV-7), Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855, 301-827-4535, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: FDA regulations, Sec. 10.75 (21 CFR 10.75),
provide a mechanism for any interested person to obtain internal review
of any agency decision by raising the matter through the established
agency channels of supervision or review for that matter.
On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-
115). Section 404 of FDAMA creates new section 562 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-1). Section 562 of
the act provides that, if a procedure under which an applicant,
sponsor, or manufacturer (applicant) could request a review of a
scientific controversy related to human drugs, animal drugs, human
biologics, or devices did not already exist, either as a provision in
the act or a regulation issued under the act, FDA must, by regulation,
establish a procedure under which such an applicant may request a
review of the controversy, including review by an appropriate
scientific advisory panel or advisory committee.
In the Federal Register of November 18, 1998 (63 FR 63978), FDA
amended Sec. 10.75 to state explicitly that an applicant of a drug
(including human drugs, animal drugs, and human biologics) or device
may request review of a scientific controversy by an appropriate
scientific advisory panel or an advisory committee. In the preamble to
the final rule, FDA stated that implementation of this provision would
be undertaken by the individual FDA centers and would be described in
guidance documents. This draft guidance describes CVM's dispute
resolution procedures under section 562 of the act.
CVM Appeals Procedure Guide 1240.3130 (Guide 1240.3130) of the CVM
Program Policy and Procedures Manual (P & P Manual) describes CVM's
current appeals procedure. Because this guidance predates FDAMA, CVM is
revising its procedures. Draft Guidance [numsign]79, when finalized,
will supercede Guide 1240.3130, and, at that time, CVM will eliminate
the guide from the P & P Manual.
This draft guidance document describes CVM's procedures for
handling requests for internal review of scientific controversies
relating to agency decisions affecting animal drugs or other products
regulated by CVM. Incorporated in this document is the dispute
resolution procedure set forth in section 404 of FDAMA. While CVM seeks
comments on all aspects of this draft guidance, CVM is particularly
interested in the definition of a scientific controversy, standards for
granting and denying a request for the review of a scientific
controversy by an advisory committee, and the time frames for
conducting the review.
II. Significance of Guidance
This Level 1 draft guidance is being issued consistent with FDA's
Good Guidance Practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the agency's current thinking on dispute
resolution and the procedures regarding requests for review of
scientific controversies relating to decisions affecting animal drugs
or other products regulated by CVM. The document does not create or
confer any rights for or on any person and will not operate to bind FDA
or the public. Alternative methods may be used as long as they satisfy
the requirements of the applicable statutes and regulations. If an
applicant wants to discuss an alternative approach, they should contact
the FDA staff responsible for implementing the guidance. If the
applicant cannot identify the appropriate FDA staff, call 301-827-4535.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or
[[Page 27095]]
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506 (c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing a notice
of the proposed collection of information set forth below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Appeals of Science-Based Decisions Above the Division Level
Description: FDA is issuing a draft guidance on the CVM process for
formally resolving disputes relating to scientific controversies. The
draft guidance describes procedures for formally appealing such
disputes. The draft guidance provides information on how the agency
intends to interpret and apply provisions of the existing regulations
regarding internal agency review of decisions (21 CFR 10.75). In a
final rule issued in the Federal Register on November 18, 1998 (63 FR
63978), FDA amended Sec. 10.75 to reflect the provisions of FDAMA.
This draft guidance document outlines the recommended procedure for
persons who are applicants for approval of animal drugs or other
products regulated by CVM who wish to submit a request for review of a
scientific dispute.
The guidance recommends a procedure whereby applicants first seek
review through the supervisory chain of command. If the issue is not
resolved at the supervisor's level, the interested person may request
in writing that the matter be reviewed at the next higher supervisory
level. This process may continue through the agency's entire
supervisory chain of command through CVM and to the Commissioner of
Food and Drugs (Commissioner). At each level of review (Division,
Office Director, Deputy Center Director, and Center Director levels)
CVM recommends that the applicant identify the information in the
administrative file upon which the request is based. If the appeal
contains new information not previously contained in the administrative
file, the matter will, in accordance with 21 CFR 10.75(d), be returned
to the appropriate lower level in CVM for reevaluation based on the new
information. After the applicant has appealed the decision through the
supervisory chain of command, they may request review through an ad hoc
appeals committee or review by the Veterinary Medicine Advisory
Committee (VMAC) in writing to the CVM Ombudsman. If the applicant
seeks review by the Ad Hoc Committee, the Chair should provide them the
opportunity to submit written arguments to the Committee. The applicant
may submit a letter appealing the Ad Hoc Committee's decision to the
CVM director and then to the Commissioner. CVM recommends that persons
filing a request for review by VMAC provide the CVM Ombudsman with a
concise summary of the scientific issue in dispute, including a summary
of the particular FDA action or decision to which the requesting party
objects, the results of all efforts that have been made to resolve the
dispute to date, and a clear articulated summary of the arguments and
relevant data and information.
The information collected will form the basis for resolving the
dispute between the requester and FDA. The likely respondents to this
collection are applicants for approval of animal drugs or other
products regulated by CVM who have a scientific dispute with FDA and
who request a review of the matter.
Based on FDA's experience with dispute resolution, the agency
expects that most persons seeking formal dispute resolution will have
gathered the materials during any previous efforts to resolve the
dispute with the agency. CVM considered the number and substance of
similar appeals made to FDA in recent years under Guide 1240.3130 to
arrive at the numbers reflected in table 1. Guidance [numsign]79, when
finalized, will supercede Guide 1240.3130, and at that time, CVM will
eliminate the guide from the P & P Manual.
FDA estimates the burden for this collection of information as
follows:
TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN \1\
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Annual
No. of Frequency Total Hours per Total
Respondents of Annual Response Hours
Responses Responses
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Guidance 1 2 2 30 60
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\1\ There are no capital costs or operating and maintenance costs
associated with this collection of information.
The use of VMAC for resolving scientific disputes represents a new
process for CVM. Although the procedures for requesting dispute
resolution by a scientific advisory committee as set forth in the draft
guidance document are new, CVM estimates that the number of respondents
who would submit requests would not increase. The number of hours per
response (30) encompasses a wide range depending on the dispute
involved. This estimate was based on discussions with industry and is
an average of hours per response.
IV. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Dockets Management Branch (address
above) written or electronic comments regarding this draft guidance
document. Submit written or electronic comments by August 4, 2003 to
ensure adequate consideration in preparation of the final document.
Written comments concerning the information collection requirements
must be received by the Dockets Management Branch by July 18, 2003. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. A copy of the draft
guidance and received comments are available for public examination in
the Dockets
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Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on this site, select Docket No.
03D-0167 draft guidance for industry on ``Dispute Resolution Procedures
for Science-Based Decisions on Products Regulated by the Center for
Veterinary Medicine'' and follow the directions. Copies of this draft
guidance may be obtained on the Internet from the CVM home page at
http://www.fda.gov/cvm.
Dated: May 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12369 Filed 5-16-03; 8:45 am]
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