[Federal Register Volume 68, Number 96 (Monday, May 19, 2003)]
[Notices]
[Pages 27094-27096]
From the Federal Register Online via the Government Printing 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Draft Guidance for Industry on Dispute Resolution Procedures for 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availability of the draft guidance for industry ([numsign]79) entitled 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 This draft 
guidance document describes dispute resolution procedures by which 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 This draft 
guidance does not address procedures for handling issues associated 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DATES: Submit written or electronic comments on this draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 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    Submit written comments on the draft guidance document to the 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with the full title of the draft guidance document and the docket 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INFORMATION section of this document for electronic access to the draft 
guidance document.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: mlarkins@cvm.fda.gov.

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\
------------------------------------------------------------------------
                              Annual
                No. of      Frequency      Total      Hours per   Total
             Respondents        of         Annual     Response    Hours
                            Responses    Responses
------------------------------------------------------------------------
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

[[Page 27096]]

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]
BILLING CODE 4160-01-S