[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Pages 46397-46399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21965]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0297]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Draft Guidance for Industry on Formal Dispute
Resolution; Appeals Above the Division Level
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
September 24, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Wendy Taylor, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Title: Draft Guidance for Industry on Formal Dispute Resolution;
Appeals Above the Division Level
Description: FDA is issuing a draft guidance on the process for
formally resolving scientific and procedural disputes in the Center for
Drug Evaluation and Research (CDER) and the Center for Biological
Evaluation and Research (CBER) that cannot be resolved at the division
level. The draft guidance describes procedures for formally appealing
such disputes to the office or center level and for submitting
information to assist center officials in resolving the issue(s)
presented. The draft guidance provides information on how the agency
will interpret and apply provisions of the existing regulations
regarding internal agency review of decisions (Sec. 10.75 (21 CFR
10.75)) and dispute resolution during the investigational new drug
(IND) process (21 CFR 312.48) and the new drug application (NDA)/
abbreviated new drug application (ANDA) process (21 CFR 314.103). In
addition, the draft guidance provides information on how the agency
will interpret and apply the specific Prescription Drug User Fee Act of
1992 (PDUFA) (Public Law 102-571) goals for major dispute resolution
associated with the development and review of PDUFA products.
Existing regulations, which appear primarily in parts 10, 312, and
314 (21 CFR parts 10, 312, and 314), establish procedures for the
resolution of scientific and procedural disputes between interested
persons and the agency, CDER, and CBER. All agency decisions on such
matters are based on information in the administrative file
(Sec. 10.75(d)). In general, the information in an administrative file
is collected under existing regulations in parts 312 (OMB Control No.
0910-0001), 314 (OMB Control No. 0910-0014), and part 601 (21 CFR part
601) (OMB Control No. 0910-0315), which specify the information that
manufacturers must submit so that FDA may properly evaluate the safety
and effectiveness of drugs and biological products. This information is
usually submitted as part of an IND, NDA, or biologics license
application (BLA), or as a supplement to an approved application. While
FDA already possesses in the administrative file the information that
would form the basis of a decision on a matter in dispute resolution,
the submission of particular information regarding the request itself
and the data and information relied on by the requester in the appeal
would facilitate timely resolution of the dispute. The draft guidance
describes the following collection of information not expressly
specified under existing regulations: The submission of the request for
dispute resolution as an amendment to the application for the
underlying product, including the submission of supporting information
with the request for dispute resolution.
Agency regulations (Sec. Sec. 312.23(11)(d), 314.50, 314.94, and
601.2) state that information provided to the agency as part of an IND,
NDA, ANDA, or BLA is to be submitted in triplicate and with an
appropriate cover form. Form FDA 1571 must accompany submissions under
IND's, and Form FDA 356h must accompany submissions under NDA's,
ANDA's, and BLA's. Both forms have valid OMB control numbers as
follows: Form FDA 1571, OMB Control No. 0910-0014, expires December 31,
1999; and Form FDA 356h, OMB Control No. 0910-0338, expires April 30,
2000.
In the draft guidance, CDER and CBER ask that a request for formal
dispute resolution be submitted as an amendment to the application for
the underlying product and that it be submitted to the agency in
triplicate with the appropriate form attached, either Form FDA 1571 or
Form FDA 356h. The agency recommends that a request be submitted as an
amendment in this manner for two reasons: To ensure that each request
is kept in the administrative file with the entire underlying
application and to ensure that pertinent information about the request
is entered into the appropriate
[[Page 46398]]
tracking data bases. Use of the information in the agency's tracking
data bases enables the appropriate agency official to monitor progress
on the resolution of the dispute and to ensure that appropriate steps
will be taken in a timely manner.
CDER and CBER have determined and the draft guidance recommends
that the following information should be submitted to the appropriate
center with each request for dispute resolution so that the Center may
quickly and efficiently respond to the request:
A brief but comprehensive statement of each issue to be
resolved, including a description of the issue, the nature of the issue
(i.e., scientific, procedural, or both), possible solutions based on
information in the administrative file, whether informal dispute
resolution was sought prior to the formal appeal, whether advisory
committee review is sought, and the expected outcome;
A statement identifying the review division/office that
issued the original decision on the matter and, if applicable, the last
agency official that attempted to formally resolve the matter;
A list of documents in the administrative file, or
additional copies of such documents, that are deemed necessary for
resolution of the issue(s); and
A statement that the previous supervisory level has
already had the opportunity to review all of the material relied on for
dispute resolution. The information that the agency suggests submitting
with a formal request for dispute resolution consists of : (1)
Statements describing the issue from the perspective of the person with
a dispute, (2) brief statements describing the history of the matter,
and (3) documents previously submitted to FDA under an OMB approved
collection of information (see previous discussion).
Based on FDA's experience with dispute resolution, the agency
expects that most persons seeking formal dispute resolution will have
gathered the materials listed previously when identifying the existence
of a dispute with the agency. Consequently, FDA anticipates that the
collection of information attributed solely to the guidance will be
minimal.
Description of Respondents: A sponsor, applicant, or manufacturer
of a drug or biologic product regulated by the agency under the act or
section 351 of the Public Health Service Act who requests formal
resolution of a scientific or procedural dispute.
Burden Estimate: Table 1 of this document provides an estimate of
the annual reporting burden for requests for dispute resolution. In
fiscal year (FY) 1998, 39 sponsors and applicants (respondents)
submitted requests for formal dispute resolution to CDER and 12
respondents submitted requests for formal dispute resolution to CBER .
Although the procedures for requesting formal dispute resolution that
are set forth in the draft guidance were not in place in FY 1998, FDA
estimates that the number of respondents who would submit requests for
dispute resolution under the guidance would remain the same. The total
annual responses are the total number of requests submitted to CDER and
CBER in 1 year, including requests for dispute resolution that a single
respondent submits more than one time. In FY 1998, CDER received
approximately 49 requests and CBER received approximately 15 requests.
The agency estimates that the total annual responses will remain the
same, averaging to 1.26 responses per respondent. The hours per
response is the estimated number of hours that a respondent would spend
preparing the information to be submitted with a request for formal
dispute resolution in accordance with this draft guidance, including
the time it takes to gather and copy brief statements describing the
issue from the perspective of the person with the dispute, brief
statements describing the history of the matter, and supporting
information that has already been submitted to the agency. Based on
experience, FDA estimates that approximately 8 hours on average would
be needed per response. Therefore, FDA estimates that 512 hours will be
spent per year by respondents requesting formal dispute resolution
under the guidance.
On Friday, March 9, 1999, FDA invited comments on this analysis of
information collection burdens. FDA received one comment regarding the
agency's estimate of the paperwork burden. The comment stated that
FDA's estimate is a relatively accurate accounting of time used in
administrative preparation of information for requests for dispute
resolution of procedural matters. The comment stated that FDA
underestimated the time required for creative writing and editing tasks
associated with preparation of paperwork to resolve disputes of a
scientific or technical nature.
The agency's estimates are based in part on the expectation that
respondents will have already compiled for submission to the agency
most of the data and information that is described in the guidance
document. The agency anticipates that respondents will have submitted
the information as part of the underlying product application.
Therefore, the bulk of the paperwork burden is related to
administrative tasks (i.e., gathering and copying brief statements
describing the issue from the perspective of the person with the
dispute and brief statements describing the history of the matter).
Table 1.--Estimated Annual Reporting Burden\1\
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No. of
Results for Formal Dispute No. of Responses per Total Annual Hours per Total Hours
Resolution Respondents Respondent Responses Response
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CDER 39 1.26 49 8 392
CBER 12 1.25 15 8 120
Total 512
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 46399]]
Dated: August 18, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-21965 Filed 8-24-99; 8:45 am]
BILLING CODE 4160-01-F
