[Federal Register: October 16, 2002 (Volume 67, Number 200)]
[Notices]
[Page 63929-63931]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc02-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0303]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Guidance for Industry on Formal Dispute
Resolution; Appeals Above the Division Level
AGENCY: Food and Drug Administration, HHS.
[[Page 63930]]
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.
DATES: Submit written comments on the collection of information by
November 15, 2002.
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:
Stuart Shapiro, 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 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Formal Dispute Resolution; Appeals Above the
Division Level (OMB Control Number 0910-0430)--Extension
This information collection approval request is for an FDA guidance
on the process for formally resolving scientific and procedural
disputes in the Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) that cannot be
resolved at the division level. The 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 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
application (IND) process (21 CFR 312.48) and the new drug application/
abbreviated new drug application (NDA/ANDA) process (21 CFR 314.103).
In addition, the guidance provides information on how the agency will
interpret and apply the specific Prescription Drug User Fee Act (PDUFA)
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 number
0910-0014), 314 (OMB control number 0910-0001), and part 601 (21 CFR
part 601) (OMB control number 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
requestor in the appeal would facilitate timely resolution of the
dispute. The 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.
FDA's regulations (Sec. Sec. 312.23(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 INDs and
Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs.
Both forms have valid OMB control numbers as follows: FDA Form 1571,
OMB control number 0910-0014, expires November 30, 2002; and FDA Form
356h, OMB control number 0910-0001, expires March 31, 2005. In the
guidance document, 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 the following two reasons: (1) To ensure that each
request is kept in the administrative file with the entire underlying
application, and (2) to ensure that pertinent information about the
request is entered into the appropriate tracking databases. Use of the
information in the agency's tracking databases 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 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: (1) 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; (2) 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; (3) 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 (4) 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) the documents previously submitted to FDA under an OMB approved
collection of information.
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 biological 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.
[[Page 63931]]
Burden Estimate: Provided below is an estimate of the annual
reporting burden for requests for dispute resolution. Based on data
collected from review divisions and offices within CDER and CBER, FDA
estimates that approximately seven sponsors and applicants
(respondents) submit requests for formal dispute resolution to CDER
annually and approximately one respondent submits requests for formal
dispute resolution to CBER annually. 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. FDA estimates that CDER receives
approximately 10 requests annually and CBER receives approximately 1
request annually. 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 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 96 hours will be spent per year by respondents requesting formal
dispute resolution under the guidance.
In the Federal Register of July 18, 2002 (67 FR 47385), the agency
requested comments on the proposed collections of information. No
comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of
Request for Formal Dispute No. of [chyph]Respondents Total Annual Hours per Total
[chyph]Resolution [chyph]Respondents per [chyph]Responses [chyph]Response Hours
[chyph]Response
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CDER 7 1.4 10 8 80
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CBER 1 2 2 8 16
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Total 96
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26326 Filed 10-15-02; 8:45 am]
BILLING CODE 4160-01-S