[Federal Register: October 18, 2002 (Volume 67, Number 202)]
[Notices]
[Page 64390-64392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc02-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0302 ]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Guidance for Industry on Formal Meetings With
Sponsors and Applicants for Prescription Drug User Fee Act Products
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 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 18, 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 Meetings With Sponsors and Applicants
for Prescription Drug User Fee Act (PDUFA) Products--(OMB Control
Number 0910-0429)--Extension
This information collection approval request is for a FDA guidance
on the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of Prescription Drug
User Fee Act (PDUFA) products. The guidance describes procedures for
requesting, scheduling, conducting, and documenting such formal
meetings. The guidance provides information on how the agency will
interpret and apply section 119(a) of the Food and Drug Administration
Modernization Act (the Modernization Act), specific PDUFA goals for the
management of meetings associated with the review of human drug
applications for PDUFA products, and provisions of existing regulations
describing certain meetings (Sec. Sec. 312.47 and 312.82 (21 CFR
312.47 and 312.82)).
The guidance describes two collections of information: The
submission of a meeting request containing certain information and the
submission of an information package in advance of the formal meeting.
Agency regulations at Sec. 312.47(b)(1)(ii), (b)(1)(iv), and (b)(2)
describe information that should be submitted in support of a request
for an end-of-phase 2 meeting and a pre-NDA (new drug application)
meeting. The information collection provisions of Sec. 312.47 have
been approved by OMB (OMB control number 0910-0014). However, the
guidance provides additional recommendations for submitting information
to FDA in support of a meeting request. As a result, FDA is submitting
additional estimates for OMB approval.
A. Request for a Meeting
Under the guidance, a sponsor or applicant interested in meeting
with the Center for Drug Evaluation and Research (CDER) or the Center
for Biologics Evaluation and Research (CBER) should submit a meeting
request to the appropriate FDA component as an amendment to the
underlying application. FDA regulations (Sec. Sec. 312.23, 314.50, and
601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information
provided to the agency as part of an investigational new drug
application (IND), NDA, or biological license application (BLA) must 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 and BLAs. Both forms have valid OMB
control numbers as follows: FDA Form 1571, OMB control number 0910-
0014, expires September 30, 2002; and FDA Form 356h, OMB control number
0910-0001, expires March 31, 2005, OMB control number 0910-338, which
expires March 31, 2003.
In the guidance document, CDER and CBER ask that a request for a
formal meeting be submitted as an amendment to the application for the
underlying product under the requirements of Sec. Sec. 312.23, 314.50,
and 601.2; therefore, requests should 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 in
this manner for 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 agency to monitor progress on
the activities attendant to scheduling and holding a formal meeting and
to ensure that appropriate steps will be taken in a timely manner.
Under the guidance, the agency requests that sponsors and
applicants include in meeting requests certain information about the
proposed meeting. Such information includes:
[sbull] Information identifying and describing the product;
[sbull] The type of meeting being requested;
[sbull] A brief statement of the purpose of the meeting;
[sbull] A list of objectives and expected outcomes from the
meeting;
[sbull] A preliminary proposed agenda;
[sbull] A draft list of questions to be raised at the meeting;
[sbull] A list of individuals who will represent the sponsor or
applicant at the meeting;
[sbull] A list of agency staff requested to be in attendance;
[sbull] The approximate date that the information package will be
sent to the agency; and
[sbull] Suggested dates and times for the meeting.
This information will be used by the agency to determine the
utility of the meeting, to identify agency staff necessary to discuss
proposed agenda items, and to schedule the meeting.
B. Information Package
A sponsor or applicant submitting an information package to the
agency in advance of a formal meeting should provide summary
information relevant to the product and supplementary information
pertaining to any issue raised by the sponsor, applicant, or agency.
The agency recommends that information packages generally include:
[sbull] Identifying information about the underlying product;
[sbull] A brief statement of the purpose of the meeting;
[sbull] A list of objectives and expected outcomes of the meeting;
[sbull] A proposed agenda for the meeting;
[sbull] A list of specific questions to be addressed at the
meeting;
[sbull] A summary of clinical data that will be discussed (as
appropriate);
[sbull] A summary of preclinical data that will be discussed (as
appropriate); and
[sbull] Chemistry, manufacturing, and controls information that may
be discussed (as appropriate).
The purpose of the information package is to provide agency staff
the
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opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product. Although FDA reviews similar
information in the meeting request, the information package should
provide updated data that reflect the most current and accurate
information available to the sponsor or applicant. The agency finds
that reviewing such information is critical to achieving a productive
meeting.
The collection of information described in the guidance reflects
the current and past practice of sponsors and applicants to submit
meeting requests as amendments to INDs, NDAs, and BLAs and to submit
background information prior to a scheduled meeting. Agency regulations
currently permit such requests and recommend the submission of an
information package before an end-of-phase 2 meeting (Sec.
312.47(b)(1)(ii) and (b)(1)(iv)) and a pre-NDA meeting (Sec.
312.47(b)(2)).
Description of respondents: A sponsor or applicant for a drug or
biological product who requests a formal meeting with the agency
regarding the development and review of a PDUFA product.
Burden estimate: Provided in table 1 of this document is an
estimate of the annual reporting burden for the submission of meeting
requests and information packages under the guidance.
C. Request for a Formal Meeting
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 500 sponsors and
applicants (respondents) request approximately 1,253 formal meetings
with CDER annually and approximately 176 respondents request
approximately 388 formal meetings with CBER annually regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be approximately 10
hours. Based on FDA's experience, the agency expects it will take
respondents this amount of time to gather and copy brief statements
about the product and a description of the purpose and details of the
meeting.
D. Information Package
Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 450 respondents
submitted approximately 1,118 information packages to CDER annually and
approximately 155 respondents submitted approximately 341 information
packages to CBER annually prior to a formal meeting regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information package in accordance with the guidance, is
estimated to be approximately 18 hours. Based on FDA's experience, the
agency expects it will take respondents this amount of time to gather
and copy brief statements about the product, a description of the
details for the anticipated meeting, and data and information that
generally would already have been compiled for submission to the
agency.
As stated earlier, the guidance provides information on how the
agency will interpret and apply section 119(a) of the Modernization
Act, specific PDUFA goals for the management of meetings associated
with the review of human drug applications for PDUFA products, and
provisions of existing regulations describing certain meetings
(Sec. Sec. 312.47 and 312.82). The information collection provisions
in Sec. 312.47 concerning end-of-phase 2 meetings and pre-NDA meetings
have been approved by OMB (OMB control number 0910-0014). However, the
guidance provides additional recommendations for submitting information
to FDA in support of a meeting request. As a result, FDA is submitting
for OMB approval these additional estimates.
In the Federal Register of July 18, 2002 (67 FR 47383), the agency
requested comments on the proposed collections of information. The
agency received no comments to the notice.
Table 1--Estimated Annual Reporting Burden\1\
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Number of Number of Responses Total Annual Hours per
Meeting Requests and Information Packages [chyph]Respondents Per Respondent [chyph]Responses [chyph]Response Total Hours
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Meeting requests .................. ...................... .................. ............... ....................
CDER 500 2.5 1,250 10 12,500
CBER 176 2.2 387.2 10 3,872
Total .................. ...................... .................. ............... 16,372
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Information packages .................. ...................... .................. ............... ....................
CDER 450 2.5 1,125 18 20,250
CBER 155 2.2 341 18 6,138
Total .................. ...................... .................. ............... 26,388
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Meeting requests .................. ...................... .................. ............... 16,372
Information packages .................. ...................... .................. ............... 26,388
Total .................. ...................... .................. ............... 42,760
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: October 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26474 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S