Federal Register, Volume 73 Issue 220 (Thursday, November 13, 2008)

[Federal Register Volume 73, Number 220 (Thursday, November 13, 2008)]
[Notices]
[Pages 67184-67186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27008]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0556]

Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
contained in the guidance for industry on formal meetings with sponsors
and applicants for Prescription Drug User Fee Act (PDUFA) products.

DATES: Submit written or electronic comments on the collection of
information by January 12, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.

SUPPLEMENTARY INFORMATION: Under 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(c) and includes agency requests or 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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.

Guidance for Industry on Formal Meetings With Sponsors and Applicants
for Prescription Drug User Fee Act Products (OMB Control Number 0910-
0429)--Extension

This information collection approval request is for an FDA guidance
on the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of 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. Sec. 312.47(b)(1)(ii), (b)(1)(iv), and
(b)(2) describe information that should be submitted in

[[Page 67185]]

support of a request for an End-of-Phase 2 meeting and a Pre-New Drug
Application meeting. The information collection provisions of Sec.
312.47 have been approved by OMB (OMB Control No. 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.

I. 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 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 No. 0910-0014) and FDA Form 356h
(OMB Control No. 0910-0338).
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 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 as follows:
Information identifying and describing the product,
The type of meeting being requested,
A brief statement of the purpose of the meeting,
A list of objectives and expected outcomes from the
meeting,
A preliminary proposed agenda,
A draft list of questions to be raised at the meeting,
A list of individuals who will represent the sponsor or
applicant at the meeting,
A list of agency staff requested to be in attendance,
The approximate date that the information package will be
sent to the agency, and
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.

II. 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:
Identifying information about the underlying product,
A brief statement of the purpose of the meeting,
A list of objectives and expected outcomes of the meeting,
A proposed agenda for the meeting,
A list of specific questions to be addressed at the
meeting,
A summary of clinical data that will be discussed (as
appropriate),
A summary of preclinical data that will be discussed (as
appropriate), and
Chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
The purpose of the information package is to provide agency staff
the 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. 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: An estimate of the annual reporting burden for the
submission of meeting requests and information packages under the
guidance is provided in table 1 of this document.

III. Request for a Formal Meeting

Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 907 sponsors and
applicants (respondents) request approximately 2,210 formal meetings
with CDER annually and approximately 144 respondents request
approximately 287 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.

IV. Information Package

Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 774 respondents
submitted approximately 1,705 information packages to CDER annually and
approximately 120 respondents submitted approximately 198 information
packages to CBER annually before 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

[[Page 67186]]

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 No. 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
these additional estimates for OMB approval.

Table 1.--Estimated Annual Reporting Burden\1\
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Meeting Requests
and Information No. of No. of responses Total Annual Hours per Total Hours
Packages Respondents per Respondent Responses Response
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Meeting Requests ................. ................. ................. ................. .................
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CDER 907 2.44 2,210 10 22,100
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CBER 144 1.99 287 10 2,870
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Total ................. ................. ................. ................. 24,970
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Information ................. ................. ................. ................. .................
Packages
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CDER 774 2.20 1,705 18 30,690
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CBER 120 1.65 198 18 3,564
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Total ................. ................. ................. ................. 34,254
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Grand Total 59,224
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27008 Filed 11-12-08; 8:45 am]
BILLING CODE 4160-01-S