[Federal Register Volume 71, Number 15 (Tuesday, January 24, 2006)]
[Notices]
[Pages 3858-3860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-765]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0395]


Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
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: Fax written comments on the collection of information by 
February 23, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (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 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 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 New Drug Application (NDA) 
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.

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 number 0910-0014; and FDA Form 
356h, OMB control number 0910-0338, expires September 30, 2008.
    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 
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 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 the following:
     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 the 
following:
     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;

[[Page 3859]]

     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: Provided in the following paragraphs is an 
estimate of the annual reporting burden for the submission of meeting 
requests and information packages under the guidance.

III. Request For a Formal Meeting

    Based on data collected from the review divisions and offices 
within CDER and CBER, FDA estimates that approximately 713 sponsors and 
applicants (respondents) request approximately 1,783 formal meetings 
with CDER annually and approximately 164 respondents request 
approximately 286 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 615 respondents 
submitted approximately 1,365 information packages to CDER annually and 
approximately 132 respondents submitted approximately 208 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 October 24, 2005 (70 FR 61445), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         No. of Responses       Total Annual        Hours per
      Meeting Requests and  Information Packages           Respondents        per Respondent         Responses           Response         Total Hours
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Meeting Requests
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CDER                                                                  713                  2.50              1,783                 10             17,830
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CBER                                                                  164                  1.74                286                 10              2,860
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Total                                                                                                                                             20,690
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Information Packages
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CDER                                                                  615                  2.22              1,365                 18             24,570
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CBER                                                                  132                  1.58                208                 18              3,744
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Total                                                                                                                                             28,314
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Grand Total                                                                                                                                       49,004
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 3860]]

    Dated: January 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-765 Filed 1-23-06; 8:45 am]
BILLING CODE 4160-01-S