
[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42744-42746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0247]


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 August 
20, 2012.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0429. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@fda.hhs.gov.

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 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 (FDAMA), 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 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.

[[Page 42745]]

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), New Drug Application (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: Form FDA 1571--OMB control number 0910 
0014, and Form FDA 356h--OMB control number 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. Such information includes:
     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.

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:
     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.  
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 below 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 975 sponsors and 
applicants (respondents) request approximately 2,014 formal meetings 
with CDER annually and approximately 127 respondents request 
approximately 253 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 756 respondents 
submitted approximately 1,394 information packages to CDER annually and 
approximately 112 respondents submitted approximately 203 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 FDAMA, 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

[[Page 42746]]

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.
    In the Federal Register of March 20, 2012 (77 FR 16235), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of                        Average
Meeting requests and information     Number of     responses per   Total annual     burden per      Total hours
            packages                respondents     respondent       responses       response
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Meeting Requests:
    CDER........................             975            2.06           2,014              10          20,140
    CBER........................             127            1.99             253              10           2,530
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        Total...................  ..............  ..............  ..............  ..............          22,670
Information Packages:
    CDER........................             756            1.84           1,394              18          25,092
    CBER........................             112            1.81             203              18           3,654
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        Total...................  ..............  ..............  ..............  ..............          28,746
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            Grand Total.........  ..............  ..............  ..............  ..............          51,416
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    Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17557 Filed 7-19-12; 8:45 am]
BILLING CODE 4160-01-P


