
[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16235-16237]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6691]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

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 either electronic or written comments on the collection 
of information by May 21, 2012.

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: 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: 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,

[[Page 16236]]

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 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 of 1997 (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. 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.

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: FDA Form 1571--OMB control number 0910-
0014 and FDA Form 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. Sec.  
312.47(b)(1)(ii) and (b)(1)(iv)) and a Pre-NDA meeting (Sec.  
312.47(b)(2)).

[[Page 16237]]

    1. 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.
    2. 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 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.

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
Meeting requests and information     Number of     responses per   Total annual   Average burden    Total hours
            packages                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
                                                Meeting Requests
----------------------------------------------------------------------------------------------------------------
CDER............................             975            2.06           2,014              10          20,140
CBER............................             127            1.99             253              10           2,530
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,670
----------------------------------------------------------------------------------------------------------------
                                              Information Packages
----------------------------------------------------------------------------------------------------------------
CDER............................             756            1.84           1,394              18          25,092
CBER............................             112            1.81             203              18           3,654
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          28,746
                                 -------------------------------------------------------------------------------
        Grand Total.............  ..............  ..............  ..............  ..............          51,416
----------------------------------------------------------------------------------------------------------------


    Dated: March 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6691 Filed 3-19-12; 8:45 am]
BILLING CODE 4160-01-P


