[Federal Register Volume 67, Number 138 (Thursday, July 18, 2002)]
[Notices]
[Pages 47383-47385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0302]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Formal Meetings With Sponsors 
and Applicants for PDUFA 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 of 1992 (PDUFA) 
products.

DATES: Submit written or electronic comments on the collection of 
information by September 16, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: Karen Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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: (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.

[[Page 47384]]

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 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 (Secs. 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. 
The 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 for OMB approval 
additional estimates.

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's regulations (Secs. 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 biologics 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 Secs. 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:
     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. The agency 
regulations currently permit such requests and recommend the submission 
of an information package before an end-of-phase 2 meeting 
(Secs. 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.

A. 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

[[Page 47385]]

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.

B. 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 
(Secs. 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\1\
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                                                      Number of       Number of Responses      Total Annual
   Meeting Requests and Information Packages         Respondents         per Respondent         Responses        Hours per 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.


    Dated: July 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18120 Filed 7-17-02; 8:45 am]
BILLING CODE 4160-01-S