[Federal Register Volume 64, Number 165 (Thursday, August 26, 1999)]
[Notices]
[Pages 46684-46686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22100]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0296]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Draft Guidance for Industry on Formal Meetings 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the proposed collection of 
information by September 27, 1999.
ADDRESSES: Submit written comments on the proposed collection of 
information to the Office of Information and Regulatory Affairs, OMB, 
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 
20503, Attn: Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (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.

Draft Guidance for Industry on Formal Meetings with Sponsors and 
Applicants for PDUFA Products; Availability

I. Description

    FDA is issuing a draft guidance on the procedures for formal 
meetings between FDA and sponsors or applicants regarding the 
development and review of the Prescription Drug User Fee Act (PDUFA) 
products. The draft guidance describes procedures for requesting, 
scheduling, conducting, and documenting such formal meetings. The draft 
guidance provides information on how the agency will interpret and 
apply section 119(a) of the FDA Modernization Act of 1997 (the 
Modernization Act) (Public Law 105-115). Specific PDUFA goals for the 
management 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 draft 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 No. 0910-0014). However, the draft 
guidance provides additional recommendations for submitting information 
to FDA in support of a meeting request. As a result, FDA is providing 
revised estimates in this notice.

II. Request for a Meeting

    Under the draft guidance, a sponsor or applicant interested in 
meeting with the Center for Drug Evaluation and Research (CDER) and and 
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 (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), NDA, or 
biologics license application (BLA) must be submitted in triplicate and 
with an appropriate cover form. Form FDA 1571 must accompany 
submissions under IND's and Form FDA 356h must accompany submissions 
under NDA's and BLA's. Both forms have valid OMB control numbers as 
follows: FDA Form 1571, OMB Control No. 0910-0014, expires December 31, 
1999; and FDA Form 356h, OMB Control No. 0910-0338, expires April 30, 
2000.
    In the draft guidance, 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 data bases. Use of the information in the 
agency's tracking data bases 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 draft 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.

III. 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

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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 proposed collection of information described in the draft 
guidance reflects the current and past practice of sponsors and 
applicants to submit meeting requests as amendments to IND's, NDA's, 
and BLA's 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 Respondent: A sponsor or applicant for a drug or 
biologic product who requests a formal meeting with the agency 
regarding the development and review of a PDUFA product.
    Burden Estimate: Table 1 of this document provides an estimate of 
the annual reporting burden for the submission of meeting requests and 
information packages under the draft guidance.
    Request for a Formal Meeting: Based on data collected from the 
review divisions and offices within CDER and CBER, FDA estimates that 
in fiscal year (FY) 1998, 548 sponsors and applicants (respondents) 
requested formal meetings with CDER and 495 respondents requested 
formal meetings with CBER regarding the development and review of a 
PDUFA product. FDA anticipates that the potential number of respondents 
submitting meeting requests will remain the same, and therefore 
estimates that the total number of respondents will be 1,043. The 
agency further estimates that the total annual responses, i.e., the 
total number of meetings requested per year, will be 1,043, based on 
data collected from the offices within CDER and CBER. 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 draft 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. Therefore, the agency estimates that sponsors 
will use 10,430 hours per year requesting formal meetings with CDER and 
CBER regarding the development and review of PDUFA products.
    Information Package: Based on data collected from the review 
divisions and offices within CDER and CBER, FDA estimates that in FY 
1998, CDER held 527 formal meetings and CBER held 415 formal meetings 
regarding the review of human drug applications as defined in section 
735(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
379g). FDA anticipates that the potential number of meetings will 
remain the same; thus, the agency estimates that total annual responses 
will be 942. As stated previously, it is the current practice for 
sponsors and applicants to submit information packages to the agency in 
advance of any such meeting. In FY 1998, 527 respondents submitted 
information packages to CDER and 415 respondents submitted information 
packages to CBER prior to the scheduled meetings. FDA anticipates that 
the potential number of respondents submitting an information package 
will remain the same; thus, the agency estimates that the total number 
of respondents will be 942. The hours per response, which is the 
estimated number of hours that a respondent would spend preparing the 
information package in accordance with this draft 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. Therefore, the agency estimates that respondents will spend 
16,856 hours per year submitting information packages to the agency 
prior to a formal meeting regarding the development and review of a 
PDUFA product.
    As stated earlier, the draft 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 No. 0910-0014). These estimates 
provide for 100 respondents submitting 100 total annual responses at 24 
hours per response, equalling 2,400 total burden hours. Therefore, FDA 
is subtracting these estimates from the estimates described previously 
for all formal meetings between FDA and sponsors or applicants 
regarding the development and review of PDUFA products. Specifically, 
the agency is subtracting in Table 1 of this document burden estimates 
for meeting requests and information packages for end-of-Phase 2 
meetings and pre-NDA meetings. This reduces the total estimated burden 
hours from 27,386 to 24,986.
    In the Federal Register of March 19, 1999 (64 FR 13591), FDA 
invited comments regarding the agency's estimate of the paperwork 
burden. One comment was received. The comment stated that FDA's 
estimate is a relatively accurate accounting of time used in 
administrative preparation of information for routine meetings. The 
comment stated that FDA underestimated the time required for creative 
writing and editing tasks associated with preparation of paperwork 
prior to a formal meeting where many issues or complicated topics will 
be discussed.
    The agency's estimates are based in part on the expectation that 
respondents will have already compiled for submission to the agency 
most of the data and information that is described in the guidance 
document. The agency anticipates that respondents will have submitted 
the information as part of the underlying product application. 
Therefore, the bulk of the paperwork burden is related to 
administrative tasks, i.e., gathering and copying brief statements 
about the product and describing details of the anticipated meeting.
    FDA invites comments on this analysis of information collection 
burdens.

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                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      No. of
 Meeting Request and Information      No. of       Responses per   Total Annual      Hours per      Total Hours
             Package                Respondents     Respondent       Responses       Response
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Meeting Request
CDER                                  548               1             548              10           5,480
CBER                                  495               1             495              10           4,950
Total                                                                                              10,430
Information Packages
CDER                                  527               1             527              18           9,486
CBER                                  415               1             415              18           7,470
Total                                                                                              16,956
Subtotal                                                                                           27,386
Less 2,400 hours                                                                                   24,986
Total                                                                                              24,986
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information


    Dated: August 19, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-22100 Filed 8-25-99; 8:45 am]
BILLING CODE 4160-01-F