[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Notices]
[Pages 13591-13594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft Guidance for Industry on Formal Meetings with Sponsors and 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Formal 
Meetings with Sponsors and Applicants for PDUFA Products.'' This draft 
guidance document is intended to provide guidance to industry on 
procedures that will be adopted by the Center for Drug Evaluation and 
Research (CDER) and the Center for Biologics Evaluation and Research 
(CBER) for formal meetings between the agency and sponsors or 
applicants concerning certain drug products.

DATES: Written comments on the draft guidance may be submitted by May 
18, 1999. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Copies of the draft guidance for industry are available on 
the Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or 
``http://www.fda.gov/cber/guidelines.htm''. Submit written requests for 
single copies of ``Formal Meetings with Sponsors and Applicants for 
PDUFA Products'' to the Drug Information Branch (HFD-210), Center for 
Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3844, or FAX 888-CBERFAX. Send two self-addressed 
adhesive labels to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Requests and comments are to be identified 
with the docket number found in brackets in the heading of this 
document. After the comment period, comments may be submitted to the 
centers at the following addresses.

FOR FURTHER INFORMATION CONTACT:
     Murray M. Lumpkin, Center for Drug Evaluation and Research (HFD-
2), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5400, or
    Rebecca A. Devine, Center for Biologics Evaluation and Research 
(HFM-10), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0373.

SUPPLEMENTARY INFORMATION:

 I. Description of the Draft Guidance

     FDA is announcing the availability of a draft guidance for 
industry entitled ``Formal Meetings with Sponsors and Applicants for 
PDUFA Products.'' CDER and CBER participate in many meetings each year 
with sponsors of

[[Page 13592]]

investigations and applicants for marketing who seek guidance relating 
to the development and review of products in human drug applications as 
defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 379g(1)) (the Prescription Drug User Fee Act 
(PDUFA) products). These meetings often represent critical points in 
the regulatory process. It is essential that FDA maintain procedures 
for the timely and effective conduct of such meetings.
     Section 119(a) of the Food and Drug Administration Modernization 
Act of 1997 (the Modernization Act) (Pub. L. 105-115) amends section 
505(b) of the act (21 U.S.C. 355(b)) and directs FDA to meet with 
sponsors and applicants, provided certain conditions are met, for the 
purpose of reaching agreement on the design and size of clinical trials 
intended to form the primary basis of an effectiveness claim in a new 
drug application (NDA) submitted under section 505(b) of the act or in 
a biologics license application (BLA) submitted under section 351 of 
the Public Health Service Act (42 U.S.C. 262) (21 U.S.C. 355(b)(4)(B)). 
Moreover, in conjunction with the reauthorization of PDUFA in November 
1997, FDA agreed to specific performance goals for the management of 
meetings with sponsors and applicants for PDUFA products. The 
performance goals are summarized in an enclosure to a letter dated 
November 12, 1997, from Donna E. Shalala, Secretary of Health and Human 
Services, to Senator James M. Jeffords.
     The procedures and policies described in this draft guidance 
document are designed to promote efficient, well-managed meetings 
between sponsors, applicants, and CDER or CBER. These procedures will 
implement section 119(a) of the Modernization Act and are consistent 
with the timeframes described in the performance goals.
     FDA participates in formal meetings with various external 
constituents who seek guidance relating to the development or marketing 
of drug and biological products. This draft guidance document is the 
first of two guidances describing CDER's and CBER's procedures for 
formal meetings. FDA intends to issue additional guidance documents 
describing CDER's and CBER's procedures for formal meetings with 
sponsors and applicants for non-PDUFA products (including generic drug 
products) and for nonapplication related meetings with external 
constituents.
     This draft Level 1 guidance document is being issued consistent 
with FDA's ``Good Guidance Practices'' (62 FR 8961, February 27, 1997). 
It represents the agency's current thinking on formal meetings with 
sponsors and applicants for PDUFA products. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute, regulations, or 
both.
     Interested persons may, on or before May 18, 1999, submit to the 
Dockets Management Branch (address above) written comments on the draft 
guidance document. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The draft guidance and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

 II. The Paperwork Reduction Act of 1995

     Under the Paperwork Reduction Act (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. 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 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 comment 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 on respondents, including through the use of automated 
collection techniques and other forms of information technology, when 
appropriate.
    Title: Draft Guidance for Industry on Formal Meetings with Sponsors 
and Applicants for PDUFA Products.
    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 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 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 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-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.

A. Request for a Meeting

     Under the draft guidance, a sponsor or applicant interested in 
meeting with CDER or 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 IND, NDA, or 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 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

[[Page 13593]]

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.

 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 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 Respondents: 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 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 act. 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

[[Page 13594]]

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.
     FDA invites comments on this analysis of information collection 
burdens.

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                                 No. of
                                                    No. of     Responses      Total      Hours per
   Meeting Requests and Information Packages     Respondents      per         Annual      Response   Total Hours
                                                               Respondent   Responses
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Meeting Requests
  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.

     In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)), 
the agency has submitted the information collection provisions of this 
draft guidance to OMB for review. Interested persons are requested to 
send comments on this information collection by April 19, 1999, to the 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk 
Officer for FDA.

    Dated: March 9, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-6748 Filed 3-18-99; 8:45 am]
BILLING CODE 4160-01-F