[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]
[[Page 46684]]
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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Review; Comment Request; Draft Guidance for Industry on Formal Meetings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Draft Guidance for Industry on Formal Meetings with Sponsors and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FDA is issuing a draft guidance on the procedures for formal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 The draft guidance describes procedures for requesting,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 The draft
guidance provides information on how the agency will interpret and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The draft guidance describes two collections of information: The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