[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53262-53264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2434]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 21, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0429. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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.

Guidance for Industry on Formal Meetings With Sponsors and Applicants 
for Prescription Drug User Fee Act Products

OMB Control Number 0910-0429--Extension

    This information collection supports the above captioned Agency 
guidance document. The guidance document was issued to help individuals 
with procedures on 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 FDA interprets and 
applies section 119(a) of the Food and Drug Administration 
Modernization Act of 2007 (Pub. L. 105-115), 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.  12.47 and 312.82 (21 CFR 312.47 
and 312.82)). The collection of information described in the guidance 
reflects the current and past practice of sponsors and applicants to 
submit meeting requests and 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.  [thinsp]312.47(b)(1)(ii) and (iv)) and a 
``pre-NDA meeting'' (Sec.  [thinsp]312.47(b)(2)). While the information 
collection provisions of Sec.  [thinsp]312.47 are currently approved 
under OMB control number 0910-0014, the guidance provides additional 
recommendations for submitting information to FDA in support of a 
meeting request. The guidance document is available on our website at: 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf.
    Request for a Meeting--Consistent with recommendations found in 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

[[Page 53263]]

meeting request to the appropriate FDA component as an amendment to the 
application for the underlying product in accordance with our 
regulations (Sec. Sec.  [thinsp]312.23, 314.50, and 601.2 (21 CFR 
312.23, 314.50, and 601.2)). 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 IND 
submissions, and Form FDA 356h must accompany NDA and BLA submissions. 
These Agency forms are approved under OMB control numbers 0910-0014 and 
0910-0338, respectively.
    We recommend that a request be submitted in this manner to ensure 
that each request is kept in the administrative file with the complete 
application, and to ensure that pertinent information about the request 
is entered into appropriate tracking databases. Using information from 
our tracking databases enables us to monitor progress on activities 
attendant to scheduling and holding a formal meeting and to ensure that 
appropriate steps will be taken in a timely manner.
    The guidance recommends that meeting requests include the following 
information:

 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
 suggested dates and times for the meeting

    We use the information to determine the purpose of the meeting, the 
necessary participants, the proposed agenda, and to schedule the 
meeting.
    Information Package--The guidance also recommends that a sponsor or 
applicant submitting an information package provide summary information 
relevant to the product and supplementary information pertaining to any 
issue raised by the sponsor, applicant, or FDA. Information packages 
should 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)
 chemistry, manufacturing, and controls information that may be 
discussed (as appropriate)

    The information package enables Agency staff to prepare for the 
meeting and allows appropriate time for reviewing relevant product 
data. Although FDA reviews similar information in the meeting request, 
the information package should provide updated data reflecting the most 
current and accurate information available to the sponsor or applicant.
    In the Federal Register of July 11, 2018 (83 FR 32130), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
    Guidance recommendations         Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
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Meeting Requests:
    CDER........................           1,319            2.31           3,058              10          30,580
    CBER........................             301            1.21             363              10           3,630
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Subtotal................  ..............  ..............  ..............  ..............          34,210
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Information Packages:
    CDER........................           1,149            2.19           2,522              18          45,396
    CBER........................             187            1.12             210              18           3,780
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Subtotal................  ..............  ..............  ..............  ..............          49,176
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
            Total...............  ..............  ..............  ..............  ..............          83,386
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall increase since the previous OMB approval. We attribute this 
adjustment to an increase in the number of meeting requests and 
information packages received over the last few years.
    Based on Agency data, we estimate 1,319 sponsors and applicants 
(respondents) request 3,058 formal meetings with CDER annually, and 301 
respondents request 363 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 spends 
preparing the information to be submitted with a meeting request in 
accordance with the guidance, is estimated to be 10 hours. We expect it 
takes this amount of time to gather and copy brief statements about the 
product as well as a description of the purpose and details of the 
meeting.
    Also consistent with Agency data, we estimate 1,149 respondents 
submitted 2,522 information packages to CDER annually, and 187 
respondents submitted 210 information packages to CBER annually, prior 
to a formal meeting regarding the development and review of a PDUFA 
product. We estimate 18 hours is needed to prepare

[[Page 53264]]

the information package in accordance with the guidance.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22954 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P