Document ID: FDA-2018-N-2434-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Formal Meetings
Between the Food and Drug Administration and Sponsors and Applicants of Prescription Drug User Fee Act Products
Posted Date: 2019-12-27T05:00Z

[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71430-71431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27835]

-----------------------------------------------------------------------

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; Formal Meetings 
Between the Food and Drug Administration and Sponsors and Applicants of 
Prescription Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) 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 January 
27, 2020.

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 oira_submission@omb.eop.gov. 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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.

Formal Meetings Between FDA and Sponsors and Applicants of Prescription 
Drug User Fee Act Products

OMB Control Number 0910-0429--Reinstatement

    This information collection supports implementation of the 
Prescription Drug User Fee Amendments (PDUFA) of the FDA 
Reauthorization Act of 2017 (FDARA). Consistent with Agency regulations 
and provisions found in our ``Reauthorization Performance Goals And 
Procedures: Fiscal Years 2018 Through 2022,'' we have established 
procedural guidance pertaining to formal meetings between FDA and 
sponsors or applicants of certain drug or biological drug products 
regulated by the Center for Drug Evaluation (CDER) and Research and the 
Center for Biologics Evaluation and Research (CBER). Because these 
meetings often represent critical points in the regulatory process, we 
intend these recommendations to facilitate the timely and effective 
scheduling of such meetings, as well as ensure their efficiency and 
appropriate documentation.
    While FDA regulations in 21 CFR 10.65, 312.47, 314.50, and 314.102 
describe general considerations and set forth certain information 
collection elements pertaining to meetings with FDA, the guidance 
document entitled, ``Formal Meetings Between the FDA and Sponsors or 
Applicants of PDUFA Products,'' discusses specific topics for sponsors 
of PDUFA products such as types of meetings, meeting formats, meetings 
requests, FDA response, and meeting packages. The guidance 
recommendations do not apply to abbreviated new drug applications, 
applications for biosimilar biological products, or submissions for 
medical devices. Issued consistent with our Good Guidance Practice 
regulations in 21 CFR 10.115, we originally developed the guidance in 
1999 and it has since undergone various revisions to reflect 
reauthorization of relevant user fee legislation. The guidance explains 
our recommendations with regard to PDUFA meetings and that the 
following elements be included in a meeting request to FDA:
     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.
    We use the information to determine the purpose of the meeting and 
to

[[Page 71431]]

arrange for scheduling and participation as appropriate.
    Similarly, the guidance explains and discusses the preparation of 
an ``information package'' and recommends that it include the following 
information:
     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 information package enables us 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) we published 
a 60-day notice under the Paperwork Reduction Act of 1995 (PRA) 
requesting public comment on the proposed collection of information 
associated with meeting requests under PDUFA. No comments were received 
in response to the PRA notice. Separately, in the Federal Register 
(December 29, 2017; 82 FR 61763), we published a notice of availability 
announcing a 2017 revised draft version of the subject guidance, 
ultimately intending it to replace the current 2009 version. In the 
December 2017 notice of availability, the 2009 version was 
inadvertently withdrawn and the associated information collection 
discontinued. Accordingly, we are requesting reinstatement of the 
information collection. Although the associated guidance is currently 
being revised to reflect 2018-2022 PDUFA reauthorization goals and is 
being issued consistent with our Good Guidance Practice Regulation at 
21 CFR 10.115, no changes have been made to the information collection 
elements recommended, nor have we modified the burden estimate we 
ascribe to the related activities.
    We therefore estimate the burden of the information collection as 
follows:

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

    Our estimate reflects an overall increase since the previous OMB 
approval. We attribute this adjustment to an increase in the number of 
PDUFA-related meeting requests and information packages we have 
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 the information 
package in accordance with the guidance.

    Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27835 Filed 12-26-19; 8:45 am]
 BILLING CODE 4164-01-P