
[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65395-65396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20592]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6530]


Formal Meetings Between the Food and Drug Administration and 
Sponsors or Applicants of Prescription Drug User Fee Act Products; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Formal 
Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products.'' This draft guidance outlines the recommendations to 
industry on formal meetings between the FDA and sponsors or applicants 
relating to the development and review of new drug or biological drug 
products. This draft guidance replaces the guidance ``Formal Meetings 
Between the FDA and Sponsors or Applicants of PDUFA Products'' issued 
on December 29, 2017.

DATES: Submit either electronic or written comments on the draft 
guidance by December 21, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-6530 for ``Formal Meetings Between the FDA and Sponsors or 
Applicants of PDUFA Products.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Mercier, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993-0002, 301-
796-0957; or Anne Taylor, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants 
of PDUFA Products.'' This draft guidance outlines the recommendations 
to industry on formal meetings between FDA and sponsors or applicants 
relating to the development and review of drug or biological drug 
products as agreed upon during the Prescription Drug User Fee Act 
(PDUFA) VII negotiations. The draft guidance describes the different 
meeting types, formats, and timelines associated with those requests. 
It also provides industry with the information necessary to have a 
complete meeting request and background package to help facilitate the 
meeting to gain useful feedback for product development. The draft

[[Page 65396]]

guidance provides examples to help guide stakeholders on selecting and 
requesting the proper meeting type for a given scenario.
    This draft guidance replaces the draft guidance entitled ``Formal 
Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' 
issued on December 29, 2017 (82 FR 61763). FDA considered comments 
received on the draft guidance as the guidance was revised. Changes 
made include the addition of Type D and Initial Targeted Engagement for 
Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings, 
request for clarification/followup opportunity correspondence, and 
virtual meetings as a face-to-face meeting.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Formal 
Meetings Between the FDA and Sponsors or Applicants of PDUFA 
Products.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget under the Paperwork Reduction Act 
of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 
21 CFR part 312 pertaining to meetings, including ``End-of-phase 2'' 
and ``pre-NDA'', have been approved under OMB control number 0910-0014. 
The collections of information in 21 CFR part 314 pertaining to formal 
meetings between sponsors or applicants and FDA have been approved 
under OMB control number 0910-0001. The collections of information 
pertaining to formal meetings between the FDA and sponsors or 
applicants for biological products have been approved under OMB control 
number 0910-0718.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: September 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20592 Filed 9-21-23; 8:45 am]
BILLING CODE 4164-01-P


