[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6877-6878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0080]


Formal Meetings Between the Food and Drug Administration and 
Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Formal 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 FDA and Sponsors or Requestors of Over-the-Counter 
Monograph Drugs.'' This draft guidance provides recommendations to 
industry on formal meetings between FDA and sponsors or requestors of 
over-the-counter (OTC) monograph drugs.

DATES: Submit either electronic or written comments on the draft 
guidance by April 8, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2022-D-0080 for ``Formal Meetings Between FDA and Sponsors or 
Requestors of Over-the-Counter Monograph Drugs.'' 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.
    <bullet> 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. 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: Trang Tran, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 240-402-7945.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Formal Meetings Between FDA and Sponsors or Requestors of 
Over-the-Counter Monograph Drugs.'' This draft guidance provides 
recommendations to industry on formal meetings between FDA and sponsors 
or requestors of nonprescription drugs without approved new drug 
applications that are governed by section 505G of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) (hereafter referred 
to as OTC monograph drugs).
    Section 505G of the FD&C Act was added by the Coronavirus Aid, 
Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which 
was enacted on March 27, 2020. As required by section 505G(l) of the 
FD&C Act, this draft guidance, when finalized, will discuss the 
procedures and principles for formal meetings between FDA and sponsors 
or requestors for an OTC monograph drug (hereafter referred to 
collectively as meeting requesters). In doing so, and as required by 
section 505G(h) of the FD&C Act, this draft

[[Page 6878]]

guidance, when finalized, will describe procedures under which meeting 
requesters can meet with appropriate FDA officials to obtain 
recommendations on the studies and other information necessary to 
support submissions under section 505G of the FD&C Act, to obtain 
information on other matters relevant to the regulation of 
nonprescription drugs, and to obtain recommendations on the development 
of new OTC monograph drugs. As required by section 505G(i) of the FD&C 
Act, this draft guidance, when finalized, will also describe procedures 
to facilitate efficient participation in joint meetings by multiple 
meeting requestors and/or organizations nominated by them to represent 
their interests.
    This draft guidance does not apply to meetings for the development 
of nonprescription drug products intended for submission in new drug 
applications or abbreviated new drug applications under section 505 of 
the FD&C Act. This draft guidance does not apply to meetings between 
FDA and pre-investigational new drug or investigational new drug 
sponsors. For the purposes of this draft guidance, a formal meeting 
includes any meeting that is requested by a meeting requester following 
the procedures provided in this draft guidance and includes meetings 
conducted in any format (i.e., face to face, teleconference/
videoconference, or written response only).
    In support of the CARES Act, FDA agreed to specific performance 
goals and procedures described in the document ``Over-the-Counter 
Monograph User Fee Program Performance Goals and Procedures--Fiscal 
Years 2018-2022,'' commonly referred to as the OMUFA Commitment Letter 
(the document can be accessed at https://www.fda.gov/media/106407/download and the document with updated goal dates for fiscal years 
2021-2025 can be accessed at https://www.fda.gov/media/146283/download). The OMUFA Commitment Letter includes meeting management 
goals for formal meetings that occur between FDA and meeting 
requesters. In the OMUFA Commitment Letter, FDA committed to issuing 
this draft guidance under specific timelines.
    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 FDA and Sponsors or Requestors of Over-the-Counter 
Monograph Drugs; Draft Guidance for Industry.'' 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

    Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act 
of 1995 does not apply to collections of information made under section 
505G of the FD&C Act. The information collections made in this guidance 
implement the provisions of three subsections of section 505G: (1) 
Section 505G(l)(1), which requires FDA to issue guidance that specifies 
the procedures and principles for formal meetings between FDA and 
sponsors or requestors for drugs subject to section 505G; (2) section 
505G(h), which requires FDA to establish procedures under which meeting 
requestors can meet with appropriate FDA officials to obtain advice on 
the studies and other information necessary to support submissions 
under section 505G, other matters relevant to the regulation of 
nonprescription drugs, and the development of new nonprescription drugs 
under section 505G; and (3) section 505G(i), which requires FDA to, 
among other things, establish procedures to facilitate efficient 
participation in joint meetings by multiple meeting requesters and/or 
organizations nominated by them to represent their interests. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required for these collections 
of information.

III. Electronic Access

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

    Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02446 Filed 2-4-22; 8:45 am]
BILLING CODE 4164-01-P