Notice2022-02446
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability
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Published
February 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs." This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs.
Full Text
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<title>Federal Register, Volume 87 Issue 25 (Monday, February 7, 2022)</title>
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[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6877-6878]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Formal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 This draft guidance provides recommendations to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DATES: Submit either electronic or written comments on the draft
guidance by April 8, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/media/106407/download">https://www.fda.gov/media/106407/download</a> and the document with updated goal dates for fiscal years
2021-2025 can be accessed at <a href="https://www.fda.gov/media/146283/download">https://www.fda.gov/media/146283/download</a>). 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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