[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60429-60430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2059]


Providing Over-the-Counter Monograph Submissions in Electronic 
Format; 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 final guidance for industry entitled ``Providing 
Over-the-Counter Monograph Submissions in Electronic Format.'' This 
guidance is intended to assist submitters by describing the electronic 
over-the-counter (OTC) monograph submissions requirement in the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations 
and other information on how to send such OTC monograph submissions to 
FDA in electronic format. This guidance finalizes the draft guidance of 
the same title issued on September 28, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on July 25, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2022-D-2059 for ``Providing Over-the-Counter Monograph Submissions 
in Electronic Format.'' 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 this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 240-402-7945, [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 60430]]

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Providing Over-the-Counter Monograph Submissions in 
Electronic Format.'' This guidance provides information on providing 
electronic submissions to FDA under section 505G of the FD&C Act (21 
U.S.C. 355h) (hereafter referred to as OTC monograph submissions). This 
guidance is intended to assist submitters by describing the electronic 
OTC monograph submissions requirement in section 505G(j) of the FD&C 
Act and providing recommendations and other information on how to send 
such OTC monograph submissions to FDA in electronic format.
    Section 505G of the FD&C Act was added by the Coronavirus Aid, 
Relief, and Economic Security Act (CARES Act), Public Law 116-136, 
which was enacted on March 27, 2020. Section 505G(j) of the FD&C Act 
requires that all OTC monograph submissions must be in electronic 
format. Section 505G(l)(3) of the FD&C Act requires FDA to issue 
guidance that specifies the format of electronic submissions under 
section 505G. This guidance is being issued to fulfill this 
requirement.
    In support of the CARES Act, FDA agreed to specific performance 
goals and procedures described in the document entitled ``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 to 2025 can be accessed at https://www.fda.gov/media/146283/download). In the OMUFA commitment letter, FDA committed to issuing 
this final guidance under specific timelines.
    This guidance finalizes the draft guidance entitled ``Providing 
Over-the-Counter Monograph Submissions in Electronic Format'' issued on 
September 28, 2022 (87 FR 58802). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft guidance to the final guidance are primarily intended to clarify 
how to submit OTC monograph submissions through the CDER NextGen 
Portal. In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Providing Over-the-Counter Monograph 
Submissions in Electronic Format.'' 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. This guidance is being issued to implement the 
provisions of section 505G(l)(3) of the FD&C Act, which specifies the 
format of electronic submissions to FDA under section 505G of the FD&C 
Act. Therefore, clearance by the Office of Management and Budget under 
the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
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: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16403 Filed 7-24-24; 8:45 am]
BILLING CODE 4164-01-P