[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22451-22453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1188]


Over-the-Counter Monograph Order Requests: Format and Content; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Over-the-
Counter Monograph Order Requests (OMORs): Format and Content.'' This 
draft guidance provides recommendations on the format and content of 
the information that a requestor should provide in an over-the-counter 
(OTC) monograph order request (OMOR) and identifies relevant guidance 
documents to assist requestors in preparing their OMORs.

DATES: Submit either electronic or written comments on the draft 
guidance by June 12, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.

[[Page 22452]]

     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-2023-D-1188 for ``Over-the-Counter Monograph Order Requests 
(OMORs): Format and Content.'' 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. 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 ``Over-the-Counter Monograph Order Requests (OMORs): Format 
and Content.'' This draft guidance is intended to assist requestors in 
preparing OMORs for submission to FDA under section 505G of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h). This draft 
guidance provides recommendations on the format and content of the 
information that a requestor should provide in an OMOR and identifies 
relevant guidance documents to assist requestors in preparing their 
OMORs.
    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 format 
and content of data submissions, specifically OMORs, to FDA.
    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). 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 ``Over-the-
Counter Monograph Order Requests (OMORs): Format and Content.'' 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 (chapter 35 of title 44, United States Code) does not apply to 
collections of information made under section 505G of the FD&C Act. The 
information collections described in this guidance implement the 
following provisions of section 505G:
    (1) Section 505G(b)(5) of the FD&C Act, which allows submission of 
administrative orders, OMORs, initiated at the request of a requestor.
    (2) Section 505G(b)(6) of the FD&C Act, which allows requestors to 
provide certain information regarding safe nonprescription product 
marketing and use as a condition for filing a generally recognized as 
safe and effective request.
    (3) Section 505G(d) of the FD&C Act confidentiality of information 
submitted to the Secretary, which requires FDA to make information 
submitted in support of an OMORs available to the public no later than 
the date of the proposed order unless it meets certain limitations on 
public availability.
    (4) Section 505G(j) of the FD&C Act, which requires that all 
submissions under section 505G must be in electronic format.
    (5) Section 505G(l)(1) of the FD&C Act, which requires FDA to issue 
guidance that specifies the procedures and principles for formal 
meetings between the Secretary and sponsors or requestors for drugs 
subject to section 505G.
    (6) Section 505G(1)(2) of the FD&C Act, which requires FDA to issue 
guidance that specifies the format and content of data submissions to 
the Secretary under section 505G.
    (7) Section 505G(1)(3) of the FD&C Act, which requires FDA to issue 
guidance that specifies the format of electronic submissions to the 
Secretary under section 505G.
    Therefore, clearance by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) 
is not required for these collections of information. In addition, this 
guidance refers to previously approved FDA collections of information. 
The previously approved collections of information are subject to 
review by OMB under the PRA. The collections of

[[Page 22453]]

information for OTC monograph products, OTC monograph order requests, 
and the OTC Monograph User Fee Program have been approved under OMB 
control number 0910-0340. The information collections for submission of 
new drug applications and abbreviated new drug applications in 21 CFR 
part 314 are approved under OMB control number 0910-0001. The 
collections of information used by FDA to assess the environmental 
impact of Agency actions and to ensure that the public is informed of 
environmental analyses under 21 CFR part 25 have been approved under 
OMB control number 0910-0322.

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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07767 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P