[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Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Over-the-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draft guidance provides recommendations on the format and content of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DATES: Submit either electronic or written comments on the draft
guidance by June 12, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
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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]
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