Federal Register, Volume 90 Issue 107 (Thursday, June 5, 2025)

[Federal Register Volume 90, Number 107 (Thursday, June 5, 2025)]
[Notices]
[Pages 23942-23943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-D-1358]


Recommendations for Complying With Over-the-Counter Monograph 
Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage 
Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for 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the availability of a draft guidance for industry titled 
``Recommendations for Complying With Over-the-Counter Monograph 
Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage 
Forms for Certain Over-the-Counter Monograph Drugs.'' The purpose of 
this guidance is to provide recommendations for how requestors can 
comply with the requirements described in the Proposed Administrative 
Order (OTC000038) titled Over-the-Counter Monograph Procedure for Minor 
Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain 
Over-the-Counter Monograph Drugs (hereinafter referred to as C001).

DATES: Submit either electronic or written comments on the draft 
guidance by October 3, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.
     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-2025-D-1358 for ``Recommendations for Complying With Over-the-
Counter Monograph Procedure for Minor Changes C001: Minor Changes to 
Solid Oral Dosage Forms for Certain 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.
     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.

[[Page 23943]]

    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: Ashley Boam, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993-0002, 301-
796-6341, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
titled ``Recommendations for Complying With Over-the-Counter Monograph 
Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage 
Forms for Certain Over-the-Counter Monograph Drugs.'' This draft 
guidance is being issued pursuant to section 505G(c) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(c)) as a 
companion to proposed C001, which specifies the requirements for making 
a minor dosage form change from a tablet or capsule to a chewable 
tablet, orally disintegrating tablet, or film for over-the-counter 
(OTC) monograph drugs without an order issued under section 505G(b) (21 
U.S.C. 355h(b)) amending an applicable monograph to add the new dosage 
form (or otherwise finding such change to be generally recognized as 
safe and effective).
    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 described in section 505G(c)(3) of 
the FD&C Act (21 U.S.C. 355h(c)(3)), the Agency will issue one or more 
administrative orders under 505G(c) specifying requirements for making 
a minor dosage form change, together with guidance for applying such 
requirements to specific dosage forms. In the Over-the-Counter 
Monograph User Fee Program Performance Goals and Procedures, commonly 
referred to as the OMUFA Commitment Letter (the document can be 
accessed at https://www.fda.gov/media/106407/download?attachment, and 
the document with updated goal dates for fiscal years 2021-2025 can be 
accessed at https://www.fda.gov/media/146283/download?attachment), FDA 
and industry agreed to specific performance goals and timelines for 
various OTC monograph drug activities conducted by the Agency. In the 
OMUFA Commitment Letter, FDA committed to issuing a proposed 
administrative order regarding minor changes to solid oral dosage forms 
(along with a draft guidance) specifying requirements for determining 
when such changes are permissible without the issuance of an order 
finding the new dosage forms to be generally recognized as safe and 
effective (when the applicable OTC monograph does not already provide 
for these types of changes). Issuance of proposed C001 and this draft 
guidance fulfills this commitment.
    C001 proposes requirements for a minor change in dosage form of an 
OTC monograph drug from a capsule or tablet to a chewable tablet, 
orally disintegrating tablet, or film when the drug meets the 
requirements under sections 505G(c) of the FD&C Act, C001, and all 
other applicable requirements. This draft guidance provides 
recommendations for how requestors can comply with the requirements 
described in C001. Specifically, this guidance provides recommendations 
for complying with the order to demonstrate that a minor change in 
solid oral dosage form from a tablet or capsule to a chewable tablet, 
orally disintegrating tablet, or film will not affect the safety or 
effectiveness of a drug. It also provides recommendations for complying 
with the order to demonstrate that such a change will not materially 
affect the extent of absorption or other exposure to an active 
ingredient in the drug in comparison to a suitable reference product. 
These recommendations include procedures for demonstrating that the 
active ingredient has high solubility and high permeability and that 
the drug product is rapidly dissolving. The draft guidance also 
provides additional dosage form-specific considerations for the dosage 
forms that are subject to C001 and recommendations regarding 
recordkeeping requirements.
    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 
``Recommendations for Complying With Over-the-Counter Monograph 
Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage 
Forms for Certain Over-the-Counter Monograph Drugs.'' 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, administrative orders, and 
regulations.
    As we develop any final guidance on this topic, FDA will consider 
comments on the applicability of Executive Order 14192, per OMB 
guidance M-25-20, and in particular, on any costs or cost savings.

II. Paperwork Reduction Act of 1995

    Under section 505G(o) of the FD&C Act (21 U.S.C. 355h(o)), the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) does not 
apply to collections of information made under section 505G of the FD&C 
Act. This draft guidance is issued pursuant to section 505G(c), which 
requires FDA to issue guidance for applying the requirements in an 
administrative order to specific dosage forms. Information collection 
in this draft guidance for this purpose is covered under section 
505G(o). Therefore, clearance by the Office of Management and Budget 
under the Paperwork Reduction Act of 1995 is not required for this 
collection of information.
    In addition, this draft guidance refers to previously approved FDA 
collections of information. The previously approved collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521). The collections of information in 21 CFR parts 210 and 211 
relating to current good manufacturing practice requirements have been 
approved under OMB control number 0910-0139. The collections of 
information for OTC monograph drug products have been approved under 
OMB control number 0910-0340.

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: June 2, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10251 Filed 6-4-25; 8:45 am]
BILLING CODE 4164-01-P