[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Notices]
[Pages 66194-66195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23791]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2336]


Assessing User Fees Under the Over-the-Counter Monograph Drug 
User Fee Program; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Assessing 
User Fees Under the Over-the-Counter Monograph Drug User Fee Program.'' 
This guidance provides stakeholders with information regarding FDA's 
implementation of the Over-the-Counter Monograph Drug User Fee Program 
authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by January 3, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-2336 for ``Assessing User Fees Under the Over-the-Counter 
Monograph Drug User Fee Program.'' 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

[[Page 66195]]

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 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: Over-the-Counter Monograph Drug User 
Fee Staff, Division of User Fee Management, Office of Management, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10001 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7900, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Assessing User Fees Under the Over-the-Counter Monograph 
Drug User Fee Program.'' This guidance provides stakeholders with 
information regarding FDA's implementation of the Over-the-Counter 
Monograph Drug User Fee Program. On March 27, 2020, new provisions were 
added to the FD&C Act (21 U.S.C. 9) by the Coronavirus Aid, Relief, and 
Economic Security Act (CARES Act) (Pub. L. 116-136). Among these new 
FD&C Act provisions were sections 744L (21 U.S.C. 379j-71) and 744M (21 
U.S.C. 379j-72), which authorize FDA to assess and collect user fees 
from qualifying manufacturers of over-the-counter (OTC) monograph drugs 
and submitters of OTC Monograph Order Requests (OMOR), other than OMORs 
for certain safety changes. FDA refers to the OTC Monograph Drug User 
Fee program as ``OMUFA'' throughout this document. The draft guidance 
also describes the types of OMUFA fees authorized by the FD&C Act, the 
due dates of the fees, and explains the exceptions to certain fees. In 
addition, this guidance describes the process for submitting fee 
payments to FDA, the consequences for failing to pay the required fees, 
and the process for submitting refund requests or disputing FDA's 
assessment of OMUFA fees. This guidance does not address how FDA 
calculates OMUFA fee rates for each fiscal year, nor does it address 
FDA's implementation of other user fee programs (e.g., under the 
Prescription Drug User Fee Act, Biosimilar User Fee Act, or Generic 
Drug User Fee Amendments).
    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 ``Assessing 
User Fees Under the Over-the-Counter Monograph Drug User Fee Program.'' 
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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. 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 this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the over-the-counter drug user fee program have been 
approved under OMB Control Number 0910-0340. The collection of 
information associated with completing and submitting FDA 3913 (User 
Fee Payment Refund Request) is approved under OMB control number 0910-
0805.

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: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23791 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P


