[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53497-53499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2851]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Time and Extent Applications for Nonprescription Drug 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on time and extent applications for 
nonprescription drug products.

DATES: Either electronic or written comments on the collection of 
information must be submitted by October 10, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 10, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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-2023-N-2851 for ``Time and Extent Applications for Nonprescription 
Drug Products.'' Received comments, those

[[Page 53498]]

filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Time and Extent Applications for Nonprescription Drug Products

OMB Control Number 0910-0688--Extension

    This information collection supports Agency regulations in 21 CFR 
part 330 regarding over-the-counter (OTC) human drugs and associated 
guidance. Specifically, FDA regulations in Sec.  330.14 (21 CFR 330.14) 
establish additional criteria and procedures for classifying OTC drugs 
as generally recognized as safe and effective and not misbranded. These 
regulations provide that OTC drug products introduced into the U.S. 
market after the OTC drug review began in 1972 and OTC drug products 
without any marketing experience in the United States can be evaluated 
under the monograph process if the conditions (e.g., active 
ingredients) meet certain ``time and extent'' criteria outlined in the 
regulations. The regulations allow a time and extent application (TEA) 
to be submitted to us by any party for our consideration to include new 
conditions in the OTC drug monograph system.
    As explained in the guidance document entitled ``Time and Extent 
Applications for Nonprescription Drug Products,'' (September 2011), 
when submitting a TEA for FDA review, the submitter must provide 
evidence as described in Sec.  330.14(c) demonstrating that the 
condition is eligible for inclusion in the monograph system. Section 
330.14(d) specifies the number of copies and address for submission of 
a TEA. If we determine that a condition is eligible for inclusion in 
the OTC monograph, we will publish a notice of eligibility that 
requests the submission of data to demonstrate general recognition of 
the safety and effectiveness of the condition, and place the TEA on 
public display. The TEA submitter can then submit the safety and 
effectiveness information described in Sec.  330.14(f).
    The guidance document explains what information an applicant should 
submit to FDA to request that a drug product be included in the OTC 
drug monograph system. The guidance document also discusses format and 
content elements as well as the submission process, consistent with the 
applicable regulations.
    Consistent with applicable statutory requirements, the information 
is required to be submitted electronically.
    Description of Respondents: Any interested party may submit a TEA 
for a change to the OTC monograph.
    We estimate the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    Number of
                                       Number of    responses      Total       Average burden per
      21 CFR section; activity        respondents      per         annual           response         Total hours
                                                    respondent   responses
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330.14(c) and (d); Time and extent              7        ~1.29            9  861.78 hours..........        7,756
 application and submission of
 information.

[[Page 53499]]

 
330.14(f) and (i); Submission of
 safety and effectiveness data,
 including data and information
 listed in 330.10(a)(2), a listing
 of all serious adverse drug
 experiences that may have occurred
 (330.14(f)(2)), and an official or
 proposed compendial monograph
 (330.14(i)).
330.14(j) and (k); Submitter
 correspondence with FDA.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden reflects time needed for submitting 
applications, followup submissions of safety and efficacy data, and 
potential correspondence from submitters to FDA after a TEA has been 
submitted (e.g., requests for an informal conference, signed statements 
that the submission is complete, requests for FDA to withdraw TEA 
consideration). The burden we attribute to reporting activities is 
assumed to be distributed among the individual elements and averaged 
among respondents.
    Based on a recent review of the information collection and 
submissions of TEAs since our last request for OMB approval, we have 
made no adjustments to the currently approved burden estimates.

    Dated: August 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16922 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P