Notice2023-26985
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Time and Extent Applications for Nonprescription Drug Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 235 (Friday, December 8, 2023)</title>
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[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85642-85643]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2851]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 the Agency) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 8, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0688. Also include the FDA docket
number found in brackets in the heading of this document.
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,
<a href="/cdn-cgi/l/email-protection#3a6a687b694e5b5c5c7a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="28787a697b5c494e4e684e4c490640405b064f475e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Time and Extent Applications for Nonprescription Drug Products
OMB Control Number 0910-0688--Revision
I. Background
This information collection supports certain Agency regulations in
part 330 (21 CFR part 330) regarding over-the-counter (OTC) human drugs
and associated guidance. Specifically, FDA regulations in Sec. Sec.
330.14 and 330.15 (21 CFR 330.14 and 330.15) 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
OTC monograph system if the conditions (e.g., active ingredients) meet
certain ``time and extent'' criteria outlined in the regulations. The
regulations in Sec. 330.14 allow a sponsor to submit certain
information to the Agency in a time and extent application (TEA) for
use to determine eligibility of a condition for consideration in the
OTC monograph system.
We developed the final guidance document entitled ``Time and Extent
Applications for Nonprescription Drug Products'' (September 2011)
(available from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products</a>) to assist respondents with the
information collection provisions found in the regulations. The
guidance was issued consistent with our good guidance practice
regulations at 21 CFR 10.115, which provide for comment at any time.
The guidance explains what information an applicant should submit to
the Agency to request that a drug product be included in the OTC drug
monograph system. The guidance also discusses format and content
elements, and the process for submitting information, consistent with
the applicable regulations.
II. OTC Monograph Reform in the Coronavirus Aid, Relief, and Economic
Security Act
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act
(Pub. L. 116-136, Stat. 281)) signed March 27, 2020, included
provisions that govern the way certain OTC drugs are regulated in the
United States. The CARES Act added section 505G to the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h), which reforms and
modernizes the OTC drug review process, including establishing new
procedures for consideration of additions or changes to conditions
covered in OTC monographs. As a result of these revised statutory
provisions, we anticipate no submissions under Sec. 330.14. Our OTC
Monographs@FDA portal (<a href="https://dps.fda.gov/omuf">https://dps.fda.gov/omuf</a>) provides additional
information about OTC monograph drugs and the OTC drug review process.
Consistent with section 505G(k)(3) of the FD&C Act, we plan to
withdraw the regulations supporting the TEA provisions in part 330 and
discontinue the related guidance document. When these actions occur, we
will also request discontinuation of the information collection
approved under OMB control number 0910-0688.
In the Federal Register of August 8, 2023 (88 FR 53497), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 85643]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sec. 330.14(c) and (d); Time 1 ~1.29 1.29 861.78 hours 1,112
and extent application and (861 hours and
submission of information. 47 minutes).
Sec. 330.14(f) and (i);
Submission of safety and
effectiveness data, including
data and information listed in
Sec. 330.10(a)(2), a listing
of all serious adverse drug
experiences that may have
occurred (Sec.
330.14(f)(2)), and an official
or proposed compendial
monograph (Sec. 330.14(i)).
Sec. 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.
As previously stated, as a result of the CARES Act statutory
provisions described above, we anticipate no TEA submissions. For
purposes of burden calculation, we assume one respondent as a
placeholder. The burden we attribute to reporting activities is assumed
to be distributed among the individual elements.
Our estimated burden for the information collection reflects, as a
result of statutory requirements, a program change decrease of 6,894
hours and a corresponding decrease of 8 responses.
Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26985 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P
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