
[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85642-85643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26985]


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

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.

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

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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products) 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 (https://dps.fda.gov/omuf) 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\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
    21 CFR section; activity        Number of     responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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


