Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Time and Extent Applications for Nonprescription Drug Products, 85642-85643 [2023-26985]

Download as PDF 85642 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices products for compliance with the requirements of section 403(w)(1) of the FD&C Act, along with the time needed to make any needed modifications to the labels of those products. We believe firms have already redesigned their labels to comply with requirements under the Food Allergen Labeling and Consumer Protection Act of 2004. However, this estimate accounts for firms that will redesign their label to comply with requirements under the FASTER Act. Our estimated reporting burden is based on our past experience with these submissions. We have increased our cumulative estimate by 12,552 hours and 776 responses annually to reflect the inclusion of sesame as a major food allergen. Dated: December 5, 2023. Lauren K. Roth, Associate Commissioner for Policy. 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, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Time and Extent Applications for Nonprescription Drug Products [FR Doc. 2023–27018 Filed 12–7–23; 8:45 am] BILLING CODE 4164–01–P OMB Control Number 0910–0688— Revision DEPARTMENT OF HEALTH AND HUMAN SERVICES I. Background 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. 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 SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 16:50 Dec 07, 2023 Jkt 262001 This information collection supports certain Agency regulations in part 330 (21 CFR part 330) regarding over-thecounter (OTC) human drugs and associated guidance. Specifically, FDA regulations in §§ 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 § 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/ PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 search-fda-guidance-documents/timeand-extent-applicationsnonprescription-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 § 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: E:\FR\FM\08DEN1.SGM 08DEN1 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85643 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 § 330.14(c) and (d); Time and extent application and submission of information. § 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. 1 There 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–E–5267] Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Tablets (New Drug Application 209816) Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, the Agency, or we) has determined the regulatory review period for Nuzyra Tablets (new drug application (NDA) 209816) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES ∼1.29 1 Average burden per response Total annual responses 1.29 861.78 hours (861 hours and 47 minutes). Total hours 1,112 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. AGENCY: Number of responses per respondent Number of respondents 21 CFR section; activity VerDate Sep<11>2014 16:50 Dec 07, 2023 Jkt 262001 Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by February 6, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 5, 2024. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 February 6, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. DATES: 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. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 • 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– 2019–E–5267 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; NUZYRA TABLETS (NDA 209816).’’ Received comments, those 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 E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[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
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