Providing Over-the-Counter Monograph Submissions in Electronic Format; Guidance for Industry; Availability, 60429-60430 [2024-16403]

Download as PDF Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Authority: 6 U.S.C. 279; 8 U.S.C. 1232; 45 CFR 410; Flores v. Reno Settlement Agreement, No. CV85–4544– RJK (C.D. Cal. 1996); Lucas R. et al v. Becerra et al (Case No. 2:18–CV–05741 DMG PLA) Disabilities Settlement Agreement Mary C. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2024–16347 Filed 7–24–24; 8:45 am] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–2059] Providing Over-the-Counter Monograph Submissions in Electronic Format; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Providing Over-the-Counter Monograph Submissions in Electronic Format.’’ This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. This guidance finalizes the draft guidance of the same title issued on September 28, 2022. DATES: The announcement of the guidance is published in the Federal Register on July 25, 2024. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:41 Jul 24, 2024 Jkt 262001 You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: 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–2059 for ‘‘Providing Over-theCounter Monograph Submissions in Electronic Format.’’ 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 information that you do not wish to be made publicly available, submit your comments only as a written/paper PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 60429 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-201509-18/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 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 guidance document. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–7945, Trang.Tran@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\25JYN1.SGM 25JYN1 60430 Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Providing Over-the-Counter Monograph Submissions in Electronic Format.’’ This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act (21 U.S.C. 355h) (hereafter referred to as OTC monograph submissions). This guidance is intended to assist submitters by describing the electronic OTC monograph submissions requirement in section 505G(j) of the FD&C Act and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116–136, which was enacted on March 27, 2020. Section 505G(j) of the FD&C Act requires that all OTC monograph submissions must be in electronic format. Section 505G(l)(3) of the FD&C Act requires FDA to issue guidance that specifies the format of electronic submissions under section 505G. This guidance is being issued to fulfill this requirement. In support of the CARES Act, FDA agreed to specific performance goals and procedures described in the document entitled ‘‘Over-the-Counter Monograph User Fee Program Performance Goals and Procedures—Fiscal Years 2018– 2022,’’ commonly referred to as the OMUFA commitment letter (the document can be accessed at https:// www.fda.gov/media/106407/download, and the document with updated goal dates for fiscal years 2021 to 2025 can be accessed at https://www.fda.gov/ media/146283/download). In the OMUFA commitment letter, FDA committed to issuing this final guidance under specific timelines. This guidance finalizes the draft guidance entitled ‘‘Providing Over-theCounter Monograph Submissions in Electronic Format’’ issued on September 28, 2022 (87 FR 58802). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft guidance to the final guidance are primarily intended to clarify how to submit OTC monograph submissions through the CDER NextGen Portal. In addition, editorial changes were made to improve clarity. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Providing Overthe-Counter Monograph Submissions in VerDate Sep<11>2014 19:41 Jul 24, 2024 Jkt 262001 Electronic Format.’’ 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 Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 does not apply to collections of information made under section 505G of the FD&C Act. This guidance is being issued to implement the provisions of section 505G(l)(3) of the FD&C Act, which specifies the format of electronic submissions to FDA under section 505G of the FD&C Act. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: July 22, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–16403 Filed 7–24–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–2307] Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory DecisionMaking for Drug and Biological Products; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘RealWorld Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.’’ FDA is issuing this guidance as part of its RealWorld Evidence (RWE) program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision SUMMARY: PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 making. This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. This guidance finalizes the draft guidance of the same title issued on September 30, 2021. DATES: The announcement of the guidance is published in the Federal Register on July 25, 2024. ADDRESSES: You may submit either electronic or written comments on Agency 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– 2020–D–2307 for ‘‘Real-World Data: E:\FR\FM\25JYN1.SGM 25JYN1

Agencies

[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60429-60430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16403]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2059]


Providing Over-the-Counter Monograph Submissions in Electronic 
Format; 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 final guidance for industry entitled ``Providing 
Over-the-Counter Monograph Submissions in Electronic Format.'' This 
guidance is intended to assist submitters by describing the electronic 
over-the-counter (OTC) monograph submissions requirement in the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations 
and other information on how to send such OTC monograph submissions to 
FDA in electronic format. This guidance finalizes the draft guidance of 
the same title issued on September 28, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on July 25, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency 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-2059 for ``Providing Over-the-Counter Monograph Submissions 
in Electronic Format.'' 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 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 240-402-7945, [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 60430]]

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Providing Over-the-Counter Monograph Submissions in 
Electronic Format.'' This guidance provides information on providing 
electronic submissions to FDA under section 505G of the FD&C Act (21 
U.S.C. 355h) (hereafter referred to as OTC monograph submissions). This 
guidance is intended to assist submitters by describing the electronic 
OTC monograph submissions requirement in section 505G(j) of the FD&C 
Act and providing recommendations and other information on how to send 
such OTC monograph submissions to FDA in electronic format.
    Section 505G of the FD&C Act was added by the Coronavirus Aid, 
Relief, and Economic Security Act (CARES Act), Public Law 116-136, 
which was enacted on March 27, 2020. Section 505G(j) of the FD&C Act 
requires that all OTC monograph submissions must be in electronic 
format. Section 505G(l)(3) of the FD&C Act requires FDA to issue 
guidance that specifies the format of electronic submissions under 
section 505G. This guidance is being issued to fulfill this 
requirement.
    In support of the CARES Act, FDA agreed to specific performance 
goals and procedures described in the document entitled ``Over-the-
Counter Monograph User Fee Program Performance Goals and Procedures--
Fiscal Years 2018-2022,'' commonly referred to as the OMUFA commitment 
letter (the document can be accessed at https://www.fda.gov/media/106407/download, and the document with updated goal dates for fiscal 
years 2021 to 2025 can be accessed at https://www.fda.gov/media/146283/download). In the OMUFA commitment letter, FDA committed to issuing 
this final guidance under specific timelines.
    This guidance finalizes the draft guidance entitled ``Providing 
Over-the-Counter Monograph Submissions in Electronic Format'' issued on 
September 28, 2022 (87 FR 58802). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft guidance to the final guidance are primarily intended to clarify 
how to submit OTC monograph submissions through the CDER NextGen 
Portal. In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Providing Over-the-Counter Monograph 
Submissions in Electronic Format.'' 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

    Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act 
of 1995 does not apply to collections of information made under section 
505G of the FD&C Act. This guidance is being issued to implement the 
provisions of section 505G(l)(3) of the FD&C Act, which specifies the 
format of electronic submissions to FDA under section 505G of the FD&C 
Act. Therefore, clearance by the Office of Management and Budget under 
the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the 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: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16403 Filed 7-24-24; 8:45 am]
BILLING CODE 4164-01-P

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