[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34164-34166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0625]


Diabetes Mellitus: Efficacy Endpoints for Clinical Trials 
Investigating Antidiabetic Drugs and Biological Products; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Diabetes 
Mellitus: Efficacy Endpoints for Clinical Trials Investigating 
Antidiabetic Drugs and Biological Products.'' This draft guidance is 
intended to help sponsors develop antidiabetic drugs for adults and 
children with type 1 and type 2 diabetes mellitus. In this draft 
guidance, antidiabetic drug refers to drugs intended to improve 
glycemic control, including drugs intended to reduce diabetes-related 
hyperglycemia (i.e., antihyperglycemic drugs) and drugs intended to 
mitigate iatrogenic hypoglycemia associated with diabetes management.

DATES: Submit either electronic or written comments on the draft 
guidance by August 24, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

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ADDRESSES: You may submit comments on any guidance 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-2023-D-0625 for ``Diabetes Mellitus: Efficacy Endpoints for 
Clinical Trials Investigating Antidiabetic Drugs and Biological 
Products.'' 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 the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Debra Reid, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 4221, Silver Spring, MD 20993, 240-402-9143.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Diabetes Mellitus: Efficacy Endpoints for Clinical Trials 
Investigating Antidiabetic Drugs and Biological Products.'' In this 
draft guidance we discuss approaches to demonstrating efficacy of 
antidiabetic drugs for adults and children with type 1 and type 2 
diabetes mellitus. This draft guidance provides recommendations for 
demonstrating efficacy for drugs that are intended to reduce diabetes-
related hyperglycemia (i.e., antihyperglycemic drugs) and to mitigate 
iatrogenic hypoglycemia associated with diabetes management. The use of 
hemoglobin A1c as a primary endpoint for glycemic-control trials is 
discussed along with recommendations for trial design and conduct to 
allow for adequate data interpretation. The draft guidance also 
provides hypoglycemia definitions, trial design considerations for 
hypoglycemia efficacy endpoints, and hypoglycemia measurement methods. 
Additional efficacy endpoints are also briefly considered.
    This draft guidance replaces, in part, the draft guidance for 
industry ``Diabetes Mellitus: Developing Drugs and Therapeutic 
Biologics for Treatment and Prevention'' (73 FR 11420) published in 
February 2008 and withdrawn in 2020. In March 2020, FDA withdrew the 
February 2008 draft guidance because its recommendations for safety 
assessment were outdated. At the same time, FDA issued the draft 
guidance for industry ``Type 2 Diabetes Mellitus: Evaluating the Safety 
of New Drugs for Improving Glycemic Control'' March 10, 2020 (85 FR 
13903) (available at https://www.fda.gov/media/135936/download). This 
draft guidance, when finalized, will provide FDA's current 
recommendations on this issue.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Diabetes 
Mellitus: Efficacy Endpoints for Clinical Trials Investigating 
Antidiabetic Drugs and Biological Products.'' 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

    While this draft guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this draft guidance. The previously approved

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collections of information are subject to review by OMB under the PRA. 
The collections of information in 21 CFR part 312 have been approved 
under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft 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: May 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11321 Filed 5-25-23; 8:45 am]
BILLING CODE 4164-01-P