Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products; Draft Guidance for Industry; Availability, 34164-34166 [2023-11321]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 34164 Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Notices 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-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, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by calling CBER at 1–800–835– 4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. VerDate Sep<11>2014 18:14 May 25, 2023 Jkt 259001 FOR FURTHER INFORMATION CONTACT: Scott N. Goldie, Center for Drug Evaluation and Research, Office of Biostatistics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993–0002, 301–796–2055, or Diane Maloney, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.’’ The guidance provides recommendations on adjusting for covariates in the analysis of randomized clinical trials. The guidance discusses the acceptability of covariate adjustment, recommendations for implementing adjusted analyses, prespecification, selection of covariates, change from baseline analyses, statistical inference, estimands, and various statistical models. The guidance includes comments on covariate adjusting using both linear and nonlinear models. This guidance finalizes the revised draft guidance issued on May 21, 2021 (86 FR 27627). Changes from the draft to the final guidance include changes to wording and organization and updated and clarified recommendations on computing standard errors, stratified randomization, estimands, treatment by covariate interactions, and additional methods. 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 ‘‘Adjusting for Covariates in Randomized Clinical Trials for 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 guidance contains no new 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 guidance. The previously approved collections of information are subject to review by PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 OMB under the PRA. The collections of information in 21 CFR 312 pertaining to the submissions of investigational new drug applications have been approved under OMB control number 0910–0014. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Dated: May 23, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–11263 Filed 5–25–23; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: 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. DATES: E:\FR\FM\26MYN1.SGM 26MYN1 Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Notices You may submit comments on any guidance at any time as follows: ADDRESSES: ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:14 May 25, 2023 Jkt 259001 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 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 34165 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 glycemiccontrol 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 E:\FR\FM\26MYN1.SGM 26MYN1 34166 Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Notices 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. DATES: III. Electronic Access Persons with access to the internet may obtain the draft 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. ADDRESSES: Dated: May 23, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–11321 Filed 5–25–23; 8:45 am] The meeting will be held on Wednesday, June 28 from approximately 12 p.m.–9 p.m. (ET) and Thursday, March 29 from approximately 12 p.m.–6 p.m. (ET). The meeting will be located at the Kimpton Hotel, Palomar Phoenix located at 2 East Jefferson Street, Phoenix, AZ 85004. To attend the meeting virtually, please visit www.hhs.gov/live. Ms. Caroline Talev, MPA, Senior Management Analyst, at PACHA@ hhs.gov or Caroline.Talev@hhs.gov. Additional information can be obtained by accessing the Council’s page on the HIV.gov site at www.hiv.gov/pacha. FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996 and is currently operating under the authority given in Executive Order 14048, dated September 30, 2021. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature. The Council consists of not more than 35 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, population health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. PACHA selections also include persons with lived HIV experience and racial/ethnic and sexual and gender minority persons disproportionately affected by HIV. Council members are appointed by the Secretary. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice of a hybrid meeting. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/ AIDS (PACHA or the Council) will convene the 77th full council meeting on Wednesday, June 28 and Thursday June 29, 2023. The meeting will convene in Phoenix, Arizona and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting inperson. Please email your name to PACHA@hhs.gov by close of business Tuesday, June 20, 2023 to pre-reigster. There will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@ hhs.gov and include your name, organization, and title by close of business June 20, 2023. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business July 12, 2023. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/ federal-response/pacha/about-pacha prior to the meeting. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:14 May 25, 2023 Jkt 259001 Dated: May 17, 2023. Caroline Talev, Senior Management Analyst, Office of Infectious Disease and HIV/AIDS Policy, Alternate Designated Federal Official, Presidential Advisory Council on HIV/AIDS, Office of the Assistant Secretary for Health, Department of Health and Human Services. [FR Doc. 2023–11250 Filed 5–25–23; 8:45 am] National Institutes of Health Office of the Secretary; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Interagency Pain Research Coordinating Committee. The meeting will be held as a virtual meeting and will be open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link: https://videocast.nih.gov/. Name of Committee: Interagency Pain Research Coordinating Committee (IPRCC). Date: June 23, 2023. Time: 11:00 a.m. to 12:30 p.m. Eastern Time (ET). Agenda: The meeting will cover committee business items and IPRCC member updates. Items discussed will include updates on the Helping to End Addiction Long-Term (HEAL) Initiative and the Federal Pain Research Strategy (FPRS) research progress, and an update from the Centers for Medicare and Medicaid Services (CMS). Deadline: Submission of intent to submit written/electronic statement for comments: Friday, June 16 by 5:00 p.m. ET. Place: National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Linda L. Porter, Ph.D., Director, Office of Pain Policy, and Planning, Office of the Director, National Institute of Neurological Disorders and Stroke, NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892. Phone: (301) 451–4460. Email: Linda.Porter@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. The meeting will be open to the public via NIH Videocast https://videocast.nih.gov/. Visit the IPRCC website for more information: https://iprcc.nih.gov. Agenda and any additional information for the meeting will be posted when available. Dated: May 22, 2023. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4150–43–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2023–11230 Filed 5–25–23; 8:45 am] BILLING CODE 4140–01–P Frm 00041 Fmt 4703 Sfmt 9990 E:\FR\FM\26MYN1.SGM 26MYN1

Agencies

[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]


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

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.

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

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.

[[Page 34165]]


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

[[Page 34166]]

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
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