National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting, 64446-64447 [2023-20245]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 64446 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices Biological Products’’ issued on December 20, 2019 (84 FR 70196) and the 1998 guidance entitled ‘‘Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products’’ issued on May 15, 1998 (63 FR 27093). In 1962, Congress required for the first time that new drugs be shown to be effective as well as safe. A new drug’s effectiveness must be established by substantial evidence. FDA has interpreted this substantial evidence requirement as generally requiring two adequate and well-controlled clinical investigations, each convincing on its own, to establish effectiveness. In 1997, Congress amended section 505(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(d)) to make clear that FDA may consider data from one adequate and well-controlled investigation and confirmatory evidence to constitute substantial evidence if FDA determines that such data are sufficient to establish effectiveness. FDA issued the 1998 Effectiveness guidance in response to this legislative change. In 2019, the Agency concluded that more guidance was needed on the flexibility in the amount and type of evidence needed to meet the substantial evidence standard and issued the 2019 Effectiveness draft guidance, which discussed a number of approaches that can yield evidence that meets the statutory standard for substantial evidence. Although both the 1998 Effectiveness guidance and the 2019 Effectiveness draft guidance provide examples of how a single adequate and well-controlled clinical investigation and confirmatory evidence can be used to support a marketing application, these guidances are not intended to provide a comprehensive discussion of meeting the substantial evidence standard based on one adequate and well-controlled clinical investigation and confirmatory evidence. Thus, there is a need for more Agency guidance to describe how one adequate and well-controlled clinical investigation and confirmatory evidence can be used to meet the substantial evidence requirement. When one adequate and wellcontrolled clinical investigation and confirmatory evidence are considered together to assess effectiveness, the quality and quantity of the confirmatory evidence are also important considerations. Confirmatory evidence should be evidence generated from quality data derived from an appropriate source. The quantity of confirmatory evidence needed in a development program will be impacted by the features of, and results from, the single adequate and well-controlled clinical VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 investigation that the confirmatory evidence is intended to substantiate. This draft guidance describes these considerations in greater detail. It also provides examples of the types of evidence that could be considered confirmatory evidence that can be used with one adequate and well-controlled clinical investigation to demonstrate substantial evidence of effectiveness. Finally, the draft guidance includes recommendations for early engagement with the Agency for sponsors who intend to establish substantial evidence of effectiveness with one adequate and well-controlled clinical investigation and confirmatory evidence. 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 ‘‘Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence.’’ 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. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in 21 CFR parts 58, 312, 314, and 601 have been approved under OMB control numbers 0910–0119, 0910–0014, 0910–0001, and 0910–0338, respectively. In addition, the collections of information pertaining to FDA’s guidance entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products’’ have been approved under OMB control number 0910–0001. III. Electronic Access Frm 00046 Fmt 4703 [FR Doc. 2023–20228 Filed 9–18–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel; Interorgan signal. Date: October 19–20, 2023. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nijaguna Prasad, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institutes of Health, National Institute on Aging, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, (301) 496–9667, prasadnb@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: September 14, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–20239 Filed 9–18–23; 8:45 am] BILLING CODE 4140–01–P 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/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. PO 00000 Dated: September 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Digestive Diseases E:\FR\FM\19SEN1.SGM 19SEN1 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices and Nutrition C Study Section, October 11, 2023, 05:30 p.m. to October 13, 2023, 05:00 p.m., National Institutes of Health, NIDDK, Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892 which was published in the Federal Register on September 07, 2023, 61605. The meeting notice is amended to change the start date of the meeting from 10/11–13/2023 to 11/1–3/2023. The meeting is closed to the public. Dated: September 14, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–20245 Filed 9–18–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: September 14, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings [FR Doc. 2023–20248 Filed 9–18–23; 8:45 am] ddrumheller on DSK120RN23PROD with NOTICES1 Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Environmental Health Sciences Review Committee. Date: October 4–5, 2023. Time: 10:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Science, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Varsha Shukla, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Science, Keystone Building, 530 Davis Drive, Room 3094, Durham, NC 27713, 984– 287–3288, Varsha.shukla@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Environmental Health Sciences Review Committee. Date: October 25–26, 2023. Time: 11:00 a.m. to 6:00 p.m. VerDate Sep<11>2014 18:21 Sep 18, 2023 Jkt 259001 Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Science, Keystone Building, 530 Davis Drive, Durham, NC 27709 (Virtual Meeting). Contact Person: Varsha Shukla, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Science, Keystone Building, 530 Davis Drive, Room 3094, Durham, NC 27713, 984– 287–3288, Varsha.shukla@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Initial Review Group; Training and Workforce Development Study Section—D. Date: October 12, 2023. Time: 9:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute of General Medical Sciences, Natcher Building, 45 Center Drive, Bethesda, Maryland 20892 (Virtual Meeting). Contact Person: Marc Rigas, Ph.D., Scientific Review Officer, Office of Scientific PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 64447 Review, National Institutes of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN18C, Bethesda, Maryland 20892, 301–827–0648, marc.rigas@nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: September 14, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–20244 Filed 9–18–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Clinical and Basic Science Study Section. Date: October 19–20, 2023. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW, Washington, DC 20015 (Hybrid Meeting). Contact Person: Rajiv Kumar, Ph.D., Chief, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6705 Rockledge Drive, Bethesda, MD 20892, (301) 827–4612, rajiv.kumar@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 13, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–20157 Filed 9–18–23; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64446-64447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20245]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases; 
Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Digestive 
Diseases

[[Page 64447]]

and Nutrition C Study Section, October 11, 2023, 05:30 p.m. to October 
13, 2023, 05:00 p.m., National Institutes of Health, NIDDK, Democracy 
II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892 which was 
published in the Federal Register on September 07, 2023, 61605.
    The meeting notice is amended to change the start date of the 
meeting from 10/11-13/2023 to 11/1-3/2023. The meeting is closed to the 
public.

    Dated: September 14, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-20245 Filed 9-18-23; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.