Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal, 76492-76493 [2022-27022]

Download as PDF 76492 Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Notices hearing and waived any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. David J. Kempema has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Mr. Kempema is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Kempema is a prohibited act. Any application by Mr. Kempema for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2022– N–0521 and sent to the Dockets Management Staff (see ADDRESSES). The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. Dated: December 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ‘‘Targeted Mechanism of Action Presentations in Prescription Drug Promotion’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On October 14, 2022, the Agency submitted a proposed collection of information entitled ‘‘Targeted Mechanism of Action Presentations in Prescription Drug Promotion’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0908. The approval expires on November 30, 2025. A copy of the supporting statement for this information collection is available on the internet at https:// www.reginfo.gov/public/do/PRAMain. SUMMARY: Dated: December 9, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27140 Filed 12–13–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2969] [FR Doc. 2022–27091 Filed 12–13–22; 8:45 am] Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration ACTION: Food and Drug Administration, HHS. Notice; renewal of Federal advisory committee. [Docket No. FDA–2021–N–1050] The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Targeted Mechanism of Action Presentations in Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:11 Dec 13, 2022 Jkt 259001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 new charter will be in effect until the August 27, 2024, expiration date. DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory Committee will expire on August 27, 2024, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–2855, EMDAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders and makes appropriate recommendations to the Commissioner. The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this committee will serve as Special Government Employees, representatives, or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumeroriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry E:\FR\FM\14DEN1.SGM 14DEN1 Federal Register / Vol. 87, No. 239 / Wednesday, December 14, 2022 / Notices interests. There may also be an alternate industry representative. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/advisory-committees/ endocrinologic-and-metabolic-drugsadvisory-committee/endocrinologicand-metabolic-drugs-advisorycommittee-charter or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. Scientific Review, National Institute of General Medical Sciences, National Institutes Health, 45 Center Drive, Room 3AN12C, Bethesda, MD 20892, 301–594–2763, seetharams@nigms.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: December 8, 2022. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–27068 Filed 12–13–22; 8:45 am] National Center for Advancing Translational Sciences; Notice of Closed Meeting lotter on DSK11XQN23PROD with NOTICES1 Name of Committee: National Institute of General Medical Sciences, Special Emphasis Panel; Review of Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA– CTR) (U54) Applications. Date: March 22, 2023. Time: 10:00 a.m. to 5:30 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, MD 20892 (Virtual Meeting). Contact Person: Saraswathy Seetharam, Ph.D., Scientific Review Officer, Office VerDate Sep<11>2014 17:11 Dec 13, 2022 Jkt 259001 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting Name of Committee: National Diabetes and Digestive and Kidney Diseases Advisory Council. Date: January 25, 2023. Open: 8:30 a.m. to 2:30 p.m. Agenda: To present the Director’s Report and other scientific presentations. Place: National Institutes of Health, Building 31, C-Wing 6th Floor Conference Center, Conference Rooms A, B, F, and G, 31 Center Drive, Bethesda, MD 20892. Closed: 2:30 p.m. to 4:30 p.m. Agenda: Grant applications. Place: National Institutes of Health, Building 31, C-Wing 6th Floor Conference Center, Conference Rooms A, B, F, and G, 31 Center Drive, Bethesda, MD 20892. Contact Person: Karl F. Malik, Ph.D., Director, Division of Extramural Activities, National Institutes of Diabetes and Digestive and Kidney Diseases, 6707 Democracy Boulevard, Room 7329, MSC 5452, Bethesda, National Institutes of Health BILLING CODE 4164–01–P Pursuant to section 10(d) 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. [FR Doc. 2022–27049 Filed 12–13–22; 8:45 am] Name of Committee: National Center for Advancing Translational Sciences, Special Emphasis Panel; CTSA Collaborative and Innovative Acceleration Awards. Date: January 18, 2023. Time: 1:00 p.m. to 5:30 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1037, Bethesda, MD 20982 (Virtual Meeting). Contact Person: M. Lourdes Ponce, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1037, Bethesda, MD 20982, 301–435–0810, lourdes.ponce@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry [FR Doc. 2022–27022 Filed 12–13–22; 8:45 am] National Institute of General Medical Sciences; Notice of Closed Meeting Dated: December 8, 2022. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. Pursuant to section 10(d) 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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. BILLING CODE 4140–01–P Dated: December 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES 76493 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76492-76493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2969]


Advisory Committee; Endocrinologic and Metabolic Drugs Advisory 
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by 
the Commissioner of Food and Drugs (the Commissioner). The Commissioner 
has determined that it is in the public interest to renew the 
Endocrinologic and Metabolic Drugs Advisory Committee for an additional 
2 years beyond the charter expiration date. The new charter will be in 
effect until the August 27, 2024, expiration date.

DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory 
Committee will expire on August 27, 2024, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services and by the General Services 
Administration, FDA is announcing the renewal of the Endocrinologic and 
Metabolic Drugs Advisory Committee (the Committee). The Committee is a 
discretionary Federal advisory committee established to provide advice 
to the Commissioner. The Committee advises the Commissioner or designee 
in discharging responsibilities as they relate to helping to ensure 
safe and effective drugs for human use and, as required, any other 
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of endocrine and metabolic disorders and makes 
appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of endocrinology, metabolism, epidemiology or statistics, and 
related specialties. Members will be invited to serve for overlapping 
terms of up to 4 years. Non-Federal members of this committee will 
serve as Special Government Employees, representatives, or Ex-Officio 
members. Federal members will serve as Regular Government Employees or 
Ex-Officios. The core of voting members may include one technically 
qualified member, selected by the Commissioner or designee, who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the Committee may include 
one non-voting representative member who is identified with industry

[[Page 76493]]

interests. There may also be an alternate industry representative.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-charter or by contacting the 
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In 
light of the fact that no change has been made to the committee name or 
description of duties, no amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27022 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P
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