Document ID: FDA-2018-N-3091-0003
Agency: fda
Document Type: Notice
Title: Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal
Posted Date: 2022-12-13T05:00Z

[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76197-76198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27014]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2022-N-3091]

Advisory Committee; Cardiovascular and Renal Drugs Advisory 
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Cardiovascular and Renal 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 
Cardiovascular and Renal 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 Cardiovascular and Renal 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: Joyce Yu, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, (301) 837-7126, 
[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 Cardiovascular and 
Renal 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 available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of cardiovascular and renal 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 cardiology, hypertension, arrhythmia, angina, congestive 
heart failure, diuresis, and biostatistics. 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

[[Page 76198]]

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 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/cardiovascular-and-renal-drugs-advisory-committee/cardiovascular-and-renal-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. 2022-27014 Filed 12-12-22; 8:45 am]
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