Document ID: FDA-2018-N-3091-0002
Agency: fda
Document Type: Notice
Title: Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee;
Renewal
Posted Date: 2020-09-29T04:00Z

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61003-61004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21465]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3091]

Advisory Committee; Cardiovascular and Renal Drugs Advisory 
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of 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

[[Page 61004]]

expiration date. The new charter will be in effect until August 27, 
2022.

DATES: Authority for the Cardiovascular and Renal Drugs Advisory 
Committee will expire on August 27, 2022, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Joyce Yu, Division of Advisory 
Committee and Consultant Management, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-9001, email: 
CRDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 41 CFR 102-3, FDA is announcing the 
renewal of the Cardiovascular and Renal Drugs Advisory Committee 
(Committee). The Committee is a discretionary Federal advisory 
committee established to provide advice to 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 of Food and 
Drugs.
    Under its Charter, 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. Almost all non-Federal 
members of this committee serve as Special Government Employees. 
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 member who is identified with industry interests. There 
may also be 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 document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21465 Filed 9-28-20; 8:45 am]
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