Purpose
The
Secretary and, by delegation, the Assistant Secretary for
the Office of Public Health and Science, and the
Commissioner of Food and Drugs are charged with the
administration of the Federal Food, Drug, and Cosmetic Act,
the Fair Packaging and Labeling Act, and various provisions
of the Public Health Service Act.
The Cardiovascular and Renal Drugs Advisory 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 the Food and Drug Administration has
regulatory responsibility.
Authority
15
USC 1451 et seq.; 21 USC 321, 341, 342, 343, 343-1, 344,
345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 360b,
360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42
USC 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14,
330.10(a); the Committee is governed by the provisions of
Public Law 92-463, as amended (5 USC App. 2), which sets
forth standards for the formation and use of advisory
committees.
Function
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.
Structure
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.
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.
The
Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve
temporarily as voting members and to designate consultants
to serve temporarily as voting members when: (1) expertise
is required that is not available among current voting
standing members of the Committee (when additional voting
members are added to the Committee to provide needed
expertise, a quorum will be based on the combined total of
regular and added members), or (2) to comprise a quorum
when, because of unforeseen circumstances, a quorum is or
will be lacking.
If
functioning as a medical device panel, a non-voting
representative of consumer interests and a non-voting
representative of industry interests will be included in
addition to the voting members.
Members
shall be invited to serve for overlapping four-year terms.
Terms of more than two years are contingent upon the
renewal of the Committee by appropriate action prior to its
expiration. A
member may serve after the expiration of the member's term
until a successor has taken office.
Temporary
subcommittees consisting of two or more committee members
may be established by the Commissioner or designee as needed to address specific issues
within their respective areas of expertise.
Subcommittees make preliminary recommendations
regarding specific issues for subsequent action by the full
Committee. The
Department Committee Management Officer shall be notified
upon establishment of each subcommittee, and shall be
provided information on its name, membership, function, and
estimated frequency of meetings.
Management
and support services shall be provided by the Center for
Drug Evaluation and Research, Food and Drug Administration.
Meetings
Meetings
shall be held approximately four times a year at the call of
the Chair with the advance approval of a Government
official, who shall also approve the agenda.
A Government official shall be present at all
meetings.
Because
of the size of the Committee and the variety in the types of
issues that it will consider, FDA may, in connection with a
particular committee meeting, specify a quorum that is less
than a majority of the current voting members.
The Agency's regulations (21 CFR ยง14.22(d))
authorize a committee charter to specify quorum
requirements.
Meetings
shall be open to the public except as determined otherwise
by the Commissioner or designee.
Notice of all meetings shall be given to the public.Meetings
shall be conducted and records of the proceedings kept as
required by applicable laws and Departmental regulations.
Compensation
Members
who are not full-time Federal employees shall be paid at the
rate of the General Schedule 15, step 10, per day for time
spent at meetings plus per diem and travel expenses in
accordance with Standard Government Travel Regulations.
Annual
Cost Estimate
The
estimated annual cost for operating the Committee, including
compensation and travel expenses for members but excluding
staff support, is $197,293.81.
The estimated personyears of staff support required
is 1.20, at an estimated annual cost of $141,061.44
Reports
In
the event that a portion of a meeting is closed to the
public, a report shall be prepared not later than November 1
of each year which contains as a minimum the function of the
Committee, a list of members and their business addresses,
the dates and places of meetings, and a summary of the
Committee's activities and recommendations during the
preceding year. A
copy of the report shall be provided to the Department
Committee Management Officer.
Termination
Date
Unless renewed by appropriate action prior to its
expiration, the Cardiovascular and Renal Drugs Advisory
Committee will terminate on August 27, 2010.
Approved:
Date:
8/17/2006 |
Randall Lutter, Ph.D.
Associate
Commissioner for
Policy and Planning, FDA |