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 Oncologic 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 data concerning the safety
and effectiveness of marketed and investigational human drug
products for use in the treatment of cancer and makes
appropriate recommendations to the Commissioner of Food and
Drugs.
Structure
The
Committee shall consist of a core of 13 voting members
including the Chair. Members
and the Chair are selected by the Commissioner or designee
from among authorities knowledgeable
in the fields of general oncology, pediatric oncology,
hematologic oncology, immunologic oncology, biostatistics,
and other related professions.
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.
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 ยง 14.22(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 $210,666.65
The estimated personyears of staff support required
is 1.45, at an estimated annual cost of $108,217.98
Reports
n 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
Oncologic Drugs Advisory Committee will terminate on
September 1, 2010.
Approved:
Date:
8/28/2006 |
Randall Lutter, Ph.D.
Associate Commissioner
for Policy and Planning, FDA |
NOTICE OF RENEWAL OF THE
ONCOLOGIC DRUGS ADVISORY COMMITTEE
I determine that renewal of the Oncologic Drugs
Advisory Committee beyond September 1, 2006, is in the public
interest in connection with the performance of duties imposed
on the Food and Drug Administration by law, and that such
duties can best be performed through the advice and counsel of
such a group. Therefore, the Committee is continued until
September 1, 2010.
I deem that it is not feasible for the Food and Drug
Administration or any of its existing committees to perform
these duties, and that a satisfactory plan for appropriate
balance of the Committee membership exists.
|
|
Date 8/29/2006 |
Randall Lutter, Ph.D.
Associate Commissioner for Policy and Planning, FDA |
Last Updated: August 8, 2008
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