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 Pulmonary-Allergy 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 pulmonary disease and diseases with allergic and/or
immunologic mechanisms 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 pulmonary medicine, allergy, clinical
immunology, and epidemiology or statistics. 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 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 $108,317.85. The estimated personyears
of staff support required is 0.98, at an estimated annual cost
of $93,228.52.
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 Pulmonary-Allergy Drugs Advisory Committee
will terminate on May 30, 2010.
Approved:
|
|
Date
5/17/06 |
Randall Lutter, Ph.D.
Associate Commissioner for
Policy and Planning, FDA |
NOTICE OF RENEWAL OF THE
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
I determine that renewal of the Pulmonary-Allergy Drugs
Advisory Committee beyond May 30, 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 May
30, 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 has been submitted.
|
|
Date
5/19/2006 |
Randall Lutter, Ph.D.
Associate Commissioner for
Policy and Planning, FDA |
Last Updated: April 23, 2008
Back
to Top
Back
to Pulmonary-Allergy Drugs Advisory Committee Info
Back to Human Drug Advisory Committee
Information