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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 Best
Pharmaceuticals for Children Act, the Pediatric Research Equity Act of 2003,
the Fair Packaging and Labeling Act, and various provisions of the Public Health
Service Act. The Pediatric Advisory Committee advises and makes recommendations
to the Commissioner of Food and Drugs on matters relating to pediatric therapeutics,
pediatric research, and any other matter involving pediatrics for which the
Food and Drug Administration has regulatory responsibility. The Committee also
advises and makes recommendations to the Secretary pursuant to 45 CFR 46.407
on research involving children as subjects that is conducted or supported by
the Department of Health and Human Services.
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, 284m, 289, 290b;
Public Law 107-109, Best Pharmaceuticals for Children Act; Public Law 108-155,
Pediatric Research Equity Act of 2003; 21 CFR Part 14, 330.10(a); 21 CFR 50.54;
45 CFR 46.407; 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 advises and makes recommendations to the Commissioner of Food
and Drugs regarding (1) pediatric research conducted under sections 351, 409I,
and 499 of the Public Health Service Act and sections 501, 502, 505, 505A, and
505B of the Federal Food, Drug, and Cosmetic Act; (2) identification of research
priorities related to pediatric therapeutics and the need for additional treatments
of specific pediatric diseases or conditions, (3) the ethics, design, and analysis
of clinical trials related to pediatric therapeutics, (4) pediatric labeling
disputes as specified in section 3 of the Best Pharmaceuticals for Children
Act (Public Law 107-109), (5) pediatric labeling changes as specified in section
5 of the Best Pharmaceuticals for Children Act (Public Law 107-109), (6) adverse
event reports for drugs granted pediatric exclusivity and any safety issues
that may occur as specified in section 17 of the Best Pharmaceuticals for Children
Act (Public Law 107-109), (7) any other pediatric issue or pediatric labeling
dispute involving FDA regulated products, (8) research involving children as
subjects as specified in 21 CFR 50.54, and (9) any other matter involving pediatrics
for which FDA has regulatory responsibility.
The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by the Department of Health and Human Services as specified in 45 CFR 46.407.
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 pediatric research, pediatric
subspecialties, statistics, and/or biomedical ethics. The core of voting members
shall also include one representative from a pediatric health organization and
one representative from a relevant patient or patient-family organization and
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 or designate consultants to serve temporarily as voting members (not to exceed 10 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, a quorum will be based on the combined total of voting 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 4-year terms. Terms of more than 2 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 Office of the Commissioner, Food and Drug Administration.
Meetings:
Meetings shall be held approximately three 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 § 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 $145,800.00.
The estimated personyears of staff support required is 1.2 at an estimated annual
cost of $106,189.00.
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 Pediatric Advisory Committee will terminate on June 18, 2006.
Approved
Date: June 18, 2004
Peter J. Pitts
Associate Commissioner
for External Relations, FDA
Structure:
The Committee shall consist of a core of 12 voting members including the Chair.
Members and the Chair are selected by the Commissioner or designee from among
authorities knowledgeable in pediatric research, pediatric subspecialties, statistics,
and/or biomedical ethics. The core of voting members shall also include one
member from a relevant patient or patient-family organization and 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 and one non-voting member who represents
a pediatric health organization.
The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees or designate consultants to serve temporarily as voting members (not to exceed 10 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, a quorum will be based on the combined total of voting 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 4-year terms. Terms of more than 2 years are contingent upon the renewal of the Committee by appropriate action prior to its expiration.
A permanent Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will be established to advise and make recommendations to the Pediatric Advisory Committee on pediatric ethical issues, as well as IRB referrals related to clinical investigations involving children as subjects as specified in 21 CFR 50.54, and IRB referrals that involve both FDA regulated products under 21 CFR 50.54 and research involving children as subjects that is conducted or supported by the Department of Health and Human Services as specified in 45 CFR 46.407. The subcommittee will consist of two or more members of the parent Pediatric Advisory Committee and additional experts (e.g. science, medicine, education, ethics and law) to address specific issues within their respective areas of expertise.
Temporary subcommittees consisting of two or more committee members may be established as needed to address specific issues within their respective areas of expertise. 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.
Subcommittees make preliminary recommendations regarding specific issues for subsequent action by the full Committee.
Management and support services shall be provided by the Office of the Commissioner, Food and Drug Administration.
Meetings:
Meetings shall be held approximately three 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 § 14.22(d)) authorize a committee charter to specify quorum requirements.
Meetings of the Subcommittee on Pediatric Research shall be held approximately twice 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 subcommittee meetings.
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.
Approved
Date: July 27, 2004
Lester M. Crawford, D.V.M, Ph.D
Acting Commissioner of Food and Drugs
[ Final Rule Announcing Establishment of the Pediatric Advisory Committee ]