Authority

The Pediatric Advisory Committee was established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 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 U.S.C. 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; Public Law 110-85, the Food and Drug Administration Amendments Act of 2007; Public Law 112-144, the Food and Drug Administration Safety and Innovation Act of 2012; 21 CFR Part 14, 330.10(a); Pub. L. 92-463 (5 U.S.C. App.), the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees.

Objectives and Scope of Activities

The Pediatric Advisory Committee advises and makes recommendations to the Commissioner or designee in discharging responsibilities as they relate to matters in pediatric therapeutics (including drugs and biological products) and medical devices, pediatric research, pediatric ethical issues and other matters 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.

Description of Duties

The Committee reviews and evaluates 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, 510K, 515, and 520m of the Federal Food, Drug, and Cosmetic Act; (2) identification of research priorities related to pediatric therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments of specific pediatric diseases or conditions, (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices, (4) pediatric labeling disputes as specified in Public Law 107-109, Public Law 110-85, and Public Law 112-144, (5) pediatric labeling changes as specified in Public Law 107-109, Public Law 110-85, and Public Law 112-144, (6) adverse event reports for drugs studied under Public Law 107-109, 110-85 and labeled, and Public Law 112-144, (7) any safety issues that may occur as specified Public Law 107-109, Public Law 110-85, and Public Law 112-144, (8) any other pediatric issue or pediatric labeling dispute involving FDA-regulated products, (9) pediatric ethical issues including research involving children as subjects as specified in 21 CFR 50.54, and (10) 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.

Agency or Official to Whom the Committee Reports

The Committee provides advice to the Commissioner of Food and Drugs.

Support

Management and support services shall be provided by the Office of Commissioner.

Estimated Annual Operating Costs and Staff Years

The estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $326,349.00. The estimated person years of staff support required is 3.5, at an estimated annual cost of $443,613.00.

Designated Federal Officer

FDA will select a fulltime or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration Manual directives. The DFO will approve and prepare all meeting agendas, call all of the Committee and subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest and chair meetings when directed to do so by the official to whom the Committee reports. The DFO shall be present at all meetings of the full committee and subcommittees.

Estimated Number and Frequency of Meetings

Meetings shall be held approximately four times a year. Meetings should be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C.552(c)) and the Federal Advisory Committee Act. Notice of all meetings shall be given to the public. A report will be prepared which will contain, as a minimum, a list of members and their business addresses, the Committee’s functions, the dates and places of meetings, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of this report will be provided to the Department Committee Management Officer.

Duration

Continuing

Termination

As provided in section 14(d) of the Best Pharmaceuticals for Children Act as amended by section 507 of the Food and Drug Administration Safety and Innovation Act of 2012, Pub. L. 112-144, notwithstanding section 14 of the Federal Advisory Committee Act, the Pediatric Advisory Committee will continue to operate to carry out the advisory committee’s responsibilities under sections 505A, 505B, and 520(m) of the Federal Food, Drug, and Cosmetic Act.

Membership and Designation

The Committee shall consist of a core of 14 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include 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 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 (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. 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.

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.

Subcommittee

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 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.

Recordkeeping

The records of the Committee, established subcommittees, or other subgroups of the committee, shall be handled in accordance with General Records Schedule 26, Item 2 or other approved agency records disposition schedule. The records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.

Filing Date

September 27, 2012

Approved:

Jill Hartzler Warner, J.D.
 

Associate Commissioner for Special Medical Programs (Acting)