Charter Amendment: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Authority

The Advisory Committee for Pharmaceutical Science and Clinical Pharmacology 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; 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 Advisory Committee for Pharmaceutical Science and Clinical Pharmacology 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.

Description of Duties

The Committee reviews and evaluates scientific, clinical and technical issues related to the safety and effectiveness of drug products for use in the treatment of a broad spectrum of human diseases, the quality characteristics which such drugs purport or are represented to have, and as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. The Committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA’s drug regulatory responsibilities and its critical path initiatives related to improving the efficacy and safety of drugs and improving the efficiency of drug development.

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 Center for Drug Evaluation and Research, Food and Drug Administration.

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 $204,003. The estimated person years of staff support required is 1.10, at an estimated annual cost of $100,443.

Designated Federal Officer

FDA will select a full-time 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 shall 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. 552b(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

Unless renewed by appropriate action prior to its expiration, the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will terminate two years from the date it is filed.

Membership and Designation

The Committee shall consist of a core of 26 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of pharmaceutical sciences (pharmaceutical manufacturing, bioequivalence research, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, molecular biology, immunology, microbiology) and clinical pharmacology (dose-response, pharmacokinetics-pharmacodynamics, modeling and simulation, pharmacogenomics, clinical trial design, pediatrics and special populations and innovative methods in drug development), biostatistics, related biomedical and pharmacological specialties, current good manufacturing practices, and quality systems implementation. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include two technically qualified members, selected by the Commissioner or designee, who are identified with consumer interests and are recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include up to four non-voting members who are 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.

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

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

January 22, 2012

Approved:

Date: 12/15/11                    Jill Hartzler Warner, J.D.
                                           Associate Commissioner for Special
                                           Medical Programs (Acting), FDA