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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.

Title 21

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§ 14.95 Compensation of advisory committee members.

(a)

(1) Except as provided in paragraphs (a) (2) and (3) of this section, all voting advisory committee members shall, and nonvoting members may, be appointed as special Government employees and receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived.

(2) Members of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) are not appointed as special Government employees. Any member of TEPRSSC who is not a Federal employee or member of the uniformed services, including the Commissioned Corps of the Public Health Service, shall receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived.

(3) Voting and nonvoting advisory committee members who are members of the uniformed services, including the Commissioned Corps of the Public Health Service, provide service on Food and Drug Administration advisory committees as part of their assigned functions, are not appointed as special government employees, but are reimbursed by the Food and Drug Administration for travel expenses.

(b) Notwithstanding the member's primary residence, an advisory committee member, while attending meetings of the full committee or a subcommittee, will be paid whether the meetings are held in the Washington, DC, area or elsewhere.

(c) A committee member who participates in any agency-directed assignment will be paid at an hourly rate when doing assigned work at home, a place of business, or in an FDA facility located within the member's commuting area, and at a daily rate when required to travel outside of that commuting area to perform the assignment. A committee member will not be paid for time spent on normal preparation for a committee meeting.

(1) An agency-directed assignment is an assignment that meets the following criteria:

(i) An activity that requires undertaking a definitive study. The activity must produce a tangible end product, usually a written report. Examples are:

(a) An analysis of the risks and benefits of the use of a class of drugs or a report on a specific problem generated by an IND or NDA;

(b) The performance of similar investigations or analysis of complex industry submissions to support advisory committee deliberations other than normal meeting preparation;

(c) The preparation of a statistical analysis leading to an estimate of toxicologically safe dose levels; and

(d) The design or analysis of animal studies of toxicity, mutagenicity, teratogenicity, or carcinogenicity.

(ii) The performance of an IND or NDA review or similar review.

(2) A committee member who undertakes a special assignment, the end product of which does not represent the end product of the advisory committee, but rather of the committee member's own assignment, can be compensated. Should this preparatory work by members collectively result in an end product of the committee, this is to be considered normal meeting preparation and committee members are not to be compensated for this work.

(d) Salary while in travel status is authorized when a committee member's ordinary pursuits are interrupted for the substantial portion of an additional day beyond the day or days spent in performing those services, and as a consequence the committee member loses some regular compensation. This applies on weekends and holidays if the special Government employee loses income that would otherwise be earned on that day. For travel purposes, a substantial portion of a day is defined as 50 percent of the working day, and the traveler will be paid at a daily rate.

[44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988]