[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.95]
[Page 153-154]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 14 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
Subpart E Members of Advisory Committees
Sec. 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
[[Page 154]]
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]
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