[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.38]

[Page 194]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 861_PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of 
Contents
 
     Subpart B_Procedures for Performance Standards Development and 
                               Publication
 
Sec. 861.38  Standards advisory committees.

    (a) The Food and Drug Administration will establish advisory 
committees to which proposed regulations may be referred, and these 
committees shall consider such referrals in accordance with this section 
and part 14 of this chapter. Such advisory committees, which may not be 
classification panels, shall be considered ad hoc advisory committees. 
Their members shall be selected in accordance with Sec. Sec. 14.82 and 
14.84, except that no member may be a regular full-time FDA employee. 
Each advisory committee established under this section shall include as 
nonvoting members a representative of consumer interests and a 
representative of interests of the device manufacturing industry.
    (b) A proposed regulation to establish, amend, or revoke a 
performance standard shall be referred to an advisory committee for a 
report and recommendation with respect to any matter involved in the 
proposed regulation which requires the exercise of scientific judgment 
if:
    (1) The Food and Drug Administration determines that such referral 
is necessary or appropriate under the circumstances; or
    (2) Requested by an interested person, in the form of a citizen 
petition in accordance with Sec. 10.30 of this chapter, which is made 
within the period provided for comment on the proposed regulation and 
which demonstrates good cause for referral.
    (c) When a proposed regulation is referred to an advisory committee, 
the Food and Drug Administration will furnish the committee with the 
data and information upon which the proposed regulation is based. After 
independently reviewing the materials furnished by the Food and Drug 
Administration and any other available data and information, the 
advisory committee shall, within 60 days of the referral, submit a 
report and recommendation on the proposed regulation, together with all 
underlying data and information and a statement of the reason or basis 
for the recommendation. A copy of the report and recommendation will be 
publicly displayed in the office of the Division of Dockets Management, 
Food and Drug Administration.
    (d) Where appropriate, each proposed regulation establishing a 
standard published in the Federal Register will include a call for 
nominations to the advisory committee for that particular standard.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]

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