[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: 21CFR19.10]

[Page 186]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 19_STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  19.10  Food and Drug Administration Conflict of Interest Review Board.

    (a) The Commissioner shall establish a permanent five-member 
Conflict of Interest Review Board, which shall review and make 
recommendations to the Commissioner on all specific or policy matters 
relating to conflicts of interest arising within the Food and Drug 
Administration that are forwarded to it by: (1) The Associate 
Commissioner for Management and Operations or (2) anyone who is the 
subject of an adverse determination by the Associate Commissioner for 
Management and Operations on any matter arising under the conflict of 
interest laws, except a determination of an apparent violation of law. 
The Director, Division of Ethics and Program Integrity, Office of 
Management and Operations, shall serve as executive secretary of the 
Review Board.
    (b) It shall be the responsibility of every Food and Drug 
Administration employee with whom any specific or policy issue relating 
to conflicts of interest is raised, or who otherwise wishes to have any 
such matter resolved, to forward the matter to the Associate 
Commissioner for Management and Operations for resolution, except that 
reporting of apparent violations of law are governed by Sec.  19.21.
    (c) All general policy relating to conflicts of interest shall be 
established in guidance documents pursuant to the provisions of Sec.  
10.90(b) of this chapter and whenever feasible shall be incorporated in 
regulations in this subpart.
    (d) All decisions relating to specific individuals shall be placed 
in a public file established for this purpose by the Freedom of 
Information Staff, e.g., a determination that a consultant may serve on 
an advisory committee with specific limitations or with public 
disclosure of stock holdings, except that such determination shall be 
written in a way that does not identify the individual in the following 
situations:
    (1) A determination that an employee must dispose of prohibited 
financial interests or refrain from incompatible outside activities in 
accordance with established Department or agency regulations.
    (2) A determination that a proposed consultant is not eligible for 
employment by the agency.
    (3) A determination that public disclosure of any information would 
constitute an unwarranted invasion of personal privacy in violation of 
Sec.  20.63 of this chapter.

[42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985; 55 FR 1404, Jan. 16, 1990; 65 FR 56479, Sept. 
19, 2000]