[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR19.21]

[Page 195]
 
                        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 B--Reporting of Violations
 
Sec. 19.21  Duty to report violations.


    (a) The Office of Internal Affairs, Office of the Commissioner, is 
responsible for obtaining factual information for the Food and Drug 
Administration on any matter relating to allegations of misconduct, 
impropriety, conflict of interest, or other violations of Federal 
statutes by agency personnel.
    (b) Any Food and Drug Administration employee who has factual 
information showing or who otherwise believes that any present or former 
Food and Drug Administration employee has violated or is violating any 
provision of this subpart or of 45 CFR parts 73 or 73a or of any statute 
listed in appendix A to 45 CFR part 73 should report such information 
directly to the Office of Internal Affairs. Any such reports shall be in 
writing or shall with the assistance of the Office of Internal Affairs, 
be reduced to writing, and shall be promptly investigated.
    (c) Any report pursuant to paragraph (b) of this section and any 
records relating to an investigation of such reports shall be maintained 
in strict confidence in the files of the Office of Internal Affairs, 
shall be exempt from public disclosure, and may be reviewed only by 
authorized Food and Drug Administration employees who are required to do 
so in the performance of their duties.

[42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 
FR 52278, Dec. 23, 1985; 60 FR 47478, Sept. 13, 1995]