[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: 21CFR19.21]
[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 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]
[[Page 187]]
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