[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: 21CFR20.107]
[Page 214]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20 PUBLIC INFORMATION--Table of Contents
Subpart F Availability of Specific Categories of Records
Sec. 20.107 Food and Drug Administration manuals.
(a) Food and Drug Administration administrative staff manuals and
instructions that affect a member of the public are available for public
disclosure. An index of all such manuals is available by writing to the
Freedom of Information Staff (HFI-35), Food and Drug Administration, rm.
12A.16, 5600 Fishers Lane, Rockville, MD 20857, or by visiting the
Freedom of Information Public Reading Room, located in rm. 12A-30 at the
same address. The index and all manuals created by the agency on or
after November 1, 1996, will be made available through the Internet at
http://www.fda.gov.
(b) Manuals relating solely to internal personnel rules and
practices are not available for public disclosure except to the extent
that the Commissioner determines that they should be disclosed pursuant
to Sec. 20.82.
(c) All Food and Drug Administration action levels which are used to
determine when the agency will take regulatory action against a
violative product, limits of sensitivity and variability of analytical
methods which are used in determining whether a product violates the
law, and direct reference levels above which Food and Drug
Administration field offices may request legal action directly to the
office of the General Counsel, are available for public disclosure.
[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 46
FR 14340, Feb. 27, 1981; 68 FR 25287, May 12, 2003]
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