[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.5]

[Page 175-176]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 16.5  Inapplicability and limited applicability.

    (a) This part does not apply to the following:
    (1) Informal presentation of views before reporting a criminal 
violation under section 305 of the act and section 5 of the Federal 
Import Milk Act and Sec. 1210.31.
    (2) A hearing on a refusal of admission of a food, drug, device, or 
cosmetic under section 801(a) of the act and Sec. 1.94, or of an 
electronic product under section 360(a) of the Public Health Service Act 
and Sec. 1005.20.
    (3) Factory inspections, recalls (except mandatory recalls of 
medical devices intended for human use), regulatory letters, and similar 
compliance activities related to law enforcement.
    (b) If a regulation provides a person with an opportunity for 
hearing and specifies some procedures for the hearing but not a 
comprehensive set of procedures, the procedures in this part apply to 
the extent that they are supplementary and not in conflict with the 
other procedures specified for the hearing. Thus, the procedures in 
subpart A of part 108 relating to emergency permit control are 
supplemented by the nonconflicting procedures in this part, e.g., the 
right to counsel, public notice of the hearing, reconsideration and 
stay, and judicial review.

[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992]

    Effective Date Note: At 65 FR 76110, Dec. 5, 2000, Sec. 16.5 was 
amended by adding paragraph (a)(4), effective Sept. 4, 2001. For the 
convenience of the user, the added text is set forth as follows:

[[Page 176]]

Sec. 16.5  Inapplicability and limited applicability.

    (a) * * *
    (4) A hearing on an order for relabeling, diversion, or destruction 
of shell eggs under section 361 of the Public Health Service Act (42 
U.S.C. 264) and Secs. 101.17(h) and 115.50 of this chapter.

                                * * * * *