[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.24]

[Page 172]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 861--PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT--Table of Contents
 
    Subpart B--Procedures for Performance Standards Development and 
                               Publication
 
Sec. 861.24  Existing standard as a proposed standard.

    (a) The Food and Drug Administration may accept an existing standard 
or a proposed or draft standard if it includes:
    (1) A description of the procedures used to develop the standard and 
a list of the persons and organizations that participated in its 
development, to the extent that such information is available or 
reasonably obtainable;
    (2) An identification of the specific portions of the existing 
standard that the person submitting the standard believes are 
appropriate for adoption as, or inclusion in, the proposed standard; and
    (3) A summary of the test data, or, if requested by the Food and 
Drug Administration, all such data or other information supporting the 
specific portions of the standard identified by the person submitting 
the standard.
    (b) The Food and Drug Administration will publish a notice in the 
Federal Register stating either that it has accepted, or accepted with 
modification, as a proposed standard, an existing standard or one that 
has been developed, or that an existing standard is not acceptable, 
together with the reasons therefor.

[45 FR 7484, Feb. 1, 1980, as amended at 57 FR 58405, Dec. 10, 1992]