[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR861.30]

[Page 187-188]
 
                        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. 861.30  Development of standards.

    The Food and Drug Administration (FDA), while engaged in the 
development of a proposed standard under this section will:
    (a) Support its proposed performance standard by such test data or 
other documents or materials as may reasonably be required;
    (b) Provide interested persons an opportunity to participate in the 
development of the standard by accepting comments and, where 
appropriate, holding public meetings on issues relating to development 
of the standard.

[[Page 188]]

Notice of the opportunity to participate in the development of the 
standard will be furnished in a manner reasonably calculated to reach 
the majority of persons interested in the development of the standard. 
This requirement shall be satisfied by publishing such a notice in the 
Federal Register. Whenever it is appropriate, FDA will use the Federal 
Register to make announcements about the standard development process of 
standard developers other than Federal agencies.
    (c) Maintain records disclosing the course of development of the 
proposed standard, the comments and other information submitted by a 
person in connection with such development (including comments and 
information regarding the need for a standard), and such other 
information as may be required to evaluate the standard.

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