[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: 21CFR861.30]

[Page 172-173]
 
                        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. 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

[[Page 173]]

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]