[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: 21CFR1004.6]

[Page 582]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1004--REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS--Table of Contents
 
Sec. 1004.6  Approval of plans.

    If, after review of any plan submitted pursuant to this subchapter, 
the Secretary determines that the action to be taken by the manufacturer 
will expeditiously and effectively fulfill the manufacturer's obligation 
under Sec. 1004.1 in a manner designed to encourage the public to 
respond to the proposal, the Secretary will send written notice of his 
approval of such plan to the manufacturer. Such approval may be 
conditioned upon such additional terms as the Secretary deems necessary 
to protect the public health and safety. Any person who contests denial 
of a plan shall have an opportunity for a regulatory hearing before the 
Food and Drug Administration pursuant to part 16 of this chapter.

[38 FR 28629, Oct. 15, 1973, as amended at 41 FR 48269, Nov. 2, 1976; 42 
FR 15676, Mar. 22, 1977]