[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1004.6]

[Page 590-591]
 
                        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

[[Page 591]]

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]