[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.11]

[Page 52]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart A_Delegations of Authority to the Commissioner of Food and Drugs
 
Sec. 5.11   Reservation of authority.

    (a) Notwithstanding provisions of Sec. 5.10 or any previous 
delegations of authority to the contrary, the Secretary of Health and 
Human Services (Secretary) reserves the authority to approve regulations 
of the Food and Drug Administration, except regulations to which 
sections 556 and 557 of title 5 U.S.C. apply, which:
    (1) Establish procedural rules applicable to a general class of 
foods, drugs, cosmetics, medical devices, or other subjects of 
regulation; or
    (2) Present highly significant public issues involving the quality, 
availability, marketability, or cost of one or more foods, drugs, 
cosmetics, medical devices, or other subjects of regulation.
    (b) Nothing in this section precludes the Secretary from approving a 
regulation, or being notified in advance of an action, to which sections 
556 and 557 of title 5 U.S.C. apply, which meets one of the criteria in 
paragraph (a) of this section.
    (c) This reservation of authority is intended only to improve the 
internal management of the Department of Health and Human Services, and 
it is not intended to create any right or benefit, substantive or 
procedural, enforceable at law by a party against the United States, the 
Department of Health and Human Services, the Food and Drug 
Administration, any agency, officer, or employee of the United States, 
or any person. Regulations issued by the Food and Drug Administration 
without the approval of the Secretary are to be conclusively viewed as 
falling outside the scope of this reservation of authority.