[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.200]

[Page 52-53]
 
                        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 D--Biologics; Redelegations of Authority
 
Sec. 5.200  Functions pertaining to safer vaccines.


    (a) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER) are authorized to perform the functions 
of the Commissioner of Food and Drugs (Commissioner) under part C, 
subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25 et seq.), as 
amended, and the National Childhood Vaccine Injury Act of 1986 (42 
U.S.C. 300aa-1 note), as amended hereafter, as follows:
    (1) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)-Recording and 
reporting of information.
    (2) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)-Mandate for 
safer childhood vaccines.
    (3) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)-Manufacturer 
recordkeeping and reporting.
    (4) Section 312 of the National Childhood Vaccine Injury Act of 
1986-Related studies (42 U.S.C. 300aa-1 note), except that the authority 
to provide for notice and opportunity for public hearing on the review 
of vaccines and related illnesses and conditions under sections 312(a) 
and (d) of the National Childhood Vaccine Injury Act of 1986 is not 
redelegated by the Commissioner.
    (5) Section 313 of the National Childhood Vaccine Injury Act of 
1986-Study of other vaccine risks (42 U.S.C. 300aa-1 note), except that 
the authority to provide for notice and opportunity for public hearing 
on the establishment of

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guidelines regarding the risks to children of certain vaccines under 
section 313(a)(1)(B) and (b) of the National Childhood Vaccine Injury 
Act of 1986 is not redelegated by the Commissioner.
    (6) Section 314 of the National Childhood Vaccine Injury Act of 
1986-Review of warnings, use instructions, and precautionary information 
(42 U.S.C. 300aa-1 note).
    (b) These officials may not further redelegate these authorities.