[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.29]

[Page 39]
 
                        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 B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.29  Functions pertaining to safer vaccines.

    The Director, Center for Biologics Evaluation and Research (CBER), 
and the Associate Director for Policy Coordination and Public Affairs, 
CBER, are authorized to perform the functions of the Commissioner of 
Food and Drugs under part C, subtitle 2 of title XXI of the Public 
Health Service 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:
    (a) Section 2125 of the Public Health Service Act (42 U.S.C. 300aa-
25)--Recording and reporting of information.
    (b) Section 2127 of the Public Health Service Act (42 U.S.C. 300aa-
27)--Mandate for safer childhood vaccines.
    (c) Section 2128 of the Public Health Service Act (42 U.S.C. 300aa-
28)--Manufacturer recordkeeping and reporting.
    (d) Section 312 of the National Childhood Vaccine Injury Act of 
1986--Related studies, 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 312(d) of the 
National Childhood Vaccine Injury Act of 1986 is not redelegated by the 
Commissioner.
    (e) Section 313 of the National Childhood Vaccine Injury Act of 
1986--Study of other vaccine risks, except that the authority to provide 
for notice and opportunity for public hearing on the establishment of 
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.
    (f) Section 314 of the National Childhood Vaccine Injury Act of 
1986--Review of warnings, use instructions, and precautionary 
information.

[58 FR 17106, Apr. 1, 1993]