I 
109TH CONGRESS 
1ST SESSION H. R. 4396 
To establish the National Vaccine Authority within the Department of Health 
and Human Services. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 18, 2005 
Mr. CROWLEY (for himself and Mr. GENE GREEN of Texas) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To establish the National Vaccine Authority within the 
Department of Health and Human Services. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National Vaccine Au-
thority Act’’. 
SEC. 2. NATIONAL VACCINE AUTHORITY. 
Title XVII of the Public Health Service Act (42 
U.S.C. 300u et seq.) is amended by adding at the end 
the following section:
‘‘NATIONAL VACCINE AUTHORITY 
‘‘SEC. 1711. (a) IN GENERAL.—There is established 
within the Department of Health and Human Services an 
administrative unit to be known as the National Vaccine 
Authority. There shall be in such Department the position 
of Assistant Secretary for Vaccines. The Assistant Sec-
retary shall be the head of the National Vaccine Authority, 
and shall be appointed by and shall report to the Sec-
retary. The Secretary shall carry out this section acting 
through the Assistant Secretary. 
‘‘(b) FEDERAL AND PRIVATE VACCINE CONTRACTS; 
QUANTITIES; LOCATIONS.— 
‘‘(1) IN GENERAL.—The Assistant Secretary for 
Vaccines (in this section referred to as the ‘Assistant 
Secretary’) shall ensure that the National Vaccine 
Authority serves as the central clearinghouse for the 
Department of Health and Human Services with re-
spect to Federal and private contracts for the pur-
chase or distribution of vaccines. The Assistant Sec-
retary shall monitor the supply and distribution of 
vaccines under such contracts, including ongoing 
monitoring of the location of vaccines under the con-
tracts.
‘‘(2) AUTHORITY FOR FEDERAL CONTRACTS.— 
The Assistant Secretary shall enter into contracts to 
increase production of vaccines when necessary. 
‘‘(3) CONSULTATION.—The Assistant Secretary 
shall consult with manufacturers of vaccines in order 
to determine the availability of vaccines. 
‘‘(c) SUPERVISION OF IDENTIFICATION OF VACCINE 
STRAINS.— 
‘‘(1) IN
GENERAL.—The Assistant Secretary 
shall oversee the identification of vaccine strains. 
‘‘(2) CENTERS
FOR
DISEASE
CONTROL
AND 
PREVENTION.—The Assistant Secretary shall estab-
lish, and periodically review and as appropriate re-
vise, time tables by which the Director of the Cen-
ters for Disease Control and Prevention is required 
to identify the strains necessary to produce vaccines. 
‘‘(d) MONITORING OF VACCINE PRODUCTION.—The 
Assistant Secretary shall identify any delays in the pro-
duction of vaccines and shall ensure that such delays are 
accounted for as the delays occur. 
‘‘(e) SUPERVISION OF VACCINE DISTRIBUTION.—The 
Assistant Secretary shall oversee and monitor the distribu-
tion of vaccines. In carrying out the preceding sentence, 
the Assistant Secretary shall identify parties to contracts 
for the distribution of vaccines and the entities with re-
sponsibilities under the contracts for the distribution of 
the vaccines, including pursuant to third-party contracts. 
In the event of a delay in the distribution of vaccines, the 
Assistant Secretary shall identify the reasons for the 
delay. 
‘‘(f) EMERGENCY RESPONSE
AND CONTINGENCY 
PLAN.—The Assistant Secretary shall develop, and peri-
odically review and as appropriate revise, an emergency 
response and contingency plan regarding vaccines. 
‘‘(g) COMMISSION
ON JUVENILE VACCINES.—The 
Assistant Secretary shall establish a commission to deter-
mine the current state of juvenile vaccines. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2006 through 2010.’’. 
Æ