I 
110TH CONGRESS 
1ST SESSION H. R. 4703 
To amend the Social Security Act, the Federal Food, Drug, and Cosmetic 
Act, and the Public Health Service Act to ensure a sufficient supply 
of vaccines, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 13, 2007 
Mr. WAXMAN introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Social Security Act, the Federal Food, Drug, 
and Cosmetic Act, and the Public Health Service Act 
to ensure a sufficient supply of vaccines, and for other 
purposes. 
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 ‘‘Vaccine Shortage Pre-
paredness Act of 2008’’. 
SEC. 2. SALES FROM 6-MONTH SUPPLY. 
Section 1928(d)(6) of the Social Security Act (42 
U.S.C. 1396s(d)(6)) is amended by inserting before the 
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last sentence the following: ‘‘The Secretary may sell such 
quantities of vaccines from such supply to public health 
departments or back to the vaccine manufacturers as the 
Secretary determines appropriate. Proceeds received from 
such sales shall be available to the Secretary only for the 
purposes of procuring pediatric vaccine stockpiles under 
this section and shall remain available until expended.’’. 
SEC. 3. ONE-YEAR NOTICE ON DISCONTINUING MANUFAC-
TURE OF VACCINE. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506C the following section: 
‘‘SEC. 506D. DISCONTINUANCE OF VACCINE. 
‘‘(a) IN GENERAL.— 
‘‘(1) NOTICE TO SECRETARY.—A manufacturer 
of a vaccine approved by the Secretary shall notify 
the Secretary of a discontinuance of the manufac-
ture of the vaccine at least 12 months prior to the 
date of the discontinuance. 
‘‘(2) DIRECTOR
OF
CENTERS
FOR
DISEASE 
CONTROL AND PREVENTION.—Promptly after receiv-
ing a notice under paragraph (1), the Secretary shall 
inform the Director of the Centers for Disease Con-
trol and Prevention of the notice. Promptly after de-
termining that a reduction under subsection (b) ap-
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plies with respect to such a notice, the Secretary 
shall inform such Director of the reduction. 
‘‘(3) RELATIONSHIP TO SEPARATE NOTICE PRO-
GRAM.—In the case of a vaccine that is approved by 
the Secretary and is a drug described in section 
506C(a), this section applies to the vaccine in lieu 
of section 506C. 
‘‘(b) REDUCTION IN NOTIFICATION PERIOD.—The 
notification period required under subsection (a) for a 
manufacturer may be reduced if the manufacturer certifies 
to the Secretary that good cause exists for the reduction, 
such as a situation in which— 
‘‘(1) a public health problem may result from 
continuation of the manufacturing for the 12-month 
period; 
‘‘(2) a biomaterials shortage prevents the con-
tinuation of the manufacturing for the 12-month pe-
riod; 
‘‘(3) a liability problem may exist for the manu-
facturer if the manufacturing is continued for the 
12-month period; 
‘‘(4) continuation of the manufacturing for the 
12-month period may cause substantial economic 
hardship for the manufacturer; or 
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‘‘(5) the manufacturer has filed for bankruptcy 
under chapter 7 or 11 of title 11, United States 
Code. 
‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute information on the 
discontinuation of the manufacture of vaccines to appro-
priate physician and patient organizations.’’. 
SEC. 4. CERTAIN AUTHORITIES REGARDING INFLUENZA 
AND OTHER VACCINES. 
(a) AUTHORITIES.—Part B of title III of the Public 
Health Service Act (42 U.S.C. 243 et seq.) is amended— 
(1) by redesignating section 317A as section 
317A–1; and 
(2) by inserting after section 317 the following 
section: 
‘‘SEC. 317A. CERTAIN AUTHORITIES REGARDING INFLU-
ENZA AND OTHER VACCINES. 
‘‘(a) DECLARATION.—The Secretary may declare a 
public health emergency if— 
‘‘(1) there is a shortage of an approved vaccine 
for an infectious disease; and 
‘‘(2) there is a significant risk of a significant 
outbreak of such disease. 
‘‘(b) REQUIREMENT.—If the Secretary publishes in 
the Federal Register a declaration of a public health emer-
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gency under subsection (a), each person who is a manufac-
turer or distributor of such vaccine shall provide to the 
Secretary such information as the Secretary may require 
with respect to the location of supplies of the vaccine, in-
cluding supplies in the possession of the person, supplies 
scheduled to be received by the person, and supplies sold 
by the person. Any such person who fails to comply with 
an order of the Secretary under the preceding sentence 
is liable to the United States for a civil penalty not exceed-
ing $1,000 for each day for which the person is in violation 
of the order. 
‘‘(c) AVAILABILITY TO STATES.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall, at the request of a State, pro-
vide to the State information collected by the Sec-
retary under subsection (b). 
‘‘(2) RESTRICTION; 
CONFIDENTIALITY.—The 
Secretary may provide to a State information col-
lected by the Secretary under subsection (b) only if 
the State agrees— 
‘‘(A) to restrict its use of the information 
to facilitating access to vaccines; and 
‘‘(B) to otherwise keep such information 
confidential.’’. 
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(b) STUDY ON REALLOCATION OF VACCINE.—Not 
later than 1 year after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall 
complete a study and submit a report to the Congress on 
successful models and alternatives for tracking and facili-
tating, in consultation with State and local health officials, 
reallocation of vaccine at the local level in times of short-
age or emergency. 
Æ 
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