I 
110TH CONGRESS 
2D SESSION 
H. R. 4991 
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 
JANUARY 16, 2008 
Mr. WAXMAN (for himself and Ms. ROYBAL-ALLARD) 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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(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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