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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Vaccine Shortage Pre5 paredness Act of 2008’’. 

6 SEC. 2. SALES FROM 6-MONTH SUPPLY. 

7 Section 1928(d)(6) of the Social Security Act (42 

8 U.S.C. 1396s(d)(6)) is amended by inserting before the 


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1 last sentence the following: ‘‘The Secretary may sell such 

2 quantities of vaccines from such supply to public health 

3 departments or back to the vaccine manufacturers as the 

4 Secretary determines appropriate. Proceeds received from 

5 such sales shall be available to the Secretary only for the 

6 purposes of procuring pediatric vaccine stockpiles under 

7 this section and shall remain available until expended.’’. 

8 SEC. 3. ONE-YEAR NOTICE ON DISCONTINUING MANUFAC9 TURE OF VACCINE. 

10 Subchapter A of chapter V of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend12 ed by inserting after section 506C the following section: 

13 ‘‘SEC. 506D. DISCONTINUANCE OF VACCINE. 

14 ‘‘(a) IN GENERAL.— 

15 ‘‘(1) NOTICE TO SECRETARY.—A manufacturer 

16 of a vaccine approved by the Secretary shall notify 

17 the Secretary of a discontinuance of the manufac18 ture of the vaccine at least 12 months prior to the 

19 date of the discontinuance. 

20 ‘‘(2) DIRECTOR OF CENTERS FOR DISEASE

21 CONTROL AND PREVENTION.—Promptly after receiv22 ing a notice under paragraph (1), the Secretary shall 

23 inform the Director of the Centers for Disease Con24 trol and Prevention of the notice. Promptly after de25 termining that a reduction under subsection (b) apVerDate Aug 31 2005 03:52 Jan 17, 2008 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4991.IH H4991

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1 plies with respect to such a notice, the Secretary 

2 shall inform such Director of the reduction. 

3 ‘‘(3) RELATIONSHIP TO SEPARATE NOTICE PRO4 GRAM.—In the case of a vaccine that is approved by 

5 the Secretary and is a drug described in section 

6 506C(a), this section applies to the vaccine in lieu 

7 of section 506C. 

8 ‘‘(b) REDUCTION IN NOTIFICATION PERIOD.—The 

9 notification period required under subsection (a) for a 

10 manufacturer may be reduced if the manufacturer certifies 

11 to the Secretary that good cause exists for the reduction, 

12 such as a situation in which— 

13 ‘‘(1) a public health problem may result from 

14 continuation of the manufacturing for the 12-month 

15 period; 

16 ‘‘(2) a biomaterials shortage prevents the con17 tinuation of the manufacturing for the 12-month pe18 riod; 

19 ‘‘(3) a liability problem may exist for the manu20 facturer if the manufacturing is continued for the 

21 12-month period; 

22 ‘‘(4) continuation of the manufacturing for the 

23 12-month period may cause substantial economic 

24 hardship for the manufacturer; or 


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1 ‘‘(5) the manufacturer has filed for bankruptcy 

2 under chapter 7 or 11 of title 11, United States 

3 Code. 

4 ‘‘(c) DISTRIBUTION.—To the maximum extent prac5 ticable, the Secretary shall distribute information on the 

6 discontinuation of the manufacture of vaccines to appro7 priate physician and patient organizations.’’. 

8 SEC. 4. CERTAIN AUTHORITIES REGARDING INFLUENZA 

9 AND OTHER VACCINES. 

10 (a) AUTHORITIES.—Part B of title III of the Public 

11 Health Service Act (42 U.S.C. 243 et seq.) is amended— 

12 (1) by redesignating section 317A as section 

13 317A–1; and 

14 (2) by inserting after section 317 the following 

15 section: 

16 ‘‘SEC. 317A. CERTAIN AUTHORITIES REGARDING INFLU17 ENZA AND OTHER VACCINES. 

18 ‘‘(a) DECLARATION.—The Secretary may declare a 

19 public health emergency if— 

20 ‘‘(1) there is a shortage of an approved vaccine 

21 for an infectious disease; and 

22 ‘‘(2) there is a significant risk of a significant 

23 outbreak of such disease. 

24 ‘‘(b) REQUIREMENT.—If the Secretary publishes in 

25 the Federal Register a declaration of a public health emerVerDate Aug 31 2005 03:52 Jan 17, 2008 Jkt 069200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4991.IH H4991

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1 gency under subsection (a), each person who is a manufac2 turer or distributor of such vaccine shall provide to the 

3 Secretary such information as the Secretary may require 

4 with respect to the location of supplies of the vaccine, in5 cluding supplies in the possession of the person, supplies 

6 scheduled to be received by the person, and supplies sold 

7 by the person. Any such person who fails to comply with 

8 an order of the Secretary under the preceding sentence 

9 is liable to the United States for a civil penalty not exceed10 ing $1,000 for each day for which the person is in violation 

11 of the order. 

12 ‘‘(c) AVAILABILITY TO STATES.— 

13 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

14 the Secretary shall, at the request of a State, pro15 vide to the State information collected by the Sec16 retary under subsection (b). 

17 ‘‘(2) RESTRICTION; CONFIDENTIALITY.—The 

18 Secretary may provide to a State information col19 lected by the Secretary under subsection (b) only if 

20 the State agrees— 

21 ‘‘(A) to restrict its use of the information 

22 to facilitating access to vaccines; and 

23 ‘‘(B) to otherwise keep such information 

24 confidential.’’. 


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1 (b) STUDY ON REALLOCATION OF VACCINE.—Not 

2 later than 1 year after the date of the enactment of this 

3 Act, the Secretary of Health and Human Services shall 

4 complete a study and submit a report to the Congress on 

5 successful models and alternatives for tracking and facili6 tating, in consultation with State and local health officials, 

7 reallocation of vaccine at the local level in times of short8 age or emergency. 

Æ 


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