II 

109TH CONGRESS 

1ST SESSION S. 226 

To amend the Public Health Service Act to improve immunization rates 

by increasing the supply of vaccines. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 1, 2005 

Mr. DEWINE (for himself and Mrs. CLINTON) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to improve 

immunization rates by increasing the supply of vaccines. 

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 ‘‘Improved Vaccine Sup5 ply Act’’. 

6 SEC. 2. SUPPLY OF VACCINES. 

7 Title XXI of the Public Health Service Act (42 

8 U.S.C. 300aa–1 et seq.) is amended by adding at the end 

9 the following: 
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1 ‘‘Subtitle 3—Adequate Vaccine Supply 

2 ‘‘SEC. 2141. SUPPLY OF VACCINES. 

3 ‘‘(a) IN GENERAL.— 

4 ‘‘(1) PLAN.—Not later than 6 months after the 

5 date of enactment of this section, the Secretary, act6 ing through the Director of the Centers for Disease 

7 Control and Prevention, shall develop a plan for the 

8 purchase, storage, and rotation of a supply of vac9 cines sufficient to provide routinely recommended 

10 vaccinations for a 6-month period for— 

11 ‘‘(A) a national stockpile of vaccines for all 

12 children as authorized under section 1928(d)(6) 

13 of the Social Security Act (42 U.S.C. 

14 1396s(d)(6)); and 

15 ‘‘(B) adults. 

16 ‘‘(2) SUPPLY.—The supply of vaccines under 

17 paragraph (1) shall— 

18 ‘‘(A) include all vaccines routinely rec19 ommended for children by the Advisory Com20 mittee on Immunization Practices; and 

21 ‘‘(B) include all vaccines routinely rec22 ommended for adults by the Advisory Com23 mittee on Immunization Practices. 

24 ‘‘(3) SUPPLY AUTHORITY.—The Secretary shall 

25 carry out— 
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1 ‘‘(A) paragraph (2)(A) using the authority 

2 provided for under section 1928(d)(6) of the 

3 Social Security Act (42 U.S.C. 1396s(d)(6)); 

4 and 

5 ‘‘(B) paragraph (2)(B) using— 

6 ‘‘(i) the authority provided for under 

7 section 317; and 

8 ‘‘(ii) any other authority relating to 

9 the vaccines described in such paragraph. 

10 ‘‘(b) SUBMISSION OF PLAN.— 

11 ‘‘(1) IN GENERAL.—Not later than 1 year after 

12 the date of enactment of this section, the Secretary 

13 shall submit the plan developed under subsection (a) 

14 to— 

15 ‘‘(A) the Committee on Health, Education, 

16 Labor, and Pensions of the Senate; 

17 ‘‘(B) the Committee on Finance of the 

18 Senate; and 

19 ‘‘(C) the Committee on Energy and Com20 merce of the House of Representatives. 

21 ‘‘(2) INCLUSIONS.—The plan shall include a 

22 discussion of the considerations that formed— 

23 ‘‘(A) the basis for the plan; and 

24 ‘‘(B) the prioritization of the schedule for 

25 purchasing vaccines set forth in the plan. 
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1 ‘‘(c) IMPLEMENTATION OF THE PLAN.—Not later 

2 than September 30, 2007, the Secretary shall fully imple3 ment the plan developed under subsection (a). 

4 ‘‘(d) NOTICE.— 

5 ‘‘(1) IN GENERAL.—For the purposes of main6 taining and administering the supply of vaccines de7 scribed under subsection (a), the Secretary shall re8 quire by contract that the manufacturer of a vaccine 

9 included in such supply provide not less than 1 year 

10 notice to the Secretary of a discontinuance of the 

11 manufacture of the vaccine, or of other factors, that 

12 may prevent the manufacturer from providing vac13 cines pursuant to an arrangement made to carry out 

14 this section. 

15 ‘‘(2) REDUCTION OF PERIOD OF NOTICE.—The 

16 notification period required under paragraph (1) 

17 may be reduced if the manufacturer certifies to the 

18 Secretary that good cause exists for reduction, under 

19 the conditions described in section 506C(b) of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 356c). 

22 ‘‘(e) PROCEEDS.—Any proceeds received by the Sec23 retary from the sale of vaccines contained in the supply 

24 maintained pursuant to this section, shall be available to 

25 the Secretary for the purpose of purchasing additional 
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1 vaccines for the supply. Such proceeds shall remain avail2 able until expended. 

3 ‘‘(f) ONGOING REPORTS.— 

4 ‘‘(1) IN GENERAL.—Not later than 2 years 

5 after submitting the plan pursuant to subsection (b), 

6 and periodically thereafter, the Secretary shall sub7 mit a report to the Committees identified in sub8 section (b)(1) that— 

9 ‘‘(A) details the progress made in imple10 menting the plan developed under subsection 

11 (a); and 

12 ‘‘(B) notes impediments, if any, to imple13 menting the plan developed under subsection 

14 (a). 

15 ‘‘(2) RECOMMENDATION.—The Secretary shall 

16 include in the first of such reports required under 

17 paragraph (1)— 

18 ‘‘(A) a recommendation as to whether the 

19 vaccine supply should be extended beyond the 

20 6-month period provided in subsection (a); and 

21 ‘‘(B) a discussion of the considerations 

22 that formed the recommendation under sub23 paragraph (A). 

24 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

25 are authorized to be appropriated to carry out this section 
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1 such sums as may be necessary for each of fiscal years 

2 2006 through 2011.’’. 

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