I 

109TH CONGRESS 

1ST SESSION H. R. 3502

To amend the Public Health Service Act with respect to immunizations 

against vaccine-preventable diseases, including influenza, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 28, 2005

Mr. WAXMAN (for himself, Mr. BROWN of Ohio, and Ms. ROYBAL-ALLARD) 

introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and 

Means and Education and the Workforce, for a period to be subsequently 

determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To amend the Public Health Service Act with respect to 

immunizations against vaccine-preventable diseases, including influenza, 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 Access and 

5 Supply Act’’. 
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1 SEC. 2. CERTAIN AUTHORITIES REGARDING INFLUENZA 

2 AND OTHER VACCINES. 

3 (a) IN GENERAL.—Part B of title III of the Public 

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

5 (1) by redesignating section 317A as section 

6 317A–1; and 

7 (2) by inserting after section 317 the following 

8 section: 

9 ‘‘SEC. 317A. CERTAIN AUTHORITIES REGARDING INFLU10 ENZA AND OTHER VACCINES. 

11 ‘‘(a) PURCHASE OF UNSOLD DOSES OF PERIODIC12 CHANGE VACCINES.—

13 ‘‘(1) PRODUCER-SPECIFIC NEGOTIATION ON

14 SUPPLY FOR SEASON.—In the case of influenza vac15 cine and each other periodic-change vaccine, the Sec16 retary shall, for each applicable vaccine season, ne17 gotiate with each producer of the vaccine to reach an 

18 agreement on the number of doses of the vaccine 

19 that the producer will manufacture for such season. 

20 The Secretary is not required under the preceding 

21 sentence to enter into such an agreement with any 

22 producer. 

23 ‘‘(2) PURCHASE OF PERCENTAGE OF UNSOLD

24 DOSES.—With respect to the number of doses of a 

25 periodic-change vaccine manufactured for an appli26 cable vaccine season by a producer in accordance 
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1 with an agreement under paragraph (1), the Sec2 retary shall purchase from the producer 50 percent 

3 of such doses that are unsold for the season. 

4 ‘‘(3) PRICE PER DOSE.—

5 ‘‘(A) AVERAGE SALES PRICE.—Subject to 

6 subparagraph (B), the price per dose paid by 

7 the Secretary in a purchase of periodic-change 

8 vaccine under paragraph (2) shall be the aver9 age sales price for the vaccine for the applicable 

10 vaccine season, as determined by the Secretary. 

11 ‘‘(B) AUDITS; ADJUSTMENTS.—The Sec12 retary may enter into an agreement under para13 graph (1) with a producer regarding a periodic14 change vaccine only if the agreement includes a 

15 provision that permits the Secretary to conduct 

16 audits of sales of such vaccine at wholesale by 

17 the producer. The average sales price deter18 mined under subparagraph (A) for a dose of 

19 the vaccine for an applicable vaccine season 

20 shall be adjusted by the Secretary as deter21 mined necessary by the Secretary on the basis 

22 of such audits and on the basis of any other in23 formation available to the Secretary on sales of 

24 the vaccine at wholesale. 
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1 ‘‘(4) DEFINITIONS.—For purposes of this sec2 tion: 

3 ‘‘(A) The term ‘periodic-change vaccine’ 

4 means a federally recommended vaccine (as de5 fined in subsection (g)) that is designed only for 

6 a single applicable vaccine season due to char7 acteristics of the etiologic agent or agents for 

8 the disease involved, or due to characteristics of 

9 the vaccine, that adversely affect the extent to 

10 which the vaccine is safe and effective after 

11 such season. Such term includes influenza vac12 cine. 

13 ‘‘(B) The term ‘producer’ means a person 

14 who—

15 ‘‘(i) manufactures an approved vac16 cine (as defined in subsection (g)); or 

17 ‘‘(ii) who intends to manufacture such 

18 a vaccine and is determined by the Sec19 retary to have the capacity to meet legal 

20 requirements applicable to such manufac21 turing. 

22 ‘‘(C)(i) The term ‘vaccine season’, with re23 spect to a periodic-change vaccine, means a 

24 consecutive number of months, not exceeding 

25 24 months, during which the Secretary rec-
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1 ommends that the public in general, or par2 ticular populations, as the case may be, receive 

3 immunizations against the disease involved. 

4 ‘‘(ii) The term ‘applicable vaccine season’, 

5 with respect to a periodic-change vaccine, 

6 means the vaccine season that is applicable to 

7 such vaccine. 

8 ‘‘(5) DIRECT SPENDING.—The requirement 

9 under paragraph (2) that the Secretary make pur10 chases of doses of periodic-change vaccine con11 stitutes budget authority in advance of appropria12 tions Acts, and represents the obligation of the 

13 United States to make outlays for such purchases in 

14 accordance with this subsection. 

15 ‘‘(b) IMMUNIZATION PROGRAM FOR ELIGIBLE

16 ADULTS.—

17 ‘‘(1) IN GENERAL.—The Secretary shall by reg18 ulation establish a program for the distribution of 

19 qualified adult vaccines through States with ap20 proved applications under paragraph (4)(C), under 

21 which program—

22 ‘‘(A) each vaccine-eligible adult, in receiv23 ing an immunization with a qualified adult vac24 cine from a program-registered provider on or 

25 after October 1, 2006, is entitled to receive the 
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1 immunization without charge for the cost of 

2 such vaccine; and 

3 ‘‘(B)(i) each program-registered provider 

4 who administers such a vaccine to a vaccine-eli5 gible adult on or after such date is entitled to 

6 receive such vaccine under the program without 

7 charge either for the vaccine or its delivery to 

8 the provider; and 

9 ‘‘(ii) no vaccine is distributed under the 

10 program to a provider unless the provider is a 

11 program-registered provider. 

12 ‘‘(2) RELATIONSHIP TO PROGRAM FOR DIS13 TRIBUTION OF PEDIATRIC VACCINES.—The provi14 sions of the program under section 1928 of the So15 cial Security Act (including provisions taking effect 

16 on or after the effective date of this section) apply 

17 with respect to immunizations for vaccine-eligible 

18 adults under the program under paragraph (1) to 

19 the same extent and in the same manner as such 

20 provisions apply with respect to immunizations for 

21 vaccine-eligible children under the program under 

22 such section 1928, except to the extent that such a 

23 provision conflicts with this subsection. The pre24 ceding section may not be construed as having any 

25 effect on the program under title XIX of the Social 
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1 Security Act, or as having the effect that, in the pro2 gram under paragraph (1), State plans comparable 

3 to State plans under section 1902 of such Act are 

4 required. 

5 ‘‘(3) VACCINE-ELIGIBLE ADULT.—

6 ‘‘(A) IN GENERAL.—For purposes of this 

7 subsection, the term ‘vaccine-eligible adult’ 

8 means a federally vaccine-eligible adult or a 

9 State vaccine-eligible adult. 

10 ‘‘(B) FEDERALLY VACCINE-ELIGIBLE

11 ADULT.—For purposes of this subsection, the 

12 term ‘federally vaccine-eligible adult’ means 

13 each of the following: 

14 ‘‘(i) An adult who is not insured. 

15 ‘‘(ii) An adult who—

16 ‘‘(I) is administered a qualified 

17 adult vaccine by a Federally-qualified 

18 health center (as defined in section 

19 1905(l)(2)(B)) of the Social Security 

20 Act), by any other entity that is a cov21 ered entity under section 340B(a)(4), 

22 or by any public clinic; and 

23 ‘‘(II) is not insured with respect 

24 to the vaccine. 

25 ‘‘(iii) An adult who—
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1 ‘‘(I) is administered a qualified 

2 adult vaccine while incarcerated in a 

3 Federal, State, or local penal or cor4 rectional institution, including an 

5 adult who is held pending judicial or 

6 administrative proceedings; and 

7 ‘‘(II) is not insured with respect 

8 to the vaccine. 

9 ‘‘(C) STATE VACCINE-ELIGIBLE ADULT.—

10 For purposes of this subsection, the term ‘State 

11 vaccine-eligible adult’ means, with respect to a 

12 State and a qualified adult vaccine, an adult 

13 who is within a class of adults for which the 

14 State is purchasing the vaccine pursuant to 

15 provisions that apply pursuant to paragraph 

16 (2). 

17 ‘‘(4) PARTICIPATION OF STATES.—

18 ‘‘(A) IN GENERAL.—In the case or each 

19 State with an approved application under sub20 paragraph (C), the Secretary shall provide, in 

21 accordance with provisions that apply pursuant 

22 to paragraph (2), for the purchase and delivery 

23 on behalf of the State, without charge to the 

24 State, of such quantities of qualified adult vac25 cines as may be necessary for the administra-
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1 tion of such vaccines to all vaccine-eligible 

2 adults in the State on or after October 1, 2006. 

3 ‘‘(B) PROGRAM CRITERIA.—The Secretary, 

4 in accordance with provisions that apply pursu5 ant to paragraph (2), shall establish criteria for 

6 State programs under paragraph (1). 

7 ‘‘(C) STATE APPLICATION.—A State may 

8 participate in the program under paragraph (1) 

9 only if the State submits to the Secretary an 

10 application for such participation. The Sec11 retary shall approve any such application 

12 that—

13 ‘‘(i) is submitted in such form and 

14 such manner as the Secretary may require; 

15 and 

16 ‘‘(ii) demonstrates that the State is in 

17 compliance with criteria under subpara18 graph (B). 

19 ‘‘(5) ADDITIONAL DEFINITIONS.—For purposes 

20 of this subsection: 

21 ‘‘(A) The term ‘adult’ means an individual 

22 who is not a child as defined in section 1928 of 

23 the Social Security Act. 

24 ‘‘(B) The term ‘adult vaccine’ means a fed25 erally recommended vaccine for adults. 
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1 ‘‘(C)(i) The term ‘insured’, with respect to 

2 an adult, means that the adult is enrolled 

3 under, and entitled to benefits under, a health 

4 insurance policy or plan, including a group 

5 health plan, a prepaid health plan, or an em6 ployee welfare benefit plan under the Employee 

7 Retirement Income Security Act of 1974. 

8 ‘‘(ii) An adult is not insured with respect 

9 to a qualified adult vaccine if the adult is enti10 tled to benefits under such a health insurance 

11 policy or plan, but such benefits are not avail12 able with respect to the cost of such vaccine. 

13 ‘‘(D) The term ‘qualified adult vaccine’ 

14 means an adult vaccine with respect to which a 

15 contract is in effect pursuant to provisions that 

16 apply pursuant to paragraph (2). 

17 ‘‘(6) DIRECT SPENDING.—The requirement 

18 under paragraph (1) that the Secretary carry out a 

19 program constitutes budget authority in advance of 

20 appropriations Acts, and represents the obligation of 

21 the Federal Government to make outlays to provide 

22 for immunizations of vaccine-eligible adults in ac23 cordance with this subsection, including with respect 

24 to program-registered providers and with respect to 
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1 the purchase and delivery of qualified adult vaccines 

2 on behalf of States. 

3 ‘‘(c) INFORMATION ON LOCATION OF SUPPLIES OF

4 VACCINES; EMERGENCY AUTHORITY OF SECRETARY.—

5 ‘‘(1) IN GENERAL.—If the Secretary publishes 

6 in the Federal Register a declaration that there is 

7 a shortage of an approved vaccine that constitutes a 

8 public health emergency, each person who is a man9 ufacturer or distributor of the vaccine shall provide 

10 to the Secretary such information as the Secretary 

11 may require with respect to the location of supplies 

12 of the vaccine, including supplies in the possession 

13 of the person, supplies scheduled to be received by 

14 the person, and supplies sold by the person. Any 

15 such person who fails to comply with an order of the 

16 Secretary under the preceding sentence is liable to 

17 the United States for a civil penalty not exceeding 

18 $1,000 for each day for which the person is in viola19 tion of the order. 

20 ‘‘(2) AVAILABILITY TO STATES.—Upon the re21 quest of a State, the Secretary shall provide to the 

22 State the information collected by the Secretary 

23 under paragraph (1) that relates to the State. 

24 ‘‘(d) EMERGENCY RESPONSE PLAN REGARDING

25 SHORTAGES.—The Secretary shall develop and maintain 
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1 a plan for the response of the Secretary to potential short2 ages in supplies of vaccines that would constitute public 

3 health emergencies. The plan shall include provisions with 

4 respect to communication among the relevant entities; dis5 tribution of available supplies of the vaccine involved; the 

6 designation of populations to be given priority for immuni7 zations; interactions with State and local governments; use 

8 of the vaccine stockpile; and special considerations for spe9 cific vaccines. The initial plan shall be completed not later 

10 than 12 months after the date of the enactment of the 

11 Vaccine Access and Supply Act. 

12 ‘‘(e) RESEARCH.—For the purpose of carrying out re13 search toward the development of new vaccines for human 

14 use, including vaccines to prevent or control pandemic in15 fections, there are authorized to be appropriated 

16 $250,000,000 for fiscal year 2006, and such sums as may 

17 be necessary for each of the fiscal years 2007 through 

18 2010. Such authorization is in addition to any other au19 thorizations of appropriations for such purpose. 

20 ‘‘(f) EDUCATION PROGRAM REGARDING ADULT IM21 MUNIZATIONS.—

22 ‘‘(1) IN GENERAL.—The Secretary shall develop 

23 and implement a program to promote, among the 

24 adult population, immunizations with federally rec25 ommended vaccines. 
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1 ‘‘(2) CONTENT OF PROGRAM.—The program 

2 developed under paragraph (1) shall include the use 

3 of a mass media campaign. 

4 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—

5 For the purpose of carrying out this subsection, 

6 there are authorized to be appropriated such sums 

7 as may be necessary for each of the fiscal years 

8 2006 through 2010. 

9 ‘‘(g) GENERAL DEFINITIONS.—For purposes of this 

10 section: 

11 ‘‘(1) The term ‘approved vaccine’ means a vac12 cine for which a biologics license under section 351 

13 is in effect. 

14 ‘‘(2)(A) The term ‘federally recommended vac15 cine’, with respect to an adult, means an approved 

16 vaccine recommended by the Advisory Committee on 

17 Immunization Practices (an advisory committee es18 tablished by the Secretary, acting through the Direc19 tor of the Centers for Disease Control and Preven20 tion). 

21 ‘‘(B) The term ‘federally recommended vaccine’, 

22 with respect to a child, means a vaccine on the list 

23 referred to in section 1928(e) of the Social Security 

24 Act.’’. 
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1 (b) IMMUNIZATIONS FOR ELIGIBLE ADULTS; CON2 TINUED COVERAGE UNDER GROUP HEALTH PLANS.—

3 With respect to the program under section 317A(b) of the 

4 Public Health Service Act (as added by subsection (a) of 

5 this section) (referred to in this subsection as the ‘‘adult 

6 program’’): 

7 (1) Pursuant to paragraph (2) of such section, 

8 the provisions of section 1928 of the Social Security 

9 Act (referred to in this section as the ‘‘pediatric pro10 gram’’) that apply with respect to the adult program 

11 include subsection (f) of the pediatric program (re12 lating to State maintenance of immunization laws). 

13 (2) Section 609(d) of the Employee Retirement 

14 Income Security Act, and the effective date for such 

15 section (under section 4301(d) of Public Law 103–

16 66), apply with respect to the adult program to the 

17 same extent and in the same manner as such section 

18 and effective date apply with respect to the pediatric 

19 program. For purposes of such section 609(d) as ap20 plied pursuant to the preceding sentence, the ref21 erence in such section to May 1, 1993, shall be con22 sidered a reference to July 1, 2005. 

23 (3) Section 4980B(f)(1) of the Internal Rev24 enue Code of 1986 (as added by section 13422(a) of 

25 Public Law 103–66) applies with respect to adult 
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1 vaccines (as defined in the adult program) to the 

2 same extent and in the same manner as such section 

3 applies with respect to pediatric vaccines. For pur4 poses of such section 4980B(f)(1) as applied pursu5 ant to the preceding sentence, the reference in such 

6 section to May 1, 1993, shall be considered a ref7 erence to July 1, 2005. This paragraph applies with 

8 respect to plan years beginning after the date of the 

9 enactment of this Act. 

10 (4) Section 13631(d) of Public Law 103–66 

11 (relating to title XXII of the Public Health Service 

12 Act) applies with respect to the adult program to the 

13 same extent and in the same manner as such section 

14 applies with respect to the pediatric program. For 

15 purposes of such section 13631(d) as applied pursu16 ant to the preceding sentence, the reference in such 

17 section to May 1, 1993, shall be considered a ref18 erence to July 1, 2005. 

19 SEC. 3. PROGRAM FOR DISTRIBUTION OF PEDIATRIC VAC20 CINES. 

21 (a) INCLUSION OF ALL PUBLIC CLINICS.—Section 

22 1928(b)(2)(A)(iii)(I) of the Social Security Act (42 U.S.C. 

23 1396s(b)(2)(A)(iii)(I)) is amended—

24 (1) by striking ‘‘or a rural health clinic’’ and in25 serting ‘‘, a rural health clinic’’; and 
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1 (2) by inserting ‘‘or a public clinic,’’ after 

2 ‘‘1905(l)(1)),’’. 

3 (b) AUTHORITY TO REMOVE CERTAIN LIMITATIONS

4 ON PAYMENTS TO MANUFACTURERS.—Section 

5 1928(d)(3)(B) of the Social Security Act (42 U.S.C. 

6 1396s(d)(3)(B)) is amended by adding at the end the fol7 lowing: ‘‘In the case of a contract entered into on or after 

8 the date of the enactment of the Vaccine Access and Sup9 ply Act, the limitation established in the preceding sen10 tence with respect to the price per dose of a pediatric vac11 cine does not apply if the Secretary determines that the 

12 limitation is having a significant adverse effect on the 

13 availability of sufficient supplies of the vaccine.’’. 

14 (c) SALES FROM 6-MONTH SUPPLY.—Section 

15 1928(d)(6) of the Social Security Act (42 U.S.C. 

16 1396s(d)(6)) is amended by inserting before the last sen17 tence the following: ‘‘The Secretary may sell such quan18 tities of vaccines from such supply as the Secretary deter19 mines appropriate. Proceeds received from such sales shall 

20 be available to the Secretary only for the purposes of pro21 curing pediatric vaccine stockpiles under this section and 

22 shall remain available until expended.’’. 
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1 SEC. 4. AMENDMENTS TO PROGRAM OF VACCINE-RELATED 

2 GRANTS TO STATES. 

3 Section 317(j) of the Public Health Service Act (42 

4 U.S.C. 247b(j)) is amended by adding at the end the fol5 lowing paragraph: 

6 ‘‘(3)(A)(i) For fiscal year 2006, the Secretary shall 

7 make grants described in paragraphs (1) and (2) (relating 

8 to immunizing individuals without charge) in an aggregate 

9 amount not exceeding $515,536,000. 

10 ‘‘(ii) Of the amount available under subparagraph 

11 (A) for fiscal year 2006, the Secretary shall reserve not 

12 less than $80,000,000 for the purpose of providing immu13 nizations for adults who have not, prior to fiscal year 

14 2006, been served by immunization programs carried out 

15 with grants made pursuant to paragraph (1) or (2). 

16 ‘‘(B)(i) For fiscal year 2007 and each subsequent fis17 cal year, the Secretary shall make grants described in 

18 paragraphs (1) and (2) in an aggregate amount equal to 

19 the sum of the amounts determined under subclauses (I) 

20 and (II), as follows: 

21 ‘‘(I) Of the aggregate amount provided in such 

22 grants for fiscal year 2006, the Secretary shall de23 termine the portion that was obligated to purchase 

24 vaccines. The amount determined under this sub25 clause is such portion as increased to offset the per26 centage increase in the average sales price for such 
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1 vaccines for the most recent five-year period for 

2 which data are available, taking into account reports 

3 under subparagraph (F) (in the case of fiscal year 

4 2007 and subsequent fiscal years). 

5 ‘‘(II) Of the aggregate amount provided in such 

6 grants for fiscal year 2006, the Secretary shall de7 termine the portion that was obligated for purposes 

8 other than the purchase of vaccines. The amount de9 termined under this subclause is such portion as in10 creased to offset the percentage increase in the Con11 sumer Price Index for all urban consumers (all 

12 items; United States city average) for the most re13 cent five-year period for which data are available. 

14 ‘‘(ii) Of the amount available under clause (i) for a 

15 fiscal year, the Secretary shall, for the purpose described 

16 in subparagraph (A)(ii), reserve not less than the amount 

17 specified in such subparagraph as increased in accordance 

18 with the same methodology as applies under clause (i). 

19 ‘‘(C) Subject to subparagraphs (D) through (F)), 

20 grants made pursuant to this paragraph shall be made in 

21 accordance with criteria of the Secretary issued under 

22 paragraphs (1) and (2) for immunization programs. The 

23 preceding sentence may not be construed as terminating 

24 the authority of the Secretary to modify such criteria. 
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1 ‘‘(D) The purposes for which grants made pursuant 

2 to this paragraph may be expended by a State or political 

3 subdivision include the following: 

4 ‘‘(i) Conducting assessments to determine the 

5 number of adults in the area involved who need im6 munizations and the barriers to providing immuniza7 tions to such adults. 

8 ‘‘(ii) Developing and implementing strategies to 

9 increase the rate of immunizations in populations in 

10 which a significant number of individuals have not 

11 received immunizations with the federally rec12 ommended vaccines (as defined in section 317A(g)) 

13 for the populations. 

14 ‘‘(iii) Educating care givers, health care profes15 sionals, and the public about the need to be immu16 nized. 

17 ‘‘(iv) Consulting with health care providers with 

18 respect to ensuring proper and timely immunizations 

19 for their patients. 

20 ‘‘(v) Investigating and responding to outbreaks 

21 of vaccine-preventable diseases. 

22 ‘‘(vi) Developing and modifying plans to re23 spond to potential shortages in supplies of vaccines. 
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1 ‘‘(vii) Preparing reports under subparagraph 

2 (F) and any additional reports that are submitted to 

3 the Secretary pursuant to this paragraph. 

4 ‘‘(E) A condition for the receipt by a State of a grant 

5 made pursuant to this paragraph for a fiscal year is that 

6 the State have (or agree to develop, in the case of a grant 

7 for fiscal year 2006) a State plan that—

8 ‘‘(i) ensures the distribution and administration 

9 of vaccines in the event that the Secretary declares 

10 a shortage of approved vaccines as a public health 

11 emergency; and 

12 ‘‘(ii) includes plans for communication and co13 ordination between—

14 ‘‘(I) State and local public health depart15 ments; 

16 ‘‘(II) community health centers; 

17 ‘‘(III) hospitals; 

18 ‘‘(IV) private physicians licensed within the 

19 State; and 

20 ‘‘(V) to the extent practicable, vaccine 

21 manufacturers and suppliers. 

22 ‘‘(F) A condition for the receipt of a grant made pur23 suant to this paragraph for a fiscal year is that the appli24 cant involved agree to submit to the Secretary a report 

25 that specifies for such year the quantity of each type of 
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1 vaccine purchased with the grant and the per-dose cost 

2 of the vaccine. 

3 ‘‘(G) The requirements under subparagraphs (A) and 

4 (B) that the Secretary make grants constitutes budget au5 thority in advance of appropriations Acts, and represents 

6 the obligation of the Federal Government to make outlays 

7 to provide for immunizations without charge pursuant to 

8 the grants in accordance with this paragraph.’’. 

9 SEC. 5. ONE-YEAR NOTICE ON DISCONTINUING MANUFAC10 TURE OF VACCINE. 

11 Subchapter A of chapter V of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend13 ed by inserting after section 506C the following section: 

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

15 ‘‘(a) IN GENERAL.—

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

17 of a vaccine approved by the Secretary shall notify 

18 the Secretary of a discontinuance of the manufac19 ture of the vaccine at least 12 months prior to the 

20 date of the discontinuance. 

21 ‘‘(2) DIRECTOR OF CENTERS FOR DISEASE

22 CONTROL AND PREVENTION.—Promptly after receiv23 ing a notice under paragraph (1), the Secretary shall 

24 inform the Director of the Centers for Disease Con25 trol and Prevention of the notice. Promptly after de-
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1 termining that a reduction under subsection (b) ap2 plies with respect to such a notice, the Secretary 

3 shall inform such Director of the reduction. 

4 ‘‘(3) RELATIONSHIP TO SEPARATE NOTICE PRO5 GRAM.—In the case of a vaccine that is approved by 

6 the Secretary and is a drug described in section 

7 506C(a), this section applies to the vaccine in lieu 

8 of section 506C. 

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

10 notification period required under subsection (a) for a 

11 manufacturer may be reduced if the manufacturer certifies 

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

13 such as a situation in which—

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

15 continuation of the manufacturing for the 12-month 

16 period; 

17 ‘‘(2) a biomaterials shortage prevents the con18 tinuation of the manufacturing for the 12-month pe19 riod; 

20 ‘‘(3) a liability problem may exist for the manu21 facturer if the manufacturing is continued for the 

22 12-month period; 

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

24 12-month period may cause substantial economic 

25 hardship for the manufacturer; 
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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; or 

4 ‘‘(6) the manufacturer can continue the dis5 tribution of the vaccine involved for 12 months. 

6 ‘‘(c) DISTRIBUTION.—To the maximum extent prac7 ticable, the Secretary shall distribute information on the 

8 discontinuation of the manufacture of vaccines to appro9 priate physician and patient organizations.’’. 

10 SEC. 6. PROGRAM FOR PEDIATRIC VACCINE STOCKPILE; 

11 PARTICIPATION OF MANUFACTURERS OF 

12 VACCINES. 

13 (a) IN GENERAL.—Not later than 30 days after the 

14 date of the enactment of this Act, the Secretary of Health 

15 and Human Services, in consultation with the Chairman 

16 of the Securities and Exchange Commission, shall submit 

17 to the Congress a plan to facilitate the participation of 

18 manufacturers of pediatric vaccines in the program oper19 ated by the Secretary to maintain a six-month supply of 

20 such vaccines (commonly referred to as the pediatric vac21 cine stockpile). With respect to the purchase of pediatric 

22 vaccines for such program, the plan shall include, as nec23 essary, provisions for the accounting-rules treatment of 

24 amounts paid by the Secretary to such manufacturers that 
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1 will permit the manufacturers to treat the amounts as rev2 enue upon receipt of the amounts. 

3 (b) DEFINITION.—For purposes of subsection (a), 

4 the term ‘‘pediatric vaccine’’ means a vaccine on the list 

5 referred to in section 1928(e) of the Social Security Act. 

6 SEC. 7. PROHIBITION ON MEDICAID COST-SHARING FOR 

7 VACCINES RECOMMENDED BY ADVISORY 

8 COMMITTEE ON IMMUNIZATION PRACTICES. 

9 (a) IN GENERAL.—Section 1916 of the Social Secu10 rity Act (42 U.S.C. 1396o) is amended by adding at the 

11 end the following: 

12 ‘‘(h) The State plan shall require that no provider 

13 participating under the State plan may impose a copay14 ment, cost sharing charge, or similar charge for admin15 istering to an adult individual who is eligible for medical 

16 assistance under such plan a vaccine that is included on 

17 the recommended vaccine schedule for adults that is estab18 lished (and periodically reviewed and appropriately re19 vised) by the Advisory Committee on Immunization Prac20 tices of the Centers for Disease Control and Prevention 

21 and that is otherwise covered under the State plan.’’. 

22 (b) EFFECTIVE DATE.—The amendment made by 

23 subsection (a) shall take effect on October 1, 2005. 

Æ