To amend the Public Health Service Act to ensure an adequate supply of vaccines.

February 12, 2003

Mr. DEWINE (for himself, Mrs. CLINTON, and Mr. REED) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

To amend the Public Health Service Act to ensure an adequate supply of vaccines.

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

SECTION 1. SUPPLY OF VACCINES.

Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1 et seq.) is amended by adding at the end the following:

`Subtitle 3--Adequate Vaccine Supply

`SEC. 2141. SUPPLY OF VACCINES.

`(a) IN GENERAL-

`(1) PLAN- Not later than 6 months after the date of enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a plan for the purchase, storage, and rotation of a supply of vaccines sufficient to provide routinely recommended vaccinations for a 6-month period for--

`(A) a national stockpile of vaccines for all children as authorized under section 1928(d)(6) of the Social Security Act (42 U.S.C. 1396s(d)(6)); and

`(B) adults.

`(2) SUPPLY- The supply of vaccines under paragraph (1) shall--

`(A) include all vaccines routinely recommended for children by the Advisory Committee on Immunization Practices; and

`(B) include all vaccines routinely recommended for adults by the Advisory Committee on Immunization Practices.

`(3) SUPPLY AUTHORITY- The Secretary shall carry out--

`(A) paragraph (2)(A) using the authority provided for under section 1928(d)(6) of the Social Security Act (42 U.S.C. 1396s(d)(6)); and

`(B) paragraph (2)(B) using--

`(i) the authority provided for under section 317; and

`(ii) any other authority relating to the vaccines described in such paragraph.

`(b) SUBMISSION OF PLAN-

`(1) IN GENERAL- Not later than 1 year after the date of enactment of this section, the Secretary shall submit the plan developed under subsection (a) to--

`(A) the Committee on Health, Education, Labor, and Pensions of the Senate;

`(B) the Committee on Finance of the Senate; and

`(C) the Committee on Energy and Commerce of the House of Representatives.

`(2) INCLUSIONS- The plan shall include a discussion of the considerations that formed--

`(A) the basis for the plan; and

`(B) the prioritization of the schedule for purchasing vaccines set forth in the plan.

`(c) IMPLEMENTATION OF THE PLAN- Not later than September 30, 2006, the Secretary shall fully implement the plan developed under subsection (a).

`(d) NOTICE-

`(1) IN GENERAL- For the purposes of maintaining and administering the supply of vaccines described under subsection (a), the Secretary shall require by contract that the manufacturer of a vaccine included in such supply provide not less than 1 year notice to the Secretary of a discontinuance of the manufacture of the vaccine, or of other factors, that may prevent the manufacturer from providing vaccines pursuant to an arrangement made to carry out this section.

`(2) REDUCTION OF PERIOD OF NOTICE- The notification period required under paragraph (1) may be reduced if the manufacturer certifies to the Secretary that good cause exists for reduction, under the conditions described in section 506C(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c).

`(e) PROCEEDS- Any proceeds received by the Secretary from the sale of vaccines contained in the supply maintained pursuant to this section, shall be available to the Secretary for the purpose of purchasing additional vaccines for the supply. Such proceeds shall remain available until expended.

`(f) ONGOING REPORTS-

`(1) IN GENERAL- Not later than 2 years after submitting the plan pursuant to subsection (b), and periodically thereafter, the Secretary shall submit a report to the Committees identified in subsection (b)(1) that--

`(A) details the progress made in implementing the plan developed under subsection (a); and

`(B) notes impediments, if any, to implementing the plan developed under subsection (a).

`(2) RECOMMENDATION- The Secretary shall include in the first of such reports required under paragraph (1)--

`(A) a recommendation as to whether the vaccine supply should be extended beyond the 6-month period provided in subsection (a); and

`(B) a discussion of the considerations that formed the recommendation under subparagraph (A).

`(g) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2004 through 2009.'.

END