[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 371 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                 S. 371

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           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

_______________________________________________________________________

                                 A BILL


 
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.''.
                                 <all>