
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300aa-1]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                        SUBCHAPTER XIX--VACCINES
 
                    Part 1--National Vaccine Program
 
Sec. 300aa-1. Establishment

    The Secretary shall establish in the Department of Health and Human 
Services a National Vaccine Program to achieve optimal prevention of 
human infectious diseases through immunization and to achieve optimal 
prevention against adverse reactions to vaccines. The Program shall be 
administered by a Director selected by the Secretary.

(July 1, 1944, ch. 373, title XXI, Sec. 2101, as added Pub. L. 99-660, 
title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756.)


                            Prior Provisions

    A prior section 300aa-1, act July 1, 1944, Sec. 2102, was 
successively renumbered by subsequent acts and transferred, see section 
238a of this title.
    A prior section 2101 of act July 1, 1944, was successively 
renumbered by subsequent acts and transferred, see section 238 of this 
title.


                             Effective Date

    Section 323 of title III of Pub. L. 99-660, as amended by Pub. L. 
100-203, title IV, Sec. 4302(a), Dec. 22, 1987, 101 Stat. 1330-221; Pub. 
L. 102-168, title II, Sec. 201(a), Nov. 26, 1991, 105 Stat. 1102, 
provided that: ``Subtitle 1 of title XXI of the Public Health Service 
Act [part 1 of this subchapter (42 U.S.C. 300aa-1 to 300aa-6)] shall 
take effect on the date of the enactment of this Act [Nov. 14, 1986] and 
parts A and B of subtitle 2 of such title [subparts A and B of part 2 of 
this subchapter (42 U.S.C. 300aa-10 to 300aa-23)] shall take effect on 
October 1, 1988 and parts C and D of such title [subparts C and D of 
part 2 of this subchapter (42 U.S.C. 300aa-25 to 300aa-33)] and this 
title [probably means provisions of title III of Pub. L. 99-660 other 
than those that enacted this subchapter and redesignated former sections 
300aa to 300aa-15 of this title as sections 300cc to 300cc-15 of this 
title; these other provisions amended sections 218, 242c, 262, 286, and 
289f of this title and enacted provisions set out as notes under 
sections 201, 300aa-1, and 300aa-4 of this title] shall take effect on 
the date of the enactment of the Vaccine Compensation Amendments of 1987 
[Dec. 22, 1987].''


                              Severability

    Section 322 of title III of Pub. L. 99-660, as amended by Pub. L. 
101-239, title VI, Sec. 6602, Dec. 19, 1989, 103 Stat. 2293; Pub. L. 
101-502, Sec. 5(g)(1), Nov. 3, 1990, 104 Stat. 1288, provided that:
    ``(a) In General.--Except as provided in subsection (b), if any 
provision [of] part A or B of subtitle 2 of title XXI of the Public 
Health Service Act [subparts A and B of part 2 of this subchapter], as 
added by section 311(a), or the application of such a provision to any 
person or circumstance is held invalid by reason of a violation of the 
Constitution, both such parts shall be considered invalid.
    ``(b) Special Rule.--If any amendment made by section 6601 of the 
Omnibus Budget Reconciliation Act of 1989 [Pub. L. 101-239, amending 
sections 300aa-10 to 300aa-17, 300aa-21, 300aa-23, 300aa-26, and 300aa-
27 of this title] to title XXI of the Public Health Service Act [this 
subchapter] or the application of such a provision to any person or 
circumstance is held invalid by reason of the Constitution, subsection 
(a) shall not apply and such title XXI of the Public Health Service Act 
without such amendment shall continue in effect.''
    [Amendment by section 5(g)(1) of Pub. L. 101-502 to section 322(a) 
of Pub. L. 99-660, set out above, effective Nov. 14, 1986, see section 
5(h) of Pub. L. 101-502, set out as an Effective Date of 1990 Amendment 
note under section 300aa-11 of this title.]


           Evaluation of Program; Study and Report to Congress

    Pub. L. 101-239, title VI, Sec. 6601(t), Dec. 19, 1989, 103 Stat. 
2293, as amended by Pub. L. 102-168, title II, Sec. 201(b), Nov. 26, 
1991, 105 Stat. 1103, directed the Secretary of Health and Human 
Services to evaluate the National Vaccine Injury Compensation Program 
under this subchapter and report results of such study to Committee on 
Energy and Commerce of House of Representatives and Committee on Labor 
and Human Resources of Senate not later than Jan. 1, 1993.


                             Related Studies

    Section 312 of title III of Pub. L. 99-660 directed Secretary of 
Health and Human Services, not later than 3 years after the effective 
date of this title (see Effective Date note above), to conduct, through 
studies by the Institute of Medicine of the National Academy of Sciences 
or other appropriate nonprofit private groups or associations, a review 
of pertussis vaccines and related illnesses and conditions and MMR 
vaccines, vaccines containing material intended to prevent or confer 
immunity against measles, mumps, and rubella disease, and related 
illnesses and conditions, make specific findings and report these 
findings in the Federal Register not later than 3 years after the 
effective date of this title, and at the same time these findings are 
published in the Federal Register, propose regulations as a result of 
such findings, and not later than 42 months after the effective date of 
this title, promulgate such proposed regulations with such modifications 
as may be necessary after opportunity for public hearing.


                      Study of Other Vaccine Risks

    Section 313 of title III of Pub. L. 99-660 provided that:
    ``(a) Study.--
        ``(1) Not later than 3 years after the effective date of this 
    title [see Effective Date note above], the Secretary shall, after 
    consultation with the Advisory Commission on Childhood Vaccines 
    established under section 2119 of the Public Health Service Act 
    [section 300aa-19 of this title]--
            ``(A) arrange for a broad study of the risks (other than the 
        risks considered under section 102 [21 U.S.C. 382]) to children 
        associated with each vaccine set forth in the Vaccine Injury 
        Table under section 2114 of such Act [section 300aa-14 of this 
        title], and
            ``(B) establish guidelines, after notice and opportunity for 
        public hearing and consideration of all relevant medical and 
        scientific information, respecting the administration of such 
        vaccines which shall include--
                ``(i) the circumstances under which any such vaccine 
            should not be administered,
                ``(ii) the circumstances under which administration of 
            any such vaccine should be delayed beyond its usual time of 
            administration, and
                ``(iii) the groups, categories, or characteristics of 
            potential recipients of such vaccine who may be at 
            significantly higher risk of major adverse reactions to such 
            vaccine than the general population of potential recipients.
        ``(2)(A) The Secretary shall request the Institute of Medicine 
    of the National Academy of Sciences to conduct the study required by 
    paragraph (1) under an arrangement by which the actual expenses 
    incurred by such Academy in conducting such study will be paid by 
    the Secretary.
        ``(B) If the Institute of Medicine is unwilling to conduct such 
    study under such an arrangement, the Secretary shall enter into a 
    similar arrangement with other appropriate nonprofit private groups 
    or associations under which such groups or associations will conduct 
    such study.
        ``(C) The Institute of Medicine or other group or association 
    conducting the study required by paragraph (1) shall conduct such 
    studies in consultation with the Advisory Commission on Childhood 
    Vaccines established under section 2119 of the Public Health Service 
    Act [section 300aa-19 of this title].
    ``(b) Revision of Guidelines.--The Secretary shall periodically, but 
at least every 3 years after establishing guidelines under subsection 
(a), review and revise such guidelines after notice and opportunity for 
public hearing and consideration of all relevant medical and scientific 
information, unless the Secretary finds that on the basis of all 
relevant information no revision of such guidelines is warranted and 
publishes such finding in the Federal Register.
    ``(c) Factors Affecting Guidelines.--Guidelines under subsection (a) 
shall take into account--
        ``(1) the risk to potential recipients of the vaccines with 
    respect to which the guidelines are established,
        ``(2) the medical and other characteristics of such potential 
    recipients, and
        ``(3) the risks to the public of not having such vaccines 
    administered.
    ``(d) Dissemination.--The Secretary shall widely disseminate the 
guidelines established under subsection (a) to--
        ``(1) physicians and other health care providers,
        ``(2) professional health associations,
        ``(3) State and local governments and agencies, and
        ``(4) other relevant entities.''


   Review of Warnings, Use Instructions, and Precautionary Information

    Section 314 of title III of Pub. L. 99-660 directed Secretary of 
Health and Human Services, not later than 1 year after the effective 
date of this title (see Effective Date note above) and after 
consultation with Advisory Commission on Childhood Vaccines and with 
other appropriate entities, to review the warnings, use instructions, 
and precautionary information presently issued by manufacturers of 
vaccines set forth in the Vaccine Injury Table set out in section 300aa-
14 of this title and by rule determine whether such warnings, 
instructions, and information adequately warn health care providers of 
the nature and extent of dangers posed by such vaccines, and, if any 
such warning, instruction, or information is determined to be inadequate 
for such purpose in any respect, require at the same time that the 
manufacturers revise and reissue such warning, instruction, or 
information as expeditiously as practical, but not later than 18 months 
after the effective date of this title.


                  Study of Impact on Supply of Vaccines

    Section 316 of title III of Pub. L. 99-660 provided that: ``On June 
30, 1987, and on June 30 of each second year thereafter, the Secretary 
of Health and Human Services shall submit to the Committee on Energy and 
Commerce [now Committee on Commerce] of the House of Representatives and 
the Committee on Labor and Human Resources of the Senate--
        ``(1) an assessment of the impact of the amendments made by this 
    title [enacting this subchapter, amending sections 218, 242c, 262, 
    286, and 289f of this title, redesignating former sections 300aa to 
    300aa-15 of this title as sections 300cc to 300cc-15 of this title, 
    and enacting provisions set out as notes under this section and 
    sections 201 and 300aa-1 of this title] on the supply of vaccines 
    listed in the Vaccine Injury Table under section 2114 of the Public 
    Health Service Act [section 300aa-14 of this title], and
        ``(2) an assessment of the ability of the administrators of 
    vaccines (including public clinics and private administrators) to 
    provide such vaccines to children.''


                      Waiver of Paperwork Reduction

    Section 321 of title III of Pub. L. 99-660 provided that: ``Chapter 
35 of title 44, United States Code, shall not apply to information 
required for purposes of carrying out this title and implementing the 
amendments made by this title [enacting this subchapter, amending 
sections 218, 242c, 262, 286, and 289f of this title, redesignating 
former sections 300aa to 300aa-15 of this title as sections 300cc to 
300cc-15 of this title, and enacting provisions set out as notes under 
sections 201, 300aa-1, and 300aa-4 of this title].''
