[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2659 Engrossed Amendment Senate (EAS)]

103d CONGRESS

  2d Session

                               H. R. 2659

_______________________________________________________________________

                               AMENDMENT
  
  
  
  
  
  
  
  
  
  

                  In the Senate of the United States,

                         March 24 (legislative day, February 22), 1994.
      Resolved, That the bill from the House of Representatives (H.R. 
2659) entitled ``An Act to amend the Public Health Service Act to 
revise and extend programs relating to the transplantation of organs 
and of bone marrow'', do pass with the following

                               AMENDMENT:

            Strike out all after the enacting clause and insert:

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Organ Transplant Program 
Reauthorization Act of 1994''.

SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

    (a) In General.--Subsection (a) of section 371 of the Public Health 
Service Act (42 U.S.C. 273(a)) is amended to read as follows:
    ``(a)(1) The Secretary may make grants for the consolidation and 
expansion of qualified organ procurement organizations described in 
subsection (b).
    ``(2) The Secretary may make grants to, and enter into cooperative 
agreements and contracts with, qualified organ procurement 
organizations described in subsection (b) and other public or nonprofit 
private entities for the purpose of increasing organ donation through--
            ``(A) the planning and conducting of programs to provide 
        information and education to the public on the need for organ 
        donations;
            ``(B) the training of individuals in requesting such 
        donations; or
            ``(C) the provision of technical assistance to organ 
        procurement organizations and other entities in the health care 
        system.
    ``(3)(A) In making awards of grants, cooperative agreements and 
contracts under subparagraphs (A) and (B) of paragraph (2), the 
Secretary shall give priority to carrying out the purpose described in 
such paragraph with respect to minority or other populations for which 
there is a greater degree of organ shortages relative to the general 
population.
    ``(B) In making awards of grants, cooperative agreements and 
contracts under paragraph (2)(C), the Secretary shall give priority to 
carrying out the purpose described in such paragraph with respect to 
organ procurement organizations and hospitals with lower rates of 
procurement relative to other such organizations or hospitals.''.
    (b) Qualified Organ Procurement Organizations.--Section 371(b) of 
such Act (42 U.S.C. 273(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``for which grants may be made under 
                subsection (a)'' and inserting ``described in this 
                section'';
                    (B) by realigning the margin of subparagraph (E) so 
                as to align with the margin of subparagraph (D); and
                    (C) in subparagraph (G)--
                            (i) in the matter preceding clause (i), by 
                        striking ``directors or an advisory board'' and 
                        inserting ``directors (or an advisory board, in 
                        the case of a hospital-based organ procurement 
                        organization established prior to September 1, 
                        1993)''; and
                            (ii) in clause (i)--
                                    (I) by striking ``composed of'' in 
                                the matter preceding subclause (I) and 
                                inserting ``composed of a reasonable 
                                balance of''; and
                                    (II) by inserting before the comma 
                                in subclause (II) the following: ``, 
                                including individuals who have received 
                                a transplant of an organ (or transplant 
                                candidates), and individuals who are 
                                part of the family of an individual who 
                                has donated an organ'';
            (2) by striking paragraph (2);
            (3) by redesignating paragraph (3) as paragraph (2);
            (4) in paragraph (2) (as so redesignated)--
                    (A) by redesignating subparagraphs (B) through (K) 
                as subparagraphs (C) through (L), respectively,
                    (B) by inserting after subparagraph (A) the 
                following new subparagraph:
            ``(B) conduct and participate in systematic efforts, 
        including public education, to increase the number of potential 
        donors,'';
                    (C) by inserting before the comma in subparagraph 
                (F) (as so redesignated) the following: ``, which 
                system shall, at a minimum, allocate each type of organ 
                on the basis of--
                    ``(i) a single list encompassing the entire service 
                area;
                    ``(ii) a list that encompasses at least an entire 
                State; or
                    ``(iii) a list that encompasses an approved 
                alternative local unit (as defined in paragraph (4)),
        of individuals who have been medically referred to a transplant 
        center in the service area of the organization in order to 
        receive a transplant of the type of organ with respect to which 
        the list is maintained;'';
                    (D) by striking subparagraph (I) (as so 
                redesignated) and inserting the following new 
                subparagraph:
            ``(I) be a member of and abide by the rules and 
        requirements of the Organ Procurement and Transplantation 
        Network established under section 372,''; and
                    (E) by striking subparagraph (K) (as so 
                redesignated) and inserting the following new 
                subparagraph:
            ``(K) evaluate annually, and report to the Organ 
        Procurement and Transplantation Network established under 
        section 372, on the effectiveness of the organization in 
        acquiring potentially available organs, particularly among 
        minority populations, and the variation of procurement across 
        hospitals within the organ procurement organization region, and 
        identify a plan to increase procurement, particularly among 
        minority populations and other populations for which there is a 
        greater degree of organ shortages relative to the general 
        population, and at hospitals with low rates of procurement, 
        and''; and
            (5) by adding at the end thereof the following new 
        paragraphs:
    ``(3)(A) The Office of Technology Assessment shall conduct a study 
for the purpose of defining--
            ``(i) the appropriate standards by which to judge the 
        quality of performance of organ procurement organizations; and
            ``(ii) the proper criteria for a determination of 
        inadequate service from an organ procurement organization.
    ``(B) Not later than 2 years after the date of enactment of this 
paragraph, the Office of Technology Assessment shall complete the study 
required under subparagraph (A) and prepare and submit to the Committee 
on Labor and Human Resources of the Senate, the Committee on Energy and 
Commerce of the House of Representatives, and the Secretary, a report 
describing the findings made as a result of the study.
    ``(C) For purposes of this paragraph the term `organ' means a human 
kidney, liver, heart, lung, pancreas, and any other human organ or 
tissue specified by the Secretary for purposes of this paragraph.
    ``(4)(A) As used in paragraph (2)(F), the term `alternative local 
unit' means--
            ``(i) a unit composed of two or more contiguous organ 
        procurement organizations; or
            ``(ii) a subdivision of an organ procurement organization 
        that operates as a distinct procurement and distribution unit 
        as a result of special geographic, rural, or minority 
        population concerns but that is not composed of any subunit of 
        a metropolitan statistical area.
    ``(B) The Organ Procurement and Transplantation Network shall make 
recommendations to the Secretary concerning the approval or denial of 
alternative local units. The Network shall assess whether the 
alternative local units will better promote organ donation and the 
equitable allocation of organs.
    ``(C) The Secretary shall approve or deny any alternative local 
unit principle or designation recommended by the Network. If the 
Secretary does not provide otherwise prior to the expiration of the 90-
day period beginning on the date on which the application is submitted, 
the recommendations of the Network under subparagraph (B) with respect 
to the application of the alternative local unit shall go into 
effect.''.
    (c) Effective Date.--The amendments made by subsection (b)(5) shall 
apply to organ procurement organizations beginning January 1, 1995.

SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

    Section 372(b) of the Public Health Service Act (42 U.S.C. 274(b)) 
is amended--
            (1) in paragraph (1)(B)--
                    (A) in clause (i)--
                            (i) by striking ``(including organizations 
                        that have received grants under section 371)''; 
                        and
                            (ii) by striking ``; and'' at the end 
                        thereof and inserting ``(including both 
                        individuals who have received a transplant of 
                        an organ (or transplant candidates), and 
                        individuals who are part of the family of 
                        individuals who have donated an organ, the 
                        number of whom shall make up not less than 40 
                        percent of the total number of board members); 
                        and''; and
                    (B) in clause (ii), by inserting ``including a 
                patient affairs committee'' after ``committees,''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking clause (i) and 
                inserting the following new clause:
                    ``(i) with respect to each type of transplant, a 
                national list of individuals who have been medically 
                referred to receive a transplant of the type of organs 
                with respect to which the list is maintained (which 
                list shall include the names of all individuals 
                included on lists in effect under section 371(b)(2)(F), 
                and'';
                    (B) in subparagraph (B), by inserting ``, including 
                requirements under section 371(b),'' after ``membership 
                criteria'';
                    (C) by redesignating subparagraphs (E) through (L), 
                as subparagraphs (F) through (M), respectively;
                    (D) by inserting after subparagraph (D), the 
                following new subparagraph:
            ``(E) assist organ procurement organizations in the 
        equitable distribution of organs among transplant patients,'';
                    (E) in subparagraph (K) (as so redesignated), by 
                striking ``and'' at the end thereof;
                    (F) in subparagraph (L) (as so redesignated), by 
                striking the period and inserting ``, including making 
                recommendations to organ procurements organizations and 
                the Secretary based on the annual reports required 
                under section 371(b)(2)(K),'';
                    (G) in subparagraph (M) (as so redesignated), by 
                striking the period and inserting a comma; and
                    (H) by adding at the end thereof the following new 
                subparagraphs:
            ``(N) submit to the Secretary for review and approval any 
        change in the amount of fees imposed by the Network for the 
        registration of individuals on the lists maintained under 
        subparagraph (A)(i), such change to be considered as approved 
        if the Secretary does not provide otherwise prior to the 
        expiration of the 90-day period beginning on the date on which 
        the change is submitted to the Secretary,
            ``(O) make available to the Secretary such information, 
        books, and records regarding the Network as the Secretary may 
        require,
            ``(P) submit to the Secretary, on an annual basis, a report 
        on the clinical and scientific status of the organ 
        transplantations, and
            ``(Q) meet such other criteria regarding compliance with 
        this part as the Secretary may establish.''.

SEC. 4. STUDY BY GENERAL ACCOUNTING OFFICE.

    Section 377 of the Public Health Service Act (42 U.S.C. 274f) is 
amended to read as follows:

``SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE.

    ``(a) Study.--
            ``(1) In general.--The Comptroller General of the United 
        States shall conduct a study for the purpose of determining and 
        making recommendations concerning--
                    ``(A) the composition of the boards of directors of 
                organ procurement organizations and of the Organ 
                Procurement and Transplantation Network on the date of 
                enactment of this section, and the effect of the Organ 
                Transplant Program Reauthorization Act of 1994 on the 
                composition and functioning of such boards;
                    ``(B)(i) the number and percentage of cadaveric 
                organ transplants for foreign nationals and nonresident 
                aliens categorized by organ procurement organization 
                and by transplant center and information on any 
                reciprocal agreements between organ procurement 
                organizations and foreign countries or territories;
                    ``(ii) the number and percent of the organizations 
                referred to in clause (i) above the organ procurement 
                transplant network guideline of 10 percent; and
                    ``(III) any information on the current rate of 
                organ donation by individuals other than United States 
                citizens or legal residents;
                    ``(C) organ donation rates and the impact of 
                various organ allocation systems on organ procurement 
                rates; and
                    ``(D) the equitable allocation of organs 
                nationwide, including an analysis of the relative 
                probability of receiving an organ for patients with 
                similar characteristics for each category of 
                transplanted organ by organ procurement organization 
                and recommendations for developing a regional 
                allocation system in order to ensure that--
                            ``(i) patients in one region have an 
                        equivalent probability of receiving an organ as 
                        do patients with similar characteristics in 
                        another region; and
                            ``(ii) patients within a region have an 
                        equivalent probability of receiving an organ as 
                        do other patients with similar characteristics 
                        in that region.
            ``(2) Equitable allocation.--In carrying out paragraph (1) 
        with respect to subparagraph (D), the Comptroller General 
        shall--
                    ``(A) recommend regions for allocating organs to 
                encompass as large a geographic area as is practical, 
                taking into account medical appropriateness, and the 
                geographic proximity of patients with comparable 
                priority for receiving an organ;
                    ``(B) take into account the impact on organ 
                donation and procurement rates; and
            ``(C) consult with experts in the area of organ allocation 
        and organ donations and consider their recommendations 
        regarding the establishment of regions in the country for the 
        purpose of allocating organs.
    ``(b) Report.--Not later than 2 years after the date of enactment 
of the Organ Transplant Program Reauthorization Act of 1994, the 
Comptroller General of the United States shall complete the study 
required under subsection (a) and prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives, and to the 
Committee on Labor and Human Resources of the Senate, a report 
describing the findings made as a result of the study.''.

SEC. 5. GENERAL PROVISIONS.

    (a) Limitation.--Section 374(b) of the Public Health Service Act 
(42 U.S.C. 274b(b)) is amended--
            (1) by striking paragraph (2);
            (2) by redesignating paragraph (3) as paragraph (2); and
            (3) in paragraph (2) (as so redesignated), by striking 
        ``371(a)(3)'' and inserting ``371(a)(2)''.
    (b) Repeal.--Section 376 of the Public Health Service Act (42 
U.S.C. 274d) is repealed.
    (c) Transfer.--Section 378 of the Public Health Service Act (42 
U.S.C. 274g) is amended--
            (1) by transferring such section to part H of title III; 
        and
            (2) by inserting such section after section 377.
    (d) Authorization of Appropriations.--Section 378 of the Public 
Health Service Act (42 U.S.C. 274g) is amended by striking ``1991'' and 
all that follows through the period and inserting ``1994, and such sums 
as may be necessary for each of the fiscal years 1995 and 1996.''.

SEC. 6. COMPREHENSIVE CHILD IMMUNIZATION.

    (a) Short Title; References and Purpose.--
            (1) Short title.--This section may be cited as the 
        ``Comprehensive Child Immunization Act of 1994''.
            (2) References.--Except as otherwise expressly provided, 
        whenever in this section an amendment or repeal is expressed in 
        terms of an amendment to, or repeal of, a section or other 
        provision, the reference shall be considered to be made to a 
        section or other provision of the Public Health Service Act (42 
        U.S.C. 201 et seq.).
            (3) Purpose.--It is the purpose of this section to ensure 
        that children in the United States are appropriately immunized 
        against vaccine preventable infectious diseases at the earliest 
        appropriate age.
    (b) Monitoring of Childhood Immunizations.--Title XXI of the Public 
Health Service Act (42 U.S.C. 300aa-1 et seq.) is amended by adding at 
the end thereof the following new subtitle:

  ``Subtitle 3--Improved Immunization Delivery and Monitoring Systems

             ``Part A--List of Vaccines and Administration

``SEC. 2141. LIST OF PEDIATRIC VACCINES; SCHEDULE FOR ADMINISTRATION.

    ``(a) Recommended Pediatric Vaccines.--
            ``(1) In general.--The Secretary shall establish a list of 
        the vaccines that the Secretary recommends for administration 
        to all children for the purpose of immunizing the children, 
        subject to such contraindications for particular medical 
        categories of children as the Secretary may establish under 
        subsection (b)(1)(D). The Secretary shall periodically review 
        the list, and shall revise the list as appropriate.
            ``(2) Rule of construction.--
                    ``(A) The list of vaccines specified in 
                subparagraph (B) is deemed to be the list of vaccines 
                maintained under paragraph (1).
                    ``(B) The list of vaccines specified in this 
                subparagraph is the list of vaccines that, for purposes 
                of paragraph (1), is established (and periodically 
                reviewed and as appropriate revised) by the Advisory 
                Committee on Immunization Practices, an advisory 
                committee established by the Secretary, acting through 
                the Director of the Centers for Disease Control and 
                Prevention.
    ``(b) Recommended Schedule for Administration.--
            ``(1) In general.--Subject to paragraph (2), in the case of 
        a pediatric vaccine, the Secretary shall establish (and 
        periodically review and as appropriate revise) a schedule of 
        nonbinding recommendations for the following:
                    ``(A) The number of immunizations with the vaccine 
                that children should receive.
                    ``(B) The ages at which children should receive the 
                immunizations.
                    ``(C) The dose of vaccine that should be 
                administered in the immunizations.
                    ``(D) Any contraindications regarding 
                administration of the vaccine.
                    ``(E) Such other guidelines as the Secretary 
                determines to be appropriate with respect to 
                administering the vaccine to children.
            ``(2) Variations in medical practice.--In establishing and 
        revising a schedule under paragraph (1), the Secretary shall 
        ensure that, in the case of the pediatric vaccine involved, the 
        schedule provides for the full range of variations in medical 
        judgment regarding the administration of the vaccine, subject 
        to remaining within medical norms.
            ``(3) Rule of construction.--
                    ``(A) The schedule specified in subparagraph (B) is 
                deemed to be the schedule maintained under paragraph 
                (1).
                    ``(B) The schedule specified in this subparagraph 
                is the schedule that, for purposes of paragraph (1), is 
                established (and periodically reviewed and as 
                appropriate revised) by the advisory committee 
                specified in subsection (a)(2)(B).
    ``(c) Generally Applicable Rules of Construction.--This section 
does not supersede any State law or requirements with respect to 
receiving immunizations (including any such law relating to religious 
exemptions or other exemptions under such State laws).
    ``(d) Issuance of List and Schedules.--Not later than 180 days 
after the date of the enactment of this section, the Secretary shall 
establish the initial list required in subsection (a) and the schedule 
required in subsection (b).

      ``Part B--State Registry System for Immunization Information

``SEC. 2145. PURPOSE.

    ``It is the purpose of this part to authorize the Secretary, in 
consultation with State public health officials, to establish State 
registry systems to monitor the immunization status of all children.

``SEC. 2146. GRANTS FOR IMMUNIZATION REGISTRIES.

    ``(a) In general.--For the purpose described in section 2145, the 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention, shall make an allotment each fiscal year for 
each State in an amount determined in accordance with section 2151. The 
Secretary shall make a grant to the State of the allotment made for the 
State for the fiscal year if the State submits to the Secretary an 
application in accordance with section 2150 on behalf of the chief 
executive officer of such State.
    ``(b) Design of State Registries.--To carry out the purpose 
described in section 2145, a State registry established under this part 
shall be designed to--
            ``(1) provide accurate and up to date surveillance data 
        regarding immunization rates at the State and local levels;
            ``(2) assist in identifying localities with inadequate 
        immunization rates to target for necessary remedial assistance;
            ``(3) assist in the effective administration and management 
        of immunization programs at State and local levels by providing 
        data to guide immunization program efforts;
            ``(4) assist the State in providing and receiving 
        information on the immunization status of children who move 
        across geographic boundaries that are covered by different 
        State or local registries; and
            ``(5) facilitate the linkage of vaccine dosage information 
        to adverse events reported to the Centers for Disease Control 
        and Prevention under section 2125(b) and disease outbreak 
        patterns, for the purpose of monitoring vaccine safety and 
        effectiveness.
    ``(c) Eligible Use of Funds.--The Secretary may make a grant under 
subsection (a) only if the State agrees to expend the grant for the 
purpose of--
            ``(1) collecting the data described in section 2147;
            ``(2) operating registries to maintain the data (and 
        establishing such registries, in the case of a State that is 
        not operating such a registry);
            ``(3) utilizing the data to monitor the extent to which 
        children have received immunizations in accordance with the 
        schedule established under section 2141;
            ``(4) notifying parents, as appropriate, if children have 
        not received immunizations in accordance with such schedule;
            ``(5) coordinating and exchanging information with other 
        State registries to allow the monitoring of the immunization 
        status of children changing State of residence; and
            ``(6) such other activities as the Secretary may authorize 
        with respect to achieving the objectives established by the 
        Secretary for the year 2000 for the immunization status of 
        children in the United States.
    ``(d) Requirement Regarding State Law.--
            ``(1) In general.--The Secretary may make a grant under 
        subsection (a) only if the State involved--
                    ``(A) provides assurances satisfactory to the 
                Secretary that, not later than October 1, 1996, the 
                State will be operating a registry in accordance with 
                this part, including having in effect such laws and 
                regulations as may be necessary to so operate such a 
                registry;
                    ``(B) agrees that, prior to such date, the State 
                will make such efforts to operate a registry in 
                accordance with this part as may be authorized in the 
                law and regulations of the State; and
                    ``(C) has in effect such laws and regulations as 
                may be necessary to ensure the following safeguards for 
                the rights of parents:
                            ``(i) An exemption for the parent, upon the 
                        request of the parent, from the requirements 
                        established by the State, pursuant to this 
                        part, for the collection of data described in 
                        subsections (b) and (c) of section 2147, or the 
                        collection of any other data regarding any 
                        child of the parent that the State may require 
                        for incorporation in the State immunization 
                        registry.
                            ``(ii) Restrictions ensuring that no 
                        information relating to a child or to the 
                        parent or guardian of a child that is collected 
                        or maintained by the State immunization 
                        registry pursuant to this part, or the national 
                        immunization surveillance program established 
                        under section 2153, will be used as a basis for 
                        the criminal prosecution or the commencement of 
                        a criminal investigation of a parent or 
                        guardian.
            ``(2) Rules of construction.--
                    ``(A) With respect to the agreements made by a 
                State under this part, other than paragraph (1)(B), the 
                Secretary may require compliance with the agreements 
                only to the extent consistent with such paragraph.
                    ``(B) The provisions of this part do not authorize 
                the Secretary, as a condition of the receipt of a grant 
                under subsection (a) by a State, to prohibit the State 
                from providing any parent, upon the request of the 
                parent, with an exemption from the requirements 
                established by the State pursuant to this part for the 
                collection of data regarding any child of the parent.

``SEC. 2147. REGISTRY DATA.

    ``(a) In General.--For purposes of section 2146(c)(1), the data 
described in this section are the data described in subsection (b) and 
the data described in subsection (c).
    ``(b) Data Regarding Birth of Child.--With respect to the birth of 
a child, the data described in this subsection is as follows:
            ``(1) The name of each child born in the State involved 
        after the date of the implementation of the registry (in no 
        event shall such date be later than October 1, 1996).
            ``(2) Demographic data on the child.
            ``(3) The name of one or both of the parents of the child. 
        If the child has been given up for adoption, any information 
        regarding the identity of the birth parent or parents of the 
        child may not be entered into the registry, or if entered, 
        shall be deleted.
            ``(4) The address, as of the date of the birth of the 
        child, of each parent whose name is received in the registry 
        pursuant to paragraph (3).
    ``(c) Data Regarding Individual Immunizations.--With respect to a 
child to whom a pediatric vaccine is administered in the State 
involved, the data described in this subsection is as follows:
            ``(1) The name, age, and address of the child.
            ``(2) The date on which the vaccine was administered to the 
        child.
            ``(3) The name and business address of the health care 
        provider that administered the vaccine.
            ``(4) The address of the facility at which the vaccine was 
        administered.
            ``(5) The name and address of one or both parents of the 
        child as of the date on which the vaccine was administered, if 
        such information is available to the health care provider.
            ``(6) The type of vaccine.
            ``(7) The lot number or other information identifying the 
        particular manufacturing batch of the vaccine.
            ``(8) The dose of vaccine that was administered.
            ``(9) A notation of the presence of any adverse medical 
        reactions that the child experienced in relation to the vaccine 
        and of which the health care provider is aware, in accordance 
        with section 2125.
            ``(10) The presence of contraindications noted by the 
        health care provider with respect to administration of the 
        vaccine to the child.
            ``(11) Such other data regarding immunizations for the 
        child, including identifying data, as the Secretary, in 
        consultation with State public health officials, may require 
        consistent with applicable law (including social security 
        account numbers furnished pursuant to section 205(c)(2)(E) of 
        the Social Security Act).
    ``(d) Limitation.--The Secretary may not establish information 
reporting requirements in addition to those described in subsection (c) 
if such requirements are unduly burdensome.
    ``(e) Date Certain for Submission to Registry.--The Secretary may 
make a grant under section 2146 only if the State involved agrees to 
ensure that, with respect to a child--
            ``(1) the data described in subsection (b) are submitted to 
        the registry under such section as soon as possible but in no 
        event later than 8 weeks after the date on which the child is 
        born; and
            ``(2) the data described in subsection (c) with respect to 
        a vaccine are submitted to such registry as soon as possible 
        but in no event later than 4 weeks after the date on which the 
        vaccine is administered to the child.
    ``(f) Uniformity in Methodologies.--The Secretary shall, in 
consultation with State public health officials, establish standards 
regarding the methodologies used in establishing and operating 
registries under section 2146, and may make a grant under such section 
only if the State agrees to comply with the standards. The Secretary 
shall provide maximum flexibility to the States while also retaining a 
reasonable degree of uniformity among the States in such methodologies 
for the purpose of ensuring the utility, comparability, and exchange of 
the data maintained in such registries.
    ``(g) Coordination Among States.--The Secretary may make a grant 
under section 2146 to a State only if, with respect to the operation of 
the registry of the State under such section, the State agrees to 
transfer that information contained in the State registry pursuant to 
section 2146 to other States upon the request of such States for such 
information.

``SEC. 2148. FEDERAL STANDARDS ON CONFIDENTIALITY.

    ``(a) Establishment.--
            ``(1) In general.--The Secretary, in consultation with the 
        States, shall by regulation establish standards providing for 
        maintaining the confidentiality of the identity of individuals 
        with respect to whom data are maintained in registries under 
        section 2146. Such standards shall, with respect to a State, 
        provide that the State is to have in effect laws or regulations 
        regarding such confidentiality, including appropriate penalties 
        for violation of the laws. The Secretary may make a grant under 
        such section only if the State involved agrees to comply with 
        the standards.
            ``(2) Use of disclosure.--
                    ``(A) No personally identifiable information 
                relating to a child or to the parent or guardian of 
                such child that is collected or maintained by the State 
                registry may be used or disclosed by any holder of such 
                information except as permitted for--
                            ``(i) the monitoring of a child's 
                        immunization status;
                            ``(ii) oversight, audit, and evaluation of 
                        the immunization delivery and registry systems;
                            ``(iii) activities relating to establishing 
                        and maintaining a safe and effective supply of 
                        recommended childhood vaccine;
                            ``(iv) processing of insurance claims for 
                        payment for vaccine administration (but only to 
                        the extent necessary for processing claims); 
                        and
                            ``(v) administration of the National 
                        Vaccine Injury Compensation Program under 
                        subtitle 2.
                    ``(B) Information regarding immunizations provided 
                as described in subparagraph (A)(i) may be used or 
                disclosed only with the written authorization of the 
                individual to whom it refers or to the parent with 
                custody of such individual.
    ``(b) Use of Social Security Account Numbers.--Any usage or 
disclosure of data in registries under section 2146 that consists of 
social security account numbers and related information which is 
otherwise permitted under this part may be exercised only to the extent 
permitted under section 205(c)(2)(E) of the Social Security Act. For 
purposes of the preceding sentence, the term `related information' has 
the meaning given such term in clause (iv)(II) of such section.

``SEC. 2149. PROVIDER PARTICIPATION.

    ``(a) In General.--The State shall monitor and enforce compliance 
by health care providers with the requirements of sections 2147 and 
2148 and section 2155(b) for all doses of pediatric vaccine 
administered in the State. The State shall establish procedures 
satisfactory to the Secretary for discontinuing the distribution of 
federally purchased or State purchased vaccine for any health care 
provider who fails to comply with the requirements of section 2147 and 
for reinstating such vaccine supply to such provider upon receiving 
from such provider--
            ``(1) the reports necessary to make current and complete 
        the information that would have been furnished to the State 
        registry between the dates of the provider's termination and 
        reinstatement; and
            ``(2) satisfactory assurances regarding the provider's 
        future compliance.
    ``(b) Reports to Secretary.--The Secretary may make a grant under 
section 2146 only if the State involved agrees to submit to the 
Secretary such reports as the Secretary determines to be appropriate 
with respect to the activities of the State under this part.

``SEC. 2150. APPLICATION FOR GRANT.

    ``An application by a State for a grant under section 2146 is in 
accordance with this section if the application--
            ``(1) is submitted not later than the date specified by the 
        Secretary;
            ``(2) contains each agreement required in this part;
            ``(3) contains any information required in this part to be 
        submitted to the Secretary; and
            ``(4) is in such form, is made in such manner, and contains 
        such agreements, assurances, and information as the Secretary 
        determines to be necessary to carry out this part.

``SEC. 2151. DETERMINATION OF AMOUNT OF ALLOTMENT.

    ``The Secretary shall determine the amount of the allotments 
required in section 2146 for States for a fiscal year in accordance 
with a formula established by the Secretary that allots the amounts 
appropriated under section 2152 for the fiscal year on the basis of the 
costs of the States in establishing and operating registries under 
section 2146.

``SEC. 2152. AUTHORIZATION OF APPROPRIATIONS.

    ``For the purpose of carrying out this part, other than section 
2153, there are authorized to be appropriated $152,000,000 for fiscal 
year 1994, $125,000,000 for fiscal year 1995, and $35,000,000 for each 
of the fiscal years 1996 through 1999.

``SEC. 2153. NATIONAL IMMUNIZATION SURVEILLANCE PROGRAM.

    ``(a) In General.--The Secretary shall establish a national 
immunization surveillance program for the purpose of assessing the 
effects of the programs and activities provided for in this subtitle 
towards appropriately immunizing children and facilitating State 
immunization registries. The national immunization surveillance program 
shall--
            ``(1) provide technical assistance to States for the 
        development of vaccination registries and monitoring systems; 
        and
            ``(2) receive aggregate epidemiologic data (that is in a 
        format that is not person specific) collected by States as 
        provided for in section 2147 at intervals determined 
        appropriate by the Secretary for the purpose of--
                    ``(A) compiling accurate and up-to-date 
                surveillance data regarding immunization rates at the 
                State level in order to assess the progress made 
                towards achieving nationally established immunization 
                goals;
                    ``(B) assisting in the effective administration and 
                management of immunization programs at the State level 
                by providing technical assistance to guide immunization 
                program efforts at the request of the State;
                    ``(C) providing technical assistance to States and 
                localities to facilitate monitoring the immunization 
                status of children who move across geographic 
                boundaries that are covered by different State or local 
                registries at the request of such States or localities; 
                and
                    ``(D) monitoring the safety and effectiveness of 
                vaccines by linking vaccine dosage information with 
                adverse events reporting under section 2125(b) and 
                disease outbreak patterns.
    ``(b) Rule of Construction.--Nothing in this subtitle shall be 
construed to authorize the release of person specific information to 
the Secretary for the purpose of immunization surveillance.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section in 
each of the fiscal years 1994 through 1999.

``SEC. 2154. REPORT.

    ``Not later than January 1, 1995, and biennially thereafter, the 
Secretary shall prepare and submit to the appropriate committees of 
Congress a report concerning the planning, development, operation and 
effectiveness of the national immunization surveillance program and the 
State immunization registries.

   ``Part C--Distribution of Vaccines, Public Outreach and Education

``SEC. 2155. DISTRIBUTION OF VACCINES.

    ``(a) In General.--
            ``(1) Health care providers.--The Secretary shall provide 
        for the distribution, without charge, of recommended pediatric 
        vaccines (in accordance with section 2141) purchased by the 
        Secretary to health care providers who serve children and who--
                    ``(A) are members of a uniformed service, or are 
                officers or employees of the United States;
                    ``(B) are health centers (as defined in section 
                2163); or
                    ``(C) provide services under section 503 of the 
                Indian Health Care Improvement Act or pursuant to a 
                contract under section 102 of the Indian Self 
                Determination Act.
            ``(2) States.--The Secretary shall provide for the 
        distribution, without charge, of those recommended pediatric 
        vaccines that are purchased by the Secretary and provided to 
        States for the purposes of immunizing medicaid-eligible 
        children, and additional vaccines that may be purchased by the 
        Secretary for children within those States.
    ``(b) Duties of Health Care Providers.--
            ``(1) Free provision to children.--A health care provider 
        or entity receiving vaccine under this section may use such 
        vaccine only for administration to children and may not impose 
        a charge for such vaccine. A provider or health care entity may 
        impose a fee that reflects actual regional costs as determined 
        by the Secretary for the administration of such vaccine, except 
        that a provider may not deny a child a vaccination due to the 
        inability of the child's parent to pay an administration fee.
            ``(2) Reporting requirements.--A health care provider 
        receiving vaccine under this section shall report the 
        information required under section 2147 to the applicable State 
        registry operated pursuant to a grant under section 2146 if 
        such State registry exists. The provider shall additionally 
        report to such State registry any occurrence reported to the 
        Secretary pursuant to section 2125(b). The provider shall also 
        provide regular and periodic estimates to the State of the 
        provider's future dosage needs for recommended childhood 
        vaccines distributed under this section. All reports shall be 
        made with such frequency and in such detail as the Secretary, 
        in consultation with State public health officials, may 
        prescribe.

``SEC. 2156. IMPROVED IMMUNIZATION DELIVERY, OUTREACH AND EDUCATION.

    ``(a) Federal Efforts.--The Secretary, acting through the Centers 
for Disease Control and Prevention and in conjunction with State health 
officials and other appropriate public and private organizations, shall 
conduct the following activities to improve Federal, State and local 
vaccine delivery systems and immunization outreach and education 
efforts:
            ``(1) National public awareness campaign.--
                    ``(A) In general.--The Secretary, in conjunction 
                with State health officials and other appropriate 
                public and private organizations, shall develop and 
                implement a National Immunization Public Awareness 
                Campaign to assist families (through bilingual means if 
                necessary) of children under the age of 2 years, and 
                expectant parents, in obtaining knowledge concerning 
                the importance of having their children immunized and 
                in identifying the vaccines, schedules for 
                immunization, and vaccine provider locations, 
                appropriate with respect to their children.
                    ``(B) Implementation.--In implementing the Campaign 
                under subparagraph (A), the Secretary shall ensure 
                that--
                            ``(i) new and innovative methods are 
                        developed and utilized to publicly advertise 
                        the need to have children immunized in a timely 
                        manner;
                            ``(ii) print, radio and television media 
                        are utilized to convey immunization information 
                        to the public; and
                            ``(iii) with respect to immunization 
                        information, efforts are made to target 
                        pregnant women and the parents of children 
                        under the age of 2.
            ``(2) Interagency committee on immunization.--The 
        Secretary, in conjunction with the Secretary of Agriculture, 
        the Secretary of Housing and Urban Development, and the 
        Secretary of Education, shall carry out activities through the 
        Interagency Committee on Immunization to incorporate 
        immunization status assessments and referral services as an 
        integral part of the process by which individuals apply for 
        assistance under--
                    ``(A) the food stamp program under the Food Stamp 
                Act of 1977;
                    ``(B) section 17 of the Child Nutrition Act of 
                1966;
                    ``(C) the Head Start Act;
                    ``(D) part A of title IV of the Social Security 
                Act;
                    ``(E) title XIX of the Social Security Act;
                    ``(F) any of the housing assistance laws of the 
                United States; and
                    ``(G) other programs determined appropriate by any 
                of the Secretaries described in this paragraph.
            ``(3) Expanded opportunity for national service.--The 
        Secretary, in conjunction with the Commission on National and 
        Community Service and other independent agencies, is encouraged 
        to develop opportunities for participants in national and 
        community service programs to contribute to local initiatives 
        for the improvement of immunization services, including public 
        outreach and education efforts.
    ``(b) Grants to States.--
            ``(1) In general.--
                    ``(A) The Secretary may award grants to States to 
                enable such State to develop, revise and implement 
                immunization improvement plans as described in 
                paragraph (2).
                    ``(B) To be eligible to receive a grant under 
                subparagraph (A), a State shall prepare and submit to 
                the Secretary an application at such time, in such 
                manner, and containing such information as the 
                Secretary may require.
            ``(2) Design.--A State immunization improvement plan shall 
        be designed to improve immunization delivery, outreach, 
        education and coordination within the State. Such plan shall 
        provide for the creation of--
                    ``(A) a vaccine provider education campaign and the 
                distribution of any other materials determined to be 
                appropriate by State health officials--
                            ``(i) to enable such providers to make the 
                        best use of vaccination opportunities; and
                            ``(ii) to educate such providers concerning 
                        their obligation to report immunization 
                        information with respect to their patients to 
                        State registries;
                    ``(B) expanded capacity for the delivery of 
                immunizations through--
                            ``(i) increasing the number or type of 
                        facilities through which vaccines may be made 
                        available and the capacity of such facilities 
                        to immunize more children;
                            ``(ii) developing alternative methods of 
                        delivering vaccines, such as mobile health 
                        clinics;
                            ``(iii) increasing the number of hours 
                        during which vaccines are made available by 
                        providers within the State; or
                            ``(iv) coordinating with federally 
                        qualified health centers to reach and immunize 
                        underserved children through education, 
                        outreach, tracking, and the provision of 
                        services;
                except that, the Secretary may waive any specific 
                requirement of this subparagraph if the Secretary 
                determines that State immunization delivery efforts are 
                sufficient without the imposition of such requirement;
                    ``(C) population-based assessment criteria through 
                which the State is able to assess the effectiveness of 
                immunization activities in the State, which may be 
                fulfilled through the implementation of a State 
                immunization registry under section 2146;
                    ``(D) a public awareness campaign, in conjunction 
                with the National Campaign established under subsection 
                (a)(1), to provide parents with information about the 
                importance of immunization, the types and schedules for 
                the administration of vaccines, and the locations of 
                vaccines providers;
                    ``(E) coordinated community outreach activities 
                among public or private health programs, including 
                local health departments and health centers, and other 
                public or private entities, to encourage and facilitate 
                the ability of parents to obtain immunization services 
                for their children; and
                    ``(F) other activities that are not inconsistent 
                with the purposes of this subtitle, subject to the 
                approval of the Secretary.
            ``(3) Immunization improvement plan approval.--
                    ``(A) Goals.--As part of the immunization 
                improvement plan of a State, the State shall establish 
                immunization rate goals for children residing within 
                the State.
                    ``(B) Approval.--The immunization improvement plan 
                developed by a State under this subsection shall be 
                submitted to the Secretary for approval prior to the 
                distribution of grant funds to the States under this 
                subsection. The Secretary shall periodically review the 
                progress that the State has made under such plan in 
                achieving the goals established under subparagraph (A).
                    ``(C) Distribution of grants.--In awarding grants 
                under this section, the Secretary shall ensure that 
                grant awards will be equitably distributed between 
                rural and urban areas. In determining such 
                distribution, the Secretary shall take into account the 
                added costs of supporting the health care delivery 
                infrastructure in sparsely populated areas. The 
                Secretary shall give special consideration to those 
                States that have low childhood immunization rates and 
                that submit plans that demonstrate the State's 
                substantial effort and commitment to improving such 
                rates.
                    ``(D) Reporting.--A State shall annually prepare 
                and submit to the Director of the Centers for Disease 
                Control and Prevention a report concerning the 
                implementation of the State immunization improvement 
                plan.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $250,000,000 for fiscal year 
1994, and such sums as may be necessary for each of the fiscal years 
1995 through 1999.

``SEC. 2157. PERFORMANCE BASED GRANT PROGRAM.

    ``(a) Annual Report.--Not later than July 1 of each year, a State 
shall prepare and submit to the Director of the Centers for Disease 
Control and Prevention a report that contains an estimate (based on a 
base population sample) of the percentage of 2 year old residents of 
the State who have been fully immunized as described in subsection (c).
    ``(b) Payments to States.--
            ``(1) In general.--Subject to the availability of 
        appropriations, the Secretary shall provide to a State that has 
        submitted an annual report under subsection (a) that 
        demonstrates that the State has fully immunized at least 50 
        percent of the 2 year old residents of that State, with respect 
        to the year for which the report was prepared, a payment in an 
        amount equal to--
                    ``(A) with respect to a State that has demonstrated 
                the full immunization of at least 50 and less than 64 
                percent of all 2 year old residents of the State, $50 
                multiplied by the number of fully immunized 2 year old 
                resident children in excess of the number of children 
                equaling such 50 percent amount;
                    ``(B) with respect to a State that has demonstrated 
                the full immunization of at least 65 and less than 70 
                percent of all 2 year old residents of the State, $75 
                multiplied by the number of fully immunized 2 year old 
                resident children in excess of the number of children 
                equaling such 65 percent amount; and
                    ``(C) with respect to a State that has demonstrated 
                the full immunization of at least 70 and less than 91 
                percent of all 2 year old residents of the State, $100 
                multiplied by the number of fully immunized 2 year old 
                resident children in excess of the number of children 
                equaling such 70 percent amount.
            ``(2) Use of funds.--
                    ``(A) Condition.--As a condition of receiving 
                amounts under this section a State that uses a 
                combination of Federal and State funds in achieving the 
                immunization goals described in paragraph (1) shall 
                agree to reinvest, in activities related to improving 
                immunization services, that percentage of the payments 
                to the State under paragraph (1) that is equal to the 
                amount of Federal contributions to immunization 
                services in the State as compared to the amount of the 
                State contributions to such services.
                    ``(B) Discretionary use.--A State that has 
                demonstrated that the use of State-only funds was 
                responsible for the increase in the immunization rate 
                which qualified such State for payments under paragraph 
                (1), may use amounts awarded under this section for 
                other purposes, at the discretion of the State.
            ``(3) Verification.--Prior to making a payment to a State 
        under this subsection, the Secretary shall, in collaboration 
        with the Centers for Disease Control and Prevention, verify the 
        accuracy of the State report involved.
    ``(c) Definition.--For purposes of this section, the term `fully 
immunized' means a 2 year old child that has received four doses of DTP 
vaccine (diphtheria, tetanus, pertussis), three doses of polio vaccine, 
and one dose of MMR (measles, mumps, rubella) vaccine.

                      ``Part D--General Provisions

``SEC. 2161. REPORT.

    ``Not later than October 1, 1995, and biennially thereafter, the 
Secretary shall prepare and submit to the appropriate committees of 
Congress a report concerning the costs, efficiency, and effectiveness 
of procedures established to deliver vaccine to health care providers.

``SEC. 2162. NATIONAL VACCINE PROGRAM.

    ``The Secretary shall authorize a report to be prepared by the 
National Academy of Sciences concerning the role of the National 
Vaccine Program established under this title in achieving progress 
towards the nationally established immunization goals for the year 
2000, and recommendations with respect to the changes in such Program 
that would facilitate greater progress towards achieving such goals.

``SEC. 2163. DEFINITIONS.

    ``For purposes of this subtitle--
            ``(1) Health care provider.--The term `health care 
        provider', with respect to the administration of vaccines to 
        children, means an entity that is licensed or otherwise 
        authorized for such administration under the law of the State 
        in which the entity administers the vaccine, subject to section 
        333(e).
            ``(2) Health center.--The term `health center' means--
                    ``(A) a federally-qualified health center, as 
                defined in section 1905(l)(2) of the Social Security 
                Act; or
                    ``(B) a public or nonprofit private entity 
                receiving Federal funds under--
                            ``(i) section 329, 330 or 340;
                            ``(ii) section 340A (relating to grants for 
                        health services for residents of public 
                        housing); or
                            ``(iii) section 501(a)(2) of the Social 
                        Security Act (relating to special projects of 
                        regional and national significance).
            ``(3) Immunization.--The term `immunization' means an 
        immunization against a vaccine-preventable disease.
            ``(4) Parent.--The term `parent', with respect to a child, 
        means a legal guardian of the child.
            ``(5) Pediatric vaccine.--The term `pediatric vaccine' 
        means a vaccine included on the list established under section 
        2141.
            ``(6) State.--The term `State' means the 50 States, the 
        District of Columbia, the Commonwealth of Puerto Rico, Guam, 
        American Samoa, the U.S. Virgin Islands, the Republic of the 
        Marshall Islands, Micronesia, the Northern Mariana Islands, and 
        Palau.''.
    (c) National Vaccine Injury Compensation Program Amendments.--
            (1) Amendment of vaccine injury table.--
                    (A) Addition of vaccines.--Section 2114 (42 U.S.C. 
                300aa-14) is amended by adding at the end thereof the 
                following new subsection:
    ``(f) Addition of Vaccines to Table.--
            ``(1) In general.--The Vaccine Injury table contained in 
        subsection (a) shall also include any recommended childhood 
        vaccine included in the list promulgated by the Secretary under 
        section 2141.
            ``(2) Review of information and revision.--Not later than 2 
        years after the addition of a new vaccine to the table 
        contained in subsection (a), and on a regular basis thereafter, 
        the Secretary shall review information obtained under sections 
        2125 and part B of subtitle 3, and based on such review (and 
        other relevant information) shall, as appropriate, develop with 
        respect to such new vaccine--
                    ``(A) revisions with respect to illnesses, 
                disabilities, injuries or conditions covered by such 
                table;
                    ``(B) appropriate specifications of the time period 
                for the first symptom or manifestation of onset or of 
                significant aggravation of such illnesses, 
                disabilities, injuries or condition after vaccine 
                administration, for purposes of receiving compensation 
                under the Program; and
                    ``(C) recommendations as to the amount of tax that 
                should be imposed under section 4131 of the Internal 
                Revenue Code of 1986 for each dose of vaccine.
            ``(3) Limitation.--The Secretary may modify the table 
        contained in subsection (a) pursuant to paragraphs (1) and (2) 
        only in accordance with subsection (c).
            ``(4) Revision.--For purposes of section 2116(b), the 
        addition of vaccine to the table contained in subsection (a) by 
        operation of this subsection shall constitute a revision of the 
        table.''.
                    (B) Attorneys fees.--Section 2115(e) (42 U.S.C. 
                300aa-15(e)) is amended by adding at the end thereof 
                the following new paragraph:
            ``(4) The special master may award reasonable attorneys 
        fees whether or not an election has been made under section 
        2121(a) to file a civil action concerning such petition.''.
                    (C) Consent for annuity.--Subparagraphs (A) and (B) 
                of section 2115(f)(4) are amended by striking ``, with 
                the consent of the petitioner,'' each place that such 
                appears.
                    (C) Time periods for fees and costs.--
                            (i) In general.--Section 2115(e) (42 U.S.C. 
                        300aa-15(e)) (as amended by paragraph (3)) is 
                        further amended by adding at the end thereof 
                        the following new paragraph:
            ``(5) With respect to a petitioners' application for 
        attorneys' fees and costs--
                    ``(A) if the respondent enters no objection to such 
                application within 21 days of the date on which the 
                application was filed (unless such time period is 
                extended by the special master with the consent of the 
                petitioner) the special master shall enter a decision 
                on such application within 30 days of such filing;
                    ``(B) if the respondent files an objection to such 
                application and the special master does not enter a 
                decision with respect to the application within 60 days 
                after the date on which the objection is filed, the 
                special master involved shall, upon the written request 
                of the petitioner, enter a decision within 15 days 
                after the filing of such request; and
                    ``(C) if the respondent files an objection to such 
                application and the petitioner moves to reduce costs 
                and fees as provided for in the objection, the special 
                master shall enter a decision within 5 days after the 
                receipt of the petitioner's motion.
        The chief special master, upon the request of a special master, 
        may waive the time limitations applicable to the special master 
        under this paragraph if the special master demonstrates that 
        complicating factors exist with respect to the issues involved 
        to which the time limitation applies.''.
                    (B) Application.--The amendment made by 
                subparagraph (A) shall apply to all petitioners' 
                applications for attorneys' fees and costs filed under 
                section 2115(e) of the Public Health Service Act which 
                are pending on the date of enactment of this Act.
                    (E) Authorization of appropriations.--Section 
                2115(j) (42 U.S.C. 300aa-15(j)) is amended by striking 
                ``$80,000,000 for each succeeding fiscal year'' and 
                inserting in lieu thereof ``$110,000,000 for each 
                succeeding fiscal year''.
                    (F) Limitation of actions.--Section 2116(b) (42 
                U.S.C. 300aa-16(b)) is amended by striking ``such 
                person may file'' and inserting ``or to significantly 
                increase the likelihood of obtaining compensation, such 
                person may, notwithstanding section 2111(b)(2), file''.
            (2) Extension of time for decision.--
                    (A) Jurisdiction.--Section 2112(d)(3)(D) (42 U.S.C. 
                300aa-12(d)(3)(D)) is amended by striking ``540 days'' 
                and inserting ``30 months (but for not more than 6 
                months at a time)''.
                    (B) Report on collections.--Section 2117 (42 U.S.C. 
                300aa-17) is amended by adding at the end thereof the 
                following new subsection:
    ``(c) Report.--The Attorney General shall, on January 1 of each 
year, prepare and submit to the appropriate committees of Congress a 
report concerning amounts collected under this section.''.
                    (C) Increased responsibilities of commission.--
                Section 2119(f) (42 U.S.C. 300aa-19(f)) is amended--
                            (i) by striking ``and'' at the end of 
                        paragraph (4);
                            (ii) by striking the period at the end of 
                        paragraph (5) and inserting ``, and''; and
                            (iii) by adding at the end thereof the 
                        following new paragraph:
            ``(6) monitor the balance of the Vaccine Injury Trust Fund 
        established by section 9510 of the Internal Revenue Code and, 
        as appropriate, recommend changes in the tax per dose of 
        vaccine imposed under section 4131 of such Code.''.
            (3) Simplification of vaccine information materials.--
                    (A) Information.--Section 2126(b) (42 U.S.C. 300aa-
                26(b)) is amended--
                            (i) by striking ``by rule'' in the matter 
                        preceding paragraph (1);
                            (ii) in paragraph (1), by striking ``90'' 
                        and inserting ``30''; and
                            (iii) in paragraph (2), by striking ``, 
                        appropriate health care providers and parent 
                        organizations''.
                    (B) Requirements.--Section 2126(c) (42 U.S.C. 
                300aa-26(c)) is amended--
                            (i) in the matter preceding paragraph (1), 
                        by inserting ``shall be based on available data 
                        and information,'' after ``such materials''; 
                        and
                            (ii) by striking out paragraphs (1) through 
                        (10) and inserting in lieu thereof the 
                        following new paragraphs:
            ``(1) a concise description of the benefits of the vaccine;
            ``(2) a concise description of the risks associated with 
        the vaccine;
            ``(3) a statement of the availability of the National 
        Vaccine Injury Compensation Program;
            ``(4) a statement of the availability from the Secretary of 
        more detailed written information concerning the information 
        required under paragraphs (1), (2), and (3), that shall be made 
        available to the parent, legal guardian, or other responsible 
        person upon request; and
            ``(5) such other relevant information as determined 
        appropriate by the Secretary.''.
                    (C) Other individuals.--Subsections (a) and (d) of 
                section 2126 (42 U.S.C. 300aa-26(a) and (d)) are 
                amended by inserting ``or to any other individual'' 
                immediately after ``to the legal representative of any 
                child'' each place that such occurs.
                    (D) Provider duties.--Subsection (d) of section 
                2126 (42 U.S.C. 300aa-26(d)) is amended--
                            (i) by striking all after ``subsection 
                        (a),'' the second place it appears in the first 
                        sentence and inserting ``supplemented with 
                        visual presentations or oral explanations, in 
                        appropriate cases.''; and
                            (ii) by striking ``or other information'' 
                        in the last sentence.
            (4) Authorization of appropriations.--Part A of subtitle 2 
        of title XXI (42 U.S.C. 300aa-10 et seq.) is amended by adding 
        at the end thereof the following new section:

                   ``authorization of appropriations

    ``Sec. 2120. (a) Secretary.--For purposes of administering this 
part, there are authorized to be appropriated from the Vaccine Injury 
Compensation Trust Fund established under section 9510(c) of the 
Internal Revenue Code of 1986, to the Secretary, $3,000,000 for each of 
the fiscal years 1994, 1995 and 1996.
    ``(b) Attorney General.--For purposes of administering this part, 
there are authorized to be appropriated from the Vaccine Injury 
Compensation Trust Fund described in subsection (a), to the Attorney 
General, $3,000,000 for each of the fiscal years 1994, 1995 and 1996.
    ``(c) Court of Federal Claims.--For purposes of administering this 
part, there are authorized to be appropriated from the Vaccine Injury 
Compensation Trust Fund described in subsection (a), to the Court of 
Federal Claims, $3,000,000 for each of the fiscal years 1994, 1995 and 
1996.''.
    (d) Miscellaneous Provisions.--Section 317(k) (42 U.S.C. 247b(k)) 
is amended--
            (1) by striking out paragraph (1); and
            (2) by redesignating paragraphs (2) through (5) as 
        paragraphs (1) and (4), respectively.
    (e) Amendments to the Federally Supported Health Centers Assistance 
Act of 1992.--
            (1) Clarification of coverage of officers and employees of 
        clinics.--The first sentence of section 224(g)(1) of the Public 
        Health Service Act (42 U.S.C. 233(g)(1)) is amended by striking 
        ``officer, employee, or contractor'' and inserting the 
        following: ``officer or employee of such an entity, and any 
        contractor''.
            (2) Coverage for services furnished to individuals other 
        than patients of clinic.--Section 224(g) of such Act (42 U.S.C. 
        233(g)(1)), as amended by paragraph (1), is further amended--
                    (A) in the first sentence of paragraph (1), by 
                inserting after ``Service'' the following: ``with 
                respect to services provided to patients of the entity 
                and (subject to paragraph (7)) to certain other 
                individuals''; and
                    (B) by adding at the end the following new 
                paragraph:
    ``(7) For purposes of paragraph (1), an officer, employee, or 
contractor described in such paragraph may be deemed to be an employee 
of the Public Health Service with respect to services provided to 
individuals who are not patients of an entity described in paragraph 
(4) only if the Secretary determines--
            ``(A) that the provision of the services to such 
        individuals benefits health center patients and general 
        populations that could be served by the health center through 
        community-wide intervention efforts within the communities 
        served by such health center, and facilitates the provision of 
        services to health center patients; or
            ``(B) that such services are otherwise required to be 
        provided to such individuals under an employment contract (or 
        other similar arrangement) between the individual and the 
        entity.''.
            (3) Determining compliance of entity with requirements for 
        coverage.--
                    (A) In general.--Section 224(h) of such Act (42 
                U.S.C. 233(h)), as added by section 2(b) of the 
                Federally Supported Health Centers Assistance Act of 
                1992, is amended by striking ``the entity--'' and 
                inserting the following: ``the Secretary, after 
                receiving such assurances and conducting such 
                investigation as the Secretary considers necessary, 
                finds that the entity--''.
                    (B) Finding.--Section 224 of such Act (42 U.S.C. 
                233) is amended by adding at the end thereof the 
                following new subsection:
    ``(l) With respect to subsection (h), the finding of the Secretary 
that an entity meets all of the requirements under such subsection 
shall apply for the period specified by the Secretary, and shall be 
binding for all parties unless the Secretary reverses such finding for 
good cause shown at a later date.''.
            (4) Payment of judgments.--Section 224(k)(2) of such Act 
        (42 U.S.C. 233(k)(2)), as added by section 4 of the Federally 
        Supported Health Centers Assistance Act of 1992, is amended by 
        adding at the end thereof the following new sentence: 
        ``Appropriations for purposes of this paragraph shall be made 
        separate from appropriations made for purposes of sections 329, 
        330, 340 and 340A.''.
            (5) Effective date.--The amendments made by this section 
        shall take effect as if included in the enactment of the 
        Federally Supported Health Centers Assistance Act of 1992.

SEC. 7. EFFECTIVE DATES.

    (a) In General.--Except as provided in subsection (b), the 
amendments made by this Act shall become effective on the date of 
enactment of this Act.
    (b) Exception.--The amendments made by section 2(b)(4)(C) shall 
become effective 9 months after the date of enactment of this Act. 
Prior to such date, section 371(b)(3)(E) of the Public Health Service 
Act, as in effect on the day before the date of the enactment of this 
Act, shall remain in effect.

            Attest:






                                                             Secretary.

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