[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 732 Referred in House (RFH)]

103d CONGRESS
  1st Session
                                  S. 732


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 19, 1993

            Referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 AN ACT


 
 To provide for the immunization of all children in the United States 
     against vaccine-preventable diseases, and for other purposes.

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

SECTION 1. SHORT TITLE, REFERENCES AND PURPOSE.

    (a) Short Title.--This Act may be cited as the ``Comprehensive 
Child Immunization Act of 1993''.
    (b) References.--Except as otherwise expressly provided, whenever 
in this Act 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.).
    (c) Purpose.--It is the purpose of this Act to ensure that children 
in the United States are appropriately immunized against vaccine 
preventable infectious diseases at the earliest appropriate age.

SEC. 2. 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 
                2162(2)); 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.''.

SEC. 3. NATIONAL VACCINE INJURY COMPENSATION PROGRAM AMENDMENTS.

    (a) Amendment of Vaccine Injury Table.--
            (1) 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.''.
            (2) 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.''.
            (3) 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.
            (4) Time periods for fees and costs.--
                    (A) 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.
            (5) 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''.
            (6) 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''.
    (b) Extension of Time for Decision.--
            (1) 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)''.
            (2) 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.''.
            (3) Increased responsibilities of commission.--Section 
        2119(f) (42 U.S.C. 300aa-19(f)) is amended--
                    (A) by striking ``and'' at the end of paragraph 
                (4);
                    (B) by striking the period at the end of paragraph 
                (5) and inserting ``, and''; and
                    (C) 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.''.
    (c) Simplification of Vaccine Information Materials.--
            (1) Information.--Section 2126(b) (42 U.S.C. 300aa-26(b)) 
        is amended--
                    (A) by striking ``by rule'' in the matter preceding 
                paragraph (1);
                    (B) in paragraph (1), by striking ``90'' and 
                inserting ``30''; and
                    (C) in paragraph (2), by striking ``, appropriate 
                health care providers and parent organizations''.
            (2) Requirements.--Section 2126(c) (42 U.S.C. 300aa-26(c)) 
        is amended--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``shall be based on available data and 
                information,'' after ``such materials''; and
                    (B) 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.''.
            (3) 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.
            (4) Provider duties.--Subsection (d) of section 2126 (42 
        U.S.C. 300aa-26(d)) is amended--
                    (A) 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
                    (B) by striking ``or other information'' in the 
                last sentence.
    (d) 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.''.

SEC. 4. 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.

SEC. 5. AMENDMENTS TO THE FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE 
              ACT OF 1992.

    (a) 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''.
    (b) 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--
            (1) 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
            (2) 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.''.
    (c) Determining Compliance of Entity with Requirements for 
Coverage.--
            (1) 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--''.
            (2) 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.''.
    (d) 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.''.
    (d) 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.

            Passed the Senate November 4 (legislative day, November 2), 
      1993.

            Attest:

                                             WALTER J. STEWART,

                                                             Secretary.

S 732 RFH----2
S 732 RFH----3