[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 887 Reference Change Senate (RCS)]

103d CONGRESS
  1st Session
                                 S. 887

 To amend the Public Health Service Act to improve immunization rates 
    among children through the establishment of data registries and 
             educational programs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                May 4 (legislative day, April 19), 1993

Mr. Danforth (for himself, Mrs. Kassebaum, Mr. Durenberger, Mr. Gregg, 
 and Mr. Bond) introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

                May 18 (legislative day, April 19), 1993

 Committee discharged; ordered referred to the Committee on Labor and 
                            Human Resources

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to improve immunization rates 
    among children through the establishment of data registries and 
             educational programs, 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.

    This Act may be cited as the ``National Immunization Improvement 
Act of 1993''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds that--
            (1) 90 percent of all children under the age of 2 receive 
        at least one vaccination yet only 40 to 60 percent of these 
        children receive a complete set of vaccinations;
            (2) the low immunization rate for children stems from 
        inadequate immunization delivery systems and a lack of public 
        education concerning the risks related to the nonimmunization 
        of children; and
            (3) government health care programs must coordinate their 
        activities in order to increase immunization rates.
    (b) Purpose.--It is the purpose of this Act to--
            (1) assist the States in developing State systems to 
        monitor the immunization status of children in order to ensure 
        that these children are provided with the recommended number of 
        vaccinations;
            (2) in cooperation with the States, improve the 
        immunization delivery system and expand outreach and awareness 
        efforts to ensure that every child under 2 years of age is 
        properly immunized;
            (3) provide for increased coordination among Federal 
        programs in order to improve immunization rates;
            (4) encourage increased coordination among Federal, State 
        and private programs to improve immunization rates; and
            (5) make certain revisions with respect to the Vaccine 
        Injury Compensation Program.

SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

    (a) Improved Immunization.--Subtitle 2 of title XXI of the Public 
Health Service Act (42 U.S.C. 300aa-1 et seq.) is amended--
            (1) by redesignating part D as part E;
            (2) by redesignating sections 2131 through 2134 as sections 
        2151 through 2154, respectively; and
            (3) by inserting after part C, the following new part:

                ``Part D--Improved Immunization Efforts

``SEC. 2131. VOLUNTARY STATE REGISTRY GRANT PROGRAM.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this part, the Secretary shall establish a program under 
which the Secretary may award grants to States to enable such States to 
develop and operate computerized State registries to collect, track and 
monitor immunization data with respect to children residing within such 
States as described in subsection (c).
    ``(b) Application.--To be eligible to receive a grant under 
subsection (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. Such application shall 
include a plan to ensure that necessary immunization information is 
provided to the State registry.
    ``(c) Data.--
            ``(1) Data set and standards.--The Secretary shall develop 
        a minimum uniform data set and data standards applicable to 
        State registries developed under this section, in order to 
        allow compatibility between States.
            ``(2) Design.--A State immunization tracking and 
        surveillance registry established under subsection (a) shall be 
        designed to collect immunization information on each child 
        residing within the State from the time that each such child is 
        born, and track the immunization records of each such child as 
        they grow older. The registry shall contain at least the 
        following information with respect to each child residing 
        within the State:
                    ``(A) The name, address and date of birth of the 
                child.
                    ``(B) The complete immunization history of the 
                child.
                    ``(C) The type and lot numbers of each vaccine 
                provided to the child.
                    ``(D) The name and address of each health care 
                provider providing a vaccination to the child.
                    ``(E) Identifying data that is sufficient to enable 
                the registry to locate the child for purposes of 
                conducting immunization notification activities 
                concerning the child.
                    ``(F) Information designed to monitor the safety 
                and effectiveness of vaccines by linking vaccine dosage 
                information with adverse events reporting and disease 
                outbreak patterns, including events reported by 
                petitioners under parts A or B.
    ``(d) Technical Assistance.--The Secretary shall provide technical 
assistance to States for the development of State registries under this 
section.
    ``(e) Reporting.--Each State that receives a grant under this 
section shall annually prepare and submit to the Secretary a report 
concerning the progress made by the State in operating a State registry 
under the grant.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $150,000,000 for fiscal year 
1995, and such sums as may be necessary for each of the fiscal years 
1995 through 1999.

``SEC. 2132. IMPROVED IMMUNIZATION DELIVERY, OUTREACH AND EDUCATION.

    ``(a) Required Activities.--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 vaccines delivery systems and immunization 
outreach and education efforts:
            ``(1) Immunization educational materials for providers.--
        Not later than 1 year after the date of enactment of this part, 
        the Secretary, in conjunction with State health officials and 
        other appropriate public and private organizations, shall 
        develop and disseminate standard immunization educational 
        materials for providers, including--
                    ``(A) a list of basic recommended vaccines and the 
                schedules for immunizing children with such vaccines;
                    ``(B) recommended criteria for the administration 
                of vaccines;
                    ``(C) recommended criteria for determining when 
                vaccines should not be administered;
                    ``(D) recommended criteria for the screening of 
                children prior to immunization;
                    ``(E) informed consent materials consistent with 
                those required under section 2126(c); and
                    ``(F) any other information determined appropriate 
                by the Secretary.
            ``(2) 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 parents (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.
            ``(3) 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.
            ``(4) Outreach activities.--The Secretary shall conduct 
        immunization outreach activities, including--
                    ``(A) conducting research concerning alternative 
                delivery systems (such as mobile immunization clinics);
                    ``(B) utilization of National Health Service Corps 
                members and other measures to conduct immunization 
                outreach activities in medically underserved areas and 
                for medically underserved populations;
                    ``(C) conducting research concerning the 
                implementation of innovative methods to--
                            ``(i) contact parents or legal guardians 
                        concerning their children's immunization 
                        status;
                            ``(ii) refer such parents or legal 
                        guardians to immunization providers; and
                            ``(iii) conduct follow-up activities 
                        concerning the immunization status of children 
                        affected by the activities conducted under this 
                        subparagraph;
                    ``(D) the coordination of vaccine outreach and 
                education activities with other Federal, State and 
                local programs to encourage parents to have their 
                children immunized; and
                    ``(E) any other activities determined appropriate 
                by the Secretary.
    ``(b) Immunization Action Plans.--
            ``(1) Grants.--
                    ``(A) In general.--The Secretary may award grants 
                to States to enable such State to develop, revise and 
                implement immunization action plans as described in 
                paragraph (2).
                    ``(B) Application.--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 action 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 under 
                which standard immunization criteria developed under 
                subsection (a)(1), and any other materials determined 
                to be appropriate by State health officials, will be 
                distributed to immunization providers--
                            ``(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 immunization delivery through--
                            ``(i) increasing the number or type of 
                        facilities through which vaccines may be made 
                        available;
                            ``(ii) developing alternative methods of 
                        delivering vaccines, such as mobile health 
                        clinics or through programs of the type 
                        described in subsection (a)(5); or
                            ``(iii) increasing the number of hours 
                        during which vaccines are made available by 
                        providers within the State;
                except that, the Secretary may waive the requirements 
                of this subparagraph if the Secretary determines that 
                State immunization delivery efforts are sufficient;
                    ``(C) population-based assessment criteria through 
                which the State is able to assess the effectiveness of 
                immunization activities in the State;
                    ``(D) a public awareness campaign, in conjunction 
                with the National Campaign established under subsection 
                (a)(2), to provide parents with information concerning 
                the types and schedules for the administration of 
                vaccines, and the locations of vaccines providers;
                    ``(E) coordination of outreach activities with 
                other public or private health programs to encourage 
                parents to have their children immunized; and
                    ``(F) significant collaboration with private 
                entities in achieving the goals of the plan.
            ``(3) Immunization action plan approval.--
                    ``(A) Goals.--As part of the immunization action 
                plan of a State, the State shall establish immunization 
                rate goals for children residing within the State.
                    ``(B) Approval.--The immunization action 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) 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 action plan. 
                If the Director or the Secretary, in reviewing the 
                reports submitted under this subparagraph determine 
                that the State has not made sufficient progress towards 
                achieving the goals established under subparagraph (A), 
                the Secretary may reduce the State's grant funds.

``SEC. 2133. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out 2132(b), 
$200,000,000 for fiscal year 1994, and such sums as may be necessary 
for each of the fiscal years 1995 through 1999.''.
    (b) Simplification of Informed Consent Materials.--Section 2126(c) 
of the Public Health Service Act (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 ``include--'' and all that 
                follows through the paragraph (10) and inserting in 
                lieu thereof ``include a concise description of the 
                benefits and the risks of the vaccines and a statement 
                of the availability of the National Vaccine Injury 
                Compensation Fund.''.

                                 <all>