[Congressional Bills 103th Congress] [From the U.S. Government Publishing Office] [S. 887 Introduced in Senate (IS)] 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 _______________________________________________________________________ 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>