[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2328 Reported in Senate (RS)]






                                                       Calendar No. 602
107th CONGRESS
  2d Session
                                S. 2328

To amend the Public Health Service Act and the Federal Food, Drug, and 
  Cosmetic Act to ensure a safe pregnancy for all women in the United 
  States, to reduce the rate of maternal morbidity and mortality, to 
eliminate racial and ethnic disparities in maternal health outcomes, to 
reduce pre-term labor, to examine the impact of pregnancy on the short 
and long term health of women, to expand knowledge about the safety and 
  dosing of drugs to treat pregnant women with chronic conditions and 
    women who become sick during pregnancy, to expand public health 
 prevention, education and outreach, and to develop improved and more 
 accurate data collection related to maternal morbidity and mortality.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 25, 2002

   Mr. Harkin (for himself, Mr. Kennedy, Ms. Mikulski, Mr. Dodd, Mr. 
   Edwards, Mrs. Murray, Mrs. Clinton, Mr. Gregg, Mr. Bingaman, Mr. 
    Johnson, Mr. Frist, Mr. Jeffords, Ms. Collins, Mr. DeWine, Ms. 
 Landrieu, Mr. Levin, Ms. Stabenow, Mr. Biden, Mr. Kerry, Mr. Inouye, 
 Mr. Sarbanes, Mr. Cleland, Mr. Baucus, Mr. Graham, Ms. Cantwell, and 
   Mr. Reid) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                           September 17, 2002

  Reported by Mr. Kennedy, with an amendment and an amendment to the 
                                 title
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act and the Federal Food, Drug, and 
  Cosmetic Act to ensure a safe pregnancy for all women in the United 
  States, to reduce the rate of maternal morbidity and mortality, to 
eliminate racial and ethnic disparities in maternal health outcomes, to 
reduce pre-term labor, to examine the impact of pregnancy on the short 
and long term health of women, to expand knowledge about the safety and 
  dosing of drugs to treat pregnant women with chronic conditions and 
    women who become sick during pregnancy, to expand public health 
 prevention, education and outreach, and to develop improved and more 
 accurate data collection related to maternal morbidity and mortality.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Safe Motherhood Act for 
Research and Treatment'' or the ``SMART Mom Act''.</DELETED>

<DELETED>SEC. 2. FINDINGS AND PURPOSES.</DELETED>

<DELETED>    (a) Findings.--Congress makes the following 
findings:</DELETED>
        <DELETED>    (1) Pregnancy is a natural condition. 
        Approximately 6,000,000 women become pregnant each year and 
        more than 10,000 give birth each day.</DELETED>
        <DELETED>    (2) The United States ranks 20th in maternal 
        mortality out of 49 developed countries.</DELETED>
        <DELETED>    (3) In the United States about 1,000 women will 
        die each year from pregnancy-related illnesses or conditions. 
        Two to 3 lives are lost each day due to pregnancy-related 
        mortality.</DELETED>
        <DELETED>    (4) Racial and ethnic minority women suffer a 
        significantly higher risk of pregnancy-related mortality than 
        non-Hispanic white women. African American women are almost 4 
        times more likely to die from pregnancy-related illnesses or 
        conditions than white women. Hispanic, Asian immigrant, and 
        American Indian women are twice as likely to die from 
        pregnancy-related illnesses or conditions as their non-Hispanic 
        counterparts.</DELETED>
        <DELETED>    (5) Women between the ages of 35 and 40 are 2 to 3 
        times more likely to experience a pregnancy-related death 
        compared to women between the ages of 20 and 25.</DELETED>
        <DELETED>    (6) There has been no decline in pregnancy-related 
        deaths in the United States over the last 20 years. In 1987 the 
        United States set goals as part of Healthy People 2000: 
        National Health Promotion and Disease Prevention Objectives, to 
        reduce maternal deaths from 7.5 deaths per 100,000 to 3.3 per 
        100,000 for live births and no more than 5.0 maternal deaths 
        per 100,000 births among African American women. Again in 2000, 
        as part of Healthy People 2010, new goals have been set. These 
        goals have not been met.</DELETED>
        <DELETED>    (7) In the United States, 30 percent of women, or 
        1 out of every 3 pregnant women, experience a major medical 
        complication at some point during their pregnancy. The most 
        common complications are miscarriage, ectopic pregnancy, 
        excessive vomiting, diabetes, hemorrhage, infection, pre-
        eclampsia, premature labor, and the need for a surgical 
        (caesarean) delivery.</DELETED>
        <DELETED>    (8) Women who are at high-risk, who have a chronic 
        condition, or who do not have access to health care face even 
        more difficult pregnancies, deliveries, and risk to their long-
        term health.</DELETED>
        <DELETED>    (9) African American, Hispanic, and older women, 
        have a significantly increased risk of complications.</DELETED>
        <DELETED>    (10) Pre-term infants were more than 14 times more 
        likely than infants that were not pre-term to die before their 
        first birthday.</DELETED>
        <DELETED>    (11) There is a lack of knowledge regarding the 
        causes of these complications, as well as effective 
        preventative and therapeutic interventions. Perinatal diseases 
        rank as the second lowest National Institute of Health-funded 
        group of diseases in the whole field of medicine when 
        comparisons take into account disability adjusted life years 
        (DALYs) lost due to each disease.</DELETED>
        <DELETED>    (12) Most drugs women take during pregnancy are 
        necessary to maintain health. However, 80 percent of approved 
        drugs lack adequate scientific evidence about their use in 
        pregnancy. Only 1 percent of drugs have been shown in 
        controlled studies to pose no risk to pregnant women.</DELETED>
        <DELETED>    (13) Women under age 35 take an average of 3 
        prescription drugs during pregnancy. For women over the age of 
        35 the number of prescription drugs increases to 5.</DELETED>
        <DELETED>    (14) Pregnancy is a critical time in a women's 
        life with far ranging implications for her short- and long-term 
        health and for the health of her family. The United States must 
        devote the resources and have the will of the nation to ensure 
        a safe pregnancy and good health throughout the lives of 
        American women.</DELETED>
<DELETED>    (b) Purposes.--It is the purpose of this Act to--
</DELETED>
        <DELETED>    (1) develop a national effort to achieve a healthy 
        and safe pregnancy for all women in the United 
        States;</DELETED>
        <DELETED>    (2) reduce the risk of pregnancy-related deaths 
        and complications due to pregnancy;</DELETED>
        <DELETED>    (3) eliminate racial and ethnic disparities in the 
        rates of maternal mortality and morbidity;</DELETED>
        <DELETED>    (4) improve the treatment and clinical care of 
        pregnant women;</DELETED>
        <DELETED>    (5) reduce pre-term labor;</DELETED>
        <DELETED>    (6) examine the impact of pregnancy on the short- 
        and long-term health of women;</DELETED>
        <DELETED>    (7) work toward an evidence-based standard of care 
        with respect to pregnant women;</DELETED>
        <DELETED>    (8) expand knowledge about the safety and dosing 
        of drugs and devices used to treat pregnant women with chronic 
        conditions and women who become sick during 
        pregnancy;</DELETED>
        <DELETED>    (9) expand public health prevention, education and 
        outreach; and</DELETED>
        <DELETED>    (10) develop improved and more accurate data 
        collection relating to maternal morbidity and 
        mortality.</DELETED>

<DELETED>TITLE I--AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT</DELETED>

<DELETED>Subtitle A--Reducing Maternal Morbidity and Mortality Through 
                  Coordinated Federal Action</DELETED>

<DELETED>SEC. 101. INTERAGENCY COORDINATING COMMITTEE ON SAFE 
              MOTHERHOOD.</DELETED>

<DELETED>    Part P of title III of the Public Health Service Act (42 
U.S.C. 280g et seq.) is amended by adding at the end the 
following:</DELETED>

<DELETED>``SEC. 399O. INTERAGENCY COORDINATING COMMITTEE ON SAFE 
              MOTHERHOOD.</DELETED>

<DELETED>    ``(a) Establishment.--The Secretary, acting through the 
Director of the Office of Women's Health, shall establish a committee 
to be known as the `Interagency Coordinating Committee on Safe 
Motherhood' (referred to in this section as the `Coordinating 
Committee').</DELETED>
<DELETED>    ``(b) Composition.--The Coordinating Committee shall be 
composed of--</DELETED>
        <DELETED>    ``(1) the Director of the Centers for Disease 
        Control and Prevention (and the heads of such institutes, 
        centers and offices as the Director determines 
        appropriate);</DELETED>
        <DELETED>    ``(2) the Director of the National Institutes of 
        Health (and the heads of such institutes, centers and offices 
        as the Director determines appropriate);</DELETED>
        <DELETED>    ``(3) the Director of the Health Resources and 
        Services Administration (and the heads of such institutes, 
        centers and offices as the Director determines 
        appropriate);</DELETED>
        <DELETED>    ``(4) the Commissioner of Food and Drugs (and the 
        heads of such institutes, centers and offices as the 
        Commissioner determines appropriate);</DELETED>
        <DELETED>    ``(5) the Director of the Agency for Healthcare 
        Research and Quality (and the heads of such institutes, centers 
        and offices as the Director determines appropriate);</DELETED>
        <DELETED>    ``(6) the Secretary of Labor (and the heads of 
        such institutes, centers and offices as the Secretary 
        determines appropriate);</DELETED>
        <DELETED>    ``(7) representatives of other Federal Government 
        agencies that serve women; and</DELETED>
        <DELETED>    ``(8) representatives of women's health care 
        advocacy and grassroots organizations, health care providers 
        including providers of specialty care, and researchers to be 
        appointed by the Director of the Office.</DELETED>
<DELETED>    ``(c) Administrative Support.--The Secretary shall make 
available to the Coordinating Committee necessary and appropriate 
administrative support.</DELETED>
<DELETED>    ``(d) Duties.--</DELETED>
        <DELETED>    ``(1) Evaluation.--The Coordinating Committee 
        shall assess health promotion campaigns that are administered 
        by the Federal Government (including smoking cessation 
        programs, alcohol and substance abuse treatment programs, and 
        domestic violence prevention programs), evaluate the effect 
        that such campaigns have on health during pregnancy if 
        pregnancy was a focus, and assess whether such programs may be 
        adapted to emphasize the importance of maternal 
        health.</DELETED>
        <DELETED>    ``(2) Federal research plan.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than 18 
                months after the date of enactment of this section, the 
                Coordinating Committee shall develop a coordinated 
                Federal research and strategic action plan for safe 
                motherhood.</DELETED>
                <DELETED>    ``(B) Contents.--The plan developed under 
                subparagraph (A) shall define the areas of research 
                that are necessary to carry out the purposes of the 
                SMART Mom Act and include recommendations for the 
                implementation and funding of activities under the 
                plan. Such plan shall take into consideration any 
                programs and plans existing on the date of enactment of 
                this section as well as research opportunities that 
                arise during the 5-year period beginning on such date 
                of enactment and shall at a minimum include--</DELETED>
                        <DELETED>    ``(i) recommendations for research 
                        on pregnancy-related conditions;</DELETED>
                        <DELETED>    ``(ii) recommendations for 
                        research on the impact of chronic conditions, 
                        physical impairments, or mental health 
                        conditions on pregnant women;</DELETED>
                        <DELETED>    ``(iii) recommendations for 
                        research on medical complications that occur 
                        during delivery;</DELETED>
                        <DELETED>    ``(iv) recommendations for 
                        research on post-partum conditions (such as 
                        depression, hemorrhage, and fever);</DELETED>
                        <DELETED>    ``(v) recommendations for research 
                        on racial, ethnic, social, behavioral, and 
                        economic factors effecting pregnancy;</DELETED>
                        <DELETED>    ``(vi) recommendations for 
                        research to improve outreach efforts, education 
                        programs, and prevention and health promotion 
                        strategies for pregnant women; and</DELETED>
                        <DELETED>    ``(vii) a recommended plan and 
                        research agenda to improve knowledge about the 
                        safety of drugs, devices, cosmetics, and food 
                        with respect to pregnancy.</DELETED>
                <DELETED>    ``(C) Report.--Not later than 18 months 
                after the date of enactment of this section, the 
                Coordinating Committee shall prepare and submit to the 
                Secretary and the appropriate committees of Congress, a 
                report concerning the plan developed under this 
                paragraph and the results of the evaluation conducted 
                under paragraph (1).</DELETED>
        <DELETED>    ``(3) Key indicators of well being.--</DELETED>
                <DELETED>    ``(A) In general.--The Coordinating 
                Committee, in consultation with the Centers for Disease 
                Control and Prevention, the Director of the National 
                Institute of Child Health and Human Development, the 
                Director of the Agency for Healthcare Research and 
                Quality, and the heads of other relevant Federal 
                agencies, shall determine the key indicators of 
                maternal health and the sources of data to be included 
                in the report under subparagraph (B), and shall update 
                such indicators as new data becomes 
                available.</DELETED>
                <DELETED>    ``(B) Report.--Not later than October 1, 
                2003, and biannually thereafter, the Coordinating 
                Committee shall prepare and submit to the appropriate 
                committees of Congress, a report, to be known as 
                `America's Mothers: Key National Indicators of Well 
                Being' (referred to in this section as the `Report'), 
                that contains the indicators of maternal health 
                described in subparagraph (A).</DELETED>
                <DELETED>    ``(C) Availability.--The Report shall be 
                made available to the public through the Internet 
                website established under paragraph (4).</DELETED>
        <DELETED>    ``(4) Safe motherhood campaign.--The Coordinating 
        Committee shall establish and implement a national public 
        education and health promotion campaign on safe motherhood, 
        including developing and maintaining an Internet website as 
        provided for in section 399P, promoting the establishment of 
        community partnerships, supporting community-based programs, 
        promoting the establishment of partnerships with State and 
        local health providers and educators, and promoting the 
        establishment of partnerships with private non-profit 
        organizations.</DELETED>
<DELETED>    ``(e) Nonapplicability of FACA.--The provisions of the 
Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the 
Coordinating Committee.</DELETED>
<DELETED>    ``(f) Authorization of Appropriations.--There is 
authorized to be appropriated, such sums as may be necessary to carry 
out this section.''.</DELETED>

 <DELETED>Subtitle B--Research and Data Collection To Improve Maternal 
                          Well-Being</DELETED>

<DELETED>SEC. 111. EXPAND AND INTENSIFY RESEARCH ACTIVITIES AT THE 
              NATIONAL INSTITUTE OF HEALTH.</DELETED>

<DELETED>    (a) Purpose.--It is the purpose of this section to require 
the Director of the National Institutes of Health, acting through the 
Director of the National Institute of Child Health and Human 
Development and in collaboration with the Directors of other 
appropriate Institutes and Offices, to expand and intensify research 
activities with respect to conditions that lead to pregnancy-related 
illnesses, injury and death before, during, and after pregnancy and to 
expand research to improve understanding and treatment of pregnant 
women who have chronic disease, physical impairment, or mental health 
conditions.</DELETED>
<DELETED>    (b) Safe Motherhood as a Priority Area.--Subpart 7 of part 
C of title IV of the Public Health Service Act (42 U.S.C. 285g et seq.) 
is amended by adding at the end the following:</DELETED>

<DELETED>``SEC. 452H. SAFE MOTHERHOOD REPORT.</DELETED>

<DELETED>    ``The Director of the Institute shall annually report to 
Congress and the public on the extent of the total funds obligated to 
conduct or support research on safe motherhood across the National 
Institutes of Health, including the specific support and research 
awards allocated through the such Institutes.''.</DELETED>
<DELETED>    (c) Expanded Research Into Pregnancy.--Subpart 7 of part C 
of title IV of the Public Health Service Act (42 U.S.C. 285g et seq.), 
as amended by subsection (b), is further amended by adding at the end 
the following:</DELETED>

<DELETED>``SEC. 452I. EXPANDED RESEARCH ON PREGNANCY.</DELETED>

<DELETED>    ``(a) Conditions and Complications of Pregnancy.--In order 
to improve the understanding of conditions and complications related to 
pregnancy, to lead to better treatments and care for women throughout 
their pregnancy, and to prevent pregnancy-related illnesses, injury and 
death whenever possible, the Director of NIH, acting through the 
Director of the Institute, shall enhance and expand research into the 
leading causes of pregnancy-related death and complications of 
pregnancy.</DELETED>
<DELETED>    ``(b) Reducing Pre-Term Labor and Delivery.--In order to 
reduce the rates of pre-term labor and delivery, the Director of NIH 
shall expand and intensify research on pre-term labor and 
delivery.</DELETED>
<DELETED>    ``(c) Post-Partum Health Conditions.--The Director of NIH 
shall expand and enhance research concerning the post-partum health 
conditions and illness that affect women.</DELETED>
<DELETED>    ``(d) Reductions in Racial and Ethnic Disparities.--The 
Director of NIH shall provide for the conduct of research to 
investigate the mechanisms contributing to the disparities in maternal 
and perinatal outcomes of racial and ethnic populations and immigrant 
groups.</DELETED>
<DELETED>    ``(e) Authorization of Appropriations.--There is 
authorized to be appropriated, such sums as may be necessary to carry 
out this section.''.</DELETED>
<DELETED>    (d) Improving the Understanding and Treatment of Chronic 
Conditions of Women During Pregnancy.--Part H of title IV of the Public 
Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting 
after section 494A, the following:</DELETED>

<DELETED>``SEC. 494B. IMPROVING THE UNDERSTANDING AND TREATMENT OF 
              CHRONIC CONDITIONS OF WOMEN DURING PREGNANCY.</DELETED>

<DELETED>    ``(a) In General.--The Director of NIH shall expand 
research concerning the impact of chronic conditions, physical 
impairments, and mental health problems on the health of women during 
their pregnancy.</DELETED>
<DELETED>    ``(b) Collaboration.--In carrying out subsection (a), the 
Director of the Institute shall act in collaboration with the Directors 
of other appropriate Institutes and Offices of the National Institutes 
of Health.''.</DELETED>
<DELETED>    ``(c) Authorization of Appropriations.--There is 
authorized to be appropriated, such sums as may be necessary to carry 
out this section.''.</DELETED>
<DELETED>    (e) Maternal Fetal Medicine Units Network.--Subpart 7 of 
part C of title IV of the Public Health Service Act (42 U.S.C. 285g et 
seq.), as amended by subsection (c), is further amended by adding at 
the end the following:</DELETED>

<DELETED>``SEC. 452J. MATERNAL FETAL MEDICINE UNITS NETWORK.</DELETED>

<DELETED>    ``(a) In General.--The Director of the Institute shall 
establish a Maternal Fetal Medicine Units Network. In carrying out this 
subsection, the Director may enter into agreements to utilize the 
existing Maternal Fetal Medicine Units Network.</DELETED>
<DELETED>    ``(b) Expansion of Network.--The Director of the Institute 
shall, through grants, contracts, or cooperative agreements, expand the 
Maternal Fetal Medicine Units Network established or utilized under 
subsection (a) to assist in the implementation of sections 452I and 
494B.</DELETED>
<DELETED>    ``(c) Authorization of Appropriations.--There is 
authorized to be appropriated, such sums as may be necessary to carry 
out this section.''.</DELETED>

<DELETED>SEC. 112. EXPAND AND INTENSIFY RESEARCH ACTIVITIES AT THE 
              CENTERS FOR DISEASE CONTROL AND PREVENTION.</DELETED>

<DELETED>    (a) Reduction in Poor Pregnancy Outcomes of Ethnic and 
Minority Women.--Section 317K of the Public Health Service Act (42 
U.S.C. 247b-12) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsection (d) as subsection 
        (f); and</DELETED>
        <DELETED>    (2) by inserting after subsection (c), the 
        following:</DELETED>
<DELETED>    ``(d) Reduction in Poor Pregnancy Outcomes of Ethnic and 
Minority Women.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, acting through 
        the Director of the Centers for Disease Control and Prevention, 
        shall award grants to States to support community-based 
        demonstration projects in disease prevention and health 
        promotion to reduce disparities in pregnancy outcomes, with 
        particular emphasis on social, economic, and behavioral health 
        issues (including violence and obesity) affecting racial and 
        ethnic populations and immigrant groups. Where practicable, 
        such demonstration projects shall be based on relevant 
        scientific studies.</DELETED>
        <DELETED>    ``(2) Technical Assistance.--In carrying out 
        paragraph (1), the Secretary may provide technical assistance 
        to States.''.</DELETED>
<DELETED>    (b) Prevention Research Centers.--Section 317K of the 
Public Health Service Act (42 U.S.C. 247b-12) is amended by inserting 
after subsection (d), as added by subsection (a) of this section, the 
following:</DELETED>
<DELETED>    ``(e) Prevention Research Centers.--The Director of the 
Centers for Disease Control and Prevention, acting through the National 
Center for Chronic Disease Prevention and Health Promotion, shall award 
grants to universities and other non-profit research institutions and 
centers to enable such entities to conduct research concerning 
improving maternal outcomes and eliminating racial disparities in 
maternal morbidity and mortality, with special emphasis provided to 
research concerning the role of stress, violence, discrimination, 
access, nutrition, obesity and literacy.''.</DELETED>

<DELETED>SEC. 113. IMPROVE QUALITY HEALTH CARE FOR PREGNANT WOMEN 
              THROUGH AGENCY FOR HEALTHCARE RESEARCH AND 
              QUALITY.</DELETED>

<DELETED>    Section 913 of the Public Health Service Act (42 U.S.C. 
299b-2) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(c) Maternal Health Care.--</DELETED>
        <DELETED>    ``(1) In general.--The Director shall provide for 
        the conduct of research concerning the quality of maternal 
        health care from a patient-centered perspective, including--
        </DELETED>
                <DELETED>    ``(A) the type of care that is available 
                and provided prior to, during, and after 
                pregnancy;</DELETED>
                <DELETED>    ``(B) an examination of all types of care 
                and interventions, both medical and non-medical, as 
                well as barriers women face in gaining access to 
                recommended treatments; and</DELETED>
                <DELETED>    ``(C) recommendations for the minimum care 
                needed to be considered as having received quality 
                care.</DELETED>
        <DELETED>    ``(2) Report.--The results of the research 
        conducted under paragraph (1) shall be provided by the Director 
        to Congress as part of the annual report submitted under 
        subsection (b)(2).''.</DELETED>

    <DELETED>Subtitle C--Data Collection and Surveillance</DELETED>

<DELETED>SEC. 121. EXPAND AND INTENSIFY DATA COLLECTION ACTIVITIES AT 
              THE CENTERS FOR DISEASE CONTROL AND PREVENTION.</DELETED>

<DELETED>    Part B of title III of the Public Health Service Act (42 
U.S.C. 243 et seq.) is amended by inserting after section 317K the 
following:</DELETED>

<DELETED>``SEC. 317K-1. DATA COLLECTION REGARDING SAFE 
              MOTHERHOOD.</DELETED>

<DELETED>    ``(a) Standard Definitions for Pregnancy-Related Mortality 
and Morbidity.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention and in cooperation with 
State officials, professional medical experts, medical organizations, 
and health care advocacy groups, shall develop a standard definition of 
`maternal mortality' and `maternal morbidity'.</DELETED>
<DELETED>    ``(b) Grants for Surveillance of Pregnancy-Related 
Mortality and Morbidity Data.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, acting through 
        the Director of the Centers for Disease Control and Prevention, 
        shall establish a program to award grants to States, counties, 
        and cities for the development of surveillance systems, that 
        use the standard definitions established under subsection (a), 
        to gather data on maternal mortality and maternal 
        morbidity.</DELETED>
        <DELETED>    ``(2) Eligibility.--To be eligible to receive a 
        grant under paragraph (1), a State, county, or city shall--
        </DELETED>
                <DELETED>    ``(A) prepare and submit to the Secretary 
                an application, at such time, in such manner, and 
                containing such information as the Secretary may 
                require;</DELETED>
                <DELETED>    ``(B) provide an assurance that the 
                applicant will work with the Centers for Disease 
                Control and Prevention to adopt standard procedures for 
                the identification, collection, and analysis of the 
                data that is to be collected under the grant; 
                and</DELETED>
                <DELETED>    ``(C) provide an assurance that the 
                applicant will contribute $1 (in cash or in kind) to 
                activities under the grant for every $4 provided by the 
                Federal Government.</DELETED>
        <DELETED>    ``(3) Technical assistance.--The Centers for 
        Disease Control and Prevention shall provide technical 
        assistance to grantees under this subsection.</DELETED>
        <DELETED>    ``(4) Incorporation of data into report.--Where 
        determined appropriate by the Secretary, data collected by the 
        surveillance systems established under this subsection shall be 
        incorporated into the report submitted under section 
        399O(d)(3)(B).</DELETED>
<DELETED>    ``(c) Prevalence of Pre-Term Labor and Delivery.--The 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention, shall work with States and other entities to 
improve knowledge regarding the incidence and prevalence of symptoms 
and risk factors for pre-term births.</DELETED>
<DELETED>    ``(d) Authorization of Appropriations.--There is 
authorized to be appropriated, such sums as may be necessary to carry 
out this section.''.</DELETED>

<DELETED>SEC. 122. STUDY ON EFFECTS OF PREGNANCY ON WOMEN.</DELETED>

<DELETED>    Section 1004 of the Children's Health Act of 2000 (42 
U.S.C. 285g note) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsections (d) and (e) as 
        subsections (e) and (f), respectively; and</DELETED>
        <DELETED>    (2) by inserting after subsection (c), the 
        following:</DELETED>
<DELETED>    ``(d) Study on Effects of Pregnancy on Women.--As part of 
the study conducted under this section, the Director of the National 
Institute of Child Health and Human Development, in collaboration with 
the Director of the Centers for Disease Control and Prevention, the 
Commission on Food and Drugs, and other appropriate Federal officials, 
shall plan, develop, and implement a prospective cohort study of 
mothers to determine the effects of pregnancy on the health of women. 
Such study shall evaluate--</DELETED>
        <DELETED>    ``(1) the effects of pregnancy on women's 
        health;</DELETED>
        <DELETED>    ``(2) the effects of both preexisting and chronic 
        conditions, physical impairments, and mental health problems 
        related to pregnancy;</DELETED>
        <DELETED>    ``(3) the impact of stress and anxiety; 
        and</DELETED>
        <DELETED>    ``(4) environmental health factors that influence 
        both the mother's health and that of her child.''.</DELETED>

      <DELETED>Subtitle D--Public Education and Outreach</DELETED>

<DELETED>SEC. 131. PURPOSE.</DELETED>

<DELETED>    It is the purpose of this subtitle to address the need for 
providing women with accurate and up-to-date information through a 21st 
century public education and outreach Campaign for Safe Motherhood that 
shall raise the public awareness of the issues related to safe 
motherhood, including--</DELETED>
        <DELETED>    (1) preventing pregnancy-related illnesses, 
        injury, and death; and</DELETED>
        <DELETED>    (2) providing women and other interest parties 
        with the tools necessary to achieve safe and healthy 
        pregnancies.</DELETED>

<DELETED>SEC. 132. SAFE MOTHERHOOD CAMPAIGN.</DELETED>

<DELETED>    Part P of title III of the Public Health Service Act (42 
U.S.C. 280g et seq.), as amended by section 101, is further amended by 
adding at the end the following:</DELETED>

<DELETED>``SEC. 399P. SAFE MOTHERHOOD CAMPAIGN.</DELETED>

<DELETED>    ``(a) Establishment.--The Secretary, acting through the 
Director of the Office of Women's Health and the Interagency 
Coordinating Committee on Safe Motherhood (referred to in this section 
as the `Coordinating Committee') established under section 399O, shall 
develop and implement a national public education and health promotion 
campaign to be known as the Safe Motherhood Campaign (referred to in 
this section as the `Campaign').</DELETED>
<DELETED>    ``(b) Elements of Campaign.--The Campaign shall at a 
minimum include the following:</DELETED>
        <DELETED>    ``(1) Website.--An Internet website to be 
        established in accordance with subsection (c).</DELETED>
        <DELETED>    ``(2) Community partnerships.--The provision of 
        support for community-based programs to provide outreach, 
        education, information and health promotion services and 
        information to give women the tools they need to achieve a safe 
        and healthy pregnancy.</DELETED>
        <DELETED>    ``(3) State and local partnerships.--The 
        facilitation of consultations with State and local public 
        health officials to gain access to the broadest number of women 
        in an effort to provide outreach and education assistance and 
        information to help women succeed in having a safe and healthy 
        pregnancy.</DELETED>
        <DELETED>    ``(4) Special populations.--The implementation of 
        procedures to ensure that activities under the Campaign are 
        accessible to low-literate, non-English speaking, and nonnative 
        immigrant communities where determined appropriate by the 
        Secretary.</DELETED>
<DELETED>    ``(c) Internet Website.--</DELETED>
        <DELETED>    ``(1) Establishment.--The Secretary, acting 
        through the Office of Women's Health and the Coordinating 
        Committee, shall develop and maintain a single Internet website 
        to provide pregnant women, and research and health 
        practitioners with the most up-to-date and accurate information 
        on pregnancy, in a manner designed to carry out the purpose 
        described in paragraph (2).</DELETED>
        <DELETED>    ``(2) Purpose.--It is the purpose of the website 
        established under paragraph (1) to consolidate information, 
        research, and data related to pregnancy (prenatal, intrapartum, 
        and postpartum) together in one place and to provide links for 
        women to other critical websites (Federal agencies, community 
        health programs, State and tribal health programs, and self-
        help professional and advocacy organizations).</DELETED>
        <DELETED>    ``(3) Address.--The Secretary shall ensure that 
        the uniform resource locator for the website established under 
        paragraph (1) is www.pregnancy.gov. If such locator is not 
        available, the Secretary shall select another similar 
        locator.</DELETED>
        <DELETED>    ``(4) Contents.--The website established under 
        paragraph (1) shall, at a minimum, contain--</DELETED>
                <DELETED>    ``(A) educational materials for how to 
                succeed in having the safest pregnancy possible, 
                including a description of chronic conditions, 
                pregnancy-related illnesses, and other health problems 
                that could pose risks to the mother or fetus;</DELETED>
                <DELETED>    ``(B) information concerning the safety 
                and risk of prescription and over-the-counter 
                medications and other products that women might use 
                during pregnancy;</DELETED>
                <DELETED>    ``(C) information concerning standards for 
                clinical care throughout pregnancy;</DELETED>
                <DELETED>    ``(D) information on trends in labor 
                intervention, such as induction, epidural, and 
                caesarean sections, and alternative 
                approaches;</DELETED>
                <DELETED>    ``(E) information concerning the issue of 
                domestic violence during pregnancy, including how women 
                can obtain assistance;</DELETED>
                <DELETED>    ``(F) information concerning infertility 
                and maternal health; and</DELETED>
                <DELETED>    ``(G) information concerning pregnancy-
                related workplace laws and policies, such as the Family 
                and Medical Leave Act of 1993.</DELETED>
        <DELETED>    ``(5) Appropriate form of information.--The 
        information contained on the website established under 
        paragraph (1) shall be maintained in a culturally sensitive and 
        appropriate form.</DELETED>
<DELETED>    ``(d) Authorization of Appropriations.--There is 
authorized to be appropriated, such sums as may be necessary to carry 
out this section.''.</DELETED>

       <DELETED>TITLE II--PREGNANT AND LACTATING WOMEN</DELETED>

<DELETED>SEC. 201. AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC 
              ACT.</DELETED>

<DELETED>    (a) Amendment to Chapter V.--Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
adding at the end the following:</DELETED>

<DELETED>``SEC. 564. SAFE DRUGS AND DEVICES FOR PREGNANT AND LACTATING 
              WOMEN.</DELETED>

<DELETED>    ``(a) Improving the Quality of Information on Drugs and 
Biological Products for Women Who Are Pregnant or Lactating.--
</DELETED>
        <DELETED>    ``(1) Marketed drugs for which additional 
        information is needed.--</DELETED>
                <DELETED>    ``(A) Identifying drugs to be studied.--
                The Secretary, acting through the Director of the 
                National Institutes of Health and in consultation with 
                the Commissioner of Food and Drugs and experts in 
                maternal and fetal health, shall--</DELETED>
                        <DELETED>    ``(i) identify marketed drugs and 
                        biological products that were not approved or 
                        licensed based on studies in pregnant women for 
                        which studies are needed--</DELETED>
                                <DELETED>    ``(I) to establish 
                                appropriate dosing for women who are 
                                pregnant or lactating; and</DELETED>
                                <DELETED>    ``(II) to investigate the 
                                marketed drugs and biological products' 
                                safe use for pregnant women and fetuses 
                                through the use of pregnancy registries 
                                and pharmacoepidemiological databases; 
                                and</DELETED>
                        <DELETED>    ``(ii) design protocols for the 
                        needed studies described in clause 
                        (i).</DELETED>
                <DELETED>    ``(B) Studying marketed drugs.--The 
                Director of the National Institutes of Health shall 
                award grants, enter into contracts, or use other 
                appropriate mechanisms to aid in promptly completing 
                the studies designed under subparagraph (A), as the 
                National Institutes of Health's resources 
                allow.</DELETED>
        <DELETED>    ``(2) Postmarketing studies.--As a condition of 
        approval of an application submitted under section 505(b)(1) or 
        of a biologics license application under section 351 of the 
        Public Health Service Act (42 U.S.C. 262), the Secretary may 
        require that the holder of the application conduct 
        postmarketing studies, to be completed and submitted to the 
        Secretary by a date specified by the Secretary, to--</DELETED>
                <DELETED>    ``(A) establish dosing recommendations for 
                such drug or biological product for women who are 
                pregnant or lactating; and</DELETED>
                <DELETED>    ``(B) investigate the safe use of such 
                drug or biological product for pregnant women and 
                fetuses through the use of pregnancy registries and 
                pharmacoepidemiological databases.</DELETED>
        <DELETED>    ``(3) Pregnancy registries and 
        pharmacoepidemiological databases.--</DELETED>
                <DELETED>    ``(A) Registries.--The Secretary shall 
                issue guidances on the use and evaluation of data from 
                pregnancy registries, including data from centralized 
                registries for drugs and biological products.</DELETED>
                <DELETED>    ``(B) Databases.--</DELETED>
                        <DELETED>    ``(i) Establishment.--The 
                        Secretary shall establish or award grants, 
                        enter into contracts and cooperative 
                        agreements, and use other appropriate 
                        mechanisms to provide for 
                        pharmacoepidemiological databases (including a 
                        teratogen surveillance system) to study safety 
                        issues related to drugs and biological 
                        products, including safety issues for pregnant 
                        women and fetuses.</DELETED>
                        <DELETED>    ``(ii) Study and use of data.--The 
                        Secretary shall hold workshops and issue 
                        guidances on how to study and use the data from 
                        the pharmacoepidemiological databases 
                        established or provided for under clause 
                        (i).</DELETED>
        <DELETED>    ``(4) Clarification regarding market exclusivity 
        interactions.--A clinical investigation involved in any study 
        conducted under this subsection shall not be considered to be a 
        new clinical investigation for purposes of clauses (iii) and 
        (iv) of section 505(j)(5(D).</DELETED>
<DELETED>    ``(b) Improving Communication of Information to Pregnant 
and Lactating Women and Their Health Care Providers Through Drug 
Labeling.--</DELETED>
        <DELETED>    ``(1) Regulations.--</DELETED>
                <DELETED>    ``(A) Proposed regulation.--Not later than 
                6 months after the date of enactment of this section, 
                the Secretary shall promulgate a proposed regulation 
                requiring enhanced communication of safety and dosage 
                information for women who are pregnant or lactating in 
                the labeling of drugs, including drugs licensed under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262).</DELETED>
                <DELETED>    ``(B) Final rule.--Not later than 2 years 
                after the date of enactment of this section, the 
                Secretary shall promulgate a final regulation requiring 
                enhanced communication of safety and dosage information 
                for women who are pregnant or lactating in the labeling 
                of drugs, including drugs licensed under section 351 of 
                the Public Health Service Act (42 U.S.C. 
                262).</DELETED>
        <DELETED>    ``(2) Biennial review of certain drugs.--Not later 
        than 32 months after the date of enactment of this section, and 
        biennially thereafter, each person who holds an approved 
        application for a drug under section 505(b) that was not 
        approved based on studies of pregnant women or who holds an 
        approved biologics license application for a drug under section 
        351 of the Public Health Service Act (42 U.S.C. 262) that was 
        not licensed based on studies of pregnant women, shall--
        </DELETED>
                <DELETED>    ``(A) review any newly available data or 
                information for such drug, including data or 
                information from the studies completed under subsection 
(a), to determine whether such data or information, and all other 
relevant data and information, warrants a labeling change for women who 
are pregnant or lactating; and</DELETED>
                <DELETED>    ``(B) submit to the Secretary--</DELETED>
                        <DELETED>    ``(i) a supplement to the holders' 
                        new drug application or biologics license 
                        application that includes--</DELETED>
                                <DELETED>    ``(I) a summary of the 
                                data or information reviewed under 
                                subparagraph (A);</DELETED>
                                <DELETED>    ``(II) an analysis of why 
                                such data or information warrants a 
                                labeling change for women who are 
                                pregnant or lactating;</DELETED>
                                <DELETED>    ``(III) a proposal for the 
                                labeling change; and</DELETED>
                                <DELETED>    ``(IV) a certification 
                                that the review, summary, and analysis 
                                is complete and accurate; or</DELETED>
                        <DELETED>    ``(ii) a letter that includes--
                        </DELETED>
                                <DELETED>    ``(I) a summary of the 
                                data or information, if any, reviewed 
                                under subparagraph (A);</DELETED>
                                <DELETED>    ``(II) an analysis of why 
                                such data or information does not 
                                warrant a labeling change for women who 
                                are pregnant or lactating; 
                                and</DELETED>
                                <DELETED>    ``(III) a certification 
                                that the review, summary, and analysis 
                                is complete and accurate.</DELETED>
        <DELETED>    ``(3) Biennial submissions.--In the regulations 
        promulgated under paragraph (1), the Secretary shall prescribe 
        requirements for--</DELETED>
                <DELETED>    ``(A) the summary of data or information 
                reviewed under paragraph (2)(A); and</DELETED>
                <DELETED>    ``(B) the analysis of why such data or 
                information does or does not warrant a labeling change 
                required to be submitted to the Secretary in a 
                supplement or in a letter under paragraph 
                (2)(B).</DELETED>
        <DELETED>    ``(4) Periodic review of drugs.--</DELETED>
                <DELETED>    ``(A) Priority.--Not later than 2 years 
                after the date of enactment of this section, the 
                Secretary shall prioritize marketed drugs that were not 
                approved or licensed based on studies in pregnant 
                women, considering--</DELETED>
                        <DELETED>    ``(i) how widely such drugs are 
                        used by women who are pregnant or 
                        lactating;</DELETED>
                        <DELETED>    ``(ii) whether new information 
                        available about such drugs may warrant a 
                        labeling change for such women; and</DELETED>
                        <DELETED>    ``(iii) which of such drugs have 
                        labeling for such women that is most in need of 
                        revision.</DELETED>
                <DELETED>    ``(B) Regulations and orders.--</DELETED>
                        <DELETED>    ``(i) Initial regulations and 
                        orders.--Based on the prioritization of drugs 
                        under subparagraph (A), the Secretary shall, as 
                        resources allow--</DELETED>
                                <DELETED>    ``(I) promulgate 
                                regulations for such drugs that meet 
                                the conditions contained in any 
                                applicable monograph to revise safety 
                                and dosage information required in 
                                labeling for women who are pregnant or 
                                lactating; and</DELETED>
                                <DELETED>    ``(II) issue orders for 
                                other such drugs to require revised 
                                safety and dosage information required 
                                in labeling for women who are pregnant 
                                or lactating.</DELETED>
                        <DELETED>    ``(ii) Subsequent regulations and 
                        orders.--The Secretary shall periodically 
                        review new data or information as it becomes 
                        available on the drugs described in 
                        subparagraph (A), and shall promulgate 
                        regulations or issue orders, as appropriate, to 
                        revise safety and dosage information required 
                        in labeling for such drugs for women who are 
                        pregnant or lactating.</DELETED>
<DELETED>    ``(c) Improving Communication and Information About Fetal 
Risk From Devices.--</DELETED>
        <DELETED>    ``(1) Research on materials used in devices.--
        </DELETED>
                <DELETED>    ``(A) Identifying materials to be 
                studied.--The Secretary, acting through the Director of 
                the National Institutes of Health and in consultation 
                with the Commissioner of Food and Drugs, shall--
                </DELETED>
                        <DELETED>    ``(i) periodically review all 
                        available data and information about the safety 
                        for persons and fetuses of materials used in 
                        devices that may come into contact with, or be 
                        absorbed into, the body;</DELETED>
                        <DELETED>    ``(ii) identify materials for 
                        which additional data or information is needed 
                        to assess the safety for persons and fetuses of 
                        such materials; and</DELETED>
                        <DELETED>    ``(iii) design protocols for 
                        studies to collect data or information 
                        described in clause (ii).</DELETED>
                <DELETED>    ``(B) Studying device materials.--The 
                Director of the National Institutes of Health shall 
                award grants, enter into contracts, or use other 
                appropriate mechanisms to aid in promptly completing 
                the studies designed under subparagraph (A), as the 
                National Institutes of Health's resources 
                allow.</DELETED>
                <DELETED>    ``(C) Safety studies.--The Secretary may 
                require a person that manufactures a device that bears 
                or contains a material for which the Secretary has 
                designed studies under subparagraph (A), to complete 
                and submit such studies to the Secretary, by a date 
                specified by the Secretary.</DELETED>
        <DELETED>    ``(2) Review of device material and labeling.--
        Considering all available data and information about the safety 
        for persons and fetuses of a material that may come into 
        contact with, or be absorbed into, the body when used in a 
        device, including data and information from studies conducted 
        under paragraph (1), the Secretary shall--</DELETED>
                <DELETED>    ``(A) require appropriate statements 
                disclosing any risks to persons or fetuses from the 
                material in the labeling of a device that bears or 
                contains such material; or</DELETED>
                <DELETED>    ``(B) if use of the material in a device 
                presents an unreasonable and substantial risk of 
                illness or injury to persons or fetuses, ban the use of 
                such material in such device.</DELETED>
<DELETED>    ``(d) Limitations on Injunctive Relief To Ensure Prompt 
Revision of Drug and Device Labeling.--In an action under section 302 
with respect to a drug or a device deemed to be misbranded under 
section 502(k) or section 502(l), such misbranding shall not be the 
sole basis for any judicial order that requires a person to cease the 
manufacturing, distribution, or sale of such drug or device.</DELETED>
<DELETED>    ``(e) Outreach and Education.--The Secretary shall expand 
the Women's Health: Take Time to Care program or establish a new 
program that is directed at--</DELETED>
        <DELETED>    ``(1) women who are pregnant or lactating to 
        inform such women about the safety issues involved in taking 
        prescription and over-the-counter drugs, and using medical 
        devices, while such women are pregnant or breast feeding; 
        and</DELETED>
        <DELETED>    ``(2) health care providers and the public to 
        provide information about the safety issues involved when 
        women, who are pregnant or breast feeding, take prescription 
        and over-the-counter drugs or use medical devices.</DELETED>
<DELETED>    ``(f) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section, such sums as 
are necessary.''.</DELETED>
<DELETED>    (b) Amendment to Adulterated Drugs and Devices.--Section 
501(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(g)) 
is amended by striking ``device'' and inserting ``device or it is a 
device that bears or contains a material whose use in such a device has 
been banned under section 564(c)(2)(B)''.</DELETED>
<DELETED>    (c) Amendment to Misbranded Drugs and Devices.--Section 
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 
amended by inserting after subsection (j) the following:</DELETED>
<DELETED>    ``(k)(1) If it is a drug; and--</DELETED>
<DELETED>    ``(2)(A) a study required under section 564(a)(2) with 
respect to such drug is not completed and submitted to the Secretary by 
the date specified by the Secretary;</DELETED>
<DELETED>    ``(B) a supplement or letter required to be submitted to 
the Secretary under section 564(b)(2)(B) with respect to such drug is 
not submitted to the Secretary;</DELETED>
<DELETED>    ``(C) a supplement or letter required to be submitted to 
the Secretary under section 564(b)(2)(B) with respect to such drug does 
not include an adequate summary or analysis of relevant information or 
data; or</DELETED>
<DELETED>    ``(D) its labeling does not include safety or dosage 
information for pregnant or lactating women required by the Secretary 
by regulation or order under section 564(b)(4)(B).</DELETED>
<DELETED>    ``(l) If it is a device and its labeling does not include 
statements required by the Secretary under section 
564(c)(2)(A).''.</DELETED>
<DELETED>    (d) Amendment to Civil Penalties.--Section 307(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (6)(B), by striking ``or''; 
        and</DELETED>
        <DELETED>    (2) by inserting after paragraph (7) the 
        following:</DELETED>
        <DELETED>    ``(8) has failed to complete and submit to the 
        Secretary, by the date specified by the Secretary, a study 
        required by the Secretary under section 564(a)(2);</DELETED>
        <DELETED>    ``(9) has failed to submit to the Secretary a 
        supplement or letter required to be submitted to the Secretary 
        under section 564(b)(2)(B);</DELETED>
        <DELETED>    ``(10) has failed to include an adequate summary 
        or analysis of relevant information or data in a supplement or 
        letter required to be submitted to the Secretary under section 
        564(b)(2)(B);</DELETED>
        <DELETED>    ``(11) has distributed in interstate commerce a 
        drug whose labeling does not include safety or dosage 
        information for pregnant or lactating women required by the 
        Secretary by regulation or order under section 
        564(b)(4)(B);</DELETED>
        <DELETED>    ``(12) has failed to complete and submit to the 
        Secretary, by the date specified by the Secretary, a study 
        required under section 564(c)(1)(C);</DELETED>
        <DELETED>    ``(13) has distributed in interstate commerce a 
        device whose labeling does not include statements required by 
        the Secretary under section 564(c)(2)(A); or</DELETED>
        <DELETED>    ``(14) has distributed in interstate commerce a 
        device that bears or contains a material whose use in such 
        device has been banned under section 564(c)(2)(B).''.</DELETED>

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Women's Health Act 
of 2002''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.

                         TITLE I--HEALTHY MOMS

Sec. 101. Short title.

 Subtitle A--Achieving Goals Set by the U.S. Preventive Task Force and 
   Healthy People 2000 and Healthy People 2010 to Achieve a Healthy 
          Pregnancy and Reduce Pregnancy Related Complications

Sec. 111. Interagency Committee on Healthy Moms.

Subtitle B--Research and Data Collection To Improve Maternal Well-Being

Sec. 121. Expand and intensify research activities at the National 
                            Institutes of Health.
Sec. 122. Improving pregnancy outcomes of high risk women.
Sec. 123. Improve quality health care for pregnant women through the 
                            Agency for Healthcare Research and Quality.

              Subtitle C--Data Collection and Surveillance

Sec. 131. Expand and intensify data collection activities at the 
                            Centers for Disease Control and Prevention.
Sec. 132. Pregnancy and women's health.

               Subtitle D--Public Education and Outreach

Sec. 141. Purpose.
Sec. 142. Healthy moms campaign.

                   TITLE II--OFFICE ON WOMEN'S HEALTH

Sec. 201. Short title.
Sec. 202. Health and Human Services Office on Women's Health.
Sec. 203. Centers for Disease Control and Prevention Office of Women's 
                            Health.
Sec. 204. Agency for Healthcare Research and Quality activities 
                            regarding women's health.
Sec. 205. Health Resources and Services Administration Office of 
                            Women's Health.
Sec. 206. Food and Drug Administration Office of Women's Health.
Sec. 207. No new regulatory authority.

                     TITLE III--WISEWOMAN EXPANSION

Sec. 301. Short title.
Sec. 302. Findings.
Sec. 303. Supplemental grants for additional preventive health services 
                            for women.

                  TITLE IV--SUBSTANCE ABUSE PREVENTION

Sec. 401. Short title.
Sec. 402. Amendment to the Public Health Service Act.

              TITLE V--PERINATAL DENTAL HEALTH IMPROVEMENT

Sec. 501. Short title.
Sec. 502. Findings.
Sec. 503. Grants to conduct research and demonstration projects that 
                            apply new scientific evidence about 
                            maternal and child oral health linkages.

                       TITLE VI--EATING DISORDERS

Sec. 601. Short title.
Sec. 602. Findings.
Sec. 603. Purposes.
Sec. 604. Amendments.

                         TITLE I--HEALTHY MOMS

SEC. 101. SHORT TITLE.

    This title may be cited as the ``Healthy Moms Act for Research and 
Treatment'' or the ``Healthy Moms Act''.

 Subtitle A--Achieving Goals Set by the U.S. Preventive Task Force and 
   Healthy People 2000 and Healthy People 2010 to Achieve a Healthy 
          Pregnancy and Reduce Pregnancy Related Complications

SEC. 111. INTERAGENCY COMMITTEE ON HEALTHY MOMS.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399O. INTERAGENCY COMMITTEE ON HEALTHY MOMS.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Office of Women's Health, shall establish a committee to be known 
as the `Interagency Committee on Healthy Moms' (referred to in this 
section as the `Interagency Committee').
    ``(b) Composition.--The Interagency Committee shall be composed 
of--
            ``(1) the Director of the Centers for Disease Control and 
        Prevention (and the heads of such institutes, centers, and 
        offices as the Director determines appropriate);
            ``(2) the Director of the National Institutes of Health 
        (and the heads of such institutes, centers, and offices as the 
        Director determines appropriate);
            ``(3) the Director of the Indian Health Service (and the 
        heads of such institutes, centers, and offices as the Director 
        determines appropriate);
            ``(4) the Director of the Health Resources and Services 
        Administration (and the heads of such institutes, centers, and 
        offices as the Director determines appropriate);
            ``(5) the Commissioner of Food and Drugs (and the heads of 
        such institutes, centers, and offices as the Commissioner 
        determines appropriate);
            ``(6) the Director of the Agency for Healthcare Research 
        and Quality (and the heads of such institutes, centers, and 
        offices as the Director determines appropriate);
            ``(7) the Secretary of Labor (and the heads of such 
        institutes, centers, and offices as the Secretary determines 
        appropriate);
            ``(8) representatives of other Federal Government agencies 
        that the Secretary determines appropriate; and
            ``(9) representatives of women's health care advocacy and 
        grassroots organizations, health care providers including 
        providers of specialty care, pediatric advocates, and 
        researchers to be appointed by the Director of the Office.
    ``(c) Administrative Support.--The Secretary shall make available 
to the Interagency Committee necessary and appropriate administrative 
support.
    ``(d) Duties.--
            ``(1) Evaluation.--The Interagency Committee shall assess 
        health promotion campaigns that are administered by the Federal 
        Government, evaluate the effect that such campaigns have on 
        health during pregnancy if pregnancy was a focus, and assess 
        whether such programs may be adapted to emphasize the 
        importance of maternal health.
            ``(2) Federal research plan.--
                    ``(A) In general.--Not later than 18 months after 
                the date of enactment of this section, the Secretary 
                shall develop a coordinated Federal research and 
                strategic action plan for women's health (referred to 
                in this paragraph as the `plan'), that includes 
                provisions developed by the Secretary after review of 
                the recommendations made by the Interagency Committee 
                to improve the pregnancy-related health of women 
                before, during and after pregnancy and improve  
pregnancy outcomes. In developing the plan, the Secretary shall 
coordinate with the Coordinating Committee of the Office of Women's 
Health.
                    ``(B) Report.--Not later than 18 months after the 
                date of enactment of this section, the Interagency 
                Committee shall prepare and submit to the Secretary, a 
                report concerning the plan developed under this 
                paragraph and the results of the evaluation conducted 
                under paragraph (1). The Secretary shall transmit the 
                report, with such comments as the Secretary determines 
                to be appropriate, to the appropriate committees of 
                Congress.
            ``(3) Key indicators of well-being.--
                    ``(A) In general.--The Interagency Committee shall 
                identify the key indicators of maternal health and 
                pregnancy outcomes and the sources of data to be 
                included in the report under subparagraph (B), and 
                shall update such indicators as new data become 
                available.
                    ``(B) Report.--Not later than October 1, 2003, and 
                every 2 years thereafter, the Interagency Committee 
                shall prepare and submit to the Secretary, a report, to 
                be known as `America's Mothers: Key National Indicators 
                of Well Being' (referred to in this section as the 
                `Report'), that contains the indicators of maternal 
                health described in subparagraph (A). The Secretary 
                shall transmit the report, with such comments as the 
                Secretary determines to be appropriate, to the 
                appropriate committees of Congress.
                    ``(C) Availability.--The Report shall be made 
                available to the public through the Internet website 
                established under section 399P(c).
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

Subtitle B--Research and Data Collection to Improve Maternal Well-Being

SEC. 121. EXPAND AND INTENSIFY RESEARCH ACTIVITIES AT THE NATIONAL 
              INSTITUTES OF HEALTH.

    (a) Purpose.--It is the purpose of this section to require the 
Director of the National Institutes of Health, acting through the 
Director of the National Institute of Child Health and Human 
Development and in collaboration with the Directors of other 
appropriate Institutes and Offices, to expand and intensify research 
activities with respect to pregnancy and pregnancy-related conditions 
and complications and to expand research to improve understanding and 
treatment of pregnant women who have chronic disease, physical 
impairment, or mental health conditions.
    (b) Healthy Moms as a Priority Area.--Subpart 7 of part C of title 
IV of the Public Health Service Act (42 U.S.C. 285g et seq.) is amended 
by adding at the end the following:

``SEC. 452H. HEALTHY MOMS REPORT.

    ``The Director of the Institute shall, as part of the annual report 
submitted by the Director under this part, report to Congress and the 
public on the extent of the total funds obligated to conduct or support 
research on healthy mothers across the National Institutes of Health, 
including the specific support and research awards allocated through 
such Institutes.''.
    (c) Expanded Research Into Pregnancy.--Subpart 7 of part C of title 
IV of the Public Health Service Act (42 U.S.C. 285g et seq.), as 
amended by subsection (b), is further amended by adding at the end the 
following:

``SEC. 452I. EXPANDED RESEARCH ON PREGNANCY.

    ``(a) Conditions and Complications of Pregnancy.--In order to 
improve the understanding of conditions and complications related to 
pregnancy, to lead to better treatments and care for women throughout 
their pregnancy, and to prevent pregnancy-related complications 
whenever possible, the Director of the Institute shall enhance and 
expand research into the leading causes of pregnancy-related conditions 
and complications of pregnancy.
    ``(b) Reducing Pre-Term Labor and Delivery.--In order to reduce the 
rates of pre-term labor and delivery, the Director of the Institute 
shall expand and intensify research on pre-term labor and delivery.
    ``(c) Reductions in Health Disparities in Pregnant Women and New 
Moms.--The Director of the Institute shall provide for the conduct of 
research to investigate the mechanisms contributing to the disparities 
in maternal and perinatal outcomes among pregnant women and new 
mothers.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this section.

``SEC. 452J. IMPROVING THE UNDERSTANDING AND TREATMENT OF CHRONIC 
              CONDITIONS OF WOMEN DURING PREGNANCY.

    ``(a) In General.--The Director of the Institute shall expand 
research concerning the impact of chronic conditions, physical 
impairments, and mental health problems on the health of women during 
their pregnancy.
    ``(b) Collaboration.--In carrying out subsection (a), the Director 
of the Institute shall act in collaboration with the Directors of other 
appropriate Institutes and Offices of the National Institutes of 
Health.''.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this section.

``SEC. 452K. MATERNAL FETAL MEDICINE UNITS NETWORK.

    ``(a) In General.--The Director of the Institute shall establish a 
Maternal Fetal Medicine Units Network and may, based on an evaluation 
of the activities of such Network, expand such Network. In carrying out 
this subsection, the Director may enter into agreements to utilize the 
existing Maternal Fetal Medicine Units Network.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

SEC. 122. IMPROVING PREGNANCY OUTCOMES OF HIGH RISK WOMEN.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.), 
as amended by section 1302, is further amended by adding at the end the 
following:

                      ``PART S--PREGNANCY OUTCOMES

``SEC. 399BB. IMPROVING PREGNANCY OUTCOMES OF HIGH RISK WOMEN.

    ``(a) In General.--The Secretary, after consultation with the 
Director of the Centers for Disease Control and Prevention and the 
Administrator of the Health Resources and Services Administration, 
shall award grants to States and Indian tribes to support community-
based demonstration projects in disease prevention and health promotion 
to improve maternal pregnancy outcomes, with particular emphasis on 
social, economic, and behavioral health issues affecting high risk 
populations. Where practicable, such demonstration projects shall be 
based on relevant scientific studies.
    ``(b) Technical Assistance.--In carrying out subsection (a), the 
Secretary may provide technical assistance to States and Indian tribes.
    ``(c) Definition.--In this section, the term `Indian tribe' has the 
meaning given the term in section 317M.''.

SEC. 123. IMPROVE QUALITY HEALTH CARE FOR PREGNANT WOMEN THROUGH THE 
              AGENCY FOR HEALTHCARE RESEARCH AND QUALITY.

    Part B of title IX of the Public Health Service Act (42 U.S.C. 299b 
et seq.) is amended by adding at the end the following:

``SEC. 918. MATERNAL HEALTH CARE.

    ``(a) Research.--The Secretary, acting through the Director, shall 
provide for the conduct of research concerning the quality of maternal 
health care, including providing for--
            ``(1) synthesis of effective health services related to 
        pregnancy for women before, during, and after pregnancy; and
            ``(2) research concerning the barriers women face in 
        receiving health services consistent with effective health 
        services under paragraph (1) or equivalent health services.
    ``(b) Report.--The results of the research conducted under 
subsection (a) shall be provided by the Director to Congress as part of 
the annual report submitted under section 913(b)(2).''.

              Subtitle C--Data Collection and Surveillance

SEC. 131. EXPAND AND INTENSIFY DATA COLLECTION ACTIVITIES AT THE 
              CENTERS FOR DISEASE CONTROL AND PREVENTION.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317K the following:

``SEC. 317K-1. DATA COLLECTION REGARDING HEALTHY MOMS.

    ``(a) Standard Definitions for Maternal Mortality and Morbidity.--
The Secretary, acting through the Director of the Centers for Disease 
Control and Prevention and in cooperation with State officials, 
professional medical experts, medical organizations, and health care 
service researchers, shall develop a standard definition of `maternal 
mortality' and `maternal morbidity'.
    ``(b) Grants for Surveillance of Maternal Mortality and Morbidity 
Data.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall establish a program to award grants to States, Indian 
        tribes, counties, and cities for the development of 
        surveillance systems, that use the standard definitions 
        established under subsection (a), to gather data on maternal 
        mortality and maternal morbidity.
            ``(2) Eligibility.--To be eligible to receive a grant under 
        paragraph (1), a State, Indian tribe, county, or city shall--
                    ``(A) prepare and submit to the Secretary an 
                application, at such time, in such manner, and 
                containing such information as the Secretary may 
                require; and
                    ``(B) provide an assurance that the applicant will 
                work with the Centers for Disease Control and 
                Prevention to adopt standard procedures for the 
                identification, collection, and analysis of the data 
                that are to be collected under the grant.
            ``(3) Technical assistance.--The Centers for Disease 
        Control and Prevention shall provide technical assistance to 
        grantees under this subsection.
            ``(4) Incorporation of data into report.--Where determined 
        appropriate by the Secretary, data collected by the 
        surveillance systems established under this subsection shall be 
        incorporated into the report submitted under section 
        399O(d)(3)(B).
            ``(5) Definition.--In this subsection, the term `Indian 
        tribe' has the meaning given the term in section 317M.
    ``(c) Prevalence of Pre-Term Labor and Delivery.--The Secretary, 
acting through the Director of the Centers for Disease Control and 
Prevention, shall work with States and other entities to improve 
knowledge regarding the incidence and prevalence of symptoms and risk 
factors for pre-term births.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

SEC. 132. PREGNANCY AND WOMEN'S HEALTH.

    Section 1004 of the Children's Health Act of 2000 (42 U.S.C. 285g 
note) is amended--
            (1) by redesignating subsections (d) and (e) as subsections 
        (e) and (f), respectively; and
            (2) by inserting after subsection (c), the following:
    ``(d) Study on Effects of Pregnancy on Women.--As part of the study 
conducted under this section, the Secretary, acting through the 
Director of the National Institute of Child Health and Human 
Development, shall plan, develop, and implement a 2-year prospective 
cohort study of mothers to determine the effects of pregnancy on the 
health of women. Such study shall evaluate--
            ``(1) the effects of pregnancy on women's health;
            ``(2) the effects of both preexisting and chronic 
        conditions, physical impairments, and mental health problems 
        related to pregnancy;
            ``(3) the impact of stress and anxiety; and
            ``(4) environmental health factors that influence both the 
        mother's health and that of her child.''.

               Subtitle D--Public Education and Outreach

SEC. 141. PURPOSE.

    It is the purpose of this subtitle to address the need for 
providing women with accurate and up-to-date information through a 21st 
century public education and outreach Campaign for Healthy Moms that 
shall raise the public awareness of the issues related to healthy 
mothers.

SEC. 142. HEALTHY MOMS CAMPAIGN.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.), as amended by section 111, is further amended by adding 
at the end the following:

``SEC. 399P. HEALTHY MOMS CAMPAIGN.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Office of Women's Health and the Interagency Committee on Healthy 
Moms (referred to in this section as the `Interagency Committee') 
established under section 399O, shall develop and implement a national 
public education and health promotion campaign to be known as the 
Healthy Moms Campaign (referred to in this section as the `Campaign').
    ``(b) Elements of Campaign.--The Campaign shall at a minimum 
include the following:
            ``(1) Website.--An Internet website to be established in 
        accordance with subsection (c).
            ``(2) Community partnerships.--The provision of support for 
        community-based programs to provide outreach, education, 
        information, and health promotion services to pregnant women 
        and new mothers.
            ``(3) State, tribal, and local partnerships.--The 
        facilitation of consultations with State, tribal, and local 
        public health officials to gain access to high risk women in an 
        effort to provide outreach and education assistance and 
        information to help women have a healthy pregnancy.
            ``(4) Special populations.--The implementation of 
        procedures to ensure that activities under the Campaign are 
        accessible to low-literate, non-English speaking where 
        determined appropriate by the Secretary.
    ``(c) Internet Website.--
            ``(1) Establishment.--The Secretary, acting through the 
        Office of Women's Health and in consultation with the 
        Interagency Committee, shall develop and maintain a single 
        Internet website to provide pregnant women, and research and 
        health practitioners with the most up-to-date and accurate 
        information on pregnancy, in a manner designed to carry out the 
        purpose described in paragraph (2).
            ``(2) Purpose.--It is the purpose of the website 
        established under paragraph (1) to consolidate information, 
        research, and data related to pregnancy (prenatal, intrapartum, 
        and postpartum) together in one place and to provide links for 
        women to other critical websites (such as websites of Federal 
        agencies, community health programs, and State and tribal 
        health programs).
            ``(3) Contents.--The website established under paragraph 
        (1) shall, at a minimum, contain educational materials for how 
        to have the healthiest pregnancy possible.
            ``(4) Appropriate form of information.--The information 
        contained on the website established under paragraph (1) shall 
        be maintained in a culturally sensitive and appropriate form.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

                   TITLE II--OFFICE ON WOMEN'S HEALTH

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Women's Health Office Act of 
2002''.

SEC. 202. HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S HEALTH.

    (a) Establishment.--Part A of title II of the Public Health Service 
Act (42 U.S.C. 202 et seq.) is amended by adding at the end the 
following:

``SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S HEALTH.

    ``(a) Establishment of Office.--The Secretary shall establish 
within the Office of the Secretary, an Office on Women's Health 
(referred to in this section as the `Office'). The Office shall be 
headed by a Deputy Assistant Secretary for Women's Health.
    ``(b) Duties.--The Secretary, acting through the Office, with 
respect to the health concerns of women, shall--
            ``(1) establish short-range and long-range goals and 
        objectives within the Department of Health and Human Services 
        and, as relevant and appropriate, coordinate with other 
        appropriate offices on activities within the Department that 
        relate to disease prevention, health promotion, service 
        delivery, research, and public and health care professional 
        education, for issues of particular concern to women;
            ``(2) provide expert advice and consultation to the 
        Secretary concerning scientific, legal, ethical, and policy 
        issues relating to women's health;
            ``(3) monitor the Department of Health and Human Services' 
        offices, agencies, and regional activities regarding women's 
        health and stimulate activities and facilitate coordination of 
        such departmental and agency offices on women's health;
            ``(4) establish a Department of Health and Human Services 
        Coordinating Committee on Women's Health, which shall be 
        chaired by the Deputy Assistant Secretary for Women's Health 
        and composed of senior level representatives from each of the 
        agencies and offices of the Department of Health and Human 
        Services;
            ``(5) establish a National Women's Health Information 
        Center to--
                    ``(A) facilitate the exchange of information 
                regarding matters relating to health information, 
                health promotion, preventive health services, research 
                advances, and education in the appropriate use of 
                health care;
                    ``(B) facilitate access to such information;
                    ``(C) assist in the analysis of issues and problems 
                relating to the matters described in this paragraph; 
                and
                    ``(D) provide technical assistance with respect to 
                the exchange of information (including facilitating the 
                development of materials for such technical 
                assistance);
            ``(6) coordinate efforts to promote women's health programs 
        and policies with the private sector; and
            ``(7) through publications and any other means appropriate, 
        provide for the exchange of information between the Office and 
        recipients of grants, contracts, and agreements under 
        subsection (c), and between the Office and health professionals 
        and the general public.
    ``(c) Grants and Contracts Regarding Duties.--
            ``(1) Authority.--In carrying out subsection (b), the 
        Secretary may make grants to, and enter into cooperative 
        agreements, contracts, and interagency agreements with, public 
        and private entities, agencies, and organizations.
            ``(2) Evaluation and dissemination.--The Secretary shall 
        directly or through contracts with public and private entities, 
        agencies, and organizations, provide for evaluations of 
        projects carried out with financial assistance provided under 
        paragraph (1) and for the dissemination of information 
        developed as a result of such projects.
    ``(d) Reports.--Not later than January 31, 2004, and January 31 of 
each second year thereafter, the Secretary shall prepare and submit to 
the appropriate committees of Congress a report describing the 
activities carried out under this section during the period for which 
the report is being prepared.
    ``(e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2003 through 2007.''.
    (b) Transfer of Functions.--There are transferred to the Office on 
Women's Health (established under section 229 of the Public Health 
Service Act, as added by this section), all functions exercised by the 
Office on Women's Health of the Public Health Service prior to the date 
of enactment of this section, including all personnel and compensation 
authority, all delegation and assignment authority, and all remaining 
appropriations. All orders, determinations, rules, regulations, 
permits, agreements, grants, contracts, certificates, licenses, 
registrations, privileges, and other administrative actions that--
            (1) have been issued, made, granted, or allowed to become 
        effective by the President, any Federal agency or official 
        thereof, or by a court of competent jurisdiction, in the 
        performance of functions transferred under this subsection; and
            (2) are in effect at the time this section takes effect, or 
        were final before the date of enactment of this section and are 
        to become effective on or after such date;
shall continue in effect according to their terms until modified, 
terminated, superseded, set aside, or revoked in accordance with law by 
the President, the Secretary, or other authorized official, a court of 
competent jurisdiction, or by operation of law.

SEC. 203. CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN'S 
              HEALTH.

    Part A of title III of the Public Health Service Act (42 U.S.C. 241 
et seq.) is amended by adding at the end the following:

 ``centers for disease control and prevention office of women's health

    ``Sec. 310A. (a) Establishment.--The Secretary shall establish 
within the Office of the Director of the Centers for Disease Control 
and Prevention, an office to be known as the Office of Women's Health 
(referred to in this section as the `Office'). The Office shall be 
headed by a director who shall be appointed by the Director of such 
Centers.
    ``(b) Purpose.--The Director of the Office shall--
            ``(1) report to the Director of the Centers for Disease 
        Control and Prevention on the current level of the Centers' 
        activity regarding women's health conditions across, where 
        appropriate, age, biological, and sociocultural contexts, in 
        all aspects of the Centers' work, including prevention 
        programs, public and professional education, services, and 
        treatment;
            ``(2) establish short-range and long-range goals and 
        objectives within the Centers for women's health and, as 
        relevant and appropriate, coordinate with other appropriate 
        offices on activities within the Centers that relate to 
        prevention, research, education and training, service delivery, 
        and policy development, for issues of particular concern to 
        women;
            ``(3) identify projects in women's health that should be 
        conducted or supported by the Centers;
            ``(4) consult with health professionals, nongovernmental 
        organizations, consumer organizations, women's health 
        professionals, and other individuals and groups, as 
        appropriate, on the policy of the Centers with regard to women; 
        and
            ``(5) serve as a member of the Department of Health and 
        Human Services Coordinating Committee on Women's Health 
        (established under section 229(b)(4)).
    ``(c) Coordinating Committee.--
            ``(1) Establishment.--In carrying out subsection (b), the 
        Director of the Office shall establish a committee to be known 
        as the Coordinating Committee on Women's Health (referred to in 
        this subsection as the `Coordinating Committee').
            ``(2) Composition.--The Coordinating Committee shall be 
        composed of the directors of the national centers and other 
        appropriate officials of the Centers for Disease Control and 
        Prevention.
            ``(3) Chairperson.--The Director of the Office shall serve 
        as the Chairperson of the Coordinating Committee.
            ``(4) Duties.--With respect to women's health, the 
        Coordinating Committee shall assist the Director of the Office 
        in--
                    ``(A) identifying the need for programs and 
                activities that focus on women's health;
                    ``(B) identifying needs regarding the coordination 
                of activities, including intramural and extramural 
                multidisciplinary activities; and
                    ``(C) making recommendations to the Director of the 
                Centers for Disease Control and Prevention concerning 
                findings made under subparagraphs (A) and (B).
    ``(d) Reports.--Not later than January 31, 2004, and January 31 of 
each second year thereafter, the Director of the Office shall prepare 
and submit to the appropriate committees of Congress a report 
describing the activities carried out under this section during the 
period for which the report is being prepared.
    ``(e) Definition.--As used in this section, the term `women's 
health conditions', with respect to women of all age, ethnic, and 
racial groups, means diseases, disorders, and conditions--
            ``(1) unique to, significantly more serious for, or 
        significantly more prevalent in women; and
            ``(2) for which the factors of medical risk or type of 
        medical intervention are different for women, or for which 
        there is reasonable evidence that indicates that such factors 
        or types may be different for women.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2003 through 2007.''.

SEC. 204. AGENCY FOR HEALTHCARE RESEARCH AND QUALITY ACTIVITIES 
              REGARDING WOMEN'S HEALTH.

    Part C of title IX of the Public Health Service Act (42 U.S.C. 299c 
et seq.) is amended--
            (1) by redesignating sections 927 and 928 as sections 928 
        and 929, respectively;
            (2) by inserting after section 926 the following:

``SEC. 927. ACTIVITIES REGARDING WOMEN'S HEALTH.

    ``(a) Establishment.--The Director shall designate an official of 
the Office of Priority Populations to carry out the responsibilities 
described in this section for such official.
    ``(b) Purpose.--The official designated under subsection (a) 
shall--
            ``(1) report to the Director on the current Agency level of 
        activity regarding women's health, across, where appropriate, 
        age, biological, and sociocultural contexts, in all aspects of 
        Agency work, including the development of evidence reports and 
        clinical practice protocols and the conduct of research into 
        patient outcomes, delivery of health care services, quality of 
        care, and access to health care;
            ``(2) establish short-range and long-range goals and 
        objectives within the Agency for research important to women's 
        health and, as relevant and appropriate, coordinate with other 
        appropriate offices on activities within the Agency that relate 
        to health services and medical effectiveness research, for 
        issues of particular concern to women;
            ``(3) identify projects in women's health that should be 
        conducted or supported by the Agency;
            ``(4) consult with health professionals, nongovernmental 
        organizations, consumer organizations, women's health 
        professionals, and other individuals and groups, as 
        appropriate, on Agency policy with regard to women; and
            ``(5) serve as a member of the Department of Health and 
        Human Services Coordinating Committee on Women's Health 
        (established under section 229(b)(4)).
    ``(c) Coordinating Committee.--
            ``(1) Establishment.--In carrying out subsection (b), the 
        official designated under subsection (a) shall establish a 
        committee to be known as the Coordinating Committee on Women's 
        Health (referred to in this subsection as the `Coordinating 
        Committee').
            ``(2) Composition.--The Coordinating Committee shall be 
        composed of the official designated under subsection (a) and 
        the directors of the centers and offices of the Agency.
            ``(3) Chairperson.--The official designated under 
        subsection (a) shall serve as the Chairperson of the 
        Coordinating Committee.
            ``(4) Duties.--With respect to research on women's health, 
        the Coordinating Committee shall assist the official designated 
        under subsection (a) in--
                    ``(A) identifying the need for such research, and 
                making an estimate each fiscal year of the funds needed 
                to adequately support the research;
                    ``(B) identifying needs regarding the coordination 
                of research activities, including intramural and 
                extramural multidisciplinary activities; and
                    ``(C) making recommendations to the Director of the 
                Agency concerning findings made under subparagraphs (A) 
                and (B).
    ``(d) Reports.--Not later than January 31, 2004, and January 31 of 
each second year thereafter, the official designated under subsection 
(a) shall prepare and submit to the appropriate committees of Congress 
a report describing the activities carried out under this section 
during the period for which the report is being prepared.''; and
            (3) by adding at the end of section 928 (as redesignated by 
        paragraph (1)) the following:
    ``(e) Women's Health.--For the purpose of carrying out section 927 
regarding women's health, there are authorized to be appropriated such 
sums as may be necessary for each of the fiscal years 2003 through 
2007.''.

SEC. 205. HEALTH RESOURCES AND SERVICES ADMINISTRATION OFFICE OF 
              WOMEN'S HEALTH.

    Title VII of the Social Security Act (42 U.S.C. 901 et seq.) is 
amended by adding at the end the following:

                       ``office of women's health

    ``Sec. 713. (a) Establishment.--The Secretary shall establish 
within the Office of the Administrator of the Health Resources and 
Services Administration, an office to be known as the Office of Women's 
Health. The Office shall be headed by a director who shall be appointed 
by the Administrator.
    ``(b) Purpose.--The Director of the Office shall--
            ``(1) report to the Administrator on the current 
        Administration level of activity regarding women's health 
        across, where appropriate, age, biological, and sociocultural 
        contexts;
            ``(2) establish short-range and long-range goals and 
        objectives within the Health Resources and Services 
        Administration for women's health and, as relevant and 
        appropriate, coordinate with other appropriate offices on 
        activities within the Administration that relate to health care 
        provider training, health service delivery, research, and 
        demonstration projects, for issues of particular concern to 
        women;
            ``(3) identify projects in women's health that should be 
        conducted or supported by the bureaus of the Administration;
            ``(4) consult with health professionals, nongovernmental 
        organizations, consumer organizations, women's health 
        professionals, and other individuals and groups, as 
        appropriate, on Administration policy with regard to women; and
            ``(5) serve as a member of the Department of Health and 
        Human Services Coordinating Committee on Women's Health 
        (established under section 229(b)(4) of the Public Health 
        Service Act).
    ``(c) Coordinating Committee.--
            ``(1) Establishment.--In carrying out subsection (b), the 
        Director of the Office shall establish a committee to be known 
        as the Coordinating Committee on Women's Health (referred to in 
        this subsection as the `Coordinating Committee').
            ``(2) Composition.--The Coordinating Committee shall be 
        composed of the directors of the bureaus of the Administration.
            ``(3) Chairperson.--The Director of the Office shall serve 
        as the Chairperson of the Coordinating Committee.
            ``(4) Duties.--With respect to women's health, the 
        Coordinating Committee shall assist the Director of the Office 
        in--
                    ``(A) identifying the need for programs and 
                activities that focus on women's health;
                    ``(B) identifying needs regarding the coordination 
                of activities, including intramural and extramural 
                multidisciplinary activities; and
                    ``(C) making recommendations to the Administrator 
                concerning findings made under subparagraphs (A) and 
                (B).
    ``(d) Reports.--Not later than January 31, 2004, and January 31 of 
each second year thereafter, the Director of the Office shall prepare 
and submit to the appropriate committees of Congress a report 
describing the activities carried out under this section during the 
period for which the report is being prepared.
    ``(e) Definitions.--For purposes of this section:
            ``(1) Administration.--The term `Administration' means the 
        Health Resources and Services Administration.
            ``(2) Administrator.--The term `Administrator' means the 
        Administrator of the Health Resources and Services 
        Administration.
            ``(3) Office.--The term `Office' means the Office of 
        Women's Health established under this section in the 
        Administration.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2003 through 2007.''.

SEC. 206. FOOD AND DRUG ADMINISTRATION OFFICE OF WOMEN'S HEALTH.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 908. OFFICE OF WOMEN'S HEALTH.

    ``(a) Establishment.--The Secretary shall establish within the 
Office of the Commissioner, an office to be known as the Office of 
Women's Health (referred to in this section as the `Office'). The 
Office shall be headed by a director who shall be appointed by the 
Commissioner of Food and Drugs.
    ``(b) Purpose.--The Director of the Office shall--
            ``(1) report to the Commissioner of Food and Drugs on 
        current Food and Drug Administration (referred to in this 
        section as the `Administration') levels of activity regarding 
        women's participation in clinical trials and the analysis of 
        data by sex in the testing of drugs, medical devices, and 
        biological products across, where appropriate, age, biological, 
        and sociocultural contexts;
            ``(2) establish short-range and long-range goals and 
        objectives within the Administration for issues of particular 
        concern to women's health within the jurisdiction of the 
        Administration, including, where relevant and appropriate, 
        adequate inclusion of women and analysis of data by sex in 
        Administration protocols and policies;
            ``(3) provide information to women and health care 
        providers on those areas in which differences between men and 
        women exist;
            ``(4) consult with pharmaceutical, biologics, and device 
        manufacturers, health professionals with expertise in women's 
        issues, consumer organizations, and women's health 
        professionals on Administration policy with regard to women;
            ``(5) make annual estimates of funds needed to monitor 
        clinical trials and analysis of data by sex in accordance with 
        needs that are identified; and
            ``(6) serve as a member of the Department of Health and 
        Human Services Coordinating Committee on Women's Health 
        (established under section 229(b)(4) of the Public Health 
        Service Act).
    ``(c) Coordinating Committee.--
            ``(1) Establishment.--In carrying out subsection (b), the 
        Director of the Office shall establish a committee to be known 
        as the Coordinating Committee on Women's Health (referred to in 
        this subsection as the `Coordinating Committee').
            ``(2) Composition.--The Coordinating Committee shall be 
        composed of the directors of the centers of the Administration.
            ``(3) Chairperson.--The Director of the Office shall serve 
        as the Chairperson of the Coordinating Committee.
            ``(4) Duties.--With respect to women's health, the 
        Coordinating Committee shall assist the Director of the Office 
        in--
                    ``(A) identifying whether there is a need for 
                further studies and, if so, developing strategies to 
                foster such studies;
                    ``(B) identifying issues in specific areas of 
                women's health that fall within the mission of the 
                Administration;
                    ``(C) identifying whether any need exists for the 
                coordination of Administration activities, including 
                internal and external activities;
                    ``(D) maintaining the Administration's focus in 
                areas of importance to women;
                    ``(E) supporting the development of methodologies 
                to determine how to obtain data specific to women 
                (including data relating to the age of women and the 
                membership of women in ethnic or racial groups); and
                    ``(F) supporting the development and expansion of 
                clinical trials of treatments and therapies for which 
                obtaining such data has been determined to be an 
                appropriate function.
    ``(d) Reports.--Not later than January 31, 2004, and January 31 of 
each second year thereafter, the Director of the Office shall prepare 
and submit to the appropriate committees of Congress a report 
describing the activities carried out under this section during the 
period for which the report is being prepared.
    ``(e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2003 through 2007.''.

SEC. 207. NO NEW REGULATORY AUTHORITY.

    Nothing in this Act and the amendments made by this Act may be 
construed as establishing regulatory authority or modifying any 
existing regulatory authority.

                     TITLE III--WISEWOMAN EXPANSION

SEC. 301. SHORT TITLE.

    This Act may be cited as the ``WISEWOMAN Expansion Act of 2002''.

SEC. 302. FINDINGS.

    Congress makes the following findings:
            (1) Cardiovascular disease, including heart disease and 
        stroke, remains the leading cause of death among females in the 
        United States, killing more than 500,006 women each year.
            (2) About 1 in 5 females have some form of cardiovascular 
        disease.
            (3) More American women die of cardiovascular disease than 
        the next 14 causes of death combined.
            (4) In women, cardiovascular disease is frequently 
        undetected and untreated until the disease has become severe, 
        causing 38 percent of women who have heart attacks to die 
        within 1 year.
            (5) Obesity increases women's risk for some of the leading 
        causes of death, including heart disease, stroke, diabetes, and 
        certain cancers.
            (6) Better nutrition and lifestyle changes can effectively 
        prevent and treat obesity.
            (7) Osteoporosis afflicts more than 20,000,000 American 
        women.
            (8) More than half of all American women over 65 have 
        osteoporosis.
            (9) One out of every 2 women over the age of 50 will have 
        an osteoporosis-related fracture during her lifetime.
            (10) The national annual costs associated with osteoporosis 
        are estimated at approximately $14,000,000,000.
            (11) Physical activity is necessary for bone acquisition 
        and maintenance throughout adulthood.
            (12) Muscular strength and balance may be very significant 
        in future risk reduction for osteoporosis.
            (13) There is consensus that adequate vitamin D and calcium 
        intakes are required for bone health.
            (14) Research has demonstrated that--
                    (A) the uninsured often have significantly poorer 
                health than the insured; and
                    (B) being uninsured is an obstacle to receiving 
                preventive health care services.
            (15) The WISEWOMAN demonstration program, which is 
        currently operating in 12 States, has--
                    (A) provided improved access for preventive health 
                services, such as cholesterol and blood pressure 
                screening, for over 11,000 women and identified risk 
                factors for heart disease such as obesity, high 
                cholesterol, high blood pressure, sedentary behavior 
                and poor diet; and
                    (B) improved follow up and maintenance care, 
                resulting in improved weight management, lower blood 
                pressure and lower cholesterol.
            (16) Expansion of the WISEWOMAN demonstration model program 
        to additional States would help reduce women's risk of illness 
        and death from heart disease and other preventable diseases and 
        provide further insights into the feasibility and effectiveness 
        of making comprehensive, integrated preventive services, 
        including enhanced case management services, available to low-
        income and uninsured women across the nation.

SEC. 303. SUPPLEMENTAL GRANTS FOR ADDITIONAL PREVENTIVE HEALTH SERVICES 
              FOR WOMEN.

    Section 1509 of the Public Health Service Act (42 U.S.C. 300n-4a) 
is amended to read as follows:

``SEC. 1509. ESTABLISHMENT OF PROGRAM FOR ADDITIONAL PREVENTIVE HEALTH 
              SERVICES.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may, through a 
competitive review process, award grants to States that have received 
grants under section 1501 for a fiscal year, to enable such State to 
carry out programs--
            ``(1) to provide preventive health services, in addition to 
        the services authorized in such section 1501, for diseases such 
        as cardiovascular diseases, osteoporosis, and obesity;
            ``(2) to provide screenings, such as screening for blood 
        pressure, cholesterol, and osteoporosis, and other services 
        that the Secretary, acting through the Director of the Centers 
        for Disease Control and Prevention, determines to be 
        appropriate and feasible;
            ``(3) for health education, counseling, and interventions 
        for behavioral risk factors, such as physical inactivity and 
        poor nutrition, and diseases referred to in paragraph (1);
            ``(4) to provide appropriate referrals for medical 
        treatment of women receiving services pursuant to paragraph (1) 
        through (3), and ensuring, to the extent practicable, the 
        provision of appropriate follow-up services; and
            ``(5) to evaluate the activities conducted under paragraphs 
        (1) through (4) through appropriate surveillance, research, or 
        program monitoring activities.
    ``(b) Status as Participant in Program Regarding Breast and 
Cervical Cancer.--The Secretary may not make a grant to a State under 
subsection (a) unless the State involved agrees that services under the 
grant will be provided in conjunction with entities that are screening 
women for breast or cervical cancer pursuant to a grant under section 
1501.
    ``(c) Applicability of Provisions.--The provisions of this title 
shall apply to a grant under subsection (a) to the same extent and in 
the same manner as such provisions apply to a grant under section 1501.
    ``(d) Funding.--There is authorized to be appropriated to carry out 
this section--
            ``(1) $20,000,000 for fiscal year 2003;
            ``(2) $25,000,000 for fiscal year 2004; and
            ``(3) such sums as may be necessary for each of fiscal 
        years 2005 through 2007.

                  TITLE IV--SUBSTANCE ABUSE PREVENTION

SEC. 401. SHORT TITLE.

    This title may be cited as the ``Substance Abuse Prevention and 
Treatment for Safe Motherhood Act''.

SEC. 402. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    Section 519A of the Public Health Service Act (42 U.S.C. 290bb-25a) 
is amended--
            (1) in subsection (d)--
                    (A) in paragraph (1), by striking ``and'' at the 
                end;
                    (B) in paragraph (2), by striking the period and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
            ``(3) identify women with children in the judicial or child 
        welfare system in the State or locality who are in need of 
        substance abuse services;
            ``(4) provide early referral for substance abuse treatment 
        for women with children;
            ``(5) develop a comprehensive treatment plan for the women 
        and children to address--
                    ``(A) the substance abuse service needs of the 
                women in the State or locality;
                    ``(B) the health services needs for the women with 
                children, including services for HIV, tuberculosis, or 
                any sexually transmitted disease; and
                    ``(C) the mental health needs of the women and the 
                children;
            ``(6) provide treatment that follows best practices in 
        addressing the needs of the women;
            ``(7) provide services to the women to ensure stable 
        housing, employment, health, and social support for women who 
        are transitioning from treatment;
            ``(8) monitor the progress of women in substance abuse 
        treatment;
            ``(9) provide prevention and early intervention services 
        for women who are at risk for substance abuse;
            ``(10) provide prevention and early intervention services 
        for the children;
            ``(11) provide for the health and educational needs of the 
        children;
            ``(12) provide parenting classes for the women; and
            ``(13) provide training for the staff of each of the 
        participating agencies in order that such staff may--
                    ``(A) identify women with children in need of 
                substance abuse services;
                    ``(B) provide referrals to agencies that provide 
                services for such women and children; and
                    ``(C) determine how to use the program to the 
                advantage of the women and children.'';
            (2) in subsection (e)--
                    (A) in paragraph (2), by striking ``and'' at the 
                end;
                    (B) in paragraph (3), by striking the period and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
            ``(4) provides assurances that the applicant has 
        established, or will establish, a network consisting of a 
        substance abuse service agency, a child welfare agency, and an 
        agency of a State judicial system that proposes to work 
        cooperatively to provide the substance abuse program described 
        in subsection (a); and
            ``(5) identifies a State that will develop a cooperative 
        group as described in paragraph (4).''; and
            (3) by striking subsection (i) and inserting the following:
    ``(i) High-Risk Families.--In this section, the term ``high-risk 
family'' means--
            ``(1) a family in which the individuals of such family are 
        at a significant risk of using or abusing alcohol or any 
        illegal substance and
            ``(2) a woman with a minor child who is involved with the 
        State or local child welfare agency or protective services, or 
        who is involved with an agency of the State or local judicial 
        system.''.

              TITLE V--PERINATAL DENTAL HEALTH IMPROVEMENT

SEC. 501. SHORT TITLE.

    This title may be cited as the ``Perinatal Dental Health 
Improvement Act of 2002''.

SEC. 502. FINDINGS.

    Congress makes the following findings:
            (1) The National Institutes of Health reports that ``as 
        many as 18 percent of the 250,000 premature low-weight infants 
        born in the United States each year may be attributable to 
        infectious oral disease.''.
            (2) Recent scientific studies suggest that the severe 
        consequences of premature delivery and associated low birth 
        weight may be partially preventable through improved oral 
        health of pregnant women.
            (3) Additionally, extensive laboratory, clinical and 
        epidemiologic studies show that a mother's experience with 
        tooth decay determines their young children's risk of 
        developing cavities.
            (4) Dental caries (tooth decay) is now understood to be an 
        infectious and transmissible disease acquired by children 
        primarily from their mothers.

SEC. 503. GRANTS TO CONDUCT RESEARCH AND DEMONSTRATION PROJECTS THAT 
              APPLY NEW SCIENTIFIC EVIDENCE ABOUT MATERNAL AND CHILD 
              ORAL HEALTH LINKAGES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317M the following:

``SEC. 317M-1. GRANTS TO CONDUCT RESEARCH AND DEMONSTRATION PROJECTS 
              THAT APPLY NEW SCIENTIFIC EVIDENCE ABOUT MATERNAL AND 
              CHILD ORAL HEALTH LINKAGES.

    ``(a) Authority To Award Grants.--The Secretary, acting through the 
Director of the Maternal and Child Health Bureau, shall award grants to 
eligible entities to conduct surveillance research and demonstration 
projects concerning possible maternal and child oral health linkages 
related to adverse pregnancy outcomes and maternal transmission of 
dental caries.
    ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means a nonprofit organization, accredited dental education and 
research institution, an Indian tribe (as defined in section 4 of the 
Indian Self-Determination and Education Assistance Act (25 U.S.C. 
450b)), or tribal organization.
    ``(c) Requirement for Nonprofit Organizations, Accredited Dental 
Education and Research Institutions, and Indian Tribes and Tribal 
Organizations.--In order to be eligible for a grant under this section, 
an eligible entity shall provide the Secretary with an assurance that 
it such entity is an eligible entity.
    ``(d) Use of Funds.--
            ``(1) In general.--Funds provided under this section may be 
        used to provide direct funding to support projects in the 
        following areas:
                    ``(A) Professional education.--The development of 
                programs based on the most recent research available as 
                of the date of the conduct of the program with respect 
                to maternal and child health to inform dentists, 
                pediatricians, family physicians, obstetricians, nurse 
                practitioners, and other primary care providers in 
                order to educate women of childbearing age on the 
                possible maternal-child health consequences of poor 
                oral health, and to conduct surveillance research on 
                the outcomes of such programs.
                    ``(B) Public education.--The development of 
                programs based on the most recent research available as 
                of the date of the conduct of the program with respect 
                to maternal and child health to raise the public's 
                awareness of possible maternal and child health 
                consequences of poor oral health, to improve the oral 
                health practices of women of childbearing age, and to 
                conduct surveillance research on the outcomes of such 
                programs.
            ``(2) Limitation.--Funds provided under a grant awarded 
        under this section may not be used for payment of direct 
        dental, medical, or other services or to obtain Federal 
        matching funds under any Federal program.
    ``(e) Application.--An eligible entity desiring a grant under this 
section shall submit an application to the Secretary in such form and 
manner and containing such information as the Secretary may require.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to make grants under this section $7,500,000 for fiscal 
year 2003, and such sums as may be necessary for each of fiscal years 
2004 through 2007.''.

                       TITLE VI--EATING DISORDERS

SEC. 601. SHORT TITLE.

    This title may be cited as the ``Promoting Healthy Eating Behaviors 
in Youth Act''.

SEC. 602. FINDINGS.

    Congress makes the following findings:
            (1) Anorexia Nervosa is an eating disorder characterized by 
        self-starvation and excessive weight loss.
            (2) Anorexia Nervosa is common: an estimated .5 to 3.7 
        percent of American women will suffer from this disorder in 
        their lifetime.
            (3) Anorexia Nervosa is associated with serious health 
        consequences including heart failure, kidney failure, 
        osteoporosis, and death.
            (4) Anorexia Nervosa has the highest mortality rate of all 
        psychiatric disorders. A young woman is 12 times more likely to 
        die than other women her age without Anorexia.
            (5) Anorexia Nervosa usually appears in adolescence.
            (6) Bulimia Nervosa is an eating disorder characterized by 
        excessive food consumption followed by inappropriate 
        compensatory behaviors, such as self-induced vomiting, misuse 
        of laxatives, fasting, or excessive exercise.
            (7) Bulimia Nervosa is common: an estimated 1.1 to 4.2 
        percent of American women will suffer from this disorder in 
        their lifetime.
            (8) Bulimia Nervosa is associated with cardiac, 
        gastrointestinal, and dental problems including irregular 
        heartbeats, gastric rupture, peptic ulcer, and tooth decay.
            (9) Bulimia Nervosa usually appears in adolescence.
            (10) On the 1999 Youth Risk Behavior Survey, 7.5 percent of 
        high school girls reported recent use of laxatives or vomiting 
        to control their weight.
            (11) Binge Eating Disorder is characterized by frequent 
        episodes of uncontrolled overeating.
            (12) Binge Eating Disorder is common: an estimated 2 to 5 
        percent of Americans experience this disorder in a 6-month 
        period.
            (13) Binge Eating is associated with obesity, heart 
        disease, gall bladder disease, and diabetes.
            (14) Eating disorders are commonly associated with 
        substantial psychological problems, including depression, 
        substance abuse, and suicide.
            (15) Obesity is reaching epidemic proportions: 27 percent 
        of United States adults are obese and 13 percent of children 
        and 14 percent of adolescents are seriously overweight.
            (16) Poor eating habits have led to a ``calcium crisis'' 
        among American youth: only 13.5 percent of adolescent girls get 
        the recommended daily amount of calcium, placing them at 
        serious risk for osteoporosis and other bone diseases. Because 
        nearly 90 percent of adult bone mass is established by the end 
        of this age range, the Nation's youth's insufficient calcium 
        intake is truly a calcium crisis.
            (17) Eating disorders of all types are more common in women 
        than men.
            (18) Eating preferences and habits are established in 
        childhood.
            (19) Poor eating habits are a risk factor for the 
        development of eating disorders, obesity and osteoporosis.
            (20) However, simply urging overweight youth to be thin has 
        not reduced the prevalence of obesity and may result in other 
        problems including body dissatisfaction, low self-esteem, and 
        eating disorders.
            (21) Therefore, effective interventions for promoting 
        healthy eating behaviors in youth should promote healthy 
        lifestyle and not inadvertently promote unhealthy weight 
        management techniques.

SEC. 603. PURPOSES.

    The purposes of this title are as follows:
            (1) To increase preventive health activities designed to 
        promote the development of healthy eating habits and behaviors 
        in youth.
            (2) To support research to develop and test educational 
        curricula and intervention programs aimed at promoting healthy 
        eating habits and behaviors in youth.
            (3) To identify and disseminate effective intervention 
        programs aimed at promoting healthy eating habits and behaviors 
        in youth.

SEC. 604. AMENDMENTS.

    (a) Use of Allotments.--Section 1904(a)(1) of the Public Health 
Service Act (42 U.S.C. 300w-3) is amended by adding after subparagraph 
(G) the following:
            ``(H) Activities designed to address and prevent eating 
        disorders, obesity, and osteoporosis through effective programs 
        to promote healthy eating and exercise habits and behaviors in 
        youth.''.
    (b) Grants.--Section 399W of the Public Health Service Act (42 
U.S.C. 280h) is amended to read as follows:

``SEC. 399W. GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL 
              ACTIVITY.

    ``(a) Program Authorized.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention (hereafter 
the `Director') and in coordination with the Office of Women's Health 
and the National Institutes of Health, shall award competitive grants 
to States, political subdivisions of States, accredited universities, 
colleges, or nonprofit organizations, for the implementation of State 
and community-based intervention programs to promote good nutrition, 
including promoting healthy eating behaviors and physical activity in 
children and adolescents. Such grants may be awarded to target youth or 
specific at-risk populations, such as adolescent girls.
    ``(b) Eligibility.--To be eligible to receive a grant under this 
section a State, political subdivision of a State, university, college, 
or nonprofit organization shall prepare and submit to the Secretary an 
application at such time, in such manner, and containing such 
information as the Secretary may require, including a plan that 
describes--
            ``(1) how the applicant proposes to develop a comprehensive 
        program of school- and community-based approaches to encourage 
        and promote good nutrition and appropriate levels of physical 
        activity with respect to children or adolescents in local 
        communities;
            ``(2) the manner in which the applicant shall coordinate 
        with appropriate State and local authorities, such as State and 
        local school departments, State departments of health, chronic 
        disease directors, State directors of programs under section 17 
        of the Child Nutrition Act of 1966, 5-a-day coordinators, 
        governors councils for physical activity and good nutrition, 
        and State and local parks and recreation departments; and
            ``(3) the manner in which the applicant will evaluate the 
        effectiveness of the program carried out under this section.
    ``(c) Use of Funds.--A State, political subdivision of a State, 
university, college, or nonprofit organization that receives a grant 
under this section shall use funds received to--
            ``(1) develop and test educational curricula and 
        intervention programs designed to promote healthy eating 
        behaviors and habits in youth, including science-based 
        interventions with multiple components such as--
                    ``(A) nutritional content;
                    ``(B) understanding and responding to hunger and 
                satiety;
                    ``(C) positive body image development;
                    ``(D) positive self-esteem development; and
                    ``(E) learning life skills, such as stress 
                management, communication skills, problem solving and 
                decision making skills, as well as consideration of 
                cultural and developmental issues, and the role of 
                family, school, and community;
            ``(2) develop, implement, disseminate, and evaluate school 
        and community-based strategies to reduce inactivity and improve 
nutrition among children and adolescents;
            ``(3) expand opportunities for physical activity programs 
        in school- and community-based settings; and
            ``(4) develop, implement, and evaluate programs that 
        promote good eating habits and physical activity including 
        opportunities for children and adolescents with cognitive and 
        physical disabilities.
    ``(d) Technical Assistance.--The Secretary may set-aside an amount 
not to exceed 10 percent of the amount appropriated for a fiscal year 
under subsection (h) to permit the Director of the Centers for Disease 
Control and Prevention to--
            ``(1) provide States and political subdivisions of States 
        with technical support in the development and implementation of 
        programs under this section; and
            ``(2) disseminate information about effective strategies 
        and interventions in preventing and treating obesity through 
        the promotion of good nutrition and physical activity.
    ``(e) Limitation on Administrative Costs.--Not to exceed 10 percent 
of the amount of a grant awarded to the State or political subdivision 
under subsection (a) for a fiscal year may be used by the State or 
political subdivision for administrative expenses.
    ``(f) Term.--A grant awarded under subsection (a) shall be for a 
term of not to exceed 4 years.
    ``(g) Definitions.--In this section:
            ``(1) Children and adolescents.--The term `children and 
        adolescents' means individuals who do not exceed 18 years of 
        age.
            ``(2) Healthy eating.--The term `healthy eating' means 
        having regular eating habits, such as eating 3 meals a day to 
        satisfy hunger, eating for nourishment, health, and energy, 
        eating in such a manner as to acknowledge internal signals of 
        appetite and satiety, and eating in a healthy manner in 
        ordinary social environments to promote healthy social 
        relationships with family, peers, and community.
    ``(h) Report.--The Director shall review the results of the grants 
awarded under this section and other related research and identify 
programs that have demonstrated effectiveness in promoting healthy 
eating behaviors and habits in youth. Such programs shall be referred 
to as ``Programs that Work''. Information about Programs that Work, 
including program curricula, shall be made readily available to the 
public.
    ``(i) Sunset.--The provisions of this section shall be effective 
for 5 years after the date of enactment of this section.
    ``(j) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $5,000,000 for fiscal year 
2003, $5,500,000 for fiscal year 2004, $6,000,000 for fiscal year 2005, 
$6,500,000 for year 2006, and $1,000,000 for year 2007.''.
            The title is amended so as to read: ``A bill to enhance the 
        health of women in the United States.''.




                                                       Calendar No. 602

107th CONGRESS

  2d Session

                                S. 2328

_______________________________________________________________________

                                 A BILL

To amend the Public Health Service Act and the Federal Food, Drug, and 
  Cosmetic Act to ensure a safe pregnancy for all women in the United 
  States, to reduce the rate of maternal morbidity and mortality, to 
eliminate racial and ethnic disparities in maternal health outcomes, to 
reduce pre-term labor, to examine the impact of pregnancy on the short 
and long term health of women, to expand knowledge about the safety and 
  dosing of drugs to treat pregnant women with chronic conditions and 
    women who become sick during pregnancy, to expand public health 
 prevention, education and outreach, and to develop improved and more 
 accurate data collection related to maternal morbidity and mortality.

_______________________________________________________________________

                           September 17, 2002

        Reported with an amendment and an amendment to the title