116th CONGRESS 1st Session |
To address mental health issues for youth, particularly youth of color, and for other purposes.
December 17, 2019
Mrs. Watson Coleman (for herself, Mr. Hastings, Ms. Norton, Mr. Cleaver, Ms. Omar, Mr. Danny K. Davis of Illinois, Ms. Adams, Mrs. Hayes, Mr. Horsford, and Ms. Lee of California) introduced the following bill; which was referred to the Committee on Energy and Commerce
To address mental health issues for youth, particularly youth of color, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Pursuing Equity in Mental Health Act of 2019”.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 101. Amendments to the Public Health Service Act.
Sec. 201. Integrated Health Care Demonstration Program.
Sec. 202. Addressing racial and ethnic minority mental health disparities research gaps.
Sec. 203. Health professions competencies to address racial and ethnic minority mental health disparities.
Sec. 204. Racial and ethnic minority behavioral and mental health outreach and education strategy.
Sec. 205. Additional funds for National Institutes of Health.
Sec. 206. Additional funds for National Institute on Minority Health and Health Disparities.
Sec. 301. Reauthorization of Minority Fellowship Program.
Sec. 302. Commission on the Effects of Smartphone and Social Media Use on Adolescents.
Sec. 303. No Federal funds for conversion therapy.
(a) Technical amendments.—The second part G (relating to services provided through religious organizations) of title V of the Public Health Service Act (42 U.S.C. 290kk et seq.) is amended—
(1) by redesignating such part as part J; and
(2) by redesignating sections 581 through 584 as sections 596 through 596C, respectively.
(b) School-Based mental health and children.—Section 581 of the Public Health Service Act (42 U.S.C. 290hh) (relating to children and violence) is amended to read as follows:
“SEC. 581. School-based mental health; children and adolescents.
“(a) In general.—The Secretary, in collaboration with the Secretary of Education, shall, directly or through grants, contracts, or cooperative agreements awarded to eligible entities described in subsection (c), assist local communities and schools (including schools funded by the Bureau of Indian Education) in applying a public health approach to mental health services both in schools and in the community. Such approach shall provide comprehensive developmentally appropriate services and supports that are linguistically and culturally appropriate and trauma-informed, and incorporate developmentally appropriate strategies of positive behavioral interventions and supports. A comprehensive school-based mental health program funded under this section shall assist children in dealing with traumatic experiences, grief, bereavement, risk of suicide, and violence.
“(b) Activities.—Under the program under subsection (a), the Secretary may—
“(1) provide financial support to enable local communities to implement a comprehensive culturally and linguistically appropriate, trauma-informed, and developmentally appropriate, school-based mental health program that—
“(A) builds awareness of individual trauma and the intergenerational, continuum of impacts of trauma on populations;
“(B) trains appropriate staff to identify, and screen for, signs of trauma exposure, mental health disorders, or risk of suicide; and
“(C) incorporates positive behavioral interventions, family engagement, student treatment, and multigenerational supports to foster the health and development of children, prevent mental health disorders, and ameliorate the impact of trauma;
“(2) provide technical assistance to local communities with respect to the development of programs described in paragraph (1);
“(3) provide assistance to local communities in the development of policies to address child and adolescent trauma and mental health issues and violence when and if it occurs;
“(4) facilitate community partnerships among families, students, law enforcement agencies, education agencies, mental health and substance use disorder service systems, family-based mental health service systems, child welfare agencies, health care providers (including primary care physicians, mental health professionals, and other professionals who specialize in children’s mental health such as child and adolescent psychiatrists), institutions of higher education, faith-based programs, trauma networks, and other community-based systems; and
“(5) establish mechanisms for children and adolescents to report incidents of violence or plans by other children, adolescents, or adults to commit violence.
“(1) IN GENERAL.—To be eligible for a grant, contract, or cooperative agreement under subsection (a), an entity shall—
“(A) be a partnership that includes—
“(i) a State educational agency, as defined in section 8101 of the Elementary and Secondary Education Act of 1965, in coordination with one or more local educational agencies, as defined in section 8101 of the Elementary and Secondary Education Act of 1965, or a consortium of any entities described in subparagraph (B), (C), (D), or (E) of section 8101(30) of such Act; and
“(ii) in accordance with paragraph (2)(A)(i), appropriate public or private entities that employ interventions that are evidence-based, as defined in section 8101 of the Elementary and Secondary Education Act of 1965; and
“(B) submit an application, that is endorsed by all members of the partnership, that—
“(i) specifies which member will serve as the lead partner; and
“(ii) contains the assurances described in paragraph (2).
“(2) REQUIRED ASSURANCES.—An application under paragraph (1) shall contain assurances as follows:
“(A) The eligible entity will ensure that, in carrying out activities under this section, the eligible entity will enter into a memorandum of understanding—
“(i) with at least 1 community-based mental health provider, including a public or private mental health entity, health care entity, family-based mental health entity, trauma network, or other community-based entity, as determined by the Secretary (and which may include additional entities such as a human services agency, law enforcement or juvenile justice entity, child welfare agency, agency, an institution of higher education, or another entity, as determined by the Secretary); and
“(I) the responsibilities of each partner with respect to the activities to be carried out, including how family engagement will be incorporated in the activities;
“(II) how school-employed and school-based or community-based mental health professionals will be utilized for carrying out such responsibilities;
“(III) how each such partner will be accountable for carrying out such responsibilities; and
“(IV) the amount of non-Federal funding or in-kind contributions that each such partner will contribute in order to sustain the program.
“(B) The comprehensive school-based mental health program carried out under this section supports the flexible use of funds to address—
“(i) universal prevention, through the promotion of the social, emotional, mental, and behavioral health of all students in an environment that is conducive to learning;
“(ii) selective prevention, through the reduction in the likelihood of at risk students developing social, emotional, mental, behavioral health problems, suicide, or substance use disorders;
“(iii) the screening for, and early identification of, social, emotional, mental, behavioral problems, suicide risk, or substance use disorders and the provision of early intervention services;
“(iv) the treatment or referral for treatment of students with existing social, emotional, mental, behavioral health problems, or substance use disorders;
“(v) the development and implementation of evidence-based programs to assist children who are experiencing or have been exposed to trauma and violence, including program curricula, school supports, and after-school programs; and
“(vi) the development and implementation of evidence-based programs to assist children who are grieving, which may include training for school personnel on the impact of trauma and bereavement on children, and services to provide support to grieving children.
“(C) The comprehensive school-based mental health program carried out under this section will provide for in-service training of all school personnel, including ancillary staff and volunteers, in—
“(i) the techniques and supports needed to promote early identification of children with trauma histories, children who are grieving, and children with a mental health disorder or at risk of developing a mental health disorder, or who are at risk of suicide;
“(ii) the use of referral mechanisms that effectively link such children to appropriate prevention, treatment, and intervention services in the school and in the community and to follow-up when services are not available;
“(iii) strategies that promote a school-wide positive environment, including strategies to prevent bullying, which includes cyber-bullying;
“(iv) strategies for promoting the social, emotional, mental, and behavioral health of all students; and
“(v) strategies to increase the knowledge and skills of school and community leaders about the impact of trauma and violence and on the application of a public health approach to comprehensive school-based mental health programs.
“(D) The comprehensive school-based mental health program carried out under this section will include comprehensive training for parents or guardians, siblings, and other family members of children with mental health disorders, and for concerned members of the community in—
“(i) the techniques and supports needed to promote early identification of children with trauma histories, children who are grieving, children with a mental health disorder or at risk of developing a mental health disorder, and children who are at risk of suicide;
“(ii) the use of referral mechanisms that effectively link such children to appropriate prevention, treatment, and intervention services in the school and in the community and follow-up when such services are not available; and
“(iii) strategies that promote a school-wide positive environment, including strategies to prevent bullying, including cyber-bullying.
“(E) The comprehensive school-based mental health program carried out under this section will demonstrate the measures to be taken to sustain the program (which may include seeking funding for the program under a State Medicaid plan under title XIX of the Social Security Act or a waiver of such a plan, or under a State plan under subpart 1 of part B or part E of title IV of the Social Security Act).
“(F) The eligible entity is supported by the State agency with primary responsibility for behavioral health to ensure that the comprehensive school-based mental health program carried out under this section will be sustainable after funding under this section terminates.
“(G) The comprehensive school-based mental health program carried out under this section will be coordinated with early intervening activities carried out under the Individuals with Disabilities Education Act or activities funded under part A of title IV of the Elementary and Secondary Education Act of 1965.
“(H) The comprehensive school-based mental health program carried out under this section will be trauma-informed, evidence-based, and developmentally, culturally, and linguistically appropriate.
“(I) The comprehensive school-based mental health program carried out under this section will include a broad needs assessment of youth who drop out of school due to policies of ‘zero tolerance’ with respect to drugs, alcohol, or weapons and an inability to obtain appropriate services.
“(J) The mental health services provided through the comprehensive school-based mental health program carried out under this section will be provided by qualified mental and behavioral health professionals who are certified, credentialed, or licensed in compliance with applicable Federal and State law and regulations by the State involved and who are practicing within their area of expertise.
“(K) Students will be permitted to self-refer to the mental health program for mental health care and self-consent for mental health crisis care to the extent permitted by State or other applicable law.
“(3) COORDINATOR.—Any entity that is a member of a partnership described in paragraph (1)(A) may serve as the coordinator of funding and activities under the grant if all members of the partnership agree.
“(4) COMPLIANCE WITH HIPAA.—A grantee under this section shall be deemed to be a covered entity for purposes of compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 with respect to any patient records developed through activities under the grant.
“(5) COMPLIANCE WITH FERPA.—Section 444 of the General Education Provisions Act (commonly known as the ‘Family Educational Rights and Privacy Act of 1974’) shall apply to any entity that is a member of the partnership in the same manner that such section applies to an educational agency or institution (as that term is defined in such section).
“(d) Priority for schools with high poverty levels.—In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall give highest priority to eligible entities that are partnerships including one or more public elementary or secondary schools in which 50.1 percent or more of the students are eligible for a free or reduced price lunch under the Richard B. Russell National School Lunch Act.
“(e) Geographical distribution.—The Secretary shall ensure that grants, contracts, or cooperative agreements under subsection (a) will be distributed equitably among the regions of the country and among urban and rural areas.
“(f) Duration of awards.—With respect to a grant, contract, or cooperative agreement under subsection (a), the period during which payments under such an award will be made to the recipient shall be 5 years, with options for renewal.
“(g) Evaluation and measures of outcomes.—
“(1) DEVELOPMENT OF PROCESS.—The Assistant Secretary shall develop a fiscally appropriate process for evaluating activities carried out under this section. Such process shall include—
“(A) the development of guidelines for the submission of program data by grant, contract, or cooperative agreement recipients;
“(B) the development of measures of outcomes (in accordance with paragraph (2)) to be applied by such recipients in evaluating programs carried out under this section; and
“(C) the submission of annual reports by such recipients concerning the effectiveness of programs carried out under this section.
“(A) IN GENERAL.—The Assistant Secretary shall develop measures of outcomes to be applied by recipients of assistance under this section, and the Assistant Secretary, in evaluating the effectiveness of programs carried out under this section. Such measures shall include student and family measures as provided for in subparagraph (B) and local educational measures as provided for under subparagraph (C).
“(B) STUDENT AND FAMILY MEASURES OF OUTCOMES.—The measures for outcomes developed under paragraph (1)(B) relating to students and families shall, with respect to activities carried out under a program under this section, at a minimum include provisions to evaluate whether the program is effective in—
“(i) increasing social and emotional competency;
“(ii) improving academic outcomes, including as measured by proficiency on the annual assessments under section 1111(b)(2) of the Elementary and Secondary Education Act of 1965;
“(iii) reducing disruptive and aggressive behaviors;
“(iv) improving child functioning;
“(v) reducing substance use disorders;
“(vi) reducing rates of suicide;
“(vii) reducing suspensions, truancy, expulsions, and violence;
“(viii) increasing high school graduation rates, calculated using the four-year adjusted cohort graduation rate or the extended-year adjusted cohort graduation rate (as such terms are defined in section 8101 of the Elementary and Secondary Education Act of 1965);
“(ix) improving attendance rates and rates of chronic absenteeism;
“(x) improving access to care for mental health disorders, including access to mental health services that are trauma-informed, and developmentally, linguistically, and culturally appropriate;
“(xi) improving health outcomes; and
“(xii) decreasing disparities among vulnerable and protected populations in outcomes described in clauses (i) through (viii).
“(C) LOCAL EDUCATIONAL OUTCOMES.—The outcome measures developed under paragraph (1)(B) relating to local educational systems shall, with respect to activities carried out under a program under this section, at a minimum include provisions to evaluate—
“(i) the effectiveness of comprehensive school mental health programs established under this section;
“(ii) the effectiveness of formal partnership linkages among child and family serving institutions, community support systems, and the educational system;
“(iii) the progress made in sustaining the program once funding under the grant has expired;
“(iv) the effectiveness of training and professional development programs for all school personnel that incorporate indicators that measure cultural and linguistic competencies under the program in a manner that incorporates appropriate cultural and linguistic training;
“(v) the improvement in perception of a safe and supportive learning environment among school staff, students, and parents;
“(vi) the improvement in case-finding of students in need of more intensive services and referral of identified students to prevention, early intervention, and clinical services;
“(vii) the improvement in the immediate availability of clinical assessment and treatment services within the context of the local community to students posing a danger to themselves or others;
“(viii) the increased successful matriculation to postsecondary school;
“(ix) reduced suicide rates;
“(x) reduced referrals to juvenile justice; and
“(xi) increased educational equity.
“(3) SUBMISSION OF ANNUAL DATA.—An eligible entity described in subsection (c) that receives a grant, contract, or cooperative agreement under this section shall annually submit to the Assistant Secretary a report that includes data to evaluate the success of the program carried out by the entity based on whether such program is achieving the purposes of the program. Such reports shall utilize the measures of outcomes under paragraph (2) in a reasonable manner to demonstrate the progress of the program in achieving such purposes.
“(4) EVALUATION BY ASSISTANT SECRETARY.—Based on the data submitted under paragraph (3), the Assistant Secretary shall annually submit to Congress a report concerning the results and effectiveness of the programs carried out with assistance received under this section.
“(5) LIMITATION.—An eligible entity shall use not more than 20 percent of amounts received under a grant under this section to carry out evaluation activities under this subsection.
“(h) Information and education.—The Secretary shall establish comprehensive information and education programs to disseminate the findings of the knowledge development and application under this section to the general public and to health care professionals.
“(i) Amount of grants and authorization of appropriations.—
“(1) AMOUNT OF GRANTS.—A grant under this section shall be in an amount that is not more than $2,000,000 for each of the first 5 fiscal years following the date of enactment of the Pursuing Equity in Mental Health Act of 2019. The Secretary shall determine the amount of each such grant based on the population of children up to age 21 of the area to be served under the grant.
“(2) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section, $250,000,000 for each of the first 5 fiscal years following the date of enactment of the Pursuing Equity in Mental Health Act of 2019”..”.
(c) Conforming amendment.—Part G of title V of the Public Health Service Act (42 U.S.C. 290hh et seq.), as amended by subsection (b), is further amended by striking the part designation and heading and inserting the following:
Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is amended by adding at the end the following:
“SEC. 550. Interprofessional health care teams for provision of behavioral health care in primary care settings.
“(a) Grants.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance Abuse, shall award grants to eligible entities for the purpose of establishing interprofessional health care teams that provide behavioral health care.
“(b) Eligible entities.—To be eligible to receive a grant under this section, an entity shall be a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act), rural health clinic, or behavioral health program, serving a high proportion of individuals from racial and ethnic minority groups (as defined in section 1707(g)).
“(c) Scientifically based.—Integrated health care funded through this section shall be scientifically based, taking into consideration the results of the most recent peer-reviewed research available.
“(d) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $20,000,000 for each of the first 5 fiscal years following the date of enactment of the Pursuing Equity in Mental Health Act of 2019”..”.
Not later than 6 months after the date of the enactment of this Act, the Director of the National Institute on Minority Health and Health Disparities shall enter into an arrangement with the National Academy of Sciences (or, if the National Academy of Sciences declines to enter into such an arrangement, an arrangement with the Institute of Medicine, the Patient Centered Outcomes Research Institute, the Agency for Healthcare Quality, or another appropriate entity)—
(1) to conduct a study with respect to mental health disparities in racial and ethnic minority groups (as defined in section 1707(g) of the Public Health Service Act (42 U.S.C. 300u–6(g))); and
(2) to submit to the Congress a report on the results of such study, including—
(A) a compilation of information on the dynamics of mental disorders in such racial and ethnic minority groups; and
(B) a compilation of information on the impact of exposure to community violence, adverse childhood experiences, and other psychological traumas on mental disorders in such racial and minority groups.
(a) In general.—The Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, shall award grants to qualified national organizations for the purposes of—
(1) developing, and disseminating to health professional educational programs curricula or core competencies addressing mental health disparities among racial and ethnic minority groups for use in the training of students in the professions of social work, psychology, psychiatry, marriage and family therapy, mental health counseling, and substance abuse counseling; and
(2) certifying community health workers and peer wellness specialists with respect to such curricula and core competencies and integrating and expanding the use of such workers and specialists into health care to address mental health disparities among racial and ethnic minority groups.
(b) Curricula; core competencies.—Organizations receiving funds under subsection (a) may use the funds to engage in the following activities related to the development and dissemination of curricula or core competencies described in subsection (a)(1):
(1) Formation of committees or working groups comprised of experts from accredited health professions schools to identify core competencies relating to mental health disparities among racial and ethnic minority groups.
(2) Planning of workshops in national fora to allow for public input into the educational needs associated with mental health disparities among racial and ethnic minority groups.
(3) Dissemination and promotion of the use of curricula or core competencies in undergraduate and graduate health professions training programs nationwide.
(4) Establishing external stakeholder advisory boards to provide meaningful input into policy and program development and best practices to reduce mental health disparities among racial and ethnic minority groups.
(c) Definitions.—In this section:
(1) QUALIFIED NATIONAL ORGANIZATION.—The term “qualified national organization” means a national organization that focuses on the education of students in programs of social work, psychology, psychiatry, and marriage and family therapy.
(2) RACIAL AND ETHNIC MINORITY GROUP.—The term “racial and ethnic minority group” has the meaning given to such term in section 1707(g) of the Public Health Service Act (42 U.S.C. 300u–6(g)).
(d) Authorization of appropriations.—There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the first 5 fiscal years following the date of enactment of this Act.
Part D of title V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is amended by adding at the end the following new section:
“SEC. 553. Behavioral and mental health outreach and education strategy.
“(a) In general.—The Secretary, acting through the Assistant Secretary, shall, in coordination with advocacy and behavioral and mental health organizations serving racial and ethnic minority groups, develop and implement an outreach and education strategy to promote behavioral and mental health and reduce stigma associated with mental health conditions and substance abuse among racial and ethnic minority groups. Such strategy shall—
“(A) meet the diverse cultural and language needs of the various racial and ethnic minority groups; and
“(B) be developmentally and age-appropriate;
“(2) increase awareness of symptoms of mental illnesses common among such groups, taking into account differences within subgroups, such as gender, gender identity, age, or sexual orientation, of such groups;
“(3) provide information on evidence-based, culturally and linguistically appropriate and adapted interventions and treatments;
“(4) ensure full participation of, and engage, both consumers and community members in the development and implementation of materials; and
“(5) seek to broaden the perspective among both individuals in these groups and stakeholders serving these groups to use a comprehensive public health approach to promoting behavioral health that addresses a holistic view of health by focusing on the intersection between behavioral and physical health.
“(b) Reports.—Beginning not later than 1 year after the date of the enactment of this section and annually thereafter, the Secretary, acting through the Assistant Secretary, shall submit to Congress, and make publicly available, a report on the extent to which the strategy developed and implemented under subsection (a) increased behavioral and mental health outcomes associated with mental health conditions and substance abuse among racial and ethnic minority groups.
“(c) Definition.—In this section, the term ‘racial and ethnic minority group’ has the meaning given to that term in section 1707(g).
“(d) Authorization of appropriations.—There is authorized to be appropriated to carry out this section $10,000,000 for the first fiscal year following the date of enactment of the Pursuing Equity in Mental Health Act of 2019”..”.
(a) In general.—In addition to amounts otherwise authorized to be appropriated to the National Institutes of Health, there is authorized to be appropriated to such Institutes $100,000,000 for each of the first 5 fiscal years following the date of enactment of this Act to build relations with communities and conduct or support clinical research, including clinical research on racial or ethnic disparities in physical and mental health.
(b) Definition.—In this section, the term “clinical research” has the meaning given to such term in section 409 of the Public Health Service Act (42 U.S.C. 284d).
In addition to amounts otherwise authorized to be appropriated to the National Institute on Minority Health and Health Disparities, there is authorized to be appropriated to such Institute $650,000,000 for each of the first 5 fiscal years following the date of enactment of this Act.
Section 597(c) of the Public Health Service Act (42 U.S.C. 297ll(c)) is amended by striking “$12,669,000 for each of fiscal years 2018 through 2022” and inserting “$25,000,000 for each of the first 5 fiscal years following the date of enactment of the Pursuing Equity in Mental Health Act of 2019”.
(a) In general.—Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall establish a commission, to be known as the Commission on the Effects of Smartphone and Social Media Usage on Adolescents, to examine—
(1) the extent of smartphone and social media use in schools; and
(2) the effects of such use on—
(A) the emotional and physical health of students; and
(B) the academic performance of students.
(1) NUMBER.—The Commission shall consist of 15 members appointed by the Secretary.
(2) COMPOSITION.—The members of the Commission—
(A) shall not include any government officials or employees; and
(B) shall include representatives of academia, technology companies, and advocacy groups.
(c) Guidelines.—The Secretary shall authorize the Commission to establish guidelines for its operation.
(d) Report.—Not later than 1 year after its establishment, the Commission shall submit to the Congress, and make publicly available, a report on the findings and conclusions of the Commission.
(e) Definitions.—In this section:
(1) The term “Commission” means the Commission on the Effects of Smartphone and Social Media Usage on Adolescents established under subsection (a).
(2) The term “Secretary” means the Secretary of Health and Human Services.
(f) Sunset.—Not later than 6 months after the Commission submits the report required by subsection (c), the Secretary shall terminate the Commission.
(a) In general.—No Federal funds may be used for conversion therapy.
(b) Discouraging States from funding conversion therapy.—Beginning on the date that is 180 days after the date of enactment of this Act, any State that funds conversion therapy shall be ineligible to be awarded a grant or other financial assistance under any program of the Substance Abuse and Mental Health Services Administration, including any program under title V of the Public Health Service Act (42 U.S.C. 290aa et seq.).
(c) Definitions.—For purposes of this section:
(1) CONVERSION THERAPY.—The term “conversion therapy”—
(A) means any practice or treatment by any person that seeks to change another individual’s sexual orientation or gender identity, including efforts to change behaviors or gender expressions, or to eliminate or reduce sexual or romantic attractions or feelings toward individuals of the same gender, if such person receives monetary compensation in exchange for any such practice or treatment; and
(B) does not include any practice or treatment, which does not seek to change sexual orientation or gender identity, that—
(i) provides assistance to an individual undergoing a gender transition; or
(ii) provides acceptance, support, and understanding of a client or facilitation of a client’s coping, social support, and identity exploration and development, including sexual orientation-neutral interventions to prevent or address unlawful conduct or unsafe sexual practices.
(2) GENDER IDENTITY.—The term “gender identity” means the gender-related identity, appearance, mannerisms, or other gender-related characteristics of an individual, regardless of the individual’s designated sex at birth.
(3) PERSON.—The term “person” means any individual, partnership, corporation, cooperative, association, or any other entity.
(4) SEXUAL ORIENTATION.—The term “sexual orientation” means homosexuality, heterosexuality, or bisexuality.
(5) STATE.—The term “State” has the meaning given to such term in section 2 of the Public Health Service Act (42 U.S.C. 201).