
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document affected by Public Law 106-345 Section 401]
[CITE: 42USC300ff-71]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
            SUBCHAPTER XXIV--HIV HEALTH CARE SERVICES PROGRAM
 
                       Part D--General Provisions
 
Sec. 300ff-71. Grants for coordinated services and access to 
        research for women, infants, children, and youth
        

(a) In general

    The Secretary, acting through the Administrator of the Health 
Resources and Services Administration and in consultation with the 
Director of the National Institutes of Health, shall make grants to 
public and nonprofit private entities that provide primary care 
(directly or through contracts) for the following purposes:
        (1) Providing through such entities, in accordance with this 
    section, opportunities for women, infants, children, and youth to be 
    voluntary participants in research of potential clinical benefit to 
    individuals with HIV disease.
        (2) In the case of women, infants, children, and youth with HIV 
    disease, and the families of such individuals, providing to such 
    individuals--
            (A) health care on an outpatient basis; and
            (B) additional services in accordance with subsection (d) of 
        this section.

(b) Provisions regarding participation in research

                           (1) In general

        With respect to the projects of research with which an applicant 
    under subsection (a) of this section is concerned, the Secretary may 
    make a grant under such subsection to the applicant only if the 
    following conditions are met:
            (A) The applicant agrees to make reasonable efforts--
                (i) to identify which of the patients of the applicant 
            are women, infants, children, and youth who would be 
            appropriate participants in the projects;
                (ii) to carry out clause (i) through the use of criteria 
            provided for such purpose by the entities that will be 
            conducting the projects of research; and
                (iii) to offer women, infants, children, and youth the 
            opportunity to participate in the projects (as appropriate), 
            including the provision of services under subsection (d)(3) 
            of this section.

            (B) The applicant agrees that, in the case of the research-
        related functions to be carried out by the applicant pursuant to 
        subsection (a)(1) of this section, the applicant will comply 
        with accepted standards that are applicable to such functions 
        (including accepted standards regarding informed consent and 
        other protections for human subjects).
            (C) For the first and second fiscal years for which grants 
        under subsection (a) of this section are to be made to the 
        applicant, the applicant agrees that, not later than the end of 
        the second fiscal year of receiving such a grant, a significant 
        number of women, infants, children, and youth who are patients 
        of the applicant will be participating in the projects of 
        research.
            (D) Except as provided in paragraph (3) (and paragraph (4), 
        as applicable), for the third and subsequent fiscal years for 
        which such grants are to be made to the applicant, the Secretary 
        has determined that a significant number of such individuals are 
        participating in the projects.

                           (2) Prohibition

        Receipt of services by a patient shall not be conditioned upon 
    the consent of the patient to participate in research.

    (3) Significant participation; consideration by Secretary of 
                            certain circumstances

        In administering the requirement of paragraph (1)(D), the 
    Secretary shall take into account circumstances in which a grantee 
    under subsection (a) of this section is temporarily unable to comply 
    with the requirement for reasons beyond the control of the grantee, 
    and shall in such circumstances provide to the grantee a reasonable 
    period of opportunity in which to reestablish compliance with the 
    requirement.

    (4) Significant participation; temporary waiver for original 
                                  grantees

        (A) In general

            In the case of an applicant under subsection (a) of this 
        section who received a grant under such subsection for fiscal 
        year 1995, the Secretary may, subject to subparagraph (B), 
        provide to the applicant a waiver of the requirement of 
        paragraph (1)(D) if the Secretary determines that the applicant 
        is making reasonable progress toward meeting the requirement.

        (B) Termination of authority for waivers

            The Secretary may not provide any waiver under subparagraph 
        (A) on or after October 1, 1998. Any such waiver provided prior 
        to such date terminates on such date, or on such earlier date as 
        the Secretary may specify.

(c) Provisions regarding conduct of research

                           (1) In general

        With respect to eligibility for a grant under subsection (a) of 
    this section:
            (A) A project of research for which subjects are sought 
        pursuant to such subsection may be conducted by the applicant 
        for the grant, or by an entity with which the applicant has made 
        arrangements for purposes of the grant. The grant may not be 
        expended for the conduct of any project of research, except for 
        such research-related functions as are appropriate for providing 
        opportunities under subsection (a)(1) of this section (including 
        the functions specified in subsection (b)(1) of this section).
            (B) The grant may be made only if the Secretary makes the 
        following determinations:
                (i) The applicant or other entity (as the case may be 
            under subparagraph (A)) is appropriately qualified to 
            conduct the project of research. An entity shall be 
            considered to be so qualified if any research protocol of 
            the entity has been recommended for funding under this 
            chapter pursuant to technical and scientific peer review 
            through the National Institutes of Health.
                (ii) The project of research is being conducted in 
            accordance with a research protocol to which the Secretary 
            gives priority regarding the prevention or treatment of HIV 
            disease in women, infants, children, or youth, subject to 
            paragraph (2).

                   (2) List of research protocols

        (A) In general

            From among the research protocols described in paragraph 
        (1)(B)(ii), the Secretary shall establish a list of research 
        protocols that are appropriate for purposes of subsection (a)(1) 
        of this section. Such list shall be established only after 
        consultation with public and private entities that conduct such 
        research, and with providers of services under subsection (a) of 
        this section and recipients of such services.

        (B) Discretion of Secretary

            The Secretary may authorize the use, for purposes of 
        subsection (a)(1) of this section, of a research protocol that 
        is not included on the list under subparagraph (A). The 
        Secretary may waive the requirement specified in paragraph 
        (1)(B)(ii) in such circumstances as the Secretary determines to 
        be appropriate.

(d) Additional services for patients and families

    A grant under subsection (a) of this section may be made only if the 
applicant for the grant agrees as follows:
        (1) The applicant will provide for the case management of the 
    patient involved and the family of the patient.
        (2) The applicant will provide for the patient and the family of 
    the patient--
            (A) referrals for inpatient hospital services, treatment for 
        substance abuse, and mental health services; and
            (B) referrals for other social and support services, as 
        appropriate.

        (3) The applicant will provide the patient and the family of the 
    patient with such transportation, child care, and other incidental 
    services as may be necessary to enable the patient and the family to 
    participate in the program established by the applicant pursuant to 
    such subsection.

(e) Coordination with other entities

    A grant under subsection (a) of this section may be made only if the 
applicant for the grant agrees as follows:
        (1) The applicant will coordinate activities under the grant 
    with other providers of health care services under this chapter, and 
    under title V of the Social Security Act [42 U.S.C. 701 et seq.].
        (2) The applicant will participate in the statewide coordinated 
    statement of need under part B of this subchapter (where it has been 
    initiated by the public health agency responsible for administering 
    grants under part B of this subchapter) and in revisions of such 
    statement.

(f) Application

    A grant under subsection (a) of this section may be made only if an 
application for the grant is submitted to the Secretary and the 
application is in such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary determines to 
be necessary to carry out this section.

(g) Coordination with National Institutes of Health

    The Secretary shall develop and implement a plan that provides for 
the coordination of the activities of the National Institutes of Health 
with the activities carried out under this section. In carrying out the 
preceding sentence, the Secretary shall ensure that projects of research 
conducted or supported by such Institutes are made aware of applicants 
and grantees under subsection (a) of this section, shall require that 
the projects, as appropriate, enter into arrangements for purposes of 
such subsection, and shall require that each project entering into such 
an arrangement inform the applicant or grantee under such subsection of 
the needs of the project for the participation of women, infants, 
children, and youth.

(h) Annual review of programs; evaluations

    (1) Review regarding access to and participation in programs

        With respect to a grant under subsection (a) of this section for 
    an entity for a fiscal year, the Secretary shall, not later than 180 
    days after the end of the fiscal year, provide for the conduct and 
    completion of a review of the operation during the year of the 
    program carried out under such subsection by the entity. The purpose 
    of such review shall be the development of recommendations, as 
    appropriate, for improvements in the following:
            (A) Procedures used by the entity to allocate opportunities 
        and services under subsection (a) of this section among patients 
        of the entity who are women, infants, children, or youth.
            (B) Other procedures or policies of the entity regarding the 
        participation of such individuals in such program.

                           (2) Evaluations

        The Secretary shall, directly or through contracts with public 
    and private entities, provide for evaluations of programs carried 
    out pursuant to subsection (a) of this section.

(i) Training and technical assistance

    Of the amounts appropriated under subsection (j) of this section for 
a fiscal year, the Secretary may use not more than five percent to 
provide, directly or through contracts with public and private entities 
(which may include grantees under subsection (a) of this section), 
training and technical assistance to assist applicants and grantees 
under subsection (a) of this section in complying with the requirements 
of this section.

(j) 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 1996 through 2000.

(July 1, 1944, ch. 373, title XXVI, Sec. 2671, as added Pub. L. 101-381, 
title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 617; amended Pub. L. 104-
146, Sec. 3(e), May 20, 1996, 110 Stat. 1358.)

                       References in Text

    The Social Security Act, referred to in subsec. (e)(1), is act Aug. 
14, 1935, ch. 531, 49 Stat. 620, as amended. Title V of the Act is 
classified generally to subchapter V (Sec. 701 et seq.) of chapter 7 of 
this title. For complete classification of this Act to the Code, see 
section 1305 of this title and Tables.


                               Amendments

    1996--Pub. L. 104-146 amended section generally, substituting 
provisions authorizing grants for coordinated services and access to 
research for women, infants, children, and youth living with the HIV 
virus for provisions authorizing demonstration grants for research and 
services for pediatric patients regarding AIDS.


                    Effective Date of 1996 Amendment

    Amendment by Pub. L. 104-146 effective Oct. 1, 1996, see section 13 
of Pub. L. 104-146, set out as a note under section 300ff-11 of this 
title.

                  Section Referred to in Other Sections

    This section is referred to in sections 300ff-12, 300ff-23, 300ff-
41, 300ff-51 of this title.
