119-hr1750

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1750 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 1750

 To amend the Public Health Service Act to provide for greater 
 investments in research on rare diseases and conditions 
 disproportionately affecting minority populations, and for other 
 purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 February 27, 2025

Ms. Strickland introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
Ways and Means, and Natural Resources, for a period to be subsequently 
 determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

 A BILL

 To amend the Public Health Service Act to provide for greater 
 investments in research on rare diseases and conditions 
 disproportionately affecting minority populations, and for other 
 purposes.

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

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Health Equity and Rare Disease Act 
of 2025'' or the ``HEARD Act of 2025''.

SEC. 2. NIH EXPANSION, INTENSIFICATION, AND COORDINATION OF RESEARCH ON 
 RARE DISEASES HEALTH EQUITY.

 Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``

SEC. 409K. RARE DISEASES HEALTH EQUITY.

 ``

    (a) Expansion, Intensification, and Coordination of Activities.--
 ``

    (1) In general.--The Director of NIH shall expand, 
 intensify, and coordinate research and other activities of the 
 National Institutes of Health with respect to rare diseases 
 health equity.
 ``

    (2) Allocations by director of nih.--With respect to 
 amounts appropriated to carry out this section for a fiscal 
 year, the Director of NIH shall allocate the amounts among the 
 national research institutes that are carrying out paragraph

    (1) .
 ``

    (b) Coordinating Committee.--
 ``

    (1) In general.--The Secretary shall maintain a 
 coordinating committee with respect to rare diseases health 
 equity (referred to in this section as the `Coordinating 
 Committee') to coordinate activities across the National 
 Institutes and with other Federal health programs and 
 activities relating to rare diseases health equity.
 ``

    (2) Composition.--The Coordinating Committee shall be 
 composed of--
 ``
        (A) the directors (or their designees) of each of 
 the national research institutes involved in research 
 with respect to rare diseases and minority health or 
 health equity; and
 ``
        (B) representatives of all other Federal 
 departments and agencies whose programs involve health 
 functions or responsibilities relevant to such rare 
 diseases, including the Centers for Disease Control and 
 Prevention and the Food and Drug Administration.
 ``

    (3) Chair.--
 ``
        (A) In general.--With respect to rare diseases 
 health equity, the Chair of the Coordinating Committee 
 shall serve as the principal advisor to the Secretary, 
 the Assistant Secretary for Health, and the Director of 
 NIH, and shall provide advice to the Director of the 
 Centers for Disease Control and Prevention, the 
 Commissioner of Food and Drugs, and other relevant 
 agencies.
 ``
        (B) Director of nih.--The Chair of the 
 Coordinating Committee shall be directly responsible to 
 the Director of NIH.
 ``
            (c) Plan for NIH Activities.--
 ``

    (1) In general.--Not later than 1 year after the date of 
 the enactment of this section, the Coordinating Committee shall 
 develop a plan for conducting and supporting research and 
 education on rare diseases health equity, and rare diseases or 
 conditions in minority populations, through the national 
 research institutes. The Coordinating Committee shall 
 periodically review and revise the plan. The plan shall--
 ``
        (A) provide for a broad range of research and 
 education activities relating to biomedical, 
 psychosocial, and rehabilitative issues, including 
 studies of the disproportionate impact of such diseases 
 or conditions on minority populations;
 ``
        (B) identify priorities among the programs and 
 activities of the National Institutes of Health 
 regarding such diseases or conditions; and
 ``
            (C) reflect input from a broad range of 
 scientists, patients, and advocacy groups.
 ``

    (2) Certain elements of plan.--The plan under paragraph

    (1) shall, with respect to rare diseases or conditions in 
 minority populations, provide for the following as appropriate:
 ``
        (A) Research to determine the reasons underlying 
 the incidence and prevalence of the diseases or 
 conditions, including among subpopulations.
 ``
        (B) Basic research concerning the etiology and 
 causes of the diseases or conditions.
 ``
            (C) Epidemiological studies to address the 
 frequency and natural history of the diseases or 
 conditions, including any differences among the sexes 
 and among racial and ethnic groups.
 ``
            (D) The development of improved screening 
 techniques.
 ``
        (E) Clinical research for the development and 
 evaluation of new treatments, including new biological 
 agents.
 ``
        (F) Information and education programs for health 
 care professionals and the public.
 ``

    (3) Implementation of plan.--The Director of NIH shall 
 ensure that programs and activities of the National Institutes 
 of Health regarding rare diseases or conditions in minority 
 populations are implemented in accordance with the plan under 
 paragraph

    (1) .
 ``
            (d) === Definitions. ===
-In this section:
 ``

    (1) The term `minority' has the meaning given such term 
 in 

section 464z-3.
 ``

    (2) The term `rare disease or condition' has the meaning 
 given such term in 

section 526 of the Federal Food, Drug, and 
 Cosmetic Act (21 U.S.C. 360bb).''.

SEC. 3. COLLABORATIVE COMPREHENSIVE PLAN TO ADDRESS RARE DISEASES AND 
 CONDITIONS IN MINORITY POPULATIONS.

 Subpart 20 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285t et seq.) is amended by adding at the end the following:

``

SEC. 464Z-7. COLLABORATIVE COMPREHENSIVE PLAN TO ADDRESS RARE 
 DISEASES AND CONDITIONS IN MINORITY POPULATIONS.

 ``Not later than 180 days after the date of enactment of this 
section, the Director of NIH, the Director of the Institute, the 
Director of the National Center for Advancing Translational Sciences, 
the Director of the National Heart, Lung, and Blood Institute, and the 
directors of the other agencies of the National Institutes of Health in 
collaboration (and in consultation with the advisory council for the 
Institute) shall--
 ``

    (1) develop a comprehensive Federal plan to address rare 
 diseases and conditions in minority populations (as those terms 
 are defined in 

section 409K), including a strategy to increase 
 diversity in genetic programs at the program for Therapeutics 
 for Rare and Neglected Diseases at the National Institutes of 
 Health;
 ``

    (2) conduct or support through grants or cooperative 
 agreements basic, clinical, and translational research on rare 
 diseases and conditions in minority populations, including 
 research on--
 ``
        (A) early detection, diagnosis, and treatment of 
 such diseases and conditions in such populations; and
 ``
        (B) improving the quality of life for individuals 
 with rare diseases or conditions and their families;
 ``

    (3) conduct or support clinical training programs for 
 physicians and other health care practitioners with respect to 
 detecting, diagnosing, and treating such diseases and 
 conditions in such populations; and
 ``

    (4) develop guidance for increasing participation of 
 health professionals who are members of minority groups (as 
 defined in 

section 464z-3) in research conducted or supported 
 by the National Institutes of Health on such diseases and 
 conditions in such populations.''.

SEC. 4. GRANTS TO COLLECT AND ANALYZE DATA ON RARE DISEASES AND 
 CONDITIONS IN MINORITY POPULATIONS.

 

Section 1707

    (b) of the Public Health Service Act (42 U.S.C. 300u-
6

    (b) ) is amended by adding at the end the following:
 ``

    (11) In coordination with the Director of the Centers for 
 Disease Control and Prevention, award grants to public and 
 private nonprofit entities to--
 ``
        (A) collect, analyze, and report data on rare 
 diseases and conditions in minority populations, 
 including on epidemiological data with respect to 
 incidence of such diseases and conditions in such 
 populations;
 ``
        (B) conduct outreach and engagement activities 
 with the minority populations impacted by such rare 
 diseases and conditions by--
 ``
            (i) improving health literacy with 
 respect to rare diseases and conditions;
 ``
            (ii) disseminating information on health 
 and community services related to rare diseases 
 and conditions; and
 ``
            (iii) providing information regarding the 
 maintenance of rare diseases and conditions.
 ``

    (12) Submit to Congress, on a biannual basis (beginning 
 not later than 2 years after the date of the enactment of the 
 HEARD Act of 2025), a report describing the activities carried 
 out pursuant to paragraph

    (11) .''.

SEC. 5. PHYSICIAN TRAINING PROGRAMS WITH RESPECT TO RARE DISEASES.

 Subpart II of part C of title VII of the Public Health Service Act 
is amended by adding at the end the following:

``

SEC. 749C. PHYSICIAN TRAINING PROGRAMS WITH RESPECT TO RARE DISEASES.

 ``

    (a) In General.--The Secretary shall establish a program to award 
grants to accredited schools of allopathic medicine, osteopathic 
medicine, and nursing, and other health professional training programs 
for the training of health care professionals--
 ``

    (1) to improve the provision of care to individuals who 
 have rare diseases or conditions (as defined in 

section 526 of 
 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb));
 ``

    (2) to improve the provision of care to such individuals 
 via telehealth; and
 ``

    (3) to conduct research relevant to rare diseases and 
 conditions.
 ``

    (b) Eligibility.--To be eligible for a grant under subsection

    (a) , an entity described in such subsection shall submit to the 
Secretary an application at such time, in such manner, and containing 
such information as the Secretary may require.
 ``
            (c) Reporting Requirements.--
 ``

    (1) Periodic reports.--Each entity awarded a grant under 
 this section shall periodically submit to the Secretary a 
 report on the status of activities conducted using the grant, 
 including a description of the impact of such training on 
 patient outcomes, as applicable.
 ``

    (2) Report to congress.--Not later than 2 years after the 
 date of enactment of this section, the Secretary shall submit a 
 report to Congress on the activities conducted using grants 
 under subsection

    (a) and any best practices identified and 
 disseminated under subsection
            (d) .
 ``
            (d) Best Practices.--The Secretary may identify and disseminate 
best practices for the training described in subsection

    (a) .

``

SEC. 749D. HEALTH PROFESSIONALS EDUCATION ON RARE DISEASES AND 
 CONDITIONS IN MINORITY POPULATIONS.

 ``

    (a) In General.--The Secretary may award grants, cooperative 
agreements, and contracts to accredited schools of medicine and 
nursing, and other health professional training programs, for the 
development and implementation of programs to provide education and 
training to health care professionals on the causes and effects of rare 
diseases and conditions in minority populations.
 ``

    (b) 

=== Definitions. ===
-In this section:
 ``

    (1) The term `minority' has the meaning given such term 
 in 

section 464z-3.
 ``

    (2) The term `rare disease or condition' has the meaning 
 given such term in 

section 526 of the Federal Food, Drug, and 
 Cosmetic Act (21 U.S.C. 360bb).

``

SEC. 749E. MENTORING PROGRAM FOR HEALTH CARE PROFESSIONALS SEEKING TO 
 WORK IN RARE DISEASES AND CONDITIONS.

 ``The Secretary, acting through the Administrator of the Health 
Resources and Services Administration, may award grants, contracts, or 
cooperative agreements to public and nonprofit private entities 
(including Tribal entities) for the establishment of a mentoring 
program for health care professionals seeking to treat patients with 
rare diseases and conditions.

``

SEC. 749F. SCHOLARSHIP AND LOAN REPAYMENT PROGRAM FOR PHYSICIANS AND 
 GENETIC COUNSELORS SERVING POPULATIONS WITH RARE DISEASES 
 AND CONDITIONS.

 ``

    (a) Loan Repayment Program.--
 ``

    (1) In general.--The Secretary shall establish a program 
 of entering into contracts with eligible individuals under 
 which the individuals agree to serve as health care 
 professionals serving populations with rare diseases or 
 conditions in consideration of the Federal Government agreeing 
 to pay, for each year of such service, up to $50,000 (plus an 
 amount determined by the Secretary on an annual basis to 
 reflect inflation) of the principal and interest of the 
 educational loans of such individuals.
 ``

    (2) Determination of amount.--In making a determination 
 of the amount to pay for a year of such service by an 
 individual, the Secretary shall consider the extent to which 
 each such determination--
 ``
        (A) affects the ability of the Secretary to 
 maximize the number of contracts that can be provided 
 under the program from the amounts appropriated for 
 such contracts;
 ``
        (B) provides an incentive to serve as health care 
 professionals serving populations with rare diseases or 
 conditions; and
 ``
            (C) provides an incentive with respect to the 
 health professional involved to remain serving 
 populations with rare diseases or conditions, including 
 after the completion of the period of obligated service 
 under the program.
 ``

    (3) Eligible individuals.--In this subsection, the term 
 `eligible individual' means an individual who is enrolled or 
 accepted for enrollment as a full-time or part-time student in 
 a school of medicine.
 ``

    (4) Applicability of certain provisions.--With respect to 
 the National Health Service Corps Loan Repayment Program 
 established in subpart III of part D of title III of this Act, 
 the provisions of such subpart shall, except as inconsistent 
 with paragraph

    (1) , apply to the program established in this 
 section in the same manner and to the same extent as such 
 provisions apply to the National Health Service Corps Loan 
 Repayment Program.
 ``

    (b) Scholarship Program.--
 ``

    (1) In general.--The Secretary shall carry out a program 
 of entering into contracts with eligible individuals under 
 which each such individual agrees to serve, for a period of not 
 less than 5 years, as a health care professional primarily 
 serving populations with rare diseases or conditions, in 
 consideration of the Federal Government agreeing to provide to 
 the individual a scholarship for attendance at a school of 
 medicine.
 ``

    (2) Eligible individuals.--In this subsection, the term 
 `eligible individual' means an individual who is enrolled or 
 accepted for enrollment as a full-time or part-time student in 
 a school of medicine.
 ``

    (3) Applicability of certain provisions.--The provisions 
 of subpart III of part D of title III shall, except as 
 inconsistent with this section, apply to the program 
 established in paragraph

    (1) in the same manner and to the same 
 extent as such provisions apply to the National Health Service 
 Corps Scholarship Program established in such subpart.''.

SEC. 6. INCREASING MINORITY REPRESENTATION IN RESEARCH ON RARE DISEASES 
 AND CONDITIONS.

 Part G of title IV of the Public Health Service Act (42 U.S.C. 288 
et seq.) is amended by adding at the end the following:

``

SEC. 487E. INCREASING MINORITY REPRESENTATION IN RESEARCH ON RARE 
 DISEASES AND CONDITIONS.

 ``

    (a) Grant Program.--In carrying out 

section 487, the Secretary 
may award grants to eligible entities involved in research on rare 
diseases and minority health to establish programs to increase the 
recruitment and retention of members of minority groups to conduct 
research in matters relating to the cause, diagnosis, prevention, and 
treatment of rare diseases or conditions, including by expanding the 
number of internships and mentoring opportunities.
 ``

    (b) Eligible Entities.--In subsection

    (a) , the term `eligible 
entities' means accredited schools of allopathic medicine, osteopathic 
medicine, and nursing, and other health professional training 
programs.''.

SEC. 7. REPORT TO CONGRESS ON FEDERAL EFFORTS ON RARE DISEASES AND 
 CONDITIONS IN MINORITY POPULATIONS.

 Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting through the Director of 
the National Institutes of Health and in consultation with the Director 
of the Centers for Disease Control and Prevention, shall submit to 
Congress--

    (1) a report on research and public health activities 
 carried out by the Federal Government with respect to rare 
 diseases or conditions in minority populations (as those terms 
 are defined in 

section 409K of the Public Health Service Act, 
 as added by 

section 2 of this Act);

    (2) a comprehensive list of known rare diseases and 
 conditions that impact minority populations heavily or 
 disproportionately; and

    (3) an analysis of data gaps with respect to rare diseases 
 and conditions and the effect of such diseases and conditions 
 on minority populations.

SEC. 8. RESEARCH AND AWARENESS CAMPAIGNS WITH RESPECT TO RARE DISEASES 
 AND CONDITIONS IN MINORITY POPULATIONS.

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

section 317V (42 U.S.C. 247b-24) 
the following:

``

SEC. 317W. RESEARCH AND AWARENESS CAMPAIGNS WITH RESPECT TO RARE 
 DISEASES AND CONDITIONS IN MINORITY POPULATIONS.

 ``

    (a) Research.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall conduct or support 
research and carry out public health awareness campaigns with respect 
to rare diseases and conditions in minority populations (as defined in 

section 409K).
 ``

    (b) Awareness Campaign.--The Secretary shall, directly or through 
grants or contracts, establish a public education program in 
cooperation with existing national public awareness campaigns to 
increase awareness about rare diseases and conditions in minority 
populations through culturally and linguistically appropriate 
information campaigns about prevention and management of rare diseases 
and conditions.''.

SEC. 9. FDA SURVEY AND REPORT ON CLINICAL TRIAL DIVERSITY.

 Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall--

    (1) conduct a survey of policies and programs of the Food 
 and Drug Administration to support an increase the availability 
 of clinical trial data on minority populations, with an 
 emphasis on minority populations with rare diseases and 
 conditions; and

    (2) submit to Congress a report containing--
        (A) the findings of such survey;
        (B) the Secretary's recommendations for statutory 
 or regulatory changes to increase the availability of 
 such data;
            (C) the Secretary's recommendations for strategies 
 to encourage drug manufacturers to address racial 
 equity and inclusion in research and development of 
 treatments of rare diseases or conditions that 
 disproportionately impact minority populations; and
            (D) the Secretary's recommendations for strategies 
 to address research and development of treatments of 
 rare diseases or conditions that disproportionately 
 impact minority populations.

SEC. 10. TRIBAL EPIDEMIOLOGY CENTER GRANT PROGRAM.

 Title II of the Indian Health Care Improvement Act (25 U.S.C. 1621 
et seq.) is amended by adding at the end the following:

``

SEC. 227. TRIBAL EPIDEMIOLOGY CENTER GRANT PROGRAM.

 ``

    (a) In General.--The Secretary, acting through the Service, shall 
award grants to Tribal Epidemiology Centers and Tribal and Urban Indian 
Health Centers to support clinically and culturally appropriate 
research and other activities with respect to rare diseases and 
conditions in Native American or Tribal communities.
 ``

    (b) Permissible Activities.--The activities funded through a 
grant under subsection

    (a) may include coordination of data collection 
on the prevention, diagnosis, treatment, and care of rare diseases and 
conditions by health care professionals serving American Indian and 
Alaska Native populations.''.

SEC. 11. MEDICARE REVIEW AND REPORT.

 Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Service shall conduct a review of and 
submit to Congress a report on the following:

    (1) Regulatory barriers under the Medicare program under 
 title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) 
 that inhibit access to the treatment of rare diseases for 
 Medicare beneficiaries of color, including barriers that 
 inhibit health care providers from improving care related to 
 such diseases for such beneficiaries.

    (2) Requirements relating to the furnishing of telehealth 
 services under such title insofar as such services relate to 
 the treatment of rare diseases.
Such report shall include any recommendations determined appropriate by 
the Secretary based on such review.
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