[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9907 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 9907
To provide for a comprehensive Federal response to Long COVID,
including research, education, and support for affected individuals, to
direct the National Institutes of Health to establish a Long COVID
research program, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 1, 2024
Ms. Omar (for herself, Ms. Pressley, Ms. Norton, Mrs. Watson Coleman,
Mr. Grijalva, Ms. Tlaib, Mr. Smith of Washington, Ms. Bush, Ms.
Jayapal, Ms. Lee of California, Mr. McGovern, Mrs. Hayes, Ms.
Velazquez, Mr. Bowman, Mrs. Ramirez, Ms. Moore of Wisconsin, Ms.
Lofgren, Mr. Mullin, Mr. Frost, Mr. Robert Garcia of California, Ms.
Schakowsky, and Ms. Chu) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committee on Education and the Workforce, 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 provide for a comprehensive Federal response to Long COVID,
including research, education, and support for affected individuals, to
direct the National Institutes of Health to establish a Long COVID
research program, 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 ``Long COVID Research Moonshot Act''.
TITLE I--LONG COVID BIOMEDICAL RESEARCH
SEC. 101. ESTABLISHMENT OF LONG COVID RESEARCH PROGRAM.
Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.)
is amended by adding at the end the following:
``PART K--LONG COVID PROGRAMS
``SEC. 499B. ESTABLISHMENT OF LONG COVID RESEARCH PROGRAM.
``(a) In General.--There is established within the Office of the
Director of the National Institutes of Health a research program, to be
known as the Long COVID Research Program (referred to in this part as
the `Program'), for purposes of expediting research to identify new
ways to prevent, detect, manage, and treat symptoms associated with
Long COVID.
``(b) Director.--
``(1) Appointment.--
``(A) In general.--The Program shall be headed by a
Director, appointed by the Secretary, in consultation
with the Director of NIH, who has--
``(i) experience managing clinical or
research programs focused on pathogenic
mechanisms and biological pathways related to
Long COVID; and
``(ii) demonstrated commitment to
addressing Long COVID and other infection-
associated chronic conditions, such as myalgic
encephalomyelitis/chronic fatigue syndrome,
postural orthostatic tachycardia syndrome, and
post-treatment Lyme disease syndrome/persistent
Lyme disease.
``(B) Consultation.--In appointing the Director
under subparagraph (A), the Secretary shall consult
with independent, patient-led organizations or advocacy
groups representing Long COVID patients and their
families.
``(2) Responsibilities.--The Director of the Program
shall--
``(A) act as the primary Federal official with
responsibility for coordinating all Long COVID research
conducted or supported by the National Institutes of
Health;
``(B) represent the National Institutes of Health
Long COVID Research Program at all relevant Executive
branch task force meetings and committees; and
``(C) maintain communication with all relevant
Federal departments and agencies to ensure the timely
transmission of information concerning advances in Long
COVID research and the clinical treatment of Long COVID
and other infection-associated chronic conditions
between such departments and agencies, and for
dissemination to affected communities and health care
providers.
``(c) Activities.--The Program shall--
``(1) investigate the etiology, pathophysiology, risk
factors, and pathology of Long COVID in adults and children;
``(2) explore the best ways to prevent, detect, monitor,
manage, and treat Long COVID in adults and children;
``(3) contribute knowledge to the understanding,
prevention, mitigation, management, and treatment of Long
COVID;
``(4) develop and facilitate programs on Long COVID, within
the National Institutes of Health and in other settings;
``(5) conduct comparative research to understand the
similarities and differences between Long COVID and other
infection-associated chronic conditions with similar
phenotypes, such as myalgic encephalomyelitis/chronic fatigue
syndrome, postural orthostatic tachycardia syndrome, and post-
treatment Lyme disease syndrome/persistent Lyme disease, and
how activities funded by the Program could improve
understanding of such other conditions; and
``(6) conduct comparative research to understand the
similarities and differences between Long COVID and severe,
long-term effects from COVID-19 vaccinations.
``(d) Duties.--
``(1) Interagency coordination of long covid activities.--
The Director of the Program shall coordinate with the national
research institutes and national centers, as appropriate, on
Long COVID research. In carrying out this paragraph, the
Director of the Program shall evaluate the Long COVID
activities of each such institute or center and shall provide
for the periodic reevaluation of such activities.
``(2) Consultation.--The Director of the Program shall
carry out all duties, including the development of the research
plan under section 499B-1 in consultation with the heads of the
national research institutes and national centers, with the
advisory councils of such institutes and centers, and with the
Long COVID Research Program Advisory Board established under
section 499B-4.
``(e) Non-Duplication of Effort.--The Director shall ensure that
activities carried out under this section do not unnecessarily
duplicate the efforts of other Federal departments or agencies.
``SEC. 499B-1. LONG COVID RESEARCH PLAN.
``(a) In General.--Not later than 1 year after the date of
enactment of the Long COVID Research Moonshot Act, the Director of the
Program established under section 499B shall develop and make public a
comprehensive research plan for the conduct and support of all Long
COVID research activities of the national research institutes and
national centers. The Director of the Program shall update such plan
annually.
``(b) Contents.--The research plan developed under subsection (a)
shall--
``(1) identify current Long COVID research conducted or
supported by the national research institutes and national
centers, opportunities and needs for additional research,
including among patients who face the highest disease burden
and pediatric patients, and priorities for such research;
``(2) evaluate the progress of Long COVID research against
strategic priorities, goals, and objectives, identified in
previous versions of the research plan;
``(3) make recommendations for the coordination of such
research conducted or supported by the National Institutes of
Health and other agencies of the Federal Government; and
``(4) include goals and objectives of the Program for
conducting, supporting, and coordinating Long COVID research.
``(c) Requirements.--In developing the research plan under
subsection (a), the Director of the Program shall--
``(1) ensure that the plan establishes priorities among
Long COVID research that the Program is authorized to carry
out;
``(2) ensure that the plan establishes objectives regarding
such research and describes the means for achieving the
objectives;
``(3) ensure that all amounts appropriated for such
research under section 499B-6 are expended in accordance with
the plan;
``(4) review the plan not less frequently than annually,
and revise the plan as appropriate to prioritize funding and
research relative to scientific urgency;
``(5) ensure that the plan serves as a broad, binding
statement of policies regarding Long COVID research of the
National Institutes of Health, but does not affect the
responsibility of any of the national research institutes or
centers with respect to the programs or projects of such
institutes and centers; and
``(6) annually prepare and submit to the Director of NIH
for review and transmittal by the Director of NIH to the
President and to Congress a budget estimate for carrying out
the plan for the upcoming fiscal year.
``(d) Consultation.--In developing, implementing, reviewing, and
prioritizing elements of the research plan under this section, the
Director of the Program shall consult, as appropriate with--
``(1) representatives of other Federal agencies involved in
Long COVID research, including the Centers for Disease Control
and Prevention, the Agency for Healthcare Research and Quality,
and the Administration for Community Living;
``(2) the Long COVID Research Advisory Board established
under section 499B-4;
``(3) the Office of Long COVID Research and Practice of the
Department of Health and Human Services;
``(4) leading scientific experts on Long COVID; and
``(5) independent, patient-led organizations or advocacy
groups representing patients with Long COVID and other
infection-associated chronic conditions with similar
phenotypes, and the families of such patients.
``(e) Report.--The Director of the Program shall submit the
research plan developed under subsection (a), and updates to such plan,
to--
``(1) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(2) the Committee on Energy and Commerce of the House of
Representatives;
``(3) the Secretary;
``(4) the Office of Long COVID Research and Practice of the
Department of Health and Human Services; and
``(5) the Director of NIH, who shall post the plan, and
updates to the plan, on the website of the National Institutes
of Health.
``SEC. 499B-2. EXPEDITED LONG COVID RESEARCH.
``(a) In General.--The Director of NIH shall establish a process to
expedite the award of grants, contracts, and cooperative agreements for
research projects conducted or supported by the National Institutes of
Health and relating to Long COVID.
``(b) Requirements for Making External Funding Available.--With
respect to programs of grants, contracts, and cooperative agreements
described in subsection (a), the Director of NIH shall--
``(1) make publicly available the deadlines for submitting
applications for such programs, and ensure that such deadlines
provide applicants with sufficient time from the date of the
announcement for such grant, contract, and cooperative
agreement to submit an application;
``(2) ensure that applicants receive a final decision on
their applications within 120 days of submission; and
``(3) with respect to applications that are denied, provide
a written explanation to the applicant on the reasons for the
denial.
``(c) Evaluation of Grant Applications.--In making a determination
to award a grant, contract, and cooperative agreement for research
projects described in subsection (a), the Director of NIH shall--
``(1) give priority to research that--
``(A) tests the outcomes of existing drug and
device interventions in patients with Long COVID;
``(B) focuses on identifying interventions for
pediatric patients with Long COVID;
``(C) aids in the development of new interventions
that have evidence to suggest effectiveness in treating
or curing Long COVID; or
``(D) includes institutions that represent, or have
a successful track record of providing equitable care
or services to, historically underserved communities;
``(2) consider research that has the ability to begin
interventions in a timely manner;
``(3) consider research that uses decentralized trials or
remote monitoring techniques for data collection; and
``(4) consider research that includes patients with other
infection-associated chronic conditions with similar
phenotypes, such as myalgic encephalomyelitis/chronic fatigue
syndrome, postural orthostatic tachycardia syndrome, and post-
treatment Lyme disease syndrome/persistent Lyme disease.
``(d) Reasonable Pricing.--In awarding contracts, grants, and
cooperative agreements for research projects described in subsection
(a) that relates to the development of a drug or device for the
potential treatment or management of Long COVID, or identifying a new
indication or use specific to the treatment or management of Long COVID
in a drug or device that is already approved or cleared by the Food and
Drug Administration, the Director of NIH shall include terms and
conditions requiring that the price of such a drug or device for
purposes of procurement by the Federal Government or if sold on the
commercial market, whether procured from, or sold by, the recipient of
such Federal award or another person--
``(1) is fair and reasonable, taking into account--
``(A) the value of the drug and device to the
public health, including the impact of the price on
access to the drug or device;
``(B) the costs incurred by the Federal Government
in research and development of the drug or device;
``(C) the costs incurred by the recipient of the
award in research and development of the drug or
device, and the costs of manufacturing such drug or
device;
``(D) whether the drug or device provided a
significant improvement in health outcomes, compared to
other therapies available at the time of its approval
or authorization;
``(E) the cumulative expected global revenues
generated by the drug or device; and
``(F) other factors, as the Secretary determines
appropriate; and
``(2) does not exceed the lowest price charged for such
drug or device, among Canada, France, Germany, Italy, Japan,
and the United Kingdom.
``(e) Consultation.--In making a determination to award a grant,
contract, or cooperative agreement for research projects relating to
Long COVID, the Director of NIH shall consult with the Long COVID
Research Advisory Board. Members of the Long COVID Research Advisory
Board shall provide a recommendation on any final funding decisions. If
the Director of NIH makes a decision that is different than the
recommendation, the Director of NIH shall provide a written
justification for the decision within 5 days.
``SEC. 499B-3. SCIENTIFIC REVIEW GROUP.
``(a) In General.--In order to ensure high quality, rigorous
scientific review of applications for grants, contracts, and
cooperative agreements described in section 499B-2(a), consistent with
section 492, the Director of NIH shall establish a scientific review
group on Long COVID and other infection-associated chronic conditions,
and shall convene a group of leading scientific experts to serve on
such group, for terms of up to 5 years.
``(b) Duties.--The scientific research group shall conduct an
initial review of applications for grants, contracts, and other
cooperative agreements described in section 499B-2(a), and submit a
funding recommendation to the Director of NIH for final determination.
``SEC. 499B-4. LONG COVID RESEARCH PROGRAM ADVISORY BOARD.
``(a) In General.--The Director of NIH shall establish the Long
COVID Research Program Advisory Board (referred to in this section as
the `Advisory Board').
``(b) Membership.--
``(1) In general.--The Advisory Board shall be comprised of
18 members, including appointed members and nonvoting ex
officio members, as follows:
``(A) The Secretary shall conduct a nomination
process that allows for public input on nominees. The
Secretary shall appoint nominated individuals, giving
particular consideration to individuals from
backgrounds that represent the diversity of the Long
COVID population, with an emphasis on patients who face
the highest disease burden. Individuals so appointed
shall include the following:
``(i) 10 members who are scientists,
physicians, and other health care
professionals, who are not officers or
employees of the Federal Government, and who
have primary expertise in Long COVID and other
infection-associated chronic conditions, with
consideration given to such individuals with
expertise in pediatric populations.
``(ii) 5 members who live with Long COVID.
``(iii) 1 member who is a caregiver to an
individual with Long COVID.
``(iv) 2 members who are employed by the
National Institutes of Health and have
expertise in Long COVID research.
``(B) The following shall be ex officio members of
the Advisory Board:
``(i) A representative of the Long COVID
Research Program established under section 499.
``(ii) A representative of the National