Rare disease Advancement, Research, and Education Act of 2018 or the RARE Act of 2018
This bill reauthorizes through FY2023 the Office of Rare Diseases in the National Institutes of Health.
The bill requires (1) the Centers for Disease Control and Prevention to expand infrastructure and activities to track the epidemiology of rare diseases and conditions and to incorporate this information into a National Rare Disease or Condition Surveillance System, and (2) the Agency for Healthcare Research and Quality to expand its activities to increase providers' awareness of rare diseases and conditions.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5115 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 5115
To expand and improve the programs and activities of the Department of
Health and Human Services for awareness, education, research,
surveillance, diagnosis, and treatment concerning rare diseases and
conditions.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 27, 2018
Mr. Carson of Indiana (for himself and Mr. Costello of Pennsylvania)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To expand and improve the programs and activities of the Department of
Health and Human Services for awareness, education, research,
surveillance, diagnosis, and treatment concerning rare diseases and
conditions.
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 ``Rare disease Advancement, Research,
and Education Act of 2018'' or the ``RARE Act of 2018''.
SEC. 2. IMPROVING PROGRAMS AND ACTIVITIES OF HHS CONCERNING RARE
DISEASES AND CONDITIONS.
(a) NIH.--Paragraph (1) of section 402A(a) of the Public Health
Service Act (42 U.S.C. 282a(a)) is amended by adding at the end the
following:
``In addition to the amounts authorized to be appropriated by
the preceding sentence, there is authorized to be appropriated
$10,000,000 for each of fiscal years 2019 through 2023 for
carrying out section 481A (relating to rare disease regional
centers of excellence).''.
(b) CDC Surveillance of Rare Diseases and Conditions.--Title III of
the Public Health Service Act is amended by inserting after section
317T of such Act (42 U.S.C. 247b-22) the following:
``SEC. 317U CDC SURVEILLANCE OF RARE DISEASES AND CONDITIONS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in coordination with
other agencies as the Secretary determines, shall, as appropriate--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of rare diseases and conditions; and
``(2) incorporate information obtained through such
activities into an integrated surveillance system, which may
consist of or include a registry, to be known as the National
Rare Disease or Condition Surveillance System.
``(b) Research.--The Secretary shall ensure that the National Rare
Disease or Condition Surveillance System is designed in a manner that
facilitates further research on rare diseases and conditions.
``(c) Content.--In carrying out subsection (a), the Secretary--
``(1) shall provide for the collection and storage of
information on the incidence and prevalence of rare diseases
and conditions in the United States;
``(2) to the extent practicable, shall provide for the
collection and storage of other available information on rare
diseases and conditions, including information related to
persons living with a rare disease or condition who choose to
participate, such as--
``(A) demographics, such as age, race, ethnicity,
sex, geographic location, family history, and other
information, as appropriate;
``(B) risk factors that may be associated with a
rare disease or condition, such as genetic and
environmental risk factors and other information, as
appropriate; and
``(C) diagnosis and progression markers;
``(3) to the extent practicable, shall provide for the
collection and storage of information relevant to analysis on
rare diseases and conditions, such as information concerning--
``(A) the natural history of the diseases and
conditions;
``(B) the prevention of the diseases and
conditions;
``(C) the detection, management, and treatment
approaches for the diseases and conditions; and
``(D) the development of outcomes measures;
``(4) may address issues identified during the consultation
process under subsection (d); and
``(5) initially may address a limited number of rare
diseases or conditions.
``(d) Consultation.--In carrying out this section, the Secretary
shall consult with individuals with appropriate expertise, which may
include--
``(1) epidemiologists with experience in disease
surveillance or registries;
``(2) representatives of national voluntary health
associations that--
``(A) focus on rare diseases or conditions; and
``(B) have demonstrated experience in research,
care, or patient services;
``(3) health information technology experts or other
information management specialists;
``(4) clinicians with expertise in rare diseases or
conditions;
``(5) research scientists with expertise in rare diseases
or conditions, or experience conducting translational research
or utilizing surveillance systems for scientific research
purposes; and
``(6) patients and caregivers of patients with rare
diseases or conditions.
``(e) Grants.--The Secretary may award grants to, or enter into
contracts or cooperative agreements with, public or private nonprofit
entities to carry out activities under this section.
``(f) Coordination With Other Federal, State, and Local Agencies.--
Subject to subsection (h), the Secretary shall--
``(1) make information and analysis in the National Rare
Disease or Condition Surveillance System available, as
appropriate--
``(A) to Federal departments and agencies, such as
the National Institutes of Health and the Department of
Veterans Affairs; and
``(B) to State and local agencies; and
``(2) identify, build upon, leverage, and coordinate among
existing data and surveillance systems, surveys, registries,
and other Federal public health infrastructure, wherever
practicable.
``(g) Public Access.--Subject to subsection (h), the Secretary
shall ensure that information and analysis in the National Rare Disease
or Conditions Surveillance System are available, as appropriate, to the
public, including researchers.
``(h) Privacy.--The Secretary shall ensure that information and
analysis in the National Rare Disease or Condition Surveillance System
are made available only to the extent permitted by applicable Federal
and State law, and in a manner that protects personal privacy, to the
extent required by applicable Federal and State privacy law, at a
minimum.
``(i) Reports.--
``(1) Report on information and analyses.--Not later than 1
year after the date on which any system is established under
this section, the Secretary shall submit an interim report to
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives regarding aggregate information collected
pursuant to this section and epidemiological analyses, as
appropriate. Such report shall be posted on the Internet
website of the Department of Health and Human Services and
shall be updated biennially.
``(2) Implementation report.--Not later than 4 years after
the date of the enactment of this section, the Secretary shall
submit a report to the Congress concerning the implementation
of this section. Such report shall include information on--
``(A) the development and maintenance of the
National Rare Disease or Condition Surveillance System;
``(B) the type of information collected and stored
in the surveillance system;
``(C) the use and availability of such information,
including guidelines for such use; and
``(D) the use and coordination of databases that
collect or maintain information on rare diseases or
conditions.
``(j) Definitions.--In this section:
``(1) National voluntary health association.--The term
`national voluntary health association' means a national
nonprofit organization with chapters, other affiliated
organizations, or networks in States throughout the United
States with experience serving the population of individuals
with a rare disease or condition and have demonstrated
experience in rare disease or condition research, care, and
patient services.
``(2) Rare.--The term `rare', with respect to a disease or
condition, means affecting fewer than 200,000 individuals in
the United States.
``(k) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $5,000,000 for each of fiscal
years 2018 through 2023.''.
(c) AHRQ Health Care Provider Awareness Activities.--
(1) In general.--The Director of the Agency for Healthcare
Research and Quality shall expand and intensify the activities
of the Agency to increase the awareness and knowledge of health
care providers about rare diseases and conditions.
(2) Definition.--In this subsection, the term ``rare
diseases and conditions'' refers to any disease or condition
affecting fewer than 200,000 individuals in the United States.
(d) National Academies Report.--
(1) In general.--The Secretary of Health and Human Services
shall seek to enter into an arrangement with the National
Academies (or another appropriate entity if the National
Academies decline) to update and republish, by not later than 3
years after the date of enactment of this Act, the 2010 report
of the National Academies entitled ``Rare Diseases and Orphan
Products: Accelerating Research and Development''.
(2) Authorization of appropriations.--To carry out this
subsection, there is authorized to be appropriated $1,000,000.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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