Rare disease Advancement, surveillance Research, and Education Act of 2019 or the RARE Act of 2019
The bill reauthorizes through FY2024 the National Institutes of Health Rare Disease Regional Centers of Excellence and expands activities to facilitate research and increase awareness of rare diseases and conditions. (Rare diseases and conditions are those with a prevalence of fewer than 200,000 individuals in the United States.)
The Centers for Disease Control and Prevention (CDC) may expand infrastructure and activities to track the epidemiology of up to four rare diseases and conditions and incorporate this information into a National Rare Disease or Condition Surveillance System.
The Agency for Healthcare Research and Quality must expand its activities to increase health care providers' awareness of rare diseases and conditions.
The National Academies of Sciences, Engineering, and Medicine, or another appropriate entity, must update the 2010 report Rare Diseases and Orphan Products: Accelerating Research and Development.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4228 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 4228
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
September 6, 2019
Mr. Carson of Indiana (for himself, Mr. Hudson, Ms. Brownley of
California, Mr. Bucshon, Mr. DeFazio, Mr. Deutch, Mr. Fitzpatrick, Ms.
Jackson Lee, Mr. Lujan, Mrs. Carolyn B. Maloney of New York, Ms. Moore,
Mrs. Murphy, Ms. Norton, Mr. Raskin, Mr. Rouda, Mr. Suozzi, and Mrs.
Walorski) 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,
surveillance Research, and Education Act of 2019'' or the ``RARE Act of
2019''.
SEC. 2. NIH RARE DISEASE REGIONAL CENTERS OF EXCELLENCE.
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 are authorized to be appropriated such sums as may be
necessary for each of fiscal years 2020 through 2024 for carrying out
section 481A (relating to rare disease regional centers of
excellence).''.
SEC. 3. 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 may, as appropriate--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of up to 4 rare diseases and conditions
selected under subsection (c)(1); and
``(2) incorporate information obtained through such
activities into an integrated surveillance system 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
provides information that facilitates further research on rare diseases
and conditions.
``(c) Content.--In carrying out subsection (a), the Secretary--
``(1) shall select up to 4 rare diseases and conditions
that are determined by the Secretary to have--
``(A) a high rate of mortality or morbidity; or
``(B) potential for meaningful research and
treatment;
``(2) shall provide for the collection and storage of
information on the incidence and prevalence of such rare
diseases and conditions in the United States;
``(3) to the extent practicable, shall provide for the
collection and storage of other available information on such
rare diseases and conditions, including information related to
persons living with such a rare disease or condition who choose
to participate in surveillance activities, and including
information on--
``(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 the
rare disease or condition, such as genetic and
environmental risk factors and other information, as
appropriate; and
``(C) diagnosis and progression markers;
``(4) to the extent practicable, shall provide for the
collection and storage of information relevant to analysis on
such rare diseases and conditions, such as information
concerning--
``(A) the natural history of the diseases and
conditions;
``(B) the prevention of the disease or condition,
including secondary diseases and conditions;
``(C) the detection, management, and treatment
approaches for the diseases and conditions; and
``(D) the development of outcomes measures; and
``(5) may address issues identified during the consultation
process under subsection (d).
``(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;
``(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) Supplement Not Supplant.--The activities under this section
may supplement, but shall not supplant, any activities with respect to
spina bifida, muscular dystrophy, or fragile X syndrome that are
ongoing as of the date of enactment of this section.
``(j) Reports.--
``(1) Report on information and analyses.--Not later than 2
years 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.
``(k) 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 having a prevalence of fewer than 200,000
individuals in the United States.
``(l) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $10,000,000 for each of fiscal
years 2020 through 2025.''.
SEC. 4. INCREASING HEALTH PROFESSIONALS' AWARENESS OF RARE DISEASES.
(a) 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.
(b) Definition.--In this section, the term ``rare diseases and
conditions'', with respect to a disease or condition, means having a
prevalence of fewer than 200,000 individuals in the United States.
SEC. 5. REPORT.
(a) 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''.
(b) Authorization of Appropriations.--To carry out this section,
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.
Sponsor introductory remarks on measure. (CR E1107)
Referred to the Subcommittee on Health.
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