I 
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, surveil-
lance, 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 Cali-
fornia, Mr. BUCSHON, Mr. DEFAZIO, Mr. DEUTCH, Mr. FITZPATRICK, 
Ms. JACKSON LEE, Mr. LUJA´N, 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 aware-
ness, education, research, surveillance, diagnosis, and 
treatment concerning rare diseases and conditions. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Rare disease Advance-
ment, surveillance Research, and Education Act of 2019’’ 
or the ‘‘RARE Act of 2019’’. 
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SEC. 2. NIH RARE DISEASE REGIONAL CENTERS OF EXCEL-
LENCE. 
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 CON-
DITIONS. 
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 appro-
priate— 
‘‘(1) enhance and expand infrastructure and ac-
tivities to track the epidemiology of up to 4 rare dis-
eases and conditions selected under subsection 
(c)(1); and 
‘‘(2) incorporate information obtained through 
such activities into an integrated surveillance system 
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to be known as the National Rare Disease or Condi-
tion Surveillance System. 
‘‘(b) RESEARCH.—The Secretary shall ensure that 
the National Rare Disease or Condition Surveillance Sys-
tem is designed in a manner that provides information 
that facilitates further research on rare diseases and con-
ditions. 
‘‘(c) CONTENT.—In carrying out subsection (a), the 
Secretary— 
‘‘(1) shall select up to 4 rare diseases and con-
ditions 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 informa-
tion on such rare diseases and conditions, including 
information related to persons living with such a 
rare disease or condition who choose to participate 
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in surveillance activities, and including information 
on— 
‘‘(A) demographics, such as age, race, eth-
nicity, 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 ge-
netic 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 con-
dition, including secondary diseases and condi-
tions; 
‘‘(C) the detection, management, and 
treatment approaches for the diseases and con-
ditions; and 
‘‘(D) the development of outcomes meas-
ures; and 
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‘‘(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 appro-
priate 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 re-
search, 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 sys-
tems 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, 
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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 Na-
tional Rare Disease or Condition Surveillance Sys-
tem 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 coordi-
nate 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 re-
searchers. 
‘‘(h) PRIVACY.—The Secretary shall ensure that in-
formation 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, 
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