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 2024 
through 2028 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 317U of such Act (42 U.S.C. 
247b–23) the following: 
‘‘SEC. 317V. 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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and in a manner that protects personal privacy, to the ex-
tent 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 dys-
trophy, or fragile X syndrome that are ongoing as of the 
date of enactment of this section. 
‘‘(j) REPORTS.— 
‘‘(1) REPORT
ON
INFORMATION
AND
ANAL-
YSES.—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 Pen-
sions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives re-
garding aggregate information collected pursuant to 
this section and epidemiological analyses, as appro-
priate. 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 
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