Title: RARE Act of 2018
Policy area: Health

Summary:
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)]

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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.
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