[House Report 111-636]
[From the U.S. Government Publishing Office]
111th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 111-636
======================================================================
NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE SYSTEM ACT OF 2010
_______
September 28, 2010.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Waxman, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1362]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1362) to amend the Public Health Service Act to
provide for the establishment of permanent national
surveillance systems for multiple sclerosis, Parkinson's
disease, and other neurological diseases and disorders, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings and Recommendations................. 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Statement of General Performance Goals and Objectives............ 5
Constitutional Authority Statement............................... 5
Earmarks and Tax and Tariff Benefits............................. 5
Federal Advisory Committee Statement............................. 5
Applicability of Law to the Legislative Branch................... 5
Federal Mandates Statement....................................... 5
Committee Cost Estimate.......................................... 5
Congressional Budget Office Cost Estimate........................ 5
Section-by-Section Analysis of the Legislation................... 7
Explanation of Amendment......................................... 8
Changes in Existing Law Made by the Bill, as Reported............ 8
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Neurological Diseases
Surveillance System Act of 2010''.
SEC. 2. NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE SYSTEM.
Part P of title III of the Public Health Service Act (42 U.S.C. 280g
et seq.) is amended by adding at the end the following:
``SEC. 399V-5 SURVEILLANCE OF NEUROLOGICAL DISEASES.
``(a) In General.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, shall--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of neurological diseases, including
multiple sclerosis and Parkinson's disease; and
``(2) incorporate information obtained through such
activities into a statistically-sound, scientifically-credible,
integrated surveillance system, to be known as the National
Neurological Diseases Surveillance System.
``(b) Research.--The Secretary shall ensure that the National
Neurological Diseases Surveillance System is designed in a manner that
facilitates further research on neurological diseases.
``(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 neurological
diseases in the United States;
``(2) to the extent practicable, shall provide for the
collection and storage of other available information on
neurological diseases, such as information concerning--
``(A) demographics and other information associated
or possibly associated with neurological diseases, such
as age, race, ethnicity, sex, geographic location, and
family history;
``(B) risk factors associated or possibly associated
with neurological diseases, including genetic and
environmental risk factors; and
``(C) diagnosis and progression markers;
``(3) may provide for the collection and storage of
information relevant to analysis on neurological diseases, such
as information concerning--
``(A) the epidemiology of the diseases;
``(B) the natural history of the diseases;
``(C) the prevention of the diseases;
``(D) the detection, management, and treatment
approaches for the diseases; and
``(E) the development of outcomes measures; and
``(4) 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, including--
``(1) epidemiologists with experience in disease surveillance
or registries;
``(2) representatives of national voluntary health
associations that--
``(A) focus on neurological diseases, including
multiple sclerosis and Parkinson's disease; 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 neurological diseases; and
``(5) research scientists with experience conducting
translational research or utilizing surveillance systems for
scientific research purposes.
``(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 Agencies.--Subject to
subsection (h), the Secretary shall make information and analysis in
the National Neurological Diseases Surveillance System available, as
appropriate, to Federal departments and agencies, such as the National
Institutes of Health, the Food and Drug Administration, the Centers for
Medicare & Medicaid Services, the Agency for Healthcare Research and
Quality, the Department of Veterans Affairs, and the Department of
Defense.
``(g) Public Access.--Subject to subsection (h), the Secretary shall
make information and analysis in the National Neurological Diseases
Surveillance System available, as appropriate, to the public, including
researchers.
``(h) Privacy.--The Secretary shall ensure that privacy and security
protections applicable to the National Neurological Diseases
Surveillance System are at least as stringent as the privacy and
security protections under HIPAA privacy and security law (as defined
in section 3009(a)(2)).
``(i) 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--
``(1) the development and maintenance of the National
Neurological Diseases Surveillance System;
``(2) the type of information collected and stored in the
System;
``(3) the use and availability of such information, including
guidelines for such use; and
``(4) the use and coordination of databases that collect or
maintain information on neurological diseases.
``(j) Definition.--In this section, the term `national voluntary
health association' means a national nonprofit organization with
chapters, other affiliated organizations, or networks in States
throughout the United States.
``(k) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for each of fiscal
years 2012 through 2016.''.
Purpose and Summary
H.R. 1362, the ``National Neurological Diseases
Surveillance System Act of 2010'', was introduced on March 5,
2009, by Rep. Chris Van Hollen (D-MD), and referred to the
Committee on Energy and Commerce.
The goal of H.R. 1362 is to improve our understanding of
Multiple Sclerosis (MS), Parkinson's disease, and other
neurological diseases. The bill provides for systematic data
collection, analysis, and interpretation (epidemiological
surveillance) regarding these diseases.
Background and Need for Legislation
Multiple Sclerosis affects an estimated 400,000 people in
the United States.\1\ The exact cause of MS is unknown though
it is thought to be an autoimmune disorder where the immune
system incorrectly attacks healthy nerve fibers of the central
nervous system (myelin).\2\ Symptoms range from blurriness and
difficulty with coordination and balance to partial or complete
paralysis. There is currently no cure for MS, though use of
certain Food and Drug Administration-approved therapies can
reduce the duration and severity of attacks among some
patients. Parkinson's disease is diagnosed among an estimated
60,000 people each year; however, the exact prevalence of this
disease is unknown.\3\ Parkinson's disease results from the
loss of dopamine-producing brain cells (or neurotransmitter
cells).\4\ Parkinson's is also a chronic and progressive
disease though symptoms vary from patient-to-patient, and like
MS, there is no cure for Parkinson's, but treatments can
provide relief from symptoms.
---------------------------------------------------------------------------
\1\National Multiple Sclerosis Society, FAQs about MS (online at
http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-
about-ms/faqs-about-ms/index.aspx) (accessed Sept. 21, 2010).
\2\National Institute of Neurological Disorders and Stroke, NINDS
Multiple Sclerosis Information Page (online at http://
www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm)
(accessed Sept. 21, 2010).
\3\Parkinson's Action Network, About Parkinson's Disease (online at
http://www.parkinsonsaction.org/parkinsons-disease/about-parkinsons-
disease) (accessed Sept. 21, 2010).
\4\National Institute of Neurological Disorders and Stroke, NINDS
Parkinson's Disease Information Page (online at http://
www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm)
(accessed Sept. 21, 2010).
---------------------------------------------------------------------------
The Centers for Disease Control and Prevention (CDC) does
extensive monitoring of health and disease; however, with the
exception of an amyotrophic lateral sclerosis (ALS) registry
and tracking on causes of death, its surveillance efforts on
MS, Parkinson's, and other neurological diseases to date have
been limited. H.R. 1362 seeks to address the gaps in our
understanding of MS, Parkinson's, and other neurological
diseases through collection, analysis, and interpretation of
data (epidemiological surveillance), including the incidence
and prevalence of these diseases and the characteristics of
people affected by them.
Committee Consideration
H.R. 1362, the ``National Neurological Disease Surveillance
System Act of 2010'', was introduced by Mr. Van Hollen of
Maryland on March 5, 2009, and referred to the Committee on
Energy and Commerce. The bill was subsequently referred to the
Subcommittee on Health on March 6, 2009. On September 15, 2010,
the Subcommittee held a legislative hearing on the bill. The
Subcommittee met in open markup session to consider H.R. 1362
on September 16, 2010. An amendment in the nature of a
substitute by Mr. Burgess was adopted by a voice vote.
Subsequently, H.R. 1362 was forwarded to the full Committee,
amended, by a voice vote.
On September 23, 2010, the Committee on Energy and Commerce
met in open markup session and considered H.R. 1362 as approved
by the Subcommittee. There were no amendments offered in full
Committee and subsequently the Committee ordered H.R. 1362
favorably reported to the House, as amended by the Subcommittee
on Health, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. A
motion by Mr. Pallone ordering H.R. 1362 reported to the House,
as amended, was approved by a voice vote. There were no record
votes taken during consideration of this bill.
Committee Oversight Findings and Recommendations
In compliance with clause 3(c)(1) of rule XIII and clause
(2)(b)(1) of rule X of the Rules of the House of
Representatives, the oversight findings and recommendations of
the Committee are reflected in the descriptive portions of this
report, including the finding that CDC surveillance of MS,
Parkinson's disease, and certain neurological diseases has been
limited.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 1362 would result in no new budget authority,
entitlement authority, or tax expenditures or revenues.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the performance goals and
objectives of the Committee are reflected in the descriptive
portions of this report, including the goal of improving
epidemiological surveillance regarding MS, Parkinson's, and
other neurological diseases.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
constitutional authority for H.R. 1362 is provided under
article I, section 8, clauses 3 and 18 of the Constitution of
the United States.
Earmarks and Tax and Tariff Benefits
H.R. 1362 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9 of rule XXI of the Rules of the House of
Representatives.
Federal Advisory Committee Statement
The Committee finds that the legislation does not establish
or authorize the establishment of an advisory committee within
the definition of 5 U.S.C. App., section 5(b) of the Federal
Advisory Committee Act.
Applicability of Law to the Legislative Branch
Section 102(b)(3) of Public Law 104-1 requires a
description of the application of this bill to the legislative
branch where the bill relates to terms and conditions of
employment or access to public services and accommodations.
H.R. 1362 contains no such provisions.
Federal Mandates Statement
Section 423 of the Congressional Budget and Impoundment
Control Act of 1974 (as amended by section 101(a)(2) of the
Unfunded Mandates Reform Act, Public Law 104-4) requires a
statement on whether the provisions of the report include
unfunded mandates. In compliance with this requirement the
Committee adopts as its own the analysis of federal mandates
prepared by the Director of the Congressional Budget Office
regarding H.R. 1362.
Committee Cost Estimate
Pursuant to clause 3(d)(2) of rule XIII of the Rules of the
House of Representatives, the Committee adopts as its own the
cost estimate of H.R. 1362 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Congressional Budget Office Cost Estimate
With respect to the requirements of clause (3)(c)(3) of
rule XIII of the Rules of the House of Representatives and
section 402 of the Congressional Budget Act of 1974, the
Committee has received the following cost estimate for H.R.
1362 from the Director of Congressional Budget Office:
September 24, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 1362, the National
Neurological Diseases Surveillance System Act of 2010.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Lara
Robillard.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 1362--National Neurological Diseases Surveillance System Act of
2010
Summary: H.R. 1362 would amend the Public Health Service
Act to require the Secretary of Health and Human Services to
increase epidemiological tracking of neurological diseases. It
also would authorize the Secretary to create a surveillance
system for neurological disorders. CBO estimates that
implementing H.R. 1362 would cost $16 million over the 2011-
2015 period, assuming appropriation of the authorized amounts.
Enacting H.R. 1362 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 1362 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 1362 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------
2011-
2011 2012 2013 2014 2015 2015
------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Authorization Level.......... 0 5 5 5 5 20
Estimated Outlays............ 0 2 4 5 5 16
------------------------------------------------------------------------
Basis of estimate: H.R. 1362 would direct the Secretary of
Health and Human Services, acting through the Director of the
Centers for Disease Control and Prevention (CDC), to expand
tracking of the epidemiology of neurological diseases, such as
multiple sclerosis and Parkinson's disease.
The Secretary would use this information to create a
National Neurological Diseases Surveillance System, which
would, in part, facilitate additional research into
neurological diseases. Among the data collected and analyzed
through the new tracking and surveillance systems would be
information on demographic characteristics, risk factors, and
diagnoses. The Secretary would ensure coordination with other
federal agencies and compliance with existing privacy laws.
To implement the tracking and surveillance systems, the
Secretary could award grants to, or enter into contracts or
cooperative agreements with, public or not-for-profit entities.
The bill would authorize the appropriation of $5 million a year
for fiscal years 2012 through 2016 to implement those programs.
Based on historical patterns of spending for grant programs
administered by the CDC and assuming appropriation of the
authorized amounts, CBO estimates that implementing the bill
would cost $16 million over the 2012-2015 period and an
additional $9 million after 2015.
Pay-As-You-Go considerations: None.
Intergovernmental and private-sector impact: H.R. 1362
contains no intergovernmental or private-sector mandates as
defined in UMRA. State and local governments that collect and
store information concerning neurological diseases would
benefit from grant funds authorized in the bill.
Estimate prepared by: Federal costs: Lara Robillard; Impact
on state, local, and tribal governments: Lisa Ramirez-Branum;
Impact on the private sector: Jimmy Jin.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title may be cited as
the ``National Neurological Diseases Surveillance System Act of
2010''.
Section 2. National Neurological Diseases Surveillance System
Section 2 amends part P of title III of the Public Health
Service Act to create a new section (399V-5) that requires the
Secretary of Health and Human Services, acting through the
Director of the CDC, to: (1) enhance and expand infrastructure
and activities to track neurological diseases, including MS and
Parkinson's disease; and (2) incorporate information obtained
through these efforts into a surveillance system.
In so doing, the Secretary is required to: (1) ensure the
surveillance system is designed in a manner that facilitates
further research; (2) collect and store certain information
(incidence and prevalence and, to the extent practicable, other
available information); (3) consult with individuals with
specified expertise; (4) make information and analysis in the
surveillance system available to federal departments and
agencies and the public, including researchers (as
appropriate); and (5) ensure that privacy and security
provisions applicable to the surveillance system are at least
as stringent as required under the Health Insurance Portability
and Accountability Act (HIPAA).
Additionally, the Secretary is permitted to: (1) collect
and store other information relevant to the analysis on
neurological diseases; (2) address other issues identified
through the required consultation process; and (3) award grants
to, or enter into contracts with, public or private nonprofit
entities to carry out the activities in the legislation.
Section 2 requires the Secretary to report to Congress no
later than four years after enactment of the legislation on its
implementation. This section also authorizes $5 million for
each of fiscal years 2012 through 2016 to carry out the
activities in the legislation.
The bill provides the Secretary with discretion in
collecting and storing data on neurological diseases to: (1)
allow for maximum efficiency in data collection efforts, and
(2) permit a more integrated approach that can include
surveillance of other neurological diseases and incorporate new
information as it becomes available.
H.R. 1362 requires the Secretary to collect and store other
available information on neurological diseases (beyond
incidence and prevalence) and provides two illustrative
examples of this information--demographics and risk factors
associated or possibly associated with these diseases. While
currently-available information suggests a relationship or
strong potential of a relationship between certain demographic
variables and these diseases (e.g., age and MS), there may be
other variables where a relationship may later be established
(e.g., work history). With the proliferation of health
information technology, and electronic health records in
particular, the Committee expects additional information
surrounding diagnosis and treatment of these diseases will
become more readily available and facilitate opportunities for
more in-depth surveillance of neurological and other diseases.
The Committee intends for the requirement that the
Secretary share information and analysis from this surveillance
effort with other federal departments and agencies to be a
first step in facilitating collaboration and information-
sharing to improve our understanding of these diseases, where
appropriate and consistent with the privacy and security
protections outlined in the legislation.
In carrying out H.R. 1362, the Committee expects the
Secretary to first focus on the collection and storage of data
on MS and Parkinson's. Contingent upon annual appropriations
and the availability of information on other diseases, the
Committee encourages the Secretary to broaden surveillance
efforts to also capture additional neurological diseases.
Explanation of Amendment
During the Subcommittee on Health markup of H.R. 1362, Mr.
Burgess of Texas offered an amendment in the nature of a
substitute, which was adopted by a voice vote. The substance of
the substitute amendment is reflected in the section-by-section
analysis contained in this report.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
PART P--ADDITIONAL PROGRAMS
* * * * * * *
SEC. 399V-5. SURVEILLANCE OF NEUROLOGICAL DISEASES.
(a) In General.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall--
(1) enhance and expand infrastructure and activities
to track the epidemiology of neurological diseases,
including multiple sclerosis and Parkinson's disease;
and
(2) incorporate information obtained through such
activities into a statistically-sound, scientifically-
credible, integrated surveillance system, to be known
as the National Neurological Diseases Surveillance
System.
(b) Research.--The Secretary shall ensure that the National
Neurological Diseases Surveillance System is designed in a
manner that facilitates further research on neurological
diseases.
(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
neurological diseases in the United States;
(2) to the extent practicable, shall provide for the
collection and storage of other available information
on neurological diseases, such as information
concerning--
(A) demographics and other information
associated or possibly associated with
neurological diseases, such as age, race,
ethnicity, sex, geographic location, and family
history;
(B) risk factors associated or possibly
associated with neurological diseases,
including genetic and environmental risk
factors; and
(C) diagnosis and progression markers;
(3) may provide for the collection and storage of
information relevant to analysis on neurological
diseases, such as information concerning--
(A) the epidemiology of the diseases;
(B) the natural history of the diseases;
(C) the prevention of the diseases;
(D) the detection, management, and treatment
approaches for the diseases; and
(E) the development of outcomes measures; and
(4) 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, including--
(1) epidemiologists with experience in disease
surveillance or registries;
(2) representatives of national voluntary health
associations that--
(A) focus on neurological diseases, including
multiple sclerosis and Parkinson's disease; 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 neurological
diseases; and
(5) research scientists with experience conducting
translational research or utilizing surveillance
systems for scientific research purposes.
(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 Agencies.--Subject to
subsection (h), the Secretary shall make information and
analysis in the National Neurological Diseases Surveillance
System available, as appropriate, to Federal departments and
agencies, such as the National Institutes of Health, the Food
and Drug Administration, the Centers for Medicare & Medicaid
Services, the Agency for Healthcare Research and Quality, the
Department of Veterans Affairs, and the Department of Defense.
(g) Public Access.--Subject to subsection (h), the Secretary
shall make information and analysis in the National
Neurological Diseases Surveillance System available, as
appropriate, to the public, including researchers.
(h) Privacy.--The Secretary shall ensure that privacy and
security protections applicable to the National Neurological
Diseases Surveillance System are at least as stringent as the
privacy and security protections under HIPAA privacy and
security law (as defined in section 3009(a)(2)).
(i) 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--
(1) the development and maintenance of the National
Neurological Diseases Surveillance System;
(2) the type of information collected and stored in
the System;
(3) the use and availability of such information,
including guidelines for such use; and
(4) the use and coordination of databases that
collect or maintain information on neurological
diseases.
(j) Definition.--In this section, the term ``national
voluntary health association'' means a national nonprofit
organization with chapters, other affiliated organizations, or
networks in States throughout the United States.
(k) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $5,000,000 for
each of fiscal years 2012 through 2016.
* * * * * * *