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[From the U.S. Government Publishing Office]


111th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     111-631
======================================================================
 
             SCLERODERMA RESEARCH AND AWARENESS 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. 2408]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2408) to expand the research and awareness 
activities of the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases and the Centers for Disease 
Control and Prevention with respect to scleroderma, and for 
other purposes, 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..............................................     2
Background and Need for Legislation..............................     2
Committee Consideration..........................................     2
Committee Votes..................................................     3
Committee Oversight Findings and Recommendations.................     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Statement of General Performance Goals and Objectives............     3
Constitutional Authority Statement...............................     3
Earmarks and Tax and Tariff Benefits.............................     3
Federal Advisory Committee Statement.............................     4
Applicability of Law to the Legislative Branch...................     4
Federal Mandates Statement.......................................     4
Committee Cost Estimate..........................................     4
Congressional Budget Office Cost Estimate........................     4
Section-by-Section Analysis of the Legislation...................     5
Explanation of Amendments........................................     6
Changes in Existing Law Made by the Bill, as Reported............     6

                               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 ``Scleroderma Research and Awareness Act 
of 2010''.

SEC. 2. NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN 
                    DISEASES; SCLERODERMA RESEARCH EXPANSION.

  Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et 
seq.) is amended by adding at the end the following:

``SEC. 409K. SCLERODERMA RESEARCH.

  ``The Director of NIH may expand, intensify, and coordinate the 
activities of the National Institutes of Health with respect to 
scleroderma, with particular emphasis on the following:
          ``(1) Research focused on the etiology of scleroderma and the 
        development of new treatment options.
          ``(2) Clinical research to evaluate new treatments options.
          ``(3) Basic research on the relationship between scleroderma 
        and secondary conditions such as pulmonary hypertension, 
        gastroparesis, Raynaud's phenomenon, Sjogren's Syndrome, and 
        other diseases as determined by the Director.''.

SEC. 3. PROMOTING PUBLIC AWARENESS OF SCLERODERMA.

  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. PROMOTING PUBLIC AWARENESS OF SCLERODERMA.

  ``The Secretary may carry out an educational campaign to increase 
public awareness of scleroderma. Print, video, and Web-based materials 
distributed through this campaign may include--
          ``(1) basic information on scleroderma and its symptoms; and
          ``(2) information on--
                  ``(A) the incidence and prevalence of scleroderma;
                  ``(B) diseases and conditions affiliated with 
                scleroderma; or
                  ``(C) the importance of early diagnosis and treatment 
                of scleroderma.''.

                          Purpose and Summary

    H.R. 2408, the ``Scleroderma Research and Awareness Act of 
2010'', was introduced by Rep. Lois Capps (D-CA) on May 14, 
2010, and referred to the Committee on Energy and Commerce.
    The goal of H.R. 2408 is to address the need for research 
on scleroderma, a chronic systemic autoimmune disease.

                  Background and Need for Legislation

    Scleroderma is a chronic connective tissue disease that can 
involve changes in the skin, blood vessels, muscles, and 
internal organs. An estimated 300,000 people in the United 
States have scleroderma. The exact cause or causes of 
scleroderma are still unknown and there is no cure, 
necessitating more research into and awareness of this disease.

                        Committee Consideration

    H.R. 2408, the ``Scleroderma Research and Awareness Act of 
2010'', was introduced by Mrs. Capps of California on May 14, 
2010, and referred to the Committee on Energy and Commerce. The 
bill was subsequently referred to the Subcommittee on Health on 
May 15, 2010. On September 15, 2010, the Subcommittee held a 
legislative hearing on the bill. The Subcommittee met in open 
markup session to consider H.R. 2408 on September 16, 2010. An 
amendment in the nature of a substitute (manager's amendment) 
by Mrs. Capps of California was adopted by a voice vote. 
Subsequently, H.R. 2408 was favorably 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. 2408 as approved 
by the Subcommittee on Health. There were no amendments offered 
in full Committee and subsequently the Committee ordered H.R. 
2408 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. 2408 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 there is a need for 
increased research on and awareness of scleroderma.

   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. 2408 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 increasing 
research on and awareness of scleroderma.

                   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. 2408 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. 2408 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. 2408 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. 2408.

                        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. 2408 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. 2408 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. 2408, the 
Scleroderma Research and Awareness Act of 2010.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Jamease 
Kowalczyk and Stephanie Cameron.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 2408--Scleroderma Research and Awareness Act of 2010

    Summary: H.R. 2408 would encourage the Director of the 
National Institutes of Health (NIH) to expand, intensify, and 
coordinate scleroderma research activities. It also would 
authorize the Secretary of Health and Human Services (HHS) to 
conduct an educational campaign to increase public awareness of 
scleroderma. CBO estimates that implementing H.R. 2408 would 
cost $12 million over the 2011-2015 period, assuming 
appropriation of the necessary amounts. Enacting H.R. 2408 
would not affect direct spending or revenues; therefore, pay-
as-you-go procedures do not apply.
    H.R. 2408 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. 2408 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

Estimated Authorization Level.......................         3         5         4         0         0        12
Estimated Outlays...................................         1         3         4         3         1        12
----------------------------------------------------------------------------------------------------------------

    Basis of estimate: For this estimate, CBO assumes that H.R. 
2408 will be enacted near the beginning of fiscal year 2011 and 
that the necessary amounts will be appropriated each year. The 
bill would encourage the Director of NIH to expand, intensify, 
and coordinate scleroderma-related activities with a focus on 
the etiology and development of new treatments for scleroderma, 
clinical research for new treatment options, and basic research 
on the relationship between scleroderma and secondary 
conditions. Currently, those activities are underway at NIH, so 
implementing those provisions would have no budgetary effect.
    H.R. 2408 also would authorize the Secretary of HHS to 
conduct an educational campaign through print, video, and Web-
based materials to increase public awareness of scleroderma. 
Based on spending by the Centers for Disease Control and 
Prevention for similar activities, CBO estimates that 
implementing H.R. 2408 would cost $1 million in 2011 and $12 
million over the 2011-2015 period.
    Pay-As-You-Go considerations: None.
    Intergovernmental and private-sector impact: H.R. 2408 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Estimate prepared by: Federal costs: Stephanie Cameron and 
Jamease Kowalczyk; 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 Act may be cited as the 
``Scleroderma Research and Awareness Act of 2010''.

Section 2. National Institute of Arthritis and Musculoskeletal and Skin 
        Diseases; Scleroderma research expansion

    Section 2 amends the Public Health Services Act (PHSA) to 
authorize the Director of the National Institutes of Health 
(NIH) to expand, intensify, and coordinate the activities of 
NIH with respect to scleroderma.

Section 3. Promoting public awareness of scleroderma

    Section 3 amends the PHSA to authorize the Secretary of 
Health and Human Services to carry out an educational campaign 
to increase public awareness of scleroderma.

                        Explanation of Amendment

    During the Subcommittee on Health markup of H.R. 2408, Mrs. 
Capps of California offered an amendment in the nature of a 
substitute (manager), 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 italics 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. PROMOTING PUBLIC AWARENESS OF SCLERODERMA.

  The Secretary may carry out an educational campaign to 
increase public awareness of scleroderma. Print, video, and 
Web-based materials distributed through this campaign may 
include--
          (1) basic information on scleroderma and its 
        symptoms; and
          (2) information on--
                  (A) the incidence and prevalence of 
                scleroderma;
                  (B) diseases and conditions affiliated with 
                scleroderma; or
                  (C) the importance of early diagnosis and 
                treatment of scleroderma.

           *       *       *       *       *       *       *


TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *


Part B--General Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


SEC. 409K. SCLERODERMA RESEARCH.

  The Director of NIH may expand, intensify, and coordinate the 
activities of the National Institutes of Health with respect to 
scleroderma, with particular emphasis on the following:
          (1) Research focused on the etiology of scleroderma 
        and the development of new treatment options.
          (2) Clinical research to evaluate new treatments 
        options.
          (3) Basic research on the relationship between 
        scleroderma and secondary conditions such as pulmonary 
        hypertension, gastroparesis, Raynaud's phenomenon, 
        Sjogren's Syndrome, and other diseases as determined by 
        the Director.

           *       *       *       *       *       *       *