[House Report 111-635] [From the U.S. Government Publishing Office] 111th Congress Report 2d Session HOUSE OF REPRESENTATIVES 111-635 ======================================================================= TO REAUTHORIZE AND ENHANCE JOHANNA'S LAW TO INCREASE PUBLIC AWARENESS AND KNOWLEDGE WITH RESPECT TO GYNECOLOGIC CANCERS _______ 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. 2941] [Including cost estimate of the Congressional Budget Office] The Committee on Energy and Commerce, to whom was referred the bill (H.R. 2941) to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers, 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.......................................... 3 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............ 4 Constitutional Authority Statement............................... 4 Earmarks and Tax and Tariff Benefit.............................. 4 Federal Advisory Committee Statement............................. 4 Applicability of Law to the Legislative Branch................... 4 Federal Mandates Statement....................................... 5 Committee Cost Estimate.......................................... 5 Congressional Budget Office Cost Estimate........................ 5 Section-by-Section Analysis of the Legislation................... 6 Explanation of Amendment......................................... 7 Changes in Existing Law Made by the Bill, as Reported............ 7 Amendment The amendment is as follows: Strike all after the enacting clause and insert the following: SECTION 1. REAUTHORIZATION AND ENHANCEMENT OF JOHANNA'S LAW. (a) In General.--Section 317P(d) of the Public Health Service Act (42 U.S.C. 247b-17(d)(4)) is amended-- (1) in paragraph (4), by inserting after ``2009'' the following: ``and $18,000,000 for the period of fiscal years 2012 through 2014''; and (2) by redesignating paragraph (4) as paragraph (6). (b) Consultation With Nonprofit Gynecologic Cancer Organizations.-- Section 317P(d) of such Act (42 U.S.C. 247b-17(d)), as amended by subsection (a), is further amended by inserting after paragraph (3) the following: ``(4) Consultation with nonprofit gynecologic cancer organizations.--In carrying out the national campaign under this subsection, the Secretary shall consult with the leading nonprofit gynecologic cancer organizations, with a mission both to conquer ovarian or other gynecologic cancer nationwide and to provide outreach to State and local governments and communities, for the purpose of determining the best practices for providing gynecologic cancer information and outreach services to varied populations.''. SEC. 2. DEMONSTRATION PROJECTS REGARDING OUTREACH AND EDUCATION STRATEGIES RELATING TO GYNECOLOGIC CANCER. (a) In General.--Section 317P(d) of the Public Health Service Act (42 U.S.C. 247b-17(d)), as amended by section 1, is further amended by inserting after paragraph (4) the following: ``(5) Demonstration projects regarding outreach and education strategies.-- ``(A) In general.--The Secretary may carry out a program to award grants or contracts to public or nonprofit private entities for the purpose of carrying out demonstration projects to test and compare different evidence-based outreach and education strategies to increase the awareness and knowledge of women and health care providers with respect to gynecologic cancers, including early warning signs, risk factors, prevention, screening, and treatment options. Such strategies shall include efforts directed at women and their families, physicians, nurses, and key health professionals. ``(B) Preferences in awarding grants or contracts.-- In making awards under subparagraph (A), the Secretary shall give preference to-- ``(i) applicants with demonstrated expertise in gynecologic cancer education or treatment or in working with groups of women who are at increased risk of gynecologic cancers; and ``(ii) applicants that, in the demonstration project funded by the grant or contract, will establish linkages between physicians, nurses, and key health professionals, health profession students, hospitals, payers, and State health departments. ``(C) Application.--To seek a grant or contract under subparagraph (A), an entity shall submit an application to the Secretary in such form, in such manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this paragraph. ``(D) Certain requirements.--In making awards under subparagraph (A), the Secretary shall-- ``(i) make awards, as practicable, to not fewer than five applicants; and ``(ii) ensure that information provided through demonstration projects under this paragraph is consistent with the best available medical information. ``(E) Report to congress.--Not later than 12 months after the date of the enactment of this paragraph, and annually thereafter, the Secretary shall submit to the Congress a report that-- ``(i) summarizes the activities of demonstration projects under subparagraph (A); ``(ii) evaluates the extent to which the projects were effective in increasing early detection of gynecologic cancers and awareness and knowledge of risk factors and early warning signs in the populations to which the projects were directed; and ``(iii) identifies barriers to early detection and appropriate treatment of such cancers.''. (b) Conforming Amendment.--Section 317P(d)(3)(A) of the Public Health Service Act (42 U.S.C. 247b-17(d)(3)(A)) is amended by inserting ``(other than paragraph (5))'' after ``this section''. Purpose and Summary H.R. 2941, a bill to reauthorize Johanna's Law, was introduced on June 18, 2009, by Rep. Rosa DeLauro (D-CT), and referred to the Committee on Energy and Commerce. The goal of H.R. 2941 is to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers. Background and Need for Legislation Gynecologic cancers--cervical, ovarian, uterine, vaginal, vulvar, and of the fallopian tube--are diagnosed in 77,000 women and kill approximately 28,000 women in the United States every year.\1\ In December 2006, Congress passed the Gynecologic Cancer Education Act of 2005, or Johanna's Law, to direct the Department of Health and Human Services (HHS) to develop a national awareness campaign about the signs, symptoms, and risks of these cancers to educate women and healthcare providers.\2\ This effort is administered through the Centers for Disease Control and Prevention (CDC). --------------------------------------------------------------------------- \1\CDC, Basic Information About Gynecologic Cancers (online at http:www.cdc.gov/cancer/gynecologic/basic_info/). \2\H.R. 1245, 109th Cong. (2005). --------------------------------------------------------------------------- Since first receiving funds for these activities in fiscal year 2008, CDC has developed a campaign called Inside Knowledge: Get the Facts About Gynecologic Cancer, which includes a Web site and factsheets, supported by focus group research to assess the effectiveness of the efforts.\3\ Additional development and dissemination of materials is ongoing.\4\ --------------------------------------------------------------------------- \3\CDC, Report to Congress Related to H.R. 1245, The Gynecologic Cancer Education and Awareness Act of 2005, or Johanna's Law (Sept. 2008). \4\Committee staff email communication with CDC (July 16, 2010). --------------------------------------------------------------------------- Committee Consideration H.R. 2941, a bill to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers, was introduced by Ms. DeLauro of Connecticut on June 18, 2009, and referred to the Committee on Energy and Commerce. The bill was subsequently referred to the Subcommittee on Health on June 19, 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. 2941 on September 16, 2010. During Subcommittee consideration an amendment in the nature of a substitute (manager's amendment) by Mr. Pallone was adopted by a voice vote. Subsequently, H.R. 2941 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. 2941 as approved by the Subcommittee. There were no amendments offered in full Committee and subsequently the Committee ordered H.R. 2941 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. Waxman ordering H.R. 2941 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 gynecological cancers kill tens of thousands of women in the United States each year. 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. 2941 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 public awareness and knowledge with respect to gynecologic cancers. 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. 2941 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. 2941 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. 2941 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. 2941. 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. 2941 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. 2941 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. 2941, a bill to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers. If you wish further details on this estimate, we will be pleased to provide them. The CBO staff contact is Lori Housman. Sincerely, Douglas W. Elmendorf. Enclosure. H.R. 2941--A bill to reauthorize and enhance Johanna's Law to increase public awareness and knowledge with respect to gynecologic cancers Summary: H.R. 2941 would reauthorize Johanna's Law, which directs the Secretary of Health and Human Services to conduct a campaign to increase the awareness and knowledge of health care providers and women with respect to gynecologic cancers. The bill also would authorize additional activities including outreach to state and local governments to determine best practices for providing information and services, and awarding grants to entities to test and compare outreach and education strategies. The bill would authorize the appropriation of $18 million for fiscal years 2012 through 2014. Based on historical spending patterns for similar activities, and assuming the appropriation of the authorized amounts, CBO estimates that implementing H.R. 2941 would cost $17 million over the 2011- 2015 period. Enacting this legislation would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. H.R. 2941 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. 2941 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 APPROPRIATIONEstimated Authorization Level....................... 0 6 6 6 0 18 Estimated Outlays................................... 0 2 5 6 4 17 ---------------------------------------------------------------------------------------------------------------- Basis of estimate: H.R. 2941 would direct the Centers for Disease Control and Prevention (CDC) to award grants to eligible entities to conduct demonstration projects to test and compare different outreach and education strategies to increase the awareness and knowledge of women and health care providers with respect to gynecologic cancers. The bill would authorize the appropriation of $18 million for fiscal years 2012 through 2014. For this estimate, CBO assumes that one-third of the authorized amount ($6 million) would be appropriated in each of those three years. The activities authorized in this act would be carried out by the CDC. Based on historical spending patterns for similar activities, CBO estimates that implementing H.R. 2941 would cost $17 million over the 2012-2015 period. Pay-as-you-go considerations: None. Intergovernmental or private-sector impact: H.R. 2941 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: Lori Housman; Impact on State, Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on the Private Sector: Sarah Axeen. Estimate approved by: Holly Harvey, Deputy Assistant Director for Budget Analysis. Section-by-Section Analysis of the Legislation Section 1. Reauthorization and enhancement of Johanna's Law Section 1 reauthorizes Johanna's Law at a total level of $18 million for the period of FY2012 through FY2014. It also requires the Secretary of HHS to consult with nonprofit gynecologic cancer organizations in determining best practices for a national public awareness campaign. Section 2. Demonstration projects regarding outreach and education strategies relating to gynecologic cancer Section 2 permits the Secretary of HHS to make grants for demonstration projects to test outreach and education strategies to inform women and healthcare providers about gynecologic cancers, and to report to Congress on the effectiveness of the projects. Explanation of Amendment During the Subcommittee on Health markup, Mr. Pallone of New Jersey offered an amendment in the nature of a substitute (manager's amendment), 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 (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 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 B--Federal-State Cooperation * * * * * * * HUMAN PAPILLOMAVIRUS (JOHANNA'S LAW) Sec. 317P. (a) * * * * * * * * * * (d) Johanna's Law.-- (1) * * * * * * * * * * (3) Full compliance.-- (A) In general.--Not later than March 1, 2008, the Secretary shall ensure that all provisions of this section (other than paragraph (5)), including activities directed to be carried out by the Centers for Disease Control and Prevention and the Food and Drug Administration, are fully implemented and being complied with. Not later than April 30, 2008, the Secretary shall submit to Congress a report that certifies compliance with the preceding sentence and that contains a description of all activities undertaken to achieve such compliance. * * * * * * * (4) Consultation with nonprofit gynecologic cancer organizations.--In carrying out the national campaign under this subsection, the Secretary shall consult with the leading nonprofit gynecologic cancer organizations, with a mission both to conquer ovarian or other gynecologic cancer nationwide and to provide outreach to State and local governments and communities, for the purpose of determining the best practices for providing gynecologic cancer information and outreach services to varied populations. (5) Demonstration projects regarding outreach and education strategies.-- (A) In general.--The Secretary may carry out a program to award grants or contracts to public or nonprofit private entities for the purpose of carrying out demonstration projects to test and compare different evidence-based outreach and education strategies to increase the awareness and knowledge of women and health care providers with respect to gynecologic cancers, including early warning signs, risk factors, prevention, screening, and treatment options. Such strategies shall include efforts directed at women and their families, physicians, nurses, and key health professionals. (B) Preferences in awarding grants or contracts.--In making awards under subparagraph (A), the Secretary shall give preference to-- (i) applicants with demonstrated expertise in gynecologic cancer education or treatment or in working with groups of women who are at increased risk of gynecologic cancers; and (ii) applicants that, in the demonstration project funded by the grant or contract, will establish linkages between physicians, nurses, and key health professionals, health profession students, hospitals, payers, and State health departments. (C) Application.--To seek a grant or contract under subparagraph (A), an entity shall submit an application to the Secretary in such form, in such manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this paragraph. (D) Certain requirements.--In making awards under subparagraph (A), the Secretary shall-- (i) make awards, as practicable, to not fewer than five applicants; and (ii) ensure that information provided through demonstration projects under this paragraph is consistent with the best available medical information. (E) Report to congress.--Not later than 12 months after the date of the enactment of this paragraph, and annually thereafter, the Secretary shall submit to the Congress a report that-- (i) summarizes the activities of demonstration projects under subparagraph (A); (ii) evaluates the extent to which the projects were effective in increasing early detection of gynecologic cancers and awareness and knowledge of risk factors and early warning signs in the populations to which the projects were directed; and (iii) identifies barriers to early detection and appropriate treatment of such cancers. [(4)](6) Authorization of appropriations.--For the purpose of carrying out this subsection, there is authorized to be appropriated $16,500,000 for the period of fiscal years 2007 through 2009 and $18,000,000 for the period of fiscal years 2012 through 2014. * * * * * * *