SECTION 1. SHORT TITLE. This Act may be cited as the ``National Cancer Act of 2003''. SEC. 2. FINDINGS. Congress makes the following findings: (1) In 2003, an estimated 1,334,100 Americans will be diagnosed with some form of cancer. (2) In 2003, an estimated 556,500 Americans will die of cancer. In the United States, 1 in every 4 deaths results from cancer. (3) In 2002, the National Institutes of Health estimated the overall cost of cancer at $171,600,000,000. (4) In 2003, an estimated 211,300 American women and 1,300 men will be diagnosed with breast cancer, and 40,200 will die of the disease. A mammogram every 1-2 years can reduce the risk of dying by about 16 percent for women 40 years of age and older. (5) In 2003, an estimated 40,100 women will be newly diagnosed with cancer of the uterine corpus and 6,800 women will die of the disease. (6) In 2003, an estimated 147,500 Americans will be diagnosed with colorectal cancer and 57,100 will die of the disease. (7) Incidence rates of colorectal cancer stabilized between 1995 and 1999. Research suggests that declines may be in part due to increased screening and polyp removal. (8) The Chronic Disease Prevention Department found that screening for colorectal cancer can reduce the number of deaths by at least 30 percent. (9) Regular screening examinations by a health care professional can result in early detection of cancers of the breast, colon, rectum, prostate, testis, oral cavity, and skin. If all these cancers were diagnosed at a localized stage through regular examinations, the 5-year survival rate would increase from 82 percent to 95 percent. (10) Cancers of the lung, mouth, larynx, bladder, kidney, cervix, esophagus, and pancreas are related to tobacco use. The American Cancer Society estimates that in 2003 more than 180,000 cancer deaths will be caused by tobacco use. Smoking alone causes \1/3\ of all cancer deaths. (11) More than 1,000,000 skin cancers expected to be diagnosed in 2003 could have been prevented by protection from the sun's rays. (12) An estimated 9,000 new cases of childhood cancer are expected to occur in 2003. (13) Cancer is the chief cause of death by disease in children between the ages of 1 and 14. (14) The American Cancer Society estimates that approximately \1/3\ of the 556,500 cancer deaths expected in 2003 will be related to nutrition, physical inactivity, obesity, and other lifestyle factors that could be prevented. (15) About 77 percent of all cancers are diagnosed at age 55 and older. In order to ensure high quality cancer care for American seniors, medicare reimbursements must reflect the true cost of treatment in every treatment setting and medicare payments should accurately reflect the cost of drug and biologics as well as the cost of administering drugs and supportive care therapies. (16) Despite an aging population, death rates for the most common cancers, lung, colorectal, breast, and prostate continue to drop at an average of 1.7 percent per year. (17) In May 2001, Gleevec, the first in what is expected to be a number of cancer treatments, was approved for use by the Food and Drug Administration as it appeared to be effective in stopping the growth of deadly Chronic Myeloid Leukemia cells within 3 months of use. In 2002, Gleevec showed ability to stop growth of gastrointestinal stromal tumors. (18) In early 2003, researchers used gene chips to accurately predict whether or not breast cancer tumors would spread in the future. If the findings are validated, doctors will be able to determine which patients are likely to relapse and need chemotherapy, while sparing those with a favorable prognosis from additional treatment. (19) The Lance Armstrong Foundation, a leading national organization providing services and support for cancer survivors, defines cancer survivorship as living with, through, and beyond cancer. (20) In 2001, there were 9,600,000 cancer survivors in the United States. (21) Sixty percent of adults diagnosed with cancer survive at least 5 years. (22) While nearly every childhood cancer diagnosis 20 years ago was fatal, today more than 80 percent of children diagnosed with cancer survive at least 5 years. SEC. 3. SENSE OF THE SENATE. It is the sense of the Senate that the United States is at a point in history in which we must take the proper steps to reach the goal of making cancer survivorship the rule and cancer deaths rare by the year 2015. TITLE I--PUBLIC HEALTH PROVISIONS SEC. 101. NATIONAL PROGRAM OF CANCER REGISTRIES. Part M of title III of the Public Health Service Act (42 U.S.C. 280e et seq.) is amended by inserting after section 399B the following: ``SEC. 399B-1. ENHANCING CANCER REGISTRIES AND PREPARING FOR THE FUTURE. ``(a) Strategic Plan.--Not later than 1 year after the date of enactment of the National Cancer Act of 2003 the Secretary shall develop a plan and submit a report to Congress that outlines strategies by which the State cancer registries funded with grants under section 399B and the Surveillance, Epidemiology, and End Results program of the National Cancer Institute (in this section referred to as the `SEER program') can share information to ensure more comprehensive cancer data. The report shall include ways in which the Secretary will-- ``(1) standardize data between State cancer registries and the SEER program; ``(2) increase the portability and usability of data files from each registry for researchers and public health planners; ``(3) ensure data collection from the greatest number of health care facilities possible; ``(4) maximize the use of State registry data and data from the SEER program in State and regional public health planning processes; and ``(5) promote the use of data to-- ``(A) improve the health status of cancer survivors; and ``(B) research quality of cancer care and access to that care.''. SEC. 102. ENHANCING EXISTING SCREENING EFFORTS. (a) Grant and Contract Authority of States.--Section 1501(b)(2) of the Public Health Service Act (42 U.S.C. 300k(b)(2)) is amended to read as follows: ``(2) Certain applications.-- ``(A) Strategies for colorectal cancer screening.-- If any entity submits an application to a State to receive an award of a grant or contract pursuant to paragraph (1) that includes strategies for colorectal cancer screening and outreach, the State may give priority to the application submitted by that entity in any case in which the State determines that the quality of such application is equivalent to the quality of the application submitted by the other entities. ``(B) Women diagnosed with cancer.--If any entity submits an application to a State to receive an award of a grant or contract pursuant to paragraph (1) that includes strategies for the provision of treatment for uninsured women diagnosed with cancer discovered in the course of the screening, the State may give priority to the application submitted by that entity in any case in which the State determines that the quality of such application is equivalent to the quality of the application submitted by the other entities.''. (b) Requirements With Respect to Type and Quality of Services.-- Section 1503 of the Public Health Service Act (42 U.S.C. 300m) is amended by adding at the end the following: ``(d) Waiver of Direct Services Requirement.--The Secretary may waive the requirement under subsection (a)(1) if-- ``(1) the State involved will use the grant under this section for a demonstration project that will leverage private funds to supplement program efforts; or ``(2) such requirement would cause a barrier to the enrollment of qualifying women.''. (c) Authorization of Appropriations.--Section 1510(a) of the Public Health Service Act (42 U.S.C. 300n-5(a)) is amended by striking ``$50,000,000'' and all that follows and inserting ``such sums as may be necessary for each of fiscal years 2004 through 2008.''. (d) Report on the Comprehensive Colorectal Cancer Initiative.--Not later than 6 months after the date of enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of Congress a report containing an assessment of the success of the Comprehensive Colorectal Cancer Initiative (within the Centers for Disease Control and Prevention) in-- (1) increasing public awareness of colorectal cancer; (2) increasing awareness of screening guidelines among health care providers; (3) monitoring national colorectal cancer screening rates; (4) promoting increased patient-provider communication about colorectal cancer screening; (5) supporting quantitative and qualitative research efforts; and (6) providing funding to State programs to implement colorectal cancer priorities. SEC. 103. ENHANCED PATIENT EDUCATION. 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. 399O. ENHANCED PATIENT EDUCATION. ``(a) Grants Authorized.--The Secretary is authorized to award grants to eligible entities to implement programs to educate patients and their families about-- ``(1) the availability and options of effective medical techniques and pain management technology therapies to reduce and prevent pain and suffering for those with cancer upon diagnosis; ``(2) the unique health challenges associated with cancer survivorship, including-- ``(A) the role of followup care and monitoring to support and improve the long-term quality of life for cancer survivors; ``(B) physical activity and healthy lifestyles; and ``(C) the availability of peer and mentor support programs; and ``(3) community resources available to increase access to quality cancer care. ``(b) Application.--An eligible entity desiring a grant under this section shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. ``(c) Authorization of Appropriations.--There are authorized to be appropriated to carry out this section such sums as may be necessary.''. SEC. 104. PRACTITIONER EDUCATION PROGRAM. Section 414 of the Public Health Service Act (42 U.S.C. 285a-3) is amended by adding at the end the following: ``(d) In order to receive funding under this section, a center described under subsection (a) shall maintain a program for disseminating to patients and research participants, as well as their caregivers, the latest information about-- ``(1) pain and symptom management and palliative care; and ``(2) the unique clinical and research challenges associated with cancer survivorship. ``(e) The Secretary may provide additional amounts to fund centers under subsection (a) that develop innovative relationships with community cancer centers, community health centers, rural hospitals, and other community-based health care providers who target medically underserved populations for the purpose of increasing access to quality cancer care.''. SEC. 105. ELEVATING THE IMPORTANCE OF PAIN MANAGEMENT AND CANCER SURVIVORSHIP THROUGHOUT THE NATION'S CANCER PROGRAMS. (a) National Cancer Program.--Section 411 of the Public Health Service Act (42 U.S.C. 285a) is amended to read as follows: ``Sec. 411. The National Cancer Program shall consist of-- ``(1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including research programs for-- ``(A) pain and symptom management; ``(B) survivorship; and ``(C) the prevention of cancer caused by occupational or environmental exposure to carcinogens; and ``(2) the other programs and activities of the Institute, including research on populations with both uniquely diverse genetic variation and geographic isolation.''. (b) Cancer Control Programs.--Section 412(2) of the Public Health Service Act (42 U.S.C. 285a-1(2)) is amended-- (1) in subparagraph (A), by striking ``, and'' and inserting a semicolon; and (2) by adding at the end the following: ``(C) appropriate methods of pain and symptom management for individuals with cancer, including end- of-life care and cancer survivorship; and''. (c) Special Authorities of the Director.--Section 413(a)(2) of the Public Health Service Act (42 U.S.C. 285a-2(a)(2)) is amended-- (1) in subparagraph (D), by striking ``and'' at the end; (2) in subparagraph (E), by striking the period and inserting ``; and''; and (3) by adding at the end the following: ``(F) assess and improve pain and symptom management of cancer throughout the course of treatment and cancer survivorship.''. (d) Breast and Gynecological Cancers.--Section 417 of the Public Health Service Act (42 U.S.C. 285a-6) is amended-- (1) in subsection (c)(1)-- (A) in subparagraph (D), by striking ``and'' at the end; (B) in subparagraph (E), by striking the period and inserting ``; and''; and (C) by inserting after subparagraph (E) the following: ``(F) basic, clinical, and applied research concerning pain and symptom management and cancer survivorship.''; and (2) in subsection (d)-- (A) in paragraph (4), by striking ``and'' at the end; (B) in paragraph (5), by striking the period and inserting ``; and''; and (C) by adding at the end the following: ``(6) basic, clinical, and applied research concerning pain and symptom management and cancer survivorship.''. (e) Prostate Cancer.--Section 417A(c)(1) of the Public Health Service Act (42 U.S.C. 285a-7(c)(1)) is amended-- (1) in subparagraph (F), by striking ``and'' at the end; (2) in subparagraph (G), by striking the period and inserting ``; and''; and (3) by inserting after subparagraph (G) the following: ``(H) basic and clinical research concerning pain and symptom management and cancer survivorship.''. SEC. 106. SURVIVORSHIP RESEARCH PROGRAM. Subpart 1 of part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.) is amended by adding at the end the following: ``SEC. 417D. SURVIVORSHIP RESEARCH PROGRAM. ``(a) Establishment.--There is established, within the Institute, an Office on Cancer Survivorship (in this section referred to as the `Office'), which may be headed by an Associate Director, to implement and direct the expansion and coordination of the activities of the Institute with respect to cancer survivorship research. ``(b) Collaboration Among Agencies.--In carrying out the activities described in subsection (a), the Office shall collaborate with other institutes, centers, and offices within the National Institutes of Health that are determined appropriate by the Office. ``(c) Report.--Not later than 1 year after the date of enactment of this section, the Secretary shall prepare and submit to the appropriate committees of Congress a report providing a description of the survivorship activities of the Office and strategies for future activities.''. TITLE II--RESEARCH PROVISIONS SEC. 201. NATIONAL CANCER INSTITUTE. (a) Other Transactions Authority.--Subpart 1 of part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.), as amended by section 106, is further amended by adding at the end the following: ``SEC. 417E. OTHER TRANSACTIONS AUTHORITY. ``Notwithstanding any other provision of this subpart, the Director of the National Cancer Institute may cofund grant projects with private entities for any purpose described in this subpart.''. (b) Sense of the Senate on a Central Institutional Review Board.-- It is the sense of the Senate that-- (1) the current procedure of sending 1 clinical trial through multiple local institutional review boards may not be the most efficient method for the protection of patients enrolled in the trial and may delay the process of bringing lifesaving treatment to cancer patients; (2) the National Cancer Institute should be commended for its work in centralizing the institutional review board process; and (3) the research community should continue to streamline the institutional review board process in order to bring lifesaving treatments to patients as quickly as possible. (c) Patient and Provider Outreach Opportunities With Experimental Therapies.--For the purpose of enhancing patient access to experimental therapies, the National Cancer Institute shall conduct the following activities: (1) Integrate, to the maximum extent practicable, trials being conducted by private manufacturers into the National Cancer Institute's clinical trials online database. Such integration may require specific awareness-raising and outreach activities by the National Cancer Institute to private industry. (2) Establish an education program which provides patients and providers with-- (A) information about how to access and use the National Cancer Institute clinical trials database online; and (B) information about the Food and Drug Administration process for approving the use of drugs and biologics for a single patient.

Summary: National Cancer Act of 2003 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to develop an information-sharing plan for State cancer registries. Modifies provisions concerning preventive health measures with respect to breast and cervical cancers to permit priority to be given to certain projects involving: (1) colorectal cancer screening and outreach; and (2) treating uninsured women diagnosed with cancer during such screening. Authorizes specified waivers of the direct services requirement for breast and cervical cancer screening grants. Authorizes the Secretary to award grants to eligible entities to educate cancer patients and their families about medical techniques to reduce and prevent pain, survivorship care and support programs, and related community resources. Requires a national cancer research center to have a practitioner education program that includes pain and symptom management and survivorship care. Amends various provisions of the Act to emphasize the importance of pain and symptom management throughout the nation's cancer programs. Establishes within the National Cancer Institute (the NCI) an Office on Cancer Survivorship. Authorizes the Director of NCI to co-fund grant projects for various cancer programs. Expresses the sense of the Senate with respect to: (1) cancer survivorship; and (2) institutional review board procedures.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Tick-Borne Disease Research Accountability and Transparency Act of 2014''. SEC. 2. LYME DISEASE AND OTHER TICK-BORNE DISEASES. Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following new part: ``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES ``SEC. 399OO. RESEARCH. ``(a) In General.--The Secretary shall conduct or support epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne diseases. ``(b) Biennial Reports.--The Secretary shall ensure that each biennial report under section 403 includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to Lyme disease and other tick-borne diseases, including an assessment of the progress made in improving the outcomes of Lyme disease and such other tick-borne diseases. ``SEC. 399OO-1. WORKING GROUP. ``(a) Establishment.--The Secretary shall establish a permanent working group, to be known as the Interagency Lyme and Tick-Borne Disease Working Group (in this section and section 399OO-2 referred to as the `Working Group'), to review all efforts within the Department of Health and Human Services concerning Lyme disease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research priorities. ``(b) Responsibilities.--The Working Group shall-- ``(1) not later than 24 months after the date of enactment of this part, and every 24 months thereafter, develop or update a summary of-- ``(A) ongoing Lyme disease and other tick-borne disease research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, intervention, and access to services and supports for individuals with Lyme disease or other tick-borne diseases; ``(B) advances made pursuant to such research; ``(C) the engagement of the Department of Health and Human Services with persons that participate at the public meetings required by paragraph (5); and ``(D) the comments received by the Working Group at such public meetings and the Secretary's response to such comments; ``(2) ensure that a broad spectrum of scientific viewpoints is represented in each such summary; ``(3) monitor Federal activities with respect to Lyme disease and other tick-borne diseases; ``(4) make recommendations to the Secretary regarding any appropriate changes to such activities; and ``(5) ensure public input by holding annual public meetings that address scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms. ``(c) Membership.-- ``(1) In general.--The Working Group shall be composed of a total of 14 members as follows: ``(A) Federal members.--Seven Federal members, consisting of one or more representatives of each of-- ``(i) the Office of the Assistant Secretary for Health; ``(ii) the Food and Drug Administration; ``(iii) the Centers for Disease Control and Prevention; ``(iv) the National Institutes of Health; and ``(v) such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate. ``(B) Non-federal public members.--Seven non- Federal public members, consisting of representatives of the following categories: ``(i) Physicians and other medical providers with experience in diagnosing and treating Lyme disease and other tick-borne diseases. ``(ii) Scientists or researchers with expertise. ``(iii) Patients and their family members. ``(iv) Nonprofit organizations that advocate for patients with respect to Lyme disease and other tick-borne diseases. ``(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group. ``(2) Appointment.--The members of the Working Group shall be appointed by the Secretary, except that of the non-Federal public members under paragraph (1)(B)-- ``(A) one shall be appointed by the Speaker of the House of Representatives; and ``(B) one shall be appointed by the Majority Leader of the Senate. ``(3) Diversity of scientific perspectives.--In making appointments under paragraph (2), the Secretary, the Speaker of the House of Representatives, and the Majority Leader of the Senate shall ensure that the non-Federal public members of the Working Group represent a diversity of scientific perspectives. ``(4) Terms.--The non-Federal public members of the Working Group shall each be appointed to serve a 4-year term and may be reappointed at the end of such term. ``(d) Meetings.--The Working Group shall meet as often as necessary, as determined by the Secretary, but not less than twice each year. ``(e) Applicability of FACA.--The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act. ``(f) Reporting.--Not later than 24 months after the date of enactment of this part, and every 24 months thereafter, the Working Group-- ``(1) shall submit a report on its activities, including an up-to-date summary under subsection (b)(1) and any recommendations under subsection (b)(4), to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate; ``(2) shall make each such report publicly available on the website of the Department of Health and Human Services; and ``(3) shall allow any member of the Working Group to include in any such report minority views. ``SEC. 399OO-2. STRATEGIC PLAN. ``Not later than 3 years after the date of enactment of this section, and every 5 years thereafter, the Secretary shall submit to the Congress a strategic plan, informed by the most recent summary under section 399OO-1(b)(1), for the conduct and support of Lyme disease and tick-borne disease research, including-- ``(1) proposed budgetary requirements; ``(2) a plan for improving outcomes of Lyme disease and other tick-borne diseases, including progress related to chronic or persistent symptoms and chronic or persistent infection and co-infections; ``(3) a plan for improving diagnosis, treatment, and prevention; ``(4) appropriate benchmarks to measure progress on achieving the improvements described in paragraphs (2) and (3); and ``(5) a plan to disseminate each summary under section 399OO-1(b)(1) and other relevant information developed by the Working Group to the public, including health care providers, public health departments, and other relevant medical groups.''. SEC. 3. NO ADDITIONAL AUTHORIZATION OF APPROPRIATIONS. No additional funds are authorized to be appropriated to carry out this Act and the amendment made by this Act, and this Act and such amendment shall be carried out using amounts otherwise available for such purpose. Passed the House of Representatives September 9, 2014. Attest: KAREN L. HAAS, Clerk.

Summary: Tick-Borne Disease Research Accountability and Transparency Act of 2014 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to conduct or support epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne diseases. Directs the Secretary to establish the Interagency Lyme and Tick-Borne Disease Working Group to review all HHS efforts concerning tick-borne diseases to ensure interagency coordination and examine research priorities. Requires the Working Group to: (1) provide a summary of tick-borne disease research, advances, and scientific viewpoints every two years; (2) make recommendations to HHS regarding tick-borne disease activities; and (3) hold annual public meetings.Requires HHS to submit a strategic plan for tick-borne disease research within three years of enactment and every five years thereafter that includes: (1) budgetary requirements; (2) benchmarks for improving tick-borne disease diagnosis, treatment, outcomes, and prevention; and (3) a plan to disseminate Working Group summaries and other relevant information on tick-borne disease to health professionals and the public.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Seniors Financial Fraud Prevention Act of 2010''. SEC. 2. OFFICE FOR THE PREVENTION OF FRAUD TARGETING SENIORS. (a) Establishment of Office.--The Federal Trade Commission shall establish a separate office within the Commission for the purpose of preventing fraud targeting seniors and to assist the Commission with the following: (1) Oversight.--The office shall monitor the market for mail, telemarketing, television, and Internet fraud targeting seniors and shall coordinate with other relevant agencies regarding the requirements of this section. (2) Consumer education.--The Federal Trade Commission through the office shall, after consultation with the Attorney General, the Secretary of Health and Human Services, the Postmaster General, and the Chief Postal Inspector for the United States Postal Inspection Service-- (A) disseminate to seniors and families and caregivers of seniors general information on mail, telemarketing, television, and Internet fraud targeting seniors, including descriptions of the most common fraud schemes; (B) disseminate to seniors and families and caregivers of seniors information on means of referring complaints of fraud targeting seniors to appropriate law enforcement agencies, including the Director of the Federal Bureau of Investigation, the attorneys general of the States, and a national toll-free telephone number for reporting mail, telemarketing, television, and Internet fraud established by the Federal Trade Commission; (C) in response to a specific request about a particular entity or individual, provide publicly available information on any record of civil or criminal law enforcement action for mail, telemarketing, television, or Internet fraud against such entity; and (D) maintain a website to serve as a resource for information for seniors and families and caregivers of seniors regarding mail, telemarketing, television, and Internet fraud targeting seniors. (3) Complaints.--The Federal Trade Commission through the office shall, after consultation with the Attorney General, establish procedures to-- (A) log and acknowledge the receipt of complaints by individuals who certify that they have a reasonable belief that they have been the victim of fraud in connection with the conduct of mail, telemarketing (as that term is defined in section 2325 of title 18, United States Code), television, and Internet; (B) provide to individuals described in subparagraph (A), and to any other persons, information on mail, telemarketing, television, and Internet fraud, including-- (i) general information on mail, telemarketing, television, and Internet fraud, including descriptions of the most common mail, telemarketing, television, and Internet fraud schemes; (ii) information on means of referring complaints on mail, telemarketing, television, and Internet fraud to appropriate law enforcement agencies, including the Director of the Federal Bureau of Investigation and the Attorney General; and (iii) information, if available, on the number of complaints of mail, telemarketing, television, and Internet fraud against particular companies and any record of convictions for mail, telemarketing, television, and Internet fraud by particular companies for which a specific request has been made; and (C) refer complaints described in subparagraph (A) to appropriate entities, including State consumer protection agencies or entities and appropriate law enforcement agencies, for potential law enforcement action. (b) Commencement.--The Federal Trade Commission shall commence carrying out the requirements of this section not later than one year after the date of enactment of this Act.

Summary: Seniors Financial Fraud Prevention Act of 2010 - Establishes a separate office within the Federal Trade Commission (FTC) for the prevention of fraud targeting seniors and requires the office to assist the FTC in monitoring the market for mail, telemarketing, television, and Internet fraud which targets seniors. Requires the FTC through such office: (1) to disseminate to seniors and their families and caregivers information on mail, telemarketing, television, and Internet fraud targeting seniors, including on ways of referring complaints to appropriate law enforcement agencies; (2) in response to a request about a particular entity or individual, to provide publicly available information on any record of civil or criminal law enforcement action for such fraud; and (3) to maintain a website as a resource for such individuals on those kinds of fraud. Requires the FTC through such office to establish procedures to: (1) log and acknowledge complaints from individuals who certify that they believe they have been victims of mail, telemarketing, television, or Internet fraud; (2) provide certain information on those kinds of fraud; and (3) refer such complaints to appropriate entities, including state consumer protection agencies and entities and appropriate law enforcement agencies, for potential law enforcement action.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Hope Offered through Principled, Ethically-Sound Stem Cell Research Act'' or the ``HOPE Act''. SEC. 2. PURPOSES. It is the purpose of this Act to-- (1) intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions; and (2) promote the derivation of pluripotent stem cell lines without the creation of human embryos for research purposes or discarding, destroying, or knowingly harming a human embryo. SEC. 3. DEFINITIONS. In this Act: (1) Altered nuclear transfer.--The term ``altered nuclear transfer'' means a method for obtaining pluripotent stem cells using a modified form of somatic cell nuclear transfer to produce a biological artifact. (2) Biological artifact.--The term ``biological artifact'' means an artificially created non-embryonic cellular system, engineered to lack the essential elements of embryogenesis but still capable of some cell division and growth. (3) Direct reprogramming of adult cells.--The term ``direct reprogramming of adult cells'' means a procedure whereby differentiated, somatic cells are restored to a more undifferentiated, multipotent condition. Such process is also known as ``dedifferentiation''. (4) Embryo adoption.--The term ``embryo adoption'' means the occurrence of a woman receiving into her uterus a human embryo or embryos to which neither she nor her partner has contributed a gamete for the purpose of child bearing. (5) Embryonic stem cells.--The term ``embryonic stem cells'' means primitive cells derived from the inner cell mass of the human embryo or embryos, that have the potential to become a wide variety of specialized cell types. (6) Human embryo or embryos.--The term ``human embryo or embryos'' includes any organism, not protected as a human subject under part 46 of title 45, Code of Federal Regulations, as of the date of enactment of this section, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. (7) In vitro fertilization.--The term ``in vitro fertilization'' means the union of an egg and sperm, where the event takes place outside the body and in an artificial environment. (8) Oocyte.--The term ``oocyte'' means an unfertilized human egg cell. (9) Organismically dead embryo.--The term ``organismically dead embryo'' means the irreversible loss of the capacity of continued and integrated cellular division, growth and differentiation. (10) Pluripotent cell.--The term ``pluipotent cell'' means a cell that can produce all the cell types of the developing body. Embryonic stem cells, as well as the inner cell mass cells of the blastocyst, are pluripotent cells. (11) Pluripotent stem cells.--The term ``pluripotent stem cells'' means precursor cells that are capable both of perpetuating themselves as stem cells and of producing all or almost all the cell types of the developing body, and that have functional capacity (stable pluripotency) as an embryonic stem cell, though not necessarily the same origin. (12) Review board.--The term ``Review Board'' means the National Stem Cell Review Board established under section 5. (13) Secretary.--The term ``Secretary'' means the Secretary of Health and Human Services. (14) Stem cell line.--The term ``stem cell line'' means stem cells which have been cultured under in vitro conditions that allow proliferation without differentiation from months to years. SEC. 4. PROVISION OF FEDERAL FUNDING. (a) Basic and Applied Research.-- (1) In general.--The Secretary shall conduct and support basic and applied research to develop techniques for the isolation, derivation, production, or testing of pluripotent stem cells that have the flexibility of embryonic stem cells (whether or not they have an embryonic source), and may result in improved understanding of or treatments for diseases and other adverse health conditions, provided that such isolation, derivation, production, or testing will not involve-- (A) the creation of a human embryo or embryos for research purposes; or (B) the destruction or discarding of a human embryo or embryos, or knowingly subjecting a human embryo or embryos to risk of injury or death greater than that allowed for research on fetuses in utero under section 498(b) of this Act and section 46.204(b) of title 45, Code of Federal Regulations. (2) Inclusions.--Research under paragraph (1) may include-- (A) Methods that use-- (i) cells derived from altered nuclear transfer; or (ii) cells derived from organismically dead embryos; and (B) the investigation of evidence for pluripotent potential in adult stem cells from various sources; or (C) the direct reprogramming of adult cells, the derivation of stem cells from human germ cells, and other methods that do not harm or destroy a human embryo or embryos and that are certified by the Review Board. (b) Limitations.--If any research described in subsection (a) is determined by the Secretary to create an embryo or embryos for research purposes, or harm or destroy a human embryo or embryos, such research shall immediately be terminated until such determination is reviewed and resolved to the satisfaction of the Review Board. (c) Guidelines.--Not later than 90 days after the date of the enactment of this section, the Secretary, after consultation with the Director, shall issue final guidelines that-- (1) provide guidance concerning the next steps required for additional research, which shall include a determination of the extent to which specific techniques may require additional basic or animal research to ensure that any research involving human cells using these techniques would clearly be consistent with subsection (a); (2) prioritize research with the greatest potential for near-term clinical benefit; and (3) consistent with subsection (a), take into account techniques outlined by the President's Council on Bioethics and any other appropriate techniques and research. (d) Reporting Requirements.--Not later than January 1 of each year, the Secretary shall prepare and submit to the appropriate committees of the Congress a report describing the activities carried out under this section during the fiscal year, including a description of the research conducted under this section. (e) Rule of Construction.--Nothing in this section shall be construed as altering the policy in effect on the date of enactment of this section regarding the eligibility of stem cell lines for funding by the National Institutes of Health. SEC. 5. NATIONAL STEM CELL RESEARCH REVIEW BOARD. (a) In General.--There shall be established within the Department of Health and Human Services a board to be known as the ``National Stem Cell Research Review Board'' which shall be responsible for-- (1) monitoring research to ensure that it is in compliance with the principles of this Act; (2) prioritizing research with the greatest potential for near term benefits; (3) ensuring fair consideration of both embryonic stem cell and adult stem cell research for funding; and (4) completing their duties under this section in a timely matter to promote rather than hinder appropriate research. (b) Composition.-- (1) In general.--The Review Board shall be composed of 11 individuals, to be appointed by the Secretary. (2) Requirements.--The members appointed under paragraph (1) shall include-- (A) scientists or physicians with relevant expertise (including areas of assisted reproduction, developmental biology, and clinical medicine), including scientists that are not directly engaged in the research considered by the Board; (B) ethicists or professionals from other disciplines with a specialized ability to interpret the moral justifications and implications of the research considered by the Board; (C) members or advisors familiar with relevant national legal statutes governing the research considered by the Board; and (D) community members, unaffiliated with the institutions involved through employment or other remunerative relationships, who are objective and reasonably familiar with the views and needs of research subjects, patients and patient communities who could be benefitted or harmed by stem cell research, and community standards. (3) Terms of office.-- (A) In general.--The term of office of a member of a the Review Board appointed under paragraph (1) shall be 4 years, except that any member appointed to fill a vacancy for an unexpired term shall serve for the remainder of such term. The Secretary shall ensure that appointments are made to the Board in such a manner as to ensure that the terms of the members not all expire in the same year and that not all members' terms concur with the 4-year Presidential term. A member of the Board may serve after the expiration of such member's term until a successor has been appointed and taken office. (B) Time for appointment.--If a vacancy occurs among the members of the Review Board, the Secretary shall ensure that an appointment to fill such vacancy occurs within 90 days from the date the vacancy occurs. (c) Limitation.--The Review Board shall not be responsible for dispersing funds. The Board shall ensure that funds which are to be provided by the Federal Government are being used appropriately and under the provisions of this Act. (d) Additional Administrative Provisions.-- (1) Compensation.--Members of the Review Board who are officers or employees of the United States shall not receive any compensation for service on the Board. The remaining members of the Board shall receive, for each day (including travel time) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent to the annual rate in effect for grade GS-15 of the General Schedule. (2) Executive secretary and staff.--The Review Board may appoint an individual to serve as the Executive Secretary of the Board. The Secretary shall make available to the Board such staff, information, and other assistance as it may require to carry out its functions. SEC. 6. INFORMED CONSENT PROVISIONS. (a) Purpose.--It is the purpose of this section to ensure that individuals are empowered to make voluntary and informed decisions regarding the use of human embryo or embryos created using their biological materials or their oocytes. (b) Timing of Consent.--Consent from an individual for the donation of materials for research described in this Act shall be obtained from such individual, in writing, at the time of the proposed transfer of the donated materials from the storage site to the research team. (c) Provision of Information to Donors.--At the time that the consent described in subsection (b) is given, the donor shall be informed, verbally and in writing, that the donor retains the right to withdraw such consent until such time as the donated materials involved are actually utilized in research. SEC. 7. PRIVACY. Provisions protecting individually identifiable information under the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note) shall apply to donors under this Act. SEC. 8. PROHIBITION ON PROFITEERING FROM COMMERCE IN EMBRYOS, HUMAN OVUMS, OR EMBRYONIC STEM CELL LINES. (a) No Valuable Consideration.--Section 301 of the National Organ Transplant Act (42 U.S.C. 274e) is amended-- (1) in subsection (a), by inserting ``, human ovum, human blastocyst, human embryo, or stem cell derived from a human embryo'' after ``any human organ''; and (2) in subsection (c)(2)-- (A) by striking ``human organ'' each place the term appears and inserting ``human organ, human ovum, human blastocyst, human embryo, or stem cell derived from a human embryo''; and (B) by inserting ``, ovum, blastocyst, embryo, or stem cell'' after ``the organ''. (b) No Profits From Therapies That Destroy Human Embryos.--Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding at the end the following: ``SEC. 498D. REQUIREMENTS FOR RESEARCH INVOLVING HUMAN EMBRYOS. ``(a) Ensuring Access to Affordable Treatments.-- ``(1) In general.--It shall be unlawful for any person to knowingly receive any valuable consideration for any therapy that-- ``(A) affects interstate commerce or is funded, in full or in part, by Federal assistance; and ``(B) utilizes cells from a human embryo, if the process of deriving such cells destroyed the embryo. ``(2) Definition of valuable consideration.--In this subsection, the term `valuable consideration' does not include the reasonable production and administrative costs associated with developing a therapy described in paragraph (1).''. SEC. 9. FUNDING FOR STEM CELL RESEARCH. (a) In General.--There is authorized to be appropriated to carry out this Act, $5,000,000,000 for the period beginning with fiscal year 2008 and ending with fiscal year 2017. (b) Distribution of Funds.-- (1) In general.--Not less than 90 percent of the amount appropriated in each fiscal year under subsection (a) shall be allocated by the Secretary for the research and administrative costs described in this Act. (2) Remainder.--Not more than 10 percent of the amount appropriated in each fiscal year under subsection (a) shall be allocated by the Secretary for-- (A) the Federal promotion of human embryo or embryos adoption from in vitro fertilization clinics; (B) research towards prevention and medical treatment of genetic conditions consistent with this Act that do not involve harming or destroying human embryos in order to promote the health of the population; and (C) research to advance the understanding of clinical techniques to minimize the creation of human embryo or embryos that remain unimplanted after clinical in vitro fertilization treatments.

Summary: Hope Offered through Principled, Ethically-Sound Stem Cell Research Act or the HOPE Act - Requires the Secretary of Health and Human Services to conduct and support research to develop techniques for the isolation, derivation, production, or testing of pluripotent stem cells that have the flexibility of embryonic stem cells and that may result in improved understanding of, or treatments for, diseases and other adverse health conditions, provided that such techniques do not involve: (1) the creation of a viable human embryo for research purposes; (2) the destruction or discarding of a human embryo; or (3) knowingly subjecting a human embryo to risk of injury or death greater than that allowed on fetuses in utero. Establishes the National Stem Cell Research Review Board to: (1) monitor research to ensure that it is in compliance with this Act; (2) prioritize research with the greatest potential for near term benefits; and (3) ensure fair consideration of both embryonic and adult stem cell research for funding. Sets forth consent requirements for the donation of materials for research. Applies federal provisions protecting individually identifiable health information to donors. Amends the National Organ Transplant Act to prohibit the transfer of any human ovum, human blastocyst, human embryo, or stem cell derived from a human embryo for valuable consideration. Amends the Public Health Service Act to prohibit any person from knowingly receiving any valuable consideration for any therapy that: (1) affects interstate commerce or is funded by federal assistance; and (2) utilizes cells from a human embryo if the process of deriving such cells destroyed the embryo.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Community Health Center Volunteer Provider Protection Act of 2005''. SEC. 2. FINDINGS. Congress finds as follows: (1) As there are over 45,000,000 individuals lacking health insurance or who have inadequate health care coverage in the United States, health centers under section 330 of the Public Health Service Act (42 U.S.C. 254b), including community health centers, are increasingly called upon to provide care to the uninsured and underinsured. (2) These health centers are being challenged by increasing financial pressures that jeopardize their ability to provide access to health services for a number of large medically underserved populations, including the elderly, the uninsured, and lower-income individuals. (3) Granting volunteer physician liability coverage through the program under section 224(g) of the Public Health Service Act (relating to the provisions of title 28, United States Code, that are commonly referred to as the Federal Tort Claims Act) (42 U.S.C. 233(g)) would significantly increase the number of physicians available onsite at such health centers. Federal studies have concluded that by offering liability coverage, such centers are able to redirect funds to recruit full-time physicians and provide needed health care services to their communities. (4) In addition, an increase in volunteer physicians at the health centers will result in a direct improvement in the ability of the centers to offer quality health care services where the services are needed most. SEC. 3. HEALTH CENTERS UNDER PUBLIC HEALTH SERVICE ACT; LIABILITY PROTECTIONS FOR VOLUNTEER PRACTITIONERS. (a) In General.--Section 224 of the Public Health Service Act (42 U.S.C. 233) is amended-- (1) in subsection (g)(1)(A)-- (A) in the first sentence, by striking ``or employee'' and inserting ``employee, or (subject to subsection (k)(4)) volunteer practitioner''; and (B) in the second sentence, by inserting ``and subsection (k)(4)'' after ``subject to paragraph (5)''; and (2) in each of subsections (g), (i), (j), (k), (l), and (m), by striking ``employee, or contractor'' each place such term appears and inserting ``employee, volunteer practitioner, or contractor''. (b) Applicability; Definition.--Section 224(k) of the Public Health Service Act (42 U.S.C. 233(k)) is amended by adding at the end the following paragraph: ``(4)(A) Subsections (g) through (m) apply with respect to volunteer practitioners beginning with the first fiscal year for which an appropriations Act provides that amounts in the fund under paragraph (2) are available with respect to such practitioners. ``(B) For purposes of subsections (g) through (m), the term `volunteer practitioner' means a practitioner who, with respect to an entity described in subsection (g)(4), meets the following conditions: ``(i) The practitioner is a licensed physician or a licensed clinical psychologist. ``(ii) At the request of such entity, the practitioner provides services to patients of the entity, at a site at which the entity operates or at a site designated by the entity. The weekly number of hours of services provided to the patients by the practitioner is not a factor with respect to meeting conditions under this subparagraph. ``(iii) The practitioner does not for the provision of such services receive any compensation from such patients, from the entity, or from third-party payors (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program).''. SEC. 4. STUDY ON ADEQUACY OF FUNDING FOR COVERAGE. (a) Study.--The Comptroller General of the United States shall conduct a study concerning the adequacy of funding for liability coverage through the program under section 224(g) of the Public Health Service Act (relating to the provisions of title 28, United States Code, that are commonly referred to as the Federal Tort Claims Act) (42 U.S.C. 233(g)) for-- (1) public or nonprofit private entities receiving Federal funds for health centers under section 330 of such Act (42 U.S.C. 254b); and (2) volunteer practitioners serving such health centers. (b) Report.--Not later than 6 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to the appropriate committees of Congress a report containing findings and recommendations from the study conducted under subsection (a), including recommendations concerning the adequacy of the funding described in subsection (a).

Summary: Community Health Center Volunteer Provider Protection Act of 2005 - Amends the Public Health Service Act to deem volunteer practitioners at health centers as employees of the Public Health Service for purposes of any civil action that may arise due to providing services to patients at such health centers. Defines "volunteer practitioner" as a licensed physician who: (1) at the request of the entity, provides services to patients of a public or nonprofit entity receiving Federal funds for serving medically underserved areas; (2) provides such service at a site at which the entity operates or at a site designated by the entity; and (3) does not receive any compensation for the provision of services. Requires the Comptroller General to study the adequacy of funding for liability coverage for: (1) public or nonprofit private entities receiving federal funds for health centers; and (2) volunteer practitioners serving such centers.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Consultation and Coordination With Indian Tribal Governments Act''. SEC. 2. DEFINITIONS. For purposes of this Act: (1) Accountable consultation process.--The term ``accountable consultation process'' means a process of government-to-government dialogue between the agency and Indian tribes to ensure meaningful and timely input by tribal officials in the formulating, amending, implementing, or recinding one or more policies that have tribal implications. The process shall ensure, at a minimum, the following: (A) That tribal officials have ample opportunity to provide input and recommendations to the agencies regarding formulating, amending, implementing, or recinding policies that have tribal implications. (B) That tribal input and recommendations are fully considered by the agency before policies that have tribal implications are formulated, amended, implemented, or recinded. (C) That, upon the formulation, amendment, implementation, or recision of policies that have tribal implications, tribal officials shall be provided with written notification of the formulation, amendment, implementation, or recision of such policies and given a copy of those policies. (D) That any policies that have tribal implications shall not become effective until at least 60 days after written notification to tribal officials pursuant to subparagraph (D). (2) Agency.--The term ``agency'' means the Department of the Interior, the Indian Health Service, and the National Indian Gaming Commission. (3) Indian tribe.--The term ``Indian tribe'' means an Indian or Alaska Native tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994 (25 U.S.C. 479a). (4) Policies that have tribal implications.--The term ``policies that have tribal implications'' means any measure by the agency that has or is likely to have a direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, such as regulations, legislative comments or proposed legislation, and other policy statements or actions, guidance, clarification, standards, or sets of principles. (5) Tribal officials.--The term ``tribal officials'' means elected or duly appointed officials of Indian tribal governments, or their designees. SEC. 3. FUNDAMENTAL PRINCIPLES. When formulating, amending, implementing, or recinding one or more policies that have tribal implications, an agency shall be guided by the following fundamental principles: (1) The United States has a unique legal and political relationship with Indian tribal governments as set forth in the Constitution of the United States, treaties, statutes, Executive orders, and court decisions. The Federal Government has enacted numerous statutes and promulgated numerous regulations that establish and define a trust relationship with Indian tribes. (2) Our Nation, under the law of the United States, in accordance with treaties, statutes, Executive orders, and judicial decisions, has recognized the right of Indian tribes to self-government. Indian tribes exercise inherent sovereign powers over their members and territory. The United States continues to work with Indian tribes on a government-to- government basis to address issues concerning Indian tribal self-government, tribal trust resources, and Indian tribal treaty and other rights. (3) The United States recognizes the right of Indian tribes to self-government and supports tribal sovereignty and self- determination. SEC. 4. POLICYMAKING CRITERIA. In addition to adhering to the fundamental principles set forth in section 3, when formulating, amending, implementing, or recinding one or more policies that have tribal implications each agency shall adhere to the following criteria: (1) Each agency shall respect Indian tribal self-government and sovereignty, honor tribal treaty and other rights, and strive to meet the responsibilities that arise from the unique legal and political relationship between the Federal Government and Indian tribal governments. (2) With respect to Federal statutes and regulations administered by Indian tribal governments, each agency shall ensure Indian tribal governments the maximum administrative discretion possible. (3) Each agency shall-- (A) encourage Indian tribes to develop their own policies to achieve program objectives; (B) to the extent they do not violate other applicable laws, defer to Indian tribes to establish standards; and (C) in determining whether to establish Federal standards, consult with tribal officials as to the need for Federal standards and any alternatives that would limit the scope of Federal standards or otherwise preserve the prerogatives and authority of Indian tribes. SEC. 5. CONSULTATION. Each agency shall have an accountable consultation process. Not later than 30 days after the date of the enactment of this Act, the head of each agency shall designate an official with principal responsibility for the agency's implementation of this Act. Not later than 60 days after the date of the enactment of this Act, the designated official shall submit a description of the agency's accountable consultation process to the Committee on Natural Resources of the House of Representative and the Committee on Indian Affairs of the Senate. SEC. 6. UNFUNDED MANDATES. To the extent practicable and permitted by law, no agency shall formulate, amend, or implement any policy that has tribal implications that imposes substantial direct compliance costs on Indian tribal governments and is not required by Federal law unless-- (1) funds necessary to pay the substantial direct costs incurred by the Indian tribal government or the Indian tribe in complying with the policy are provided by the Federal Government; or (2) the agency, before the implementation of the policy-- (A) consulted through the accountable consultation process with tribal officials early in the process of developing the proposed policy; and (B) in a separately identified portion of the preamble to the policy, provided to the Committee on Natural Resources of the House of Representative, the Committee on Indian Affairs of the Senate, and affected Indian tribes a tribal summary impact statement containing-- (i) a description of the extent of the agency's prior consultation with tribal officials; (ii) a summary of the nature of the concerns of the tribal officials and the agency's position supporting the need to issue the regulation; and (iii) a statement of the extent to which the concerns of tribal officials have been met. SEC. 7. TRIBAL SELF-GOVERNMENT, TRIBAL TRUST RESOURCES, OR INDIAN TRIBAL TREATY AND OTHER RIGHTS. On issues relating to tribal self-government, tribal trust resources, or Indian tribal treaty and other rights, each agency shall explore and, where appropriate, use consensual mechanisms for developing policies, including consideration of negotiated rulemaking. SEC. 8. PREEMPTION OF TRIBAL LAW. To the extent practicable and permitted by law, no agency shall establish or implement any policy that has tribal implications and that preempts tribal law unless the agency, before the implementation of the policy-- (1) consulted through the accountable consultation process with tribal officials in development of the proposed policy; and (2) in a separately identified portion of the preamble to the policy, provided to the Committee on Natural Resources of the House of Representative, the Committee on Indian Affairs of the Senate, and affected Indian tribes a tribal summary impact statement containing-- (A) a description of the extent of the agency's prior consultation with tribal officials; (B) a summary of the nature of the concerns of the tribal officials and the agency's position supporting the need to issue the regulation; and (C) a statement of the extent to which the concerns of tribal officials have been met. SEC. 9. INCREASING FLEXIBILITY FOR INDIAN TRIBAL WAIVERS. (a) Review; Streamlining of Waiver Process.--Each agency shall review the processes under which Indian tribes apply for waivers of statutory and regulatory requirements and take appropriate steps to streamline those processes. (b) Flexible Policy Approaches.--Each agency shall, to the extent practicable and not in violation with other Federal laws, consider any application by an Indian tribe for a waiver of statutory or regulatory requirements in connection with any program administered by the agency with a general view toward increasing opportunities for using flexible policy approaches at the Indian tribal level in cases in which the proposed waiver is consistent with the applicable Federal policy objectives and is otherwise appropriate. (c) Decision on Application for Waiver.--Each agency shall, to the extent practicable and not in violation with other Federal laws, render a decision upon a complete application for a waiver not later than 120 days of receipt of such application by the agency, or as otherwise provided by Federal law or regulation. If the application for waiver is not granted, the agency shall provide the applicant with timely written notice of the decision and the reasons therefor. (d) Applicability of Section.--This section applies only to statutory or regulatory requirements that are discretionary and subject to waiver by the agency.

Summary: Consultation and Coordination with Indian Tribal Governments Act - Requires the Department of the Interior, the Indian Health Service, and the National Indian Gaming Commission, when formulating, amending, implementing, or rescinding policies that have tribal implications, to adhere to certain fundamental principles and policymaking criteria, including that the United States: (1) has a unique legal and political relationship with Indian tribal governments; (2) recognizes the right of Indian tribes to self government; and (3) shall encourage Indian tribes to develop their own policies to meet program objectives. Prohibits such entities from formulating, amending, or implementing policies that impose substantial direct compliance costs on Indian tribal governments and are not required by federal law, unless: (1) funds necessary to pay such costs are provided by the federal government; or (2) the entities consulted with tribal officials early in the process of developing the proposed policy and provided a tribal summary impact statement to specified congressional committees and affected tribes. Requires such entities to have accountable consultation processes and to explore and use consensual mechanisms for developing policies on issues relating to tribal self-government, tribal trust resources, or Indian tribal treaty and other rights. Prohibits such entities from implementing policies that have tribal implications and that preempt tribal law unless the entities: (1) consulted with tribal officials in the policy's development; and (2) provided to specified congressional committees and affected Indian tribes a tribal summary impact statement. Sets forth provisions concerning the process for Indian tribes applying for waivers from requirements.


SECTION 1. SHORT TITLE. This Act may be cited as the ``New Medications to Treat Addiction Act of 1998''. TITLE I--PHARMACOTHERAPY RESEARCH SEC. 101. REAUTHORIZATION FOR MEDICATION DEVELOPMENT PROGRAM. Section 464P(e) of the Public Health Service Act (42 U.S.C. 285o- 4(e)) is amended to read as follows: ``(e) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 1999 through 2001 of which the following amount may be appropriated from the Violent Crime Reduction Trust Fund: ``(1) $100,000,000 for fiscal year 2000; and ``(2) $100,000,000 for fiscal year 2001.''. TITLE II--PATENT PROTECTIONS FOR PHARMACOTHERAPIES SEC. 201. RECOMMENDATION FOR INVESTIGATION OF DRUGS. Section 525(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa(a)) is amended-- (1) in the first sentence, by striking ``States'' and inserting ``States, or for treatment of an addiction to illegal drugs,''; (2) in the second sentence, by striking ``States'' and inserting ``States, or for treatment of an addiction to illegal drugs''; and (3) by striking ``such disease or condition'' each place it appears and inserting ``such disease or condition, or treatment of such addiction,''. SEC. 202. DESIGNATION OF DRUGS. Section 526(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb(a)) is amended-- (1) in paragraph (1)-- (A) by inserting before the period in the first sentence the following: ``, or for treatment of an addiction to illegal drugs''; (B) in the third sentence, by striking ``rare disease or condition'' and inserting ``rare disease or condition, or for treatment of an addiction to illegal drugs,''; (C) by striking ``such disease or condition,'' and inserting ``such disease or condition, or treatment of such addiction,''; and (D) by striking ``such disease or condition.'' and inserting ``such disease or condition, or treatment of such addiction.''; and (2) in paragraph (2)-- (A) by striking ``(2) For'' and inserting ``(2)(A) For''; (B) by striking ``(A) affects'' and inserting ``(i) affects''; (C) by striking ``(B) affects'' and inserting ``(ii) affects''; and (D) by adding at the end the following: ``(B) For purposes of this subchapter, the term `treatment of an addiction to illegal drugs' means treatment by any pharmacological agent or medication that-- ``(i) reduces the craving for an illegal drug for an individual who-- ``(I) habitually uses the illegal drug in a manner that endangers the public health, safety, or welfare; or ``(II) is so addicted to the use of the illegal drug that the individual is not able to control the addiction through the exercise of self-control; ``(ii) blocks the behavioral and physiological effects of an illegal drug for an individual described in clause (i); ``(iii) safely serves as a replacement therapy for the treatment of abuse of an illegal drug for an individual described in clause (i); ``(iv) moderates or eliminates the process of withdrawal from an illegal drug for an individual described in clause (i); ``(v) blocks or reverses the toxic effect of an illegal drug on an individual described in clause (i); or ``(vi) prevents, where possible, the initiation of abuse of an illegal drug in individuals at high risk. ``(C) The term `illegal drug' means a controlled substance identified under schedules I, II, III, IV, and V in section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).''. SEC. 203. PROTECTION FOR DRUGS. Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended-- (1) in subsection (a), by striking ``rare disease or condition,'' and inserting ``rare disease or condition, or for treatment of an addiction to illegal drugs,''; (2) in subsection (b), by striking ``rare disease or condition'' and inserting ``rare disease or condition, or for treatment of an addiction to illegal drugs,''; (3) by striking ``such disease or condition'' each place it appears and inserting ``such disease or condition, or treatment of such addiction,''; and (4) in subsection (b)(1), by striking ``the disease or condition'' and inserting ``the disease, condition, or addiction''. SEC. 204. OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS. Section 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360dd) is amended-- (1) by striking ``rare disease or condition'' and inserting ``rare disease or condition, or for treatment of an addiction to illegal drugs,''; and (2) by striking ``the disease or condition'' each place it appears and inserting ``the disease, condition, or addiction''. SEC. 205. CONFORMING AMENDMENTS. (a) Subchapter Heading.--The subchapter heading of subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by striking ``Conditions'' and inserting ``Conditions, or for Treatment of an Addiction''. (b) Section Headings.--The section heading of sections 525 through 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa through 360dd) are amended by striking ``conditions'' and inserting ``conditions, or for treatment of an addiction''. (c) Fees.--Section 736(a)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)(E)) is amended-- (1) in the subparagraph heading, by striking ``orphan''; (2) by striking ``for a rare disease or condition'' each place it appears and inserting ``for a rare disease or condition, or for treatment of an addiction to illegal drugs,''; and (3) in the first sentence, by striking ``rare disease or condition.'' and inserting ``rare disease or condition, or other than for treatment of an addiction to illegal drugs, respectively.''. TITLE III--ENCOURAGING PRIVATE SECTOR DEVELOPMENT OF PHARMACOTHERAPIES SEC. 301. DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE TREATMENT OF ADDICTION TO ILLEGAL DRUGS. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``Subchapter F--Drugs for Cocaine and Heroin Addictions ``SEC. 571. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR COCAINE AND HEROIN ADDICTIONS. ``(a) In General.--Subject to subsections (b) and (c), the Secretary shall, in cooperation with the Institute of Medicine of the National Academy of Sciences, establish criteria for an acceptable drug for the treatment of an addiction to cocaine and for an acceptable drug for the treatment of an addiction to heroin. The criteria shall be used by the Secretary in making a contract, or entering into a licensing agreement, under section 572. ``(b) Requirements.--The criteria established under subsection (a) for a drug shall include requirements-- ``(1) that the application to use the drug for the treatment of addiction to cocaine or heroin was filed and approved by the Secretary under this Act after the date of enactment of this section; ``(2) that a performance based test on the drug-- ``(A) has been conducted through the use of a randomly selected test group that received the drug as a treatment and a randomly selected control group that received a placebo; and ``(B) has compared the long term differences in the addiction levels of control group participants and test group participants; ``(3) that the performance based test conducted under paragraph (2) demonstrates that the drug is effective through evidence that-- ``(A) a significant number of the participants in the test who have an addiction to cocaine or heroin are willing to take the drug for the addiction; ``(B) a significant number of the participants in the test who have an addiction to cocaine or heroin and who were provided the drug for the addiction during the test are willing to continue taking the drug as long as necessary for the treatment of the addiction; and ``(C) a significant number of the participants in the test who were provided the drug for the period of time required for the treatment of the addiction refrained from the use of cocaine or heroin, after the date of the initial administration of the drug on the participants, for a significantly longer period than the average period of refraining from such use under currently available treatments (as of the date of the application described in paragraph (1)); and ``(4) that the drug shall have a reasonable cost of production. ``(c) Review and Publication of Criteria.--The criteria established under subsection (a) shall, prior to the publication and application of such criteria, be submitted for review to the Committee on the Judiciary, and the Committee on Education and the Workplace, of the House of Representatives, and the Committee on the Judiciary, and the Committee on Labor and Human Resources, of the Senate. Not later than 90 days after notifying each of the committees, the Secretary shall publish the criteria in the Federal Register. ``SEC. 572. PURCHASE OF PATENT RIGHTS FOR DRUG DEVELOPMENT. ``(a) Application.-- ``(1) In general.--The patent owner of a drug to treat an addiction to cocaine or heroin, may submit an application to the Secretary-- ``(A) to enter into a contract with the Secretary to sell to the Secretary the patent rights of the owner relating to the drug; or ``(B) in the case in which the drug is approved under section 505 by the Secretary for more than 1 indication, to enter into an exclusive licensing agreement with the Secretary for the manufacture and distribution of the drug to treat an addiction to cocaine or heroin. ``(2) Requirements.--An application described in paragraph (1) shall be submitted at such time and in such manner, and accompanied by such information, as the Secretary may require. ``(b) Contract and Licensing Agreements.-- ``(1) Requirements.--The Secretary may enter into a contract or a licensing agreement described in subsection (a) with a patent owner who has submitted an application in accordance with subsection (a) if the drug covered under the contract or licensing agreement meets the criteria established by the Secretary under section 551(a). ``(2) Special rule.--The Secretary may, under paragraph (1), enter into-- ``(A) not more than 1 contract or exclusive licensing agreement relating to a drug for the treatment of an addiction to cocaine; and ``(B) not more than 1 contract or licensing agreement relating to a drug for the treatment of an addiction to heroin. ``(3) Coverage.--A contract or licensing agreement described in subparagraph (A) or (B) of paragraph (2) shall cover not more than 1 drug. ``(4) Purchase amount.--Subject to amounts provided in advance in appropriations Acts-- ``(A) the amount to be paid to a patent owner who has entered into a contract or licensing agreement under this subsection relating to a drug to treat an addiction to cocaine shall not exceed $100,000,000; and ``(B) the amount to be paid to a patent owner who has entered into a contract or licensing agreement under this subsection relating to a drug to treat an addiction to heroin shall not exceed $50,000,000. ``(c) Transfer of Rights Under Contracts and Licensing Agreement.-- ``(1) Contracts.--A contract under subsection (b)(1) to purchase the patent rights relating to a drug to treat cocaine or heroin addiction shall transfer to the Secretary-- ``(A) the exclusive right to make, use, or sell the patented drug within the United States for the term of the patent; ``(B) any foreign patent rights held by the patent owner with respect to the drug; ``(C) any patent rights relating to the process of manufacturing the drug; and ``(D) any trade secret or confidential business information relating to the development of the drug, process for manufacturing the drug, and therapeutic effects of the drug. ``(2) Licensing agreements.--A licensing agreement under subsection (b)(1) to purchase an exclusive license relating to manufacture and distribution of a drug to treat an addiction to cocaine or heroin shall transfer to the Secretary-- ``(A) the exclusive right to make, use, or sell the patented drug for the purpose of treating an addiction to cocaine or heroin within the United States for the term of the patent; ``(B) the right to use any patented processes relating to manufacturing the drug; and ``(C) any trade secret or confidential business information relating to the development of the drug, process for manufacturing the drug, and therapeutic effects of the drug relating to use of the drug to treat an addiction to cocaine or heroin. ``SEC. 573. PLAN FOR MANUFACTURE AND DEVELOPMENT. ``(a) In General.--Not later than 90 days after the date on which the Secretary purchases the patent rights of a patent owner, or enters into a licensing agreement with a patent owner, under section 572, relating to a drug under section 571, the Secretary shall develop a plan for the manufacture and distribution of the drug. ``(b) Plan Requirements.--The plan shall set forth-- ``(1) procedures for the Secretary to enter into licensing agreements with private entities for the manufacture and the distribution of the drug; ``(2) procedures for making the drug available to nonprofit entities and private entities to use in the treatment of a cocaine or heroin addiction; ``(3) a system to establish the sale price for the drug; and ``(4) policies and procedures with respect to the use of Federal funds by State and local governments or nonprofit entities to purchase the drug from the Secretary. ``(c) Applicability of Procurement and Licensing Laws.--Federal law relating to procurements and licensing agreements by the Federal Government shall be applicable to procurements and licenses covered under the plan described in subsection (a). ``(d) Review of Plan.-- ``(1) In general.--Upon completion of the plan under subsection (a), the Secretary shall notify the Committee on the Judiciary, and the Committee on Education and the Workplace, of the House of Representatives, and the Committee on the Judiciary, and the Committee on Labor and Human Resources, of the Senate, of the development of the plan and publish the plan in the Federal Register. The Secretary shall provide an opportunity for public comment on the plan for a period of not more than 30 days after the date of the publication of the plan in the Federal Register. ``(2) Final plan.--Not later than 60 days after the date of the expiration of the comment period described in paragraph (1), the Secretary shall publish in the Federal Register a final plan described in subsection (a). The implementation of the plan shall begin on the date of the publication of the final plan. ``(e) Construction.--The development, publication, or implementation of the plan, or any other agency action with respect to the plan, shall not be considered agency action subject to judicial review. No official or court of the United States shall have power or jurisdiction to review the decision of the Secretary on any question of law or fact relating to any agency action with respect to the plan. ``(f) Regulations.--The Secretary may promulgate regulations to carry out this section. ``SEC. 574. AUTHORIZATION OF APPROPRIATIONS. ``There is authorized to be appropriated to carry out this subchapter, such sums as may be necessary in each of the fiscal years 1999 through 2001.''.

Summary: TABLE OF CONTENTS: Title I: Pharmacotherapy Research Title II: Patent Protections for Pharmacotherapies Title III: Encouraging Private Sector Development of Pharmacotherapies New Medications to Treat Addiction Act of 1998 - Title I: Pharmacotherapy Research - Amends the Public Health Service Act to authorize appropriations as necessary to carry out provisions relating to development of medications to treat drug addiction, allowing specified sums of those amounts to be appropriated from the Violent Crime Reduction Trust Fund. Title II: Patent Protections for Pharmacotherapies - Amends the Federal Food, Drug, and Cosmetic Act to add references to drugs for the treatment of addiction to illegal drugs to provisions relating to drugs for rare diseases or conditions, allowing exclusive approval, certification, or licensure, subject to exception. Requires that the sponsor of such a treatment drug be encouraged to design open protocols. Title III: Encouraging Private Sector Development of Pharmacotherapies - Mandates establishment of criteria for an acceptable drug for the treatment of addiction to cocaine and an acceptable drug for the treatment of addiction to heroin. Allows the patent owner of a drug to treat cocaine or heroin addiction to apply to the Secretary of Health and Human Services to sell the patent rights to, or make an exclusive licensing agreement with, the Secretary. Sets the purchase amount at $100 million for the cocaine treatment drug and $50 million for the heroin treatment drug. Directs the Secretary, after the sale or licensing, to develop a manufacturing and distribution plan. Authorizes appropriations to carry out this title.


SECTION 1. SHORT TITLE. This Act may be cited as the ``Fix United States Government Contracting Deficit with China Act''. SEC. 2. FINDINGS AND STATEMENT OF POLICY. (a) Findings.--Congress finds the following: (1) The purchase of government goods and services is an important means through which the government fulfills its constitutional duties to provide for the common defense and promote the general welfare of the United States. (2) American taxpayers expect that government procurement serves the interests of all Americans. (3) The United States and several of its trading partners are signatories to the WTO Agreement on Government Procurement, which holds that signatories agree to certain restraints with regard to government procurement. (4) However, the People's Republic of China is not a signatory to the Agreement on Government Procurement, and that, accordingly, it is not a violation of that agreement for the Congress to establish procurement policies as best suit the American public interest with regard to Chinese goods. (5) China has structured its government procurement law to favor its domestic goods, as noted in article 10 of such law. (6) China has also recently announced a plan to favor so- called ``indigenous innovation'' under which the Chinese Government would expressly favor locally developed products and technologies. (7) American companies have had little or no success in accessing Chinese Government procurement contracts, while Chinese companies have had great success in selling goods for United States Government projects. (b) Statement of Policy.--Accordingly, it shall be the policy of the United States to limit the total value of Chinese goods that may be procured by the United States Government during a calendar year to not more than the total value of United States goods procured by the Chinese Government if any during the preceding calendar year. SEC. 3. CERTIFICATION; PROHIBITION AND LIMITATION ON UNITED STATES PROCUREMENT OF CHINESE GOODS. (a) Certification.--Not later than March 1 of each year beginning in 2012, the Secretary of Commerce shall submit to Congress a certification in writing that contains the following: (1) A determination of whether or not the Chinese Government has prohibited the procurement of United States goods by the Chinese Government during the preceding calendar year. (2) If the Chinese Government has not prohibited the procurement of United States goods by the Chinese Government during the preceding calendar year, an identification of the total value of United States goods procured by the Chinese Government during the preceding calendar year, as determined by the International Trade Administration under section 4. (b) Prohibition.--If the Secretary determines and certifies to Congress under subsection (a)(1) that the Chinese Government has prohibited the procurement of United States goods by the Chinese Government during the preceding calendar year, then-- (1) the head of each executive agency may not award a contract for the procurement of Chinese goods during the succeeding calendar year; and (2) the Secretary of Transportation shall prohibit a State or other entity from using funds made available from the Highway Trust Fund or the Airport and Airway Trust Fund for the award of a contract for the procurement of Chinese goods during the succeeding calendar year. (c) Limitation.-- (1) In general.--If the Secretary determines and certifies to Congress under subsection (a)(1) that the Chinese Government has not prohibited the procurement of United States goods by the Chinese Government during the preceding calendar year, then the total value of Chinese goods that may be procured by the United States Government during the succeeding calendar year may not exceed the total value of United States goods procured by the Chinese Government during the preceding calendar year, as identified under subsection (a)(2). (2) Rule of construction.--For purposes of determining the total value of Chinese goods that may be procured by the United States Government during a calendar year under paragraph (1), the total value of Chinese goods procured by a State or other entity using funds made available from the Highway Trust Fund or the Airport and Airway Trust Fund during the preceding calendar year shall be deemed to be Chinese goods procured by the United States Government. SEC. 4. ITA PROGRAM AND NOTIFICATION. (a) Program.--The International Trade Administration shall establish a program-- (1) to identify the total value of United States goods procured by the Chinese Government on an annual basis, as required under section 3(a)(2), including an accounting of the value of such procurement; and (2) to provide notification in accordance with subsection (b). (b) Notification.--The International Trade Administration shall publish notice in the Federal Register on or as soon as practicable after the date on which the total value of Chinese goods procured by the United States Government equals 50 percent, 75 percent, and 100 percent of the total value of United States goods procured by the Chinese Government during the preceding calendar year for purposes of complying with the limitation under section 3(c). SEC. 5. DEFINITIONS. In this Act: (1) Chinese good.--The term ``Chinese good'' means a good that is the growth, product, or manufacture of the People's Republic of China. A good shall be determined to be the manufacture of the People's Republic of China for purposes of this paragraph if the sum of-- (A) the cost or value of the materials produced in China, plus (B) the direct costs of processing operations performed in China, is not less than 50 percent of the appraised value of such good at the time it is entered. (2) Chinese government.--The term ``Chinese Government'' means the central government of the People's Republic of China and any other governmental entity, including-- (A) any agency or instrumentality of the Chinese Government; (B) any entity that is owned or controlled, directly or indirectly, by the Chinese Government; and (C) any Chinese provincial or local governmental entity. (3) Executive agency.--The term ``executive agency'' has the meaning given the term in section 4 of the Office of Federal Procurement Policy Act (41 U.S.C. 403). (4) Secretary.--The term ``Secretary'' means the Secretary of Commerce. (5) United states good.--The term ``United States good'' means a good that is the growth, product, or manufacture of the United States. A good shall be determined to be the manufacture of the United States for purposes of this paragraph if the sum of-- (A) the cost or value of the materials produced in the United States, plus (B) the direct costs of processing operations performed in the United States, is not less than 50 percent of the appraised value of such good at the time it is entered.

Summary: Fix United States Government Contracting Deficit with China Act - Directs the Secretary of Commerce to certify annually to Congress: (1) a determination of whether the Chinese government has prohibited its procurement of U.S. goods during the preceding calendar year; and (2) the total value of U.S. goods procured by the Chinesse government during that year, if the Chinese government has not prohibited such procurement. Prohibits the head of each executive agency from awarding a contract for the procurement of Chinese goods during the succeeding calendar year if the Chinese government has prohibited procurement of U.S. goods during the preceding calendar year. Directs the Secretary of Transportation (DOT), in such an instance, to prohibit a state or other entity from using funds made available to it from the Highway Trust Fund or the Airport and Airway Trust Fund for the award of a contract for the procurement of Chinese goods during the succeeding calendar year. Limits the total value of Chinese goods that may be procured by the U.S. government during the succeeding calendar year to the total value of U.S. goods procured by the Chinese Government during the preceding calendar year, if in fact the Chinese government has not prohibited its procurement of U.S. goods during that preceding calendar year. Directs the International Trade Administration to establish a program to: (1) identify annually the total value of U.S. goods procured by the Chinese government; and (2) provide notice in the Federal Register on or as soon as practicable after the date on which the total value of Chinese goods procured by the U.S. government equals 50%, 75%, and 100% of the total value of U.S. goods procured by the Chinese government during the preceding calendar year, for purposes of compliance with the limitation required by this Act.