		II
		110th CONGRESS
		1st Session
		S. 1056
		IN THE SENATE OF THE UNITED STATES

			March 29, 2007
			Mrs. Feinstein (for
			 herself and Mr. Brownback) introduced the
			 following bill; which was read twice and referred to the
			 Committee on Health, Education, Labor,
			 and Pensions

		A BILL
		To provide for a comprehensive Federal effort relating to
		  early detection of, treatments for, and the prevention of cancer, and for other
		  purposes.

		1.Short title; table of
			 contents
			(a)Short
			 titleThis Act may be cited as the National Cancer Act of 2007.
			(b)Table of
			 contentsThe table of contents for this Act is as follows:

					Sec. 1. Short title; table of contents.
					Sec. 2. Findings.
					TITLE I—Expansion of cancer-related research, prevention,
				detection, and treatment programs
					Sec. 101. Sense of the Senate concerning investments in cancer
				research funding.
					Sec. 102. Sense of the Senate concerning investments in cancer
				research to develop targeted drugs.
					Sec. 103. Expansion of cancer-related research, prevention,
				detection, treatment, and survivorship programs.
					Sec. 104. National Institute for Environmental Health
				Sciences.
					Sec. 105. National Center on Minority Health and Health
				Disparities.
					Sec. 106. Comprehensive cancer
				control plans.
					Sec. 107. Lung cancer early
				detection demonstration project.
					Sec. 108. Colorectal cancer screening.
					Sec. 109. National program of cancer registries.
					Sec. 110. Other transactions authority.
					TITLE II—Expanding access to cancer drugs and
				treatment
					Sec. 201. Drugs to prevent cancer.
					Sec. 202. Compassionate access to investigational drugs and
				devices.
					Sec. 203. Oncology Drugs Advisory Committee.
					Sec. 204. Technical amendment.
					TITLE III—Payments for cancer-related services and
				products
					Sec. 301. Coordinating cancer care for patients.
					Sec. 302. Elimination of
				optional exclusion from medicaid prescription drug coverage for tobacco
				cessation medications.
					TITLE IV—Promoting biospecimen collection to accelerate the
				genomic mapping of the most lethal cancers
					Sec. 401. Adoption of National Cancer
				Institute guidelines for biorepositories.
					Sec. 402. MedPac report on payments for
				specimen collection.

			2.FindingsCongress makes the following
			 findings:
			(1)Cancer killed
			 6,700,000 people around the world in 2002 and this figure is expected to rise
			 to 10,100,000 in 2020.
			(2)In 2007, an
			 estimated 1,444,920 new cancer cases will be diagnosed in the United States.
			 More than 1,000,000 cases of skin cancer are also expected to be diagnosed this
			 year. Cancer accounts for one in every four deaths, and about 559,650 Americans
			 are expected to die from cancer this year. Approximately 40 percent of all
			 Americans in the United States will be diagnosed with cancer at some point in
			 their lives, 1 of every 2 men and 1 of every 3 women.
			(3)The National
			 Institutes of Health estimated the overall cost of cancer for 2006 at
			 $206,300,000,000.
			(4)Cancer can strike
			 at any age, but it remains largely a disease of aging. As the American
			 population ages, the number of cancer cases will rise. It is estimated that
			 between 2000 and 2010, the number of cancer diagnoses will increase by 20
			 percent based on this change in population dynamics and no change in cancer
			 risk. With such increases in the incidence of cancer, not only will costs
			 continue to grow, but there will be a serious shortage of individuals in the
			 workforce to provide cancer care, particularly in long-term care
			 settings.
			(5)Since 1971, when
			 the National Cancer Act was enacted, and the War on Cancer was
			 declared, the science of cancer has advanced dramatically. The revolution in
			 molecular and cellular biology and advances in technology have created
			 unprecedented opportunities for understanding cancer and the role of genetics,
			 environmental risk factors, and lifestyle factors in relation to cancer.
			(6)Since 1971,
			 mortality rates for some cancers have decreased, while such rates for other
			 cancers remain high. The United States has seen the number of cancer deaths
			 drop for 2 consecutive years, despite an older and larger population. This
			 success is largely due to reductions in smoking prevalence over the past
			 several decades, improvements in cancer screening rates, and the use of
			 increasingly effective treatment regimens.
			(7)Since 1971, the
			 United States population has become increasingly diverse and cancer affects
			 various minority, socioeconomic, and ethnic groups disproportionately. For
			 example, in 2003, the death rate from cancer among African American males was
			 35 percent higher than that among white males and for African American females,
			 it was 18 percent higher than white females.
			(8)The quality of
			 cancer care is uneven across the Nation. Many cancer patients do not receive
			 optimal care.
			(9)Cancer is the
			 chief cause of death by disease in children between the ages of 1 and 14. Each
			 year, 14,000 children and adolescents are diagnosed with cancer. However, while
			 nearly every childhood cancer diagnosis 20 years ago was fatal, today
			 approximately 80 percent of children diagnosed with cancer survive at least 5
			 years.
			(10)Survivors of
			 childhood cancer are 5 times more likely to suffer moderate to severe health
			 problems in adulthood than their healthy siblings.
			(11)Adolescents and
			 young adults diagnosed with cancer between ages 15 and 39 have seen little or
			 no improvement in cancer survival rates in decades and are the least
			 represented population in clinical trials. Survivors in this age range are at
			 risk for many long-term adverse treatments effects such as second primary
			 cancers, heart failure, hearing loss, and cognitive dysfunction.
			(12)Cancers that can
			 be prevented or detected earlier by screening account for at least half of all
			 new cancer cases. Screening can detect cancers of the breast, colon, rectum,
			 cervix, prostate, oral cavity and skin at early stages, resulting in a 5-year
			 survival rate of about 86 percent, a reflection of real reductions in mortality
			 as well as earlier diagnosis because of screening. Cancer screening rates vary
			 by cancer site, population group, and health insurance coverage.
			(13)Approximately
			 10,500,000 cancer survivors are living in the United States. These survivors
			 may experience physical, psychological, social and economic effects as a result
			 of cancer and its treatment.
			(14)About 76 percent
			 of all cancers are diagnosed at age 55 and older, and 6 of every 10 cancer
			 diagnoses are at age 65 and above. Medicare plays a critical role in providing
			 cancer care for many Americans.
			(15)Scientific
			 advances in cancer treatment since 1971 have helped shift cancer care, such as
			 the administration of chemotherapy, increasingly from inpatient to outpatient
			 settings.
			(16)Clinical trials
			 are a critical resource for the discovery of new prevention, diagnostic, and
			 treatment methods for cancer. However, only 3 to 5 percent of the nearly
			 1,400,000 adult cancer patients each year participate in cancer clinical
			 trials, contrasted with the 60 percent participation rate of children with
			 cancer.
			(17)New
			 translational research centers focused on cancer are needed to provide the
			 preclinical and early clinical trial support required to advance scientific
			 discoveries into new drugs and technologies to prevent, detect, treat, and
			 diagnose cancer.
			(18)The number of
			 medical researchers is declining, a decrease which will negatively affect the
			 prevention, detection, and treatment of cancer.
			(19)Since 1971, the
			 conduct of research has involved more collaboration between public and private
			 sectors and more multidisciplinary approaches. The biotechnology pharmaceutical
			 and device industries have grown and provided a broad array of prevention,
			 detection, and treatment approaches and scientific opportunities for cancer
			 patients, providers, and researchers.
			(20)In May 2001,
			 Gleevec, the first in what is expected to be a number of targeted cancer
			 treatments, was approved for use by the Food and Drug Administration. 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. Trials have now demonstrated that 89
			 percent of CML patients taking Gleevec are alive 5 years after
			 diagnosis.
			(21)Other targeted
			 cancer therapies, such as Avastin, Tarceva, and Herceptin are emerging as
			 promising cancer treatments.
			(22)In 2006, the
			 Food and Drug Administration approved the first vaccine to prevent the two
			 strains of Human Papillomavirus (HPV) responsible for 70 percent of cervical
			 cancer cases.
			(23)Tobacco use is
			 the leading preventable cause of disease and premature death in the United
			 States, resulting in approximately 1/3 of all cancer deaths, including 87
			 percent of lung cancer deaths. Smoking alone causes more than $167,000,000 in
			 annual health related costs.
			(24)The development
			 of molecular technology and chemopreventative agents to attack precancerous
			 cells before they develop into tumors is a promising way to reduce cancer
			 incidence and death rates.
			IExpansion of
			 cancer-related research, prevention, detection, and treatment programs
			101.Sense of the
			 Senate concerning investments in cancer research fundingIt is the sense of the Senate that—
				(1)past investments
			 in cancer research have resulted in better health, an improved quality of life,
			 and new discoveries; and
				(2)to build on, and
			 sustain, the progress made between 1998 and 2003 during which Congress doubled
			 the budget at the National Institutes of Health, the National Cancer Institute
			 requires continued Federal investment, as outlined in the National Cancer
			 Institute Directors Bypass Budget: The Nation's Investment in Cancer, to
			 achieve a balanced research portfolio and to develop more targeted, more
			 effective therapies or drugs and other cancer treatments and to address those
			 rare, deadly cancers lacking effective early detection tests or treatments for
			 a wide range of cancers, commensurable with the National Cancer Institute
			 bypass budget.
				102.Sense of the
			 Senate concerning investments in cancer research to develop targeted
			 drugs
				(a)FindingsThe
			 Senate finds that—
					(1)all cells have
			 molecular signatures, unique identifiable characteristics related to a cells’
			 function in the body;
					(2)as a normal cell
			 becomes malignant, its signature changes and this change becomes a signal of
			 the presence of cancer; and
					(3)with new
			 technologies, scientists are reading cancer-associated signatures and using
			 this information to devise treatments that target specific cells.
					(b)Sense of the
			 SenateIt is the sense of the Senate that to build on the
			 research currently conducted by the National Institutes of Health, continued
			 funding is necessary to further develop this new generation of low toxicity,
			 high efficacy agents which target only the cancer cells leaving in place the
			 healthy cells.
				103.Expansion of
			 cancer-related research, prevention, detection, treatment, and survivorship
			 programsSubpart 1 of part C
			 of title IV of the Public Health Service
			 Act (42
			 U.S.C. 285) is amended—
				(1)by inserting
			 after the subpart heading the following:

						IPurpose of
				Institute and national cancer
				programs
						;
				and
				(2)by adding at the
			 end the following:

						IIPrograms to
				prevent and treat cancer
							417E.Study and
				strategic plans
								(a)In
				generalNot later than 6 months after the date of enactment of
				the National Cancer Act of
				2007, the Institute shall prepare a progress report on the goal
				of reducing death and suffering from cancer in the next 10 years, that
				identifies unmet needs, recommends progress goals and benchmarks, recommends
				programmatic restructuring, and recommends a level of funding necessary in the
				following areas:
									(1)Understanding the
				causes of cancer.
									(2)Research
				regarding cancer prevention.
									(3)Improving early
				detection and diagnosis of cancer.
									(4)Developing
				effective and efficient cancer treatments.
									(5)Understanding the
				factors that influence patient outcomes.
									(6)Improving the
				quality of cancer care.
									(7)Research
				regarding the quality of life for cancer patients and survivors.
									(8)Overcoming cancer
				health disparities.
									(b)Detailed
				reportThe Institute shall include in future reports to Congress
				an accounting for the manner in which Congressional funding for cancer
				activities described in subsection (a) was used during the 5-fiscal year period
				preceding the date of enactment of the National Cancer Act of 2007, that includes a
				detailed description of the type of cancer and the treatment, device, tool, or
				discovery that was procured and the estimated number of individuals with cancer
				who benefitted from such activities.
								(c)PrioritiesNot
				later than 6 months after the date of enactment of the
				National Cancer Act of 2007,
				the Institute shall determine priorities based on scientific opportunities, in
				consultation with medical, scientific, patient, and provider representatives,
				and prepare 1 or more strategic plans.
								417E–1.Grants for
				development of targeted drugs
								(a)In
				generalThe Director of the Institute shall carry out a research
				grant program to provide funding to projects that seek to develop cancer
				treatments that target cancer cells.
								(b)Duties of
				DirectorIn carrying out the program under subsection (a), the
				Director of the Institute shall—
									(1)award grants and
				facilitate the process to award grants to public or nonprofit private entities
				to conduct research to develop a molecularly-oriented, knowledge-based approach
				to cancer drug discovery and development; and
									(2)not later than 6
				months after the date of enactment of the National Cancer Act of 2007, develop and
				implement a strategic plan for intensifying and expanding research conducted to
				increase the number of cancer treatments available that are low toxicity, high
				efficacy agents, and in particular, research to develop treatments that
				selectively target malignant or cancerous cells.
									(c)LimitationsAmounts
				awarded under grants under this section shall not be used for the construction
				of facilities.
								(d)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section, such sums as may be necessary for each of fiscal years 2008
				through 2011.
								417E–2.Clinical
				trials
								(a)In
				generalFor the purpose of enhancing patient access to clinical
				trials and investigational therapies for the treatment or prevention of cancer,
				the National Cancer Institute shall establish an education program that
				provides patients and providers with—
									(1)information about
				how to access and use the National Cancer Institute clinical trials database
				online;
									(2)information about
				the Food and Drug Administration process for approving the use of drugs and
				biologics for a single patient;
									(3)information
				targeted to populations of age and cultural demographics that are frequently
				underrepresented in clinical trials; and
									(4)recommendations
				regarding logistical support and sources of funding for patients support
				costs.
									(b)Information
				disseminationIn carrying out such information dissemination
				described under this section, the Director of the Institute shall regularly
				provide information to cancer care providers, professional and patient
				organizations, including community-based organizations, and patients to
				increase provider participation and patient enrollment in clinical
				trials.
								(c)Diversity
				assuranceThe Director of the Institute shall require that all
				research grant applications include assurances that the applicant will actively
				recruit a diverse patient population, including disparity populations, to
				participate in trials, when such recruitment is medically appropriate.
								(d)Sense of the
				Senate on a central institutional review boardIt 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 should continue to recommend and support
				meaningful reform of the existing Central Institutional Review Board
				Initiative; 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.
									417E–3.Cancer care
				researchers
								(a)Supply of
				cancer researchersIn order to ensure a sufficient number of
				researchers who are trained in the prevention, early detection, diagnosis,
				cure, and treatment of cancer in future fiscal years, the Director of the
				Institute, in coordination with the Secretary of Veterans Affairs and the
				National Institute of Nursing Research, shall conduct a study as described in
				section 417E–4 for the purpose of recommending activities to promote training
				and education for health care professionals and institutions supporting cancer
				research.
								(b)Loan
				repayment
									(1)In
				generalThe Director of the Institute shall establish a program
				of entering into contracts with qualified health professionals under which such
				health professionals agree to engage in cancer prevention research in
				consideration of the Federal Government agreeing to repay, for each year of
				engaging in such research, not more than $35,000 of the principal and interest
				of the educational loans of such health professionals.
									(2)Service
				provisionsThe provisions of sections 338B, 338C, and 338E shall,
				except as inconsistent with paragraph (1), apply to the program established in
				such paragraph to the same extent and in the same manner as such provisions
				apply to the National Health Service Corps Loan Repayment Program established
				in subpart III of part D of title III.
									(c)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section, such sums as may be necessary for each of fiscal years 2008
				through 2011.
								417E–4.Cancer care
				workforce
								(a)In
				general
									(1)StudyThe
				Secretary shall conduct a study on the current and future cancer care workforce
				needs in the following areas:
										(A)Cancer
				research.
										(B)Care and
				treatment of cancer patients and survivors.
										(C)Quality of life,
				symptom management, and pain management.
										(D)Early detection
				and diagnosis.
										(E)Cancer
				prevention.
										(F)Genetic testing,
				counseling, and ethical considerations related to such testing.
										(G)Diversity and
				appropriate care for disparity populations.
										(H)Palliative and
				end-of-life care.
										(2)ReportNot
				later than 1 year after the date of enactment of the
				National Cancer Act of 2007,
				the Secretary shall submit to Congress a report that describes the findings of
				the study conducted under subsection (a).
									(b)Program
									(1)EstablishmentThe
				Secretary shall issue programmatic recommendations and establish a program to
				carry out activities based on the results of the study conducted under
				subsection (a).
									(2)RecommendationsThe
				programmatic recommendations described in paragraph (1) shall—
										(A)set annual and
				long-term training goals to assure an adequate cancer care workforce;
										(B)prepare and
				implement a plan to assist to cancer healthcare professions with the most
				severe shortages, under which awards will be made under this section to
				eligible individuals to increase cancer care workforce training for individuals
				to become cancer care providers, which may include such individuals who make a
				commitment to serve in underserved communities or areas with disproportionately
				high cancer incidence or mortality and for health professions for which there
				are anticipated shortages; and
										(C)be coordinated
				with existing programs to prevent duplication.
										(c)EligibilityTo
				be eligible to receive assistance under this section, an individual shall
				submit an application to the Secretary at such time, in such manner, and
				containing such information as the Secretary reasonably requires. In such
				application, such individual shall demonstrate the intent to seek training to
				obtain a certificate, license, or postsecondary degree as the Secretary
				provides in the report under subsection (a), or in the case of licensed health
				care professionals, the intent to seek professional development to upgrade
				skills and knowledge or to obtain specialized knowledge according to criteria
				developed by the Secretary.
								(d)Use of
				fundsThe use of funds by a recipient of assistance under this
				section shall be deemed by the Secretary and reported to Congress not later
				than 1 year after the issuance of the report under subsection (a).
								(e)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section, such sums as may be necessary in each year for each of fiscal
				years 2008 through and 2011.
								417F–5.Cancer
				survivorship
								(a)In
				generalThe Secretary, acting through the Director of the
				National Cancer Institute, shall conduct a study of the unique health
				challenges associated with cancer survivorship and carry out projects and
				interventions to improve the long-term health status of cancer survivors. Such
				projects shall be carried out directly or through the awarding of grants or
				contracts.
								(b)ActivitiesActivities
				that may be carried out under subsection (a) include—
									(1)the coordination
				of a partnership between the National Cancer Institute and the Centers for
				Disease Control and Prevention to assess the unique challenges associated with
				cancer survivorship and the enhancement of cancer related surveillance systems
				to track the status of cancer survivors and determine whether cancer survivors
				are at-risk for other chronic and disabling conditions;
									(2)the development
				of a national cancer survivorship action plan, in partnership with health
				organizations focused on cancer survivorship, including further support for the
				Childhood Cancer Survivors Study, to be carried out in coordination with the
				State-based comprehensive cancer control program of the Centers for Disease
				Control and Prevention to—
										(A)develop unique
				and innovative post-treatment programs, services, and demonstrations designed
				to support and advance cancer survivorship through—
											(i)promotion of
				physical activity and healthy lifestyles;
											(ii)educational
				outreach programs for health care providers;
											(iii)support for
				innovative programs to improve the quality of life among cancer
				survivors;
											(iv)home and
				community-based interventions;
											(v)peer support and
				mentor programs;
											(vi)public awareness
				and outreach campaigns; and
											(vii)information
				dissemination to inform health care providers and cancer survivors of their
				health care options and available survivorship programs; and
											(B)develop unique
				cancer survivorship demonstration programs designed to address the needs of
				underserved populations, including minorities, children, and individuals
				residing in rural areas.
										(c)Coordination of
				activitiesThe Secretary shall ensure that activities carried out
				under this section are coordinated as appropriate with other agencies of the
				Public Health Service.
								(d)Report to
				CongressNot later than October 1, 2008, the Secretary shall
				submit to Congress a report describing the results of the study conducted under
				subsection (a), and as applicable, the strategies developed under such
				subsection.
								(e)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section, such sums as may be necessary for each of fiscal years 2008
				through 2011.
								417G–6.Monitoring
				and evaluating cancer care in cancer survivorship
								(a)In
				generalThe Secretary, acting through the Director of the
				Institute and the Director of the National Cancer Institute, shall make grants
				to eligible entities for the purpose of enabling such entities to develop,
				monitor, and evaluate information concerning quality cancer care in cancer
				survivorship.
								(b)Eligible
				entitiesAn entity shall be eligible for a grant under this
				section for a fiscal year if such entity—
									(1)operates a
				statewide cancer registry with funds from a grant made under section 399B for
				such fiscal year; or
									(2)has the
				capacities for ideal systems and the ability to link data on phases of cancer
				care that go beyond medical record data (on initial course of cancer diagnosis
				and treatment) to longer term care and to also allow for ascertaining patient’s
				needs and perspectives.
									(c)Contracting
				authorityIn carrying the purpose described in subsection (a), an
				eligible entity may expend a grant under such subsection to enter into
				contracts with academic institutions, cancer centers, and other entities, when
				determined appropriate by the Secretary.
								(d)ApplicationTo
				be eligible for a grant under subsection (a), an eligible entity shall submit
				to the Secretary an application at such time, in such manner, and containing
				such agreements, assurances, and information as the Secretary determines to be
				necessary to carry out this section.
								(e)Authority of
				Secretary regarding use of grant fundsThe Secretary shall
				determine the appropriate uses of grant funds under subsection (a) to achieve
				the purpose described in such subsection.
								(f)Authorization
				of appropriationsFor the purpose of carrying out this section,
				there are authorized to be appropriated such sums as may be necessary for each
				of fiscal years 2007 through 2011.
								417E–7.Cancer care
				guidelinesThe National Cancer
				Institute shall regularly convene cancer experts, cancer care providers,
				practicing oncologists, patients, representatives of disparity populations, and
				other relevant experts and organizations, including representatives of the
				Agency for Healthcare Research and Quality, the Health Resources
				Administration, and the Centers for Disease Control and Prevention, to
				coordinate the development and regularly update—
								(1)consensus
				protocols and guidelines for optimal cancer treatments and prevention,
				including palliation, symptom management, and end-of-life care; and
								(2)guidelines for
				providing patients with multidisciplinary consultation before treatment is
				initiated to provide overall coordination and management of cancer care among
				all providers of the patient’s treatment and services.
								417E–8.Other
				activities to improve outcomes of cancer care
								(a)In
				general
									(1)ResearchThe
				Director of the Institute, in consultation with the entities described in
				section 417E–8, shall conduct and support research and other activities to
				build an evidence base regarding effective clinical and organizational
				intervention strategies to improve the quality and outcomes of cancer care, and
				access to such care, at all stages of the health care continuum.
									(2)FactorsIn
				carrying out paragraph (1), the Director of the Institute shall take into
				account the breadth of the continuum of cancer care, from prevention and early
				detection, through diagnosis and treatment, to rehabilitation, long term
				survivorship and remission, through psychosocial, palliative, and end-of-life
				care.
									(b)Specific
				requirementsThe Director of the Institute shall—
									(1)ensure the
				targeted dissemination of the most current scientific evidence in appropriate
				formats for use by organizations representing cancer patients and their
				families, professional societies and organizations representing cancer care
				providers, and organizations through which health care and support services are
				delivered; and
									(2)develop effective
				strategies to facilitate patient communication with health care providers
				regarding such protocols and guidelines and to ensure overall coordination and
				management of cancer care by providers.
									(c)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section such sums as may be necessary for each of fiscal years 2007
				through
				2011.
								.
				104.National
			 Institute for Environmental Health Sciences
				(a)In
			 generalNot later than 6 months after the date of enactment of
			 this Act, the Director of the National Institute for Environmental Health
			 Sciences shall, in coordination with the National Cancer Institute, prepare and
			 submit to the Secretary of Health and Human Services a strategic plan that
			 identifies the unmet needs, progress goals and benchmarks, and the level of
			 funding necessary for research on environmental risk factors for cancer and
			 gene-environment interactions.
				(b)Authorization
			 of appropriationsThere is authorized to be appropriated to carry
			 out this section such sums as may be necessary.
				105.National
			 Center on Minority Health and Health DisparitiesNot later than 6 months after the date of
			 enactment of this Act, the Director of the National Cancer Institute, in
			 coordination with the National Center on Minority Health and Health
			 Disparities, shall prepare a strategic plan that identifies progress goals,
			 benchmarks, and needed resources for research on disparities in cancer
			 treatment, control, and prevention.
			106.Comprehensive
			 cancer control plansSection
			 412 of the Public Health Service Act
			 (42 U.S.C.
			 285a–1) is amended—
				(1)in the first
			 sentence, by inserting , for survivorship, after
			 treatment of cancer;
				(2)in paragraph
			 (1)(B), by striking cancer patients and all that follows and
			 inserting the following: cancer patients, families of cancer patients,
			 and cancer survivors, and; and
				(3)in paragraph (3),
			 by inserting and concerning cancer survivorship programs, after
			 control of cancer.
				107.Lung cancer
			 early detection and research demonstration projectTitle
			 XV of the Public Health Service Act (42 U.S.C. 300k et seq.) is amended by
			 adding at the end the following:

					1511.Lung cancer
				early detection and research demonstration project
						(a)In
				generalThe Secretary, acting through the Director of the Centers
				for Disease Control and Prevention, shall award not less than 10 competitive
				grants to public and non-profit private entities to enable such entities to
				establish demonstration programs pursuant to the general authority under title
				III to carry out lung cancer early detection and research activities using
				Computer Tomography (CT) scanning within a high risk population utilizing the
				comprehensive protocol that encompasses pre-diagnosis and post-diagnosis, that
				was developed under the best published clinical practices, and that was
				established by the multi-institutional, multi-disciplinary research program
				initiated in the year 1993. Such demonstration programs shall continue and
				enhance the research initiated by such protocol into all aspects of early
				detection and disease management, the incorporation of technological advances
				in imaging and the development of computer assisted diagnostic tools, and shall
				include the provision of appropriate referral and case management for the
				medical treatment of individuals screened pursuant to this section to ensure
				appropriate follow-up services for abnormal tests, diagnostic and therapeutic
				services, and treatment for detected cancers subject to the requirements of
				this section.
						(b)Requirements
							(1)In
				generalTo be eligible for a grant under this section, an entity
				shall agree to adopt the protocol as defined in subsection (a) for the
				selection of participants in the program funded under the grant, the scanning
				equipment used in such program, the personnel involved in the scanning and
				diagnoses provided under such program, the method of diagnosing used in the
				program, the scans utilized under the program, and the follow-up procedures
				used under such program.
							(2)Collection of
				imaging dataTo be eligible for a grant under this section, an
				entity shall agree to collect, transmit, and preserve imaging data as required
				under the protocol as defined in subsection (a). Prior to such collection,
				transmission, and preservation of imaging data, patient consent shall be
				obtained from participating entities as defined by subsection (a).
							(3)Relationship to
				items and services under other programsTo be eligible for a
				grant under this section, an entity shall agree that grant funds will not be
				expended to make payments for any item or service to the extent that payment
				has been made, or can reasonably be expected to be made, with respect to such
				item or service—
								(A)under any State
				compensation program, under an insurance policy, or under any Federal or State
				health benefits program; or
								(B)by an entity that
				provides health service on a prepaid basis.
								(4)Records and
				auditsTo be eligible for a grant under this section, an entity
				shall—
								(A)establish such
				fiscal control and fund accounting procedures as may be necessary to ensure
				proper disbursal of, and accounting for, amounts received under this section;
				and
								(B)provide agreed
				upon annual reports to the Secretary or the Comptroller General of the United
				States for the purposes of auditing the expenditures of the entity.
								(5)ReportsTo
				be eligible for a grant under subsection (a) an entity shall agree to submit to
				the Secretary such reports as the Secretary deems appropriate.
							(c)DefinitionIn
				this section, the term high risk population means those
				individuals over the age of 50 with a smoking history of 20 pack years or a
				family history of lung cancer, or those individuals whose occupation or
				military service exposed them to asbestos, Agent Orange and other herbicides,
				beryllium, radon, nuclear fuels or waste, or other lung cancer
				carcinogens.
						(d)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section such sums as may be necessary for each of the fiscal years
				2007 through
				2011.
						.
			108.Colorectal
			 cancer screeningTitle XV of
			 the Public Health Service Act
			 (42 U.S.C.
			 300k et seq.), as amended by section 106, is further amended by
			 adding at the end the following:

					1512.Colorectal
				cancer screening demonstration project
						(a)In
				generalThe Secretary, acting through the Director of the Centers
				for Disease Control and Prevention, shall award competitive grants to public
				and nonprofit private entities to enable such entities to establish
				demonstration programs pursuant to the general authority of title III to carry
				out colorectal screening activities including—
							(1)screening
				asymptomatic individuals for colorectal cancer as a preventive health measure
				according to scientific evidence-based screening guidelines;
							(2)providing the
				full continuum of cancer care for individuals screened pursuant to this section
				and to ensure the appropriate follow-up services for abnormal tests, diagnostic
				and therapeutic services, and treatment for detected cancers, subject to the
				requirements of subsection (c)(2);
							(3)activities to
				improve the education, training, and skills of health professionals (including
				allied health professionals) in the detection and control of colorectal
				cancer;
							(4)activities to
				evaluate the programs under this section through appropriate surveillance or
				program monitoring activities;
							(5)the development
				and dissemination of findings derived through such evaluations through public
				and professional education; and
							(6)activities to
				promote participation in the colorectal cancer screening under this
				section.
							(b)Use of certain
				standards under medicare programA grant may be awarded under
				subsection (a) only if the applicant involved agrees that—
							(1)screenings under
				subsection (a)(1) will be carried out as preventive health measures in
				accordance with evidence-based screening procedures as specified in section
				1861(pp)(1) of the Social Security Act;
							(2)an individual
				will be considered high risk for purposes of subsection (a)(1)(B)(ii) only if
				the individual is high risk within the meaning of section 1861(pp)(2) of such
				Act; and
							(3)the payment made
				from the grant for a screening procedure under subsection (a)(1) will not
				exceed the amount that would be paid under part B of title XVIII of such Act if
				payment were made under such part for furnishing the procedure to an individual
				enrolled under such part.
							(c)Requirements
							(1)PriorityTo
				be eligible for a grant under subsection (a), an entity shall agree to give
				priority with respect to activities and services under the grant to a
				low-income—
								(A)individual who is
				at least 50 years of age; or
								(B)individual at
				high risk for colorectal cancer (as defined in section 1861(pp)(2) of the
				Social Security Act) and is under 50
				years of age.
								(2)Relationship to
				items and services under other programsTo be eligible for a
				grant under subsection (a), an entity shall agree that grant funds will not be
				expended to make payments for any item or service to the extent that payment
				has been made, or can reasonably be expected to be made, with respect to such
				item or service—
								(A)under any State
				compensation program, under an insurance policy, or under any Federal or State
				health benefits program; or
								(B)by an entity that
				provides health service on a prepaid basis.
								(3)Records and
				auditsTo be eligible for a grant under subsection (a), an entity
				shall agree that the entity will—
								(A)establish such
				fiscal control and fund accounting procedures as may be necessary to ensure
				proper disbursal of, and accounting for, amounts received under this section;
				and
								(B)provide agreed
				upon annual reports to the Secretary or the Comptroller General of the United
				States for the purposes of auditing the expenditures by the entity.
								(4)ReportsTo
				be eligible for a grant under subsection (a), an entity shall agree to submit
				to the Secretary such reports as the Secretary determines appropriate.
							(d)Authorization
				of appropriationsThere is authorized to be appropriated to carry
				out this section, such sums as may be necessary for each of the fiscal years
				2007 through
				2011.
						.
			109.National
			 program of cancer registriesPart 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:

					399B–1.Enhancing
				cancer registries and preparing for the futureNot later than 1 year after the date of
				enactment of the National Cancer Act of
				2007 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.
							399B–2.National
				childhood cancer registry
						(a)In
				generalThe Director of the National Institute of Health (in this
				section referred to as the Director) shall, through the awarding
				of a grant to, or contract or cooperative agreement with, support the existing
				National Cancer Institute-designated multi-center national infrastructure for
				collaborative pediatric cancer research to support a national population-based
				childhood cancer database, the Childhood Cancer Research Network, in order
				to—
							(1)formalize the
				consent process by which pediatric cancer patients enroll on to a clinical
				trial or receive treatment within the multi-center infrastructure;
							(2)conduct
				non-therapeutic studies, monitor and evaluate the incidence, survival rate, and
				long-term health outcomes of childhood cancer patients, develop information
				concerning best practices in pediatric cancer care; and
							(3)evaluate the
				quality of pediatric cancer care, and monitor long-term pediatric cancer
				survivorship.
							(b)CoordinationThe
				Director shall carry out this section jointly through the Director of the
				Centers for Disease Control and Prevention and the Director of the National
				Cancer Institute.
						(c)Authorization
				of appropriationsThere is authorized to be appropriated, such
				sums as may be necessary to carry out this
				section.
						.
			110.Other
			 transactions authoritySection
			 402(i) of the Public Health Service Act (42 U.S.C. 282(i)) is amended by adding
			 at the end the following:

					(4)Notwithstanding any other provision of law,
				the Director of the National Cancer Institute may use amounts appropriated
				under section 417B(a) to enter into transactions (other than contracts,
				cooperative agreements, or grants) to carry out research in support of the
				development of advanced technologies leading to the expedited delivery of
				clinical products to benefit the cancer
				patient.
					.
			IIExpanding access
			 to cancer drugs and treatment
			201.Drugs to
			 prevent cancer
				(a)In
			 generalChapter 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:

						GChemoprevention
				drugs
							581.Recommendations
				for investigations of chemoprevention drugs
								(a)In
				generalThe sponsor of a chemoprevention drug in the States may
				request the Secretary to provide written recommendations for the nonclinical
				and clinical investigations which must be conducted with the drug
				before—
									(1)it may be
				approved under section 505 for the high-risk condition that the drug is
				designed to treat; or
									(2)if the drug is a
				biological product, it may be licensed under section 351 of the Public Health
				Service Act for such condition.
									If the
				Secretary has reason to believe that a drug for which a request is made under
				this section is a chemoprevention drug, the Secretary shall provide the person
				making the request written recommendations for the nonclinical and clinical
				investigations which the Secretary believes, on the basis of information
				available to the Secretary at the time of the request under this section, would
				be necessary for approval under section 505 or licensing under section 351 of
				the Public Health Service Act of such chemoprevention drug for the high-risk
				condition that such drug is designed to treat.(b)RegulationsThe
				Secretary shall by regulation promulgate procedures for the implementation of
				subsection (a).
								582.Designation of
				chemoprevention drugs
								(a)Designation
									(1)In
				generalThe manufacturer or
				the sponsor of a drug may request the Secretary to designate the drug as a
				chemoprevention drug. A request for designation of a drug shall be made before
				the submission of an application under section 505(b) for the drug or the
				submission of an application for licensing of the drug under section 351 of the
				Public Health Service Act. If the Secretary finds that a drug for which a
				request is submitted under this subsection is a chemoprevention drug that is
				being or will be investigated for a high-risk condition and—
										(A)if an application
				for such drug is approved under section 505; or
										(B)if a license for
				such drug is issued under section 351 of the Public Health Service Act,
										the
				approval or license would be for use for such high-risk condition, the
				Secretary shall designate the drug as a chemoprevention drug for such high-risk
				condition. A request for a designation of a drug under this subsection shall
				contain the consent of the applicant to notice being given by the Secretary
				under subsection (b) respecting the designation of the drug.(2)DefinitionsIn
				this subtitle:
										(A)Chemoprevention
				drugThe term chemoprevention drug means a drug
				designed to treat a high-risk condition.
										(B)High-risk
				conditionThe term high-risk condition means a
				medical condition that—
											(i)has been
				diagnosed in individuals who have not been diagnosed with cancer or who do not
				currently have progressive, life-threatening cancer; and
											(ii)unless treated,
				could develop into progressive and life-threatening cancer
											(C)DeterminationDeterminations
				under subparagraphs (A) and (B) with respect to any drug shall be made on the
				basis of the facts and circumstances as of the date the request for designation
				of the drug under this subsection is made.
										(b)Conditions of
				designationA designation of a drug under subsection (a) shall be
				subject to the condition that—
									(1)if an application
				was approved for the drug under section 505(b) or a license was issued for the
				drug under section 351 of the Public Health Service Act, the manufacturer of
				the drug will notify the Secretary of any discontinuance of the production of
				the drug at least 1 year before discontinuance; and
									(2)if an application
				has not been approved for the drug under section 505(b) or a license has not
				been issued for the drug under section 351 of the Public Health Service Act and
				if preclinical investigations or investigations under section 505(i) are being
				conducted with the drug, the manufacturer or sponsor of the drug will notify
				the Secretary of any decision to discontinue active pursuit of approval of an
				application under section 505(b) or approval of a license under section 351 of
				the Public Health Service Act.
									(c)NoticeNotice
				respecting the designation of a drug under subsection (a) shall be made
				available to the public.
								(d)RegulationsThe
				Secretary shall by regulation promulgate procedures for the implementation of
				subsection (a).
								583.Protection for
				chemoprevention drugs
								(a)In
				generalExcept as provided in
				subsection (b), if the Secretary—
									(1)approves an
				application filed pursuant to section 505(b); or
									(2)issues a license
				under section 351 of the Public Health Service Act,
									for a
				drug designated as a chemoprevention drug under section 582, the Secretary may
				not approve another application under section 505(b) or issue another license
				under section 351 of the Public Health Service Act for such drug for the
				high-risk condition that such drug is designated for a person who is not the
				holder of such approved application or of such license until the expiration 7
				years from the date of the approval of the approved application or the issuance
				of the license. Section 505(c)(2) does not apply to the refusal to approve an
				application under the preceding sentence.(b)Other
				application approvalIf an application filed pursuant to section
				505(b) is approved for a drug designated as a chemoprevention drug under
				section 582 or if a license is issued under section 351 of the Public Health
				Service Act for such a drug, the Secretary may, during the 7-year period
				beginning on the date of the application approval or of the issuance of the
				license, approve another application under section 505(b) or issue a license
				under section 351 of the Public Health Service Act, for such drug for the
				high-risk condition that such drug is designated for a person who is not the
				holder of such approved application or of such license if—
									(1)the Secretary
				finds, after providing the holder notice and opportunity for the submission of
				views, that in such period the holder of the approved application or of the
				license cannot assure the availability of sufficient quantities of the drug to
				meet the needs of persons with such high-risk condition for which the drug was
				designated; or
									(2)such holder
				provides the Secretary in writing the consent of such holder for the approval
				of other applications or the issuance of other licenses before the expiration
				of such 7-year period.
									(c)Market
				exclusivity for chemoprevention drugs designated for a high-risk
				conditionIf the Secretary designates a drug as a chemoprevention
				drug for a high-risk condition under section 582—
									(1)(A)the period referred to
				in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of
				such section, is deemed to be twelve years rather than five years, and the
				references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to
				four years, to forty-eight months, and to seven and one-half years are deemed
				to be eleven years, one hundred thirty-two months, and fourteen and one-half
				years, respectively; or
										(B)the period referred to in clauses
				(iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii)
				and (iv) of subsection (j)(5)(F) of such section, is deemed to be ten years
				rather than three years;
										(2)(A)if the drug is the
				subject of—
											(i)a listed patent for which a
				certification has been submitted under subsection (b)(2)(A)(ii) or
				(j)(2)(A)(vii)(II) of section 505; or
											(ii)a listed patent for which a
				certification has been submitted under subsections (b)(2)(A)(iii) or
				(j)(2)(A)(vii)(III) of section 505,
											the
				period during which an application may not be approved under section 505(c)(3)
				or section 505(j)(5)(B) shall be extended by a period of seven years after the
				date the patent expires (including any patent extensions); or(B)if the drug is the subject of a listed
				patent for which a certification has been submitted under subsection
				(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent
				infringement litigation resulting from the certification the court determines
				that the patent is valid and would be infringed, the period during which an
				application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
				shall be extended by a period of seven years after the date the patent expires
				(including any patent extensions); and
										(3)with respect to a
				drug that is so designated that is also subject to market exclusivity extension
				under section 505A, the extension of the periods described under paragraphs (1)
				and (2) of this subsection shall be increased by six months in accordance with
				such section 505A.
									584.Open protocols
				for investigations of chemoprevention drugsIf a drug is designated under section 582 as
				a chemoprevention drug and if notice of a claimed exemption under section
				505(i) or regulations issued thereunder is filed for such drug, the Secretary
				shall encourage the sponsor of such drug to design protocols for clinical
				investigations of the drug which may be conducted under the exemption to permit
				the addition to the investigations of persons with the high-risk condition for
				which such drug was
				designated.
							.
				(b)Grants and
			 contracts for development of chemoprevention drugs
					(1)In
			 generalThe Secretary may
			 make grants to and enter into contracts with public and private entities and
			 individuals to assist in—
						(A)defraying the costs of qualified clinical
			 testing expenses incurred in connection with the development of chemoprevention
			 drugs;
						(B)defraying the costs of developing
			 chemoprevention devices; and
						(C)defraying the costs of developing
			 chemoprevention foods.
						(2)DefinitionsFor purposes of this subsection:
						(A)Chemoprevention
			 deviceThe term chemoprevention device means a
			 device to be approved to treat a high-risk condition.
						(B)Chemoprevention
			 drugThe term chemoprevention drug means a drug
			 designed to treat a high-risk condition.
						(C)Chemoprevention
			 foodThe term chemoprevention food means a food
			 which is formulated to be consumed or administered enterally under the
			 supervision of a physician and which is intended for the specific dietary
			 management of a type of high-risk condition for which distinctive nutritional
			 requirements, based on recognized scientific principles, are established by
			 medical evaluation.
						(D)High-risk
			 condition
							(i)In
			 generalThe term high-risk condition means, with
			 respect to a chemoprevention drug, chemoprevention device, or chemoprevention
			 food, a medical condition that—
								(I)has been
			 diagnosed in individuals who have not been diagnosed with cancer or who do not
			 currently have progressive, life-threatening cancer; and
								(II)unless treated,
			 could develop into progressive and life-threatening cancer.
								(ii)DeterminationDeterminations
			 under this subparagraph with respect to any drug, device, or food shall be made
			 on the basis of the facts and circumstances as of the date the request for
			 designation of the drug or food under section 582 of the Federal Food, Drug,
			 and Cosmetic Act is made.
							(E)Qualified
			 testingThe term qualified testing means—
							(i)human clinical
			 testing—
								(I)which is carried
			 out under an exemption for a chemoprevention drug under section 505(i) of the
			 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); and
								(II)which occurs
			 after the date such drug is designated under section 582 of such Act (as added
			 by subsection (a)) and before the date on which an application with respect to
			 such drug is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) or
			 under section 351 of the Public Health Service Act (42 U.S.C. 292); and
								(ii)preclinical
			 testing involving a drug is designated under such section 582 and before the
			 date on which an application with respect to such drug is submitted under such
			 section 505(b) or under such section 351.
							(3)Authorization
			 of appropriationsThere is authorized to be appropriated to carry
			 out this section such sums as may be necessary for each of fiscal years 2008
			 through 2010.
					(c)Studies
					(1)Medical devices
			 or medical food for high risk conditionsThe Secretary of Health
			 and Human Services shall conduct a study to determine whether the application
			 of subchapter G of chapter V of the Federal Food, Drug, and Cosmetic Act (as
			 added by subsection (a)) to medical devices or medical foods for the high-risk
			 condition for which such devices or foods are designated, or to both, is needed
			 to encourage the development of such devices and foods. The Secretary shall
			 report the results of the study to the Committee on Energy and Commerce of the
			 House of Representatives and the Committee on Health, Education, Labor and
			 Pensions of the Senate not later than 1 year after the date of the enactment of
			 this Act.
					(2)Chemoprevention
			 productsThe Director of the Institute of Medicine shall conduct
			 a study to measure the quality and quantity of chemoprevention products
			 resulting from the application of subpart G of chapter V of the Federal Food,
			 Drug, and Cosmetic Act to drugs, medical devices, and medical foods for which
			 such drugs, devices, and foods are designated, or to all.
					(d)Chemoprevention
			 products boardPart A of title II of the Public Health Service
			 Act (42 U.S.C. 202 et seq.) is amended by adding at the end the
			 following:

						229.Chemoprevention
				products board
							(a)In
				generalThere is established
				in the Department of Health and Human Services a board for the development of
				chemoprevention drugs (including biologics) and devices (including diagnostic
				products), to be known as the Chemoprevention Products Board (referred to in
				this section as the Board). The Board shall be comprised of the
				Assistant Secretary for Health of the Department of Health and Human Services
				and representatives, selected by the Secretary, of the Food and Drug
				Administration, the National Institutes Health, the Centers for Disease Control
				and Prevention, and any other Federal department or agency which the Secretary
				determines has activities relating to chemoprevention drugs and devices. The
				Assistant Secretary for Health shall chair the Board.
							(b)DefinitionsIn
				this section:
								(1)Chemoprevention
				deviceThe term chemoprevention device has the
				meaning given such term in section 582 of the Federal Food, Drug, and Cosmetic
				Act.
								(2)Chemoprevention
				drugThe term chemoprevention drug has the meaning
				given such term in section 582 of the Federal Food, Drug, and Cosmetic
				Act.
								(3)High-risk
				conditionThe term high-risk condition has the
				meaning given such term in section 582 of the Federal Food, Drug, and Cosmetic
				Act.
								(c)FunctionThe
				function of the Board shall be to promote the development of chemoprevention
				drugs and devices and the coordination among Federal, other public, and private
				agencies in carrying out their respective functions relating to the development
				of such articles for such drugs to treat high-risk conditions.
							(d)DutiesIn
				the case of chemoprevention drugs, the Board shall—
								(1)evaluate—
									(A)the effect of
				subchapter G of chapter V of the Federal Food, Drug, and Cosmetic Act on the
				development of such drugs; and
									(B)the
				implementation of such subchapter; and
									(2)evaluate the
				activities of the National Institutes of Health and the Alcohol, Drug Abuse,
				and Mental Health Administration for the development of such drugs for
				high-risk conditions;
								(3)assure
				appropriate coordination among the Food and Drug Administration, the National
				Institutes of Health, the Alcohol, Drug Abuse, and Mental Health
				Administration, and the Centers for Disease Control and Prevention in the
				carrying out of their respective functions relating to the development of drugs
				for high-risk conditions to assure that the activities of each agency are
				complementary;
								(4)assure
				appropriate coordination among all interested Federal agencies, manufacturers,
				and organizations representing patients, in their activities relating to such
				drugs;
								(5)with the consent
				of the sponsor of a chemoprevention drug exempt under section 505(i) of the
				Federal Food, Drug, and Cosmetic Act or regulations issued under such section,
				inform physicians and the public respecting the availability of such drug for
				the high-risk condition for which it is designated under section 582 of such
				Act and inform physicians and the public respecting the availability of drugs
				approved under section 505(c) of such Act or licensed under section 351 of this
				Act for chemoprevention;
								(6)seek business
				entities and others to undertake the sponsorship of chemoprevention drugs, seek
				investigators to facilitate the development of such drugs, and seek business
				entities to participate in the distribution of such drugs;
								(7)reorganize and
				incentivize collaborative efforts between public and private entities and
				efforts by individuals seeking the development of chemoprevention drugs in
				developing such drugs; and
								(8)promote healthy
				competition to support the steady movement of chemoprevention products through
				the research and development process.
								(e)ConsultationThe
				Board shall consult with interested persons respecting the activities of the
				Board under this section and as part of such consultation shall provide the
				opportunity for the submission of oral views.
							(f)Annual
				report
								(1)In
				generalNot later than June 1 of each year, the Board shall
				submit to the Committee on Health, Education, Labor and Pensions of the Senate
				and the Committee on Energy and Commerce of the House of Representatives an
				annual report, that, with respect to the preceding calendar year—
									(A)identifies the
				drugs which have been designated under section 582 of the Federal Food, Drug,
				and Cosmetic Act as chemoprevention drugs;
									(B)describes the
				activities of the Board; and
									(C)contains the
				results of the evaluations carried out by the Board.
									(2)Additional
				information for inclusion in annual report
									(A)Research
				activitiesThe Director of the National Institutes of Health and
				the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration
				shall submit to the Board for inclusion in the annual report under paragraph
				(1) a report on the chemoprevention research activities of the Institutes of
				the National Institutes of Health and the Alcohol, Drug Abuse, and Mental
				Health Administration.
									(B)Effect of
				provisionsThe Secretary shall submit to the Board for inclusion
				in the annual report under paragraph (1) a report on the program of assistance
				under section __(c) of the National Cancer
				Act of 2007 for the development of chemoprevention
				drugs.
									.
				(e)Sense of the
			 Senate on chemoprevention drugsIt is the sense of the Senate that—
					(1)adequate
			 chemoprevention drugs have not been developed;
					(2)there is reason
			 to believe that promising chemoprevention drugs will not be developed unless
			 changes are made in the applicable Federal laws to reduce the costs of
			 developing such drugs and to provide incentives to develop such drugs;
			 and
					(3)it is in the
			 public interest to provide such changes and incentives for the development of
			 chemoprevention drugs.
					202.Compassionate
			 access to investigational drugs and devices
				(a)In
			 generalSection 561 of the Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 360bbb) is amended by adding at the end the following:

						(f)Oncologic
				compassionate access programActing under the existing expanded
				access program, the Secretary shall establish a new program to expand access to
				investigational treatments for individuals diagnosed with cancer who have
				exhausted all treatment options approved by Secretary for the condition or
				disease for which the patient is a reasonable candidate, and have
				unsuccessfully sought treatment, or obtained treatment that was not effective,
				with an investigational drug, biological product, or device for which such
				individual is a reasonable candidate. In carrying out this compassionate access
				program, the Secretary shall publish and broadly disseminate written guidance
				to health care providers and organizations representative of patients diagnosed
				with cancer that—
							(1)describes such
				compassionate access programs for investigational drugs, biological products,
				and devices intended to treat cancer;
							(2)facilitates the
				provision of investigational drugs and devices to seriously ill cancer patients
				without unreasonable delay by recognizing that the use of available
				investigational products for treatment is the responsibility of the physician
				and the patient; and
							(3)facilitates the
				contribution of safety and efficacy data of investigational treatments from
				participants in such compassionate access program.
							(g)Implementation
				of compassionate access programs
							(1)Training of
				personnelNot later than 90 days after the date of enactment of
				this subsection, the Secretary shall implement training programs at the Food
				and Drug Administration with respect to existing expanded access program
				established under this section.
							(2)Policies,
				regulations, and guidanceThe Secretary shall establish policies,
				regulations, and guidance designed to most directly benefit seriously ill
				cancer
				patients.
							.
				(b)Development of
			 surrogate endpoints and biomarkersThe Federal Food, Drug, and
			 Cosmetic Act is amended by inserting after section 561 (21 U.S.C. 360bbb) the
			 following:

						561A.Development
				of surrogate endpoints and biomarkersThe Secretary shall—
							(1)establish a
				program to encourage the development of surrogate endpoints and biomarkers,
				which shall include medical images, that are reasonably likely to
				predict—
								(A)clinical benefit
				for cancer-related conditions for which there exist significant unmet medical
				needs; and
								(B)individual risk
				for cancer-related conditions for which there exist unmet medical needs;
								(2)request the
				Institute of Medicine to undertake a study to identify validated surrogate
				endpoints and biomarkers, which shall include medical images, and recommend
				research to validate such surrogate endpoints and biomarkers, that may support
				approvals for products intended for the treatment of cancer;
							(3)request the
				Institute of Medicine to undertake a study to evaluate the practicality of
				expanding the use of large, community-based simple trials designed to identify
				product safety and efficacy in a larger and more representative patient
				population of individuals diagnosed with cancer prior to approving the product
				for widespread use; and
							(4)make available to
				the public a list of drugs, biological products, and devices that are being
				investigated for cancer and that are in no earlier than the Phase II stage of
				clinical
				trials.
							.
				(c)Conforming
			 amendmentSection 561(c) of the Federal Food, Drug, and Cosmetic
			 Act (21 U.S.C. 360bbb(c)) is amended by striking the heading and inserting
			 Compassionate Access to
			 Investigational Drugs and Devices for Cancer
			 Patients.—.
				203.Oncology Drugs
			 Advisory CommitteeSubchapter
			 E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et
			 seq.) is amended by adding at the end the following:

					566.Membership of
				Oncology Drugs Advisory CommitteeMembership of the Oncology Drugs Advisory
				Committee of the Food and Drug Administration shall consist of no less than 2
				patient representatives who are voting members of the
				committee.
					.
			204.Technical
			 amendmentSection 526(a)(2) of
			 the Federal Food, Drug, and Cosmetic
			 Act (21 U.S.C. 360bb(a)(2)) is
			 amended by inserting or targets and mechanisms of pathogenesis of
			 diseases after disease or condition.
			IIIPayments for
			 cancer-related services and products
			301.Coordinating
			 cancer care for patients
				(a)Cancer coverage
			 requirementsPart B of title XVIII of the
			 Social Security Act (42 U.S.C. 1395j et
			 seq.) is amended by adding at the end the following:

						1849.Cancer coverage requirements(a)In
				generalThe following
				provisions shall apply to a participating cancer care coordinator treating an
				individual who has been diagnosed with cancer and who is covered under the
				insurance program established under this part.
							(b)DefinitionsIn
				this section:
								(1)Cancer care
				coordinator
									(A)In
				generalThe term cancer care coordinator means,
				with respect to items or services provided under the coverage related to the
				treatment of cancer, a lead managing physician, nurse practitioner with an
				oncology certification (as provided by a nationally accredited organization),
				or registered nurse (as provided by a nationally accredited organization) that
				is designated at the time of cancer diagnosis by the provider, in consultation
				with the participant or beneficiary, and other providers involved to provide
				for the overall coordination and management of the cancer care of the
				individual among all providers who provide items or services to the individual,
				and who otherwise meet the requirements of this paragraph.
									(B)ResponsibilitiesA
				designee under subparagraph (A) shall be responsible for the overall
				coordination and management of the medical, nursing, and other health services
				provided to the individual during the period in which the individual is
				undergoing treatment for such cancer.
									(C)Coordination
				and management
										(i)In
				generalThe overall coordination and management under
				subparagraph (A) shall include the development of a plan of care that—
											(I)details, to the
				greatest extent practicable, all aspects of the care to be provided to the
				individual, with respect to the treatment of such cancer, including any
				curative treatment and comprehensive symptom management (such as palliative
				care) involved;
											(II)is furnished in
				written form to the individual in person within a period specified by the
				Secretary that is as soon as practicable after the date on which the individual
				is so diagnosed;
											(III)is furnished in
				a form that is appropriate for use by disparity populations, to the extent
				practicable; and
											(IV)is in accordance
				with standards determined by the Secretary to be appropriate;
											(ii)Covered
				individualWith respect to an individual for whom the plan of
				care has been developed under clause (i), such plan shall be revised as
				necessary to account for any substantial change in the condition of the
				individual, if such revision—
											(I)is in accordance
				with subclauses (I) and (III) of such clause; and
											(II)is furnished in
				written form to the individual within a period specified by the Secretary that
				is as soon as practicable after the date of such revision.
											(iii)Follow-up
				planWith respect to an individual who has completed the primary
				treatment for cancer, as defined by the Secretary (such as completion of
				chemotherapy or radiation treatment), the development of a follow-up cancer
				care plan that—
											(I)describes the
				elements of the primary treatment, including symptom management, furnished to
				such individual;
											(II)provides
				recommendations for the subsequent care of the individual with respect to the
				cancer involved;
											(III)is furnished in
				written form to the individual in person within a period specified by the
				Secretary that is as soon as practicable after the completion of such primary
				treatment;
											(IV)is furnished in
				a form that is appropriate for use by disparity populations to the extent
				practicable; and
											(V)is in accordance
				with standards determined by the Secretary to be appropriate.
											(iv)Revisions to
				follow up planWith respect to an individual for whom a follow-up
				cancer care plan has been developed under clause (iii), the revision of such
				plan as necessary to account for any substantial change in the condition of the
				individual, if such revision—
											(I)is in accordance
				with subclauses (I), (II), and (IV) of such clause; and
											(II)is furnished in
				written form to the individual within a period specified by the Secretary that
				is as soon as practicable after the date of such revision.
											(D)StandardsThe
				Secretary shall establish standards to carry out this paragraph in consultation
				with appropriate organizations that represent providers of services related to
				cancer treatment and organizations representing survivors of cancer. Such
				standards shall include standards for determining the need and frequency for
				revisions of the plans of care and follow-up plans based on changes in the
				condition of the individual and standards for the communication of the plan to
				the patient.
									(2)IndividualThe
				term individual means a person who has been diagnosed with cancer
				and who is covered under the insurance program established under this
				part.
								.
				(b)Additional
			 paymentSection 1833(m) of the Social Security Act (42 U.S.C.
			 1395 l(m)) is amended by adding at the end the following new paragraph:

						(5)In the case of
				physician or nursing services furnished to an individual under this section who
				receives care for such cancer, there shall be paid to the cancer care
				coordinator of that individual during the period in which that individual is
				undergoing treatment for such cancer from the Federal Supplementary Medical
				Insurance Trust Fund, a separate and additional payment amount for the services
				under this part in addition to any amount otherwise paid under this
				part.
						.
				302.Elimination of
			 Optional Exclusion From Medicaid Prescription Drug Coverage for Tobacco
			 Cessation Medications
				(a)In
			 generalSection 1927(d)(2) of
			 the Social Security Act (42 U.S.C.
			 1396r–8(d)(2)) is amended—
					(1)by striking
			 subparagraph (E);
					(2)by redesignating
			 subparagraphs (F) through (K) as subparagraphs (E) through (J), respectively;
			 and
					(3)in subparagraph
			 (F) (as redesignated by paragraph (2)), by inserting before the period at the
			 end the following: , other than agents approved by the Food and Drug
			 Administration for purposes of promoting, and when used to promote, tobacco
			 cessation.
					(b)Effective
			 DateThe amendments made by subsection (a) shall apply to
			 services furnished on or after the date of enactment of this Act.
				IVPromoting
			 biospecimen collection to accelerate the genomic mapping of the most lethal
			 cancers
			401.Adoption of
			 National Cancer Institute guidelines for biorepositories
				(a)In
			 generalA biorepository may adopt the First-Generation Guidelines
			 for NCI-Supported Biospecimen Resources, published by the National Cancer
			 Institute of the National Institutes of Health on November 21, 2006 (or any
			 successor guidelines), for the collection of biospecimens and any accompanying
			 data.
				(b)DefinitionsFor
			 purposes of this section:
					(1)BiorepositoryThe
			 term biorepository means a collection of biological materials
			 (which may include tissues, biomolecules, body fluids, and medical imaging)
			 derived from patients, stored under specifically-defined conditions, and
			 accessed for the purpose of scientific research or patient care.
					(2)BiospecimenThe
			 term biospecimen means any material or medical images of material
			 that is biologically-derived, such as blood, tissue, and urine, and used for
			 diagnosis and analysis.
					402.MedPAC report
			 on payments for specimen collection
				(a)In
			 generalNot later than 1 year after the date of enactment of this
			 Act, the Medicare Payment Assessment Commission shall submit to Congress a
			 report (in this section referred to as the report) on approaches
			 to developing a payment system within Medicare for the collection and storage
			 of cancer and related tissues for use in research involving the application of
			 genomic or proteomic technologies.
				(b)Report
			 details
					(1)In
			 generalThe report shall include recommendations on the
			 following:
						(A)Potential billing
			 code systems for the collection, storage, and pathological definition of cancer
			 and related tissues.
						(B)Potential payment
			 systems for the collection, storage, and pathological definition of cancer and
			 related tissues.
						(C)The feasibility
			 of expanding the recommended payment system to cover tissue collection,
			 storage, and pathological definition for research on conditions unrelated to
			 cancer.
						(2)Payment
			 systemsProposed payment systems referred to in paragraph (1)(B)
			 shall consider the following factors:
						(A)Numbers and types
			 of cancer tissues collected for the purpose of research involving the
			 application of genomic or proteomic technologies.
						(B)Professional time
			 required for pathologists, surgeons, other experts to collect these tissues for
			 post-genomics research.
						(C)Specific
			 annotation of collected tissue required beyond normal diagnostic needs
			 currently in practice.
						(D)Numbers of
			 tissues collected on government sponsored clinical trials and method of
			 coverage for the collection of these tissues.
						(E)The cost of
			 maintenance of such highly annotated resources.
						(F)The cost of
			 overseeing the standards needed to ensure that the tissues collected for
			 molecular oncology research, including the certification and oversight by a
			 qualified professional body.


115 HR 1788 IH: Recognizing Mayaguez Veterans Act
U.S. House of Representatives
2017-03-29
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I115th CONGRESS1st SessionH. R. 1788IN THE HOUSE OF REPRESENTATIVESMarch 29, 2017Mr. Meadows (for himself and Ms. Gabbard) introduced the following bill; which was referred to the Committee on Armed ServicesA BILLTo extend the Vietnam Service Medal to veterans of the Armed Forces who participated in the S.S. Mayaguez rescue operation.
1.Short titleThis Act may be cited as the Recognizing Mayaguez Veterans Act. 2.Award of Vietnam Service Medal to veterans who participated in Mayaguez rescue operation (a)Award authorizedThe Secretary of the military department concerned shall, upon the application by or on behalf of an individual who is an eligible veteran, award that individual the Vietnam Service Medal, notwithstanding any otherwise applicable requirements for the award of that medal. Any such award shall be made in lieu of any Armed Forces Expeditionary Medal awarded the individual for the individual’s participation in the Mayaguez rescue operation.
(b)Treatment of deceased veteransIn the case of a veteran who is deceased, the application described in subsection (a) may be submitted by the next of kin of the veteran. (c)Eligible veteranFor purposes of this section, the term eligible veteran means a veteran of the Armed Forces—
(1)who was awarded the Armed Forces Expeditionary Medal for participation in military operations known as the Mayaguez rescue operation of May 12–15, 1975; or (2)who participated in such operation.