42 USC CHAPTER 6A, SUBCHAPTER III, Part C, subpart 1: national cancer institute

From Title 42—THE PUBLIC HEALTH AND WELFARECHAPTER 6A—PUBLIC HEALTH SERVICESUBCHAPTER III—NATIONAL RESEARCH INSTITUTESPart C—Specific Provisions Respecting National Research Institutes

subpart 1—national cancer institute

§285. Purpose of Institute

The general purpose of the National Cancer Institute (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

(July 1, 1944, ch. 373, title IV, §410, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 832; amended Pub. L. 100–607, title I, §121, Nov. 4, 1988, 102 Stat. 3054.)

Editorial Notes

Amendments

1988—Pub. L. 100–607 inserted ", rehabilitation from cancer," after "treatment of cancer".

Executive Documents

White House Cancer Moonshot Task Force

Memorandum of President of the United States, Jan. 28, 2016, 81 F.R. 5361, provided:

Memorandum for the Heads of Executive Departments and Agencies

Cancer is a leading cause of death, and cancer incidence is expected to increase worldwide in the coming decades. But today, cancer research is on the cusp of major breakthroughs. It is of critical national importance that we accelerate progress towards prevention, treatment, and a cure—to double the rate of progress in the fight against cancer—and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more. To that end, I hereby direct the following:

Section 1. White House Cancer Moonshot Task Force. There is established, within the Office of the Vice President, a White House Cancer Moonshot Task Force (Task Force), which will focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care. The Vice President shall serve as Chair of the Task Force.

(a) Membership of the Task Force. In addition to the Vice President, the Task Force shall consist of the heads of the executive branch departments, agencies, and offices listed below:

(i) the Department of Defense;

(ii) the Department of Commerce;

(iii) the Department of Health and Human Services;

(iv) the Department of Energy;

(v) the Department of Veterans Affairs;

(vi) the Office of Management and Budget;

(vii) the National Economic Council;

(viii) the Domestic Policy Council;

(ix) the Office of Science and Technology Policy;

(x) the Food and Drug Administration;

(xi) the National Cancer Institute (NCI);

(xii) the National Institutes of Health (NIH);

(xiii) the National Science Foundation; and

(xiv) such other executive branch departments, agencies, or offices as the President may designate.

A member of the Task Force may designate, to perform the Task Force functions of the member, any person who is a part of the member's department, agency, or office, and who is a full time officer or employee of the Federal Government. At the direction of the Chair, the Task Force may establish subgroups consisting exclusively of Task Force members or their designees under this section, as appropriate.

(b) Administration of the Task Force. The NIH shall provide funding and administrative support for the Task Force to the extent permitted by law and within existing appropriations. The Vice President shall designate an officer or employee of the executive branch as the Executive Director of the Task Force, who shall coordinate the work of the Task Force.

Sec. 2. Mission and Functions of the Task Force. The Task Force shall work with a wide array of executive departments and agencies that have responsibility for key issues related to basic, translational, and clinical research, therapy development, regulation of medical products, and medical care related to cancer. Consistent with applicable law, the Task Force also will consult with external experts from relevant scientific sectors, including the Presidentially appointed National Cancer Advisory Board (NCAB). The NCAB shall advise the Director of NCI on its recommendations respecting the future direction and program and policy emphasis of NCI as it relates to the work of the Task Force. To assist the NCAB in providing this advice, the NCAB is strongly encouraged to establish a working group consisting of a Blue Ribbon Panel of scientific experts. The Director shall relay the advice of the NCAB to the Task Force, as appropriate. The functions of the Task Force are advisory only and shall include, but shall not be limited to, producing a detailed set of findings and recommendations to:

(a) accelerate our understanding of cancer, and its prevention, early detection, treatment, and cure;

(b) improve patient access and care;

(d) encourage development of cancer treatments;

(e) identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms;

(f) ensure optimal investment of Federal resources; and

(g) identify opportunities to develop public-private partnerships and increase coordination of the Federal Government's efforts with the private sector, as appropriate.

Sec. 3. Outreach. Consistent with the objectives set out in section 2 of this memorandum, the Task Force, in accordance with applicable law, in addition to regular meetings, shall conduct outreach with representatives of the cancer patient community, academia, business, nonprofit organizations, State and local government agencies, the research community, and other interested persons that will assist with the Task Force's development of a detailed set of recommendations.

Sec. 4. Transparency and Reports. The Task Force shall facilitate the posting on the Internet of reports and engage in an open, reciprocal dialogue with the American people. The Task Force shall present to the President a report before December 31, 2016, on its findings and recommendations, which shall be made available to the public and posted on the Internet.

Sec. 5. General Provisions. (a) The heads of executive departments and agencies shall assist and provide information to the Task Force, consistent with applicable law, as may be necessary to carry out the functions of the Task Force. Each executive department and agency shall bear its own expense for participating in the Task Force.

(b) Nothing in this memorandum shall be construed to impair or otherwise affect:

(i) authority granted by law to an executive department, agency, or the head thereof; or

(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(c) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(d) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Sec. 6. Publication. The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.

§285a. National Cancer Program

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 an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute.

(July 1, 1944, ch. 373, title IV, §411, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 832.)

§285a–1. Cancer control programs

The Director of the Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include—

(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting—

(A) the detection, diagnosis, prevention, and treatment of cancer,

(B) the continuing care of cancer patients and the families of cancer patients, and

to physicians and other health professionals who provide care to individuals who have cancer;

(2) the demonstration of and the education of students of the health professions and health professionals in—

(A) effective methods for the prevention and early detection of cancer and the identification of individuals with a high risk of developing cancer, and

(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and

(3) the demonstration of new methods for the dissemination of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer.

(July 1, 1944, ch. 373, title IV, §412, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 832.)

§285a–2. Special authorities of Director

(a) Information and education program

(1) The Director of the Institute shall establish an information and education program to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to cancer patients and their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The Director of the Institute may take such action as may be necessary to insure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the public and between the Institute and other scientific, medical, and biomedical disciplines and organizations nationally and internationally.

(2) In carrying out paragraph (1), the Director of the Institute shall—

(A) provide public and patient information and education programs, providing information that will help individuals take personal steps to reduce their risk of cancer, to make them aware of early detection techniques and to motivate appropriate utilization of those techniques, to help individuals deal with cancer if it strikes, and to provide information to improve long-term survival;

(B) continue and expand programs to provide physicians and the public with state-of-the-art information on the treatment of particular forms of cancers, and to identify those clinical trials that might benefit patients while advancing knowledge of cancer treatment;

(C) assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessments in the biennial reports required under section 284b ¹ of this title;

(D) maintain and operate the International Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as feasible the results of cancer research and treatment undertaken in any country for the use of any person involved in cancer research and treatment in any country; and

(E) to the extent practicable, in disseminating the results of such cancer research and treatment, utilize information systems available to the public.

(b) National Cancer Program

The Director of the Institute in carrying out the National Cancer Program—

(1) shall establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances for cancer research and set standards of safety and care for persons using such materials;

(2) shall, in consultation with the advisory council for the Institute, support (A) research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people, (B) collaborative research involving American and foreign participants, and (C) the training of American scientists abroad and foreign scientists in the United States;

(3) shall, in consultation with the advisory council for the Institute, support appropriate programs of education and training (including continuing education and laboratory and clinical research training);

(4) shall encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research;

(5) may obtain (after consultation with the advisory council for the Institute and in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of service) the services of not more than one hundred and fifty-one experts or consultants who have scientific or professional qualifications;

(6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve, repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal property as the Director determines necessary;

(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and

(C) may, in consultation with the advisory council for the Institute, acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years;

(7) may, in consultation with the advisory council for the Institute, appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments to advise the Director with respect to the Director's functions;

(8) may, subject to section 284(b)(2) of this title and without regard to section 3324 of title 31 and section 6101 of title 41, enter into such contracts, leases, cooperative agreements, as may be necessary in the conduct of functions of the Director, with any public agency, or with any person, firm, association, corporation, or educational institution; and

(9) shall, notwithstanding section 284(a) of this title, prepare and submit, directly to the President for review and transmittal to Congress, an annual budget estimate (including an estimate of the number and type of personnel needs for the Institute) for the National Cancer Program, after reasonable opportunity for comment (but without change) by the Secretary, the Director of NIH, and the Institute's advisory council.

Except as otherwise provided, experts and consultants whose services are obtained under paragraph (5) shall be paid or reimbursed, in accordance with title 5 for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (5) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence.

(c) Pre-clinical models to evaluate promising pediatric cancer therapies

(1) Expansion and coordination of activities

The Director of the National Cancer Institute shall expand, intensify, and coordinate the activities of the Institute with respect to research on the development of preclinical models to evaluate which therapies are likely to be effective for treating pediatric cancer.

(2) Coordination with other institutes

The Director of the Institute shall coordinate the activities under paragraph (1) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that those Institutes and agencies have responsibilities that are related to pediatric cancer.

(July 1, 1944, ch. 373, title IV, §413, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 833; amended Pub. L. 100–607, title I, §122, Nov. 4, 1988, 102 Stat. 3054; Pub. L. 101–93, §5(c), Aug. 16, 1989, 103 Stat. 611; Pub. L. 103–43, title III, §301(a)(2), June 10, 1993, 107 Stat. 150; Pub. L. 107–109, §15(b), Jan. 4, 2002, 115 Stat. 1420.)

Editorial Notes

References in Text

Section 284b of this title, referred to in subsec. (a)(2)(C), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

Codification

In subsec. (b)(6)(C), "section 8141 of title 40" substituted for "the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L. 107–217, §5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.

In subsec. (b)(8), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2002—Subsec. (c). Pub. L. 107–109 added subsec. (c).

1993—Subsec. (b)(9). Pub. L. 103–43 struck out subpar. (A) designation and subpar. (B) which permitted Director to receive from President and Office of Management and Budget directly all funds appropriated by Congress for obligation and expenditure by Institute.

1989—Subsec. (a)(1). Pub. L. 101–93 substituted "Institute and" for "Institute and and".

1988—Subsec. (a). Pub. L. 100–607, §122(1), designated existing provisions as par. (1), substituted "education program" for "education center", inserted "and the public and between the Institute and" after "between the Institute", and added par. (2).

Subsec. (b)(5). Pub. L. 100–607, §122(2)(A), substituted "after consultation with" for "with the approval of".

Subsec. (b)(8) to (10). Pub. L. 100–607, §122(2)(B), inserted "and" after "or educational institution;" in par. (8), redesignated par. (10) as (9), and struck out former par. (9) which related to International Cancer Research Data Bank.

¹ See References in Text note below.

§285a–3. National cancer research and demonstration centers

(a) Cooperative agreements and grants for establishing and supporting

(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, control, and treatment methods for cancer.

(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute's advisory council.

(b) Uses for Federal payments under cooperative agreements or grants

Federal payments made under a cooperative agreement or grant under subsection (a) may be used for—

(1) construction (notwithstanding any limitation under section 289e of this title);

(2) staffing and other basic operating costs, including such patient care costs as are required for research;

(3) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer; and

(4) demonstration purposes.

As used in this paragraph, the term "construction" does not include the acquisition of land, and the term "training" does not include research training for which Ruth L. Kirschstein National Research Service Awards may be provided under section 288 of this title.

(c) Period of support; additional periods

Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(d) Construction

Research centers under this section may not be considered centers of excellence for purposes of section 282(b)(10) of this title.

(July 1, 1944, ch. 373, title IV, §414, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 835; amended Pub. L. 100–607, title I, §123, Nov. 4, 1988, 102 Stat. 3055; Pub. L. 107–206, title I, §804(c), Aug. 2, 2002, 116 Stat. 874; Pub. L. 109–482, title I, §108(b), Jan. 15, 2007, 120 Stat. 3697.)

Editorial Notes

Amendments

2007—Subsec. (d). Pub. L. 109–482 added subsec. (d).

2002—Subsec. (b). Pub. L. 107–206 substituted "Ruth L. Kirschstein National Research Service Awards" for "National Research Service Awards" in concluding provisions.

1988—Subsec. (a)(1). Pub. L. 100–607 inserted "control," after "prevention,".

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

§285a–4. President's Cancer Panel; establishment, membership, etc., functions

(a)(1) The President's Cancer Panel (hereafter in this section referred to as the "Panel") shall be composed of three persons appointed by the President who by virtue of their training, experience, and background are exceptionally qualified to appraise the National Cancer Program. At least two members of the Panel shall be distinguished scientists or physicians.

(2)(A) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of such term, and (ii) a member may serve until the member's successor has taken office. If a vacancy occurs in the Panel, the President shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred.

(B) The President shall designate one of the members to serve as the chairman of the Panel for a term of one year.

(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Panel and shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.

(3) The Panel shall meet at the call of the chairman, but not less often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the public.

(b) The Panel shall monitor the development and execution of the activities of the National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the President. The Panel shall submit to the President periodic progress reports on the National Cancer Program and shall submit to the President, the Secretary, and the Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct.

(July 1, 1944, ch. 373, title IV, §415, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 835.)

Statutory Notes and Related Subsidiaries

Termination of Reporting Requirements

For termination, effective May 15, 2000, of provisions in subsec. (b) of this section relating to the requirement that the Panel submit to Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, see section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and page 189 of House Document No. 103–7.

Termination of Advisory Panels

Advisory panels established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a panel established by the President or an officer of the Federal Government, such panel is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a panel established by the Congress, its duration is otherwise provided by law. See sections 1001(2) and 1013 of Title 5, Government Organization and Employees.

Pub. L. 93–641, §6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

§285a–5. Associate Director for Prevention; appointment; function

(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of cancer. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine.

(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under section 284b ¹ of this title a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities.

(July 1, 1944, ch. 373, title IV, §416, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 836.)

Editorial Notes

References in Text

Section 284b of this title, referred to in subsec. (b), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

¹ See References in Text note below.

§285a–6. Breast and gynecological cancers

(a) Expansion and coordination of activities

The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on breast cancer, ovarian cancer, and other cancers of the reproductive system of women.

(b) Coordination with other institutes

The Director of the Institute shall coordinate the activities of the Director under subsection (a) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes ¹ and agencies have responsibilities that are related to breast cancer and other cancers of the reproductive system of women.

(c) Programs for breast cancer

(1) In general

In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—

(A) basic research concerning the etiology and causes of breast cancer;

(B) clinical research and related activities concerning the causes, prevention, detection and treatment of breast cancer;

(C) control programs with respect to breast cancer in accordance with section 285a–1 of this title, including community-based programs designed to assist women who are members of medically underserved populations, low-income populations, or minority groups;

(D) information and education programs with respect to breast cancer in accordance with section 285a–2 of this title; and

(E) research and demonstration centers with respect to breast cancer in accordance with section 285a–3 of this title, including the development and operation of centers for breast cancer research to bring together basic and clinical, biomedical and behavioral scientists to conduct basic, clinical, epidemiological, psychosocial, prevention and treatment research and related activities on breast cancer.

Not less than six centers shall be operated under subparagraph (E). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.

(2) Implementation of plan for programs

(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) ² of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.

(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary and the Director of NIH.

(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.

(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.

(d) Other cancers

In carrying out subsection (a), the Director of the Institute shall conduct or support research on ovarian cancer and other cancers of the reproductive system of women. Activities under such subsection shall provide for the conduct and support of—

(1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive system of women;

(2) clinical research and related activities into the causes, prevention, detection and treatment of ovarian cancer and other cancers of the reproductive system of women;

(3) control programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with section 285a–1 of this title;

(4) information and education programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with section 285a–2 of this title; and

(5) research and demonstration centers with respect to ovarian cancer and cancers of the reproductive system in accordance with section 285a–3 of this title.

(e) Report

The Director of the Institute shall prepare, for inclusion in the biennial report submitted under section 284b ³ of this title, a report that describes the activities of the National Cancer Institute under the research programs referred to in subsection (a), that shall include—

(1) a description of the research plan with respect to breast cancer prepared under subsection (c);

(2) an assessment of the development, revision, and implementation of such plan;

(3) a description and evaluation of the progress made, during the period for which such report is prepared, in the research programs on breast cancer and cancers of the reproductive system of women;

(4) a summary and analysis of expenditures made, during the period for which such report is made, for activities with respect to breast cancer and cancers of the reproductive system of women conducted and supported by the National Institutes of Health; and

(5) such comments and recommendations as the Director considers appropriate.

(July 1, 1944, ch. 373, title IV, §417, as added Pub. L. 103–43, title IV, §401, June 10, 1993, 107 Stat. 153.)

Editorial Notes

References in Text

Section 284b of this title, referred to in subsec. (e), was repealed by Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

¹ So in original. Probably should not be capitalized.

² So in original. Probably should be section "285a–2(b)(9)".

³ See References in Text note below.

§285a–7. Prostate cancer

(a) Expansion and coordination of activities

(b) Coordination with other institutes

(c) Programs

(1) In general

In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, prostate cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—

(A) basic research concerning the etiology and causes of prostate cancer;

(B) clinical research and related activities concerning the causes, prevention, detection and treatment of prostate cancer;

(C) prevention and control and early detection programs with respect to prostate cancer in accordance with section 285a–1 of this title, particularly as it relates to intensifying research on the role of prostate specific antigen for the screening and early detection of prostate cancer;

(D) an Inter-Institute Task Force, under the direction of the Director of the Institute, to provide coordination between relevant National Institutes of Health components of research efforts on prostate cancer;

(E) control programs with respect to prostate cancer in accordance with section 285a–1 of this title;

(F) information and education programs with respect to prostate cancer in accordance with section 285a–2 of this title; and

(G) research and demonstration centers with respect to prostate cancer in accordance with section 285a–3 of this title, including the development and operation of centers for prostate cancer research to bring together basic and clinical, biomedical and behavioral scientists to conduct basic, clinical, epidemiological, psychosocial, prevention and control, treatment, research, and related activities on prostate cancer.

Not less than six centers shall be operated under subparagraph (G). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.

(2) Implementation of plan for programs

(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.

(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.

(July 1, 1944, ch. 373, title IV, §417A, as added Pub. L. 103–43, title IV, §402, June 10, 1993, 107 Stat. 155.)

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

¹ So in original. Probably should not be capitalized.

² So in original. Probably should be section "285a–2(b)(9)".

§285a–8. Repealed. Pub. L. 109–482, title I, §103(b)(15), Jan. 15, 2007, 120 Stat. 3687

Section, act July 1, 1944, ch. 373, title IV, §417B, as added Pub. L. 103–43, title IV, §403(a), June 10, 1993, 107 Stat. 157; amended Pub. L. 105–340, title I, §103, Oct. 31, 1998, 112 Stat. 3192; Pub. L. 106–505, title VI, §602(b), Nov. 13, 2000, 114 Stat. 2346, related to authorization of appropriations.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Effective Date of 2007 Amendment note under section 281 of this title.

§285a–9. Grants for education, prevention, and early detection of radiogenic cancers and diseases

(a) Definition

In this section the term "entity" means any—

(1) National Cancer Institute-designated cancer center;

(2) Department of Veterans Affairs hospital or medical center;

(3) Federally Qualified Health Center, community health center, or hospital;

(4) agency of any State or local government, including any State department of health; or

(5) nonprofit organization.

(b) In general

The Secretary, acting through the Administrator of the Health Resources and Services Administration in consultation with the Director of the National Institutes of Health and the Director of the Indian Health Service, may make competitive grants to any entity for the purpose of carrying out programs to—

(1) screen individuals described under section 4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note) for cancer as a preventative health measure;

(2) provide appropriate referrals for medical treatment of individuals screened under paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up services;

(3) develop and disseminate public information and education programs for the detection, prevention, and treatment of radiogenic cancers and diseases; and

(4) facilitate putative applicants in the documentation of claims as described in section 5(a) of the Radiation Exposure Compensation Act (42 U.S.C. 2210 note).

(c) Indian Health Service

The programs under subsection (a) shall include programs provided through the Indian Health Service or through tribal contracts, compacts, grants, or cooperative agreements with the Indian Health Service and which are determined appropriate to raising the health status of Indians.

(d) Grant and contract authority

Entities receiving a grant under subsection (b) may expend the grant to carry out the purpose described in such subsection.

(e) Health coverage unaffected

Nothing in this section shall be construed to affect any coverage obligation of a governmental or private health plan or program relating to an individual referred to under subsection (b)(1).

(July 1, 1944, ch. 373, title IV, §417C, as added Pub. L. 106–245, §4, July 10, 2000, 114 Stat. 508; amended Pub. L. 109–482, title I, §§103(b)(16), 104(b)(1)(F), Jan. 15, 2007, 120 Stat. 3687, 3693.)

Editorial Notes

References in Text

Sections 4 and 5 of the Radiation Exposure Compensation Act, referred to in subsec. (b)(1) and (4), are sections 4 and 5 of Pub. L. 101–426, which are set out as a note under section 2210 of this title.

Amendments

2007—Subsec. (f). Pub. L. 109–482, §104(b)(1)(F), struck out heading and text of subsec. (f). Text read as follows: "Beginning on October 1 of the year following the date on which amounts are first appropriated to carry out this section and annually on each October 1 thereafter, the Secretary shall submit a report to the Committee on the Judiciary and the Committee on Health, Education, Labor, and Pensions of the Senate and to the Committee on the Judiciary and the Committee on Commerce of the House of Representatives. Each report shall summarize the expenditures and programs funded under this section as the Secretary determines to be appropriate."

Subsec. (g). Pub. L. 109–482, §103(b)(16), struck out heading and text of subsec. (g). Text read as follows: "There are authorized to be appropriated for the purpose of carrying out this section $20,000,000 for fiscal year 1999 and such sums as may be necessary for each of the fiscal years 2000 through 2009."

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

§285a–10. Research, information, and education with respect to blood cancer

(a) Joe Moakley Research Excellence Program

(1) In general

The Director of NIH shall expand, intensify, and coordinate programs for the conduct and support of research with respect to blood cancer, and particularly with respect to leukemia, lymphoma, and multiple myeloma.

(2) Administration

The Director of NIH shall carry out this subsection through the Director of the National Cancer Institute and in collaboration with any other agencies that the Director determines to be appropriate.

(b) Geraldine Ferraro Cancer Education Program

(1) In general

The Secretary shall direct the appropriate agency within the Department of Health and Human Services, in collaboration with the Director of NIH, to establish and carry out a program to provide information and education for patients and the general public with respect to blood cancer, and particularly with respect to the treatment of leukemia, lymphoma, and multiple myeloma.

(2) Administration

The Agency determined by the Secretary under paragraph (1) shall carry out this subsection in collaboration with private health organizations that have national education and patient assistance programs on blood-related cancers.

(July 1, 1944, ch. 373, title IV, §417D, as added Pub. L. 107–172, §3, May 14, 2002, 116 Stat. 541; amended Pub. L. 109–482, title I, §103(b)(17), Jan. 15, 2007, 120 Stat. 3688; Pub. L. 115–180, title II, §204(a), June 5, 2018, 132 Stat. 1390.)

Editorial Notes

Amendments

2018—Pub. L. 115–180 made technical correction to directory language of Pub. L. 107–172, §3, which enacted this section.

2007—Subsec. (a)(3). Pub. L. 109–482, §103(b)(17)(A), struck out heading and text of par. (3). Text read as follows: "For the purpose of carrying out this subsection, there is authorized to be appropriated such sums as may be necessary for fiscal year 2002 and each subsequent fiscal year. Such authorizations of appropriations are in addition to other authorizations of appropriations that are available for such purpose."

Subsec. (b)(3). Pub. L. 109–482, §103(b)(17)(B), struck out heading and text of par. (3). Text read as follows: "For the purpose of carrying out this subsection, there is authorized to be appropriated such sums as may be necessary for fiscal year 2002 and each subsequent fiscal year. Such authorizations of appropriations are in addition to other authorizations of appropriations that are available for such purpose."

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Pub. L. 115–180, title II, §204(b), June 5, 2018, 132 Stat. 1390, provided that: "The amendment made by subsection (a) [amending section 3 of Pub. L. 107–172] shall take effect as if included in section 3 of the Hematological Cancer Research Investment and Education Act of 2002 (Public Law 107–172; 116 Stat. 541) [enacting this section]."

Effective Date of 2007 Amendment

Congressional Findings

Pub. L. 107–172, §2, May 14, 2002, 116 Stat. 541, provided that: "Congress finds that:

"(1) An estimated 109,500 people in the United States will be diagnosed with leukemia, lymphoma, and multiple myeloma in 2001.

"(2) New cases of the blood cancers described in paragraph (1) account for 8.6 percent of new cancer cases.

"(3) Those devastating blood cancers will cause the deaths of an estimated 60,300 persons in the United States in 2001. Every 9 minutes, a person in the United States dies from leukemia, lymphoma, or multiple myeloma.

"(4) While less than 5 percent of Federal funds for cancer research are spent on those blood cancers, those blood cancers cause 11 percent of all cancer deaths in the United States.

"(5) Increased Federal support of research into leukemia, lymphoma, and multiple myeloma has resulted and will continue to result in significant advances in the treatment, and ultimately the cure, of those blood cancers as well as other cancers."

§285a–11. Pediatric cancer research, awareness, and survivorship

(a) Children's cancer biorepositories

(1) Award

The Secretary, acting through the Director of NIH, may make awards to an entity or entities described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and demographic information of children, adolescents, and young adults with selected cancer subtypes (and their recurrences) for which current treatments are least effective, in order to achieve a better understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of treatments for such cancers.

(2) Use of funds

Amounts received under an award under paragraph (1) may be used to carry out the following:

(A) Collect and store high-quality, donated biospecimens and associated clinical and demographic information on children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children, adolescents, and young adults with cancer enrolled in clinical trials for whom current treatments are least effective. Activities under this subparagraph may include storage of biospecimens and associated clinical and demographic data at existing biorepositories supported by the National Cancer Institute, such as collected samples of both solid tumor cancer and paired samples.

(B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the purposes of research by scientists and qualified health care professionals.

(C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.

(D) Provide access to biospecimens and clinical and demographic data from children, adolescents, and young adults with cancer to researchers and qualified health care professionals for peer-reviewed research—

(i) consistent with the procedures established pursuant to subparagraph (C);

(ii) only to the extent permitted by applicable Federal and State law; and

(iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at minimum.

(3) No requirement

No child, adolescent, or young adult with cancer shall be required under this subsection to contribute a specimen to a biorepository or share clinical or demographic data.

(4) Application; considerations

(A) Application

To be eligible to receive an award under paragraph (1) an entity shall submit an application to the Secretary at such a time, in such manner, and containing such information as the Secretary may reasonably require.

(B) Considerations

In evaluating applications submitted under subparagraph (A), the Secretary shall consider the existing infrastructure of the entity that would allow for the timely capture of biospecimens and related clinical and demographic information for children, adolescents, and young adults with cancer for whom current treatments are least effective.

(5) Privacy protections and informed consent

(A) In general

The Secretary may not make an award under paragraph (1) to an entity unless the Secretary ensures that such entity—

(i) collects biospecimens and associated clinical and demographic information only from participants who have given their informed consent in accordance with Federal and State law; and

(ii) protects personal privacy to the extent required by applicable Federal and State law, at minimum.

(B) Informed consent

The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).

(6) Guidelines and oversight

The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection, including appropriate oversight, to facilitate further research on select cancer subtypes (and their recurrences) in children, adolescents, and young adults with such cancers (and their recurrences).

(7) Coordination

To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this subsection, the Secretary shall ensure the appropriate coordination of programs supported under this section with existing federally supported cancer registry programs and the activities under section 280e–3a of this title, as appropriate.

(8) Supplement not supplant

Funds provided under this subsection shall be used to supplement, and not supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.

(9) Report

Not later than 4 years after January 5, 2023, the Secretary shall submit to Congress a report on—

(A) the number of biospecimens and corresponding clinical demographic data collected through the biospecimen research efforts supported under paragraph (1);

(B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;

(D) barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and

(E) recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.

(10) Report on researcher access to children's cancer biorepository samples

Not later than 2 years after January 5, 2023, the Director of NIH shall—

(A) conduct a review of the procedures established under paragraph (2)(C) and other policies or procedures related to researcher access to such biospecimens to identify any opportunities to reduce administrative burden, consistent with paragraph (2)(D), in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at a minimum; and

(B) 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 a report on the findings of the review under subparagraph (A) and whether the Director of NIH plans to make any changes to the policies or procedures considered in such review, based on such findings.

(11) Definitions

For purposes of this subsection:

(A) Award

The term "award" includes a grant, contract, or cooperative agreement determined by the Secretary.

(B) Biospecimen

The term "biospecimen" includes—

(i) solid tumor tissue or bone marrow;

(ii) normal or control tissue;

(iii) blood and plasma;

(iv) DNA and RNA extractions;

(v) familial DNA; and

(vi) any other sample relevant to cancer research, as required by the Secretary.

(C) Clinical and demographic information

The term "clinical and demographic information" includes—

(i) date of diagnosis;

(ii) age at diagnosis;

(iii) the patient's sex, race, ethnicity, and environmental exposures;

(iv) extent of disease at enrollment;

(v) site of metastases;

(vi) location of primary tumor coded;

(vii) histologic diagnosis;

(viii) tumor marker data when available;

(ix) treatment and outcome data;

(x) information related to specimen quality; and

(xi) any other applicable information required by the Secretary.

(b) Improving care for pediatric cancer survivors

(1) Research on pediatric cancer survivorship

The Director of NIH, in coordination with ongoing research activities, may continue to conduct or support pediatric cancer survivorship research including in any of the following areas:

(A) Outcomes of pediatric cancer survivors, including within minority or other medically underserved populations and with respect to health disparities of such outcomes.

(B) Barriers to follow-up care for pediatric cancer survivors, including within minority or other medically underserved populations.

(C) The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on treatment outcomes and survivorship.

(D) The development of indicators used for long-term follow-up and analysis of the late effects of cancer treatment for pediatric cancer survivors.

(E) The identification of, as applicable—

(i) risk factors associated with the late effects of cancer treatment;

(ii) predictors of adverse neurocognitive and psychosocial outcomes; and

(iii) the molecular basis of long-term complications.

(F) The development of targeted interventions to reduce the burden of morbidity borne by cancer survivors in order to protect such cancer survivors from the late effects of cancer.

(2) Balanced approach

In conducting or supporting research under paragraph (1)(A)(i) on pediatric cancer survivors within minority or other medically underserved populations, the Director of NIH shall ensure that such research addresses both the physical and the psychological needs of such survivors, as appropriate.

(c) Rule of construction

Nothing in this section shall be construed as being inconsistent with the goals and purposes of the Minority Health and Health Disparities Research and Education Act of 2000.

(d) Authorization of appropriations

For purposes of carrying out this section and section 280e–3a of this title, there are authorized to be appropriated $30,000,000 for each of fiscal years 2024 through 2028. Funds appropriated under this subsection shall remain available until expended.

(July 1, 1944, ch. 373, title IV, §417E, as added Pub. L. 110–285, §4(a), July 29, 2008, 122 Stat. 2629; amended Pub. L. 115–180, title I, §§101, 102(b), title II, §202, June 5, 2018, 132 Stat. 1383, 1386, 1389; Pub. L. 117–350, §2(a), Jan. 5, 2023, 136 Stat. 6262.)

Editorial Notes

References in Text

The Minority Health and Health Disparities Research and Education Act of 2000, referred to in subsec. (c), is Pub. L. 106–525, Nov. 22, 2000, 114 Stat. 2495. For complete classification of this Act to the Code, see Short Title of 2000 Amendments note set out under section 201 of this title and Tables.

Amendments

2023—Subsec. (a)(2)(A). Pub. L. 117–350, §2(a)(1)(A), inserted ", such as collected samples of both solid tumor cancer and paired samples" after "National Cancer Institute".

Subsec. (a)(9). Pub. L. 117–350, §2(a)(1)(B), substituted "January 5, 2023" for "June 5, 2018" in introductory provisions.

Subsec. (a)(10), (11). Pub. L. 117–350, §2(a)(1)(C), (D), added par. (10) and redesignated former par. (10) as (11).

Subsec. (d). Pub. L. 117–350, §2(a)(2), substituted "2024 through 2028" for "2019 through 2023".

2018—Pub. L. 115–180, §101(1), substituted "research, awareness, and survivorship" for "research and awareness" in section catchline.

Subsec. (a). Pub. L. 115–180, §101(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows:

"(1) Programs of research excellence in pediatric cancer.—The Secretary, in collaboration with the Director of NIH and other Federal agencies with interest in prevention and treatment of pediatric cancer, shall continue to enhance, expand, and intensify pediatric cancer research and other activities related to pediatric cancer, including therapeutically applicable research to generate effective treatments, pediatric preclinical testing, and pediatric clinical trials through National Cancer Institute-supported pediatric cancer clinical trial groups and their member institutions. In enhancing, expanding, and intensifying such research and other activities, the Secretary is encouraged to take into consideration the application of such research and other activities for minority, health disparity, and medically underserved communities. For purposes of this section, the term 'pediatric cancer research' means research on the causes, prevention, diagnosis, recognition, treatment, and long-term effects of pediatric cancer.

"(2) Peer review requirements.—All grants awarded under this subsection shall be awarded in accordance with section 289a of this title."

Subsec. (b). Pub. L. 115–180, §202, added subsec. (b) and struck out former subsec. (b) which related to public awareness of pediatric cancers and available treatments and research.

Subsec. (c). Pub. L. 115–180, §101(3), struck out "(42 U.S.C. 202 note)" before period at end.

Subsec. (d). Pub. L. 115–180, §102(b), substituted "2019 through 2023" for "2009 through 2013" and struck out "Such authorization of appropriations is in addition to the authorization of appropriations established in section 282a of this title with respect to such purpose." before "Funds appropriated".

Statutory Notes and Related Subsidiaries

Reporting on Childhood Cancer Research Projects

Pub. L. 115–180, title I, §121, June 5, 2018, 132 Stat. 1387, provided that: "The Director of the National Institutes of Health shall ensure that childhood cancer research projects conducted or supported by the National Institutes of Health are included in appropriate reports to Congress, which may include the Pediatric Research Initiative report."

§285a–11a. Cancer survivorship programs

(a) Research to evaluate model systems of care for pediatric cancer survivors

(1) In general

The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall, as appropriate, make awards to eligible entities to conduct or support research to develop, study, or evaluate approaches for monitoring and caring for childhood and adolescent cancer survivors throughout their lifespan, including transition to adult care and care coordination.

(2) Awards

(A) Types of entities

In making awards under this subsection, the Secretary shall, to the extent practicable, within the existing peer review process, include—

(i) small, medium, and large-sized eligible entities; and

(ii) sites located in different geographic areas, including rural and urban areas.

(B) Eligible entities

In this subsection, the term "eligible entity" means—

(i) a medical school;

(ii) a children's hospital;

(iii) a cancer center;

(iv) a community-based medical facility; or

(v) any other entity with significant experience and expertise in carrying out the activities described in paragraph (1).

(3) Use of funds

Funds awarded under this subsection may be used—

(A) to develop, study, or evaluate one or more models for monitoring and caring for cancer survivors; and

(B) in developing, studying, and evaluating such models, to give special emphasis to—

(i) design of models of follow-up care, monitoring, and other survivorship programs (including peer support and mentoring programs);

(ii) development of models for providing multidisciplinary care;

(iii) dissemination of information to health care providers about culturally and linguistically appropriate follow-up care for cancer survivors and their families, as appropriate and practicable;

(iv) development of psychosocial and support programs to improve the quality of life of cancer survivors and their families, which may include peer support and mentoring programs;

(v) design tools to support the secure electronic transfer of treatment information and care summaries between health care providers or, as applicable and appropriate, longitudinal childhood cancer survivorship cohorts (including risk factors and a plan for recommended follow-up care);

(vi) dissemination of the information and programs described in clauses (i) through (v) to other health care providers (including primary care physicians and internists) and to cancer survivors and their families, where appropriate and in accordance with Federal and State law; and

(vii) development of initiatives that promote the coordination and effective transition of care between cancer care providers, primary care physicians, mental health professionals, and other health care professionals, as appropriate, including models that use a team-based or multi-disciplinary approach to care.

(b) Workforce development for health care providers on medical and psychosocial care for childhood cancer survivors

(1) In general

The Secretary shall, not later than 1 year after January 5, 2023, conduct a review of the activities of the Department of Health and Human Services related to workforce development for health care providers who treat pediatric cancer patients and survivors. Such review shall include—

(A) identification of existing models relevant to providing medical and psychosocial services to individuals surviving pediatric cancers, and programs related to training for health professionals who provide such services to individuals surviving pediatric cancers; and

(B) recommendations for enhancing or promoting activities of the Department of Health and Human Services related to workforce development for health care providers who provide psychosocial care to pediatric cancer patients and survivors.

(2) Report

Not later than 2 years after January 5, 2023, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives, a report concerning the findings and recommendations from the review conducted under paragraph (1).

(Pub. L. 115–180, title II, §201, June 5, 2018, 132 Stat. 1387; Pub. L. 117–350, §2(b), Jan. 5, 2023, 136 Stat. 6263.)

Editorial Notes

Codification

Section was enacted as part of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018, also known as the Childhood Cancer STAR Act, and not as part of the Public Health Service Act which comprises this chapter.

Amendments

2023—Subsec. (a). Pub. L. 117–350, §2(b)(1)(A), substituted "Research to evaluate" for "Pilot programs to explore" in heading.

Subsec. (a)(1). Pub. L. 117–350, §2(b)(1)(B), substituted "shall, as appropriate, make awards to eligible entities to conduct or support research" for "may make awards to eligible entities to establish pilot programs" and "approaches" for "model systems", inserted "and adolescent" after "childhood", and struck out "evaluation of models for" before "transition".

Subsec. (a)(2)(A). Pub. L. 117–350, §2(b)(1)(C)(i), inserted "within the existing peer review process," after "practicable," in introductory provisions.

Subsec. (a)(2)(B)(v). Pub. L. 117–350, §2(b)(1)(C)(ii), substituted "in carrying out the activities described in paragraph (1)" for "in treating survivors of childhood cancers".

Subsec. (a)(3)(B)(v). Pub. L. 117–350, §2(b)(1)(D), substituted "design tools to support the secure electronic transfer of treatment information and care summaries between health care providers or, as applicable and appropriate, longitudinal childhood cancer survivorship cohorts" for "design of systems for the effective transfer of treatment information and care summaries from cancer care providers to other health care providers".

Subsec. (b)(1). Pub. L. 117–350, §2(b)(2)(A), substituted "January 5, 2023" for "June 5, 2018" in introductory provisions.

Subsec. (b)(1)(A) to (C). Pub. L. 117–350, §2(b)(2)(B), added subpar. (B), redesignated former subpar. (B) as (A), and struck out former subpars. (A) and (C) which read as follows:

"(A) an assessment of the effectiveness of supportive psychosocial care services for pediatric cancer patients and survivors, including pediatric cancer survivorship care patient navigators and peer support programs;

"(C) recommendations for improving the provision of psychosocial care for pediatric cancer survivors and patients."

Subsec. (b)(2). Pub. L. 117–350, §2(b)(2)(A), substituted "January 5, 2023" for "June 5, 2018".

§285a–11b. Best practices for long-term follow-up services for pediatric cancer survivors

The Secretary of Health and Human Services may facilitate the identification of best practices for childhood and adolescent cancer survivorship care, and, as appropriate, may consult with individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers, which may include—

(1) oncologists, which may include pediatric oncologists;

(2) primary care providers engaged in survivorship care;

(3) survivors of childhood and adolescent cancer;

(4) parents of children and adolescents who have been diagnosed with and treated for cancer and parents of long-term survivors;

(5) nurses and social workers;

(6) mental health professionals;

(7) allied health professionals, including physical therapists and occupational therapists; and

(8) others, as the Secretary determines appropriate.

(Pub. L. 115–180, title II, §203, June 5, 2018, 132 Stat. 1389.)

Editorial Notes

Codification

§285a–12. Interagency Breast Cancer and Environmental Research Coordinating Committee

(a) Interagency Breast Cancer and Environmental Research Coordinating Committee

(1) Establishment

Not later than 6 months after October 8, 2008, the Secretary shall establish a committee, to be known as the Interagency Breast Cancer and Environmental Research Coordinating Committee (in this section referred to as the "Committee").

(2) Duties

The Committee shall—

(A) share and coordinate information on existing research activities, and make recommendations to the National Institutes of Health and other Federal agencies regarding how to improve existing research programs, that are related to breast cancer research;

(B) develop a comprehensive strategy and advise the National Institutes of Health and other Federal agencies in the solicitation of proposals for collaborative, multidisciplinary research, including proposals to evaluate environmental and genomic factors that may be related to the etiology of breast cancer that would—

(i) result in innovative approaches to study emerging scientific opportunities or eliminate knowledge gaps in research to improve the research portfolio;

(ii) outline key research questions, methodologies, and knowledge gaps;

(iii) expand the number of research proposals that involve collaboration between 2 or more national research institutes or national centers, including proposals for Common Fund research described in section 282(b)(7) of this title to improve the research portfolio; and

(iv) expand the number of collaborative, multidisciplinary, and multi-institutional research grants;

(C) develop a summary of advances in breast cancer research supported or conducted by Federal agencies relevant to the diagnosis, prevention, and treatment of cancer and other diseases and disorders; and

(D) not later than 2 years after the date of the establishment of the Committee, make recommendations to the Secretary—

(i) regarding any appropriate changes to research activities, including recommendations to improve the research portfolio of the National Institutes of Health to ensure that scientifically-based strategic planning is implemented in support of research priorities that impact breast cancer research activities;

(ii) to ensure that the activities of the National Institutes of Health and other Federal agencies, including the Department of Defense, are free of unnecessary duplication of effort;

(iii) regarding public participation in decisions relating to breast cancer research to increase the involvement of patient advocacy and community organizations representing a broad geographical area;

(iv) on how best to disseminate information on breast cancer research progress; and

(v) on how to expand partnerships between public entities, including Federal agencies, and private entities to expand collaborative, cross-cutting research.

(3) Rule of construction

For the purposes of the Committee, when focusing on research to evaluate environmental and genomic factors that may be related to the etiology of breast cancer, nothing in this section shall be construed to restrict the Secretary from including other forms of cancer, as appropriate, when doing so may advance research in breast cancer or advance research in other forms of cancer.

(4) Membership

(A) In general

The Committee shall be composed of the following voting members:

(i) Not more than 7 voting Federal representatives as follows:

(I) The Director of the Centers for Disease Control and Prevention.

(II) The Director of the National Institutes of Health and the directors of such national research institutes and national centers (which may include the National Institute of Environmental Health Sciences) as the Secretary determines appropriate.

(III) One representative from the National Cancer Institute Board of Scientific Advisors, appointed by the Director of the National Cancer Institute.

(IV) The heads of such other agencies of the Department of Health and Human Services as the Secretary determines appropriate.

(V) Representatives of other Federal agencies that conduct or support cancer research, including the Department of Defense.

(ii) 12 additional voting members appointed under subparagraph (B).

(B) Additional members

The Committee shall include additional voting members appointed by the Secretary as follows:

(i) 6 members shall be appointed from among scientists, physicians, and other health professionals, who—

(I) are not officers or employees of the United States;

(II) represent multiple disciplines, including clinical, basic, and public health sciences;

(III) represent different geographical regions of the United States;

(IV) are from practice settings, academia, or other research settings; and

(V) are experienced in scientific peer review process.

(ii) 6 members shall be appointed from members of the general public, who represent individuals with breast cancer.

(C) Nonvoting members

The Committee shall include such nonvoting members as the Secretary determines to be appropriate.

(5) Chairperson

The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.

(6) Meetings

The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.

(b) Review

The Secretary shall review the necessity of the Committee in calendar year 2011 and, thereafter, at least once every 2 years.

(July 1, 1944, ch. 373, title IV, §417F, as added Pub. L. 110–354, §2(a), Oct. 8, 2008, 122 Stat. 3984.)

§285a–13. Scientific framework for recalcitrant cancers

(a) Development of scientific framework

(1) In general

For each recalcitrant cancer identified under subsection (b), the Director of the Institute shall develop (in accordance with subsection (c)) a scientific framework for the conduct or support of research on such cancer.

(2) Contents

The scientific framework with respect to a recalcitrant cancer shall include the following:

(A) Current status

(i) Review of literature

A summary of findings from the current literature in the areas of—

(I) the prevention, diagnosis, and treatment of such cancer;

(II) the fundamental biologic processes that regulate such cancer (including similarities and differences of such processes from the biological processes that regulate other cancers); and

(III) the epidemiology of such cancer.

(ii) Scientific advances

The identification of relevant emerging scientific areas and promising scientific advances in basic, translational, and clinical science relating to the areas described in subclauses (I) and (II) of clause (i).

(iii) Researchers

A description of the availability of qualified individuals to conduct scientific research in the areas described in clause (i).

(iv) Coordinated research initiatives

The identification of the types of initiatives and partnerships for the coordination of intramural and extramural research of the Institute in the areas described in clause (i) with research of the relevant national research institutes, Federal agencies, and non-Federal public and private entities in such areas.

(v) Research resources

The identification of public and private resources, such as patient registries and tissue banks, that are available to facilitate research relating to each of the areas described in clause (i).

(B) Identification of research questions

The identification of research questions relating to basic, translational, and clinical science in the areas described in subclauses (I) and (II) of subparagraph (A)(i) that have not been adequately addressed with respect to such recalcitrant cancer.

(C) Recommendations

Recommendations for appropriate actions that should be taken to advance research in the areas described in subparagraph (A)(i) and to address the research questions identified in subparagraph (B), as well as for appropriate benchmarks to measure progress on achieving such actions, including the following:

(i) Researchers

Ensuring adequate availability of qualified individuals described in subparagraph (A)(iii).

(ii) Coordinated research initiatives

Promoting and developing initiatives and partnerships described in subparagraph (A)(iv).

(iii) Research resources

Developing additional public and private resources described in subparagraph (A)(v) and strengthening existing resources.

(3) Timing

(A) Initial development and subsequent update

For each recalcitrant cancer identified under subsection (b)(1), the Director of the Institute shall—

(i) develop a scientific framework under this subsection not later than 18 months after January 2, 2013; and

(ii) review and update the scientific framework not later than 5 years after its initial development.

(B) Other updates

The Director of the Institute may review and update each scientific framework developed under this subsection as necessary.

(4) Public notice

With respect to each scientific framework developed under subsection (a), not later than 30 days after the date of completion of the framework, the Director of the Institute shall—

(A) submit such framework to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate; and

(B) make such framework publically available on the Internet website of the Department of Health and Human Services.

(b) Identification of recalcitrant cancer

(1) In general

Not later than 6 months after January 2, 2013, the Director of the Institute shall identify two or more recalcitrant cancers that each—

(A) have a 5-year relative survival rate of less than 20 percent; and

(B) are estimated to cause the death of at least 30,000 individuals in the United States per year.

(2) Additional cancers

The Director of the Institute may, at any time, identify other recalcitrant cancers for purposes of this section. In identifying a recalcitrant cancer pursuant to the previous sentence, the Director may consider additional metrics of progress (such as incidence and mortality rates) against such type of cancer.

(c) Working groups

For each recalcitrant cancer identified under subsection (b), the Director of the Institute shall convene a working group comprised of representatives of appropriate Federal agencies and other non-Federal entities to provide expertise on, and assist in developing, a scientific framework under subsection (a). The Director of the Institute (or the Director's designee) shall participate in the meetings of each such working group.

(d) Reporting

(1) Biennial reports

The Director of NIH shall ensure that each biennial report under section 283 of this title includes information on actions undertaken to carry out each scientific framework developed under subsection (a) with respect to a recalcitrant cancer, including the following:

(A) Information on research grants awarded by the National Institutes of Health for research relating to such cancer.

(B) An assessment of the progress made in improving outcomes (including relative survival rates) for individuals diagnosed with such cancer.

(2) Additional one-time report for certain frameworks

For each recalcitrant cancer identified under subsection (b)(1), the Director of the Institute shall, not later than 6 years after the initial development of a scientific framework under subsection (a), submit a report to the Congress on the effectiveness of the framework (including the update required by subsection (a)(3)(A)(ii)) in improving the prevention, detection, diagnosis, and treatment of such cancer.

(e) Recommendations for exception funding

The Director of the Institute shall consider each relevant scientific framework developed under subsection (a) when making recommendations for exception funding for grant applications.

(f) Definition

In this section, the term "recalcitrant cancer" means a cancer for which the five-year relative survival rate is below 50 percent.

(July 1, 1944, ch. 373, title IV, §417G, as added Pub. L. 112–239, div. A, title X, §1083, Jan. 2, 2013, 126 Stat. 1960.)