Collapse to view only § 299c-7. Definitions

§ 299c. Advisory Council for Healthcare Research and Quality
(a) Establishment
(b) Duties
(1) In general
(2) Certain recommendations
Activities of the Advisory Council under paragraph (1) shall include making recommendations to the Director regarding—
(A) priorities regarding health care research, especially studies related to quality, outcomes, cost and the utilization of, and access to, health care services;
(B) the field of health care research and related disciplines, especially issues related to training needs, and dissemination of information pertaining to health care quality; and
(C) the appropriate role of the Agency in each of these areas in light of private sector activity and identification of opportunities for public-private sector partnerships.
(c) Membership
(1) In general
(2) Appointed members
The Secretary shall appoint to the Advisory Council 21 appropriately qualified individuals. At least 17 members of the Advisory Council shall be representatives of the public who are not officers or employees of the United States and at least 1 member who shall be a specialist in the rural aspects of 1 or more of the professions or fields described in subparagraphs (A) through (G). The Secretary shall ensure that the appointed members of the Council, as a group, are representative of professions and entities concerned with, or affected by, activities under this subchapter and under section 1320b–12 of this title. Of such members—
(A) three shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care;
(B) three shall be individuals distinguished in the fields of health care quality research or health care improvement;
(C) three shall be individuals distinguished in the practice of medicine of which at least one shall be a primary care practitioner;
(D) three shall be individuals distinguished in the other health professions;
(E) three shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems;
(F) three shall be individuals distinguished in the fields of health care economics, information systems, law, ethics, business, or public policy; and
(G) three shall be individuals representing the interests of patients and consumers of health care.
(3) Ex officio members
The Secretary shall designate as ex officio members of the Advisory Council—
(A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Commissioner of the Food and Drug Administration, the Director of the Office of Personnel Management, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of the Department of Veterans Affairs; and
(B) such other Federal officials as the Secretary may consider appropriate.
(d) Terms
(1) In general
(2) Staggered terms
(3) Service beyond term
(e) Vacancies
(f) Chair
(g) Meetings
(h) Compensation and reimbursement of expenses
(1) Appointed members
(2) Ex officio members
(i) Staff
(j) Duration
(July 1, 1944, ch. 373, title IX, § 941, formerly § 921, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1663; amended Pub. L. 108–173, title IX, § 900(e)(2)(D), Dec. 8, 2003, 117 Stat. 2372; renumbered § 931, Pub. L. 109–41, § 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered § 941, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381; Pub. L. 117–286, § 4(a)(242), Dec. 27, 2022, 136 Stat. 4332.)
§ 299c–1. Peer review with respect to grants and contracts
(a) Requirement of review
(1) In general
(2) Reports to Director
(b) Approval as precondition of awards
(c) Establishment of peer review groups
(1) In general
(2) Membership
(3) Duration
(4) Qualifications
Members of any peer review group shall, at a minimum, meet the following requirements:
(A) Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information.
(B) Such members shall agree in writing to recuse themselves from participation in the peer review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer review.
(d) Authority for procedural adjustments in certain cases
(e) Regulations
(July 1, 1944, ch. 373, title IX, § 942, formerly § 922, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1665; renumbered § 932, Pub. L. 109–41, § 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered § 942, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381; amended Pub. L. 117–286, § 4(a)(243), Dec. 27, 2022, 136 Stat. 4332.)
§ 299c–2. Certain provisions with respect to development, collection, and dissemination of data
(a) Standards with respect to utility of data
(1) In general
To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency for the purpose described in section 299(b) of this title, the Director shall establish standard methods for developing and collecting such data, taking into consideration—
(A) other Federal health data collection standards; and
(B) the differences between types of health care plans, delivery systems, health care providers, and provider arrangements.
(2) Relationship with other Department programs
(b) Statistics and analyses
The Director shall—
(1) take appropriate action to ensure that statistics and analyses developed under this subchapter are of high quality, timely, and duly comprehensive, and that the statistics are specific, standardized, and adequately analyzed and indexed; and
(2) publish, make available, and disseminate such statistics and analyses on as wide a basis as is practicable.
(c) Authority regarding certain requests
(July 1, 1944, ch. 373, title IX, § 943, formerly § 923, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1666; renumbered § 933, Pub. L. 109–41, § 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered § 943, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381.)
§ 299c–3. Dissemination of information
(a) In general
The Director shall—
(1) without regard to section 501 of title 44, promptly publish, make available, and otherwise disseminate, in a form understandable and on as broad a basis as practicable so as to maximize its use, the results of research, demonstration projects, and evaluations conducted or supported under this subchapter;
(2) ensure that information disseminated by the Agency is science-based and objective and undertakes consultation as necessary to assess the appropriateness and usefulness of the presentation of information that is targeted to specific audiences;
(3) promptly make available to the public data developed in such research, demonstration projects, and evaluations;
(4) provide, in collaboration with the National Library of Medicine where appropriate, indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of information on research, demonstration projects, and evaluations with respect to health care to public and private entities and individuals engaged in the improvement of health care delivery and the general public, and undertake programs to develop new or improved methods for making such information available; and
(5) as appropriate, provide technical assistance to State and local government and health agencies and conduct liaison activities to such agencies to foster dissemination.
(b) Prohibition against restrictions
(c) Limitation on use of certain information
(d) Penalty
(July 1, 1944, ch. 373, title IX, § 944, formerly § 924, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1667; renumbered § 934, Pub. L. 109–41, § 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered § 944, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381.)
§ 299c–4. Additional provisions with respect to grants and contracts
(a) Financial conflicts of interest
With respect to projects for which awards of grants, cooperative agreements, or contracts are authorized to be made under this subchapter, the Director shall by regulation define—
(1) the specific circumstances that constitute financial interests in such projects that will, or may be reasonably expected to, create a bias in favor of obtaining results in the projects that are consistent with such interests; and
(2) the actions that will be taken by the Director in response to any such interests identified by the Director.
(b) Requirement of application
(c) Provision of supplies and services in lieu of funds
(1) In general
(2) Corresponding reduction in funds
(d) Applicability of certain provisions with respect to contracts
(July 1, 1944, ch. 373, title IX, § 945, formerly § 925, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1668; renumbered § 935, Pub. L. 109–41, § 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered § 945, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381.)
§ 299c–5. Certain administrative authorities
(a) Deputy director and other officers and employees
(1) Deputy director
(2) Other officers and employees
(b) Facilities
The Secretary, in carrying out this subchapter—
(1) may acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or portions of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed 10 years; and
(2) may acquire, construct, improve, repair, operate, and maintain laboratory, research, and other necessary facilities and equipment, and such other real or personal property (including patents) as the Secretary deems necessary.
(c) Provision of financial assistance
(d) Utilization of certain personnel and resources
(1) Department of Health and Human Services
(2) Other agencies
(e) Consultants
(f) Experts
(1) In general
(2) Travel expenses
(A) In general
(B) Limitation
(g) Voluntary and uncompensated services
(July 1, 1944, ch. 373, title IX, § 946, formerly § 926, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1668; renumbered § 936, Pub. L. 109–41, § 2(a)(3), July 29, 2005, 119 Stat. 424; renumbered § 946, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381.)
§ 299c–6. Funding
(a) Intent
(b) Authorization of appropriations
(c) Evaluations
(d) Health disparities research
(e) Patient safety and quality improvement
(July 1, 1944, ch. 373, title IX, § 947, formerly § 927, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1670; amended Pub. L. 106–525, title II, § 201(b), Nov. 22, 2000, 114 Stat. 2507; renumbered § 937 and amended Pub. L. 109–41, § 2(a)(3), (b), July 29, 2005, 119 Stat. 424, 434; renumbered § 947, Pub. L. 111–148, title III, § 3013(a)(2), Mar. 23, 2010, 124 Stat. 381.)
§ 299c–7. Definitions
In this subchapter:
(1) Advisory Council
(2) Agency
(3) Director
(July 1, 1944, ch. 373, title IX, § 948, formerly § 928, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1670; renumbered § 938 and amended Pub. L. 109–41, § 2(a)(3), (4), July 29, 2005, 119 Stat. 424; renumbered § 948 and amended Pub. L. 111–148, title III, § 3013(a)(2), (3), Mar. 23, 2010, 124 Stat. 381.)