health, and other supportive services, as well as models that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families. (b) Grants and technical assistance The Secretary may award grants, cooperative agreements and contracts and provide technical assistance to eligible entities described in section 280f-1 of this title to carry out subsection (a) of this section. (c) Dissemination of criteria In carrying out this section, the Secretary shall develop a procedure for disseminating the Fetal Alcohol Syndrome and Fetal Alcohol Effect diagnostic criteria developed pursuant to section 705 of the ADAMHA Reorganization Act to health care providers, educators, social workers, child welfare workers, and other individuals. (d) National Task Force (1) In general The Secretary shall establish a task force to be known as the National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect (referred to in this subsection as the "Task Force") to foster coordination among all governmental agencies, academic bodies and community groups that conduct or support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome and Fetal Alcohol Effect. (2) Membership The Task Force established pursuant to paragraph (1) shall— (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and (B) include the Chairperson of the Interagency Coordinating Committee on Fetal Alcohol Syndrome of the Department of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and representatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS Family Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic community, and Federal, State and local government agencies and offices. (3) Functions The Task Force shall (A) advise Federal, State and local programs and research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect, including programs and research concerning education and public awareness for relevant service providers, school-age children, women at-risk, and the general public, medical diagnosis, interventions for women atrisk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, (B) coordinate its efforts with the Interagency Coordinating Committee on Fetal Alcohol Syndrome of the Department of Health and Human Services; and (C) report on a biennial basis to the Secretary and relevant committees of Congress on the current and planned activities of the participating agencies. (4) Time for appointment The members of the Task Force shall be appointed by the Secretary not later than 6 months after November 13, 1998. (July 1, 1944, ch. 373, title III, §399G, as added Pub. L. 105-392, title IV, §419(d), Nov. 13, 1998, 112 Stat. 3593.) REFERENCES IN TEXT Section 705 of the ADAMHA Reorganization Act, referred to in subsec. (c), is section 705 of Pub. L. 102-321, title VII, July 10, 1992, 106 Stat. 438, which was formerly set out as a note under section 285n of this title. CONGRESSIONAL FINDINGS AND PURPOSE Pub. L. 105-392, title IV, §419(b), (c), Nov. 13, 1998, 112 Stat. 3591, 3592, provided that: "(b) FINDINGS.-Congress finds that "(1) Fetal Alcohol Syndrome is the leading preventable cause of mental retardation, and it is 100 percent preventable; "(2) estimates on the number of children each year vary, but according to some researchers, up to 12,000 infants are born in the United States with Fetal Alcohol Syndrome, suffering irreversible physical and mental damage; "(3) thousands more infants are born each year with Fetal Alcohol Effect, also known as Alcohol Related Neurobehavioral Disorder (ARND), a related and equally tragic syndrome; "(4) children of women who use alcohol while pregnant have a significantly higher infant mortality rate (13.3 per 1,000) than children of those women who do not use alcohol (8.6 per 1,000); "(5) Fetal Alcohol Syndrome and Fetal Alcohol Effect are national problems which can impact any child, family, or community, but their threat to American Indians and Alaska Natives is especially alarming; "(6) in some American Indian communities, where alcohol dependency rates reach 50 percent and above. the chances of a newborn suffering Fetal Alcohol Syndrome or Fetal Alcohol Effect are up to 30 times greater than national averages; "(7) in addition to the immeasurable toll on children and their families. Fetal Alcohol Syndrome and Fetal Alcohol Effect pose extraordinary financial costs to the Nation, including the costs of health care, education, foster care, job training, and general support services for affected individuals; "(8) the total cost to the economy of Fetal Alcohol Syndrome was approximately $2,500,000,000 in 1995, and over a lifetime, health care costs for one Fetal Alcohol Syndrome child are estimated to be at least $1,400,000; "(9) researchers have determined that the possibility of giving birth to a baby with Fetal Alcohol Syndrome or Fetal Alcohol Effect increases in proportion to the amount and frequency of alcohol consumed by a pregnant woman, and that stopping alcohol consumption at any point in the pregnancy reduces the emotional, physical, and mental consequences of alcohol exposure to the baby; and "(10) though approximately 1 out of every 5 pregnant women drink alcohol during their pregnancy, we know of no safe dose of alcohol during pregnancy, or of any safe time to drink during pregnancy, thus, it is in the best interest of the Nation for the Federal Government to take an active role in encouraging all women to abstain from alcohol consumption during pregnancy. "(c) PURPOSE.-It is the purpose of this section to establish, within the Department of Health and Human Services, a comprehensive program to help prevent Fetal Alcohol Syndrome and Fetal Alcohol Effect nationwide and to provide effective intervention programs and services for children, adolescents and adults already affected by these conditions. Such program shall "(1) coordinate, support, and conduct national, State, and community-based public awareness, prevention, and education programs on Fetal Alcohol Syndrome and Fetal Alcohol Effect; "(2) coordinate, support, and conduct prevention and intervention studies as well as epidemiologic research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect; "(3) coordinate, support and conduct research and demonstration projects to develop effective developmental and behavioral interventions and programs that foster effective advocacy, educational and vocational training, appropriate therapies, counseling, medical and mental health, and other supportive services, as well as models that integrate or coordinate such services, aimed at the unique challenges facing individuals with Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families; and "(4) foster coordination among all Federal, State and local agencies, and promote partnerships between research institutions and communities that conduct or support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, surveillance, prevention, and interventions and otherwise meet the general needs of populations already affected or at risk of being impacted by Fetal Alcohol Syndrome and Fetal Alcohol Effect." SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 280f-2, 280f-3 of this title. § 280f-1. Eligibility To be eligible to receive a grant, or enter into a cooperative agreement or contract under this part, an entity shall (1) be a State, Indian tribal government, local government, scientific or academic institution, or nonprofit organization; and (2) prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may prescribe, including a description of the activities that the entity intends to carry out using amounts received under this part. (July 1, 1944, ch. 373, title III, § 399H, as added Pub. L. 105–392, title IV, § 419(d), Nov. 13, 1998, 112 Stat. 3594.) CODIFICATION Another section 399H of act July 1, 1944, is classified to section 280e of this title. SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 280f of this title. § 280f-2. Authorization of appropriations (a) In general There are authorized to be appropriated to carry out this part, $27,000,000 for each of the fiscal years 1999 through 2003. (b) Task Force From amounts appropriated for a fiscal year under subsection (a) of this section, the Secretary may use not to exceed $2,000,000 of such amounts for the operations of the National Task Force under section 280f(d) of this title. (July 1, 1944, ch. 373, title III, §3991, as added Pub. L. 105-392, title IV, § 419(d), Nov. 13, 1998, 112 Stat. 3595.) CODIFICATION Another section 3991 of act July 1, 1944, is classified to section 280e-1 of this title. § 280f-3. Sunset provision This part shall not apply on the date that is 7 years after the date on which all members of the National Task Force have been appointed under section 280f(d)(1) of this title. (July 1, 1944, ch. 373, title III, §399J, as added Pub. L. 105-392, title IV, § 419(d), Nov. 13, 1998, 112 Stat. 3595.) CODIFICATION Another section 399J of act July 1, 1944, is classified to section 280e-2 of this title. SUBCHAPTER III-NATIONAL RESEARCH INSTITUTES PART A-NATIONAL INSTITUTES OF HEALTH § 281. Organization of National Institutes of Health [See main edition for text of (a)] (b) Agencies within (1) The following national research institutes are agencies of the National Institutes of Health: [See main edition for text of (A) to (G)] (H) The National Institute of Dental and Craniofacial Research. [See main edition for text of (I) to (Q)] (2) The following entities are agencies of the National Institutes of Health: [See main edition for text of (A) to (E)] (F) The National Center for Complementary and Alternative Medicine. [See main edition for text of (c) and (d)] (As amended Pub. L. 105–277, div. A, § 101(f) [title II, §212, title VI, §601(k)], Oct. 21, 1998, 112 Stat. 2681-337, 2681-359, 2681-388.) AMENDMENTS 1998 Subsec. (b)(1)(H). Pub. L. 105-277, § 101(f) [title II, § 212], substituted "National Institute of Dental and Craniofacial Research" for "National Institute of Dental Research". Subsec. (b)(2)(F). Pub. L. 105-277, §101(f) [title VI, § 601(k)], added subpar. (F). CHANGE OF NAME 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. § 282. Director of National Institutes of Health [See main edition for text of (a)] (b) Duties and authority In carrying out the purposes of section 241 of this title, the Secretary, acting through the Director of NIH [See main edition for text of (1) to (10)] (11) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter; (12) after consultation with the Director of the Office of Research on Women's Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women's health that are identified under section 287d(b) of this title; (13) may conduct and support research training (A) for which fellowship support is not provided under section 288 of this title; and (B) which does not consist of residency training of physicians or other health professionals; and (14) may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter 74 of title 38. The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (6). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States. [See main edition for text of (c) to (e)] (f) Associate Director for Prevention; functions There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall (1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs; and (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemina tion, using advanced technologies to the maximum extent practicable, of research results to such entities. [See main edition for text of (g) to (i)] (j) Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the "data bank”). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information. (B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention. (2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers. (3) The data bank shall include the following: (A) A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section 355(i) of title 21, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, and a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol. (B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available (i) under a treatment investigational new drug application that has been submitted to the Secretary under section 360bbb(c) of title 21; or (ii) as a Group C cancer drug (as defined by the National Cancer Institute). The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments. (4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment. (5) For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary. Fees collected under section 379h of title 21 shall not be used in carrying out this subsection. (k) Day care for children of employees (1) The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis). (2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee. (3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements. (1) Interagency research on trauma The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma). (As amended Pub. L. 105-115, title I, § 113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 105-362, title VI, § 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 105-392, title IV, §409, Nov. 13, 1998, 112 Stat. 3589.) REFERENCES IN TEXT The provisions of title 5 governing appointments in the competitive service, referred to in subsec. (b)(6), (14), are classified generally to section 3301 et seq. of Title 5, Government Organization and Employees. The provisions of title 5 relating to classifications, referred to in subsec. (b)(14), are classified generally to chapter 51 (§5101 et seq.) and to subchapter III (§ 5331 et seq.) of chapter 53 of Title 5, Government Organization and Employees. The National Literacy Act of 1991, referred to in subsec. (e)(5), is Pub. L. 102-73, July 25, 1991, 105 Stat. 333, as amended, which was repealed by Pub. L. 105-220, title II. §251(a)(2), Aug. 7, 1998, 112 Stat. 1079. For complete classification of this Act to the Code, see Tables. AMENDMENTS 1998 Subsec. (b)(13), (14). Pub. L. 105-392 added pars. (13) and (14). Subsec. (f). Pub. L. 105-362 inserted "and" at end of par. (1), substituted a period for “; and" at end of par. (2), and struck out par. (3) which read as follows: “annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including "(A) a summary of the Associate Director's review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and "(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities." 1997-Subsecs. (j) to (l). Pub. L. 105-115 added subsec. (j) and redesignated former subsecs. (j) and (k) as (k) and (1), respectively. CHANGE OF NAME 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. EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115, set out as a note under section 321 of Title 21, Food and Drugs. COLLABORATION AND REPORT Section 113(b) of Pub. L. 105-115 provided that: "(1) IN GENERAL.-The Secretary of Health and Human Services, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs shall collaborate to determine the feasibility of including device investigations within the scope of the data bank under section 402(j) of the Public Health Service Act [subsec. (j) of this section]. "(2) REPORT.-Not later than two years after the date of enactment of this section [Nov. 21, 1997], the Secretary of Health and Human Services shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report “(A) of the public health need, if any, for inclusion of device investigations within the scope of the data bank under section 402(j) of the Public Health Service Act; "(B) on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations is required to be publicly disclosed; and "(C) on such other issues relating to such section 402(j) as the Secretary determines to be appropriate." SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 283, 284, 285g-4, 289a of this title; title 21 section 360bbb. § 283. Biennial report of Director to President and Congress; contents SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 283e, 284b, 285g-4, 285q-3, 287a-1, 287d, 287d-2, 289a-2 of this title. § 283a. Establishment of program regarding DES [See main edition for text of (a) to (d)] (e) Authorization of appropriations In addition to any other authorization of appropriations available for the purpose of carrying out this section, there are authorized to be appropriated for such purpose such sums as may be necessary for each of the fiscal years 1993 through 2003. (As amended Pub. L. 105-340, title I, § 101(a), Oct. 31, 1998, 112 Stat. 3191.) AMENDMENTS 1998 Subsec. (e). Pub. L. 105-340 substituted "2003" for "1996". SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300u-9 of this title. §283d. Children's Vaccine Initiative REFERENCES IN TEXT Section 300aa-4 of this title, referred to in subsec. (b), was repealed by Pub. L. 105-362, title VI, §601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285. §283e. Plan for use of animals in research CHANGE OF NAME 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. §283g. Repealed. Pub. L. 105-277, div. A, §101(f) [title VI, § 601(1)], Oct. 21, 1998, 112 Stat. 2681-337, 2681-387 Section, act July 1, 1944, ch. 373, title IV, §404E, as added Pub. L. 103-43, title II, § 209, June 10, 1993, 107 Stat. 149, related to Office of Alternative Medicine. PART B-GENERAL PROVISIONS RESPECTING § 284a. Advisory councils [See main edition for text of (a) to (g)] (h) Advisory councils in existence; application of section to National Cancer Advisory Board and advisory council to National Heart, Lung, and Blood Institute [See main edition for text of (1)] (2)(A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that [See main edition for text of (i) to (iv)] (v) the ex officio members of the Board shall be nonvoting members and shall be the Secretary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Under Secretary for Health of the Department of Veterans Affairs, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, the Assistant Secretary of Defense for Health Affairs, and the Director of the Office of Science of the Department of Energy (or the designees of such officers); and [See main edition for text of (vi), (B)] amended Pub. L. 105-245, title III, § 309(b)(2)(C), Oct. 7, 1998, 112 Stat. 1853.) (As AMENDMENTS 1998 Subsec. (h)(2)(A)(v). Pub. L. 105-245 substituted "Science of the Department of Energy" for "Energy Research of the Department of Energy". SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 284, 284b, 285b-7, 285c-6, 287c-21, 289c, 300cc-40a of this title. § 284b. Biennial report SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 284a, 285a-2, 285a-5, 285a-6, 285b-6, 285c-7, 285g-4, 285n-1, 2850-1, 285p-1 of this title. § 284c. Certain uses of funds (a) [See main edition for text of (1) and (2)] (3) For purposes of paragraph (1), the term "administrative expenses" means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health. [See main edition for text of (b)] (As amended Pub. L. 104-316, title I, § 122(a), Oct. 19, 1996, 110 Stat. 3836; Pub. L. 105-362, title VI, § 601(a)(1)(B), Nov. 10, 1998, 112 Stat. 3285.) AMENDMENTS 1998 Subsec. (a)(4). Pub. L. 105-362 struck out par. (4) which read as follows: "Not later than December 31, 1987, and December 31 of each succeeding year, the Secretary shall report to the Congress the amount obligated in the fiscal year preceding such date for administrative expenses of the National Institutes of Health and the total amount appropriated for the National Institutes of Health for such fiscal year. The Secretary shall consult with the Comptroller General of the United States in preparing each report." 1996 Subsec. (a)(3). Pub. L. 104-316 struck out at end "In identifying expenses incurred for such support and administration the Secretary shall consult with the Comptroller General of the United States." § 284e. Research on osteoporosis, Paget's disease, and related bone disorders [See main edition for text of (a) to (c)] (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2003. (As amended Pub. L. 105-340, title I, §102, Oct. 31, 1998, 112 Stat. 3192.) AMENDMENTS 1998 Subsec. (d). Pub. L. 105-340 substituted "through 2003" for "and 1996". §284f. Parkinson's disease (a) In general The Director of NIH shall establish a program for the conduct and support of research and training with respect to Parkinson's disease (subject to the extent of amounts appropriated under subsection (e) of this section). (b) Inter-institute coordination (1) In general The Director of NIH shall provide for the coordination of the program established under subsection (a) of this section among all of the national research institutes conducting Parkinson's disease research. (2) Conference Coordination under paragraph (1) shall include the convening of a research planning |