Notice of Listing of Grants for Research Projects

AGENCY:

National Institutes of Health, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

Section 52.1(b) of the regulations governing grants for research projects, codified at 42 CFR part 52, authorizes the Secretary of Health and Human Services to publish periodically a list of all of the research project grant programs to which the research project grant regulations apply. This Notice provides the most recent list of the programs covered by the regulations and supersedes the prior Notice published on November 25, 2003 (68 FR 66114-66117).

DATES:

Effective Date: September 26, 2006.

FOR FURTHER INFORMATION CONTACT:

Jerry Moore, NIH Regulations Officer, Office of Management Assessment, 6011 Executive Boulevard, Room 601, MSC 7669, Rockville, MD 20892, telephone 301-496-4607 (not a toll-free number), fax 301-402-0169, e-mail jm40z@nih.gov.

SUPPLEMENTARY INFORMATION:

The National Institutes of Health (NIH) published a final rule in the Federal Register on October 24, 1996 (61 FR 55102-55106), amending the regulations at 42 CFR part 52, Grants for Research Projects, which govern Public Health Service (PHS) research project grants. We amended the regulations to apply to all research project grant programs administered by PHS and its components, including the programs administered by NIH, except for grants for health services research, demonstrations, and evaluation projects administered by the Agency for Healthcare Research and Quality (AHRQ), to make it unnecessary to include a long list of programs in the regulations or to go through the lengthy process of amending the regulations each time a new program is established. At that time, we provided in the preamble a listing of the applicable programs and indicated that we would publish periodically a list of the research project grant programs to which the regulations apply, and that the applicability of the regulations to new programs would be announced as PHS components initiated new programs.

Subsequently, we published the Notice entitled, “Notice of Listing of Grants for Research Projects,” in the Federal Register on November 25, 2003. In the Notice we provided an updated list of programs to which the regulations at part 52 apply that reflected the addition of new authorities in sections 317J, 317K, 317L, 330E, 399M, 399N, 409E, 434A, 445I, 447B, and 1261 of the Public Health Service Act (PHS Act), as amended.

We are now publishing a further updated list that reflects the addition of the new authority in subsections (a) and (f) of section 485D of the PHS Act, as amended, concerning research in complementary and alternative medicine. Specifically, the authority in subsection (a) concerns the conduct and support of basic and applied research (including both intramural and extramural research), research training, and dissemination of health information with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic and prevention modalities, and disciplines and systems of complementary and alternative medicine. Subsection (f) concerns the conduct and support of high quality, rigorous scientific reviewing of complementary and alternative medicine modalities, including outcomes research and investigations, epidemiological studies, health services research, basic sciences research, clinical trials, and other appropriate research and investigational activities.

The regulations codified at 42 CFR part 52 apply to all PHS research project grant programs except for grants for health services research, demonstrations, and evaluation projects administered by the AHRQ. Specifically, the research project grant authorities to which the Grants for Research Projects regulations apply include:

(1) Research into the cause, diagnosis, treatment, control, or prevention of the physical or mental diseases, injuries, or impairments to human life, as authorized by sections 301, 302, and related provisions of the PHS Act (42 U.S.C. 241, 242);

(2) Research into the prevention and control of childhood lead poisoning, as authorized under section 301 of the PHS Act (42 U.S.C. 241);

(3) Epidemiologic studies and State-based research capacity building projects for the prevention of primary and secondary disabilities, as authorized under section 301 of the PHS Act (42 U.S.C. 241);

(4) Ecological and epidemiologic research studies in Lyme disease, including disease surveillance, development and evaluation of prevention and control studies, and development of improved diagnostic tests, as authorized under section 301 of the PHS Act (42 U.S.C. 241);

(5) Research for the development of knowledge and approaches to the epidemiology, eitology, diagnosis, treatment, control, and prevention of narcotic addiction and intravenous (IV)-related AIDS and drug abuse, as authorized under sections 301 and 302 of the PHS Act (42 U.S.C. 241, 242);

(6) Investigations to identify strategies for prevention of childhood deaths from diarrhea, as authorized under sections 301 and 317(k) of the PHS Act (42 U.S.C. 241, 247b(k));

(7) HIV/AIDS surveillance, HIV serosurveillance surveys and studies, and epidemiologic research studies of AIDS and HIV infection, as authorized under sections 301 and 317(k) of the PHS Act (42 U.S.C. 241, 247b(k));

(8) Surveillance and epidemiologic studies for the prevention of infectious diseases and injuries in children in child day care settings, as authorized under sections 301, 317(k), and 391 of the PHS Act (42 U.S.C. 241, 247b(k)(3), 280(b));

(9) Research into prevention and control of tuberculosis, especially research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations, as authorized by section 317E of the PHS Act (42 U.S.C. 247b-6);

(10) Research with respect to education and training for health professionals and the general public relating to the effects of folic acid in preventing birth defects, as authorized by section 317J of the PHS Act (42 U.S.C. 247b-11);

(11) Research relating to risk factors, prevention strategies, and the roles of the family, health care providers, and the community in safe motherhood, as authorized by section 317K of the PHS Act, as amended by section 901 of Public Law 106-310 (42 U.S.C. 424b-12);

(12) Epidemiological research on the prevention of prenatal and postnatal smoking, alcohol, and illegal drug use, as authorized by section 317L of the PHS Act, as amended by section 911 of Public Law 106-310 (42 U.S.C. 247b-13);

(13) Research relating to intervention strategies to improve the lives of persons with epilepsy, particularly children, as authorized by section 330E of the PHS Act, as amended by section 801 of Public Law 106-310 (42 U.S.C. 254c-5);

(14) Injury prevention and control research, as authorized by section 391 of the PHS Act (42 U.S.C. 280b);

(15) Research relating to the efficacy of new screening techniques and technology, including clinical studies of screening methods and studies on the efficacy of new interventions regarding hearing loss in infants, as authorized by section 399M of the PHS Act, as amended by section 702 of Public Law 106-310 (42 U.S.C. 280g-1);

(16) Research relating to improving the outcomes among children with childhood cancers and resultant secondary conditions, as authorized by section 399N of the PHS Act, as amended by section 1101 of Public Law 106-310 (42 U.S.C. 280g-2);

(17) Research on osteoporosis, Paget's disease, and related bone disorders, as authorized by section 409A of the PHS Act (42 U.S.C. 284e);

(18) Research relating to autoimmune diseases, as authorized by section 409E of the PHS Act, as amended by section 1901 of Public Law 106-310 (42 U.S.C. 284i);

(19) Long-term epidemiology studies relating to type 1 or juvenile diabetes, as authorized by section 434A of the PHS Act, as amended by section 402 of Public Law 106-310 (42 U.S.C. 285c-9);

(20) Biomedical research in areas relating to Alzheimer's disease and related dementias, as authorized by section 445B of the PHS Act (42 U.S.C. 285e-4);

(21) Clinical research and training to enhance and promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care, and treatment of individuals with Alzheimer's disease, as authorized by section 445I of the PHS Act (42 U.S.C. 285e-10a);

(22) Clinical research and training to enhance and promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care, and treatment of individuals with sexually transmitted diseases, as authorized by section 447B of the PHS Act, as amended by section 901 of Public Law 106-505 (42 U.S.C. 285f-3);

(23) Research relating to medical rehabilitation, as authorized by section 452 of the PHS Act (42 U.S.C. 285g-4);

(24) Research on clinical and health services on eye care and diabetes, as authorized by section 456 of the PHS Act (42 U.S.C. 285i-1);

(25) Research on multiple sclerosis, especially research on the effects of genetics and hormonal changes on the progress of the disease, as authorized by section 460 of the PHS Act (42 U.S.C. 285j-3);

(26) Research on the social, behavioral, and biomedical etiology, the mental and physical health consequences, and the social and economic consequences of alcohol abuse and alcoholism, as authorized by 464H of the PHS Act (42 U.S.C. 285n);

(27) Health services research activities with respect to the prevention of alcohol abuse and treatment of alcoholism, as authorized by section 464H of the PHS Act (42 U.S.C. 285n) and as defined in section 409 of the PHS Act (42 U.S.C. 284d);

(28) Research under the Medication Development Program to encourage and promote the development and use of medications to treat drug addiction; and to collect, analyze, and disseminate data, as authorized by section 464P of the PHS Act (42 U.S.C. 285o-4);

(29) Research on health-related educational technologies, on medical library science and related activities, and for the development or dissemination of new knowledge, techniques, systems, and equipment for processing, storing, retrieving, and distributing information pertaining to health sciences, as authorized by section 473 of the PHS Act (42 U.S.C. 286b-4);

(30) Research with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems of complementary and alternative medicine, as authorized by section 485D (a) and (f) of the PHS Act, as amended (42 U.S.C. 287c-21(a), (f));

(31) Research in the biomedical, contraceptive, development, behavioral and program implementation fields related to family planning and population, as authorized by section 1004 of the PHS Act (42 U.S.C. 300a-2);

(32) Basic and applied research regarding traumatic brain injury, including the development, modification, and evaluation of therapies and programs of rehabilitation toward reaching or restoring normal capabilities, as authorized by section 1261 of the PHS Act, as amended by section 1301 of Public Law 106-310 (42 U.S.C. 300d-61);

(33) Research on the causes, consequences, and approaches of coping with adolescent sexual relations, contraceptive use, pregnancy, and parenthood, as authorized by section 2008 of the PHS Act (42 U.S.C. 300z-7);

(34) Research relating to the evaluation of drug treatments for AIDS not approved by the Commissioner of Food and Drugs, as authorized by section 2314 of the PHS Act (42 U.S.C. 300cc-14);

(35) International research relating to the development and evaluation of vaccines and treatments for AIDS, as authorized by section 2315 of the PHS Act (42 U.S.C. 300cc-15);

(36) Long-term research into treatments for AIDS, as authorized by section 2320 of the PHS Act (42 U.S.C. 300cc-20);

(37) Research relating to AIDS conducted outside the United States by qualified foreign professionals and collaborative research involving American and foreign participants, as authorized by section 2354 of the PHS Act (42 U.S.C. 300cc-41);

(38) Basic research to identify, characterize, and quantify risks to human health from air pollutants, as authorized by section 103 of the Clean Air Act, as amended (42 U.S.C. 7403);

(39) Electronic product radiation control research programs designed to protect the public health and safety from electronic product radiation, as authorized by section 532 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 360ii);

(40) Research into areas where a microgravity environment may contribute to significant progress in the understanding and treatment of diseases and other medical conditions, as authorized by section 603 of the National Aeronautics and Space Administration Authorization Act, Fiscal Year 1993 (42 U.S.C. 2487b);

(41) Support for radiation studies and research, as authorized under section 301 of the PHS Act (42 U.S.C. 241) and by section 20(a) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a));

(42) Research on occupational safety and health problems in industry, as authorized by section 20(a) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a)) and section 501 of the Federal Coal Mine Health and Safety Act of 1969 (30 U.S.C. 951); and

(43) Research to stimulate health-related technological innovation especially through the use of small business, minority, and disadvantaged firms and increased private sector commercialization of innovations derived from Federal research and development, as authorized under section 301 of the PHS Act (42 U.S.C. 241), in accordance with the procedures prescribed pursuant to section 2[9] of the Small Business Innovation Development Act of 1982, as amended (15 U.S.C. 638).

The Catalog of Federal Domestic Assistance (CFDA) numbered programs affected by title 42 of the Code of Federal regulations, part 52, are:

93.113—Biological Response to Environmental Health Hazards

93.114—Applied Toxicological Research and Testing

93.115—Biometry and Risk Estimation—Health Risks from Environmental Exposures

93.118—Acquired Immunodeficiency Syndrome (AIDS) Activity

93.121—Oral Diseases and Disorders Research

93.135—Centers for Research and Demonstration for Health Promotion and Disease Prevention

93.136—Injury Prevention and Control Research and State and Community Based Programs

93.172—Human Genome Research

93.173—Research Related to Deafness and Communication Disorders

93.184—Disabilities Prevention

93.213—Research and Training in Complementary and Alternative Medicine

93.242—Mental Health Research Grants

93.262—Occupational Safety and Health Program

93.271—Alcohol Research Career Development Awards for Scientists and Clinicians

93.273—Alcohol Research Programs

93.279—Drug Abuse and Addiction Research Programs

93.281—Mental Health Research Career/Scientist Development Awards

93.283—Centers for Disease Control and Prevention—Investigations and Technical Assistance

93.361—Nursing Research

93.389—National Center for Research Resources

93.390—Academic Research Enhancement Award

93.393—Cancer Cause and Prevention Research

93.394—Cancer Detection and Diagnosis Research

93.395—Cancer Treatment Research

93.396—Cancer Biology Research

93.821—Biophysics and Physiological Sciences Research

93.837—Heart and Vascular Diseases Research

93.838—Lung Diseases Research

93.839—Blood Diseases and Resources Research

93.846—Arthritis, Musculoskeletal and Skin Diseases Research

93.847—Diabetes, Endocrinology and Metabolic Research

93.848—Digestive Diseases and Nutrition Research

93.849—Kidney Diseases, Urology and Hematology Research

93.853—Clinical Research Related to Neurological Disorders

93.855—Allergy, Immunology, and Transplantation Research

93.856—Microbiology and Infectious Diseases Research

93.859—Biomedical Research and Research Training

93.865—Child Health and Human Development Extramural Research

93.866—Aging Research

93.867—Vision Research

93.879—Medical Library Assistance

93.941—HIV Demonstration, Research, Public and Professional Education Projects

93.942—Research, Treatment and Education Programs on Lyme Disease in the United States

93.943—Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected Population Groups

93.947—Tuberculosis Demonstration, Research, Public and Professional Education