Tribal Self-Governance Study
Description of Program,
Service, Function or Activity (PSFA)
INVENTORY
1. Agency Name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, HHS
2. Program Name: Digestive Diseases and Nutrition Research
3. CFDA #: 93.848
4. Program Objectives: To encourage basic and clinical biomedical research and research training for a greater understanding of the basic and clinical studies on normal abnormal function of the enteric nervous system, on gastrointestinal hormones and peptides including their structure, biological actions, receptors, release and correlation with physiological events. Other studies include the action of drugs on gastrointestinal motility, intestinal obstruction, the biochemistry of contractile processes and diseases such as irritable bowel syndrome, colonic diverticular disease, swallowing disorder, and gastro esophageal reflux as well as studies on the process of food digestion in the gastrointestinal tract; the assembly of digestive enzymes; the growth and differentiation of gastrointestinal cells in normal and disease states; and studies on gastrointestinal diseases such as maldigestion and malabsorption syndromes, celiac sprue, diarrhea, inflammatory bowel disease, and gastric and duodenal ulcers. To encourage biomedical research and research training for a greater understanding of the normal function and the diseases of the liver and biliary tract including factors leading to liver cell injury, fibrosis, and death; basic and applied studies on liver transplantation; metabolism of bile acids and bilirubin; and factors controlling cholesterol levels in bile as well as disease research on inborn errors in bile metabolism hepatitis, and various liver diseases such as Wilson's disease, primary biliary cirrhosis, and others. To encourage biomedical research on the structure, function, and diseases of the exocrine pancreas. To encourage biomedical research and research training in obesity, anorexia, bulimia and other eating disorders, the metabolism of nutrients and other dietary components at the organ, cellular and subcellular levels in normal and diseased states. To extramurally support basic laboratory research and clinical investigations and provide postdoctoral biomedical research training for individuals interested in careers in health sciences and fields related to these programs.
Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; To increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
Small Business Technology Transfer (STTR) program: To stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
5. Titles and Descriptions of at least Three Funded Grantees: Look AHEAD (Action for Health in Diabetes) (formerly called SHOW): Look AHEAD (formerly called SHOW) led by the NIDDK and co-sponsored by the NHLBI, NINR, the OWH, the NCHD, and the CDC, is a multicenter, randomized clinical trial to study if interventions designed to produce sustained weight loss in obese individuals with type 2 diabetes improve health. The trial is expected to enroll 5,000 obese patients with type 2 diabetes. Participants will include a wide range of minority populations with varying ethnic/racial backgrounds to reflect the disproportionate impact of diabetes in these groups. In addition, a center focused on Native Americans will be funded through the NIDDK Phoenix Epidemiology and Clinical Research Branch.
Obesity Prevention for Native American Children: The purpose of this study is to pilot test an intervention aimed at preventing obesity. In high-risk children-those with overweight parents. Forty-five Native American (Mohawk) parents will be randomly assigned to a Parenting Skills (control) condition or a Parenting Skills+Obesity Prevention condition. The results of this investigation will be used as the basis for planning a larger project that will measure the influence of the intervention on acceleration of weight gain in young children.
Mechanisms of Bile Pigment Excretion: The investigators preliminary studies have demonstrated the absence of MDR 3 protein and messenger RNA in 5 patients with Navajo neuropathy, a recessively inherited progressive cholestatic liver and degenerative neurological disease of children living on the Western Arizona Navajo reservation. The human MDR 3 gene has been localized to chromosome 7. In proposed studies, sequence tag sites will be used as markers for homozygosity analysis of the MBR 3 region of chromosome 7 in patients and their families. Further studies will attempt to determine the precise genetic and molecular defect in MDR 3 in these patients. Experiments are designed to examine the MDR 3 gene for nonsense mutations, alternate splicing of the primary mRNA transcript leading to destabilization of the MDR 3 message, and possible mutations in the promoter region resulting in decreased transcription. The proposed studies plan to establish molecular diagnostic test and genetic counseling, develop novel therapies, based on the molecular defect and identify and modify correctable environmental factors involved in the neurological disorder.
AUTHORITY
6. Authorizing Statute(s): Public Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493, 495, and 498, as amended, Public Laws 78-410, 99- 158, and 100-607, 42 U.S.C. 241, as amended; 42 U.S.C. 285c-2, 42 U.S.C. 285c-5, 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
7. Regulatory/Administrative Requirements: None
8. Mandatory Statutory Changes Needed to Operate PSFA as a Demonstration: Authority would need to modify the grant making process, enable the Department to make self-governance funding awards, and alter federal monitoringing mandates.
APPLICANTS, BENEFICIARIES and FORMULAS
9. Type of Funding: Competitive project grants.
10. Eligible Applicants: Research grants: Individuals and public and private institutions, both nonprofit and for-profit, who propose to establish, expand, and improve research activities in health sciences and related fields.
National Research Service Awards: Individuals must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Nonprofit domestic organizations may apply for the Institutional National Research Service grant.
Small Business Innovation Research grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
11. Allotment Formulas, Etc.: This program has no statutory formula or matching requirements.
12. Applicant Provisions/Allotments in Law for Indians: NA
13. Eligible Beneficiaries: Research Grants: Although no degree of education is either specified or required, nearly all successful applicants have doctoral degrees in one of the sciences or professions. National Research Service Awards: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.
14. Beneficiary Provisions/Allotments in Law for Indians: NA
15. Amount and Percent of Total that is Mandatory for Indians: No amount and percent of total is mandatory for Indians.
FINANCIAL
16. Total FY 2000 Funding for Diabetes, Endocrinology and Metabolism; Digestive Diseases and Nutrition Research; and Kidney Diseases, Urology and Hematology Research: $3.298 million.
17. Amount and Percent of Total Funding Awarded to Indians: NA
18. For Awards to Tribes: Number, Range and Average Amounts: NA
19. Total FY 2001 Funding and Amount for Indians, If Known: Currently, FY2001 funding is not known.
OTHER
20. NIDDK is required to develop an Annual Performance Report on the Institute=s Actions to Assist Tribal Colleges and Universities (TCUs) and Native American Tribes. NIDDK is also required to develop an Annual Federal Plan to Implement Executive Order 13021 on Tribal Colleges and Universities.
CONTACTS
21. DHHS Workgroup Contact: John Ruffin, Ph.D., Director
National
Center on Minority Health and Health Disparities
(301) 402-1366
22. HHS Agency/Program Contact: Lawrence Y. Agodoa, M.D.,
Director
Office of Minority Health Research Coordination, NIDDK