Diabetes, Endocrinology and Metabolism Research (93.847)

Program

93.847 Diabetes, Endocrinology and Metabolism Research

Federal Agency

Agency: Department of Health and Human Services
Office: National Institutes of Health

Authorization

Public Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493, 495, and 498, as amended; Public Laws 78-410, 99- 158, 100-607, 106-554, and 107-360; 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.

Program Number

93.847

Last Known Status

Active

Objectives

(1) To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.
Specific programs areas of interest include the following:
(a) For diabetes, endocrine, and metabolic diseases areas: Fundamental and clinical studies including the etiology, pathogenesis, prevention, diagnosis, treatment and cure of diabetes mellitus and its complications; Normal and abnormal function of the pituitary, thyroid, parathyroid, adrenal, and other hormone secreting glands; Hormonal regulation of bone, adipose tissue, and liver; on fundamental aspects of signal transduction, including the action of hormones, coregulators, and chromatin remodeling proteins; Hormone biosynthesis, secretion, metabolism, and binding; and on hormonal regulation of gene expression and the role(s) of selective receptor modulators as partial agonists or antagonists of hormone action; and Fundamental studies relevant to metabolic disorders including membrane structure, function, and transport phenomena and enzyme biosynthesis; and basic and clinical studies on the etiology, pathogenesis, prevention, and treatment of inherited metabolic disorders (such as cystic fibrosis).
(b) For digestive disease and nutrition areas: Genetics and genomics of the GI tract and its diseases; Genetics and genomics of liver/pancreas and diseases; Genetics and genomics of nutrition; genetics and genomics of obesity; Bariatric surgery; Clinical nutrition research; Clinical obesity research; Complications of chronic liver disease; Fatty liver disease; Genetic liver disease; HIV and liver; Cell injury, repair, fibrosis and inflammation in the liver; Liver cancer; Liver transplantation; Pediatric liver disease; Viral hepatitis and infectious diseases; Gastrointestinal and nutrition effects of AIDS; Gastrointestinal mucosal and immunology; Gastrointestinal motility; Basic neurogastroenterology; Gastrointestinal development; Gastrointestinal epithelial biology; Gastrointestinal inflammation; Digestive diseases epidemiology and data systems; Nutritional epidemiology and data systems; Autoimmune liver disease; Bile, Bilirubin and cholestasis; Bioengineering and biotechnology related to digestive diseases, liver, nutrition and obesity; Cell and molecular biology of the liver; Developmental biology and regeneration; Drug-induced liver disease; Gallbladder disease and biliary diseases; Exocrine pancreas biology and diseases; Gastrointestinal neuroendocrinology; Gastrointestinal transport and absorption; Nutrient metabolism; Pediatric clinical obesity; Clinical trials in digestive diseases; Liver clinical trials; Obesity prevention and treatment; and Obesity and eating disorders.
(c) For kidney, urologic and hematologic diseases areas: Studies of the development, physiology, and cell biology of the kidney; Pathophysiology of the kidney; Genetics of kidney disorders; Immune mechanisms of kidney disease; Kidney disease as a complication of diabetes; Effects of drugs, nephrotoxins and environmental toxins on the kidney; Mechanisms of kidney injury repair; Improved diagnosis, prevention and treatment of chronic kidney disease and end-stage renal disease; Improved approaches to maintenance dialysis therapies; Basic studies of lower urinary tract cell biology, development, physiology, and pathophysiology; Clinical studies of bladder dysfunction, incontinence, pyelonephritis, interstitial cystitis, benign prostatic hyperplasia, urolithiasis, and vesicoureteral reflux; Development of novel diagnostic tools and improved therapies, including tissue engineering strategies, for urologic disorders;Research on hematopoietic cell differentiation; metabolism of iron overload and deficiency; Structure, biosynthesis and genetic regulation of hemoglobin; as well as Research on the etiology, pathogenesis, and therapeutic modalities for the anemia of inflammation and chronic diseases.
(2) To encourage basic and clinical research training and career development of scientists during the early stages of their careers. The Ruth L. Kirschstein National Research Service Award (NRSA) funds basic and clinical research training, support for career development, and the transition from postdoctoral biomedical research training to independent research related to diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.
(3) To expand and improve the Small Business Innovation Research (SBIR) program. The SBIR Program aims to increase and facilitate private sector commercialization of innovations derived from Federal research and development; to enhance 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.
(4) To utilize the Small Business Technology Transfer (STTR) program. The STTR Program intends 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.

Types of Assistance

PROJECT GRANTS

Uses and Use Restrictions

Project Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives. NRSAs are made directly to individuals for research training in specified biomedical shortage areas, or, to institutions to enable them to make NRSAs to individuals selected by them. Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.

Eligibility Requirements

Applicant Eligibility

Project Grants: Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both non-profit and for-profit, and individuals who propose to establish, expand, and improve research activities in health sciences and related fields. NRSAs: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. 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). 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. Nonprofit domestic organizations may apply for the Institutional NRSA. SBIR and STTR grants can be awarded only to domestic small businesses that meet the following criteria: 1) Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit; 2) Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States. 3) Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. STTR grants 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.

Beneficiary Eligibility

Health professionals, graduate students, health professional students, scientists, and researchers, any nonprofit or for-profit organization, company, or institution engaged in biomedical research. Project 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. NRSAs: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.

Credentials/Documentation

Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Individual NRSA applications for postdoctoral training must include the candidate's academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training. Institutional Training grant applications for predoctoral and postdoctoral training must show the objectives, methodology and resources for the research training program; the qualifications and experience of directing staff; the criteria to be used in selecting individuals for stipend support; and a detailed budget and justification for the amount of grant funds requested.
Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant form PHS 398 is used to apply for SBIR and STTR Phase I Phase II and Phase I/Phase II Fast Track. OMB Circular No. A-87 applies to this program.

Application and Award Process

Preapplication Coordination

Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.

Application Procedure

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. Project Grants: Applications for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. Applications may not be submitted in paper format. A registration process through Grants.gov is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. Two steps are required for on time submission: (1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date. (2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons. The standard application forms, as furnished by PHS and required by 45 CFR Part 92, must be used for this program by those applicants that are State or local units of government. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms.

Award Procedure

Research Grant and Training Program applications are reviewed initially for scientific merit by an appropriate review panel, composed of scientific authorities, and by the National Diabetes and Digestive and Kidney Diseases Advisory Council composed of leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. The successful applicant is sent a Notice of Grant Award. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Range of Approval/Disapproval Time

Project Grants: From 6 to 9 months. National Research Service Awards: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months.

Appeals

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals

Project Grants: Renewals are determined by competitive application and review. Extensions considered upon request. Individual NRSAs: Awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula.

Matching requirements are not applicable to this program.

MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

Project Grants: Awards are usually made for a 12-month period with recommendation of up to 4 years of additional support. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: The Notice of Award (NoA) is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual increments following the annual assessment of progress. This funding is also contingent on the availability of funds. The NoA includes all applicable terms of award either by reference or specific statements. It provides contact information for the assigned program officer and grants management specialist. The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.

Post Assistance Requirements

Reports

Project Grants: Expenditures and other financial records, including documents supporting accounting records and substantive charges to each grant, must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period. NRSAs: Documentation of expenditures and other fiscal records must be kept readily available for examination by authorized Government personnel and must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period. Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions. Cash reports are not applicable. Annual and terminal progress reports, annual reports of inventions, and annual certification with respect to research involving human subjects are required. Reports of expenditures are required. NRSAs: Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions. Performance monitoring is not applicable.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In accordance with OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend $500,000 or more in a year in Federal awards shall have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133, but records must be available for review or audit by appropriate officials of the Federal agency, pass-through entity, and Government Accountability Office (GAO).

In accordance with 45 Code of Federal Regulations, Part 74.26, for-profit (commercial) organizations are subject to audit requirements for a non-Federal audit if, during it s fiscal year, it expended $500,000 or more under HHS awards and at least one award is a HHS grant or subgrant. The regulation incorporates the thresholds and deadlines of OMB Circular No. A-133, but provides for profit organizations with two options for the type of audit that will satisfy the audit requirement:
1.a financial related audit of the HHS awards in accordance with Government Auditing Standards, or
2.an audit that meets the requirements of OMB Circular No. A-133.

In accordance with NIH grants policy, Foreign grantees are subject to the same audit requirements as for-profit (commercial) organizations.

Records

Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants.
In accordance with 45 Code of Federal Regulations, Part 74.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipient�s personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.

Program Accomplishments

Fiscal Year 2008: Project Grants: In FY 2008, 2,920 awards were made. NRSAs: In FY 2008, 371 awards were made and 1,106 trainees were funded. SBIR: In FY 2008, 106 awards were made. Fiscal Year 2009: Project Grants: In FY 2009, 2,896 awards have been made. NRSAs: In FY 2009, 427 awards have been made and 1,110 trainees funded. SBIR: In FY 2009, 110 awards have been made. Fiscal Year 2010: Project Grants: In FY 2010, 2,961 awards are estimated. NRSAs: In FY 2010, 425 awards and 1,106 trainees are estimated. SBIR: In FY 2010, 110 awards are estimated.

Financial Information

Account Identification

75-0884-0-1-552.

Obligations

(Project Grants) FY 08 $1,221,925,000; FY 09 est $1,277,469,000; FY 10 est $1,304,385,000 - Project Grants: FY 2008 Actual: $1,120,623,000; FY 2009 Estimate: $1,174,979,000; FY2010 Estimate: $1,201,399,000
NRSAs: FY 2008 Actual: $55,903,000; FY 2009 Estimate: $56,345,000; FY 2010 Estimate: $56,345,000
SBIRs: FY 2008 Actual: $45,399,000; FY 2009 Estimate: $46,145,000; FY 2010 Estimate: $46,641,000.

Range and Average of Financial Assistance

Project Grants: $3,219 to $28,375,332; $383,775
NRSAs: $4,200 to $575,745; $46,703
SBIR: Phase I awards approximately $100,000; Phase II awards not to exceed $750,000.

Regulations, Guidelines and Literature

Project Grants: 42 CFR 52; 42 CFR 66; 42 CFR 74; 45 CFR 74; 45 CFR 92. Administration Policy Directive No. 65 01 (47 Fed. Reg. 52966 et seq. (1982), as amended by Policy Directive No. 65 01.1 (48 Fed. Reg. 38794 et seq. (1983)). Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement, http://grants.nih.gov/grants/policy/nihgps_2003/; Omnibus Solicitation of the Public Health Service for SBIR Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for STTR Grant Applications.

Related Programs

Not Applicable.

Information Contacts

Regional or Local Office

None. Project Grants: Dr. Judith Fradkin, Director, Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 689, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-7349; Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 675, 6707 Democracy Blvd., Telephone: (301) 594-7680; Dr. Robert Star, Director, Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 625, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 594-7717. Small Business Innovation Research Grants Contact: Mrs. Helen Ling, Senior Grants Management Specialist, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 732, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8857. Grants Management Contact: Mr. Robert Pike, Chief Grants Management Officer, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 731, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8854. Use the same numbers for FTS.

Headquarters Office

Terra L. Robinson 6707 Democracy Boulevard, Suite 714, Bethesda, Maryland 20892 Email: robinste@niddk.nih.gov Phone: 3014969488

Web Site Address

http://www2.niddk.nih.gov

Examples of Funded Projects

Fiscal Year 2008: (a) For diabetes, endocrine, and metabolic diseases projects: Genetic Studies of Type 2 Diabetes; Regulators of Insulin Secretion and Action; Mode of Action of Steroid Hormones; Autoimmune Basis of Type 1 Diabetes; and Activators of Mutant Cystic Fibrosis Transmembrane Regulator ; SBIR grant: Implantable Glucose Sensor
(b) For digestive diseases and nutrition projects: Pathogenesis of Gastroesophageal reflux disease (GERD). Genetics of inflammatory bowel disease. Inflammation in IBD. Prevention of weight gain. Treatment of non-alcoholic steatohepatitis (NASH). Long-term treatment of hepatitis C
(c) For kidney, urologic, and hematologic diseases projects: Functional Structure of Renal Tubule; Pathogenesis of Experimental Glomenolonephritis; Pathology of Recovery from Acute Renal Failure; Urinary Stone Prevention; and In vitro Studies of Hematopoietic Regulation; SBIR grant: Laser Fragmentation of Urinary Calculi. Fiscal Year 2009: No Current Data Available Fiscal Year 2010: No Current Data Available

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.