To foster understanding of human health effects of exposure to environmental agents in the hope that these studies will lead to: the identification of agents that pose a hazard and threat of disease, disorders and defects in humans; the development of effective disease prevention strategies; the overall

credit:

improvement of human health effects due to environmental agents; the development of products and technologies designed to better study or ameliorate the effects of environmental agents; and the successful training of research scientists in all areas of environmental health research.

Supported grant programs focus on the following areas: (1) Understanding biological responses to environmental agents by determining how chemical and physical agents cause pathological changes in molecules, cells, tissues, and organs, and become manifested as respiratory disease, neurological, behavioral and developmental abnormalities, cancer, and other disorders; (2) Determining the mechanisms of toxicity of ubiquitous agents like metals, natural and synthetic chemicals, pesticides, and materials such as asbestos and silica, and natural toxic substances, and their effects of on various human organ systems, on metabolism, on the endocrine and immune systems, and on other biological functions; (3) Developing scientific information about potentially toxic and hazardous chemicals by concentrating on toxicological research, testing, test development, and validation efforts; (4) Conducting broad-scale efforts in biometry and risk estimation for determining, monitoring and predicting the probable health risks of cancer, organ system toxicities, and diseases and disorders resulting from human exposures to various environmental hazards, including the development of new statistical analytic tools and methods; (5) Expanding and improving 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; (6) Expanding and improving the 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; (7) Providing long-term stable support for broadly based multi-disciplinary research and training on environmental health problems in Environmental Health Sciences Core Centers.

These Centers serve as national focal points and resources for research and manpower development.

The DISCOVER centers intend to advance our understanding of the role of environmental factors in influencing human disease through an interdisciplinary effort where basic mechanistic and clinical research inform each other.

Through these Center programs, NIEHS expects to achieve the long range goal of developing new clinical and public health applications to improve disease prevention, diagnosis, and therapy.

Additional Centers programs developed in recent years, include the Centers for Oceans and Human Health (P50)(co-funded with NSF), Children's Environmental Health Centers (P01)(co-funded with USEPA) and the Autism Centers of Excellence (co-funded with (NIMH) (U54); (8) Supporting research training programs which serve to increase the pool of trained research manpower with needed expertise in the Environmental Health Sciences through support of IndividualandInstitutionalNational Research Service Awards (NRSAs); (9) The Outstanding New Environmental Scientist Program which provides first time research grant funding to outstanding junior scientists in the formative stages of their career who are proposing to make a long term commitment to environmental health sciences research and to address the adverse effects on environmental exposures on human biology, human pathophysiology and human disease.

In fiscal year 2007, 573 research project grant (RPG) awards were made, of which 176 were competitive RPG applications. 4 STTR and 34 SBIR awards were also made, of which 27 were competing. In addition, 36 Center grant awards were made in fiscal year 2007 including: 2 MFB Center Grant awards(P30); 21 EHS Center grant awards (P30); 9 Specialized Centers (P50); 4 Specialized Center Cooperative Grants (U54). Nine competing Center P30 grant applications were considered and four were funded. Also in fiscal year 2007, 53 Individual and 57 Institutional NRSA's were made. 48 competing Individual NRSA applications were considered and 22 funded, while 13 competing Institutional NRSA T32 applications were considered and 8 were funded. During fiscal year 2008, 555 RPG awards are expected to be made (including SBIR and STTR awards), while 29 Center grants, 53 Individual and 53 Institutional NRSA awards are expected to be funded. In fiscal year 2009, it is anticipated that 540 RPG awards (including SBIR and STTR awards), 29 Center grants, 48 Individual and 53 Institutional NRSAs will be made. During FY 2007/08, NIEHS awarded two DISCOVER Centers which focus on the role of environmental exposures in the development of asthma. They include mechanistic, clinical and public health related research designed to advance our understanding of this prevalent respiratory disease in children. NIEHS is one of the lead agencies at NIH involved in the Genes Environment and Health Initiative responsible for the Exposure Biology Program. The development of biomarkers, biosensors and to improve our understanding of exposure assessment of environmental agents. Within the field of the health effects of endocrine disrupting chemicals, NIESH supported research looking at exposures to these agents during development and early life and their health effects during childhood, adolescence and adulthood. Organochlorine pesticides were shown to affect birth outcomes such as birth weight and head circumference and motor development. A pilot project in our Breast Cancer research centers, phthlates and other EDCs were found in detectible levels in urine of girls ages 6-8 and researchers are studying whether these levels effect the timing of puberty. Animal experiments also link these types of chemicals, especially Bis-Phenol-A to prostate and breast cancer susceptibility. Researchers supported by NIEHS are also involved in research on the cardiopulmonary effects of air pollution. NIEHS researchers have reported on the relationship between pesticides and Parkinson's Disease and other neurodegenerative diseases. Scientists are also engaged in basic research in the areas of oxidative stress, DNA repair and cellular signaling in response to exposures to a wide variety of toxicants. The National Institute of Environmental Health Sciences and the National Human Genome Research Institute jointly launched a new Ruth L Kirschstein National Research Service Award Institutional Training Program in Human Genes and the Environment. The new Genes and Environment Training Program seeks to build upon the established foundations in exposure biology an high throughput genomics to produce a new generation of scientists who are equally at home in genomics and environmental health sciences and can seamlessly interact with both groups of scientists. These results point out the usefulness of applying proteomics technology as a tool for the discovery of early biomarkers of exposure to environmental chemicals. Theoretically, similar analyses could be used to identify susceptible individuals or could be used as a diagnostic tool for discovering the cause of disease. The study also sheds light on the possible mechanisms of the immunosuppressive effects of benzene.

Uses and Use Restrictions

Research Grants and Cooperative Agreements are intended to support the direct costs of a project, in accordance with an approved budget, plus an appropriate amount for indirect costs.

Environmental health sciences education grants (R25) are limited to $100,000 direct costs plus indirect costs calculated at 8 percent of appropriate direct cost base and they should promote the development of instructional material.

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, scientific and technical merit, and commercial potential of the Phase II application.

Independent Scientist Awards (Supersedes former Research Career Development Award): These awards are in amounts up to $75,000(plus fringe benefits, eight percent indirect costs, and $25,000 for research support) and are made to institutions to provide salary and research support for research scientists who need an additional period of sponsored research as a way to gain experience in a research area new to the candidate or in an area that would demonstrably enhance the candidate's scientific career.

Supplementation from nonfederal funds is allowed.

Mentored Clinical Scientist Development Awards and Mentored Patient-Oriented Research Career Development Awards (encompass the previous Physician Scientist Awards and Clinical Investigator Awards): Awards up to $75,000 (salary), $25,000 for research support plus eight percent indirect costs and fringe benefits, to provide for specialized study for clinically trained professionals who are committed to a career in research and have the potential to develop into independent investigators.

Supplementation from nonfederal funds is allowed.

Midcareer Investigator Award in Patient Oriented Research: These awards provide salary for levels of effort between 3-6 person months per year (plus fringe benefits)and $25,000 of career development support to provide support for mid-career health professional doctorates at the mid-career level protected time to devote to patient oriented research and to act as mentors, primarily for clinical residents.

The Mentored Quantitative Research Development Award: Awards up to $75,000 salary (plus fringe) and up to $40,000 in Career Development Expenses to junior faculty with quantitative and engineering backgrounds to allow them to refocus their research on NIH-relevant topics.

Supplementation from non-federal funds is allowed.

The Pathways to Independence Award provides up to five years of support consisting of two phases.

The initial phase provides 1-2 years of mentored support for highly promising postdoctoral research scientists.

Phase 2 consists of up to 3 years of independent research support contingent on securing an independent tenure track or equivalent research position.

The total costs per year for the mentored phase should not exceed $90,000 per year, and the total costs for the independent phase may not exceed $249,000 per year.

NIEHS Center grants are primarily intended to provide infrastructure support and the support of core research facilities.

In addition, an appropriate indirect cost is provided as determined by negotiated agreement with the grantee's cognizant government organization.

National Research Service Awards (NRSAs): Individual predoctoral and postdoctoral training awards are made for the support of fellowswho engageinresearchtraining in environmental toxicology, environmental pathology, environmental mutagenesis, or environmental epidemiology/biostatistics.

These training grants enable institutions to make awards to individuals selected by them, for both predoctoral and postdoctoral research training in the aforementioned areas.

Each individual who receives a postdoctoral NRSA is obligated upon termination of the award to comply with certain service and payback provisions.

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Eligibility Requirements

Applicant Eligibility

Research Grants, Cooperative Agreements, Science Education Grants, SBIR Grants, Independent Scientist Awards, Mentored Research Scientist Development Award, Mentored Clinical Scientist Development Award, and the Academic Career Awards: A university, college, hospital, State, local or tribal governments, nonprofit research institution, or for-profit organization may submit an application and receive a grant for support of research by a named principal investigator.

Candidates for Academic Career Awards Awards and Midcareer Investigator Awards in Patient Oriented Research must have a doctoral degree and peer-reviewed, independent, research support at the time the award is made.

Candidates for Mentored Clinical Scientist Development Awards and Mentored Patient Oriented Research Career Development Awards must have a clinical degree or its equivalent and must have initiated post graduate clinical training.

Candidates holding a Ph.D.

degree are ineligible.

Candidates who have served as principal investigators on PHS-supported research projects are ineligible.

A candidate for Academic Career Awards must have a clinical or research doctorate degree.

Those eligible for the Development Award must be able to devote at least 75 percent effort.

SBIR 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.

and its possessions.

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.

Centers: A university-based, nonprofit research institution, or for-profit organization proposing an integrated research program established to accomplish a stated mission, covering activities ranging from very basic research to the actual application of research results in the prevention and control of environmental health problems, may submit an application under the direction of a named Center Director.

National Research Service Awards: (1) Nonprofit domestic organizations may apply for the Institutional NRSA; (2) Individual NRSA awardees must be nominated and sponsored by a public for-profit or nonprofit private institution having staff and facilities appropriate to the proposed research training program; (3) all awardees must be citizens or have been admitted to the United States for permanent residence; (4) 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).

Beneficiary Eligibility

For Research Grants: Any nonprofit or for-profit organization, company, or institution engaged in biomedical research. For Centers and Training Grants: University-based nonprofit institutions; for-profit organizations conducting research; and individuals nominated by a private institution conducting research.

Credentials/Documentation

Research Grants, Science Education Grants, Cooperative Agreements, Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Awards, and Academic Career Awards: Applications must be signed by appropriate officials of the submitting institution. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For educational institutions and Indian Tribal governments, Costs will be determined in accordance with OMB Circular No. A-21. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For non-profit grantees, costs will be determined by OMB Circular A-122. 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 forms PHS 6246-2 and PHS 6426-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. Centers: Application must be signed by appropriate officials of the submitting institution. National Research Service Awards: (1) Individual NRSA Awards - The applicant's academic record, research experience, citizenship, institutional sponsorship, proposed area and plan of training must be included in the application; (2)Institutional NRSA - The applicant institution 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 awards, 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 45 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations 45 CFR, Part 74, Subpart Q.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

Research Grants, Science Education Grants, Cooperative Agreements, SBIR Grants and Awards: Application forms and instructions for their submission are available from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC-7910, Bethesda, MD 20892. Small Business Technology Transfer (STTR) program uses same procedure as SBIR immediately above. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program by those applicants which are State and 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 http://grants.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. SBIR and STTR grant applications should be submitted to grants.gov at http://grants.gov. For Center grants and NRSA Training grants the standard application forms, as furnished by PHS and required by 45 CFR 92, must be used for this program by those applicants that are State or local units of government. Centers: Consultation with National Institute of Environmental Health Sciences staff is essential prior to submission of an application. National Research Service Awards (Individual): Prior to formal application, an applicant must arrange for acceptance at sponsoring institution by a sponsor who will supervise the training. Application Kits and instructions for submission are available from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, Room 6207, 6701 Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910. Specific information concerning Centers may be obtained by contacting the office indicated under Information Contacts. This program is subject to the provisions of 45 CFR, 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations.

Award Procedures

Made on the basis of dual review by peer groups of all applications. The first level of reviews is by a study section for scientific merit. In addition, a national advisory council provides a secondary level of review for all applications. As required by P.L. 109-482, the NIH Health Reform Act of 2006, all research grant and cooperative agreements must undergo Advisory Council/Board review and approval prior to funding, including those $50,000 and under in direct costs. Review of Individual NRSA applications by an Advisory Council/Board is not required. Final approval of these recommendations and decisions concerning funding are made by the Director, NIEHS. All accepted applications are evaluated first for technical merit by an appropriate scientific review group and then by a national advisory council. All accepted SBIR and STTR applications are first evaluated for scientific and technical merit by an appropriate scientific peer review panel, then by a national advisory council. All applications receiving a priority score compete for available SBIR/STTR set-aside funds based on scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

Application deadlines for all grant mechanisms can be found at: http://grants1.nih.gov/grants/funding/submissionschedule.htm .

Authorization

Public Health Service Act, Section 301 and 472, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241, as amended, 42 U.S.C. 288, Public Law 99-500, Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

Range of Approval/Disapproval Time

From 6 to 9 months. SBIR and STTR: About 7-1/2 months. Centers and Institutional National Research Service Awards: From 6 to 9 months. Individual National Research Service Awards: From 6 to 8 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://www.grants.nih.gov/grants/guide/notice-files/not97-232.html.

Renewals

Research Grants, Cooperative Agreements, Center Grants, and Institutional Training Grants: Renewal applications are subject to same criteria as new applications. Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Scientist Development Award, Academic Career Awards, and Individual Training grants are non-renewable.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance

Research Grants, Cooperative Agreements, Center Grants, and NRSA Institutional grants may be awarded for up to 5 years, generally in 12-month budget periods and may be extended through a competitive renewal. Science Education Grants may be awarded for up to 5 years, in 12-month budget periods, and are not renewable. Independent Scientist Awards are awarded for 5 years in 12-month budget periods, and are non-renewable. Mentored Research Scientist Awards are for up to 5 years, 12-month budget periods, and are non-renewable. Mentored Clinical Scientist Development Awards and Academic Career Awards are for up to 5 years and are renewable. 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. National Research Service Awards: Individual awards are non-renewable and may be for 1, 2, or 3 years, but no individual may receive NRSA support at the predoctoral level for more than 5 years and at the postdoctoral level for more than 3 years. Funds are released primarily on basis of an Electronic Transfer System.

Post Assistance Requirements

Reports

Annual and final progress reports are required for all Grant Awards.

Annual financial reports are due for a subset of grant awards.

Final financial reports are due for all grant awards.

Additional reports are required after termination of National Research Service Awards to ascertain compliance with the service and payback provisions.

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 addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records

Expenditures and other financial records must be retained for 3 years from the day on which the grantee submit the last expenditure report for the report period.

Financial Information

Account Identification

75-0862-0-1-552.

Obigations

Grants: FY 07 $312,021,779; FY 08 $303,091,000; and FY 09 est $300,805,000.

Range and Average of Financial Assistance

$2,000 to $2,472,080; $368,277.

Regulations, Guidelines, and Literature

42 CFR 52; 45 CFR 74; 45 CFR 92; NIH Guide to Grants and Contracts; various other publications and application kits, the Division of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, Room 6207, 6701 Rockledge Drive, Bethesda, MD 20892. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.

Information Contacts

Regional or Local Office

None.

Headquarters Office

Program Contacts: Research Grants: Dr. Claudia Thompson, Acting Director, Center for Risk & Integrated Sciences, DERT, NIEHS, E-mail: thompso1@niehs.nih.gov. Telephone: (919) 541-4638; or Dr. J. Patrick Mastin, Chief, Cellular, Organ and Systems Pathobiology Branch, E-mail: mastin@niehs.nih.gov . Telephone: (919) 541-3289; or Dr. Gwen Collman, Chief, Susceptibility and Population Health, E-mail: collman@niehs.nih.gov; Telephone: (919) 541-4980. Environmental Justice, Science Education Grants: Dr. Gwen Collman, Chief, Susceptibility and Population Health, E-mail: collman@niehs.nih.gov; Telephone: (919) 541-4980. Independent Scientist Awards, Mentored Research Scientist Development Awards, Mentored Clinical Research Scientist Development Awards, Academic Career Awards: Dr. Carol Shreffler, Program Administrator, Cellular, Organ and Systems Pathobiology Branch, E-mail: shreffl1@niehs.nih.gov. Telephone: (919) 541-1445. AREA, SBIR and STTR Grant Programs: Dr. Jerrold Heindel, Program Administrator, Cellular, Organ and Systems Pathobiology Branch, E-mail: heindelj@niehs.nih.gov . Telephone: (919)541-0781. For each program contact, the rest of the mailing address is: Division of Extramural Research and Training, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, Research Triangle Park, NC 27709. P30 Core Centers Program Contact: Dr. Leslie Reinlib, Susceptibility and Population Health, Division of Extramural Research and Training, NIEHS, National Institutes of Health Service, Department of Health and Human Services, P.O. Box 12233, Research Triangle Park, NC 27709. E-mail: reinlib@niehs.nih.gov; Telephone: (919) 541-4998; NRSA Program Administrator: Dr. Carol Shreffler, Cellular, Organ and Systems Pathobiology Branch, Division of Extramural Research and Training, NIEHS, National Institutes of Health Service, Department of Health and Human Services, P.O. Box 12233, Research Triangle Park, NC 27709. Telephone: (919) 541-1445. E-mail: shreffl1@niehs.nih.gov. Grants Management Contact: Ms. Dorothy Duke, Chief, Grants Management Officer, Grants Management Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, Research Triangle Park, NC 27709. Telephone: (919) 541-2749. E-mail: duke3@niehs.nih.gov .

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 stated 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.