NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
AUTHORIZATION:
Public
Health Service Act, Section 301, Public Law 78-410, 42 U.S.C. 241,
as amended; Small Business Research and Development Enhancement
Act of 1992, Public Law 102-564.
To
focus on understanding 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. Understanding biological
responses to environmental agents is one key to understanding the
human health effects of exposure to environmental agents, and is
the cornerstone to identifying those exposures that pose a hazard
and threat of disease, disorders and defects in humans. A first
step in understanding biological responses is identifying and characterizing
those biological, chemical and physical environmental agents that
are hazardous to health. By understanding the relationship between
environmental exposures and the subsequent development of disease
or biological injury, human health may be better protected. These
studies are conducted in the hope that they will lead to the development
of effective disease prevention strategies. The National Institute
of Environmental Health Sciences (NIEHS) grants also support studies
of the mechanisms of toxicity of such ubiquitous agents as metals,
natural and synthetic chemicals, pesticides, and materials such
as asbestos and silica, and natural toxic substances. Specific attention
is paid to the effects of these agents on various human organ systems,
on metabolism, on the endocrine and immune systems, and on other
biological functions. 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 h 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. Environmental
Health Sciences Education Program: To improve the understanding
of environmental health sciences research and services occupations
by developing educational materials and training instructors to
implement the newly developed materials for Grades K-12.
TYPES
OF ASSISTANCE:
Project Grants. Place Cursor Here for Definition
USES
AND USE RESTRICTIONS:
Research Grants: 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 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 for 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
Phase II application. Independent Scientist Awards (supersedes the
former Research Career Development Award): These awards in amounts
up to $50,000 (plus fringe benefits and 8 percent indirect costs)
are made to institutions to provide stable salary support for the
development of newly independent scientists to enable them to expand
their potential to make significant contributions to their field
of research. Supplementation from nonfederal funds is allowed. Mentored
Research Scientist Development Awards (encompass the previous Mid-Career
Development Awards and the Minority School Faculty Development Awards):
These awards in amounts up to $50,000 (plus fringe benefits, 8 percent
indirect costs, and $10,000 for research support) are made to institutions
to provide salary and supplies 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. Mentored
Clinical Scientist Development Award (encompasses the previous Physician
Scientist Awards and Clinical Investigator Awards). Awards up to
$50,000 (salary) $10,000 to $20,000 for research support plus 8
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.
Academic Career Awards (supersedes the Academic Award in Environmental/Occupational
Medicine): Up to $50,000 (salary), $10,000 to $20,000 for research
support, plus 8 percent indirect costs and fringe benefits to develop
Environmental/Occupational Medicine curriculum/faculty at schools
of medicine and osteopathy. Supplementation from nonfederal funds
is allowed.
ELIGIBILITY REQUIREMENTS:
Applicant Eligibility:
Research Grant and Cooperative Agreements, Science Education Grants,
Independent Scientist Awards, Mentored Research Scientist Development
Award, the mentored Clinical Scientist Development Award, and the
Academic Career Awards: A university, college, hospital, State or
local government, 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 must have a doctoral degree and peer-reviewed, independent,
research support at the time the award is made. Candidates for Mentored
Clinical Scientist Development Award 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. Those eligible for the leadership award must have an academic
appointment at a level sufficient to enable him/her to exert an
influence on the coordination of research, teaching, and clinical
practice in an emerging field and must be able to devote at least
25 percent effort to the program. 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). For SBIR
grants 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.
Beneficiary Eligibility:
Any nonprofit or for-profit organization, company, or institution
engaged in biomedical research.
Credentials/Documentation:
Research Grants, Science Education Grants, Cooperative Agreements,
Independent Scientist Awards, Mentored Research Scientist Development
Awards, Mentored Clinical Scientist Development Award, 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-profit
organizations' costs are determined in accordance with 48 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. 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 6246-1 and 6246-2 are used to apply for
Phase I and Phase II awards, respectively, of SBIR and STTR programs.
For SBIR grants, each applicant 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. Use Forms PHS 6246-1 and 6246-2 for Phase I and Phase II
applications, respectively. Use forms PHS 6246-3 and PHS 6246-4
to apply for STTR Phase I and Phase II, respectively.
Pre-application
Coordination: Not applicable. This program is
excluded from coverage under E.O. 12372.
Application Procedure:
Research Grants, Science Education Grants, and Cooperative Agreements:
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 20892-7910. 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 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 www.nih.gov/grants/funding/sbir.htm
on the World Wide Web. A limited number of hard copies of these
publications are produced. Subject to availability, they may be
obtained by contacting the NIH support services contractor: Telephone:
(301) 206-9385; fax: (301) 206-9722; e- mail: a2y@cu.nih.gov.
The Solicitations include submission procedures, review considerations,
and grant application or contract proposal forms. SBIR and STTR
grant applications should be submitted to the Center for Scientific
Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda,
MD 20892-7710.
Award Procedure:
Grants and Awards: Made on the basis of a dual review of an investigator-prepared
application. the reviews are made by peer groups: the first by
a study section for scientific merit; the second by an advisory
council for program relevance. Final approval of these recommendations
and decisions concerning funding are made by the Director, NIEHS.
All accepted SBIR 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. Formal award notices are
sent to successful applicants.
Deadlines:
New research, Independent Scientist Awards, Mentored Research
Scientist Development Award, Mentored Clinical Scientist Development
Award and Academic Career Awards: February 1, June 1, and October
1. Supplemental applications and all renewal applications: March
1, July 1, and November 1. SBIR applications: April 15, August
15, and December 15. STTR Grants: December 1, only. Education
Awards are announced in the NIH Guide.
Range of Approval/Disapproval
Time: Research Grants and Awards from 6 to
9 months. SBIR/STTR: 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: www.nih.gov/grants/guide/1997/97.11.21/n2.html.
Renewals:
Research Grants and Cooperative Agreements: Subject to same criteria
as new applications. Independent Scientist Awards, Mentored Research
Scientist Awards. Mentored Clinical Scientist Development Award,
and Academic Career Awards, 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 and Cooperative
Agreements may be awarded for up to 5 years, generally in 12-month
budget periods, and may be extended through a competitive renewal.
Funds are released primarily on the basis of an Electronic Transfer
System. Science Education Grants may be awarded for 1 to 4 years,
in 12-month budget periods, and are non-renewable. Independent
Scientist Awards are awarded for 5 years in 12-month budget periods
and are non-renewable. Mentored Research Scientist Development
Awards are for up to 5 years, in 12-month budget periods, and
are non-renewable. Mentored Clinical Scientist Development Awards
and Academic Career Awards are for up to 5-year periods, and are
non-renewable. SBIR Grants: Normally, Phase I awards are for 6
months; normally, Phase II awards are for 2 years. STTR: Normally,
Phase I awards are generally for 1 year; normally, Phase II awards
are for 2 years.
POST ASSISTANCE REQUIREMENTS:
Reports:
Research Grants and Awards: Annual and final progress reports and
reports of expenditures are required.
Audits:
In accordance with the provisions of OMB Circular No. A- 133 (Revised,
June 24, 1997), "Audits of States, Local Governments, and Non-Profit
Organizations," nonfederal entities that expend financial assistance
of $300,000 or more in Federal awards will have a single or a
program-specific audit conducted for that year. Nonfederal entities
that expend less than $300,000 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.
Obligations:
(Grants) FY 01 $150,135,000; FY 02 est $171,174,000; and FY 03
est $178,961,000.
Range
and Average of Financial Assistance:
Research Grants: $55,436 to $1,368,582; Average: $300,270.
SBIR Grants: Phase I -$100,000; Phase II - up to $750,000;
and STTR Grants: Phase I - $100,000 and Phase II- up to
$500,000.
In fiscal year 2001, 500
research grant awards were made, of which 125 were competing RPG
applications. In fiscal year 2002, it is anticipated that 495 research
grant awards will be made. In fiscal year 2003, approximately 462
research grant awards will be made. A Federal Executive Order signed
by President Clinton April 21, 1997, "Protection of Children from
Environmental Health Risks and Safety Risks," charges agencies to
consider special environmental risks to children. The centers, each
funded for 5 years, provide an atmosphere for scientists to interact
in establishing outstanding, state-of-the-art research programs
addressing environmental contributions to children's health and
disease. The centers will facilitate the transition of basic knowledge
from the laboratory into strategies that reduce the incidence of
environmentally related childhood disease, and establish a national
network that fosters communication, innovation, and research.
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: Not applicable.
Headquarters Office:
Program Contracts: Research Grants, Dr. William Suk, Director,
Office of Program Development, DERT, NIEHS, E- mail, suk@niehs.nih.gov.
Telephone: (919)541-0797; or Dr. Michael McClure, Chief, Organ
and Systems Toxicology Branch, E-mail: mcclure@niehs.nih.gov.
Telephone: (919)541-5327. Science Education Grants, Dr. Allen
Dearry, Program Administrator, Chemical Exposures and Molecular
Biology Branch, Telephone: (919)541-4943; Cooperative Agreements,
SBIR Grants, Independent Scientist Awards, Mentored Research Scientist
Development Award, Mentored Clinical Research Scientist Development
Award, Academic Career Award and SBIR and STTR Grant Programs:
Dr. Jerrold Heindel, Program Administrator, Organ and Systems
Toxicology 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.
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.
Web Site Address: http://www.cdc.gov
EXAMPLES OF FUNDED PROJECTS:
(1) Molecular mechanisms
of organ phosphate immunotoxicity; (2) a cellculture approach to
understanding cadmium nephrotoxicity; (3) the efforts of hexanedione
on Testicular Sertoli cell function; (4) a probable mechanism for
the carcinogenicity of 2-nitropropane; and (5) the mechanisms of
hepatobiliary transport of mercury.
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.
