and Human Services (HHS)
EXPIRED
INNOVATIVE TOXICOLOGY MODELS: SBIR/STTR
RELEASE DATE: March 12, 2002
PA NUMBER: PA-02-075
October 8, 2008 - This PA has been replaced by PA-09-006 (SBIR
[R43/R44]) and PA-09-007 (STTR [R41/R42])
EXPIRATION DATE: December 31, 2003, unless reissued.
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute on Deafness and Other Communication Disorders
(http://www.nidcd.nih.gov/)
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
(http://www.niehs.nih.gov/)
Letter of Intent Receipt Dates: July 26, 2002, March 26, 2003,
November 25, 2003
Application Receipt Dates, August 23, 2002: April 23, 2003,
December 23, 2003
This Program Announcement (PA) replaces PAR-01-004, which was published in the
NIH Guide on October 25, 2000.
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE
Recent advances in cancer biology, molecular biology, combinatorial chemistry,
and screening technology provide unprecedented opportunities for discovery of
new agents for the treatment and prevention of diseases. Drug discovery can
now be focused on specific molecular or regulatory sites within the diseased
cell. The National Cancer Institute (NCI) considers exploitation of this
knowledge and technology for discovery of new cancer therapies a high priority
(http://plan.cancer.gov/). It is expected that research focused on discovery
and validation of new targets and screening design efforts to identify agents
that affect these targets will result in a multitude of new chemical and
biological agents with the potential for clinical benefit. However, before
such agents can be tested and used widely in patients, safety and acceptable
toxicity to critical organs must be demonstrated. Current practices and
procedures for safety evaluations are costly and time consuming utilizing
large amounts of compound and animals. Thus, it is impractical to evaluate
large number of compounds, as well as analogs in a chemical series, identified
from new high throughput molecular target based screening models using
traditional methods.
Similarly these scientific advances provide opportunities to develop new and
innovative tests to determine the toxicity of environmental chemicals. The
National Institute of Environmental Health Sciences (NIEHS) has been directed
by Congress to develop and validate alternatives for acute and chronic
toxicity testing that will reduce or eliminate the use of animals. In 2000 the
NIEHS convened an international workshop on in vitro methods for assessing
acute systemic toxicity. The results of this meeting can be found at
http://iccvam.niehs.nih.gov/methods/invidocs/finalall.pdf. Recommendations
include suggestions for research, development and validation efforts that
would further advance the usefulness of in vitro methods especially those
directed at specific organ toxicities.
This PA encourages the development, standardization, and validation of new and
innovative assays that determine or predict specific organ toxicities (e.g.,
hematotoxicity, cardiotoxicity, gastrointestinal toxicity, hepatotoxicity,
nephrotoxicity, ototoxicity, bladder toxicity, neurotoxicity, pulmonary
toxicity, and endocrine toxicity, including pancreatic beta cell toxicity) as
well as new methodology for high throughput toxicity screening that involves
the use of molecular endpoints, computer modeling, proteomics and genomics.
The development of these toxicity assays and their incorporation early in the
development process would assist in the evaluation and prediction of human
sensitivity and allow for more cost efficient evaluations of numerous analogs
prior to the selection of the ultimate drug development candidate.
This PA must be read in conjunction with the current OMNIBUS SOLICITATION OF
THE NATIONAL INSTITUTES OF HEALTH for SMALL BUSINESS INNOVATION RESEARCH
(SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS:
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
All of the instructions within the OMNIBUS SOLICITATION apply with the
following exceptions:
o Special receipt dates
o Initial review convened by the NCI, Division of Extramural Activities
o Additional review considerations
For this PA, the Modular Grant format will not be used.
This PA will utilize the SBIR and STTR mechanisms, but will be run in parallel
with a PA of identical scientific scope that will utilize the
Exploratory/Developmental Grants mechanism,
http://grants.nih.gov/grants/guide/pa-files/PAR-02-074.html.
RESEARCH OBJECTIVES
Background
Recent advances in all branches of medical sciences provide new insight into
the underlying mechanisms in malignancy and suggest new targets and approaches
to therapy. Drug discovery can now be focused on targeting key regulatory
pathways or specific macromolecules relevant to cancer. For example, key
growth regulatory pathways and genes mutated in cancer cells are being
identified and array technology for expression of thousands of genes as well
as computer-assisted evaluation of data are available. New technologies in
chemistry that allow facile synthesis of millions of new chemicals, and high
resolution structures of important target proteins are becoming available.
These advances taken together and coupled with high throughput screening allow
identification of large numbers of agents that could be seriously considered
for clinical evaluation. Translation of these new technological discoveries
and innovations into clinical benefit for the cancer patient through these
newly discovered agents is essential, however, the later stages in this drug
development process are lengthy and costly. Obviously new procedures are
necessary to decide which of the multitude of new agents should be tested in
animals and then in humans. In addition, these scientific advances can be
extremely useful for the development of new toxicity models with novel
endpoints to determine either therapeutic agent or environmental chemical
toxicity.
Investigations focusing on the toxicity of potential cancer, AIDS or other
drugs or biologicals to healthy organs in intact experimental animals are the
final steps in the preclinical stages of new drug development. Data generated
from these studies on each new drug are evaluated in light of potential human
toxicity and form a major portion of the information required by the Food and
Drug Administration (FDA) for an Investigational New Drug (IND) application.
Preclinical toxicology studies are generally conducted in two animal species
with the following objectives: to define the Maximum Tolerated Dose (MTD),
Dose Limiting Toxicities (DLTs), schedule-dependency of toxicity,
reversibility of adverse effects, and a safe clinical Starting Dose (SD). The
animal studies required to obtain such information for an IND application have
significant limitations, both in terms of cost and time requirements as well
as prediction of problems to be encountered when agents are administered to
humans. For example, since animal studies are very expensive and time-
consuming, it is generally impractical to evaluate numerous analogs of a
chemical series or large numbers of possible candidates from a high throughput
screening program. Another concern is the lack of information gained from
animal toxicology studies in regard to molecular mechanisms for observed
toxicities. It cannot be determined if toxicities of new agents designed to
attack a key molecular target are related to actions of inhibition of that
target or to other unknown aspects of the drug"s action in various organs.
The National Toxicology Program (NTP) is an interagency program located at
NIEHS, whose mission is to evaluate agents of public health concern by
developing and applying tools of modern toxicology and molecular biology.
Currently the NTP tests chemicals of environmental or occupational concern
using study designs similar to that used in preclinical toxicology studies
described above including 30 and 90 day toxicity studies, two year bioassay to
determine the carcinogenic potential of chemicals, two generation studies to
determine reproductive toxicity and in utero exposure to determine
developmental toxicity. The goal of the NTP and NIEHS is in line with the goal
of the NCI and the other NIH Institutes participating in this PA: to develop
new and novel alternative toxicity tests that could replace or reduce the
animal tests and in addition provide mechanistic information on the target
environmental agent that would aid in intervention/prevention efforts.
New technology to improve toxicology approaches and define toxicity at the
molecular level are emerging, but as yet none has been validated and accepted
for common use. New technology will be highly valuable when combined with
other approaches to develop a total toxicological profile of specific organ
toxicity and molecular mechanisms responsible for this toxicity. In this
regard, the NIEHS has recently established the National Center for
Toxicogenomics (NCT) (http://www.niehs.nih.gov/nct/home.htm). One of the
major goals of the NCT is to determine the usefulness of genomics data in the
development of alternative toxicity tests. Data analysis software programs
are being written to predict toxicological endpoints. Individually, these
activities may not be sufficient, but they may be highly valuable when
combined with other approaches to develop a total toxicological profile of
specific organ toxicity and molecular mechanisms responsible for this
toxicity.
Objectives and Scope
The goals of this PA are the discovery, development and validation of new
assays and procedures to determine quickly and cheaply toxicological profiles
of potential therapeutic drugs and environmental agents. It is expected that
a molecular definition of toxicity in the affected organ, tissue or cell would
be a component of the procedure. Approaches for new toxicology assays in
response to this initiative are broad and are determined by the creativity of
the applicant. Genetically modified animals or cell lines, various non-
mammalian organisms, in vitro assays utilizing primary mammalian cells (human
cells are of particular interest), tissue slices, isolated organs, sub-
cellular fractions or purified enzymes could be utilized for the model.
Computer modeling utilizing existing biological and toxicological data bases
would be appropriate. Genomic and proteomic technology could be exploited to
profile total gene activity or protein expression and thereby establish
molecular correlations with specific toxicities. Molecular endpoints to
evaluate toxicity and high throughput toxicity screening could be used to help
decide which agent of a chemical series should be pursued, to allow
exploration of toxicity at an earlier stage in drug development, to define the
toxicity profile of agents selected for clinical trial or to define the
toxicity profile of agents selected for clinical trial or for which there is
significant environmental exposure.
Applicants should be aware of the activities of the Inter Agency Coordinating
Committee for the Validation of Alternative Methods (ICCVAM), a part of the
NTP: http://iccvam.niehs.nih.gov. ICCVAM has prepared documents and
instructions relating to the validation and regulatory acceptance of
alternative methods that will be helpful in writing the application and in
proper validation of the methods/tests proposed.
The NCI, through the Developmental Therapeutics Program:
http://dtp.nci.nih.gov/, on occasion utilizes its internal resources to foster
drug development. For this PA, drugs and toxicology data from previous drug
development sponsored by NCI may be made available to awardees. For
additional information contact Dr. Adaline C. Smith at the address listed
under INQUIRIES.
Summary
The overall objective of this PA is to provide a flexible funding mechanism
within the SBIR and STTR programs with regard to budgets and time of funding
to support the research activities required to develop and validate innovative
toxicology assays by small businesses.
MECHANISM OF SUPPORT
Support for this PA is through the SBIR and STTR mechanisms that are set-aside
programs. This PA is a one-time announcement that may be reissued.
Responsibility for the planning, direction and execution of the proposed
project will be solely that of the applicant. Except as otherwise stated in
this PA, awards will be administered under NIH grants policy as stated in the
NIH Grants Policy Statement, March 2001, available at:
http://grants.nih.gov/grants/policy/nihgps_2001/
Applications can be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants, Phase II STTR (R42) or Phase II SBIR (R44) grants, or the
SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATION. Phase
II applications in response to this PA will only be accepted as competing
continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II
application must be a logical extension of the Phase I research.
Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are
available at: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
Hard copies are not available.
ELIGIBLE INSTITUTIONS
Eligibility requirements are described in the OMNIBUS SOLICITATION for
SBIR/STTR grant applications. Any small business, independently owned by
United States citizens or permanent resident aliens, and located in the United
States may apply. The small business must be organized for-profit, cannot be
dominant in its field of expertise, and must have its principal place of
business in the United States. For both Phase I and Phase II, the R&D must be
performed in its entirety in the United States. Including any affiliates, the
company can be the employer of no more than 500 people.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to develop
an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Adaline C. Smith, Ph.D., D.A.B.T.
National Cancer Institute
Division of Cancer Treatment and Diagnosis
Toxicology and Pharmacology Branch
6130 Executive Blvd, Room 8036 MSC 7451
Bethesda, MD 20892-7451
Telephone: (301) 496-8777
FAX: (301) 480-4836
Email: [email protected]
James A. Crowell, Ph.D.
National Cancer Institute
Division of Cancer Prevention
Chemopreventive Agent Development Research Group
6130 Executive Blvd., Room 2118 MSC 7322
Bethesda, MD 20892-7322
Telephone: (301) 594-0459
FAX: (301) 594-2943
Email: [email protected]
Lynn E. Luethke, Ph.D.
Program Director, Hearing
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd, 400-C
Bethesda, MD 20892
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: [email protected]
Robert Star, M.D.
Senior Scientific Advisor
National Institute of Diabetes, Digestive and Kidney Diseases
Building 31, Room 9A35
31 Center Drive MSC 2560
Bethesda, MD 20892-2560
Telephone: (301) 594-7715
FAX: (301) 496-2830
Email: [email protected]
David J. McCann, Ph.D.
Chief, Medications Discovery & Toxicology Branch
National Institute on Drug Abuse
Division of Treatment Research & Development
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2999
FAX: (301) 443-2599
Email: [email protected]
Jerrold J. Heindel, Ph.D.
Scientific Program Administrator
Organs and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O.Box 12233
Research Triangle Park, NC 27709
Fedex: 79 T.W. Alexander Drive
4401 Research Commons, 3rd Floor
Phone: (919) 541-0781
Fax: (919) 541-5064
Email: [email protected]
o Direct your questions about peer review issues to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Mr. Shane Woodward
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Blvd, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-8649
FAX: (301) 496-8601
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this PA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NCI staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Adaline C. Smith, Ph.D., D.A.B.T.
National Cancer Institute
Division of Cancer Treatment and Diagnosis
Toxicology and Pharmacology Branch
6130 Executive Blvd, Room 8036 MSC 7451
Bethesda, MD 20892-7451
SUBMITTING AN APPLICATION
The PHS 398 research grant application (rev. 5/2001) must be used.
Instructions and forms are available at
http://grants.nih.gov/grants/funding/phs398/phs398.html. Refer to Chapter VI
for specific instructions for SBIR and STTR applications. Applications will
be accepted on the dates listed on the first page of this PA. This version of
PHS 398 is available in an interactive, searchable PDF and HTML format. The
NIH will return applications that are not submitted on the 5/2001 version.
For further assistance contact GrantsInfo, Telephone: (301) 710-0267, Email:
[email protected].
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying that Dr. Adaline Smith has agreed to accept
assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact Dr. Adaline Smith, listed in INQUIRIES or LETTER OF INTENT, at
least 6 weeks before submitting the application, i.e., as you are developing
plans for the study,
2) Obtain agreement from Dr. Adaline Smith that Dr. Smith will accept your
application for consideration for award, and,
3) In a cover letter sent with the application, mention that Dr. Adaline
Smith agreed to accept assignment of the application, and provide a copy of
the agreement.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised version
of these grant application types. Additional information on this policy is
available in the NIH Guide for Grants and Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
The SBIR/STTR OMNIBUS SOLICITATION is available electronically through the
NIH, Office of Extramural Research Small Business Funding Opportunities web
site: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. Application
instructions are also available at this site. Helpful information for
preparation of the application can be obtained at:
http://grants.nih.gov/grants/grant_tips.htm
THE TITLE AND NUMBER OF THIS PA MUST BE TYPED ON LINE 2 OF THE FACE PAGE OF
THE APPLICATION.
All instructions within the solicitation apply with the following exceptions:
- special receipt dates
- initial review convened by the NCI Division of Extramural Activities
- additional review considerations
Applications can be submitted for Phase I or Phase II support, or as a
combined Phase I and II (FAST-TRACK). A Phase II application will be accepted
only as continuation of a previously funded Phase I grant. The Phase II
proposal must be a logical extension of the Phase I research but not
necessarily a Phase I project supported in response to this initiative.
The OMNIBUS SOLICITATION indicates the normal levels of support and period of
time for SBIR and STTR Phase I and Phase II awards. However, some toxicology
model discovery and validation projects are likely to require longer time
periods and/or larger budgets to accomplish the proposed aims. Therefore, if
adequately justified, budgets up to $250,000 total costs per year (direct
costs, indirect costs, and profit/fee) and time periods up to 2 years for
Phase I and $650,000 total costs per year (direct costs, indirect costs, and
profit/fee) and up to 4 years for Phase II can be requested. For FAST-TRACK
applications the total duration of Phase I plus Phase II cannot exceed 5
years.
PHASE I: Demonstration of feasibility of the innovative approach. Research
should be proposed to provide sufficient reason to continue the assay
development in Phase II. It would be expected that assay methodology would be
established. If two years of support are requested, the goals for the first
year should be clearly stated and not simply a reiteration of specific aims.
Support for the second year will be contingent upon Institute programmatic
evaluation to ensure that investigators are accomplishing the goals presented.
PHASE II: Development of approach to a stage at which the assay can be used
for toxicology purposes. Extensive studies designed to validate the approach
would be expected. Validation should include analysis of compounds with known
organ toxicities and should follow the ICCVAM guidelines. Innovative aspects
of the research necessary to complete the projects such as development of new
in vivo models that may require "surrogate endpoints" should be clearly
described. Goals and milestones for each year of support should be clearly
presented. Support for years two to four, if requested, is dependent upon
Institute programmatic review of progress and achievement of the proposed
goals. For example, if a goal such as identification of a known toxicity is
not achieved, the continuation years may not be supported.
FAST TRACK: Applications may be submitted for combined Phase I and Phase II,
FAST TRACK consideration as described in the OMNIBUS SOLICITATION. However,
due to the complex nature of toxicological assay development, it is
recommended that only well defined and more advanced projects be proposed for
support through this mechanism.
Phase I, FAST TRACK applications must specify clear, measurable milestones
that should be achieved prior to Phase II funding. Failure to provide such
information in the Phase I application and/or sufficient detail in the Phase
II application may be sufficient reason for the peer review committee to
exclude the Phase II from consideration. If so, the applicant may apply later
for Phase II support. Such applications will be reviewed by an appropriate
scientific review group convened by the NIH.
Special provisions described in this PA pertaining to Phase I and Phase II
also apply to FAST TRACK applications.
An additional requirement of all Phase II and FAST TRACK applications is the
Product Development Plan. The small business must submit a Product
Development Plan (limited to ten pages) as an Appendix to the Phase II
application addressing the four areas described in the instructions for PHS
398, Chapter VI, Section C. 9. j.
Potential applicants are encouraged to contact program staff for guidance and
to read the advice and information on the web sites. However, responsibility
for planning, direction, and execution of the proposed research will be solely
that of the applicant.
The completed original application and three legible copies must be sent or
delivered to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040, MSC 7710
Bethesda, MD 20892-7710
(20817 for express/courier service)
To expedite the review process, at the time of submission, send two additional
copies of the application to:
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE
WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries
(i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-
files/NOT-CA-02-002.html) This change in practice is effective immediately.
This policy is similar to and consistent with the policy for applications
addressed to Centers for Scientific Review as published in the NIH Guide
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by or mailed before the
receipt dates listed at the top of the first page of this PA. The CSR will
not accept any application in response to this PA that is essentially the same
as one currently pending initial review unless the applicant withdraws the
pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed by CSR staff for completeness and
by NCI or another participating Institute program staff for adherence to
guidelines. Incomplete applications and applications not adhering to
instructions described above will be returned to the applicant without further
review.
Applications that are complete and adhere to the guidelines of this PA will be
evaluated for scientific and technical merit and the documented ability of the
investigators to meet the RESEARCH OBJECTIVES of this PA by an appropriate
peer review group convened by the NCI, Division of Extramural Activities, in
accordance with the peer review criteria listed below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Those that receive a priority score undergo a second level review by the
appropriate advisory council(s) of NCI, NIDCD, NIDDK, NIDA or NIEHS.
REVIEW CRITERIA
Review criteria are described in the OMNIBUS SOLICITATION and are as follows:
1. The soundness and technical merit of the proposed research. (Preliminary
data are not required for Phase I proposals.)
2. The qualifications of the proposed Principal Investigator, supporting
staff, and consultants.
3. The scientific, technical, or technological innovation of the proposed
research.
4. The potential of the proposed research for commercial application or
societal impact.
5. The appropriateness of the budget requested.
6. The adequacy and suitability of the facilities and research environment.
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.
For this PA the following points will also be considered during review. The
goals of NIH-sponsored research are to advance our understanding of biological
systems, improve the control of disease, and enhance health. Within this
framework, the specific goals of this PA are the discovery and validation of
new and innovative assays which predict specific toxicities of potential drugs
and environmental agents. Assays developed under this PA would be expected to
be effective for a quick and cost effective determination of toxicity of
specific compounds and, importantly, to decrease the number of animals
required. The reviewers will comment on the following aspects of the
application in their written critiques in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit of these
goals. Each of the criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major impact and thus deserve a high priority rating. For
example, an important research project may be proposed which does not present
novel and innovative technology but which is essential to develop an
innovative model.
SIGNIFICANCE.
Does the study address an important problem? Does the proposed project have
commercial potential to lead to a marketable product or process? What may be
the anticipated commercial and societal benefits of the proposed activity? If
the aims of the application are achieved, how will scientific knowledge be
advanced? Does the proposal lead to enabling technologies (instrumentation,
software, etc.) for further discoveries? Will the technology have a
competitive advantage over existing/alternative technologies that can meet the
market needs?
APPROACH.
Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Is
the proposed plan a sound approach for establishing technical and commercial
feasibility? Does the applicant acknowledge potential problem areas and
consider alternative strategies? Are the milestones and evaluation procedures
appropriate?
INNOVATION.
Does the project challenge existing paradigms or employ novel technologies,
approaches or methodologies? Are the aims original and innovative?
INVESTIGATOR.
Is the Principal Investigator capable of coordinating and managing the
proposed SBIR/STTR? Is the work proposed appropriate to the experience level
of the Principal Investigator and other researchers including consultants and
sub-contractors (if any)?
ENVIRONMENT.
Is there sufficient access to resources (equipment, facilities, etc.)? Does
the scientific and technological environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?
For Phase II applications: In addition to the above criteria, to what degree
was progress toward the Phase I objectives met and feasibility demonstrated in
providing a solid foundation for the proposed Phase II activity? Is there a
detailed validation plan?
For Phase I/Phase II Fast Track applications, the following additional
criteria will be applied: Does the Phase I specify clear, measurable goals
(milestones) that should be achieved prior to initiating Phase II? Did the
applicant submit a concise Product Development Plan that adequately addresses
the four areas described in Section 9.j in the Instructions for the SBIR/STTR
applications? To what extent was the applicant able to obtain letters of
interest, additional funding commitment and/or resources from private sector
or non-SBIR/STTR funding sources that would enhance the likelihood for
commercialization? The initial review group will evaluate the specific goals
for both the R43 and R44 phase. A single priority score will be assigned to
each application. The initial review group has the option of recommending
support for a shorter duration than that requested and basing the final merit
rating on the recommended portion of the application. For FAST TRACK
applications, this may result in a recommendation that only the R43 phase be
supported.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS:
The adequacy of the proposed protection for humans, animals, or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION:
The adequacy of plans to include subjects from both genders, all racial and
ethnic groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of subjects
will also be evaluated. (See Inclusion Criteria included in the section on
Federal Citations, below).
BUDGET:
The reasonableness of the proposed budget and the requested period of support
in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended SBIR and STTR applications. Portions of the SBIR
and STTR allotments will not be designated for this initiative. The following
will be considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
FAST TRACK, Phase II applications may be funded following submission of the
Phase I progress report and other documents necessary for continuation. Phase
II applications will be selected for funding based on the initial priority
score, grant Program staff"s assessment of the Phase I progress and
determination that Phase I goals were achieved, the project"s potential for
commercial success, and the availability of funds.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Dates: July 26, 2002, March 26, 2003,
November 25, 2003
Application Receipt Dates: August 23, 2002, April 23, 2003,
December 23, 2003
Council Review Dates: February, 2003, October, 2003,
June, 2004
Earliest Anticipated Award Date: April, 2003, December, 2003,
September, 2004
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NCI require special considerations.
The method and degree of monitoring should be commensurate with the degree of
risk involved in participation and the size and complexity of the clinical
trial. Monitoring exists on a continuum from monitoring by the principal
investigator/project manager or NCI program staff or a Data and Safety
Monitoring Board (DSMB). These monitoring activities are distinct from the
requirement for study review and approval by an Institutional review Board
(IRB). For details about the Policy for the NCI for Data and Safety
Monitoring of Clinical trials see:
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II
clinical trials, investigators must submit a general description of the data
and safety monitoring plan as part of the research application. See NIH Guide
Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II
Trials" for additional information: http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-00-038.html. Information concerning essential elements of data
safety monitoring plans for clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht
m. The amended policy incorporates: the use of an NIH definition of
clinical research, updated racial and ethnic categories in compliance with
the new OMB standards, clarification of language governing NIH-defined Phase
III clinical trials consistent with the new PHS Form 398, and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable,
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research in now available online at: http://cme.nci.nih.gov/
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance Nos. 93.395, 93.847, 93.848, 93.849 and 93.115, and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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