SYSTEMS AND METHODS FOR SMALL ANIMAL IMAGING (SBIR/STTR)

RELEASE DATE:  November 18, 2002

PA NUMBER: PA-03-031

EXPIRATION DATE:  November 1, 2005, unless reissued. 

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)

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 Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the 
National Heart, Lung, and Blood Institute (NHLBI), the National Institute of 
Environmental Health Sciences (NIEHS), the National Center for Research 
Resources (NCRR), the National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), and the National Institute of Neurological Disorders and 
Stroke (NINDS) invite grant applications for Small Business Innovation 
Research (SBIR) and Small Business Technology Transfer (STTR) awards to 
support research and development of small animal imaging devices and methods 
that can be applied broadly to research on diverse biological or disease 
processes.  A similar Request for Applications (RFA) for small animal imaging 
research and development to be supported by individual Research Project Grant 
(R01) awards can be found at 
(https://grants.nih.gov/grants/guide/rfa-files/RFA-EB-03-002.html). 

The primary focus of this Program Announcement (PA) is research and 
development related to devices, methods, and imaging agents for the 
investigation of biological and disease processes in small animals.  The 
integration of systems and methods with complementary imaging and/or 
spectroscopy modalities is also included as appropriate to provide anatomic, 
physiologic, metabolic, and molecular-level information in small animal 
models of disease.  

The motivation for this PA is that recent discoveries in genomics and 
molecular and cell biology have led to the development and wide use of small 
animal models of human disease.  One of the limitations with the use of these 
models is the need to sacrifice large numbers of animals for ex vivo tissue 
and molecular analysis.  Imaging instrumentation and methods that permit 
imaging on the scale of small animals offer an opportunity to address this 
problem by enabling noninvasive investigations of biological processes in 
vivo.  This capability provides the potential for longitudinal studies in the 
same animal.  The coupling of animal models of human disease with advances in 
imaging technology presents an extraordinary opportunity for biomedical 
imaging to play an important role in the early detection, diagnosis, and 
treatment of disease.  Several dedicated small animal imaging systems have 
been developed and a few commercialized, although technological hurdles still 
exist that limit the realization of the full potential of small animal 
imaging for biomedical research and drug development. Progress is needed to 
improve throughput, sensitivity, and spatial and temporal resolution of small 
animal imaging devices, to provide quantitative information through improved 
reconstruction methods that incorporate models of physical effects, and to 
provide improved methods for system validation.  System optimization 
incorporating the design of molecular probes that serve as links to 
particular biological processes in vivo is also a focus. Further improvements 
in system design, image processing and analysis software, and data sharing 
technology, coupled with improvements and innovations in animal handling 
techniques during imaging, are needed to make small animal imaging technology 
more accessible to molecular biologists and pharmaceutical scientists 
desiring to use animal models as tools for biomedical research and drug 
discovery and development. 

RESEARCH OBJECTIVES

The need to support the discovery and development of biomedical imaging 
methods has been identified at several NIH workshops and conferences on 
biomedical imaging, including a June 25-26, 1999 symposium entitled 
"Biomedical Imaging Symposium: Visualizing the Future of Biology and 
Medicine" which was coordinated by the NIH Bioengineering Consortium (BECON). 
Three scientific areas were addressed at the symposium: (1) imaging at the 
cellular- and molecular-levels such as required for the early detection of 
disease; (2) imaging for the clinical diagnosis, staging, and recurrence of 
disease; and (3) imaging applied to therapeutic applications and monitoring 
for various disease processes.  Additionally, small animal models of human 
disease, in particular mouse models, have been identified as valuable 
resources for the investigation of the underlying mechanisms of human 
disease.  Small animal imaging provides the means to address all three 
priority areas through the noninvasive monitoring of biological processes, 
disease progression, and response to therapy, with the potential to provide a 
natural bridge to the clinical environment and contribute substantially to 
the development of human medicine. 

This BECON symposium also emphasized the need to support fundamental 
discovery and technical development of imaging technologies before specific 
disease- or organ-oriented applications are determined.  These challenges can 
be accomplished effectively by multi-disciplinary teams from academia, 
national laboratories, and industry, with expertise in the quantitative, 
computational, and biomedical sciences. In addition, the need for appropriate 
research support mechanisms and NIH study section reviews that emphasize 
technology development with less emphasis on organ- or disease-specific 
clinical applications were identified.

Consistent with the recommendations of the BECON symposium and the mission of 
the NIBIB, the goals of this PA are directed at basic research and/or 
development of small animal imaging systems and methods.  Research areas of 
interest include the improvement of existing devices and methods and the 
development of novel approaches to small animal imaging that enhance spatial 
or temporal resolution, measurement sensitivity, specificity, and throughput 
as required for the detection, diagnosis, or measurement of treatment 
efficacy for different disease processes. The scope of the PA includes the 
integration of molecular imaging systems and methods with anatomical or other 
functional imaging and/or spectroscopy methods to provide more effective 
tools for biomedical research.  The development of imaging or spectroscopy 
systems that have the flexibility to accommodate a variety of protocols for 
investigations of different diseases, and the development of platform-
independent imaging methods for multi-center research is also a focus.

The following research areas are examples of appropriate topics for 
applications in response to this PA. This list is meant to be representative 
and not all-inclusive:

o   Development of small animal imaging systems that extend the capabilities 
of existing devices through improved spatial and temporal resolution, 
sensitivity, and throughput for screening applications. This research 
scope includes improvements to dedicated small animal imaging devices and 
adaptation of existing clinical devices, in addition to high-risk, high-
gain research objectives such as new in vivo imaging and/or spectroscopy 
paradigms. Development of multi-modality imaging approaches that increase 
the range of information provided for enhanced image interpretation and 
improved quantification of biological processes in vivo are also within 
the scope of this PA. Mathematical modeling of such systems and their 
performance is included as required for system optimization. 

o   Development of improved methods for image reconstruction and processing, 
and the development of analytical tools for image analysis. An emphasis of 
the PA is on technological advances that might enhance the capabilities of 
existing devices and increase the availability of small animal imaging 
devices and methods for biological research, drug discovery and 
development, and screening of toxic chemicals for disease processes. 

o   Development of complementary devices and methods for improved animal 
handling including motion compensation and correction, imaging agent 
administration, blood sampling, anesthesia delivery, and animal 
maintenance and monitoring during imaging. Implantable sensor devices that 
take advantage of microelectromechanical (MEMS) and nanoelectromechanical 
(NEMS) systems, and techniques or devices that are designed for 
immobilization of the head for functional neuroimaging in awake animals, 
are also included.

o   In vivo investigations of imaging agents and high-affinity molecular 
probes for the imaging of biological processes in small animals, including 
improved methods for probe delivery and targeting. These studies may 
include the development of molecular probes for gene expression, cell 
tracking, enzyme action or other metabolic processes, or blood flow or 
drug distribution and action, with the potential to impact the study of 
several disease processes. Single or multiple imaging agents or 
multifunctional probes suitable for multi-modality imaging and/or 
spectroscopy are included. System optimization for imaging agents and 
molecular probes can be addressed where appropriate.  Studies involving in 
vitro characterization of imaging agents and probes, and/or in vivo 
testing in human subjects, are not within the scope of this PA. 

o   Within each of the areas highlighted above, applications specific to 
studies of the cardiovascular, pulmonary, and blood systems and to the 
treatment and diagnosis of heart, lung and blood diseases will be directed 
to the National Heart, Lung and Blood Institute.

o   Within each of the areas highlighted above, applications specific to 
studies of the effects of toxic environmental exposures on organ systems, 
especially the nervous system, will be directed to the National Institute 
of Environmental Health Sciences. 

o   Within each of the areas highlighted above, applications specific to the 
studies of the nervous system and to the treatment and diagnosis of 
neurological diseases will be directed to the National Institute of 
Neurological Disorders and Stroke.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH Small Business Innovation Research (SBIR) and Small 
Business Technology Transfer (STTR) award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  

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 under 
the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR 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 proposal must be a logical extension of the Phase I 
research.

The SBIR/STTR Omnibus Solicitation and information on the FAST-TRACK process 
are available at https://grants.nih.gov/grants/funding/sbir.htm.

ELIGIBILITY REQUIREMENTS 

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. 
Small business concerns are eligible to submit applications.  A small business 
concern is one that, on the date of award for both Phase I and Phase II 
agreements, meets ALL of the following criteria:

o is organized for profit, with a place of business located in the United 
States, which operates primarily within the United States or which makes a 
significant contribution to the United States economy through payment of 
taxes or use of American products, materials or labor;

o is in the legal form of an individual proprietorship, partnership, limited 
liability company, corporation, joint venture, association, trust or 
cooperative, except that where the form is a joint venture (as defined in 
this section) there can be no more than 49 percent participation by foreign 
business entities in the joint venture;

o is at least 51 percent owned and controlled by one or more individuals who 
are citizens of, or permanent resident aliens in, the United States; has, 
including its affiliates, not more than 500 employees, and meets the other 
regulatory requirements found in 13 CFR Part 121.  Business concerns, other 
than investment companies licensed, or state development companies qualifying 
under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are 
affiliates of one another when either directly or indirectly, (a) one concern 
controls or has the power to control the other; or (b) a third-party/parties 
controls or has the power to control both. Control can be exercised through 
common ownership, common management, and contractual relationships.  The term 
"affiliates" is defined in greater detail in 13 CFR 121.3-2(a).  The term 
"number of employees" is defined in 13 CFR 121.3-2(t).

Business concerns include, but are not limited to, any individual (sole 
proprietorship), partnership, corporation, joint venture, association, or 
cooperative.  Further information may be obtained by contacting the Small 
Business Administration Size District Office at http://www.sba.gov/size/.     

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. On an SBIR, routinely the principal 
investigator must have his/her primary employment with the small business at 
the time of award and for the duration of the project.     

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 and financial or grants management issues:

o Direct questions regarding programmatic issues to: 

Brenda J. Korte, Ph.D.
Program Director 
Division of Biomedical Imaging
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Blvd. Suite 200
Bethesda, MD  20892-5469
Telephone:  301-451-4772
Fax:  301-480-4973
Email: kortebr@mail.nih.gov

Denis B. Buxton, Ph.D.
Division of Heart and Vascular Diseases
National Heart, Lung and Blood Institute
NIH/DHHS
2 Rockledge Center, Suite 9044
6701 Rockledge Drive
Bethesda, MD  20892-7940
Telephone:  301-435-0516
Fax:  301-480-1335
Email: db225a@nih.gov

Jerrold Heindel, Ph.D.
Health Science Administrator
Organs and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
NIH/DHHS
P.O. Box 12233 MD EC-23
Research Triangle Park, NC 27709
Telephone:  919-541-0781
Fax:  919-541-5064
Email: heindelj@niehs.nih.gov

Amy Swain, Ph.D.
Program Director
Division of Biomedical Technology
National Center for Research Resources
NIH/DHHS
Rockledge 1, Room 6154
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  301-435-0755
Fax:  301-480-3659
Email:  as387d@nih.gov

Leroy M. Nyberg, Ph.D., M.D.
Urology Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 617
6707 Democracy Boulevard
Bethesda, MD  20892-5458
Telephone:  301-594-7717
Fax:  301-480-3510
Email: ln10f@nih.gov

Daofen Chen, Ph.D.
Program Director, Channels/Synapses/Circuits
National Institute of Neurological Disorders and Stroke, NIH/DHHS
Neuroscience Center, Room 2131
6001 Executive Boulevard
Bethesda, MD 20892-9523
Rockville, MD 20852 (courier service only)
Phone: (301) 496-1917
FAX: (301) 402-1501
Email: daofen_chen@nih.gov

The National Institute of Mental Health, while not a sponsor of this program 
announcement, supports research and development similar to that solicited 
here, with particular interest in such projects relevant to brain research.  
Dr. Michael Huerta (mhuerta@helix.nih.gov, 301-443-3563) is an appropriate 
contact at NIMH for such research interests.

o Direct questions regarding financial or grants management matters to:

Ms. Lisa Moeller
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
NIH/DHHS
6707 Democracy Blvd., Suite 900
Bethesda, MD  20892-5469
Telephone:  301-451-4782
Fax:  301-480-4974
Email:  moellerl@mail.nih.gov

Ms. Carol Lander
Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung and Blood Institute
NIH/DHHS
Rockledge Building 2
6701 Rockledge Drive
Bethesda MD 20892-7926
Federal Express Zip: 20817
Telephone: 301-435-0150
Fax: 301-480-3310 
Email: landerc@nhlbi.nih.gov

Ms. Carolyn Winters
Grants Management Specialist
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
NIH/DHHS
P.O. Box 12233
Research Triangle Park, NC 17709
Telephone: 919-541-7823
Fax: 919-541-2860
Email: winters@niehs.nih.gov

Ms. Kimberly Pendleton
Office of Grants Management
National Center for Research Resources
NIH/DHHS
Rockledge I, Rm 6216
6705 Rockledge Dr.
MSC 7965
Bethesda, MD  20892-7965
Telephone: 301-435-0844
Email: PendletonK@ncrr.nih.gov

Ms. Helen Ling
Senior Grants Management Specialist
Grants Management Branch, DEA
National Institutes of Diabetes and Digestive and Kidney Diseases
NIH/DHHS
6707 Democracy Blvd., Room 732 MSC 5456
Bethesda, MD 20892-5456
(For Express Mail Use Zip Code 20817)
Telephone: (301) 594-8857
FAX: (301) 480-3504
Email: LingH@extra.niddk.nih.gov

Ms. Aricia Cottman
Grants Specialist
National Institute of Neurological Disorders and Stroke
NIH/DHHS
6001 Executive Boulevard, Room 3290, MSC 9537
Bethesda, MD  20892-9537
Telephone:  (301) 496-8072  
FAX:  (301) 402-0219   
Email:  ac195q@nih.gov 

SUBMITTING AN APPLICATION

You may submit your application as a Phase I or Phase II application or as a 
Fast Track pair of Phase I and Phase II applications.  See "Specific 
Instructions" below. 

The PHS 398 research grant application (rev. 5/2001) must be used.  
Instructions and forms are available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html. PHS 398 forms 
specific to SBIR applications are available at 
https://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc. Refer 
to Chapter VI of the PHS 398 for specific instructions for SBIR and STTR 
applications. 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:GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on the standard SBIR/STTR application deadlines 
(April 1, August 1, December 1).  

SPECIFIC INSTRUCTIONS FOR PHASE I APPLICATIONS:  Application forms, 
requirements, and procedures are the same as listed in the Omnibus 
Solicitation for Phase I SBIR/STTR Grant applications 
(https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf), except for the 
following:

o  Type the title and number of this PA on line 2 on the face page of the 
application.

o  The Omnibus Solicitation states levels for Phase I and Phase II budgets 
that are guidelines, not ceilings.  For this PA, we will consider larger 
budgets for longer periods of time, if they are well justified and necessary 
to complete the proposed research and development.  SBIR applications 
requesting up to $100,000 per year in total costs direct costs, indirect costs 
and fee) must be submitted in a modular grant format. The modular grant format 
simplifies the preparation of the budget in these applications by limiting the 
level of budgetary detail. Section VI of the research grant application 
instructions for the PHS 398 at 
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants. Additional information on SBIR modular 
grants is available at 
https://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR
_general_instructions.htm. 
Applications for over $100,000 total costs must include a detailed budget and 
budget justification (Form Pages 4 and 5).

SPECIFIC INSTRUCTIONS FOR Phase II Applications:  We will only accept Phase II 
applications as competing continuations of previously funded NIH Phase I SBIR 
or STTR awards.  The Phase II application must be for developmental work that 
is a logical extension of the feasibility research conducted during Phase I.  
When preparing an application for a Phase II award, you should follow the 
instructions for NIH Phase II SBIR or STTR applications.  The instructions and 
forms for a Phase II SBIR and STTR award are available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html.

SPECIFIC INSTRUCTIONS FOR Fast Track Applications:  The NIH Fast-Track 
mechanism expedites the decision and award of SBIR and STTR Phase II funding 
for scientifically meritorious applications that have a high potential for 
commercialization. Fast Track incorporates a submission and review process, in 
which complete Phase I and Phase II grant applications are submitted 
simultaneously and reviewed together.  The FAST-TRACK must have a section 
labeled Milestones at the end of the Phase I Research Plan.  This section must 
include well-defined quantifiable milestones for completion of Phase I, 
a discussion of the suitability of the proposed milestones for assessing the 
success in Phase I, and a discussion of the implications of successful 
completion of these milestones on the proposed Phase II. 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. 

In addition, the Phase II portion of a Fast Track application must 
include a concise Product Development Plan (limited to ten pages).  
Label this section clearly and include it in Section J of the Phase II 
Research Plan.  More detailed instructions on the preparation of a Fast 
Track application are described in the PHS 398 at 
https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf#page=21.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
https://grants.nih.gov/grants/funding/submissionschedule.htm.  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

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o  Receive a written critique 
o  Undergo a 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  Receive a second level review by the appropriate national advisory council 
or board

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of your application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals:

o  Significance
o  Approach
o  Milestones and Proof of Principle
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move a 
field forward.

(1)  SIGNIFICANCE:  Does your 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 your application are achieved, how do they 
advance scientific knowledge?  Does the proposal lead to technologies (e.g., 
instrumentation, software) that will enable further discoveries?  Will the 
technology have a competitive advantage over existing/alternate technologies 
that can meet market needs? 

(2)  APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?  What is the time frame for developing the proposed technologies, and 
is this time frame suitable for meeting the community's needs?  How easy will 
it be to use the proposed technology?  Are your plans adequate for the 
proposed technology, its integration as an effective solution for 
implementation, and dissemination?  If you are proposing industrial 
partnerships, how will they facilitate the development and integration of 
system components? 

(3)  MILESTONES (for Phase I R41 or R43 or Fast Track applications) AND PROOF 
OF PRINCIPLE (for Phase II applications):  If you are submitting a Phase I 
application, how appropriate are your proposed milestones for evaluating 
demonstration of feasibility for transition to the R42 or R44 Phase II 
development work?  Do the milestones provide an objective target for 
evaluating results?  If you are submitting a Phase II application, how well 
has the feasibility or proof of principle been demonstrated?

(4)  INNOVATION:  Does your project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative? Does your project challenge 
existing paradigms or develop new methodologies or technologies?  What is the 
throughput and cost-effectiveness of your proposed technology?  What 
additional uses can be projected for your proposed technology?

(5)  INVESTIGATOR:  Are you appropriately trained and well suited to direct 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(6)  ENVIRONMENT:  Is there sufficient access to resources (e.g., equipment, 
facilities)?  Does the technical and scientific environment in which your work 
will be done contribute to the probability of success?  Does the proposed work 
take advantage of unique features of the technical and scientific environment 
or employ useful collaborative arrangements?

In accordance with NIH policy, all applications will also be reviewed with 
respect to the following:

o 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. 

o The appropriateness of the proposed budget and duration in relation to the 
proposed research. The following evaluation criterion will be presented in an 
administrative note in the Summary Statement and will not factor into the 
numerical score: 

o The adequacy of plans to make the methods and materials generated in the 
project widely available in a timely fashion to the scientific community, 
given the proposed plan to exercise (or not to exercise) intellectual property 
rights. 

AWARD CRITERIA

Applications will compete for available funds with all other recommended SBIR 
and STTR applications.  Funding decisions for Phase I or Phase II applications 
will be based on quality of the proposed project as determined by peer review, 
availability of funds, and relevance to program priorities.  

Phase II applications will be selected for funding based on the initial 
priority score, 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.

FAST-TRACK Phase II applications may be funded following submission of the 
Phase I progress report and other documents necessary for continuation.  

REQUIRED FEDERAL CITATIONS 

HUMAN EMBRYONIC STEM CELLS (hESC):Criteria for federal funding of research on 
hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at  
https://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. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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 No. 93.286 & 93.287 (NIBIB), 93.849 (NIDDK), 
93.113 (NIEHS), 93.837, 93.838, & 93.839 (NHLBI), 93.853 (NINDS), and 93.371 
(NCRR) 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 https://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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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