EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of
Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Cancer Institute (NCI), (http://www.nci.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)
National Human Genome Research Institute (NHGRI), (http://www.genome.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/default.htm)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)
National Institute of Mental Health(NIMH), (http://www.nimh.nih.gov/)
Title: Innovations in Biomedical Computational Science and Technology Initiative (STTR [R41/R42])
Announcement
Type
This is a reissue of PAR-06-089,
which was previously released December 19, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov/) using the SF424 Research and Related (R&R) forms and the SF 424 (R&R) SBIR/STTR Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program
Announcement (PA) Number: PAR-06-534
Catalog of Federal
Domestic Assistance Number(s)
93.859, 93.396, 93.172, 93.389, 93.839, 93.866, 93.273, 93.855, 93.279, 93.286,
93.173, 93.114, 93.853, 93.879, 93.867
Key Dates
Release/Posted Date: August
23, 2006
Opening Date: August 24, 2006 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On time submission
requires that applications be successfully submitted to Grants.gov no later
than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission Date(s): September 24, 2006
Peer Review Date(s): October-February/March 2007
Council Review Date(s): May 2007
Earliest Anticipated
Start Date: March
2007
Additional Information
To Be Available Date (Activation Date): Not Applicable
Expiration Date:
September 25, 2006
Due Dates for E.O.
12372
Not Applicable
Additional Overview Content
Executive Summary
This funding opportunity announcement (FOA) solicits Small
Business Technology Transfer (STTR) grant applications from small
business concerns (SBCs) that propose innovative research in biomedical
computational science and technology to promote the progress of biomedical
research. There exists an expanding need to speed the progress of biomedical research
through the power of computing to manage and analyze data and to model
biological processes. The NIH is interested in promoting research and
developments in biomedical computational science and technology that will
support rapid progress in areas of scientific opportunity in biomedical
research. As defined here biomedical computing or biomedical information
science and technology includes, database design, graphical interfaces,
querying approaches, data retrieval, data visualization and manipulation, data
integration through the development of integrated analytical tools, and tools
for electronic collaboration, as well as computational research including the
development of structural, functional, integrative, and analytical models and
simulations.
Table of Contents
Part I
Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter
of Intent
B. Submitting an Application Electronically
to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
Computational and informatics tools have become increasingly important in
enabling progress in biomedical research. In recognition of the critical
role of computer science in biomedical research, the NIH Director commissioned
a Working Group on Biomedical Computing in June 1999.
The result of the deliberations of the Working Group on Biomedical Computing was a report entitled "The Biomedical Information Science and Technology Initiative" (BISTI) which can be accessed at the following site: http://www.nih.gov/welcome/director/060399.htm. A major recommendation of the BISTI is that the NIH should provide additional resources and incentives for basic research to provide adequate support for those who are inventing, refining, and applying the tools of biomedical computing. The promotion of the interface of biomedical information science and technology with biomedical research should result in new digital and electronic tools that will have substantial impact on broad areas of biomedical research.
The Institutes and Centers of the NIH acknowledge the wisdom of this recommendation and are offering support to small business through the current solicitation for fundamental research in biomedical information science and technology, as well as for the development of new informatics and computational tools and technologies. This solicitation targets support for fundamental research in biomedical computing science and technology as well as the development and application of new biocomputing tools or technologies for a particular area(s) of scientific opportunity in biomedical research. Programs may target one or multiple areas of biomedical computing that will enable progress in biomedical research. Examples of data types that could be considered include but are not limited to genomic sequences, biomedical images, qualitative descriptors for health and social science, remote sensing and geospatial images, and chemical formulae. Specific research areas solicited in informatics or computational science include but are not limited to research, development, and application of:
Areas of biomedical research likely to be critically dependent on biocomputing advances include but are not limited to:
Projects must span the interface of biomedical research and biomedical computational science and technology. Applicants will be expected to demonstrate fundamental understanding and adequate expertise in both the relevant areas of computational science and technology and biomedical research. Cross-disciplinary collaborations are strongly encouraged.
Given the expanding needs in biomedical research for advances in a variety of areas of information science and technology, the approaches and technologies proposed under this announcement should ultimately be generalizable, scalable, extensible, interoperable and use sophisticated computational resources. The projects should take into account the needs of the biomedical research community that will be the ultimate end users of the products of the research. The projects should also address plans for ensuring the dissemination of useful products of the research, including approaches, technologies, and tools, to the relevant research and user communities. The informatics and computational research proposed should be future-oriented, fill an area of need or projected need, and seek to exceed the current state- of-the-art.
See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.
1.
Mechanism(s) of Support
This funding opportunity will use the Small Business
Technology Transfer (STTR [R41/R42] grant mechanisms. Applications may be
submitted for support as Phase I, Phase II, or Fast-Track grants as described
in the SF424 (R&R) SBIR/STTR Application Guide.
Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another Department of Health and Human Services (HHS) FOA, including the SBIR or STTR Parent FOAs (see Small Business Funding Opportunities web page).
Phase
II applications in response to this funding opportunity will only be accepted
as competing renewals (formerly competing continuations ) of previously funded
Phase I STTR awards. The Phase II must be a logical extension of the Phase I
research but not necessarily as a Phase I project supported in response to this
funding opportunity.
The applicant SBC will be solely responsible for
planning, directing, and executing the proposed project. Future unsolicited,
competing renewal applications based on this project will compete with all STTR
applications and will be reviewed according to the customary peer review
procedures. Applications that are not funded in the competition
described in this FOA may be submitted as RESUBMISSION applications through Grants.gov/Apply using the standard NIH submission dates of April 1, August
1, and December 1 (or January 2, May 1, and September 1 for AIDS and
AIDS-related STTR applications).
This funding
opportunity uses just-in-time concepts. The modular budget format is no longer
accepted for STTR grant applications. Applicants must complete and submit
budget requests using the SF424 Research and Related (R&R) Budget
component found in the application package attached to this FOA in Grants.gov/Apply.
2. Funds Available
The SF424 (R&R) SBIR/STTR Application Guide indicates
the statutory guidelines of funding support and project duration periods for
Phase I and Phase II STTR awards. For this funding opportunity, budgets up to
$150,000 total costs per year and time periods
up to two years for Phase I may be requested. For Phase II, NIH will entertain well-justified applications with a
project period of up to three years with no budget limitation. FAST-TRACK
applications are subject to the same total costs limits per year as when
submitted outside of the FAST-TRACK option: Phase I (R41), not to exceed
$150,000 per year total costs; Phase II (R42), no dollar limit. However,
for this solicitation the total duration (Phase I plus Phase II applications)
cannot exceed five years. Total costs include direct costs, Facilities &
Administrative (F&A)/indirect costs, and fee.
All awards are subject to the availability of funds.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible
Institutions
Only United States small business concerns (SBCs) are
eligible to submit STTR applications. A small business concern is one that, at
the time of award for both Phase I and Phase II awards, meets all of the
following criteria:
1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.
2. Is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in Title 13 Code of Federal Regulations (CFR) Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in Title 13 Code of Federal Regulations (CFR) Part 121.103. The term "number of employees" is defined in 13 CFR 121.106.
A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's (SBA) Government Contracting Area Office or Office of Size Standards.
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project.
Title 13 C.F.R. 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13C.F.R. 121.106 Small Business Size Regulations.
All STTR grant applications
will be examined with the above eligibility considerations in mind. If it
appears that an applicant organization does not meet the eligibility
requirements, NIH will request a size determination by the SBA. If eligibility
is unclear, NIH will not make an STTR award until the SBA provides a
determination.
1.B. Eligible
Individuals
Any individual with the skills, knowledge, and
resources necessary to carry out the proposed research is invited to work with
their organization 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 support.
For a STTR application, the Project Director/Principal Investigator (PD/PI) may
be employed with the SBC or the participating non-profit research institution
as long as s/he has a formal appointment with or commitment to the applicant
SBC.
As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
The PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI’s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
The following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
2.
Cost Sharing or Matching
This program does not require cost sharing as defined
in the current NIH Grants Policy Statement.
3. Other-Special
Eligibility Criteria
In STTR Phase I and Phase II, at least 40% of the work must be performed by the
small business concern and at least 30% of the work must be performed by the
single, partnering research institution. The basis for determining the
percentage of work to be performed by each of the cooperative parties will be
the total of direct and F&A/indirect costs attributable to each party,
unless otherwise described and justified in Item 12, Consortium/Contractual
Arrangements, of the PHS398 Research Plan component of the SF424 (R&R)
application forms.
The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS FOA, including the SBIR or STTR Parent FOAs (see Small Business Funding Opportunities web page).
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
Application Guide for completing the SF424 (R&R) forms for this FOA, link
to http://www.grants.gov/Apply and
follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant SBC can submit an electronic application as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form
of Application Submission
Prepare all STTR applications using the SF424 (R&R) application forms and the SF424 (R&R) SBIR/STTR Application Guide (MS Word) or PDF) instructions.
The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover
component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
Research & Related Subaward Budget Attachment(s) Form
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information
Optional
Components:
PHS398
Cover Letter File
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: August 24,
2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not
applicable
Application Submission Date(s): September 24, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: March 2007
3.A.1. Letter of
Intent
A letter of intent is not required for the funding
opportunity.
3.B. Submitting an
Application Electronically to the NIH
Applications in response to this FOA may only be
submitted to Grants.gov through Grants.gov/Apply.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the
opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s).
(See Section IV.3.A. for all dates.) If an
application is not submitted by the receipt date(s) and time, the application
may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR), NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4.
Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement.
Pre-Award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
renewal award if such costs: are necessary to conduct the project, and would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH
Grants Policy Statement.
6. Other
Submission Requirements
An annual meeting of all investigators
funded through this program may be held to share progress and research insights
that may further progress in the program. Applicants should request
travel funds in their budgets for the principal investigator and one additional
senior investigator to attend this annual meeting.
To be eligible for the FAST-TRACK option, the Phase I (R41) application must include well defined quantifiable milestones that will be used to judge the success of the proposed research, as well as a credible development plan for the Phase II (R42) application. The FAST-TRACK must have a section labeled "Milestones" at the end of the Research Plan for Phase I R41.
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide (MS Word) or PDF) are to be followed, with the following requirements.
STTR Phase I applications:
STTR Phase II applications:
STTR Fast-Track applications:
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this PAR. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Note: While each section of the Research Plan component needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.
Plan
for Sharing Research Data
Applicants
requesting $500,000 or more in direct costs in any year should include a brief
one paragraph description of how final research data will be shared, or explain
why data-sharing is not possible. The specific nature of the data to be
collected will determine whether or not the final dataset may be shared. If the
final data are not amenable to sharing, for example, if they are proprietary,
this must be explained in the application. The Small Business Act requires NIH
to protect from disclosure and nongovernmental use all SBIR and STTR data
developed from work performed under an SBIR and STTR funding agreement for a
period of four (4) years after the closeout of either a Phase I or Phase II
grant unless NIH obtains permission from the awardee to disclose these data.
The data rights protection period lapses only upon expiration of the protection
period applicable to the SBIR and STTR award, or by agreement between the small
business concern and NIH. Applicants are encouraged to discuss their
data-sharing plan with the Institute/Center (IC) staff likely to accept
assignment of their application.
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. For more information
on data sharing see http://grants.nih.gov/grants/policy/data_sharing/ and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)
Sharing
Research Resources
NIH policy
requires that grant awardee recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section
VI.3. Reporting.
Section V. Application Review Information
1.
Criteria
Only the
review criteria described below will be considered in the review process.
2. Review and
Selection Process
Applications
submitted for this funding opportunity will be assigned to the Institutes and
Centers (ICs) on the basis of established Public Health Service (PHS) referral
guidelines.
Appropriate scientific review groups 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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended STTR applications. The following will be considered in making funding decisions:
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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
The
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.
All STTR Applications
Significance: Does the proposed project have commercial potential to lead to a marketable
product, process, or service? Does this study address an important problem?
What may be the anticipated commercial and societal benefits that may be
derived from the proposed research? If the aims of the application are achieved,
how will scientific knowledge or clinical practice be advanced? What will be
the effect of these studies on the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field? Does the
application lead to enabling technologies (e.g., instrumentation, software) for
further discoveries? Will the technology have a competitive advantage over
existing/alternate technologies that can meet the market needs?
Approach: Are
the conceptual or clinical 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: Are
the aims original and innovative? Does the project challenge existing paradigms
or clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigator: Is the PD/PI appropriately trained and capable of coordinating and managing the
proposed STTR? Are the investigators well suited to carry out this work? Does
the investigative team bring complementary and integrated expertise to the
project (if applicable)? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers, including consultants and
subcontractors (if any)? Are the relationships of the key personnel to the
small business and to other institutions appropriate for the work proposed?
Environment: Is
there sufficient access to resources (e.g., equipment, facilities)? Does the
scientific and technological environment in which the work will be done
contribute to the probability of success? Do the proposed studies benefit from
unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
Phase II Applications
In addition to the above review criteria:
1. How well did the applicant demonstrate progress
toward meeting the Phase I objectives, demonstrating feasibility, and providing
a solid foundation for the proposed Phase II activity?
2. Did the applicant submit a concise
Commercialization Plan that adequately addresses the specific areas described
in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR
Information Component?
3. Does the project carry a high degree of
commercial potential, as described in the Commercialization Plan?
Resubmission Applications (formerly
amended applications)
In
addition to the above criteria, the following criteria will be applied to
resubmission applications.
1. Are the
responses to comments from the previous scientific review group adequate?
2. Are the
improvements in the resubmission application appropriate?
Phase I/Phase II Fast-Track Application Review Criteria
For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:
1. Does the Phase I application specify clear,
appropriate, measurable goals (milestones) that should be achieved prior to
initiating Phase II?
2. Did the applicant submit a concise
Commercialization Plan that adequately addresses the specific areas described
in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR
Information Component?
3. To what extent was the applicant able to obtain
letters of interest, additional funding commitments, and/or resources from the
private sector or non-SBIR/STTR funding sources that would enhance the
likelihood for commercialization?
4. Does the project carry a high degree of
commercial potential, as described in the Commercialization Plan?
Phase I and Phase II Fast-Track applications that
satisfy all of the review criteria will receive a single rating.
For Fast-Track applications, the Phase II portion may
not be funded until a Phase I final report and other documents necessary for
continuation have been received and assessed by program staff that the Phase I
milestones have been successfully achieved. Items 2-5 of the Research
Plan may not exceed 25 pages. That is, the combined Phase I and Phase II plans
for a Fast-Track application (for Items 2-5) must be contained within the
25-page limitation.
2.A. Additional
Review Criteria:
In addition
to the above criteria, the following items will continue to be considered in
the determination of scientific merit and the priority score:
Milestones: The appropriateness and suitability of the proposed milestones to evaluate transition to Phase II.
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See item 6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and
Children in Research: 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 will be assessed. Plans
for the recruitment and retention of subjects will also be evaluated. See item
7 of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to the
proposed research may be assessed by the reviewers. Is the number of person
months listed for the effort of the PD/PI appropriate for the work proposed? Is
each budget category realistic and justified in terms of the aims and methods?
2.C. Sharing
Research Data
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The funding
organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a
sharing research resources plan addressing how unique research resources will
be shared or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section
VI.3. Reporting.
3. Anticipated
Announcement and Award Dates
Not applicable
Section VI. Award Administration Information
1.
Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his/her Summary Statement (written critique)
via the eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section
IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We
encourage your inquiries concerning this funding opportunity 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:
1.
Scientific/Research Contacts:
Inquiries or contacts concerning Institute-specific scientific, technical, or financial issues should be directed to the NIH BISTI technical or financial contacts listed at the following Web site: http://www.bisti.nih.gov/SBIR-contacts.cfm.
Direct more general questions regarding programmatic issues to:
Peter Lyster, Ph.D.
Center for Bioinformatics and Computational Biology
NIGMS 45 Center Drive, Room 2AS.55k, MSC 6200
Bethesda, MD 20892-6200
TEL: 301-451-6446
Email: [email protected]
2. Peer Review
Contacts:
Donald Schneider, Ph.D.
Center for Scientific Review
6701 Rockledge Drive, Room 4172
Bethesda, MD 20892-7806
TEL: (301) 435-1727
Email: [email protected]
3.
Financial or Grants Management Contacts:
Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AN 50B, MSC 6200
Bethesda, MD 20892-6200
Phone: (301) 594-5132
Fax: (301) 480-2554
Email: [email protected]
Section VIII. Other Information
Required
Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects and others, and
the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions on issues related to institutional policies and local IRB rules,
as well as local, state, and Federal laws and regulations, including the
Privacy Rule. Reviewers will consider the data sharing plan but will not factor
the plan into the determination of scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The OMB Circular A-110 has been revised to provide
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 the FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity 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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time, the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a description
of a specific plan for sharing and distributing unique model organism research
resources generated using NIH funding or state why such sharing is restricted
or not possible. This will permit other researchers to benefit from the
resources developed with public funding. The inclusion of a model organism
sharing plan is not subject to a cost threshold in any year and is expected to
be included in all applications where the development of model organisms is
anticipated.
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 "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
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 SF424 (R&R); 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 Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
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 (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 applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp 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 (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, 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.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH Manuscript Submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. For publications listed in the appendix and/or Progress
report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet
addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.
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.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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