and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes
of Health (NIH) (http://www.nih.gov/
Components of Participating Organizations
National Heart, Lung, and
Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
Title: New Approaches to Arrhythmia Detection and Treatment
(STTR [R41/R42])
Announcement Type
New
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 SF424 (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: PA-07-031
Catalog of Federal Domestic Assistance Number(s)
93.837
Key Dates
Release/Posted
Date: November 3, 2006
Opening Date: February
5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): A letter of intent is not required for the funding
opportunity.
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): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#SBIR for details.
AIDS Application Submission Date(s): Not applicable
Peer Review
Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s) : Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Activation Date): Not applicable
Expiration Date: December 6,
2009
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 proposing the development of new or improved
methods for arrhythmia detection, treatment, and prevention.
Table of Contents
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
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of this initiative is to improve our ability to detect, treat and prevent cardiac arrhythmias using new or improved methods, tools, and technologies. Applications are invited for the development and significant improvements of innovative monitoring tools, diagnostic methods, and therapeutic approaches for arrhythmia detection, treatment and prevention.
Background
Cardiac arrhythmias continue to represent a major public health burden associated with a high degree of morbidity and mortality. Major forms of arrhythmias, such as atrial fibrillation (AF), affect nearly 4% of the US population over 60 years of age and are associated with increased risks of heart disease and stroke. Similarly, ventricular arrhythmias which often result in sudden cardiac arrest and death (SCD) account for more than 355,000 deaths annually in the US. An estimated 95% of the victims of out-of-hospital SCD die before reaching the hospital.
Although all arrhythmias have in common an erratic electrical activity in the heart, their multiple causes and multitude of disease pathways are not currently understood fully. The disease-contributing factors are complex and include genetic, environmental, pharmacological, biological, and pathophysiological factors. In addition, many lethal ventricular arrhythmias occur without warning or prior indication of heart disease. Thus the development of accurate diagnosis and effective therapy remains challenging. Many of the present therapeutic approaches, including electrical shock-inducing devices, catheter-based radio frequency ablation, or post-event pharmacologic treatments are designed to provide palliative care at best and do not address the root cause of arrhythmogenesis that is needed for a more effective treatment.
To address these challenges of arrhythmia diagnosis, treatment, and prevention, the NHLBI convened a Working Group recently to: (1) evaluate gaps and barriers in basic research; (2) identify clinical settings where control of acute arrhythmia triggers and modulators might be effective; (3) specify basic science findings ready for translation into clinical research; and (4) provide recommendations to facilitate research to improve arrhythmia detection, treatment, and prevention. Based on recent advances in research and technology, several broad areas of potential opportunities for arrhythmia diagnostics and therapeutics were identified. These include: development of genetic screening methods for disease risk assessment, identification of arrhythmia markers, cell- and gene-based therapies, animal models for arrhythmia research, and new therapeutic targets based not only on cardiac ion channels and gap junctions but also peripheral structural and scaffold elements that comprise the cardiac electrical signaling pathway. Further information on the Working Group and recommendations can be accessed at (http://www.nhlbi.nih.gov/meetings/workshops/modifiers.htm).
Objectives and scope
The goal of this FOA is to develop innovative methods, tools, technologies and approaches to improve our ability to detect, prevent, and treat arrhythmias.
Examples of research topics might include, but are not limited to, the following:
See Section
VIII, Other Information - Required Federal Citations for policies related
to this announcement.
Section
II. Award Information
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 current SBIR or STTR Parent FOAs.
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 small business concern (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 5,
August 5, and December 5 (or January 2, May 1, and September 1 for AIDS and
AIDS-related STTR applications).
This
funding opportunity uses Just-in-Time information 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.
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 13 CFR 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 CFR 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, 13 CFR 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
his/her 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 current SBIR or
STTR Parent FOAs.
Section
IV. Application and Submission Information
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:
PDs/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 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: February 5, 2007
(Earliest date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not applicable
Application Submission/Receipt
Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application
Submission/Receipt Date(s): Not applicable
Peer
Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Council Review Date(s):
Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
Earliest Anticipated
Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details.
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
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:
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%5Fsharing/ http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)
Sharing Research
Resources
NIH policy expects 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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
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 revised/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 component 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.
Phase II
Competing Renewal Applications (formerly Phase II Competing Continuation
applications)
In addition to the
above review criteria, described under All STTR Applications, the following
items will be applied to ALL Phase II competing renewal applications in the
determination of scientific merit and the priority score.
1. Does the activity
as proposed address issues related to Federal regulatory approval processes?
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?
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:
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 expects 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.
Section VII. Agency Contacts
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:
Bishow B. Adhikari,
Ph.D.
Program Director, Heart Failure and Arrhythmias Branch
Division
of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Rockledge Two, Room 9192
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0507
Fax: (301) 480-7971
Email: [email protected]
David A.
Lathrop, Ph.D.
Deputy Chief, Heart Failure and Arrhythmias Branch
Division
of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Rockledge Two, Room 9192
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0507
Fax: (301) 451-5458
Email: [email protected]
2. Peer Review Contacts:
Not
Applicable
3. Financial or Grants Management Contacts:
Ms. Ryan Lombardi
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge Two, Room 7162
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301)
435-0141
Fax: (301) 480-3310
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)). 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.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
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 HHS 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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