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 Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National Center on Minority Health and Health Disparities (NCMHD) (http://www.ncmhd.nih.gov)
National Center for Research Resources
(NCRR)
(http://www.ncrr.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Development and Translation of Medical Technologies that
Reduce Health Disparities (SBIR [R43/R44])
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-EB-09-001
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) 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 (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.286, 99.389, 93.307, 93.242
Key Dates
Release/Posted Date: December 16, 2008
Opening Date: January 20, 2009 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 20, 2009, April 20, 2009,
August 22, 2009
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 Due Date(s): February 20, 2009, May 20, 2009, September
22, 2009
AIDS Application Due Date(s): May 7, 2009, Sep
7 20, 2009, January 7, 2010
Peer Review Date(s): July 2009, November 2009, March 2010
Council Review
Date(s): August 2009, January 2010, May 2010
Earliest
Anticipated Start Date(s): September 2009, April 2010, July 2010
Additional Information To Be
Available Date (Activation Date): Not
Applicable
Expiration Date: January 8, 2010
Due
Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
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 and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
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
Purpose
The purpose of this funding opportunity is to reduce health disparities through the development and translation of appropriate medical technologies. Appropriate medical technologies must have the following basic characteristics: effective, affordable, culturally acceptable, and easily accessible to those who need them. This announcement supports proposals to develop medical devices, imaging systems, and other technologies that adequately address the healthcare needs of health disparity populations. A population is a health disparity population if there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality or survival rates in the population as compared to the health status of the general population. Generally, health disparity populations include racial and ethnic minorities, low socioeconomic populations, and rural populations.
Background
Medical and scientific advances have introduced new opportunities for the continued improvement of health for all Americans. However, in spite of notable improvements gained as a result of the technological advancement, there continues to be an alarming disproportionate burden of illness among minority and other health disparity populations. Overcoming persistent disparities in healthcare access and health outcomes remains a foremost challenge. To meet this challenge, the NIH is committed to supporting a wide range of research, aimed at the development of innovative diagnostics, treatments, and preventative strategies to reduce, and eventually eliminate, health disparities.
Research Objectives and Scope
The primary objective of this funding opportunity is to support the translation of medical technologies, new or existing, that can have a significant impact on healthcare access and health outcomes for health disparity populations. Qualified small business concerns (SBCs) are invited to submit grant applications proposing to develop and deliver appropriate technologies to health disparity populations. Responsive proposals will involve interactions with underserved populations and/or collaborations with clinics in an underserved community. A requisite component of the research plan is a description of the healthcare requirements and needs of the population and the existing barriers to adequate healthcare delivery. Several of these barriers have been identified and are described below. Proposals submitted to this funding opportunity must address one or more of these barriers in developing technologies that will impact health disparities:
Appropriate technologies may be new and innovative, or they may be existing technologies that have been redesigned based on the needs of a specific health disparity population. Appropriate technologies have been defined as effective, affordable, culturally acceptable, and deliverable to those who need them. To be effective, a technology must provide an improvement over the current quality of care for a health disparity population by overcoming one or more of the barriers. The technology must also be low-cost, so as to be affordable to the local hospital, community health center, primary care physician, or individual patient in need. For a medical technology to be adopted by a health disparity population, the technology development must be amenable to the population’s cultural beliefs and social customs. Acceptance of the technology by the population is critical to the successful delivery of quality healthcare. To be physically delivered to those in need, a technology must be developed within the specifications of the operating environment of the end-user. The technology must be able to function given the existing resources and expertise within health disparity populations. Keeping in mind the barriers that contribute to health disparities, a non-inclusive list of appropriate medical technologies that might achieve the objectives of this initiative is described below:
Some examples are:
NIMH has specific interest in projects developing or translating technologies that reduce health disparities with regard to mental illnesses, such as autism, depression, bipolar disorder, schizophrenia, as well as health disparities in HIV/AIDS prevention, treatment, and the mental health implications of HIV/AIDS (see http://www.nimh.nih.gov).
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 Innovation Research (SBIR [R43/R44] 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.
Small
business concerns that have received a Phase I SBIR grant may apply for Phase
II funding of that project. 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. Phase II applications will compete with all SBIR
applications and will be reviewed according to the customary peer review
procedures
The Project Director/Principal Investigator (PD/PI) will
be solely responsible for planning, directing, and executing the proposed project.
This
funding opportunity uses Just-in-Time information concepts. The modular
budget format is not accepted for SBIR 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 estimated amount of funds available for support of 7-12projects awarded as a result of this announcement is $3.45 million for fiscal year 2009. The NIBIB, NCMHD, and NCRR will each contribute $1 million for fiscal year 2009, and the NIMH will contribute $450,000 for fiscal year 2009. Future year amounts will depend on annual appropriations.
For this funding opportunity, budgets up to $200,000 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets up to $400,000 total costs per year and up to 3 years may be requested for Phase II.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business
concern is one that, at the time of award of Phase I and Phase II, meets all of the following
criteria:
1. Organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
2. In the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by business entities in the joint venture;
3. At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States -- (except in the case of a joint venture);
4. Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.
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 SBIR awardee organization must be space that is available to and under the control of the SBIR 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 SBIR 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 SBIR 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 SBIR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, the organization must be recertified by the SBA prior to any future SBIR/STTR awards.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. That individual will serve as the Contact PD/PI. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.
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.
If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the Contact PD/PI, if at the time of submission of the application, the Contact PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.
If the Contact PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the Contact PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the Contact PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.
All current employment and all other appointments of the Contact PD/PI must be identified in his or her Biographical Sketch required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.
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
Applications not involving interactions with underserved populations and/or collaborations with clinics in an underserved community are non-responsive to this FOA and will not undergo peer review.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016 .
Renewals. Phase II renewals are allowed for this FOA.
Applicants may submit more than one application, provided each application is scientifically distinct.
Applicants may not simultaneously submit identical/essentially identical applications under both this SBIR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs. 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. Likewise, identical or essentially identical grant applications submitted by different organizations will not be accepted. Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review.
It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.
Only one Phase II award may be made for a single SBIR/STTR project.
You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.
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, use
the Apply for Grant Electronically button in this FOA or 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 eRA 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 Registered
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.
To affiliate the PD/PI with the applicant small business concern:
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: If a PD/PI is also an NIH peer-reviewer the DUNS number obtained and used in the reviewer role may NOT be used and is not applicable to any Grant Application to the Federal Government. This DUNS number is different from the DUNS number used by the applicant organization. The individual DUNS number should be used only for the purposes of personal reimbursement.
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) SBIR/STTR Application
Guide for this FOA using the Apply for Grant Electronically button in this
FOA or 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: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all SBIR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide.
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). Failure to include this data field will cause the application to be rejected.
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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
SBIR/STTR
Information
Optional
Components:
PHS398
Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: January 20, 2009 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 20, 2009, April 20, 2009, August
22, 2009
Application Due
Date(s):
February 20, 2009, May 20, 2009, September
22, 2009
AIDS Application
Due Date(s): May
7, 2009, Sep 7 20, 2009, January 7, 2010
Peer Review Date(s): July 2009, November 2009, March 2010
Council Review
Date(s): August 2009, January 2010, May 2010
Earliest
Anticipated Start Date(s): September 2009, April 2010, July 2010
3.A.1.
Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of
intent is to be sent by the date listed in Section
IV.3.A.
The letter of
intent should be sent to:
Mr. Todd Merchak
Program Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892-5477
Phone: 301-496-8592
Fax: 301-480-1614
Email: merchakt@mail.nih.gov
3.B.
Submitting an Application Electronically to the NIH
To
submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps
1-4. Note: Applications must only be submitted electronically. 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 weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review (CSR) and responsiveness by the NIBIB and
NCMHD.
Incomplete and non-responsive applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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.
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 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 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
Team Involvement with Health Disparities
Population
The proposed project must involve interactions with underserved populations and/or collaborations with clinics in an underserved community. The applicant is required to describe the nature of the partnership, as well as the roles and responsibilities of the parties involved.
PD/PI Credential (e.g., Agency Login)
The NIH requires each 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.
Organizational DUNS
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.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to 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. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, incorporating "Just-in-Time" information concepts, with the following requirements.
SBIR Phase I applications:
SBIR Phase II applications:
SBIR Fast-Track applications:
Resubmissions:
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
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 that are
complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review
group convened by the NIBIB and in accordance with NIH
peer review procedures (http://grants1.nih.gov/grants/peer/), using
the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, and weighted as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a meritorious priority score.
Applicants should include information in relevant sections of the grant application that addresses the questions for each review criterion below.
All SBIR 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? Will the project have a significant impact on reducing health
disparities? Does the proposed project focus on overcoming barriers to quality
healthcare delivery to health disparities populations?
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? Are the milestones and evaluation procedures appropriate? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
For applications designating multiple PD/PIs, is the leadership approach,
including he designated roles and responsibilities governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PD/PIs? Does the
applicant adequately describe the needs of the involved health disparities
population?
Innovation: Is
the project original and innovative? For example: 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(s): Are the PD/PI(s) and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the PD/PI(s) and other researchers,
including consultants and subcontractors (if any)? Do the PD/PIs and
investigative team bring complementary and integrated expertise to the project
(if applicable)? Are the relationships of the key personnel to the small
business and to other institutions appropriate for the work proposed? Does the team involve a meaningful working partnership with a clinic
serving a health disparities population?
Environment: Do(es)
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? Is there sufficient access to resources (e.g., equipment, facilities)?
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?
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 rating:
Resubmission
Applications: Are the responses to comments from the previous scientific review group
adequate? Are the improvements in the resubmission application appropriate?
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. The priority score should
not be affected by the evaluation of the budget.
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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 or her Summary Statement (written critique) via the NIH 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.
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 Section
IV.5., Funding Restrictions.
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.
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
NIH
requires that SBIR/STTR grantees submit
the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)
Final Progress Report
Final Invention Statement and Certification (HHS 568)
Annual Invention Utilization Reports
Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)
Phase II Data Collection Requirement for Government Tech-Net Database (http://technet.sba.gov)
Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF 424 (R&R) SBIR/STTR Application Guide.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:
Todd Merchak
Program Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892-5477
Phone: 301-496-8592
Fax: 301-480-1614
Email: merchakt@mail.nih.gov
Kyu Rhee, MD, MPP, FAAP, FACP
Director, Office of Innovation and Program
Coordination
National Center on Minority Health and Health Disparities, NIH
National Institutes of Health
6707 Democracy Boulevard, Suite 800
Bethesda, Maryland 20892-5465
Phone: 301-594-8731
Fax: 301-480-4049
Email: rheekb@mail.nih.gov
Vincent A. Thomas, Jr., MSW, MPA
National Center on Minority Health and Health Disparities, NIH
6707 Democracy Blvd.
Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-402-2516
Fax: 301-480-4049
Email: thomasvi@mail.nih.gov
Amy L. Swain, Ph.D.
Program Director
National Center for Research Resources, NIH
6701 Democracy Blvd., Room 964
Bethesda, MD 20892-4874
Phone: 301-435-0755
Fax: 301-480-3659
E-mail: SwainA@mail.nih.gov
Adam Haim, Ph.D.
National Institute of Mental Health, NIH
6001 Executive Blvd, Rm 7168
Bethesda, MD 20892-9649
Phone: 301-435-3593
Fax: 301-594-6784
Email: haima@mail.nih.gov
2. Peer Review Contacts:
David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd.
Democracy II, Suite 920
Bethesda, MD 20892
Phone: 301-496-8633
Fax: 301-480-0675
Email:georged@nih.gov
3. Financial or Grants Management Contacts:
Florence Turska
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd. Suite 900
Bethesda, MD 20892-5469
Phone: 301-496-9314
Fax: 301-480-4974
Email: turskaf@mail.nih.gov
Priscilla Grant, J.D., C.R.A.
Grants Management Specialist
National Center on Minority Health & Health Disparities, NIH
6707 Democracy Blvd.
Suite 800, MSC 5464
Bethesda, MD 20892-5464
Phone: 301-402-1366
Fax: 301-480-4049
Email: pg38h@nih.gov
Leslie Le
Grants Management Specialist
National Center for Research Resources, NIH
6701 Democracy Blvd, Room 1051
Bethesda, MD 20892-4874
Phone: 301-435-0856
Fax: 301-480-3777
Email: LeLeslie@mail.nih.gov
Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health, NIH
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Phone: 301-443-2811
Email: rc253d@nih.gov
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
institutional review board (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 the
scientific merit or the priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at 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.
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) application; 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 Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.
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) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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. 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/.
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NIH Funding Opportunities and Notices
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