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
Office of Behavioral and
Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
National Center for Complementary and Alternative
Medicine (NCCAM) (http:// nccam.nih.gov)
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov)
National
Eye Institute (NEI) (http://www.nei.nih.gov)
National
Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National
Human Genome Research Institute (NHGRI) (http://www.genome.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
National
Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National
Institute of Nursing Research (NINR) (http://www.ninr.nih.gov)
National
Institute on Aging (NIA) (http://www.nia.nih.gov)
National
Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov)
National
Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National
Library of Medicine (NLM) (http://www.nlm.nih.gov)
Title: Technological Innovations for
Interdisciplinary Research Incorporating the Behavioral and Social Sciences
(STTR [R41/R42])
Announcement Type
New
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 (4) weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-08-201
Note: Applications submitted for the January 15, 2009 receipt date and thereafter, will use Adobe forms, which will be available in December, 2008 (see NOT-OD-08-117).
Catalog of
Federal Domestic Assistance Number(s)
93.213, 93.389, 93.867, 93.233, 93.837-9, 93.172,
93.286, 93.121, 93.847-9, 93.859, 93.853, 93.361, 93.866, 93.173, 93.279,
93.879
Key Dates
Release/Posted
Date: July 15, 2008
Opening Date: August 17, 2008 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt
Date(s): August 17,
2008; December 15, 2008; April 1, 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): September
17, 2008; January 15, 2009; May 1, 2009
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February/March 2009; June/July
2009; October/November 2009
Council Review Date(s): May 2009; October 2009; January
2010
Earliest Anticipated Start
Date(s): June
2009; November 2009; February 2010
Additional Information To Be Available Date (Activation
Date): Not Applicable
Expiration Date: May 2, 2009
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 advance the understanding of health through development of innovative new technologies to facilitate collaborative research integrating social and/or behavioral scientific disciplines with other disciplines. This announcement supports applications to develop tools for use in conducting interdisciplinary, multilevel research that will integrate levels of analysis ranging from individual (e.g., cellular, biological, physiological, molecular, genetic) to population levels and all levels in between (e.g., interpersonal, family, community, social, global). In this FOA, the term technologies refers to such things as research tools, software, equipment or devices eligible for commercialization that provide opportunities for moving interdisciplinary research forward.
Applications must involve collaborative teams in the development of the proposed technologies. These teams will be composed of at least one or more social and/or behavioral scientists engaged with other specialists in product development. For the purposes of this FOA, behavioral and social sciences research uses the NIH Office of Behavioral and Social Sciences definition, found at: http://obssr.od.nih.gov/Content/About_OBSSR/BSSR_Definition/. Supported project development can advance and integrate social and/or behavioral science with other discipline(s) as diverse as atmospheric science, biochemistry, biology, biomedicine, computational science, computer science, economics, engineering, geography, genetics, informatics/information science, mathematics, physics, physiology, and robotics. Note that this list is meant to be illustrative, not all-inclusive.
Background
In 2007 NIH issued RFA RM-07-004 in response to the ongoing need for behavioral and social science involvement in interdisciplinary health research. The focus was on the creation of research tools (measures, methodologies and technologies) supporting integration of human social and/or behavioral science with other disciplines across varying levels of analysis. This earlier opportunity was part of the NIH Roadmap for Medical Research; all NIH Institutes and Centers (IC s) participate in Roadmap initiatives (for more information about the NIH Roadmap Initiative, please visit: http://nihroadmap.nih.gov).
Building on that effort, this FOA utilizes the STTR mechanisms (R41/R42) and departs from the earlier Roadmap initiative in several important ways. First, all applications must meet requirements for product development and small business concern eligibility criteria relevant to STTR. Second, in terms of topical focus, this FOA emphasizes funding for projects to develop new technologies rather than methodological innovations. However, unlike STTR applications that might fall under an omnibus solicitation, the research utility of the technological innovation should be paramount, while any treatment or assistive application of the device or technology might be a complement to the research function.
Scientific Rationale for Interdisciplinary, Multi-Level Approaches
Behavioral and social sciences have offered significant, fundamental insights into the comprehensive understanding of human health and diseases, including knowledge of disease etiology, prevention, and treatment, and of factors critical to the promotion of health and well-being. Integrating scientific insights and technologies gleaned from behavioral and social sciences with approaches from other scientific disciplines offers the promise of further advancing the public health mission of the NIH.
Much behavioral research on health assumes that individual action is an important vehicle for understanding and changing social and health behaviors, but acknowledges that individuals are heavily influenced by actions occurring at other levels: from genomic, molecular, cellular, and organ systems, to family, workplace and community levels, to state, national, and global socioeconomic, environmental and geopolitical factors. Each additional layer of action requires more complex models. To better understand the relationships among these multiple levels, and to more fully elucidate their interactions, more sophisticated research tools are needed.
Distinct disciplinary perspectives contribute significant sources of strength to the overall research enterprise because each discipline has its own intellectual history, experimental and analytic approaches, and theoretical context that produce a unique way of thinking about a problem. Nevertheless, with ever-expanding scientific knowledge and improved capabilities, increasingly sophisticated questions arise. Answering these questions often requires the convergence of perspectives from multiple disciplines to address challenging and complex problems in biomedical and behavioral research (such as obesity, diabetes, cardiovascular and cerebrovascular disease, HIV/AIDS, substance abuse, mental illness, etc.) in a comprehensive and effective way. Complex problems may require expertise from a variety of disciplines and the integration of data at multiple levels to be addressed adequately. The purpose of this FOA is to address this need.
Additional background on interdisciplinary approaches to technology and methodology can be found at http://nihroadmap.nih.gov/interdisciplinary/summit0806/. Additional information about priority research areas for behavioral and social sciences and interdisciplinary approaches to health, can be found in the strategic prospectus of the NIH Office of Behavioral and Social Sciences Research at http://www.thehillgroup.com/OBSSR_Prospectus.pdf.
Research and Development Scope
Participating ICs invite qualified SBCs to submit novel grant applications designed to develop innovative new technologies that support interdisciplinary integration of human social and/or behavioral research with research from other disciplines. Applicants are strongly encouraged to demonstrate how research tools can promote research integrating multiple levels of analysis ranging anywhere from subcellular micro-levels to human populations in advancing critical areas of health.
In line with the spirit of interdisciplinary research, applications must involve research teams. Teams must include behavioral and/or social scientists in addition to technicians and scientists with other backgrounds. Applicants should provide a strong and compelling rationale for how teams are constituted and how they expect the group to work synergistically.
Examples of SBC innovations sought by this FOA include, but are not limited to, those described below. Again, all examples are presumed to involve collaborative teams and approaches (including at least one behavioral or social scientist developing a technology apt for interdisciplinary research involving a social/behavioral approach), and to be relevant to health research.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement.
1. Mechanism(s) of Support
This funding
opportunity will use the Small Business Technology Transfer (STTR [R41/R42]
grant mechanisms. Applications
may be submitted for support as Phase I, Phase II, or Fast-Track grants as
described in the SF424 (R&R) SBIR/STTR Application Guide. Phase II
Competing Renewal applications are not accepted under this funding opportunity
announcement.
Small business concerns (SBCs) that have received a Phase I STTR 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 STTR 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 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. All
other participating organizations, including the single, partnering research
institution, must complete and submit requests using the Research & Related
Subaward Budget Attachment(s) Form contained in the application package.
2. Funds Available
Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
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. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed 1 year. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that is reasonable and appropriate for completion of the research project. Applicants are strongly encouraged to contact the appropriate research Program Officer regarding budgets as well as application content.
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 STTR applications. A small business
concern is one that, at the time of award for both Phase I and Phase II STTR
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 (a) 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.
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, 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.
For a STTR application, the PDs/PIs may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.
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.
Each 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 small business concern, which is characterized by an official relationship between the small business concern 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.
Applicants may submit more than one application, provided each application is scientifically distinct.
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 any other HHS FOA, including the current SBIR or STTR Parent FOAs.
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. Phase II Competing Renewal grant applications are not accepted under this FOA.
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 due dates following the expiration of the Phase I budget period.
The applicant SBC must present a team that includes a qualified technical or scientific specialist relevant to the technology being developed, working with at least one social or behavioral scientist on the proposed project. The strongest applications will justify the composition of research and development teams, and explain the roles of the different parties in technology development.
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.
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 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) 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: [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 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 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.
Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
Research
& Related Budget
Research
& Related Subaward Budget Attachment(s) Form
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
SBIR/STTR
Information
Optional Components:
PHS398
Cover Letter File
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PD/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. All funding for STTR projects goes to the small business concern, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form.
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, including 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: August 17, 2008 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt
Date(s): August 17,
2008; December 15, 2008; April 1, 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): September
17, 2008; January 15, 2009; May 1, 2009
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February/March 2009; June/July
2009; October/November 2009
Council Review Date(s): May 2009; October 2009; January
2010
Earliest Anticipated Start
Date(s): June
2009; November 2009; February 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:
Patricia
L. Mabry, Ph.D.
Office of Behavioral and
Social Sciences Research
Office of the Director, National Institutes of Health
31
Center Drive
Building
31, Room B1C19
Bethesda,
MD 20892
Telephone:
301-402-1753
Fax:
301-402-1150
Email:
[email protected]
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 due 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). Incomplete 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 (1 page maximum for Phase I and 3 pages maximum for Phase II) 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 and Information
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 (MS Word) or PDF) are to be followed, with the following requirements.
STTR Phase I applications:
STTR Phase II applications:
STTR 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: Applicants requesting $500,000 or more in direct costs in any year must 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 data set may be shared. If the final data are not amenable to sharing (for example human subject concerns, the Small Business Act provisions, etc.) this must be explained in the application.
The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal
Web site, through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.
The reasonableness of the data sharing plan or the rationale for not sharing
research data may be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. For more information on data sharing see http://grants.nih.gov/grants/policy/data_sharing.
and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)
(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 will be evaluated for
scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applications submitted for this funding opportunity will be
assigned on the basis of established PHS referral guidelines to the ICs for
funding consideration.
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 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? Are the milestones and evaluation procedures appropriate? Does the
applicant acknowledge potential problem areas and consider alternative tactics? Is a collaborative team that includes a social or
behavioral scientist and another technical expert or scientist specified? 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?
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?
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/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.
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.
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 PD/PI.
For details about each specific required report, see Section V, Award Guidelines, Reporting Requirements, and Other Considerations, of the SF 424 (R&R) SBIR/STTR Application Guide (MS Word) or PDF).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:
For general
information regarding this FOA, inquiries should be directed to:
Patricia L. Mabry, Ph.D.
Office of Behavioral and
Social Sciences Research (OBSSR)
Office of the Director, National Institutes of Health
31 Center Drive
Building 31, Room B1C19
Bethesda, MD 20892
Telephone: 301-402-1753
Fax: 301-402-1150
Email: [email protected]
For specific guidance related to application content, participating component contacts are listed below.
Carol Pontzer, Ph.D.
National Center for
Complementary & Alternative Medicine
6707 Democracy Blvd, Suite 401, MSC 5475
Bethesda, Maryland 20892-5475 (for express
mail, use 20817)
Telephone: 301-402-1272
Fax: 301-480-3621
Email: [email protected]
Amy L. Swain, Ph.D.
Division of Biomedical Technology
National Center for Research
Resources (NCRR)
Democracy 1, Room 964,
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: 301-435-0755
Fax: 301-480-3659
Email: [email protected]
Dr. Jerome Wujek
Research Resources Officer
National Eye Institute (NEI)
5635 Fishers Lane, Suite 1300
Rockville, MD 20852
Telephone: 301-451-2020
Fax: 301-402-0528
Email: [email protected]
Abby G. Ershow, Sc.D., FAHA
Program Director (Nutrition)
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute (NHLBI)
2 Rockledge Center, MSC 7956
6701 Rockledge Drive
Bethesda MD 20892
Telephone: 301-435-0550
Fax: 301-480-3667
Email: [email protected]
Erin M. Ramos, PhD, MPH
Epidemiologist, Office of Population Genomics
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD 20892-9305 (U.S. Postal
Service Express or regular mail)
Rockville, MD 20852 (express/courier service; non-USPS service)
Telephone: 301-496-7531
FAX: 301-480-2770
Email: [email protected]
Mr. Todd Merchak
Program Specialist
National Institute of Biomedical Imaging and Bioengineering,
NIH
Two Democracy Plz
6707 Democracy Blvd Suite 200
Bethesda, MD 20892-5477
Phone: 301-496-8592
Fax: 301-480-1614
Email: [email protected]
Melissa W. Riddle, Ph.D.
Chief, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research
(NIDCR)
National Institutes of Health
6701 Democracy Blvd.
Room 646, Mail Stop 4878
Bethesda, MD 20892-4878
Telephone: 301-451-3888
Email: [email protected]
Ms. Christine Densmore
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
6707 Democracy Blvd
Bethesda, MD, 20817
Telephone: 301-402-8714
Fax: 301-480-8300
Email: [email protected]
Dr. Marva Moxey-Mims
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
6707 Democracy Blvd.
Bethesda, MD 20817
Telephone: 301-594-7717
Fax: 301-480-3510
Email: [email protected]
Dr. Christine Hunter
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
6707 Democracy Blvd
Bethesda, MD, 20817
Telephone: 301-594-4728
Email: [email protected]
Dr. Matthew E. Portnoy
Program Director, Division of Genetics and Developmental
Biology
National Institute of General Medical Sciences (NIGMS)
Natcher Building, Rm. 2AS-25P
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Telephone: 301-594-0943
Fax: 301-480-2228
Email: [email protected]
Daofen Chen, Ph.D.
Program Director, Systems and Cognitive Neuroscience
National Institute of Neurological Disorders and Stroke
(NINDS)
NIH Neuroscience Center, Room
2176
6001 Executive Boulevard
Bethesda, MD 20892-9253 (FEDEX 20852)
Telephone: 301-496-9964
Fax: 301-480-2424
Email: [email protected]
Paul A. Cotton, PhD, RD
Program Director, Health Behavior & Minority Health
Division of Extramural Activities
National Institute of Nursing Research (NINR)
National Institutes of Health
6701 Democracy Blvd, Ste. 710
One Democracy Plaza
Bethesda, MD 20892-4870 (Courier zip:
20817)
Telephone: 301-402-6423
Fax: 301-451-5647
Email: [email protected]
Michael-David A.R.R. Kerns, M.B.A., M.S., Ph.D.
Health Scientist Administrator
National Institute on Aging
7201 Wisconsin Ave,
MSC 9205
Bethesda,
MD 2892-9205
Telephone: 301-496-9322
Email: [email protected]
Lana Shekim, Ph.D.
Director, Voice & Speech Programs,
Division of Scientific Programs
National Institute on Deafness and Other Communication
Disorders (NIDCD)
National Institutes of Health
6120 Executive Blvd., EPS-400-C MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-496-5061
Fax: 301-402-6251
Email: [email protected]
Cathrine A. Sasek, Ph.D.
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 5237
Rockville, MD 20852-9521
Telephone: 301-443-6071
Fax: 301-443-6277
Email: [email protected]
Jane Ye, Ph.D
Division of Extramural Programs
National Library of Medicine (NLM)
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892. MSC 7968
Phone: 301-594-4882
Fax: 301-402-0421
Email: [email protected]
http://www.nlm.nih.gov/ep/
2. Peer Review Contacts:
3. Financial or Grants Management Contacts:
George Tucker
Grants Management Officer
National Center for
Complementary and Alternative Medicine (NCCAM)
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: 301-594-9102
Email: [email protected]
Leslie Le
Grants Management Officer
National Center for Research Resources (NCRR)
Office of Grants Management
6701 Democracy Boulevard
Room 1051-MSC 4874
Bethesda, MD 20892-4874
Telephone: 301-435-0856
Fax: 301-480-3777
Email: [email protected]
William Darby
Division of Extramural Research
National Eye Institute (NEI)
5635 Fishers Lane, Suite 1300
Rockville, MD 20852
Telephone: 301-451-2020
Fax: 301-496-9997
Email: [email protected]
David Reiter
Branch Chief, Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
Rockledge II, Room 7261
6701 Rockledge Drive
Bethesda, MD 20892-7926 (Express zip:
20817)
Telephone: 301-435-0153
Fax: 301-154-5462
Email: [email protected]
Cheryl Chick
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD 20892-9306 (U.S. Postal
Service Express or regular mail)
Rockville, MD 20852 (express/courier service; non-USPS service)
Telephone: 301-435-7858
FAX: 301-402-1951
Email: [email protected]
Ms. 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: [email protected]
Mary Daley
Chief, Grants Management Branch
National Institute of Dental and Craniofacial Research
(NICDR)
6701 Democracy Blvd
Room 658, Mail Stop 4878
Bethesda, MD 20892-4878
Telephone: 301-549-4800
Fax: 301-480-3562
Email: [email protected]
Diana O Donovan
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
Two Democracy Plaza, Room 726
6707 Democracy Boulevard
Bethesda, Maryland 20892-5456
Telephone: 301-594-8868
Fax: 301-480-3504
Email: [email protected]
Ms. Patrice Molnar
Grants Management Specialist
National Institute of General Medical Sciences (NIGMS)
Natcher Building, Rm. 2AN-38C
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Phone: 301-594-5136
Fax: 301-480-2554
Email: [email protected]
Ms. Kimberly Campbell
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
(NINDS)
6001 Executive Blvd., Rm. 3254
Bethesda, MD 20892-9537
Telephone: 301-496-7809
Fax: 301-402-0219
Email: [email protected]
Mr. Brian Albertini
Chief, Grants and Contracts Management
National Institute of Nursing Research (NINR)
6701 Democracy Boulevard, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: Phone: 301-594-6869
Fax: 301-402-4502
Email: [email protected]
Ms. Linda Whipp
Chief, NIA Grants Management Office
7201 Wisconsin Avenue, Ste. 2N-212
Bethesda, MD 20814
Telephone: 301-496-1472
Fax: 301-402-3672
Email: [email protected]
Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities
National Institute on Deafness and Other Communications
Disorders (NIDCD)
Executive Plaza South, Room
400B
6120 Executive Blvd., MSC 7180
Bethesda, MD 20892-7180 (20852 for
express mail)
Telephone: 301-435-0713
Fax: 301-402-1758
Email: [email protected]
Ms. Pamela Fleming
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Blvd RM 270 MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 435-1369
Fax: (301) 594-6849
Email: [email protected]
Dwight Mowery
Extramural Programs
National Library of Medicine (NLM)
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: 301-496-4221
Fax: 301-402-0421
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
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 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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