and Human Services (HHS)
EXPIRED
Participating
Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Cancer Institute (NCI/NIH), (http://www.cancer.gov/)
National
Eye Institute (NEI/NIH), (http://www.nei.nih.gov/)
National
Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm)
National
Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov/)
National
Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov/)
National
Institute of Allergy and Infectious Diseases (NIAID/NIH), (http://www3.niaid.nih.gov/)
National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH), (http://www.niams.nih.gov/)
National
Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov/)
National
Institute on Deafness and Other Communication Disorders (NIDCD/NIH), (http://www.nidcd.nih.gov/)
National
Institute of Dental and Craniofacial Research (NIDCR/NIH), (http://www.nidcr.nih.gov/)
National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov/)
National
Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov/)
National
Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov/)
National
Institute of General Medical Sciences (NIGMS/NIH), (http://www.nigms.nih.gov/)
National
Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov/)
National
Institute of Neurological Disorders and Stroke (NINDS/NIH), (http://www.ninds.nih.gov/)
National
Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National
Library of Medicine (NLM/NIH), (http://www.nlm.nih.gov/)
National
Center for Complementary and Alternative Medicine (NCCAM/NIH), (http://nccam.nih.gov/)
National
Center on Minority Health and Health Disparities (NCMHD/NIH), (http://ncmhd.nih.gov/)
National
Center for Research Resources (NCRR/NIH), (http://www.ncrr.nih.gov/)
Office
of Dietary Supplements, National Institutes of Health (ODS), (www.ods.od.nih.gov)
Title: Recovery Act Limited Competition: Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-OD-09-008
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.
A registration process is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
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).
Catalog of Federal
Domestic Assistance Number(s)
93.701
Key Dates
Release/Posted Date: June 2, 2009
Opening Date: August 1, 2009 (Earliest date an application may be submitted to Grants.gov)
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).
Letters
of Intent Due Date: August 3, 2009
Application Due Date(s): September 1, 2009
Peer
Review Date(s): November/December 2009
Council Review
Date(s): January 2010
Earliest Anticipated
Start Date(s): April 2010
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: September 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
Section II. Award Information
Section III.
Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
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 pilot program, called Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN), is to accelerate the transition of research innovations and technologies toward the development of products or services that will improve human health, help advance the mission of NIH and its Institutes and Centers (ICs), and create significant value and economic stimulus. The BRDG-SPAN pilot is intended to help address the funding gap, often called the Valley of Death , between innovative promising research and development (R&D) and transitioning those innovations to the market, by contributing to the critical funding needed by applicants to carry out later stage research activities and to pursue the next appropriate milestone(s) necessary to move a product/technology along a promising commercialization pathway. This program also aims to foster partnerships among a variety of research and development (R&D) collaborators.
The BRDG-SPAN pilot program is specifically targeted to bridge the "Valley of Death" gap by contributing to the critical funding needed by applicants to carry out later stage research activities necessary to move a product/technology along a promising commercialization pathway.
The BRDG-SPAN pilot program encourages projects representing, for example, the following:
Note that this list is not meant to be exhaustive. For this FOA, research topics include any that are clearly relevant to the mission of NIH or its component Institutes and Centers (mission statements, research priorities, strategic plans, etc., can be found on the web sites of NIH, its Institutes and Centers).
We encourage applicants proposing drug development projects to have completed some preclinical development activities by the time of award under this FOA. Nonetheless, activities proposed for support may be used to complete additional activities or requirements for regulatory filings [e.g., Investigational New Drug (IND) application, Special Protocol Assessment, progression in clinical stage development]. Clinical evaluation, including clinical trials, can also be proposed as needed. Other R&D activities that are needed to meet the requirements and expectations of a relevant Federal regulatory agency may also be proposed.
Development efforts for therapeutic modalities and/or medical devices may include, but are not limited to: assay development to support clinical trials; process development for manufacturing (drugs or devices) and/or GMP production of lead article; completion of activities as required by the Food and Drug Administration (FDA) for advancing the device or drug toward the clinical stage of development (e.g., IND, Radioactive Drug Research Committee [RDRC], Pre-Market Approval [PMA], Investigational Device Exemption [IDE], or 510(k) applications, New Drug Application [NDA], Biologic License Application [BLA]; clinical trials).
Encouragement of Partnerships and Independent Support.
The NIH acknowledges strategic partnerships and/or the raising of independent third-party support as important means to facilitate and accelerate the capital-intensive, later stage research activities needed to commercialize new products/technologies emerging from NIH-funded projects. As such, the NIH encourages efforts to form new business relationships that will augment the efforts undertaken during the project period. The expectation is that this pilot will foster new business relationships in which strategic partners or third-party investors will provide substantial support to drive promising technologies toward the marketplace. Independent of existing partnerships, the applicant is responsible for seeing the project through to completion.
Applications received under this FOA may be given programmatic funding priority if the project or technology is deemed highly likely to result in a commercial product as indicated by the underserved need being addressed, the lack of alternative resources in the market and/or the applicant’s ability to secure funding or in-kind support from an independent third-party investor and/or strategic partner, etc.
See Section VIII, Other Information - Required Federal
Citations, for laws and policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This
FOA will use the RC3 award
mechanism. The Project Director/Principal Investigator (PD/PI) will
be solely responsible for planning, directing, and executing the project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.
2. Funds Available
This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5.
Contingent upon the submission of a sufficient number of scientifically meritorious applications, NIH intends to commit at least $35 million in response to this FOA. We anticipate that at least 10 awards will be made in fiscal year 2010, pending the number and quality of applications and availability of funds. Budget proposals are limited to $1 million total costs per year over three years.
Because
the nature and scope of the research will vary from application to application,
it is anticipated that the size of each award will also vary. Although the
financial plans of the IC(s) provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds.
The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.
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.
Note that under this FOA, funds cannot be paid as profit to any recipient. Profit is any amount in excess of allowable direct and indirect costs. In addition, program income earned during the project period cannot be added to funds committed to the project/program and used to further eligible project/program objectives. (See 45 C.F.R. Part 74: Subpart E - Special Provisions for Awards to Commercial Organizations).
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
This FOA encourages submissions by United-States for-profit enterprises/commercial organizations doing a majority of their business in the United States. Applications received under this FOA may be given funding priority if the applicant is associated with an enterprise/commercial organization that is of small size (e.g., 500 or fewer employees), and/or of limited resources, such as an early-stage company, and/or one positioned for receiving funding or in-kind support from a third-party investor and/or strategic partner, etc.
The applicant United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from Institutional Development Award (IDeA) states. Foreign organizations/institutions are not permitted as the applicant organization.
If the application includes subcontractors, the applicant for-profit enterprise/commercial organization must be substantially involved in the R&D, with a leadership role in the project and defining the research agenda.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the 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.
Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have an official relationship between the applicant organization 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 organization should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
Following are examples of situations describing the official relationship of the PD/PI with the applicant organization:
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 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. 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.
2. Cost
Sharing or Matching
The NIH encourages but does not require cost sharing (as defined in the current NIH Grants
Policy Statement) or matching
funds under this pilot program. Third party
in-kind contributions may be made by any
nonfederal source (except subcontractors working on an RC3 project) and may include, but not be limited to, equipment, supplies, research tools, software, or other
property/services/external value as distinct from monetary investments.
3.
Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct. That is, 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.
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.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Note: The BRDG-SPAN pilot is not intended to support upstream R&D for feasibility testing of an innovative idea or conducting early-stage R&D as an extension of such ideas. Applicants proposing projects such should consider other programs such as the NIH Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs if the applicant qualifies as a small business.
It is expected that the awardee organization will conduct at least 40% of the proposed work. 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 15, Consortium/Contractual Arrangements, of the PHS398 Research Plan component of the SF424 (R&R) application forms.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application
Package and SF424 (R&R) 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 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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/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 the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly
attached to a specific FOA can be used. You will not be able to use any other
SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one FOA.
For
further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].
Telecommunications
for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. 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
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
PHS398 Research & Related Budget (Required for all
applications)
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 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).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: August 1, 2009 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Due
Date: August 3, 2009
Application Due Date: September 1, 2009
Peer
Review Date(s): November/December 2009
Council Review
Date(s): January 2010
Earliest Anticipated
Start Date(s): April 2010
3.A.1. Letter of Intent
Prospective applicants are encouraged to submit a letter of intent (LOI) 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 and plan for the potential review workload.
The letter of intent is to be sent to the specific scientific/research contact person identified in the table in Section VII. The letter of intent is to be sent by the date listed in Section IV.3.A.
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 due 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 CSR and responsiveness by the IC. 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/SO receives the Grants.gov acknowledgments. The AOR/SO and the 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 the application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4.
Intergovernmental Review
This
initiative is not subject to intergovernmental
review, as
indicated in the NIH Grants Policy Statement.
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.
Note that under this FOA, funds cannot be paid as profit to any recipient. Profit is any amount in excess of allowable direct and indirect costs. In addition, program income earned during the project period cannot be added to funds committed to the project/program and used to further eligible project/program objectives. (See 45 C.F.R. Part 74: Subpart E - Special Provisions for Awards to Commercial Organizations).
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: 1) are necessary
to conduct the project, and 2) 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 and Information
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) 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.
Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)
Research Plan: The Research Plan is limited to a total of 13 pages, including 1 page for the Specific Aims and 12 pages for Research Design and Methods.
PHS398 Research Plan Component Sections
Item Number and Title |
Instructions |
1. Introduction to Application |
Omit (N/A: Resubmissions and Revisions not allowable) |
2. Specific Aims |
One page maximum. Separate PDF attachment. Include quantitative milestones for each specific aim. These milestones serve as a way of determining during the project whether an awardee has successfully reached the specified goal(s). Milestones should be clearly stated as numerical quantitative specifications for relevant measures/properties (as appropriate) and/or distinct stages in technology/product development (such as granted IND status). |
3. Background and Significance |
Omit. Do not include this section in the application. |
4. Preliminary Studies/Progress Report |
Omit. Do not include this section in the application. |
5. Research Design and Methods |
Item 5 is limited to 12 pages and must be attached as a single PDF document with the following headings: SIGNIFICANCE: Describe the significance to public health of the problem addressed by this application. If the aims of the project are achieved, describe how technological advances, technical capability, clinical practice, and/or health will be improved. Describe the commercial potential of the project to lead to a marketable product, process or service. Describe whether the technology will have a competitive advantage over existing/alternate technologies that can meet the market needs. Describe the extent to which the technology addresses an unmet medical need. INVESTIGATORS AND COMPANY EXPERIENCE: Describe investigator and company previous research experience and success with other products/technologies, explaining if/how this past experience translates to the achievement of the specific aims in the current project. Discuss any complementary and integrated expertise the PD/PI(s) and investigative team bring to the project. Describe relationships of the key personnel to the applicant organization and, if applicable, to other partnering organizations (e.g., Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), academic laboratories, clinical sites and/or strategic partners) to the work. INNOVATION: Describe how the product that will be developed solves the identified problem, and creates significant value and economic stimulus. PRELIMINARY STUDIES: Explain the current status of the project and illustrate milestones achieved to date. APPROACH: Describe the research design, including milestones to be met. Describe the complete commercialization pathway. Describe the company’s exit strategy, if applicable. Figures and illustrations may be included but must fit within the specified page limit. Do not include links to Web sites for further information. Do not include animations. If the project involves advancing the product/technology through the Federal regulatory approval process, describe the proposed plan to meet these requirements. ENVIRONMENT: Describe the facilities and collaborators that are available for the success of the research. Describe ways the applicant organization is concentrating on its core competencies in order to maximize its chances of success. Describe ways that the applicant has established alliances/collaborative partnerships that will facilitate commercialization. If subcontractors are used, describe their facilities. Explain ways the applicant will sustain itself and grow. If applicable, describe strategic partners or other third-party investors that will play an active role in facilitating the development and commercialization of the applicant’s products/technologies. If applicable, describe the role that strategic partners or third-party investors will play in facilitating the development and commercialization of the applicant products/technologies. |
Excluded from the Research Plan limitation are the following items:
Note the page limit also excludes the Project Summary/Abstract; Bibliography and Literature Cited; and Biographical Sketches (separate PDFs).
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.
Special Instructions for Other Project Information (Section 4.4 of SF424 (R&R) Application)
Item 6. Project Summary/Abstract: Follow instructions in the SF424 (R&R) Application Guide.
Item 8. Bibliography and Literature Cited: Limited to one page.
Continue with the instructions in the SF424 (R&R) Application Guide.
Special Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of SF424 (R&R) Application)
Biographical Sketches: Each biographical sketch is limited to two pages. The number of publications cited in each biosketch is limited to ten or fewer items. Individuals should cite their most relevant publications and those that highlight the significance of past accomplishments.
Special Instructions for Preparation of Commercialization Plans
Full Commercialization. The goal of this BRDG-SPAN pilot is to help address the Valley of Death funding chasm between innovative promising R&D and transitioning those innovations to the market, by contributing to the critical funding needed by applicants to carry out later stage research activities and to pursue the next appropriate milestone(s) necessary to move a product/technology along a promising commercialization pathway. Applicants are expected to provide a realistic commercialization plan (beyond the period of award), which outlines how and when the full commercialization of the product/technology can be accomplished. It is expected that the plan will include the expected source of non-Federal funds likely to be required for the full commercialization of the product/technology.
Applicants are requested to include a commercialization plan (limited to a total of 10 pages) that outlines how and when the full commercialization of the product/technology is expected to be accomplished. Applicants are expected to address each of the areas described below. Provide this information in a separate file, attaching it as Item 11, Other Attachments, using the file name Commercialization_Plan.
a. Value of the Project, Expected Outcomes, and Impact. Describe, in layperson's terms, the project and its key technology objectives. State the product, process, or service to be developed. Clarify the need addressed, specifying weaknesses in the current approaches to meet this need. In addition, describe the commercial applications of the research and the innovation inherent in this application. Be sure to also specify the potential societal, educational, and scientific benefits of this work. Explain the non-commercial impacts to the overall significance of the project. Explain how the project integrates with the overall business plan of the company.
b. Company. Give a brief description of your company including corporate objectives, core competencies, present size (annual sales level and number and types of employees), history of previous Federal and non-Federal funding, regulatory experience, and subsequent commercialization, and any current products/services that have significant sales. Include a short description of the origins of the company. Indicate your vision for the future, how you will grow/maintain a sustainable business entity, and how you will meet critical management functions as your company and the research product evolve.
c. Market, Customer, and Competition. Describe the market and/or market segments you are targeting and provide a brief profile of the potential customer. Tell what significant advantages your innovation will bring to the market, e.g., better performance, lower cost, faster, more efficient or effective, new capability, etc. Explain the hurdles you will have to overcome in order to gain market/customer acceptance of your innovation.
d. Intellectual Property (IP) Protection. Describe actions you may consider taking to protect the IP that results from your innovation.
e. Finance Plan. Describe the necessary financing you will require to commercialize the product, process, or service, and when it will be required. Describe your plans to raise the requisite financing to launch your innovation into Phase III and begin the revenue stream. Plans for this financing stage may be described in one or more of the following ways:
f. Production and Marketing Plan. Describe how the production of your product/process/service will occur (e.g., in-house manufacturing, contract manufacturing). Describe the steps you will take to market and sell your product/process/service. For example, explain plans for licensing, Internet sales, etc.
g. Revenue Stream. Explain how you plan to generate a revenue stream for your company should this project be a success. Examples of revenue stream generation include, but are not limited to, manufacture and direct sales, sales through value added resellers or other distributors, joint venture, licensing, service. Describe how your staffing will change to meet your revenue expectations.
Applicants are encouraged to seek commitment(s) of funds and/or resources from an investor or partner organization for commercialization of the product(s) or service(s) resulting from the BRDG-SPAN grant. Place relevant letters following letters from consultants and collaborators in Item 16, Letters of Support in the PHS398 Research Plan Component.
Appendix Materials
Appendices are not permitted.
No supplemental/update/post-submission or other information will be accepted.
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: Regardless of the amount requested, applicants under this FOA are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(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
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by Scientific Review Groups (SRGs) convened by the Center for Scientific Review (CSR) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/). The SRG will use the review criteria stated below.
As part of the scientific peer review, all applications will:
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance.
Investigator(s).
Innovation.
Approach.
Environment.
In addition to the above review criteria, the following criteria will be applied to ALL applications:
Commercialization Plan.
2.A.
Additional Review Criteria
As applicable for the project, reviewers will
consider the following additional items in the determination
of scientific and technical merit, but will not give separate scores for these
items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
2.B. Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:
Funding Decisions
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:
Applications received under this FOA may be given funding priority if the project is deemed to have high commercial potential to be developed into a product or service as indicated by the underserved need being addressed, the lack of alternative resources in the market and/or the applicant’s ability to secure funding or in-kind support from an independent third-party investor and/or strategic partner, etc.
Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.
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.
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.
The terms of the NoA will reference the requirements of the Recovery Act.
In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
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.
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
Awardees
will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial statements
as required in the NIH Grants
Policy Statement.
In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
Recovery Act-related reporting requirements will be incorporated as a special term of award.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Awarding Component |
Scientific/Research Contact |
Financial/Grants Mgmt. Contact |
National Institute on Aging http://www.nia.nih.gov |
Dr. Michael-David A.R.R. Kerns |
Ms. Linda Whipp |
National Institute on Alcohol Abuse and Alcoholism |
Dr. Max Q. Guo |
Ms. Judy Fox |
National Institute of Allergy and Infectious Diseases |
Dr. Gregory Milman |
Mr. Michael Wright |
National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/ |
Mr. Elijah Weisberg |
Ms. Sheila Simmons Mr. Erik (Timothy) Edgerton |
National Institute of Biomedical Imaging and Bioengineering http://www.nibib.nih.gov/ |
Mr. Todd Merchak |
Ms. Florence Turska |
National Cancer Institute |
Mr. Michael Weingarten |
Ms. Rosemary Ward |
National Institute of Child Health and Human
Development |
Dr. Louis A. Quatrano |
Mr. Ted Williams |
National Institute on Drug Abuse http://www.nida.nih.gov |
Dr. Cathrine Sasek |
Ms. Diana Haikalis |
National Institute on Deafness and Other Communication
Disorders |
Dr. Roger Miller |
Mr. Christopher P. Myers |
National Institute of Dental and Craniofacial Research |
Dr. R. Dwayne Lunsford |
Ms. Mary Daley |
National Institute of Diabetes and Digestive and Kidney
Diseases |
Dr. Sanford A. Garfield |
Ms. Helen Y. Ling |
National Institute of Environmental Health Sciences |
Dr. Jerrold J. Heindel |
Ms. Pam Clark |
National Eye Institute http://www.nei.nih.gov |
Dr. Jerome R. Wujek |
Mr. William Darby |
National Institute of General Medical Sciences |
Dr. Matthew E. Portnoy |
Ms. Patrice Molnar |
National Heart, Lung, and Blood Institute |
Ms. Susan Pucie |
Mr. Robert Vinson |
National Human Genome Research Institute |
Dr. Bettie J. Graham |
Ms. Cheryl Chick |
National Institute of Mental Health http://www.nimh.nih.gov |
Dr. Michael F. Huerta |
Ms. Rebecca Claycamp |
National Institute of Neurological Disorders and Stroke |
Dr. Thomas Miller |
Ms. Kimberly Campbell |
National Institute of Nursing Research |
Dr. Paul Cotton |
Mr. Brian Albertini |
National Center for Research Resources |
Dr. Amy L. Swain |
Ms. Leslie Le |
National Center for Complementary and Alternative Medicine |
Dr. Carol Pontzer |
Mr. George Tucker, M.B.A. |
National Center on Minority Health and Health Disparities |
Mr. Vincent A. Thomas, Jr., MSW, MPA |
Ms. Priscilla Grant, J.D., C.R.A. |
National Library of Medicine |
Dr. Jane Ye |
Mr. Dwight Mowery |
Office of Dietary Supplements, National Institutes of Health (ODS), Note: ODS is a part of the NIH’s Office of the Director and does not have its own grant-making authority. ODS does however, co-fund meritorious research through the NIH institutes and centers. |
Rebecca B. Costello, PhD |
Not Applicable |
2. Peer Review Contact(s):
Lawrence E. Boerboom, PhD
Scientific Review Officer
Center for Scientific Review
6701 Rockledge Drive, MSC-7814
Room 4140 Bethesda, MD 20892
Voice: (301) 435-8367
Fax: (301) 480-2644
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf
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 Act and 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.
NIH Public Access 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 Sections 301 and 405 of the PHS Act, as amended
(42 USC 241 and 284) and are subject to 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 (LRP):
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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