Part I Overview Information


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 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 301-435-0714; Email: GrantsInfo@nih.gov.

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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (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
National Institute on Aging, NIH
Gateway Building, Suite 2C218
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892-9205
Phone: 301-496-9322
Fax:     301-402-2945
Email:  mk417e@nih.gov

Ms. Linda Whipp
Grants Management Officer
National Institute on Aging, NIH
Gateway Building, Room 2N212
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892
Phone: 301-496-1472
Fax:     301-402-3672
Email:  lw17m@nih.gov

National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov

Dr. Max Q. Guo
National Institute on Alcohol Abuse and Alcoholism
Room 2021
5635 Fishers Lane
Bethesda, MD 20892
Phone: 301-443-0639
Fax:     301-594-0673
Email:  qmguo@mail.nih.gov

Ms. Judy Fox
Chief, Grants Management Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Room 3023
5635 Fishers Lane
Bethesda, MD 20892
Phone: 301-443-4704
Fax:     301-443-3891
Email:  jfox@mail.nih.gov

National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov

Dr. Gregory Milman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH
Room 2153
6700-B Rockledge Drive
Bethesda, MD 20892-7610
Phone: 301-496-8666
Fax:     301-402-0369
Email:  gm16s@nih.gov

Mr. Michael Wright
Grants Management Specialist
National Institute of Allergy and Infectious Diseases, NIH
6700B Rockledge Dr, Rm 2249
Bethesda, MD 20892-7614
Phone: 301-451-2688
Fax: 301-493-0597
Email: mawright@mail.nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/

Mr. Elijah Weisberg
Research Program Analyst
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892
Phone:  301-435-1002
Fax:      301-480-4543
Email:   weisberge@mail.nih.gov

Ms. Sheila Simmons
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
6701 Democracy Blvd. Suite 800
Bethesda, Maryland  20892
Phone:  301-594-9812
Fax:      301-480-5450
Email:   simmonss@mail.nih.gov

Mr. Erik (Timothy) Edgerton
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
6701 Democracy Blvd. Suite 800
Bethesda, Maryland  20892
Phone:  301-594-3968
Fax:      301-480-5450
Email:  
edgertont@mail.nih.gov

National Institute of Biomedical Imaging and Bioengineering http://www.nibib.nih.gov/

Mr. Todd Merchak
Program Director
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:  merchakt@mail.nih.gov

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:  turskaf@mail.nih.gov

National Cancer Institute
http://www.nci.nih.gov or http://www.cancer.gov

Mr. Michael Weingarten
Program Manager
National Cancer Institute, NIH
31 Center Drive
Room 10A52
Bethesda, MD 20892
Phone: 301- 496-1550
Fax:     301- 496-7807
Email:  mw498z@nih.gov

Ms. Rosemary Ward
Grants Management Specialist
National Cancer Institute, NIH
MSC 7150
6120 Executive Blvd
Rockville, MD  20892-7150
Phone: 301-496-3182 
Fax: 301-496-8662
Email: wardros@mail.nih.gov

National Institute of Child Health and Human Development
http://www.nichd.nih.gov

Dr. Louis A. Quatrano
Program Director, BSRE
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development, NIH
6100 Executive Boulevard, Room 2A03
Bethesda, MD 20892-7510
Phone: 301-402-4221
Fax:     301-402-0832
Email:  lq2n@nih.gov

Mr. Ted Williams
Grants Management Specialist
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
6001 Executive Blvd., Rm. 8A07EA
Rockville, MD 20852
Phone:   301-435-6966
Fax:       301-451-5110
Email:    williate@mail.nih.gov

National Institute on Drug Abuse http://www.nida.nih.gov

Dr. Cathrine Sasek
National Institute on Drug Abuse, NIH
6001 Executive Boulevard
Room 5230, MSC 9591
Bethesda, Maryland 20892-9591
Phone: 301-443-6071
Fax:     301-443-6277
Email:  csasek@nih.gov

Ms. Diana Haikalis
Grants Management Specialist
National Institute on Drug Abuse, NIH
6001 Executive Boulevard,
Room 3119, MSC 9591
Bethesda, Maryland 20892-9591
Phone: 301-443-6710
Fax:     301-594-6849
Email:  dhaikali@mail.nih.gov

National Institute on Deafness and Other Communication Disorders
http://www.nidcd.nih.gov

Dr. Roger Miller
Program Director, Hearing Program
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Blvd., 400-C
Rockville, MD 20852
Phone: 301-402-3458
Fax:     301-402-6251
Email: rm378j@nih.gov

Mr. Christopher P. Myers
Lead Grants Management Specialist
National Institute on Deafness and Other Communication Disorders, NIH
45 Center Drive, MSC 6402
Bldg 45 Room 4AN44
Bethesda MD 20895-6402
Phone: 301-402-0909
Fax:     301-402-1758
Email:  myersc@nidcd.nih.gov

National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov

Dr. R. Dwayne Lunsford
Coordinator, SBIR/STTR Program
Director, Microbiology Program
Integrative Biology and Infectious Disease Branch
Division of Extramural Research
National Institute of Dental and Craniofacial Research-NIH
Building 45, Room 4An18A
Bethesda, MD 20892-6402
Phone : 301-594-2421
Fax: 301-480-8319
Email: rl332k@nih.gov

Ms. Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research, NIH
Building 45, Room 4AN-44B
45 Center Drive
Bethesda, MD 20892-6402
Phone: 301-594-4808
Fax:     301-480-3562
Email:  md74u@nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov

Dr. Sanford A. Garfield
Program Director
National Institute for Diabetes and Digestive and Kidney Diseases, NIH
6707 Democracy Blvd. Rm. 685
Bethesda, MD 20892-5460
Phone: 301-594-8803
Fax:     301-402-6271
Email:  sg50o@nih.gov

Ms. Helen Y. Ling
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases, NIH
2 Democracy Plaza
6707 Democracy Blvd, Room 732
Bethesda, MD 20892-5456
Phone: 301-594-8857
Fax: 301-480-3504
Email: lingh@extra.niddk.nih.gov

National Institute of Environmental Health Sciences
http://www.niehs.nih.gov

Dr. Jerrold J. Heindel
Program Director
National Institute of Environmental Health Sciences, NIH
POB 121233 (K3-15)
Research Triangle Park, NC 27709
Phone: 919-541-0781
Fax: 919-541-5064
Email: heindelj@niehs.nih.gov

Ms. Pam Clark
Grants Management Specialist
National Institute of Environmental Health Sciences, NIH
POB 121233 (K3-11)
Research Triangle Park, NC 27709
Phone: 919-541-7629
Fax: 919-541-2860
Email: evans3@niehs.nih.gov

National Eye Institute http://www.nei.nih.gov

Dr. Jerome R. Wujek
Research Resources Officer
National Eye Institute, NIH
5635 Fishers Lane, Suite 1300
Rockville, MD 20892-9300
Phone: 301-451-2020
Fax:     301-402-0528
Email:  wujekjer@nei.nih.gov

Mr. William Darby
Chief, Grants Management Branch
National Eye Institute, NIH
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Phone: 301-451-2020
Fax: 301-496-9997
Email: wwd@nei.nih.gov 

National Institute of General Medical Sciences
http://www.nigms.nih.gov/

Dr. Matthew E.  Portnoy
Program Director
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences,
NIH
Natcher Building, Rm. 2AS-25P
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Phone:   301-594-0943
Fax:         301-480-2228
Email:    mportnoy@nigms.nih.gov

Ms. Patrice Molnar
Grants Management Specialist
National Institute of General Medical Sciences, NIH
Natcher Building, Rm. 2AN-38C
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Phone: 301-594-5136
Fax: 301-480-2554
Email: molnarp@nigms.nih.gov

National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov

Ms. Susan Pucie
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Dr
Two Rockledge Ctr, Room 10166
Bethesda, MD 20892-7950
Phone: 301-435-0079
Fax:     301-480-0867
Email:  sp34j@nih.gov

Mr. Robert Vinson
Robert Vinson, Jr.
Section Chief, DBDR Team
NHLBI, DERA, Office of Grants Management
Rockledge Centre Two, Suite 7044
6701 Rockledge Drive, MSC 7926
Bethesda, Maryland  20892-7926
Telephone:  (301) 435-0169
Fax:  (301) 451-5462
Email: rv7g@nih.gov 

National Human Genome Research Institute
http://www.genome.gov

Dr. Bettie J. Graham
Program Director
National Human Genome Research Institute, NIH
Suite 4076
5635 Fishers Lane
Rockville, MD 20852
Phone: 301-496-7531
Fax:     301-480-2770
Email:  Bettie_graham@nih.gov

Ms. Cheryl Chick
Chief Grants Management Officer
National Human Genome Research Institute, NIH
5635 Fishers Lane Ste. 4076
Rockville, MD 20852
Phone: 301-435-7858
FAX: 301-402-1951
Email: ChickC@mail.nih.gov

National Institute of Mental Health http://www.nimh.nih.gov

Dr. Michael F. Huerta
Associate Director
National Institute of Mental Health, NIH
6001 Executive Blvd. Room 7202
Bethesda, MD 20892-9645
Phone: 301-443-3563
Fax:     301-443-1731
Email:  mhuert1@mail.nih.gov

Ms. Rebecca Claycamp
Chief Grants Management Officer
National Institute of Mental Health, NIH
6001 Executive Boulevard
Room 6122
Bethesda, Maryland 20892-9605
Phone: 301-443-2811
Fax: 301-443-6885
Email: rclaycam@mail.nih.gov

National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov

Dr. Thomas Miller
Office of Translational Research
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Blvd., Room 2139
Bethesda, MD 20892-9527
301-496-1779
301-402-1501 Fax
millert@ninds.nih.gov

Ms. Kimberly Campbell
Grants Management Specialist
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Blvd., Rm. 3254
Bethesda, MD 20892-9537
Phone:  301-496-7809
Fax:      301-402-0219
Email:  campbelk@mail.nih.gov

National Institute of Nursing Research
http://www.ninr.nih.gov

Dr. Paul Cotton
Program Director
Office of Extramural Programs
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892
Phone: 301-402-6423
Fax:     301-480-8260
Email:  pc272a@nih.gov

Mr. Brian Albertini
Chief, Grants and Contracts Management
National Institute of Nursing Research, NIH
6701 Democracy Boulevard
Room 710
One Democracy Plaza
Bethesda, MD  20892-4870
Phone: 301-594-6869
Fax: 301-402-4502
Email: albertib2@mail.nih.gov

National Center for Research Resources
http://www.ncrr.nih.gov

Dr. Amy L. Swain
Program Director
National Center for Research Resources, NIH
6701 Democracy Blvd., Room 964
Bethesda, MD 20892-4874
Phone:   301-435-0755
Fax:         301-480-3659
E-mail     SwainA@mail.nih.gov

Ms. Leslie Le
Grants Management Specialist
National Center for Research Resources, NIH
6701 Democracy Blvd, Room 1051
Bethesda, MD 20892-4874
Phone: 301-435-0856
Fax: 301-480-3777
Email: LeLeslie@mail.nih.gov    

National Center for Complementary and Alternative Medicine
http://www.nccam.nih.gov/

Dr. Carol Pontzer
Program Officer
National Center for Complementary and Alternative Medicine, NIH
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-435-6286
Fax:     301-480-3621
Email:  pontzerc@mail.nih.gov

Mr. George Tucker, M.B.A.
Grants Management Officer
Complementary and Alternative Medicine, NIH
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-594-8853
Fax: 301-480-1552
Email: gt35v@nih.gov

National Center on Minority Health and Health Disparities
http://www.ncmhd.nih.gov

Mr. Vincent A. Thomas, Jr., MSW, MPA
National Center on Minority Health and Health Disparities, NIH
6707 Democracy Blvd.
Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-402-2516
Fax:     301-480-4049
Email:  thomasvi@mail.nih.gov

Ms. Priscilla Grant, J.D., C.R.A.
Grants Management Specialist
National Center on Minority Health & Health Disparities, NIH
6707 Democracy Blvd.
Suite 800, MSC 5464
Bethesda, MD 20892-5464
Phone:   301-402-1366
Fax:         301-480-4049
Email:      pg38h@nih.gov

National Library of Medicine
http://www.nlm.nih.gov

Dr. Jane Ye
Program Officer
Division of Extramural Programs
National Library of Medicine/NIH
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Tel: 301-594-4882
Fax: 301-402-2952
Email: yej@mail.nih.gov

Mr. Dwight Mowery
Grants Management Officer
National Library of Medicine, NIH
RKL1 - One Rockledge Ctr
Room 301
6705 Rockledge Dr
Bethesda, MD 20892
Phone: 301-496-4221
Fax: 301-402-0421
Email: mowerd@mail.nih.gov

Office of Dietary Supplements, National Institutes of Health (ODS),

www.ods.od.nih.gov

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
Director, Grants and Extramural Activities
Office of Dietary Supplements
6100 Executive Boulevard, Room 3B01
Bethesda, MD  20892-7517
Telephone: (301) 435-3605
Fax: (301) 480-1845
Email: bc135d@nih.gov

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:  boerboom@nih.gov

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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