This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)

Title: Cooperative Research Partnerships for Biodefense and Emerging Infectious Diseases (U01)

Announcement Type
This is a reissue with modifications of RFA-AI-07-003, which was previously released November 29, 2006.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AI-08-001

Catalog of Federal Domestic Assistance Number(s)
93.856

Key Dates
Release Date: February 21, 2008
Letters of Intent Receipt Date: May 19, 2008
Application Receipt Date: June 19, 2008
Peer Review Date: September 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: June 2009
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: June 20, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), supports extramural research focused on understanding, controlling and preventing diseases caused by virtually all infectious agents. In response to threats presented by bioterrorism and emerging infectious diseases, the NIAID Division of Microbiology and Infectious Diseases (DMID) has established research programs to facilitate development of countermeasures for select pathogens and toxins.

Through this RFA, the NIAID invites research applications for projects that will lead to development of new vaccines, vaccine technologies, adjuvants, therapeutics, immunotherapeutics or medical diagnostics focused on NIAID Category A, B, or C priority pathogens and toxins (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm). Research may include, but is not limited to: target identification and/or validation; adaptation of platform technologies or products to biodefense applications; development of broad spectrum platforms and/or production technologies; optimization of products; process development; preclinical evaluation; scale-up; and production of quantities sufficient for preclinical regulatory requirements. Applications that include collaborations between researchers from different disciplines and/or with industry are strongly encouraged.

The NIAID recognizes that the inherent nature and demands of the product development process may require funding large, complex grants with interdependent specific aims. Furthermore, some aspects of the product development process (e.g., Good Laboratory Practice [GLP] or current Good Manufacturing Practice [cGMP] production) are inherently not innovative. Recognizing that product development is often an iterative and sequential process, and that steps early in the process may not be successful and may need to be modified or reworked, NIAID staff, through the cooperative agreement grant mechanism, will be actively involved in evaluating the milestones of awardees and determining whether continued investment in the development is warranted.

NOTE: While clinical development strategies may be included within an overall product development plan, this RFA will NOT support clinical trials; applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned to the applicant without review. Utilization of human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive.

NOTE: This RFA will NOT support research on environmental or workplace detection technologies or targets. Diagnostics applications must focus on detection and identification of NIAID Category A, B or C priority pathogens or toxins in human clinical samples.

Partnerships

A key component of this initiative is the formation of collaborative partnerships between academic researchers from different disciplines or with industry. For the purpose of this RFA, "industry" is defined as large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, and chemical companies. Since academic organizations are often the source of new candidate products, this RFA will also support a partnership between industry and collaborator(s) as necessary from academic (or non-profit) research organizations. For this RFA, partnerships are strongly encouraged, but not required.

The Principal Investigator of the project may be affiliated with industry, an academic organization or non-profit research organization.

Background

The NIH and other agencies in the Department of Health and Human Services (DHHS) support development of countermeasures to protect the public from bioterrorist threats and emerging infectious diseases. The biological agents deemed to pose the greatest threat are prioritized in the NIAID Category A, B and C priority pathogens and toxins list (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm). The initial NIAID Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/strategic_plan.htm) was published in 2002 and followed by research agendas for Category A agents (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biotresearchagenda.htm) and Category B and C agents (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/categorybandc.htm). In 2007, the DHHS Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) published an Implementation Plan (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html), outlining strategies for identifying medical countermeasure requirements and establishing priorities for their research, development and acquisition.

NIAID recently published an updated Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf) that is consistent with the DHHS PHEMCE Implementation Plan and related components of the national biodefense strategy. The updated plan continues to focus on translation of basic research to product development, but with an emphasis shift from the current one bug-one drug approach towards a more flexible, broad spectrum approach. This approach is centered on development of countermeasures that are effective against multiple pathogens or toxins, development of technologies that can be widely applied to improve classes of products, and developing platforms that can reduce the time and cost of creating new products. The broad spectrum approach recognizes the expanding range of biological threats and the limited resources available to address each individual threat.

Research Goals and Objectives

To meet the objectives outlined in the updated NIAID Strategic Plan for Biodefense Research, it is imperative that promising findings/technologies are translated rapidly into new approaches and strategies for product development. The involvement of experts from diverse disciplines (e.g., biochemists, structural biologists, protein chemists, pharmacologists, immunologists, molecular biologists, engineers and clinicians) within academia and industry is needed to enable development of well-designed candidates for vaccines, vaccine technologies. adjuvants, therapeutics, immunotherapeutics, and medical diagnostics.

The objective of this RFA is to support research that will advance the development and/or production of countermeasures (vaccines, adjuvants, therapeutics, immunotherapeutics, and medical diagnostics) specific for NIAID Category A, B, or C priority pathogens or toxins. Developmental research is not required to result in a "final" product but must advance the development of a candidate product. A second objective of this RFA is to stimulate scientifically sound, original, and innovative research requiring a comprehensive team and multidisciplinary effort that will facilitate advancement of a promising candidate product or platform technology through the product development pathway.

NOTE: While clinical development strategies may be included within an overall product development plan, this RFA will NOT support Phase I, II, and III clinical trials or field trials. Applications requesting support for clinical trials will be viewed as unresponsive to this RFA and will be returned to the applicant without review. However, utilization of appropriate human cell lines and human derived material in pre-clinical studies in support of complying with regulatory requirements is considered responsive and is encouraged.

NOTE: This RFA will NOT support research on environmental or workplace detection technologies or targets. Diagnostics applications must focus on the goal of detection and identification of NIAID Category A, B or C priority pathogens or toxins in human clinical samples.

Vaccines for Biodefense

Vaccines are the most effective method of protecting the public against infectious diseases. The updated NIAID Strategic Plan for Biodefense Research emphasizes development of broad spectrum vaccines against biological threat agents. Vaccines characterized by broad spectrum activity include cross-protective forms, which induce an immune response against constant components of a microbe, and multiple component forms, which include elements that protect against microbes that are different, but closely related. Applications for development of either a broad spectrum vaccine against multiple NIAID Category A, B, or C pathogens or toxins, or a broad spectrum vaccine against a non-listed pathogen or toxin that would also protect against a listed NIAID Category A, B, or C pathogen or toxin, are highly encouraged. The updated NIAID Strategic Plan for Biodefense Research also emphasizes development of vaccine technologies. Applications focused on development of new and improved protective antigen screening technologies, vaccine delivery platforms, and vaccine production and formulation methodologies, are encouraged.

Applications for development of innovative monovalent or pathogen-specific vaccines against NIAID Category A, B, or C pathogens or toxins are also invited. Note that development of such vaccines against Category A bacterial pathogens, orthopoxviruses and influenza viruses is currently well represented within the NIAID research portfolio, and investigators are encouraged to focus on other Category A, B or C agents. For all vaccine projects, approaches should consider the ultimate potential of candidate vaccines to quickly induce safe and protective responses in a diverse civilian population. Projects may include, but are not limited to, one or more of the following areas:

NOTE: Applications proposing the development of a vaccine that does not focus on at least one NIAID Category A, B, or C priority pathogen or toxin will be deemed unresponsive and will be returned to the applicant without review.

NOTE: Clinical trials for vaccines will NOT be supported.

Adjuvants for Biodefense

The development of an enhanced immune response may require the administration or co-administration of an adjuvant or immunostimulatory compound. Applications for development of novel adjuvants that could be used in conjunction with specific pathogen components are invited. Adjuvants are broadly separated into two classes based upon their primary mechanism of action: vaccine delivery systems (e.g., emulsions, microparticles, iscoms, and liposomes) that target associated antigens to antigen presenting cells, and immunostimulatory adjuvants (e.g., LPS, MLP, or CpG DNA) that directly activate innate immune responses. In order to advance the development of vaccine adjuvants against NIAID Category A, B, or C priority pathogens and their toxins, this solicitation focuses on optimization and preclinical testing of prospective lead compounds that previously showed promise in early stages of discovery and development. Projects may include, but are not limited to, one or more of the following areas:

NOTE: Clinical trials for adjuvants will NOT be supported.

Therapeutics for Biodefense

Development of safe and effective antimicrobials against biodefense agents and emerging pathogens is a high priority. The updated NIAID Strategic Plan for Biodefense Research emphasizes development of broad spectrum therapeutics. An anti-infective characterized by broad spectrum activity might target a common, invariable, or essential component of different classes of microbes and potentially be effective against traditional and non-traditional agents. Applications for development of either a broad spectrum anti-infective against multiple NIAID Category A, B, or C pathogens, or a broad spectrum anti-infective against a non-listed pathogen that would also protect against a listed NIAID Category A, B, or C pathogen, are encouraged. Also of interest are strategies to overcome antibiotic resistance in order to extend the clinical utility of existing broad spectrum antimicrobials.

Applications for development of new therapeutics against a targeted NIAID Category A, B, or C priority pathogen or toxin are also invited, with particular interest in therapeutics targeting pathogens for which no standard clinical treatment exists. Therapeutics projects may include, but are not limited to, one or more of the following areas:

NOTE: Applications proposing the development of a therapeutic that does not focus on a NIAID Category A, B, or C priority pathogen or toxin will be deemed unresponsive and will be returned to the applicant without review.

NOTE: Clinical trials for therapeutics will NOT be supported.

Immunotherapeutics for Biodefense

Applications to discover and/or improve immune-based therapeutics including both broad-spectrum (innate immunity) and pathogen or toxin-specific (antibodies) are invited. Major objectives for products generated in this research program include prevention of infection or intoxication in the face of an immediate threat, protection of immunocompromised individuals, and post-exposure treatment to suppress infection and disease. Projects focused on compounds that directly affect pathogens/toxins and/or approaches to stimulate non-specific immunity are encouraged. Passive treatments may be especially valuable during the acute emergence of infectious diseases and may complement the use of antimicrobial drugs or vaccination programs to optimize protection. Projects may include, but are not limited to, one or more of the following areas:

Innate immunity:

Antibodies:

NOTE: Clinical trials for immunotherapeutics will NOT be supported.

Diagnostics for Biodefense

There is a need for rapid, highly sensitive, specific, easy to use, adaptable, and cost-effective medical diagnostics for public health laboratories, hospital-based clinical laboratories, and point-of-care use to diagnose individuals exposed to and/or infected with NIAID Category A, B, or C priority pathogens or their toxins. Diagnostics are needed to identify infectious agents or toxins in clinical samples from individuals that are pre- symptomatic, symptomatic, or have non-specific symptoms so appropriate therapeutic intervention or containment can be executed. Medical diagnostics that use platforms to simultaneously detect multiple pathogens in clinical specimens to rapidly distinguish whether an individual is infected by a biological threat agent or a common infection with similar, generalized symptoms and determine drug sensitivities are of high priority.

Applications for applied research or advanced product development for medical diagnostics, including both technology and assay development specific for NIAID Category A, B, or C pathogens and toxins are invited. Projects may include, but are not limited to, one or more of the following areas:

NOTE: Applications proposing the development of a diagnostic that does not focus on a NIAID Category A, B, or C priority pathogen or toxin will be deemed unresponsive and will be returned to the applicant without review.

NOTE: This program will NOT support research on the development of environmental detection devices or their deployment. As such, applications for the development of environmental detection devices and/or their deployment will be deemed unresponsive and returned to the applicant without peer review.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 cooperative agreement award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

The U01 application includes a single research project that may include consortium agreements, but does not include "Core" resources and facilities as defined for U19 multi-project applications.

This RFA is a one-time solicitation. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA.

2. Funds Available

The NIAID intends to commit approximately $26 million dollars in fiscal year (FY) 2009 to fund 15-20 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 5 years.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

The annual direct costs that can be requested are not limited but must be justified by the proposed research and will be evaluated by the review panel and program staff. Applicants may request up to a total of $300,000 in first-year costs for major equipment to ensure that research aims can be met and biohazards can be contained. Prior approval from program staff, listed below under Section VII. Agency Contact(s), must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $300,000 will not be considered for funding.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs as indicated below. When considering multiple PDs/PIs, 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 PD/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 all required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Foreign Organizations

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

Projects using the multiple PD/PI(s) plan must include a cover letter stating explicitly that the multiple PD/PI(s) approach is being undertaken for the application. The letter should include the names and institutional information for each PD/PI and the appropriate institutional business office contact information plus the name of the business official authorized to sign grant applications.

Whenever 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. The Contact PI may be changed during the project period. The Contact PI should be listed in block 3 of Form Page 1 (the Face Page), with additional PIs listed on the Face Page (Continued). All PIs must be registered in the eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Information for the Contact PD/PI should also be entered into the multiple PD/PI cover letter included in the application. All other PDs/PIs should be listed in the Key Personnel section 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. All projects including Multiple PDs/PIs are required to include Leadership plan under Section I of the Research Plan Component in the PHS 398.

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 I of the Research Plan Component in the PHS398), must be included. The governance and organizational structure of the leadership team and the overall research project should be described, including communication plans, process for making decisions on scientific direction, intellectual property issues, 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, including responsibilities for human subjects and animal studies as appropriate.

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.

Multiple PD/PI Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions for non-modular budget preparation.

Multiple PD/PI 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 non-modular budget component. All other institutions should have their individual budgets attached separately to the non-modular budget component of the prime institution indicated through use of the subaward budget form.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: May 19, 2008
Application Receipt Date: June 19, 2008
Peer Review Date: September 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: June, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Dr. Brenda Lange-Gustafson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-3684
FAX: 301 480-2408
Email: bgustafson@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Dr. Brenda Lange-Gustafson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-3684
FAX: 301 480-2408
Email: bgustafson@niaid.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIAID. Incomplete and non-responsive applications will not be reviewed.

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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Research Plan

1. Research Focus

Applicants are encouraged to read the updated NIAID Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf) before preparing an application. This program supports development of new and promising products for biodefense. Each application must propose a research and development project whose goal is to develop and/or advance a countermeasure (vaccine, adjuvant, therapeutic, immunotherapeutic or diagnostic) or vaccine technology, specific for at least one NIAID Category A, B or C priority pathogen or toxin, through the product development process. It is not necessary to propose to complete the product development process up to the point of readiness for clinical trials within the time frame of this project. Applications that would significantly advance a specific product toward clinical or field usefulness are responsive.

NOTE: Applications for development of a broad spectrum vaccine or therapeutic against a non-listed pathogen or toxin that would protect against a listed NIAID Category A, B, or C pathogen or toxin MUST include in the Research Plan:

NOTE: All applications for research projects focused on diagnostics should include in the Research Plan:

2. Mandatory Meetings

Requested budgets must include funds for travel by the Principal Investigator and key personnel to an annual meeting in Bethesda, Maryland (USA), or to a relevant scientific meeting, as determined by NIAID Program staff. See Section VI.2.A.1. Award Administration Information below.

3. Major Equipment

Applicants may request up to a total of $300,000 for major equipment to ensure that research aims can be met and biohazards can be contained. Funds for equipment must be included in the first year requested budget with justification. Prior approval from program staff, listed below in Section VII. Agency Contact(s), must be obtained for requests for equipment that exceed this amount. Unapproved equipment requests that exceed $300,000 will not be considered for funding.

4. Good Laboratory and Good Manufacturing Practices

When appropriate, applicants must document in the Research Plan compliance with guidelines that govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211), manufacturing and/or IND/IDE enabling studies that will be performed under the project award as they would be applicable to eventual product licensure in the U.S.

Applications for projects involving cGMP manufacture should ensure inclusion of appropriate personnel to provide regulatory guidance before, during and after manufacture.

5. External Advisors

External advisors may be appointed by the Principal Investigator in consultation with NIAID Program Staff to assist in progress review. Names of suggested external advisors should NOT be included in the application or in the (optional) letter of intent; external advisors should be identified and appointed only after award.

Additional Submission Requirements (Do not count towards page limits for Research Plan)

1. Milestones and Timeline

Applicants must provide detailed project performance and timeline objectives in an add-on section entitled Milestones and Timeline (may not exceed 5 pages). The Milestones and Timeline section should follow the Research Plan of the application and does not count towards the page limits for the Research Plan. This section must include:

2. Product Development Plan

Applicants must include an add-on section entitled Product Development Plan (may not exceed 5 pages) in the application. The Product Development Plan should follow the Milestones and Timeline section of the application and does not count towards the page limits for the Research Plan. This section must include:

NOTE: Applications lacking a Product Development Plan will be deemed unresponsive and will be returned to the applicant without review.

3. Physical and/or Facility Security

Applicants must address issues related to physical or facility security and biocontainment and biosafety (http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm) pertinent to the specific pathogens of interest in an add-on section entitled Biosafety and Biocontainment (may not exceed 1 page) in the application. Guidelines for Institutional Biosafety Committees are available at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm. The Biosafety and Biocontainment section should follow the Product Development Plan section of the application and does not count towards the page limits for the Research Plan.

Plan for Sharing Research Data

NIAID recognizes that the data and information generated through the Partnerships Program will be extremely valuable to other researchers and that the rapid sharing of these data will be essential in advancing research to facilitate the development of therapeutics, vaccines and diagnostics. Sharing of data and information with the broad scientific community relies upon the awardees making such data and information available by depositing them into publicly accessible data repositories. NIAID has established data release guidelines for other programs, including the Centers of Excellence for Influenza Research and Surveillance http://www3.niaid.nih.gov/research/resources/ceirs/ and the Microbial Sequencing Centers http://www.niaid.nih.gov/dmid/genomes/mscs/default.htm.

Genomic sequences data sets generated with Partnerships funding are required to follow the NIAID Data Release and Usage Plan (http://www.niaid.nih.gov/dmid/genomes/mscs/data_release.htm), which provides for releasing sequence data within 45 calendar days of being generated to Genbank, a publicly searchable, international database of genetic sequences provided by the NIH National Center for Biotechnology and Information.

Other genome-wide or proteome-wide data sets including, but not limited to, functional genomics, proteomics, metabolomics, glycomics data sets should be made available through a publicly accessible web site(s), such as one of the NIAID Bioinformatics Resource Center or other relevant sites as determined by the NIAID Program Officers; this must be done within 2 months of publication or within 1 year of generation, whichever comes first. Examples of genomics or proteomics data sets that should be made available to the broad scientific community include annotation and functional characterization of genes and their products, gene and protein expression data, mass spectrometry data, siRNA data, SNPs and other genetic variation data, genotype and phenotype associations.

All applicants must include a plan for sharing genomics, proteomics and other types of research data in their application. Those responding to this funding opportunity announcement must include a description of how such research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Final details of the data release plan must be negotiated between NIAID and each awardee to assure that the planned data releases are consistent with the guiding principles stated above. Final approval for the data release plans will be given by NIAID prior to award. Updates to the Plan will have to be submitted to NIAID as part of the Annual Progress Report. The NIAID Program Staff will review the updated Plan for approval with modifications as needed.

It is recognized that each scientific project may pose specific opportunities or challenges with respect to public data release. Therefore efforts will be made to tailor the data release guidelines to accommodate specific situations and needs as plans are negotiated between awardees and NIAID program staff.

Sharing Research Resources

NIH policy expects that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

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

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is this project likely to significantly advance the development of a vaccine, adjuvant, therapeutic, or diagnostic against one or more of the specific biologic threat agents identified in this initiative? If the aims of the application are achieved, are important biomedical agents or products likely to result? What will be the effect of these studies on the concepts or methods that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the likelihood of successful project completion high given the current state of research and development and the technical approach? Are the proposed timeline and interim milestones appropriate, feasible and technically sound? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Many aspects of vaccine, adjuvant, therapeutics, immunotherapeutics, and diagnostics product development are not inherently innovative. However, in each project, does the proposed research leverage multi-disciplinary involvement to accelerate product development? In addition, does the approach represent the best use of current or emerging technologies and appropriate collaborations to achieve the research objectives?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Do the regulatory personnel possess the appropriate expertise to guide cGMP manufacture and/or related processes (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIAID staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to the award. The responsibility for the planning, direction, and execution of the proposed project will be solely that of the Principal Investigator.

Intellectual Property

The successful development of high priority products for biodefense will require substantial investment and support of private sector industries and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this initiative to support the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:

Awardees are encouraged to reach early consensus with their proposed partners regarding intellectual property and other legal matters that may arise during the project. In addition, awardees are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms.

Select Agents and Highly Pathogenic Agents

Select Agent Rule

The awardee(s) must be in compliance with Select Agent Rule (http://www.cdc.gov/od/sap/) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html).

The NIH has established a new policy regarding the use of NIH funds for research involving Select Agents. This policy is being implemented using Terms of Award that are to be included in any grant, cooperative agreement, or contract in which select agents are or will be used.

Award to a U.S. Institution: This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using NIH funds, the awardee must complete registration with CDC (or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied.

Award to Foreign Institution: This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using NIH funds for any work directly involving the Select Agents, the awardee must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. The awardee must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73.

Award to U.S. Institution with Foreign Institution Participation: This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC or USDA, depending on the agent). No funds can be used for research involving Select Agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the Select Agents at the foreign institution, the US awardee must provide information from the foreign institution satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds. The awardee must be willing to address the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73.

Select Agents/Highly Pathogenic Agents Term of Award

NIAID will apply the following additional term of award to grants and cooperative agreements that include research with Highly Pathogenic Agents and/or Select Agents or Toxins (Agents):

The research proposed in this grant may involve Select Agents and/or Highly Pathogenic Agents. NIAID defines a Highly Pathogenic Agent as an infectious Agent or Toxin that, under some circumstances, may warrant a biocontainment safety level of BSL3 or higher according to any one of the following sources:

If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an institutional committee or institutional official, the highest recommended containment level must be used.

At the beginning of each Progress Report clearly indicate whether or not any research with a Select Agents or Highly Pathogenic Agent has been performed or is planned under this grant.

If yes, address whether your IBC or equivalent body or official has determined, for example, by conducting a risk assessment, that the work being planned or performed under this grant may be conducted at a biocontainment safety level that is lower than BSL3. If the work involves Select Agents and/or Highly Pathogenic Agents, also address the following points:

Any changes in the use of the Agent(s) or Toxin(s) that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by your IBC or equivalent body or official.

If work with a new or additional Agent(s)/Toxin(s) is proposed in the upcoming project period, provide:

For domestic work with Select Agents provide documentation of Registration status of all domestic organizations/entities where Select Agent(s) will be used.

Please be advised that changes in the use of a Highly Pathogenic Agent or Select Agent not previously described in the original application or the last progress report will likely be considered a change in scope and, therefore, require NIH awarding office prior approval.

Meetings

One mandatory progress review meeting of the awardees will be held annually at the NIAID, or at a site designated by the NIAID Program Official, during which the Principal Investigator and appropriate Key Personnel will present significant findings. The NIAID Program Official and External Advisors (when applicable) will be present. A critical determinant of success will be the degree of communication between the Principal Investigator, Project Leaders and other significantly involved parties. Therefore, in addition to the one meeting listed above, additional meetings, which may be necessary for coordination of cooperative agreement activities, may be scheduled if justified. Regular telephone and written communication with the NIAID Program Official is considered to be very important and is strongly encouraged.

Publications

The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the cooperative agreement award and supported in part or in total under this Agreement. The Principal Investigator and Project Leaders are requested to submit manuscripts to the Program Official within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained and joint press conferences and press releases prepared. Publications or oral presentations of work performed under this Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.

Data

While the NIAID Program Official has a right of access to the data (see NIAID staff responsibilities below) the awardee will retain custody of and right to the data. For more information on data sharing go to: http://grants.nih.gov/grants/policy/data_sharing/index.htm.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIAID Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NIAID Project Scientist will serve as a liaison/facilitator between the awardee, pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, USDA, CDC), and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIAID Project Scientist will facilitate coordination of project activities during the course of the project.

The NIAID Project Scientist will assist the awardee with access to other NIAID-supported resources and services, including resources for preclinical development such as animal models, screening facilities, standardized research reagents, and a genomics resource center, where available.

The NIAID Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

The specific timelines, interim objectives and funding levels agreed to by the awardee and the NIAID shall be included in the terms and conditions of award. Given the nature of product development, it is recognized that timelines and interim objectives may require revision and renegotiation during the course of the project period. The Principal Investigator and NIAID must agree to all such revisions. Release of each funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon interim objective. Where scientifically appropriate, NIAID may ask awardees to collaborate or cooperate with other NIAID-funded projects and/or US government agencies, for example CDC, FDA, and/or USDA.

External Advisors

External advisors may be appointed by the Principal Investigator in consultation with Program Staff to assist in progress review. External advisors will be identified and appointed only after award.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Michael Schaefer
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5003, MSC 6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3758
FAX: (301) 480-1263
E-Mail: mschaefer@niaid.nih.gov

2. Peer Review Contacts:

Dr. Brenda Lange-Gustafson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3122, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-3684
FAX: 301 480-2408
Email: bgustafson@niaid.nih.gov

3. Financial or Grants Management Contacts:

Katie Ellis
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2240 MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2687
FAX: 301 480-3780
Email: ke59o@nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of 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/.

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.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


NIH Office of Extramural Research Logo
   Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) 		  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®