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:  Centers for Medical Countermeasures Against Radiation (U19)

Announcement Type
This is a reissue of RFA-AI-04-045

Request For Applications (RFA) Number:  RFA-AI-09-036

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

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856

Key Dates
Release Date: August 20, 2009
Letters of Intent Receipt Date:  November 16, 2009
Application Receipt Date:  December 15, 2009
Peer Review Date:  March 2010
Council Review Date:  May 2010
Earliest Anticipated Start Date:  July 2010
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date:  December 16, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
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. Resource Sharing Plan(s)
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 goal of the Centers for Medical Countermeasures against Radiation (CMCR) program is  to support basic, translational, and applied research for the development of 1) new medical products to mitigate and/or treat the acute and delayed effects of radiation exposure, as well as radiation combined injury (radiation plus burns, wounds, trauma, or sepsis), and radiation-induced multi-organ failure, and 2) improved radiation diagnostics, including high-throughput or point-of-care radiation biodosimetry tools and predictive biomarker assays and devices to assess early and/or delayed injury to different organs/tissues. Countermeasures should be aimed at having an impact on mitigation/treatment of radiation injury to single and/or multiple organs with the ultimate goal of restoring physiological function and improving survival and other relevant clinical outcomes. NIAID envisions the development of a suite of medical countermeasures and diagnostic tools for use in the management of radiation casualties.

Background

Very few medical products exist that have been shown to counter the acute and long-term injuries that can result from a nuclear and radiological attack or accident. The threat of attack has grown in recent years, with increased activity of global terrorist organizations and a rise in illicit trafficking of radioactive materials. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was given the responsibility by the Department of Health and Human Services (DHHS) to identify, characterize and develop new medical countermeasure products against radiological and nuclear attacks that may cause a public health emergency. 

In 2005, the NIH published a Strategic Plan and Research Agenda for Medical Countermeasures against Radiological and Nuclear Threats (http://www3.niaid.nih.gov/about/overview/planningPriorities/RadNuc_StrategicPlan.pdf). This agenda includes focused product development, including medical countermeasures for mitigation and treatment of acute radiation syndromes (ARS), as well as development of radionuclide decorporation agents, and biodosimetry devices. Several NIAID-supported contract and grant programs (http://www3.niaid.nih.gov/research/topics/radnuc/default.htm) have been established to expand the medical options available to mitigate and/or treat radiation injury after any radiological/nuclear terrorist attacks or accidents. The CMCR network forms one part of this overall program. This research and development program has already begun to yield new diagnostic tools and leading candidates of mitigators/therapeutic agents. Continued successful development of medical countermeasures, mitigators and/or treatments, and biomarker assays and devices with the ultimate goal of restoring physiological function and improving survival will fill an important need for the Strategic National Stockpile (SNS).

Under normal conditions, the hematopoietic, gastrointestinal, cardiovascular, and central nervous systems (not to mention the skin) interact with each other to maintain physiological homeostasis. It is clear from data obtained from prior radiological and nuclear accidents that these homeostatic mechanisms may be severely disturbed due to the compromise and progressive physiological failure of these interdependent organ systems, potentially leading to multiple organ failure and mortality. The management of radiation casualties with multi-organ dysfunction syndrome is extremely complex and effective medical countermeasures are lacking. Therefore, there is an urgent need to develop clinical tools and new treatment strategies to treat multiple organ failure and restore physiological functions of critical organs after exposure.

Predicting the severity and specific manifestations of injury in irradiated individuals is also complex.  Radiation injury can take days or weeks to present clinical manifestations, and some delayed radiation injuries (such as fibrosis) may not manifest clinically for months or years. Moreover, individuals may differ in their sensitivity to radiation for a variety of reasons, including age, body size, immune status, and genetic background.  Finally, the severity of injury to individual organs and tissues varies with radiation dose rate, quality of radiation (low versus high linear energy transfer, LET), the heterogeneity of exposure (partial versus total body), the source of exposure (external radiation versus internal contamination), and could conceivably be modulated by such factors as the bystander effect and the host’s adaptive response to prior radiation exposure. Unfortunately, existing biodosimetry techniques and devices have limited, if any, ability to discriminate such variables and they do not predict the severity of injury sustained by specific organs and tissues.  Diagnostics that take account of such variables would facilitate the prompt organ- and tissue-directed medical treatment that might be provided by future medical countermeasures. Therefore, in addition to radiation dose assessment through biodosimetry tools and techniques, there is a critical unmet need to develop radiation-exposure biomarkers and devices that will predict the early and/or delayed damage to specific organs and tissues to facilitate precise and timely medical intervention, reduce morbidity, and save lives.

Research Objectives and Scope

The NIAID invites applications from single institutions or consortia of institutions to establish Centers for Medical Countermeasures against Radiation (CMCR) program. The overall goal of this program is the development and maintenance of a strong infrastructure combined with the multidisciplinary research expertise and development capacity to generate new medical products that will diagnose, mitigate the effects of, and treat the short- and long-term consequences of radiation exposure from terrorist attacks or accidental exposure. To realize this goal, the CMCR program will support: (1) conduct of investigator-directed basic, translational, or applied research; (2) core facilities that support the research and development activities of an individual CMCR; and (3) translational research capacity to test and validate radiation countermeasures/diagnostics for regulatory approvals. 

The CMCR program will support broad areas of multi-disciplinary research ranging from identification, characterization and validation of biomarkers of radiation injury to different organs/tissues, to development of new medical products to treat short-term and delayed radiation injuries, radiation combined with burn, blast, blunt trauma, wound injuries and/or concomitant infection and multi-organ dysfunction.  The scenarios of concern range from the use of a radiological dispersion device (RDD), with a relatively limited number of casualties incurred, to the detonation of improvised nuclear devices and explosions or leaks at nuclear power plants, where large numbers of casualties might be anticipated. Diverse research and development approaches are encouraged, but all projects must be focused on medical products to diagnose, mitigate/treat human injury incurred by radiological or nuclear attack, and must describe their feasibility for human use under emergency conditions. Countermeasures should be aimed at having an impact on mitigation/treatment of radiation injury to single and/or multiple organs with the ultimate goal of restoring physiological function and improving survival and other relevant clinical outcomes. Basic discovery or mechanistic research is allowed, but it must be made clear in the application that the results will contribute to a product or medical approach that is feasible for human use and available to be stockpiled for use in emergency situations.

This FOA will support only development of medical countermeasures that can be used to mitigate/treat radiation injuries when administered after radiation exposure occurs and                                      will not support development of medical products (i.e. radioprotectants) that must be administered prior to exposure. Within the CMCR program, current candidate products with mitigation or treatment potential will be moved into validation and licensing studies to facilitate their inclusion in the Strategic National Stockpile (http://www.bt.cdc.gov/stockpile/index.asp).The program will support applied research and studies to advance products through needed developmental stages when proposed by applicants with these capabilities. In addition, new candidate products will be developed through basic and translational research. The overall program is designed for optimal research flexibility, synergy, and efficiency with the goal of rapidly developing effective countermeasures for clinical use.

Examples of desired criteria for medical countermeasures include:

Priority for subsequent product development will be given to products that show efficacy when administered 24 hr or later after radiation exposure.

CMCR Program Components

Each CMCR application must include the two components described below: Research Projects and Core Activities

1. Research Projects

A minimum of three Research Projects are required each led by a different Project Leader. It is expected that there will be a high level of synergy among the Research Projects and that each project will include hypothesis-driven and hypothesis-generating research, and/or descriptive or applied translational research focused on biomarker/biodosimetry and/or radiation medical countermeasure.

The CMCR program is milestone-based and includes the flexibility to quickly redirect or replace research projects during the funding period. Explicit, quantitative, yearly Milestones must be included in each project of the proposed CMCR. It is recognized that Milestones may require revision and re-negotiation prior to award, and during the course of the project period. These Milestones will be used by NIAID program staff in assessing progress and recommending continued funding on an annual basis.  Funding beyond the first year will be contingent upon satisfactory progress in meeting negotiated milestones.

Areas of research and development interest for the CMCR program include, but are not limited to the following:

Activities not allowed. The following research areas are excluded:

(1)  Epidemiological studies;

(2)  Development of medical products that are effective only when given prior to radiation exposure (radioprotectants);

(3)  Studies testing the efficacy of countermeasures against injury produced by fractionated radiation protocols (such as those used in clinical radiotherapy);

(4)  Phase II, III and IV clinical trials;

(5)  Radiation-induced carcinogenesis;

(6)  Non-biologically-based dosimetric methods and/or environmental testing/sampling devices) e.g. thermo-luminescent detectors (TLDs), fortuitous dosimeters, radiation portals, etc);

(7)  Characterization and validation of biomarkers of mutagenesis and carcinogenesis.

Although research involving human subjects (“clinical research”) is encouraged within this program where relevant, clinical trials beyond Phase I will not be supported. Applications proposing clinical trials beyond Phase I will not be reviewed.  For the NIH definition of clinical research versus clinical trials, please see the Part II, Human Subjects Research Supplement at: http://grants.nih.gov/grants/funding/phs398/phs398.html.

Applications proposing studies in the excluded areas will be considered non-responsive and will not be reviewed.

Restriction on decorporation projects:

As the primary goal of the CMCR program is to identify and promote the development of medical countermeasures that diagnose, mitigate and/or treat radiation-induced normal tissue injury, no more than one project per application may focus on decorporating agents/approaches. The total budget for a decorporation project should be no more than 33% of the non-core expenditures for the total application.  Applications exceeding these limits will be considered non-responsive and will not be reviewed.

2. Core Activities

A. An Administrative Core is required and will be responsible for the overall organization, management, decision-making, and periodic evaluations within the individual Center; as well as data sharing, protection of intellectual property, and involvement of institutional resources. The PD/PI(s) of the application must serve as the Core Leader(s) of the Administrative Core.

This Administrative Core will: organize communications, group meetings, and teleconferences; organize the presentation and publication of data; allocate and re-allocate resources to meet program goals; prioritize fiscal and other resources; be responsible for resource sharing and transmission of information and reagents; manage the budget for program-related travel (including travel for the annual meetings – see below); and identify and resolve problems and unexpected outcomes. Consortia applicants must document commitment by all participant institutions and must explain the organizational management, communications, logistics and capabilities. This Core is also expected to create and implement administrative and leadership mechanisms that will foster effective interactions among the CMCR investigators and institutions to ensure a productive research effort.

In addition, the Administrative Core is required to support:

An External Scientific Advisory Group (ESAG). The ESAG will be formed after award, and will evaluate scientific progress and provide advice to the individual Center on an annual basis. In order to maintain the largest possible reviewer pool for this FOA, applicants should not propose specific potential members of the proposed ESAG in the application and ESAG candidates should not be recruited or contacted prior to review and award. However, for renewal applications, any current or former ESAG members should be identified. The duties and responsibilities of the ESAG must be defined in the application. The budget request for the Administrative Core should include the costs for travel of the ESAG members to meet with CMCR personnel on an annual basis, and any additional meeting costs. A member of the CMCR program may not serve as an ESAG member for a different CMCR Center.

B. A Pilot Projects Core is required and will support small studies to generate preliminary data for the development and submission of future research applications for support from non-CMCR sources. A designated Core Leader is required for the Pilot Projects Core. Use of this Core should attract investigators new to the field of radiation medical countermeasure development. The annual total costs for the entire Pilot Projects Core must not exceed $300,000. Each Pilot Project supported by this Core will be of limited duration (up to two years) and of limited budget (up to $75,000 direct costs/year/project). Applications must include a plan that describes the process by which requests for Pilot Projects will be equitably solicited, reviewed, selected, and monitored. The selected Pilot projects should be submitted to NIAID Program and Grants Management for approval before actual implementation.  The application must include a plan that delineates methods for tracking the success of the Pilot Projects program.  Indicators of success should include the number of Pilot Projects that obtain subsequent independent funding, investigational new drug (IND) or investigational device exemption (IDE) filings, patent applications and publications that result from the Pilot Projects and other relevant measures. Specific Pilot Projects should not be described within the application; only the process planned for support and management of the program is to be described.

All Pilot Projects funded by CMCR awardees must focus on areas of research and development interest for the CMCR program described above. However, the topics need not be related to other research being conducted at the parent Center. Pilot Projects that support research by investigators outside of the parent CMCR group are encouraged and CMCR awardees will be especially encouraged to fund collaborations with other members of the CMCR network. Pilot Projects may also support research within the parent Center.

Activities not allowed within the Pilot Projects Core include equipment purchase and phase II, III, and IV clinical trials (see above). In addition, support for an investigator, or for a specific project, is not allowed beyond a total of two years during the entire five year funding period. All pilot projects must be completed by the end of five year award period.

C. Scientific Cores (optional) may be proposed. A Science Core must support at least two of the proposed research projects. A designated Core Leader is required for each proposed Scientific Core.  The application must indicate the specific projects to be served by the Scientific Core.  This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants.  The apportionment of dollars, or percentage of dollars, that will be required to support each component research project which will utilize each scientific core should also be presented. Such core facilities should provide services that are already available, do not need to be developed, and cannot be funded through other means for the purposes proposed. Scientific Cores must be well justified within the description of the proposed core and also within each relevant Research Project description. Scientific Cores may include clinical, statistical, technical (e.g., flow cytometry, proteomics), informatics, or other non-administrative activities that directly support the research program.

If appropriate to the particular CMCR, repositories for cells, tissues, reagents, or large data sets may be funded as Scientific Core activities. In this case, applications should include methods to obtain, protect, and archive relevant clinical and/or family history information. In addition, appropriate informatics capability should be provided to track data and link to other data sets. A plan for the distribution of samples, reagents, data, and other resources should be included and conform to the NIH policies on data and resource sharing (see Section III.6. Other Submission Requirements).

Applications proposing Scientific Cores should explain why those Core resources are not otherwise available at the applicant institution or through other grant mechanisms, for example NIH-funded centers programs or clinical networks.

CMCR Steering Committee

A Steering Committee will be established and will serve as the governing board of this collaborative research program making all major scientific and budgetary recommendations; its actions and decisions will be determined by majority vote.  Voting membership will include one PD/PI from each CMCR.

Steering Committee responsibilities are further described under Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities.”

All applicants are strongly encouraged to confer with NIAID staff and with staff at the U.S. Food and Drug Administration (FDA) as soon as an appropriate product candidate or medical approach is identified. Information on FDA processes, requirements, and contacts can be found at the following web sites: http://www.fda.gov/cder/about/smallbiz/default.htm; http://www.fda.gov/cber/manufacturer.htm; and http://www.fda.gov/cdrh/devadvice. Studies in animal models will be required to demonstrate efficacy of the medical countermeasure products. It is anticipated that in most cases licensure or approval of proposed medical countermeasures will occur in accordance with the FDA “Animal Rule” (see 21 CFR 314.600 Subpart I for drug products and 21 CFR 601.90 Subpart H for biologic products http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH multi-project Cooperative Agreement (U19) grant award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA 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).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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 PD/PI, as described in Section VI.2.Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award.”

At this time, NIAID has not determined whether this solicitation will be continued beyond the present FOA.

2. Funds Available

The estimated amount of funds available for support of 8-10 awards as a result of this announcement is $24 million total costs for fiscal year 2010. Future year amounts will depend on annual appropriations. The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

Although the size of award may vary with the scope of research proposed, applicants may request no more than $3 million total costs per year.  Funds may not be used for renovations or alterations.

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 NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply but may be members of consortia headed by U.S. institutions.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 programs 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 awards can be found 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 applicant organization 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. 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 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 all required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

Note that multiple Project Leaders or Core Leaders are not allowed for individual Research Projects, the Pilot Project Core, or the Scientific Cores.  The Core Leader(s) of the Administrative Core will be the PD/PI(s) of the overall application.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications.  Applicants may submit more than one application, provided they are scientifically distinct. A PD/PI may serve as a Project Leader or Core Leader in another multi-project application under this FOA provided there is no scientific overlap with the application submitted by the PD/PI.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals.  Renewal applications are permitted in response to this FOA.

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) 435-0714, 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 exceptions from the PHS398 instructions and detailed information on the application structure and components are provided in Section IV.6. Other Submission Requirements. All applicants must follow the specific instructions in that section.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PI will be responsible for assembling the application materials outlined below, and for coordinating the progress report for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” 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.

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.

Additional information is available in the PHS 398 grant application instructions.

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:  November 16, 2009
Application Receipt Date:  December 15, 2009
Peer Review Date:  March 2010
Council Review Date:  May 2010
Earliest Anticipated Start Date:  July 2010

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Kenneth Santora, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3146, 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:  301-451-2605
FAX: 301-480-2408
Email: ksantora@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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 (CDs) of the appendix material must be sent to:

Kenneth Santora, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3146, 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:  301-451-2605
FAX: 301-480-2408
Email: ksantora@niaid.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for 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 renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Supplemental Instructions for the Preparation of Multi-project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.

The supplemental instructions for multi-project applications are divided as follows:

A.   General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.

The order of presentation should be as follows:

Form pages and composite budget as described below

Program Overview (25 page limit)

Leadership Plan for Multiple PDs/PIs (3 page limit)

Research Project 1 (research plan: 25 page limit)

Research Project 2 (research plan: 25 page limit)

Research Project 3 (research plan: 25 page limit)

Research Project 4-n (optional; research plan: 25 page limit each)

Core A: Administrative Core (research plan: 10 page limit)

Core B: Pilot Projects Core (research plan: 5 page limit)

Core C-n: Scientific Core(s) (optional; research plan: 10 page limit each)

Biographical Sketches

Checklist

Appendix

1.   Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued. All PDs/PIs must be registered in the eRA Commons prior to the submission of the application.

2.      Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD/PI(s) of the multi-project application, followed by the Leaders of the component projects and cores, other key personnel, and then other significant contributors.

When multiple PDs/PIs are proposed, list the Contact PI first and then all additional PDs/PIs in alphabetical order. Lastly, list all Key Personnel, giving name and organization.

3.      Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4.      Composite Budget

Do not use Form Page 4 of the PHS 398.Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.

SAMPLE: Consolidated Total Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2.

125,000

130,000

135,200

140,608

146,232

677,040

Project 3.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. Scientific

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850










5.      Form Page 5

Complete the Total Cost line entries for all requested budget periods (years) and the Total Cost for Entire Period of Support entry.  Detailed budgets are required within the descriptions of each project and core (see below).

6.      Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PD/PI(s) first, followed by those of other key personnel in alphabetical order.

7.      Resources Format Page

Do not complete. Essential information is to be presented in the individual research project and core sections of the application.

8.      Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated Research Projects, each capable of standing on its own scientific merit, but complementary to one another. The synergies to be achieved through the establishment of multi-disciplinary teams and novel collaborations should be fully described. The overview provides an introduction to the proposed research, outlines the specific questions to be explored, describes the key preliminary data supporting the experimental approach, and addresses the synergy of the individual Research Projects, the processes and procedures that will be developed and utilized to administer the program, and the impact on biomarker/biodosimetry and/or medical countermeasures development to mitigate/treat radiation injury. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by providing an overview of the general problem area and by laying out a broad strategy for attacking the problem. As the strategy develops, each Project and Core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

If the application is a renewal, this section should also highlight past performance and the major accomplishments from the prior funding period as described in PHS 398 Instructions.  In addition to discussing results from individual projects, describe the synergy and collaborations that occurred within the Program. Other points to include are: which institutions were part of the prior CMCR; the numbers and quality of publications; any patents filed; researchers brought into the study of radiation biology; and how the CMCR was managed.  For individual research projects and cores that will be continued, additional details should be provided in the Progress Report section of the Research Plan within each research project and core.

9. Leadership Plan for Multiple PDs/PIs

For applications designating multiple PDs/PIs, a section entitled “Multiple PD/PI Leadership Plan” must be included and is limited to three pages.  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 including responsibilities for human or live vertebrate animal subject studies as appropriate.

10. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

11. Appendix

Refer to Section IV.6. Other Submission Requirements and Information, for instructions on submitting appendix materials as described below.

For each project or core in the multi-project application, 3 publications plus other approved material are allowed.  

B.   Specific Instructions for Individual Research/Development Projects

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each project.

Each individual Research Project must include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Resources Format Page

Items 2-5 of the Research Plan as defined in the PHS 398 instructions

Items 6-17 of the Research Plan, as appropriate

Proposed Yearly Milestones

1.   Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual project. This Cover Page will demarcate each individual project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Project Number and Title:  (e.g., 1. Therapeutics to treat radiation-induced multi organ failure)

Name of Project Leader:  (e.g., Jones, Roberta A.)

Human Subjects: (Yes or No)

If Yes, exemption number:

(or)

IRB Approval Date: (e.g., 10/13/2009),or Pending)

(and)

Federalwide Assurance (FWA) number:

Vertebrate Animals: (Yes or No)

If Yes, IACUC Approval Date: (e.g., 10/13/2009, or Pending)

(and)

Animal welfare assurance number:

Proposed Period of Support:

From: (mmddyy - e.g., 07/01/2010)

To: (mmddyy - e.g., 06/30/2115)

Costs Requested for Initial Budget Period: (e.g. 07/01/2010-06/30/2011)

Direct Costs: (e.g., $ 150,000)

Total Costs: (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2010-06/30/2115)

Direct Costs: (e.g., $700,000)

Total Costs: (e.g., $1,000,000)

Applicant Organization:

(full address)

2.   Form Page 2

Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the project will contribute towards attainment of the multi-project program objectives.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

3.      Form Page 3

Prepare a Table of Contents for the project using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5).

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

5. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

6. Resources Format Page

Provide information on resources available for the project.

7. Research Plan (Items 2-5 cannot exceed 25 pages)

Follow PHS-398 instructions.

A Progress Report must be provided for Renewal applications. Provide the beginning and ending dates for the period covered since the project was last reviewed competitively. Summarize the previous application’s specific aims and the importance of the findings. Provide a succinct account of published and unpublished results, indicating progress toward their achievement. Discuss any changes in the specific aims as a result of budget reductions.

8.      Proposed Yearly Milestones

Within 2 pages maximum (these pages do not count against the 25 page limit for sections 2-5 of the Research Plan), describe specific, quantitative Milestones that should be achieved in each year of the Project. These Milestones will not be given scores by reviewers and should be not considered in providing an overall impact/priority score for the application.  Milestones are subject to negotiation with the NIH Program Officer prior to award and during the course of the project period.

9.      Appendix: Do not create a separate appendix for an individual project. All appendix material should be collated as one body of material as described below.

C.     Specific Instructions for Cores

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

1.      Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:

Core Letter and Core Title:  (e.g., A. Radiation  Core)

Name of Core Leader:  (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

If Yes, Exemption Number

(or)

IRB Approval Date (e.g., 10/13/2009, or Pending)

(and)

Federal wide Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes, IACUC Approval Date (e.g., 10/13/2009, or Pending)

(and) Animal welfare assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2010)

To: (mmddyy, e.g., 06/30/2015)

Costs Requested for Initial Budget Period

(e.g., Direct Costs: $50,000)

(e.g., Total Costs: $70,000)

Costs Requested for the Entire Budget Period

(e.g., Direct Costs: $212,323)

(e.g., Total Costs: $297,252)

Applicant Organization (full address)

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual.  For all other items in the core application, follow the usual PHS 398 instructions.

2.      Form Page 2

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3.      Form Page 3

Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

5.      Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

6.    Resources Format Page

Provide information on resources available for the core.

7.   Core Research Plan (Items 2-5 cannot exceed 10 pages for the Administrative Core, 5 pages for the Pilot Projects Core, and 10 pages for each Scientific Core).

8. Appendix: Do not create a separate appendix for an individual Core. All appendix material should be collated as one body of material as described above.

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in section VI.2.A. “Award Administration Information”.

Research Plan Page Limitations

See Section IV.2, Content and Form of Application Submission for research plan page limitations associated with single project applications and see text above for page limitations associated with multi-project applications.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process. See Section 3B, “Sending an Application to NIH” for sending appendix material.

Resource Sharing Plan(s)  

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance 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 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, investigators 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 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 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 (such as 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, NIH Guide 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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and 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 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. 

A single numerical impact/priority score will be assigned to the whole application after consideration of all of the elements. The overall impact/priority score for the application will be based primarily on the scientific merit of the individual components, with additional consideration of the overall synergy of the Research Projects, integration of all the components, the overall program organization, and the capabilities of the associated personnel. The overall impact/priority score will depend on the perceived ability of the proposed work to develop medical countermeasures against radiological and nuclear threats to the civilian population. The clarity and completeness of the application’s combined components with regard to specific goals, proposed feasibility, and progress towards stated goals are critical.

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.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the likelihood that the results of the proposed studies will be translated into new approaches, medical products and diagnostics for treatment of short- and long-term consequences of radiation exposure?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are there sufficient preliminary data to support the proposed research/development projects? Are there clear paths to translating findings from basic mechanistic research study to development of new medical countermeasures for treatment of radiation injuries?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria for Multi-Project (U19) Applications Only

Administrative Core: Reviewers will consider each of the criteria below in the determination of scientific and technical merit. Is the administrative and organizational structure appropriate and sound to facilitate attainment of the objective(s) of the proposed program? Is the management plan for fiscal accountability and communications within the overall program appropriate? Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate?  Is the experience, level of commitment, and availability of the Administrative Core Leader(s) and administrative staff adequate to manage the overall program? Are the plans to utilize the External Scientific Advisory Group adequate?

Scientific Cores:  Reviewers will consider each of the criteria below in the determination of scientific and technical merit: Is provision of resources and core services for the individual Research Projects critical and justified? Is the relationship of a scientific core to the central focus of the overall program strong?  Is the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate?  Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?

Pilot Project Core: Reviewers will consider each of the criteria below in the determination of scientific and technical merit: Is the experience, level of commitment, and availability of the Pilot Projects Core Leader and staff adequate to manage the pilot program?  Are the plans for solicitation, review, administration, evaluation, and fiscal accountability of pilot funds appropriate and sound? Are there adequate plans to track outcomes of Pilot Project support?

Overall Impact of the Multi-Project Application: The following items will be considered in the determination of the overall scientific and technical merit and impact/priority score for the entire multi-project application. Are the adequacy and significance of the proposed center’s plan to develop medical countermeasures that will mitigate/treat radiation injuries and/or develop improved radiation diagnostics, such as high-throughput and point-of-care radiation biodosimetry tools or predictive biomarker assays and devices that assess early and/or delayed injury to different organs/tissues well described and justified? Are the plans to establish, coordinate, and manage a synergistic research program to achieve the goals of the CMCR including plans for equitable resolution of conflicts and decision-making adequate and justified? Is the scientific gain achieved by combining the component Research Projects into a multi-project program beyond that which is achievable if each project were to be pursued independently (synergy) clearly described and justified? Is the overall program cohesive, including coordination and interrelationships among individual components focused on a common theme? Is there potential for productive collaboration among scientists within the CMCR network? Does the PD/PI have the leadership and scientific ability to develop an integrated, multi-disciplinary program with a well-defined central research focus, and commitment and ability to devote adequate time and effort to the program? For applications designating multiple PDs/PIs, is the Leadership Plan appropriate and adequate to ensure that there will be sufficient coordination and communication among the PDs/PIs? For renewal applications, were there adequate accomplishments achieved during the prior funding period?  Are there significant synergy and thematic relatedness between the projects?

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 impact/priority score:

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 proposed 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.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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 proposed research.

Milestones. Reviewers will comment on the adequacy and appropriateness of the yearly Milestones for each of the Research projects

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 proposed 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:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

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.

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 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. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The PD/PI will have the primary responsibility for: defining the research plan and goals; overseeing/performing the scientific activities of the plan; ensuring successful completion of Milestones within the timeframe and budget proposed; cooperating with NIAID programmatic, technical, and administrative staff; and administratively managing the U19. One PD/PI from each CMCR will be a voting member of the CMCR Steering Committee (see below), will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee. Awardees must be committed to making research samples and tools, methods, data, and materials that they develop under this program available to other members of this program as well as the research community, subject to the rights described below.

Monitoring Clinical Studies

NIH policy requires that clinical studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

All clinical activities performed under this award must be in compliance with all U.S. Federal regulations, guidance, and NIH policies applying to the conduct of research involving human subjects and regulatory applications for new drug or biological licenses when applicable. These include, but are not limited to: U.S. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314, 601 and Title 45, Part 46; ICH guidance for Good Clinical Practice (GCP); and NIH grants policy (refer to http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). In addition, the awardee must ensure that all sites in the U.S. and outside the U.S. comply with the following:

  1. Each institution engaged in human subjects research has a current, approved Assurance Number on file with the DHHS Office for Human Research  Protections (OHRP).
  2. Each protocol and informed consent document is approved by the responsible Insitutional Review Board (IRB)/Ethics Committee (EC) prior to subject entry.
  3. For Investigational New Drug (IND) studies, each local Investigator of Record has supplied a completed FDA Form 1572 to NIAID for each protocol conducted at each site. INDs may be held by the PD/PI, by a commercial subcontractor, or by the NIAID.
  4. Each study investigator and sub-investigator has provided current curriculum vitae to NIAID.
  5. Each study participant (or legal representative) will sign an IRB/EC-approved protocol consent prior to entry on study as part of the Informed Consent Process.
  6. All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for human subjects.

Milestones

The applicants will describe explicit, quantitative, yearly Milestones for each Research Project of the proposed CMCR. It is recognized that Milestones may require revision and re-negotiation prior to award and during the course of the project period. The NIH Program Official will negotiate the Milestones with the PD/PI(s) and provide approvals. Release of each yearly funding increment by NIAID will be based on a NIAID review of progress towards achieving the previously agreed upon Milestones.

External Scientific Advisory Group

After award, the PD/PI will establish an External Scientific Advisory Group (ESAG) comprised of three to four investigators who are not a part of the overall CMCR program. The ESAG will meet annually with the Center personnel to evaluate progress and provide advice on future directions.  Costs will be borne by the awardee.

Pilot Studies

The PD/PI will be responsible for ensuring that all pilot studies involving human or animal subjects have the appropriate clearances (i.e., IRB, FWA, IACUC, human subjects’ research training, and other required documentation in domestic and foreign institutions) prior to implementation. All pilot projects need to be approved by the NIAID Program and Grants Management prior to initiation. The PD/PI must inform the NIH of any awards made for pilot studies involving foreign sites prior to their initiation. Pilot studies involving foreign sites cannot be initiated without first obtaining NIH clearance and approvals for protection of human subjects and animals, including specimens. 

Site Visits

The PD/PI will host site visits by NIAID program staff as requested by the program staff. These site visits may be held in conjunction with meetings of the CMCR members with their ESAG.

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).

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.

Publications

The PD/PI will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Agreement.  The PD/PI and Project Leaders are requested to submit manuscripts to the Program Officer 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 PD/PI and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIH Project Scientist for this program. In conjunction with other NIAID scientific program staff and the CMCR Steering Committee (see below), the NIH Project Scientist will provide advice and guidance on technical issues, such as reviewing progress or recommending changes. Administrative assistance will be provided by the NIH Project Scientist in conjunction with the NIAID Grants Management Office.  The NIH Project Scientist may also:  provide input into the design of activities; advise in the selection of sources or resources (e.g., determining where a particular reagent may be found); coordinate or participate in the collection and/or analysis of data; or advice in the management and technical performance.

The NIH Project Scientist will schedule the meetings and teleconferences of the Steering Committee, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.

Additionally, an agency Program Official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Grant Award. The assigned Program Official may also serve as the Project Scientist.

2.A.3. Collaborative Responsibilities

CMCR Steering Committee

A Steering Committee will be established to serve as the governing board of the CMCR program. The committee will be comprised of PD/PI of each U19 grant and the NIAID Project Scientist, and may also include other individuals with expertise in the scientific areas, as well as Program Officials from the NIAID, National Cancer Institute, and other NIH institutes as appropriate. Only one PD/PI from each U19 grant will be voting members of the Steering Committee and each will have one vote. Awardees will be required to accept and implement policies approved by the Steering Committee.

The CMCR Steering Committee will meet quarterly by teleconference, except for one yearly face-to-face meeting in conjunction with the annual Scientific Meeting (see below). A Steering Committee Chair will be elected by majority vote from among the U19 PD/PIs at the first Steering Committee meeting.

The responsibilities of the CMCR Steering Committee will be to:

NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications. However, under special circumstances, the Steering Committee will establish guidelines and review procedures to evaluate and determine opportunities for redirection or modification of the peer-reviewed projects. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism.

Scientific Meetings

All awardees will participate together in an initial meeting, arranged by the NIAID Project Scientist, to be held soon after award in the Washington, DC area; and will participate in face-to-face scientific meetings of all PDs/PIs to be held annually thereafter. Quarterly teleconferences of the Steering Committee will also be held. All PDs/PIs are required to attend these meetings, together with additional scientific staff from their CMCR when appropriate. The scientific meetings are open to members of the CMCR program, NIH extramural staff and members of U.S. Government agencies, and will serve as opportunities for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among program members. Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance overall program goals. The PDs/PIs are required to give oral presentations at the annual meetings on current progress and planned activities and projects.

2.A.4. Dispute Resolution

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 dispute resolution. A Dispute Resolution Panel composed of three members will be convened: 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 dispute resolution 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

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.   

Special Reporting Requirements

The annual progress report for the U19 award will use the standard PHS 2590 form. In addition, an executive summary and a detailed description of the work done to achieve the specific Milestones for that funding year shall be included. If Milestones have not been met, an explanation of what has been accomplished and the alternatives, solutions, and/or problems that exist must be provided. If future year Milestones need to be modified, updated Milestones and associated timelines must be included in the report and reviewed with the Program Officer.  The Program Officer, in conjunction with the Steering Committee, will determine if major changes are appropriate and provide approval. In addition, the awardees may be contacted during or after the completion of this award for information helpful in assessing the overall impact of the program.

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Narayani Ramakrishnan, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 1110, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601

Telephone: (301) 451-3101
FAX: 301-480-6587
Email: nramakrishnan@niaid.nih.gov 

2. Peer Review Contacts:

Kenneth Santora, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3146, 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:  301-451-2605
FAX: 301-480-2408
Email: ksantora@niaid.nih.gov

3. Financial or Grants Management Contacts:

Gregory P. Smith
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2109, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Overnight Mail Only: Use Zip 20817
Phone: (301) 402-5540
Fax: (301) 493-0597
Email: gs225y@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. 

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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.


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