Part I Overview Information

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Department of Health and Human Services

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

Components of Participating Organizations
This Funding Opportunity Announcement (FOA) is developed as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act). All NIH Institutes and Centers with funding authority will participate with the NIH Office of the Director in this initiative. This FOA will be administered by the Office of the Director of the NIH (http://www.nih.gov). Awards will be administered by the participating Institutes and Centers.

Title: Recovery Act Limited Competition: NIH Director’s Opportunity for Research in Five Thematic Areas (RC4)

Announcement Type
New

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

• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
• January 22, 2010 - See Notice NOT-OD-10-051 FY2010 Recovery Act Funding Announcements: Clarification on Page Limitations for Bibliography and References Cited Section.

Request for Applications (RFA) Number: RFA-OD-10-005

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release/Posted Date: December 28, 2009
Opening Date: February 15, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 15, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date: March 15, 2010
AIDS Application Due Date: Not applicable
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 16, 2010

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The NIH has received new funds for Fiscal Years (FYs) 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ). This is one of a number of NIH initiatives related to the Recovery Act. These are listed at the following site: http://grants.nih.gov/recovery/.

Under the Recovery Act, the NIH has established a program entitled NIH Director’s Opportunity for Research in Five Thematic Areas . This program will support projects that address research endeavors in specific areas that will benefit from significant three-year funds without the expectation of continued NIH funding beyond this period. The research supported by the program should have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery.

• Purpose. This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5, solicits through this limited competition applications from domestic (United States) institutions/organizations proposing to develop and implement critical research innovations in one or more of the following five thematic areas:
  1. Applying Genomics and Other High Throughput Technologies
  2. Translating Basic Science Discoveries into New and Better Treatments
  3. Using Science to Enable Health Care Reform
  4. Focusing on Global Health
  5. Reinvigorating the Biomedical Research Community
• This program is a trans-NIH effort supported by Recovery Act funds from the Office of the Director. Applicants may propose to address either a specific disease- or technology-related research question relevant to the mission of one or more participating Institutes and Centers, or propose the creation of a unique infrastructure/resource designed to accelerate scientific progress in the future.
• Mechanism of Support. This FOA will utilize the NIH RC4 award mechanism.
• Funds Available and Anticipated Number of Awards. Contingent upon the submission of a sufficient number of scientifically meritorious applications, up to $80 million of ARRA funds will be obligated by September 30, 2010 to support requests submitted in response to this FOA. Because the nature and scope of the proposed research will vary from application to application, the size of each award will also vary. The total amount awarded and the number of awards will depend upon the numbers, quality, and costs of the applications selected for award.
• Budget and Project Period. Only applications with budgets greater than $500,000 total costs per year for a project period of three years are expected to be considered. The total annual cost for individual awards is expected to vary, depending on the scope of the project.
• Research Strategy Length: The Research Strategy component may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Foreign institutions/organizations are not eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ 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.
• Early Stage Investigators (ESIs)/New Investigators (New PIs). New PIs and ESIs are invited to apply for these funds. Because the awards are significant, recipients will not be considered New and Early Stage Investigators when they apply for NIH research grants in the future. More information can be found at http://grants.nih.gov/grants/new_investigators/index.htm.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application
• Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions. Because this is a one-time-only solicitation, resubmissions are not permitted.
• Renewals. Renewals are not permitted in response to this FOA.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV for application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the most current forms and instructions.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Objectives

The mission of the NIH is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. To that end, the NIH, through extramural grants programs of its Institutes and Centers, supports a broad range of biomedical research. Previous research has enormously increased our understanding of the molecular, cellular and behavioral bases of disease and our approaches to health care. The most recent advances in technology and science create numerous opportunities for the public and private sectors to accelerate discoveries for the prevention, diagnosis and treatment of disease. The high complexity of the technologies and data systems required for this type of research, and the requirements for large interdisciplinary teams significantly limit progress and prevent private sector investments and expansions.

Through investments of ARRA funds in FY2009, the NIH has the unprecedented opportunity to expand, accelerate and jumpstart research programs in meeting emerging biomedical and behavioral research needs. In FY2010, we continue to extend this opportunity to fuel additional research in addressing new challenges. The purpose of this program is to support high impact ideas in five broad thematic areas that lend themselves to short-term funding, and may lay the foundation for new fields of investigation. Applicants may propose to address either a specific disease- or technology-related research question relevant to one or more of the participating Institutes and Centers, or propose the creation of a unique infrastructure/resource designed to accelerate scientific progress in the future. This FOA is designed to provide investigators and institutions with the opportunity to address these unique challenges by engaging in new avenues of research where progress would produce a significant impact on growth and investment on biomedical or behavioral science and/or health research.

Note: Applicants to the Program must clearly specify the thematic area that their research addresses in the Project Summary/Abstract Component of the application. Applicants must also clearly articulate how the proposed studies would significantly extend our understanding of biomedical or behavioral science and/or health as it relates to the thematic area.

2. Scope and Specific Requirements

Scope. This grants program is aimed at research endeavors that address one or more of the following five thematic areas:

1. Applying Genomics and Other High Throughput Technologies: In the past, many basic biomedical science projects were limited in scope to some aspect of genetics, cell biology, or physiology. The revolution now sweeping the field is the ability to be comprehensive for example, to define all of the genes of the human, model organisms or the human microbiota, all of the human proteins and their structures, or all of the major pathways for signal transduction in the cell. Technologies contributing to these advances, many of which became practical at scale only in the last few years, include DNA sequencing, microarray technology, nanotechnology, small molecule screening capabilities, new imaging modalities, and computational biology. These comprehensive approaches coupled with systems-level integration, analysis and mining of large datasets now hold the promise of major advances in the understanding of the mechanisms of diseases.
   
   
2. Translating Basic Science Discoveries into New and Better Treatments: Armed with a wealth of basic science discoveries and an understanding of the pathophysiology of various diseases, we are embarking on the next frontier in designing new diagnostic and therapeutic strategies. Molecular and cellular insights into a disease can be developed into screening assays on hundreds of thousands of compounds, and tested in disease models to identify the most promising leads that can sustain the drug development pipeline and attract public-private partnerships for further pursuits. Additional pathways to therapeutics from gene therapy, biologics, and stem cells (including iPS cells) are also showing great promise. The opportunity is here for translational science to develop small molecule-based, gene-based, protein/peptide-based and cell-based therapies for common as well as rare diseases.
   
   
3. Using Science to Enable Health Care Reform: Quality, affordable health care for all Americans cannot occur without significant advances in the underlying science that will enable effective and efficient disease prevention and diagnosis, as well as better and cheaper treatments to be identified. Clinical research targeted toward health disparities, social and behavioral factors, large-scale prospective population cohort analysis, comparative effectiveness, cost-effective prevention and personalized medicine, and pharmacogenomics will allow us to assess and mitigate disease risks, predict outcome and optimize treatment. Health services research that includes health information technology and health research economics will enhance the safety, quality and efficiency of the health care delivery system, as well as facilitate health promotion.
   
   
4. Focusing on Global Health: The NIH has a long tradition of supporting the discovery phase of solutions to major global health challenges, and recent scientific advances in genomics, small molecule screening technologies, and vaccine development portend the possibility of further major impacts on some of the most challenging and harmful diseases worldwide. This theme encourages a greater focus on global health and new emphasis on formulating prevention and intervention strategies to tackle a number of infectious and parasitic diseases, chronic non-communicable diseases and injuries, and other neglected diseases striking the developing world, with the goal to reduce morbidity and mortality associated with these diseases worldwide.
   
   
5. Reinvigorating the Biomedical Research Community: The lifeblood of biomedical research in the United States rests upon the talent and dedication of its scientists and the support of innovative research. This theme encourages investigators to cultivate new collaborations and to assemble multidisciplinary or interdisciplinary teams in conducting innovative research on the most challenging biomedical and behavioral areas. The goal is to strengthen our research capacity, to broaden our research base and to enhance cross-fertilization of disciplines by recruiting new investigators and new expertise into the research community, and by developing and retaining these talents in a collaborative environment that fosters creativity and exploration.

Note: For the purpose of this FOA the definition of comparative effectiveness research (CER) will adhere to that adopted by the Federal Coordinating Council given at http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf (see in particular pages 5 and 16). The term comparative refers to comparisons of interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The term effectiveness refers to applicability to real-world needs and decisions faced by patients, clinicians, and other decision makers within real-world settings, i.e. not the ideal settings created in efficacy investigations. CER investigations compare two or more interventions and strategies that are currently available to practicing clinicians (i.e., not innovative or experimental drugs, devices, or approaches that might more typically be part of an FDA-regulated efficacy study). These interventions and strategies can include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies. As examples, CER investigations could:

• Compare two or more different existing, available drugs for prevention of major morbidity or mortality in a given medical condition
• Compare for a given medical condition the clinical outcomes of medical and surgical strategies, where all medications or surgical techniques are already available in practice
• Compare for a given medical condition the clinical outcomes of existing medical and lifestyle strategies within the framework of different health care delivery approaches

For examples of CER topics and approaches a 2009 Institute of Medicine Panel consider to be of high national priority, applicants are also encouraged to consult the Panel’s report at http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx.

Requirements. Projects submitted in response to this FOA are expected to demonstrate the following:

• The project addresses one or more of the five research themes.
• The work cannot be reasonably expected to be carried out successfully without the requested support.
• Specific outcomes of the proposed project promote and advance the mission of the NIH to improve health.
• The project is ready to be deployed immediately upon funding.
• A rapid infusion of significant funding will accelerate current and future research in the area of study and there are appropriate measurable outcomes to evaluate the short and long-term effects of the project.
• The proposed project is something that no other entity is likely or able to do, and there is a public health benefit to having the results of the research in the public domain.
• The project or generated results and resources can be expected to become integrated with other NIH and privately funded research within a reasonable timeframe.
• Projects that would require funding beyond this timeframe should provide a detailed plan for maintaining the research efforts without any expectation of further financial assistance from the sponsoring IC or other NIH components. Applicants are expected to provide a list of outcomes and include plans to obtain long-term support for research endeavors carried out with this funding.

A detailed statement addressing the scope and the requirements should be included as part of the application Research Plan and in summary form in the Letter of Intent.

Only projects with a scientific scope that requires an annual budget greater than $500,000 in total costs are expected to be considered.

The award provides three years of support to applicant organizations that can demonstrate the need for a significant short-term stimulus investment on a well defined project that is ready for deployment and implementation and that meets the goals of the Recovery Act.

Key resources and data acquired with the support of this FOA will be expected to be shared rapidly with the public and the scientific community as described under the NIH Policy for Sharing of Data and the NIH Policy for Sharing Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Timeline. Applicants should construct the project timeline to include critical milestones, measurable outcomes, and mid-term and end of project results to be publicly shared as expeditiously as possible. Awards will be made for a three-year budget period.

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

Section II. Award Information

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1. Mechanism of Support

This FOA will use the RC4 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide).

2. Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. Contingent upon the submission of a sufficient number of scientifically meritorious applications, approximately $80 million of ARRA funds will be obligated by September 30, 2010 to support requests submitted in response to this FOA.

Only applications for projects that require $500,000 or more in total costs per year are expected to be considered for funding. The total cost amount for individual awards will vary and should be commensurate with the scope and complexity of the project. However, the duration of the awards issued under this FOA will be limited to three years.

The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, with the exception of projects submitted to address topics identified as included in the Focusing on Global Health theme, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less. Projects in response to the Focusing on Global Health theme could propose a larger foreign component. NIH will consider these requests in the context of the research being proposed and its potential for critically advancing research in global health.

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

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from Institutional Development Award (IDeA) states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Other(s):
• Eligible Agencies of the Federal Government
• Faith-based or Community-based Organizations

1.B. Eligible Individuals

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

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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 each application is scientifically distinct.

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

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

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To download a current SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PI account in the Commons. Applicants should not share a Commons account for both a Signing Official (SO) role and a PI role; however, if they have both a PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and 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 (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: February 15, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 15, 2010
Application Due Date: March 15, 2010
AIDS Application Due Date: Not applicable
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: August 31, 2010

3.A.1. Letter of Intent

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

• Number and title of this funding opportunity.
• Descriptive title of proposed research.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Description of the research areas, including any subprojects
• Significance of the proposed research
• Evidence that the project is ready for immediate implementation
• Description of how the goal and outcomes of the project match the goals of the grants program and Recovery Act
• Preliminary list of the expected project milestones.
• Direct, contract F&A, and total costs for each year

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

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

The letter of intent should be sent to:

Cathleen Cooper, Ph.D.
Chief, Oncology 1: Basic Translational (OBT) IRG
NIH/Center for Scientific Review
6701 Rockledge Drive, Rm 6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone: 301-443-4512
Fax: 301-480-0287
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date. (See Section IV.3.A. for all dates.) If an application is not submitted by the due date and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov,

NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process; the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH Late Policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the OD consistent with the intent of this FOA. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, or previously solicited through ARRA-related opportunities, is to be submitted in response to this funding opportunity, it is to be prepared as a NEW application. That is, the application for this funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, as indicated in the NIH Grants Policy Statement.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. In addition, ARRA awards are subject to Standard Terms and Conditions for ARRA Awards consistent with NOT-OD-09-080, NOT-OD-09-120, and NOT-OD-10-003.

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 award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

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

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)

Research Strategy Page Limitation: The Research Strategy is limited to a total of 12 pages

PHS398 Research Plan Component Sections

Item Number and Title	Instructions
1. Introduction to Application	Omit (N/A: Resubmissions and Revisions not allowable)
2. Specific Aims	One page maximum. Separate PDF attachment
3. Research Strategy	Limited to 12 pages. Attach the 12- page Research Strategy as a single PDF document. Figures and illustrations may be included but must fit within the 12-page limit. Do not include links to Web sites for further information. Do not include animations.

Excluded from the 12-page Research Strategy limitation are the following items:

• Specific Aims (1 page maximum)
• Inclusion Enrollment Report
• Protection of Human Subjects
• Inclusion of Women and Minorities
• Targeted/Planned Enrollment
• Inclusion of Children
• Vertebrate Animals
• Select Agents Research
• MPI Leadership Plan
• Consortium/ Contractual Arrangements
• Letters of Support
• Resource Sharing Plans

Organize the Research Strategy in the specified order using the instructions provided below. Start each section with the appropriate section heading (i.e. Research Area, Opportunity and Potential Impact, Approach, Timeline, Milestones, Expected Measurable Outcomes and Deliverables, and Long Term Sustainability Plan.)

• Research Area: State the broad goals of the project and describe how the project may result in research and development innovations that could effectively be linked to long-term improvements and growth in the research enterprise, public health and health care delivery. Articulate how the research area addresses one or more of the five research themes specified in this FOA.

• Opportunity and Potential Impact: What is the research opportunity, scientific knowledge gap or technology within the five research themes that will be addressed? How broad is the potential impact in science and/or health? Which community (ies) will be affected? What is (are) the size(s) of the community(ies)? Will the potential impact be major?

• Approach: How will you attempt to explore or solve the stated research problem? How will your rationale and/or approach overcome existing challenges or barriers in the field? If you propose to improve existing technologies or to develop new technologies, what needs are being addressed and what is unconventional and exceptionally innovative about your approach? Have you demonstrated feasibility that the work can be accomplished within the project period? Provide enough information for reviewers to determine what you are proposing to do, but do not include a detailed experimental plan.

• Timeline, Milestones, Expected Measurable Outcomes and Deliverables: Provide a timeline for the proposed research within the project period indicating points where intermediate objectives will be assessed, the measurable outcomes and tangible deliverables that will be evaluated to assess progress, and the timing and process that will be used to reach decisions regarding the course and direction of the continuing research effort. Possible alternative paths that may be followed at critical junctures in the project plan should be described and indicated on the timeline.

• Long Term Sustainability Plan: Applications requesting new infrastructure support must include a plan that describes how the infrastructure and services will be maintained and supported beyond the initial NIH funded period. The plan should include potential sources of support other than NIH and preliminary budget estimates. The level of institutional support and commitment and organizational structure should also be included.

Preliminary data are not required but may be included, if necessary to demonstrate the feasibility of the proposed studies. The presentation must be clear and particularly compelling. No detailed scientific plan should be provided, but timelines must be presented.

Special Instructions for Other Project Information (Section 4.4 of SF424 (R&R) Application)

Item 7. Project Summary/Abstract: Follow instructions in the SF424 (R&R) Application Guide. Begin this section by stating the thematic area that this application addresses.

Item 9. Bibliography and Literature Cited: Limited to one page. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. When citing articles that fall under the Public Access Policy, provide the NIH Manuscript Submission reference number or the PubMed Central (PMC) reference number for each article. If the PMCID is not yet available, indicate "PMC Journal - In Process."

Continue with the instructions in the SF424 (R&R) Application Guide.

Special Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of SF424 (R&R) Application)

Biographical Sketches: Each biographical sketch is limited to two pages. The number of publications cited in each biosketch is limited to ten or fewer items. Individuals should cite their most relevant publications and those that highlight the significance of past accomplishments.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

No supplemental/update information will be accepted.

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Regardless of the amount requested, applicants under this FOA are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information

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1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review groups convened by the Center for Scientific Review and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the appropriate national advisory council or board that the project is administratively assigned to.

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).

Scored 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, technological advances, technical capability, clinical practice, and/or health be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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, technological developments, 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?

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?

Are the milestones set appropriately and could they be reached reasonably over the timeline? Are the expected measurable outcomes and results well described, and will they meaningfully fulfill the research opportunities in one or more of the five research themes?

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? Have the physical facilities, services and institutional requirements been carefully considered? Is there evidence of strong, institutional support and commitment to the rapid and efficient deployment of the new proposed infrastructure?

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the 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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Select Agents 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:

• Data Sharing Plan. [http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm]
• Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
• Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

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.

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

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1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. In addition, as part of just-in-time information for those Recovery Act awards, for any modular budget application, a detailed budget will be required prior to award.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated. Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section VII. Agency Contacts

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This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application^[1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist^[1] . This restriction applies unless:

(i) the communication is purely logistical;

(ii) the communication is made at a widely attended gathering;

(iii) the communication is to or from a Federal agency official and another Federal Government employee;

(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

(v) the communication is initiated by the Federal agency official.

For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

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

Awarding Component	Scientific/Research Contact(s):	Financial/Grants Management Contact(s):
National Institute on Aging (NIA) http://www.nia.nih.gov	Chyren Hunter, Ph.D. Deputy Director, Division of Extramural Activities NIA, NIH Gateway Building, Room 2C218 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Phone: 301-496-9322 Fax: 301-402-2945 Email: [email protected]	Linda Whipp Grants Management Officer NIA, NIH Gateway Building, Suite 2N212 Bethesda, MD 20892-2292 Phone: 301-496-1472 Fax: 301-402-3672 Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov	Abraham P. Bautista, Ph.D. Director, Office of Extramural Activities NIAAA, NIH 5635 Fishers Lane, Room 2089 Bethesda MD 20892-9304 Phone: 301-443-9737 Fax: 301-443-6077 Email: [email protected]	Judy Fox Chief, Grants Management Branch NIAAA, NIH 5635 Fishers Lane, Room 3023, MSC 9304 Bethesda, MD 20892-9304 Phone: 301-443-4704 Fax: 301-443-3891 Email: [email protected]
National Institute of Allergy and Infectious Diseases (NIAID) http://www3.niaid.nih.gov/	Dr. Patricia Haggerty Associate Director, Division of Extramural Activities NIAID, NIH 6700B Rockledge Dr. Rm 2139 Bethesda, MD 20892 Phone: 301-451-2615 Email: [email protected]	Mary Kirker Chief, Grants Management Branch NIAID, NIH 6700-B Rockledge Drive, Rm 2115 Bethesda, MD 20892-7614 Phone: 301-402-6400 Fax: 301-493-0597 Email: [email protected]
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov/	Hung Tseng PhD Director Extracellular Matrix Biology and Disease Program NIAMS, NIH One Democracy Plaza, Room 886 6701 Democracy Boulevard Bethesda, MD 20892-4872 Phone: 301-496-0810 Email: [email protected]	Gail B. Hamilton Senior Grants Management Officer NIAMS, NIH 6701 Democracy Blvd., Suite 800, Room 844 Bethesda, MD 20892-4872 Phone: 301-594-3506 Fax: 301-480-5450 Email: [email protected]
National Institute of Biomedical Imaging and Bioengineering (NIBIB) http://www.nibib.nih.gov/	Grace C.Y. Peng, Ph.D. Program Director NIBIB, NIH 6707 Democracy Blvd., Suite 200, MSC 5469 Bethesda, MD 20892 Phone: 301-451-4778 Email: [email protected]	Chris A. Darby Grants Management Specialist NIBIB, NIH 6707 Democracy Blvd., MSC 5469 Suite 900, Democracy II Bethesda, MD 20892-5469 Phone: 301-451-4786 Fax: 301-451-5735 Email: [email protected]
National Cancer Institute (NCI) http://www.nci.nih.gov or http://www.cancer.gov	Jerry S. H. Lee, Ph.D. Special Assistant and Program Director Office of the Deputy Director NCI, NIH 31 Center Drive, Room 11A30C, MSC 2590 Bethesda, MD 20892-2590 Phone: 301-496-1045 FAX: 301-480-2889 Email: [email protected]	Ms. Crystal Wolfrey Office of Grants Administration NCI, NIH 6120 Executive Boulevard, EPS Suite 243, MSC 7150 Bethesda, MD 20892-7340 Phone: 301-496-8634 Fax: 301-496-8601 E-mail: [email protected]
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov	Dennis A. Twombly, Ph.D. Extramural Training Officer Acting Deputy Director, Office of Extramural Policy NICHD, NIH 6100 Executive Boulevard, Room 2C01 Bethesda, Maryland 20892-7510 Phone: 301-451-3371 FAX: 301-480-2400 Email: [email protected]	Bryan S. Clark, M.B.A. Chief Grants Management Officer NICHD, NIH 6100 Executive Boulevard Room 8A01, MSC 7510 Bethesda, MD 20892 Phone: 301-435-6975 Fax: 301-402-0915 Email: [email protected]
National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov	Christine Colvis, PhD NIDA, NIH Director, Program Integration Neuroscience Center, Rm 5261 6001 Executive Blvd. Bethesda, MD 20892 Phone: 301-443-6480 Email: [email protected]	Carol Alderson Office of Management Grants Management Branch NIDA, NIH 6001 Executive Boulevard, 5th Floor, MSC 9560 Bethesda, MD 20892-9560 Phone: 301-933-6196 Fax: 301-594-6869 Email: [email protected]
National Institute on Deafness and Other Communication Disorders (NIDCD) http://www.nidcd.nih.gov/	Gordon B. Hughes, M.D. Program Director, Clinical Trials Division of Scientific Programs NIDCD, NIH 6120 Executive Blvd., EPS-400C MSC 7180 Bethesda, MD 20892-7180 Phone: 301-435-4085 Fax: 301-402-6251 Email: [email protected]	Christopher Myers Chief, Grants Management Branch Division of Extramural Activities NIDCD, NIH Executive Plaza South, Room 400B 6120 Executive Blvd., MSC 7180 Bethesda, MD 20892-7180 Phone: 301-435-0713 Fax: 301-451-5365 Email: [email protected]
National Institute of Dental and Craniofacial Research (NIDCR) http://www.nidcr.nih.gov	Lillian Shum, PhD Chief, Integrative Biology and Infectious Diseases Branch Division of Extramural Research NIDCR, NIH 6701 Democracy Blvd., Rm. 624 Bethesda, MD 20892-4878 Phone: 301-594-0618 Fax: 301-480-8319 Email: [email protected]	Ms. Mary Greenwood Chief Grants Management Officer NIDCR, NIH 6701 Democracy Blvd. Room 658, MSC 4878 Bethesda, MD 20892-4878 Phone: 301-594-4808 Fax: 301-480-3562 Email: [email protected]
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) http://www.niddk.nih.gov	Philip F. Smith, Ph.D. Deputy Director Division of Diabetes, Endocrinology, and Metabolic Diseases Co-Director, Office of Obesity Research NIDDK, NIH 6707 Democracy Blvd., Rm 689 MSC 5460 Bethesda, MD 20892-5460 Phone: 301.594.8816 Fax: 301.480.3503 Email: [email protected]	Elizabeth Gutierrez Grants Specialist Grants Management Branch Division of Extramural Activities NIDDK, NIH 6707 Democracy Blvd, Room 712B Bethesda, MD 20817 Phone: 301-594-8844 Email: [email protected]
National Institute of Environmental Health Sciences (NIEHS) http://www.niehs.nih.gov	NIEHS Scientific Program Contacts http://www.niehs.nih.gov/funding/grants/contacts.cfm	Dorothy Duke Chief, Grants Management Division of Extramural Research and Training NIEHS, NIH 111 TW Alexander Drive, Mail Drop K3-13 Keystone Building, Room 3044 Research Triangle Park, NC 27709-2233 Phone: 919-541-2749 Fax: 919-541-2860 Email: [email protected]
National Eye Institute (NEI) http://www.nei.nih.gov	Lisa A.Neuhold, Ph.D. Division of Extramural Research NEI, NIH 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892 Phone: 301-451-2020 Fax: 301-402-0528 Email: [email protected]	Mr. William W. Darby Division of Extramural Research NEI, NIH 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892-9300 Phone: 301-451-2020 Fax: 301-496-9997 Email: [email protected]
National Institute of General Medical Sciences (NIGMS) http://www.nigms.nih.gov/	Peter C. Preusch, Ph.D. Biophysics Branch Chief Division of Cell Biology and Biophysics NIGMS, NIH 45 Center Drive, MSC 6200 Bethesda, MD 0892-6200 Phone: 301-594-1158 FAX: 301-480-2004 Email: [email protected]	Grace Olascoaga Chief Grants Management Officer NIGMS, NIH 45 Center Drive MSC 6200 Room 2AN.32 Bethesda, MD 20892-6200 Phone: 301-594-5520 Fax: 301-480-1969 Email: [email protected]
National Heart, Lung, and Blood Institute (NHLBI) http://www.nhlbi.nih.gov	Division of Cardiovascular Sciences Stephen S. Goldman, Ph.D. NHLBI, NIH 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0560 Email: [email protected] Division of Lung Diseases James Kiley, Ph.D. NHLBI, NIH 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0233 Email: [email protected] Division of Blood Diseases and Resources Henry Chang, M.D. NHLBI, NIH 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0067 Email: [email protected]	Tony Agresti Grants Management Specialist NHLBI, NIH 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20982 Phone: 301-435-0186 Email: [email protected]
National Human Genome Research Institute (NHGRI) http://www.genome.gov	Joseph Campbell NHGRI, NIH 5635 Fishers Lane Suite 4076, MSC 9305 Bethesda, MD 20892-9305 Phone: 301-443-6811 Fax: 301-480-2770 Email: [email protected]	Cheryl Chick Chief Grants Management Officer Grants Administration Branch NHGRI, NIH 5635 Fishers Lane, Ste. 3058 Bethesda, MD 20892-9307 Phone: 301-435-7858 Fax: 301-451-5434 Email: [email protected]
National Institute of Mental Health (NIMH) http://www.nimh.nih.gov	Jean G. Noronha, Ph.D. Division of Extramural Activities NIMH, NIH 6001 Executive Blvd, Room 6147, MSC 9609, Bethesda, MD 20892-9609 Phone: 301-443-3367 Fax: 301-443-4720 Email: [email protected]	Ms. Rebecca Claycamp Chief Grants Management Officer NIMH, NIH 6001 Executive Boulevard Room 6122 Bethesda, MD 20892-9605 Phone: 301-443-2811 Fax: 301-443-6885 Email: [email protected]
National Institute of Neurological Disorders and Stroke (NINDS) http://www.ninds.nih.gov/	Emmeline Edwards, Ph.D. Deputy Director for Extramural Research NINDS, NIH NSC 3305 6001 Executive Boulevard Bethesda, MD 20892-9531 Phone: 301-496-9248 Email: [email protected]	Tijuana Decoster, MPA Chief Grants Management Officer NINDS, NIH NSC 3258 6001 Executive Blvd Bethesda, MD 20892-9537 Phone: 301-496-9231 Email: [email protected]
National Institute of Nursing Research (NINR) http://www.ninr.nih.gov	Linda S. Weglicki, PhD, RN Health Scientist Administrator Division of Extramural Activities NINR, NIH 6701 Democracy Blvd, Rm. 710 One Democracy Plaza Bethesda, MD 20892-4870 Phone: 301-594-6908 Email: [email protected]	Ron Wertz Grants Management Specialist NINR, NIH 6701 Democracy Blvd, Rm. 710 One Democracy Plaza Bethesda, MD 20892-4870 Phone: 301-594-2807 Fax: 301-402-4502 Email: [email protected]
National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/	Craig Hopp Program Officer NCCAM, NIH 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892 Phone: 301-496-5825 Fax: 301-480-1587 Email: [email protected]	George A. Tucker, M.B.A. Director, Office of Grants Management Chief Grants Management Officer NCCAM, NIH Phone: 301-594-9102 Fax: 301-480-1552 E-mail: [email protected]
National Center on Minority Health and Health Disparities (NCMHD) http://www.ncmhd.nih.gov	Francisco S. Sy, MD, DrPH Director Division of Extramural Activities & Scientific Programs NCMHD, NIH 6707 Democracy Blvd., Suite 800, MSC 5465 Bethesda, MD 20892-5465 Phone: 301-402-1366 FAX: 301-480-4049 Email: [email protected]	Priscilla Grant, J.D., C.R.A. Chief Grants Management Officer NCMHD, NIH 6707 Democracy Boulevard, Suite 800 Bethesda, MD 20892-5465 Phone: 301-594-8412 Fax: 301-480-4049 Email: [email protected]
National Center for Research Resources (NCRR) http://www.ncrr.nih.gov	Heng Xie, M.D., M.P.H., Ph.D. Supervisory Medical Officer Division for Clinical Research Resources NCRR, NIH 6701 Democracy Blvd., Democracy I, Rm. 908 Bethesda MD 20892-4874 Phone: 301-443-8063 Fax: 301-480-3661 E-mail: [email protected]	Molly Puente, Ph.D. Grants Management Specialist NCRR, NIH 6701 Democracy Blvd., Room 1035 Phone: 301-402-6737 Fax: 301-480-3777 Email: [email protected]
National Library of Medicine (NLM) http://www.nlm.nih.gov	Dr. Valerie Florance NLM Extramural Programs, NIH 6705 Rockledge Drive Rockledge 1, Suite 301 Bethesda, MD 20892 Phone: 301-496-4621 Fax: 301-402-2952 Email: [email protected]	Dwight Mowery NLM Extramural Programs, NIH 6705 Rockledge Drive Rockledge 1, Suite 301 Bethesda, MD 20892 Phone: 301-496-4221 Fax: 301-402-0421 Email: [email protected]
John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) http://www.fic.nih.gov/	Kenneth Bridbord, M.D. Division of International Training & Research FIC, NIH 31 Center Drive, Room B2C39 Bethesda, MD 20892-2220 Phone: 301-496-1653 Fax: 301-402-0779 Email: [email protected]	Bruce R. Butrum Chief Grants Management Officer Office of the Director FIC, NIH Building 31, Room B2C29 31 Center Drive Bethesda, MD 20892-2220 Phone: 301-496-1670 Fax: 301-594-1211 E-mail: [email protected]

Peer Review Contact(s):

Cathleen Cooper, Ph.D.
Chief, Oncology 1: Basic Translational (OBT) IRG
NIH/Center for Scientific Review
6701 Rockledge Drive, Rm 6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone: 301-443-4512
Fax: 301-480-0287
Email: [email protected]

Section VIII. Other Information

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Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

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

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

Loan Repayment Programs:
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/.