National Institutes of Health (NIH), (http://www.nih.gov)
of Participating Organizations
This Funding Opportunity Announcement (FOA) is developed as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act). NIH Institutes and Centers with funding authority listed below will participate with the NIH Office of the Director in this initiative.
National Cancer Institute
National Eye Institute (NEI/NIH), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov/)
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID/NIH), http://www3.niaid.nih.gov
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR/NIH), (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National Library of Medicine (NLM/NIH), (http://www.nlm.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD/NIH), (http://ncmhd.nih.gov/)Office of Research on Women’s Health (ORWH/OD/NIH) (http://orwh.od.nih.gov)
National Center for Research Resources (NCRR/NIH), (http://www.ncrr.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Title: Recovery Act Limited Competition: Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4)
Update: The following updates relating to this announcement have been issued:
Request for Applications (RFA) Number: RFA-OD-09-010
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)
Release/Posted Date: September 18, 2009
Opening Date: November 11, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 12, 2009
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(s): December 11, 2009
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 12, 2009
Due Dates for
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
Part II - Full Text of Announcement
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 (ICs), supports a broad range of health science research, including biomedical, public health and behavioral and social science. Previous research has enormously increased our understanding of the molecular, cellular, behavioral, and social bases of disease and identified targets and methods for improving health care. 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.
Communities are key consumers of NIH-supported health science research. Communities are broadly defined to include neighborhoods, schools, and workplaces; public health departments, health care providers, and social service agencies; community coalitions; state, county, and local governments; business-community collaborations; campus-community partnerships; public-private partnerships; and other types of organizations and institutions that filter or translate research findings to the American public. However, NIH recognizes that in order to maximize the relevance, dissemination, and implementation of health science research for the public, communities must have the opportunity to be actively engaged in the research enterprise, including active participation in formulating research questions, designing, and conducting research; translation and application of research findings to community-based practice and public health initiatives; and using research-generated evidence to support public health policy decisions. Improving public health often entails moving beyond the conventional health care system to include integrated and innovative methods. Moreover, the development of transformative infrastructures that collect and integrate information/data and application of health knowledge can provide an interface for the various perspectives and interests of academic health centers and communities allowing for more effective communication and dissemination of locally-relevant research findings. The availability of Recovery Act funds provides a unique opportunity for NIH to support these goals by strengthening and transforming relationships between academic health centers and communities to sustain health research.
Applications are invited from domestic (United States) institutions/organizations proposing to develop or expand needed infrastructures that will fundamentally transform collaboration and communication between academic health centers and local communities. Such collaborative infrastructures are essential to advance the health science research enterprise while ensuring that important research findings are effectively disseminated and implemented to improve public health and advance health care delivery. This RFA is not intended to fund research or evaluation projects, clinical trials, or public health campaigns. Rather, the intent is to fund projects to develop infrastructure for productive and sustainable academic-community research partnerships that can be leveraged in the future for efficiently conducting research that includes and is relevant to affected communities, and through which research findings can be disseminated in a manner that maximizes impact on public health.
It is expected that each grantee will be able to leverage this Recovery
Act funding into future research grants using the infrastructure partnership
between itself and the participating community. The NIH strongly encourages
applicants to propose infrastructures that may build upon or be linked to
extant infrastructures supported by other Federal agencies (e.g.,
Administration on Aging [AoA], Agency for Healthcare Research and Quality
[AHRQ], Centers for Disease Control and Prevention [CDC], Health Resources and
Services Administration [HRSA], Indian Health Service [IHS], Substance Abuse
and Mental Health Services Administration [SAMHSA], US Department of
Agriculture [USDA], etc.) and thus heighten their potential for long-term
2. Scope and Specific Requirements
Scope. The Community Infrastructure grants program will support the development, expansion, or reconfiguration of bi-directional relationships between academic health centers and community entities in the pursuit of improved public health through research. These transformative collaborative arrangements may influence the next generation of health science research. Projects could involve the development of public-private partnerships; connections between academic health centers and their constituent institutions (such as schools and departments, research institutes, health promotion centers or health science libraries) and community entities such as local neighborhoods, community clinics, health departments, schools, public libraries, community-based social services organizations, or workplaces; facilitate development of practice-based research; create needed information technology to support research; projects that build on existing HHS-supported programs or networks; and other organizational linkages. They should engage and empower communities in designing and conducting research projects and the dissemination of research findings in locally-relevant, practical ways. The intended partnerships and infrastructures sought through this initiative differ from traditional practice in that the fundamental purpose is to facilitate bi-directional communication, decision-making and participation in research to improve public health. The Academic Health Center (AHC), in order to facilitate this bi-directionality, may need to plan significant training of the community entities in the rationale and skills necessary to achieve equity in these partnerships. Community partnerships are not intended as simply a vehicle for recruiting participants into research (although this may be an important intermediate objective); rather, such partnerships should promote collaborative decision-making and, ultimately, facilitate and accelerate the translation of research findings to local practice. As an outgrowth of this initiative, academic centers should be positioned to leverage these partnerships to strengthen the design, feasibility, relevance, and dissemination of research. To maximize their potential, community infrastructure projects will ideally span scientific disciplines, diseases, and conditions, and will offer the potential for sustained collaboration and future research.
In this community research infrastructure program, NIH establishes the role of Community Research Associate (CRA), who will be a community representative and serve as a primary liaison facilitating communication and collaboration between the academic health center and the local community. Applicants must identify at least one CRA and include a biosketch. It must be demonstrated and documented in some manner that the CRA can represent the community’s needs and will. The NIH envisions that CRA’s will be respected community members such as local health officials, leaders of community-based organizations, or community health care providers, with a successful track record in community-based programs and projects. It is critical that this person be invested with the authority to bring the community’s views and opinions into negotiations and discussions with AHC program staff. The CRA will work closely with the PDs/PIs on the conceptualization and implementation of the transformative, sustainable infrastructure apparatus that the local award seeks to establish. The CRA is responsible for and accountable to the community and the collaboration as a whole for the proper conduct of the project or program, including sharing in decisions and appropriate distribution, sharing, and stewardship of resources. The identity and proposed role of the CRA in the project should be described in detail.
Illustrative examples of potential community-linked infrastructure projects include, but are not limited to:
To ensure efficient use of Recovery Act funds as well as maximize the likelihood of sustainability beyond the funding period, projects should build upon existing infrastructure and resources wherever feasible. Of particular interest are collaborative projects that build on activities currently supported by NIH or other HHS resources and networks (e.g., CDC, HRSA, AoA, AHRQ, SAMHSA, and IHS). The sustainability potential of projects may also be demonstrated through existing partnerships with local philanthropic organizations, foundations, or local and state governments. Organizational infrastructure may include, but need not be limited to, existing collaborative structures such as the National Network of Libraries of Medicine (NN/LM), Clinical and Translational Science Awards (CTSAs), Research Centers in Minority Institutions (RCMI), and Institutional Development Awards (IDeA) interuniversity consortia including shared library and information technology infrastructures, and existing academic/community outreach collaboratives such as the Cooperative Extension Service, among others.
Requirements. Recovery Act funding has unique and significant requirements for reporting and oversight to which established research centers are best equipped to respond. As such, NIH intends that AHCs will be the applicant organizations for this FOA. Proposed projects are expected to demonstrate the following in the context of the application’s Research Plan:
Timeline. Applicants should construct the project timeline to include critical milestones, measurable outcomes, and mid-term and end of project deliverables 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
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 funded under the Recovery Act. NIH has designated up to $30 million in Fiscal Years 2009 - 2010 to fund 30 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.
Because the nature and scope of the proposed projects will vary amongst applications, it is anticipated that the size of each award will vary. However, applicants’ budget proposals are limited to a maximum of $1 million in total costs over the entire project period. The planned duration of the proposed projects issued under this FOA may not exceed three years. Grants will be awarded upfront and in full as a single budget period.
Applicants are strongly encouraged to build upon existing programs and networks of other HHS agencies. NIH may give funding priority within this FOA to applications that leverage existing infrastructures supported by other Federal agencies (e.g., Administration on Aging, Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Health Resources and Services Administration, Indian Health Service, Substance Abuse and Mental Health Services Administration, US Department of Agriculture, etc.) in order to heighten awarded projects’ potential for long-term sustainability.
To further sustain the economic growth and progress in health science, awardees are encouraged to explore the development of Public-Private Partnerships (PPPs) during the course of the award. Information on developing PPPs can be found at http://ppp.od.nih.gov/. Note that the development plan is not part of the Community Infrastructure grant program application.
The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component may not exceed 10% of the total requested direct costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
1.A. Eligible Institutions
This FOA is particularly directed towards Academic Health Centers who have engaged with the community and may have collaborated on projects of mutual interest. The AHC should be able to demonstrate a track record of positive engagement with community entities. The NIH is particularly interested in community organizations that deliver and/or support health promotion, disease prevention, disease management, health care, or related services. Included in this definition are public health departments, health agencies, treatment agencies and providers, community coalitions, state health agencies, schools, social service agencies, business-community collaborations, campus-community partnerships, and other types of community-based organizations. “Community” may be defined geographically (e.g., a neighborhood or county), demographically (e.g., Native Americans), by health condition (e.g., mental health, wellness, primary care), or by a common interest (e.g., community coalitions, churches, local businesses). Research institutions are eligible to submit applications so long as an individual in one of the above-listed entities is also named as a Community Research Associate on the application for at least 15% effort (contributed or compensated).
Both academic and community organizations should be fully engaged in developing applications responsive to this FOA, and in designing and creating the proposed research infrastructure. Engagement of community-based organizations as research associates is expected to allow for future development of informed research and locally-relevant practices made possible by the infrastructure developed through this funding opportunity. Specifically, the following organizations/institutions are eligible and encouraged 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 listed below. The United States institution/organization must be located in the 50 states, territories and possessions of the United States, 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.
1.B. Eligible Individuals
Any individual(s) formally affiliated with an eligible applicant institution having 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 grant 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.
Working with the PDs/PIs should be one or more persons designated as Community Research Associate (CRA), who will be a community representative. This person will serve as a primary link between the PD/PI from the academic health center and the local community. The CRA may be, but is not required to be, named as a PD/PI on this application; this decision is left to the discretion of the applicant organizations.
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.
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
SF424 (R&R) (Cover
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
Research & Related Budget, as appropriate
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
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, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
Submission Dates and Times
See Section IV.3.A. for details.
Date: November 11, 2009 (Earliest date an application may be submitted to
Letters of Intent Receipt Date(s): November 12, 2009
Application Due Date(s): December 11, 2009
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 2010
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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:
Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:
Office of Extramural
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
3.B. Submitting an Application Electronically to the
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.
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time of the applicant institution/organization on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed. An application that does not comply with the required page limitations is considered non-responsive and will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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.
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or renewal
award if such costs: 1) are necessary to conduct the project, and 2) would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see theNIH 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.
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
Special Instructions for PHS398 Research Plan Component (Section 5.5 of SF424 (R&R) Application)
Research Plan: The Research Plan is limited to a total of 12 pages.
PHS398 Research Plan Component Sections
Item Number and Title
1. Introduction to Application
Omit (N/A: Resubmissions and Revisions not allowable)
2. Specific Aims
One page maximum. Separate PDF attachment
3. Background and Significance
Combined in a single PDF in item 5
4. Preliminary Studies/Progress Report
Combined in a single PDF in item 5
5. Research Design and Methods
Item 5 consists of Items 3-5 and is limited to 12 pages. Attach the 12-page Research Plan encompassing items 3-5 as a single PDF document. Figures and illustrations may be included but must fit within the specified page limit. Do not include links to Web sites for further information. Do not include animations. An application that does not comply with these page limitations is considered non-responsive and will not be reviewed.
Excluded from the 12-page Research Plan limitation are the following items:
Note the 12-page limit also excludes the Project Summary/Abstract; Bibliography and Literature Cited; and Biographical Sketches (separate PDFs).
All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Organize the Research Plan in the specified order using the instructions provided below. Start each section with the appropriate section heading (i.e. Background/Preliminary Studies, Opportunity and Potential Impact, The Approach, Timeline, Milestones and Expected Measurable Outcomes and Deliverables.)
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 6. Project Summary/Abstract: Follow instructions in the SF424 (R&R) Application Guide.
Item 8. Bibliography and Literature Cited: Limited to one page.
Continue with the instructions in the SF424 (R&R) Application Guide.
Special Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of SF424 (R&R) Application)
Biographical Sketches: Each biographical sketch is limited to two pages. The number of publications cited in each biosketch is limited to ten or fewer items. An application that does not comply with the required page limitations is considered non-responsive and will not be reviewed.
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 of the Research Plan component. An application that does not comply with the required page limitations is considered non-responsive and will not be reviewed.
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/.)
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review groups convened by CSR 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:
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, 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, Community Research Associates, 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?
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?
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.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
2.B. Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession, use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:
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:
Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under
consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
The terms of the NoA will reference the requirements of the Recovery Act.
In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
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.
This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application 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. 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:
1. Scientific/Research Contact(s):
For general inquiries about scientific/research issues please contact:
Dr. Suzanne Heurtin-Roberts
Office of the Director
The National Institutes of Health
1 Center Dr., Rm B3-11
Bethesda, MD 20892
For IC-specific inquiries, please contact the appropriate person below.
Financial/Grants Mgmt. Contact
National Institute on Aging http://www.nia.nih.gov
Chyren Hunter, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/
Shahnaz Khan, MPH
National Institute of Biomedical Imaging and Bioengineering http://www.nibib.nih.gov/
Shobha Srinivasan, Ph.D.
Ms. Crystal Wolfrey
National Institute of Child Health and Human
Tonse N. K. Raju, MD, DCH
Bryan Clark, M.B.A.
National Institute on Drug Abuse http://www.nida.nih.gov
National Institute of Dental and Craniofacial Research
Donald J. DeNucci, D.D.S., M.S.
Ms. Mary Greenwood
National Institute of Diabetes and Digestive and Kidney
Robert J. Kuczmarski, Dr.P.H.
National Institute of Environmental Health Sciences
Ms. Dorothy Duke
National Eye Institute http://www.nei.nih.gov
Tom Greenwell, PhD
For FedEx use: Rockville, MD 20852
For FedEx use: Rockville, MD 20852
National Heart, Lung, and Blood Institute
National Human Genome Research Institute
Jean E. McEwen, J.D., Ph.D.
National Institute of Mental Health http://www.nimh.nih.gov
Ms. Rebecca Claycamp
National Institute of Nursing Research
National Center for Research Resources
McCloskey, PHD, RN
National Center on Minority Health and Health Disparities
S. Sy, MD, DrPH
Grant, J.D., C.R.A.
National Library of Medicine
Office of Research on Women’s Health, National Institutes of Health,
Eleanor Z. Hanna, Ph.D.
Office of Behavioral and Social Sciences Research
Sampson, MS, MBA
Inquiries related to existing community infrastructures supported by other Department of Health and Human Services agencies may be directed to the following contacts as appropriate:
Deputy Assistant Secretary for Policy & Management
US Department of Health and Human Services
Phone: (202) 357-3460
Agency for Healthcare
Research and Quality
Gregg Taliaferro, PhD
Senior Service Fellow
Center for Primary Care Prevention and Clinical Partnerships
540 Gaither Road
Rockville, MD 20850
Phone: (301) 427-1668
for Disease Control & Prevention
Juliana Cyril, Ph.D., MPH
Office of Public Health Research
Office of the Chief Science Officer
Phone: (404) 639-4639
Fax: (404) 639-4903
Resources and Services Administration
Kaytura L. Felix, MD
Chief Medical Officer
Bureau of Primary Health Care
5600 Fishers Lane, 17-105
Rockville, MD 20857
Phone: (301) 594-4306
Fax: (301) 594-4072
Alan Trachtenberg, MD, MPH
Research Director (acting)
United States Public Health Service
801 Thompson Ave., TMP 450
Rockville, MD 20852
Phone: (301) 443-0578
Fax: (301) 443-0114
Abuse and Mental Health Services Administration
Christine Hager, Ph.D.
Social Science Analyst
Office of Applied Studies
1 Choke Cherry Road
Rockville, MD 20857
Phone: (240) 276-1287
2. Peer Review Contact(s):
Katherine N. Bent, RN, PhD, CNS
Chief, Healthcare Delivery and Methodologies Integrated Review Group
National Institutes of Health
6701 Rockledge Drive , Room 3160, MSC 7770
Bethesda , MD 20892 (20817 for overnight/courier delivery)
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
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.
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
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.
NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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/.
 Formal Application includes the preliminary application and letter of intent phases of the program.
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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