Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)

Title:  International Extramural Associates Research Development Awards (IEARDA) [G11]

Announcement Type
This is a reissue of PAR-07-431.

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

Program Announcement (PA) Number: PAR-10-172

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)
93.865, 93.989, 93.856

Key Dates - New Dates (See Notice NOT-HD-10-023)
Letters of Intent Receipt Date(s): January 28, 2011
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 Submission/Receipt Date(s):  February 28, 2011, August 3, 2011, August 3, 2012
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): March/April 2011, October/November 2011, October/November 2012
Council Review Date(s): May 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): July 2011, April 2012, April 2013
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: (New Date July 22, 2011 per issuance of PAR-11-270), Original Date: August 4, 2012

Key Dates - Old Dates
Release/Posted Date: April 23, 2010
Opening Date:  July 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):
July 3, 2010, July 3, 2011, July 3, 2012
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): August 3, 2010, August 3, 2011, August 3, 2012
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): October/November 2010, October/November 2011, October/November 2012
Council Review Date(s): January 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): April 2011, April 2012, April 2013
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date:
August 4, 2012

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary  

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives  

Purpose

This Funding Opportunity Announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Fogarty International Center (FIC) and the National Institute of Allergy and Infectious Diseases (NIAID), encourages grant (G11) applications from institutions that wish to strengthen an existing research administrative infrastructure for the purpose of enhancing and supporting biomedical and behavioral research capacity and activities. The International Extramural Associates Research Development Award (IEARDA) program goal is to produce a cadre of trained academic research administrators in countries with limited resources to facilitate and/or develop the appropriate administrative infrastructure in their home institutions to conduct and support research on all stages of human development, from preconception to adulthood, to better understand the health of children, adults, families and communities.  This program will provide training in NIH policies and procedures through a distance learning and NIH residency program, as well as funding to augment or expand upon existing research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) at the home institution. The expanded administrative capacity will enable thorough oversight and management of extramural awards, serve as the main organizational unit for the technical development of grant proposals submissions and oversight, and foster and facilitate ongoing research activities at the institution.

The International Extramural Associates Research Development Award (IEARDA) program goal is to produce a cadre of trained academic research administrators in countries with limited resources to facilitate and/or develop the appropriate administrative infrastructure in their home institutions for the implementation of a more rigorous research program.

Background

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), established the International Extramural Associates Research Development Award (IEARDA) program to help promote biomedical and behavioral research capacity and activity at public and private institutions in developing countries through the strengthening of their key research administrative staff and infrastructures.  The IEARDA is modeled after the successful NIH Extramural Associates Research Development Award (EARDA) program, which for over 25 years has

promoted the entry and participation of women and underrepresented minority institutions in the United States in biomedical and behavioral research.

Since 1997, the NIH has dramatically increased its funding of research and training in developing countries.  However, many faculty, students, and research administrators in these regions have limited knowledge of and/or experience with funding opportunities, grant applications, research program and project oversight, data management, fiscal accountability, and scientific reporting requirements of the NIH and other international research funding agencies.  The IEARDA’s goal is to address such needs by producing a cadre of trained academic research administrators in countries with limited resources to facilitate and/or develop the appropriate administrative infrastructure in their home institution to effectively manage the grant process and strengthen the institutions ability to conduct and support research.

The award supports:

Program Objectives and Components

The overall aim of the IEARDA program is to enhance or expand upon current research administrative infrastructure, thereby enhancing research capabilities of NIH-supported institutions in developing countries. This program will provide training and funding to augment the research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) at the grantee institution, for the purpose of strengthening biomedical and behavioral research activities. This expanded research administrative infrastructure will provide careful oversight and administrative management of extramural awards, serve as the main organizational unit for the technical development of grant proposal submissions and oversight, and foster and facilitate ongoing research activities at the institution.

The institution should already be undertaking significant research in the local area on any stage of human development, from preconception to adulthood, to better understand the health of children, adults, families and communities or global health disparities in the biomedical or behavioral sciences.

Program Director/International Extramural Associate

The individual from the awardee institution who participates in the residency is designated as the International Extramural Associate (PD/PI) and must be a full-time academic research administrator at the applicant institution. The PD/PI will serve as key research administrator and oversee the institution’s research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects).

Distance Learning and Residency Training

The PD/PIs will complete the Distance Learning component of their training at their home institutions prior to their on-site residency training at the NIH.  Distance Learning modules will include such topics as introduction to the NIH, NIH terminology and funding mechanisms, role of NIH officials, receipt and referral of grant applications, peer review process, program funding cycle, grants management basics, use of animals in research, and use of human subjects in research. 

PD/PIs are required to spend a two-week residency at the NIH, part of which will involve participation in the core domestic EARDA program.  Information on the domestic EARDA program curriculum can be found at http://www.nichd.nih.gov/about/org/dsp/ea/how_eap_works.cfm#curriculum.   The NICHD, the Fogarty International Center, other NIH Institutes and Centers, other components of the U.S. Public Health Service, and other public and private sector organizations may be involved in the residency training.

Upon entering the program, PD/PIs are assigned a preceptor or mentor from the NIH to oversee their residency. The PD/PI's preceptor, a senior NIH or Public Health Service (PHS) official, provides guidance with respect to working assignments and related activities to assure consistency with the grantee’s proposed infrastructure development plan.  The preceptor also advises the PD/PI on any refinements to the Plan that will need to be made and approved by the end of the residency.

During the residency, PD/PIs attend a series of in-depth orientation seminars that will prepare them to use their time effectively at the NIH.  Subsequent working assignments at NIH are intended to provide exposure to the administration of Federal extramural research programs.  PD/PIs have the opportunity to visit other Federal agencies and a nearby university's Office of Research or Office of Sponsored Projects to learn different administrative structures and procedures related to biomedical and behavioral research.  PD/PIs are expected to collaborate with, and learn from, the other PD/PIs and their domestic EA counterparts while in residence at the NIH.

The residency curriculum, in which all PD/PIs participate along with the domestic EAs, focuses on core areas related to enhancing institutional research infrastructure:

Pre Award Services:

Post Award Services:

Ethical Compliance:

Upon completion of the residency, the PD/PIs will have acquired:

Site Visit

The NICHD will conduct an on-site visit to the awardee institution and assist with the rectification of any identifiable infrastructure and research capacity issues.  The recommendations generated by the assessment will help guide the institution and PD/PI in establishing a research infrastructure that has the capacity to implement a more rigorous research program.

Post-Residency Award

Upon return to his or her home institution, the PD/PI will be responsible for implementing the Infrastructure Development Plan, ensuring adherence to the agreed-upon goals, objectives, and timelines.  The institution will be equally responsible for approving and carrying out the plan and providing sustainable support for it as an ongoing institutional component.   The PD/PI will use the funds during the period of the grant to improve and reinforce the institution’s research capacity and research administration infrastructure (through the Office of Research or Office of Sponsored Projects) as outlined in the final, approved version of the Infrastructure Development Plan. 

The NICHD will also provide information regarding relevant workshops, meetings and training opportunities to assist PD/PIs in leveraging newly gained knowledge, insights, and networks to help their research program and/or home institution.  

Institutional Commitment

The applicant organization must document in the application an institutional commitment to the IERDA program by providing

The awardee institution and PD/PI must submit progress reports (as mandated by federal funding requirements) that document activities during the report period and track efforts to meet the targeted outcomes as detailed in the infrastructure development plan.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the Extramural Associates Research Development Award (G11) 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). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

The total project period for an application submitted in response to this funding opportunity may not exceed five years.  Applicants may request up to $35,000 (plus 8 percent administrative costs) annually to support the proposed activities of the International Extramural Associate (PD/PI) and the research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) at the home institution. Applicants may request up to an additional $10,000 (plus 8 percent administrative costs, excluding equipment) in year one of the grant to support travel and living allowance during the NIH residency training period.

Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions  

The following organizations/institutions are eligible to apply:

The foreign institution must be the recipient of at least three NIH awards (e.g., D43, R01, R03, R21, U01, etc.), either through a direct grant or as a subcontract to a U.S. domestic award. Each of these awards should be currently active and/or reflect collaboration on an NIH-funded project within the past three years. The institution must have an existing research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) in place.  The institution must have the electronic connectivity and Internet access necessary for NIH electronic grants application and post-award administration.

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.

Only one PD/PI may be designated on the application.

The PD/PI –designated as the International Extramural Associate (PD/PI) -- is the individual from the awardee institution who participates in the NIH residency program.  The PD/PI must be a full-time academic research administrator at the applicant institution. The PD/PI will serve as key research administrator and oversee the institution’s research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects).

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. An applicant institution may submit only one application, per funding cycle, in response to this FOA.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

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

Section IV. Application and Submission Information


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

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral 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:

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

Both the PD(s)/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 301-435-0714, 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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm)..

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 required by NIH (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. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6. regarding appropriate required budget component.)  

Optional Components:

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

Foreign Organizations (Non-domestic [non-U.S.] Entities)

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

Applications from Foreign organizations must:

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates - New Dates (See Notice NOT-HD-10-023)
Opening Date: July 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 28, 2011
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 Submission/Receipt Date(s):  February 28, 2011, August 3, 2011, August 3, 2012
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): March/April 2011, October/November 2011, October/November 2012
Council Review Date(s): May 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): July 2011, April 2012, April 2013
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: August 4, 2012

3.A. Submission, Review and Anticipated Start Dates - Old Dates
Opening Date:  July 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July
3, 2010, July 3, 2011, July 3, 2012
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): August 3, 2010, August 3, 2011, August 3, 2012
AIDS Application Due Date(s): Not applicable
Peer Review Date(s): October/November 2010, October/November 2011, October/November 2012
Council Review Date(s): January 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): April 2011, April 2012, April 2013

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Regina Smith James, M.D.
Acting Director, Division of Special Populations
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD 20892-
7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: (301)
435-2692
Fax:
(301) 480-0393
Email:
rjames@mail.nih.gov

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(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. All applications must meet the following criteria to be considered “on-time”:

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:

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.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete 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 their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Allowable Costs

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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Applicants may request up to $35,000 (plus eight percent indirect costs) to support the activities of the PI and the Office of Research upon returning to the home institution.  Activities and other purposes for which funds may be used include, but are not limited to, the following:

Funds may not be used for the following:

6. Other Submission Requirements

Special Application Instructions for International Extramural Associates Research Development Award

The following seven application components are required, and it is imperative that applicants fully address each point described in the outline below because they are reflected in the review criteria. 

1. The Nominee (PD/PI:  International Extramural Associate)

SF424 R&R: Section 4.5 Senior/key Person Profile(s) Component(s)

Profile Program Director/Principal Investigator (PD/PI)

Biographical Sketch, Section A, Personal Statement (Biographical Sketch may not exceed four pages):

2. Infrastructure Development Plan

SF424 R&R: Section 5 Completing PHS 398 Components

Section 5.5.3 Research Strategy Component (note: the PHS398 Research Strategy Component cannot exceed 12 pages):  

Applicants must submit a plan that describes the proposed activities for enhancement and strengthening of the institution's existing research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects). The Infrastructure Development Plan should describe the key goals, specific objectives, activities, outputs (e.g., support staff hired, computers purchased, training curriculum completed), resources, short- and long-term outcomes, and key personnel involved in the enhancement and strengthening of the research office during the project period of the IEARDA. It should be clear and coherent and provide evidence of adequate coordination among key faculty and administrators in its development.

The Infrastructure Development Plan should specifically address the following key areas:  Outreach, sustainability and integration within the overall plan of the institution:

Outreach:  The plan should briefly describe any proposed outreach to other regional academic/scientific institutions to help strengthen their research capacity and research administration capabilities, and other plans to initiate or expand local or regional cooperation/collaboration in research activities, including partnering with organizations such as foundations, businesses, and industry.

Sustainability:  The Infrastructure Development Plan should describe briefly how the institution intends to sustain and continue the programs and activities of the research office once NIH support through the IEARDA expires.  The plan for sustainability should include long-range goals and objectives for the research office and indicate commitment of funding from the institution or availability of other sources of support to ensure continuation of research office activities at the enhanced level.

Integration:  The Infrastructure Development Plan should also indicate how this plan relates to and is integrated within any overall strategic plan of the institution.

The PD/PI should form a realistic and sufficiently detailed work plan that can be achieved within a specified timeframe.  Objectives should be clear, measurable and achievable.  Strategies and activities to help achieve each objective should also be stated (e.g., increased administrative staffing, establishment of database or tracking systems, enhancement of Internal Review Boards [IRB] for both human and animal subjects, training seminars to address grant preparation or grants management). Each applicant should consider carefully what it wants to accomplish within each year and over the course of the project period. For each institution, the goals, objectives, activities, timelines, and intended outcomes will differ, but there may be basic categories of activity that each applicant may want or need to undertake. 

A timeline for achieving each objective should be indicated.   It may be helpful to summarize this information for each year of the project period using a chart or table format. Examples of such activities can include but are not limited to the following:

Year 1:  Adequately staff and equip the research office; strengthen research office communication and computing capabilities; establish and activate advisory committee; assess faculty and student training needs and resources; establish baselines for evaluation plan.

Year 2:  Assess and strengthen accounting and monitoring practices; facilitate direct proposal submissions; develop core training capabilities and materials; conduct workshops; monitor performance of workshops.

Year 3:  Review and refine sustainability plan for research office; continue training workshops and seminars; continue monitoring quality of training; conduct mid-course review and refine work plan as needed.

Year 4:  Continue to develop and implement strategies to develop research capacity through improved grantsmanship; assess regional needs and plan regional activities; establish partnerships and other linkages in support of goals.

Year 5:  Implement and assess regional activities; continue training activities; finalize plan for sustainability of research office; implement (process and outcome) evaluation of program.   

Adherence to the timeline should be reported within the annual progress reports mandated by the NIH.  Please note: The goals and/or outcomes developed for the IEARDA application can be modified based on recommendations provided in consultation with the IEARDA preceptors and administrators at the NIH during the NIH residency.

The Infrastructure Development Plan proposed as part of the IEARDA application can be modified and finalized by the PD/PI during the residency to reflect the knowledge and skills gained from the distance learning and residency experiences.

3.  Establishment of Advisory Board

SF424 R&R: Section 5 Completing PHS 398 Components

Section 5.5 Research Strategy Component

The Infrastructure Development Plan should include a proposal for establishment of an Advisory Committee to review and monitor ongoing infrastructure development activities.  The purpose, function, and expectation, as well as prospective members of the committee should be described in the application, but specific members should not be appointed until after an award is made.  This committee is intended to be advisory to the IEA in the enhancement and maintenance of ongoing research development activities. All other planned committees should be included in this section with a justification for the particular committee structure and function proposed and a description of the proposed membership.

4. Evaluation Plan       

SF424 R&R: Section 5 Completing PHS 398 Components

Section 5.5 Research Strategy Component

The evaluation strategy should be linked to the statement of goals and objectives and should include benchmarks and a timeline for measuring progress or outcomes.  This information can be presented in a chart or table.  The Plan should also address how the results from the evaluation will be used to improve the research infrastructure and capabilities of the institution. Implementation of any evaluation or assessment activities should include input from the proposed advisory committee.  

5. Description of Current Research Infrastructure

SF424 R&R: Section 5 Completing PHS 398 Components

Section 5.5 Research Strategy Component

Active and previous funding should be highlighted or presented in a separate chart or list.  The FOA requires that the institution must be the recipient of at least three NIH awards, either through a direct grant or as a subcontract to a U.S. domestic award.  Each of these awards should be currently active and/or reflect collaboration on an NIH-funded project within the past three years. For each project, the chart should include the NIH grant number, PD/PI name, grantee institution name, title of project, total amount of grant award, amount of subcontract or subproject award, project period (start and completion dates), and role of the applicant institution’s research staff in the project (e.g., PI, project director, subproject director, investigator, etc.)

6.  Institutional Commitment

SF424 R&R: Section 5 Completing PHS 398 Components

Section 5.5 Research Strategy Component

The application should document support for the PD/PI and implementation of the Infrastructure Development Plan by including the following:

7.  Letters of Support

SF424 R&R: Section 5 Completing PHS 398 Components

Section 5.5.14 Research Plan Component, Letters of Support

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.”

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Budget Component

U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

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).

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.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Foreign Applications (Non-domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States 

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by NICHD 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:

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. 

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

The Nominee.  Does the application document the strengths of the nominee’s personal qualifications as indicated by training, work experience, knowledge and skills?  Does the applicant provide evidence of commitment to and experience in research administration?  Is there evidence that the applicant has rapport with faculty and students that would enable him or her to successfully engage these individuals in biomedical and behavioral research activities?  Does the application demonstrate the nominee’s ability to commit himself or herself to function as the IEA, for the duration of the grant?

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

Infrastructure Development Plan.  Is there evidence of strong institutional commitment to implementing the plan? Is there evidence that the nominee will have sufficient authority to carry out the plan? Is the Infrastructure Development Plan coherent and does it provide adequate coordination among key faculty and administrators in its development? Does the plan address outreach to other regional academic/scientific institutions? Does the plan include long range goals and objectives for sustainability? Does the application provide an adequate plan for the proposed Advisory Committee to review and monitor research development activities?  Is there evidence of a strong, viable valuation plan?

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.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. Renewal applications are not allowed for this FOA.

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.

Applications from Foreign Organizations.  As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources. 

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).

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 funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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

When multiple years are involved, 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.

A final progress report, invention statement and certification, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


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

1. Scientific/Research Contact(s):

Regina Smith James, M.D.
Acting Director, Division of Special Populations

Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD 20892-7510

Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-2692
Fax: (301) 480-0393
Email:
rjames@mail.nih.gov

Jeanne McDermott
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
Bethesda, MD  20892-2022
Telephone:  301-496-1492
Fax:  301-402-0779
Email:  mcdermoj@mail.nih.gov  

Karl A. Western, MD, DTPH
Senior International Scientific Advisor
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive (Room 4120)
Bethesda, Maryland 20892-6613 Deliveries Only ZIP Code: 20817
Phone: (301) 496-6721
Fax: (301) 402-3255 or (301) 480-1483
E-mail: kw18Q@nih.gov

2. Peer Review Contact(s):

Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD   20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1485
Fax: (301) 402-4104

3. Financial/Grants Management Contact(s):

Bryan S. Clark, M. B. A.
Chief Grants Management Officer 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 
S6100 Executive Boulevard, Room 8A07, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-UPS service)
Telephone: (301) 435-6975
Fax: (301) 480-4783
Email: clarkb1@mail.nih.gov

Bruce Butrum
Grants Management Officer
Grants Management Office
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD  20892-2022
Telephone:  301-496-1670
Fax:  301-594-1211
Email:  butrumb@mail.nih.gov    

Section VIII. Other Information


Required Federal Citations

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

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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