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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Eye Institute (NEI) (http://www.nei.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
Office of Behavioral and Social Sciences Research, Office of the Director (OBSSR/OD) (http://obssr.od.nih.gov)
Office of Dietary Supplements, Office of the Director (ODS/OD) (http://ods.od.nih.gov)
Office of Research on Women’s Health, Office of the Director (ORWH/OD) (http://orwh.od.nih.gov/)

Title: Global Research Initiative Program, Behavioral/Social Sciences (R01)

Announcement Type
This is a reissue of PAR-05-082, which was released on March 31, 2005.

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

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 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-328

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.867, 93.279, 93.113, 93.114, 93.115, 93.859

Key Dates
Release/Posted Date: February 8, 2007
Opening Date: July 21, 2007 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): August 21, 2007; August 21, 2008; August 21, 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 Receipt Date(s): September 21, 2007; September 22, 2008; September 21, 2009.
Peer Review Date(s): February/March 2008; February/March 2009; February/March 2010.
Council Review Date(s): May 2008; May 2009; May 2010.
Earliest Anticipated Start Date(s): July 2008; July 2009; July 2010.
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: September 22, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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

As part of its global health initiative under the Department of Health and Human Services (DHHS), the Fogarty International Center (FIC), in partnership with the National Eye Institute (NEI); the National Institute on Drug Abuse (NIDA); the National Institute of Environmental Health Sciences (NIEHS); the National Institute of General Medical Sciences (NIGMS); all of the National Institutes of Health (NIH), and the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Dietary Supplements (ODS), and the Office of Research on Women’s Health (ORWH), all of the Office of the Director (OD) of the NIH, invites applications from current and former NIH-supported foreign research trainees to compete for funds that will support their research efforts upon return to their home countries. In order to be eligible, foreign scientists must meet at least one of the following criteria:

  1. At least two years of research training experience under an FIC-supported training grant (classified by the D43 and U2R mechanisms).
  2. One year of such D43 or U2R training experience coupled with one year of significant, well-documented, mentored research experience (e.g., through an NIH research award such as the NIAID Small Research (R03) Grant (IRID-NIAID) program).
  3. One year of the NIDA INVEST or Humphrey Fellowship (http://www.drugabuse.gov/International/HHHRF.html) plus at least one additional year of significant, well-documented, mentored research.
  4. At least two years of research training experience through the NIH Intramural Visiting Fellows Program.
  5. One year of training through an F05 international fellowship program and one subsequent year of mentored research.
  6. Recipients of Long-Term Fellowship awards through the Human Frontier Science Program, who come from low- and middle-income countries, and who have spent at least two years in research training.
  7. At least one year of training in the U.S. and one additional year of significant, well-documented, mentored research, in the U.S. or abroad, leading to a completed master’s degree or doctoral degree, at least partially funded through a Fogarty International Center research training program, with pre-approval by the program director.
  8. Foreign trainee researchers from low- or middle-income countries trained under NIEHS R01, R37, and P01 programs, as described at http://www.niehs.nih.gov/dert/programs/capacity.htm.

All such training and research must either have been done in the U.S. or have been part of in-country research associated with a degree or mentored post-doctoral research under the D43 or U2R award mechanism and completed within four years of the receipt date of this announcement.

Candidates who are more than five years beyond their training, but who have interrupted their careers because of illness or family commitments, may also apply. They must clearly explain the interrupted hiatus and must clearly demonstrate the potential for productive independent research.

Current NIH Visiting Fellows are encouraged to apply in a timely fashion, i.e., as they begin their preparation to return home. They, as all applicants, may apply within four years of completing training.

Through various programs, the NIH has made a significant investment in training biomedical and behavioral researchers. For example, the NIH Visiting Fellows Program currently hosts more than 1,600 junior scientists from almost 100 countries for periods of one to five years. In addition, the NIH D43 research training and capacity building and the U2R cooperative agreement grant mechanisms allow hundreds of foreign researchers to receive training at prominent institutions in both the U.S. and their home countries in a range of biomedical and behavioral research areas critical to advancing global health. In summary, training supported by NIH is critical to these young investigators as they develop independent research careers.

As junior scientists complete training programs in the U.S. and in their home institutions under FIC D43 or U2R programs, many find it difficult to secure the support needed to continue their research projects and careers as independent researchers in their home countries. This Global Research Initiative Program (GRIP) provides the opportunity for junior foreign scientists to compete for such funds through a peer-reviewed process. This is a critical adjunct in the continuation of promising independent research careers that will be of benefit to the investigators home countries and the world at large. Women and underrepresented minority scientists in their countries are especially encouraged to apply for these re-entry grants. Project proposals should be geared toward the research interests of the applicant and the focus on high-priority health and health care problems in the investigator’s home country that also carry global importance, and are of interest to the collaborating NIH Institutes, Centers and Offices (ICs) listed on the first page of this announcement, as well.

It is expected that research topics will vary. Specific research interests of partnering ICs can be found on the ICs websites, as listed in the beginning of this announcement. Research related to women’s health, including studies of gender differences in disease onset and progression, identification of behavioral strategies that are effective in encouraging healthy lifestyles in young girls and women, as well as behavioral strategies to encourage prevention of diseases such as STDs and diseases with higher prevalence among women (including infectious diseases, lupus, multiple sclerosis and depression), are particularly encouraged. Research on healthy outcomes of pregnancy and child survival, and population research as associated with both behavioral and social, and economic research is encouraged. Research related to the health effects of human exposures to environmental agents is encouraged. Research focused on behavioral and social determinants and their effects on health is also encouraged. All research must be performed in accordance with NIH and U.S. Government regulations regarding the responsible conduct of research. This announcement precludes the support of research involving enrollment in pilot studies for clinical trials or the actual support of clinical trials since the resources and infrastructure to support and oversee such trials generally exceed the resources available under this award mechanism. Applicants are encouraged to visit the website of the Office of Human Research Protection (OHRP) http://www.hhs.gov/ohrp/ that outlines these regulations. For information on animal protection in research, see http://grants.nih.gov/grants/olaw/olaw.htm.

This announcement contributes to the FIC mission and to the broad NIH initiative to reduce the health disparities among nations by strengthening research infrastructure in developing countries, particularly those with the least economic resources. Additionally, it provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home.

Evaluation of the program will occur on an ongoing basis. Because this is a program to move research trainees to the status of independent investigator, there are several outcomes to be measured:

As part of its assessment of the impact and scientific productivity of this program, FIC plans to track researchers and their trainees for at least ten years after beginning their independent research. Evaluation may focus on the success of researchers (as measured by the number and quality of publications, presentations, courses, awards, subsequent employment, etc.), their sustained commitment to research careers, their ability to attract funding for their work, their contributions to future international collaborations, their influence on the development of scientific research in their countries, and their ability to act as consultants, teachers and role models to other local investigators and further disseminate the lessons learned. Applicants should describe potential metrics that would indicate the success of the individual researcher and the success in capacity building at the home institution, including the impact of the program on research at the institution in the home countries of researchers and their trainees.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.

The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

This award is non-renewable. An investigator cannot receive a second award in this program.

2. Funds Available

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

An applicant can request up to $50,000 per year in direct costs, plus facilities and administrative (F & A) costs to a maximum of eight percent for a foreign institution.

The participating organization(s), the Fogarty International Center (FIC), the National Eye Institute (NEI), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of General Medical Sciences (NIGMS), and the Office of Behavioral and Social Sciences Research (OBSSR), the Office of Dietary Supplements (ODS), and the Office of Research on Women’s Health (ORWH) of the Office of the Director (OD), intend to commit approximately $300,000 in fiscal years 2008, 2009 and 2010 to fund six applications.

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.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Only institutions in low- or middle-income ( developing ) countries are eligible to apply. Institutions in countries that have the least economic resources are particularly encouraged to apply. For the purposes of this announcement, a low- to middle-income country is defined as a country that has a Gross National Income (GNI) per capita below $10,000, according to the World Bank classification system (refer to the GNI per capita ranking in the left-hand column labeled Atlas Methodology at http://www.finfacts.com/biz10/globalworldincomepercapita.htm). (Do NOT refer to the right-hand column headed Purchasing Power Parity.) For the purposes of this announcement, institutions in the following countries or geographical regions are eligible: North Africa, West Africa, East Africa, Central Africa, Southern Africa, Russia, the Newly Independent States, Eastern Europe (except Slovenia), the Middle East (except Israel), India, Asia (except Japan, Singapore, South Korea and Taiwan), the Pacific Islands region (except Australia and New Zealand), Latin America and the Caribbean.

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 applicants from institutions in eligible countries may apply.

FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups.

In order to be eligible, applicants must meet at least one of the following criteria:

1. At least two years of research training experience under an FIC-supported training grant (classified by the D43 international training grant mechanism or the U2R cooperative agreement mechanism).

2. One year of such D43 or U2R training experience coupled with one year of significant, well-documented, mentored research experience (e.g., through an NIH research award such as the NIAID Small Research Grant (R03) (IRID-NIAID) program).

3. One year of the NIDA INVEST or Humphrey Fellowship plus at least one additional year significant, well-documented, mentored research (http://www.drugabuse.gov/International/HHHRF.html).

4. At least two years of research training experience through the NIH Intramural Visiting Fellows Program.

5. One year of training through an F05 international fellowship program and one subsequent year of significant, well-documented mentored research.

6. Recipients of Long-Term Fellowship awards through the Human Frontier Science Program, who come from low- and middle-income countries, and who have spent at least two years in research training.

7. At least one year of training in the U.S. and one additional year of significant, well-documented mentored research, in the U.S. or abroad, leading to a completed master’s degree or doctoral degree, at least partially funded through a Fogarty International Center research training program, with pre-approval by the program director.

8. Foreign trainee researchers from low- or middle-income countries trained under NIEHS R01, R37, and P01 programs, as described at http://www.niehs.nih.gov/dert/programs/capacity.htm.

All training and research, to meet eligibility requirements, must have either been done in the U.S. or have been part of in-country research associated with a degree or mentored post-doctoral research under the D43 or U2R award mechanism, and completed within four years of the receipt date of this announcement.

Applicants must return to a research position in their home country institution or in another low- to middle-income country in order to carry out research supported by this award. The award will be made to the home institution on the investigator’s behalf only after the investigator has arrived in that country. Therefore, the application must be submitted by the institution to which the applicant has returned or will be returning. It is expected that the PI will demonstrate that he/she has an appointment at an academic or other institution in his/her home country and will demonstrate or provide a letter of support indicating that the institution will have the capacity to support the research proposed. The GRIP award will support up to one-half the investigator’s salary, commensurate with the salary structure of the home institution. Funds from the institution, national government, local science research council or other public or private organization may be used to support this program. The remainder of the U.S. funds from this grant may pay for equipment, travel, supplies, or other research personnel’s salary working on the same project.

In order to build upon experience, partnership, mentorship and prior investments, applicants are encouraged to submit applications in collaboration with the NIH-supported institution or intramural laboratory from which they have received or are receiving research training, although such collaborations are not imperative. Through letters of support, U.S. collaborators should demonstrate how this program will support ongoing research collaborations. For those applicants who are eligible through both a year of training and a year of significant, well-documented, mentored research, letters of support should be received from both mentors.

While recognizing that this program is intended to foster the independence of the applicant, FIC recognizes the value of continued collaboration with NIH or other U.S. mentors. This relationship should be documented in the application.

Only one PD/PI may be designated on the application responding to this FOA. The PD/PI must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

Applicants may submit only one application to this program per cycle and may only receive one such award overall.

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, link to http://www.grants.gov/applicants/apply_for_grants.jsp 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 eRA Commons.

Several additional separate actions are required before an applicant institution/organization 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/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered 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.

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

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: 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. There are fields within the SF424 (R&R) application components that, 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
This application requires a detailed budget submission and not the PHS 398 Modular Budget or Research & Related Budget.

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

Foreign Organizations (Non-domestic (non-U.S.) Entity)

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 or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications Involving Multiple Institutions

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

3. Submission Dates and Times

See Section IV.3.A. for details.

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

Opening Date: July 21, 2007 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): August 21, 2007; August 21, 2008; August 21, 2009.
Application Receipt Date(s): September 21, 2007; September 22, 2008; September 21, 2009.
Peer Review Date(s): February/March 2008; February/March 2009; February/March 2010.
Council Review Date(s): May 2008; May 2009; May 2010.
Earliest Anticipated Start Date(s): July 2008; July 2009; July 2010.

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Aron Primack, MD, MA
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
Fax: (301) 402-0779
Email: primacka@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.

In order to expedite the review, applicants are requested to notify the Fogarty International Center (FIC) Referral Office by email (primacka@mail.nih.gov) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt 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, 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

Pre-award costs are not allowed.

6. Other Submission Requirements

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

The NIH requires the PD/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

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.

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:

Appendix Materials

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.

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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. 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.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Supplemental Instructions

Applicants may request up to $50,000 in direct costs per year. The PI is expected to devote at least 50 percent of his/her total effort to this project.

Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

Budget Instructions

Applicants may request direct costs of up to $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the instructions described below.

Other Requirements

Applications not conforming to these guidelines will be considered incomplete and will be not be reviewed review.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

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

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

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to FIC.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review groups convened by the Center for Scientific Review in accordance with the review criteria stated below.

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

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:

An award will not be made until the applicant has actually returned to his/her home country (or other developing country). A change of grantee institution that involves the transfer of a grant to or between foreign institutions or international organizations requires competitive re-review and approval of the IC Advisory Board/Council.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the health problem that is addressed specifically a priority health issue in the Principal Investigator’s home country? If the aims of this project are achieved, how will the Principal Investigator’s research career be enhanced?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts? Is the proposed research hypothesis-driven or hypothesis-generating?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? This FOA encourages, but does not require, collaborations among PDs/PIs in disciplines that contribute to social neuroscience. Are proposed collaborators sufficient for the project? Do they individually represent strengths in the subdisciplines essential to the project? Depending on the basic or translational nature of the project, these subdisciplines may include basic systems neuroscience (animal or human), social psychology or clinical science. How will this award enhance the Principal Investigator’s career development and help the Principal Investigator achieve a position of scientific leadership in his/her home country? Do the letters of support document a strong commitment to help the Principal Investigator develop his/her career?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Has the Principal Investigator’s home institution made a convincing commitment to the Principal Investigator (e.g., provided a research/academic appointment and partial salary support)? What is the continuing commitment of the U.S. collaborating institution (e.g., the institution associated with the NIH D43, U2R or other training program; the NIH intramural program laboratory; or the research program) to further develop the Principal Investigator’s career and research interest?

2.A. Additional Review Criteria

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

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)..

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan component of the SF424 (R&R).

2.B. Additional Review Considerations

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

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

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

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

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

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

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

FIC/NIH:
Aron Primack, M.D., M.A.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
Fax: (301) 402-0779
Email: primacka@mail.nih.gov

NEI/NIH:
Chyren Hunter, Ph.D.
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, MSC 9300
Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 402-0528
Email: clh@nei.nih.gov

NIDA/NIH:
Steven Gust, Ph.D.
Director, International Programs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5-274
Bethesda, MD 20892-9581
Telephone: (301) 443-6480
Fax: (301) 443-9127
Email: ipdirector@nida.nih.gov

NIEHS/NIH:
Kimberly Gray, Ph.D.
National Institute of Environmental Health Sciences
P.O. Box 12233 MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-0293
Fax: (919) 316-4606
Email: gray6@niehs.nih.gov

NIGMS/NIH:
Ann A. Hagan, Ph.D.
Associate Director for Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room2AN24H
Bethesda, MD 20892-6200
Telephone: (301) 594-4499
Fax: (301) 480-1852
Email: hagana@nigms.nih.gov

OBSSR/OD/NIH:
Virginia Cain, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
Building 1, Room 256
1 Center Drive
Bethesda, MD 20892
Telephone: (301) 402-1146
Fax: (301) 402-1150
Email: virginia_cain@nih.gov

ODS/OD/NIH:
Mary Frances Picciano, Ph.D.
Office of Dietary Supplements
Office of the Director
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
Fax: (301) 480-1845
Email: piccianm@od.nih.gov

ORWH/OD/NIH:
Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women’s Health
Office of the Director
National Institutes of Health
1 Center Drive, Room 201
Bethesda, MD 20892
Telephone: (301) 402-1770
Fax: (301) 402-1798
Email: beggl@mail.nih.gov

2. Peer Review Contact(s):

Dan Gerendasy, Ph.D.
Scientific Review Administrator
International Cooperative Programs
Center for Scientific Review
6701 Rockledge Drive, Room 5132
Bethesda, MD 20892-7843 (use ZIP 20817 for overnight mail)
Telephone: (301) 594-6830
Fax: (301) 480-1677
Email: gerendad@csr.nih.gov

3. Financial/Grants Management Contact(s):

Elizabeth Cleveland
Grants Management Specialistr
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 451-6830
Fax: (301) 594-1211
Email: clevelande@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 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.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. 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.

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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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