GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS  

RELEASE DATE:  May 16, 2003  

PA NUMBER:  PAR-03-118 (This PA has been modified, see PAR-06-394 and PAR-05-082)
                       (Change in receipt date, see NOT-TW-05-002) 
                       (See Addendum NOT-TW-04-003)

EXPIRATION DATE:  August 26, 2005, unless reissued.

Fogarty International Center (FIC)
 (http://www.fic.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Eye Institute (NEI) 
 (http://www.nei.nih.gov/)
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov) 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib1.nih.gov/)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.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/)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)  
 (http://www.ninds.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) 
 (http://obssr.od.nih.gov/)
Office of Dietary Supplements (ODS) 
 (http://ods.od.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.989, 93.279, 93.286, 
93.287, 93.853, 93.867

LETTER OF INTENT RECEIPT DATE:  July 25, 2003; July 25, 2004; July 25, 2005

APPLICATION RECEIPT DATE:  August 25, 2003; August 25, 2004; September 21, 2005

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement (PA) is intended to promote productive re-entry of 
NIH-trained foreign investigators from low-income countries into their home 
countries as part of a broader program to enhance the scientific research 
infrastructure in developing countries, to stimulate research on a wide variety 
of high priority health-related issues in these countries, and to advance NIH 
efforts to address health issues of global import.  The specific goal of this 
initiative is to provide funding opportunities for the increasing pool of 
foreign biomedical and behavioral scientists, clinical investigators, nurses, 
and other health professionals with state-of-the-art knowledge of research 
methods to advance critical issues in global health upon their return to their 
home countries.  After their term of research training, developing country 
participants supported by this PA are expected to continue independent and 
productive scientific careers, including expert training and consultation and/or 
research of biomedical issues within their home institutions. 

RESEARCH OBJECTIVES  

As a part of its global health initiative under the Department of Health and 
Human Services (DHHS), the Fogarty International Center (FIC) of the National 
Institutes of Health (NIH), in partnership with the following Institutes, 
Centers, and Offices on this PA:  National Cancer Institute (NCI), National Eye 
Institute (NEI), National Heart Lung and Blood Institute (NHLBI), National 
Institute on Aging (NIA), National Institute of Biomedical Imaging and 
Bioengineering (NIBIB), National Institute of Child Health and Human Development 
(NICHD), National Institute on Drug Abuse (NIDA), National Institute of 
Environmental Health Sciences (NIEHS), National Institute of General Medical 
Sciences (NIGMS), National Institute of Mental Health (NIMH), National Institute 
of Neurological Disorders and Stroke (NINDS), Office of Behavioral and Social 
Science Research (OBSSR), Office of Dietary Supplements (ODS), and Office of 
Research on Women's Health (ORWH), 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 a FIC-supported 
training grant (classified by the D43 "International Training Grant" mechanism).
2)  one year of such D43 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) (IRID-NIAID) program).
3)  one year of the NIDA INVEST Fellowship plus at least one additional year of 
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.

All 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 postdoctoral 
research under the D43 award mechanism and completed within three years of the 
receipt date of this PA.  

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 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 three years of completion of 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 grant mechanism allows hundreds of foreign 
researchers to receive training at prominent institutions in both the United 
States 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 foreign scientists complete training programs in the U.S., many find 
it difficult to secure the support needed to continue their research projects 
and careers in their home countries.  This Global Health 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 towards the research interests of the applicant and focus on high-
priority health and healthcare problems in the investigator's home country that 
also carry global importance and also are of interest to the collaborating NIH 
Institutes, Centers, and Offices listed on the first page of this PA.  

It is expected that research topics will be diverse.  Specific research 
interests of partnering ICs can be found on the ICs' websites as listed at the 
beginning of this PA.  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 PA 
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 for 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 PA contributes to the FIC mission and to the broad NIH initiative to reduce 
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:

o  development of the laboratory capabilities or research projects
o  training of other potential researchers
o  publications in local journals as well as international peer-reviewed 
journals
o  participation in workshops, seminars, and international conferences
o  collaborations with past mentors as well as others
o  attraction of funding from other sources

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 five 
years after beginning their independent research.  Evaluation may focus on the 
success of the 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.  Metrics should 
be stated both for 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.

MECHANISM OF SUPPORT

This PA will use the NIH Research Project Grant (R01) award mechanism using the 
modular grant format.  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.

Applications submitted in response to this PA may have a project period of no 
less than three years and no more than five years. 

An applicant can request up to two modules of $25,000 each, or total direct 
costs of $50,000 per year, plus facilities and administrative (F&A) costs to a 
maximum of eight percent for a foreign institution.  The Principal Investigator 
(PI) is expected to devote at least 50 percent of his/her total effort to this 
project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting format 
(see http://grants.nih.gov/grants/funding/modular/modular.htm.  This program 
does not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  
Animal facility information must be provided in the application.  See 
http://www.iacuc.org/ and http://grants.nih.gov/grants/olaw/olaw.htm for 
International Animal Care and Use Committee (IACUC) guidelines.

Because an investigator can receive a maximum of five years of support under the 
GRIP program and this specific GRIP award is not renewable, any future 
application will be considered to be an unsolicited competing application based 
on this project and will compete with all investigator-initiated applications 
submitted to NIH through the Center for Scientific Review (CSR). 

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your foreign institution is from a 
developing country and has any of the following characteristics:

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of State and local governments of developing countries
o  Faith-based or community-based organizations

Only institutions in developing countries are eligible to apply.  Institutions 
in countries which have the least economic resources are particularly encouraged 
to apply.  For the purpose of this PA, 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, 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.

INDIVIDUALS ELIGIBILE TO BECOME PRINCIPAL INVESTIGATORS

Any individual from an eligible institution who meets the eligibility criteria 
below is invited to develop an application in conjunction with their home 
institution.  Women and individuals from underrepresented racial and ethnic 
groups in their countries, as well as individuals with disabilities, are always 
encouraged to apply for NIH programs.  Only applicants from institutions in 
eligible developing countries may apply.  

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 a FIC-supported 
training grant (classified by the D43 "International Training Grant" mechanism).
2)  one year of such D43 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) (IRID-NIAID) program).
3)  one year of the NIDA INVEST Fellowship plus at least one additional year of 
mentored research.
4)  at least two years of research training experience through the NIH 
intramural Visiting Fellows Program.

(See Addendum NOT-TW-04-003 for additional criteria.)

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 postdoctoral research under the D43 award mechanism, and 
completed within three years of the receipt date of this PA.

Applicants must return to a research position in their home country institution 
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 funds from this grant may pay for 
equipment, travel, supplies, or other research personnel's salary working on the 
same research 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.  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 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 
U.S. mentors.  This relationship should be documented in the application.  
Because of the desired ongoing relationship between the new investigator and the 
IC where training occurred, the NIH intramural researcher must have pre-approval 
of the Scientific Director from his or her NIH Institute through a letter to be 
submitted with the application. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity to answer 
questions from potential applicants.  Inquiries may fall into four areas:  
scientific/research, eligibility, peer review, and financial or grants 
management issues.  Refer to the Fogarty International Center website 
(http://www.fic.nih.gov) for Frequently Asked Questions.

Direct your further questions about scientific/research and eligibility issues 
to:  

Aron Primack, MD, MA
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220
Tel:  (301) 496-4596
Fax:  (301) 402-0779
Email:  [email protected]

Dr. Chyren Hunter
National Eye Institute
6120 Executive Boulevard, Room 350
Bethesda, MD  20892
Tel:  (301) 451-2020
Fax:  (301) 402-0528
Email:  [email protected]

Dr. Ruth Johnsson Hegyeli
Associate Director for International Programs
Office of the Director
National Heart, Lung and Blood Institute
National Institutes of Health
31 Center Drive, Room 4A07
Bethesda, MD  20892-2490
Tel:  (301) 496-5375
Fax:  (301) 496-2734
Email:  [email protected]

Marta L. Campbell, MPP
Chief, Office of International Activities
National Institute on Aging
National Institutes of Health
Building 31, Room 5C05
9000 Rockville Pike
Bethesda, MD  20892
Email:  [email protected]

Meredith D. Temple-O'Connor, PhD
Division of Extramural Activities
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5477
Tel:  (301) 451-4792
Fax:  (301) 480-4973
Email:  [email protected]

Danuta Krotoski, Ph.D.
Acting Associate Director
Office of Prevention Research and International Programs
National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Boulevard, Room 2A-01
Bethesda, MD 20892-7510
Tel:  (301) 435-7566
Fax:  (301) 435-0009
Email:  [email protected]

Laurence Stanford, PhD
Division of Treatment, Research and Development
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Room 4234
Bethesda, MD  20892-9559
Tel:  (301) 443-4877
Fax:  (301) 443-9649
Email:  [email protected]

Christopher Schonwalder, PhD
Director
Office of International Programs
National Institute of Environmental Health Sciences
111 Alexander Drive
Research Triangle Park, NC  27709
Tel:  (919) 541-4794
Fax:  (919) 541-2583
Email:  [email protected]

Ann A. Hagan, PhD
Deputy Associate Director for Extramural Activities
National Institute of General Medical Sciences
National Institutes of Health
45 Center Drive, Room 2AN24G
Bethesda, MD  20892-6200
Tel:  (301) 594-3910
Fax:  (301) 480-1852
Email:  [email protected]

Mark Chavez, PhD
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6207
Bethesda, MD  20892-9623
Tel:  (301) 443-3563
Fax:  (301) 443-6000
Email:  [email protected]

Dr. Yuan Liu
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2110
Rockville, MD  20852
Tel:  (301) 496-1917
Fax:  (301) 480-2424
Email:  [email protected]

Lawrence J. Fine, MD, DrPH
Medical Advisor
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
Room 256, Building One
One Center Drive
Bethesda, MD  20892-0183
Tel:  (301) 435-6780
Fax:  (301) 402-1150
Email:  [email protected]

Mary Francis Picciano, PhD
Senior Nutrition Research Scientist
Office of Dietary Supplements
Office of the Director
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD  20892-7517
(For courier service use Rockville, MD  20852)
Tel:  (301) 435-3608
Fax:  (301) 480-1845
Email:  [email protected]

Lisa Begg, DrPH, RN
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
Tel:  (301) 496-7853
Fax:  (301) 402-1798
Email:  [email protected]

Direct your questions about peer review issues to:  

Don Schneider, Ph.D.
Director
Division of Molecular & Cellular Mechanisms
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Rockville, MD  20892-7842
Tel:  (301) 435-1727
Email:  [email protected] 

Direct your questions about financial or grants management matters to: 

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
31 Center Drive
Bethesda, Maryland  20892-2220
Tel:  (301) 496-1670
Fax:  (301) 594-1211
Email:  [email protected]

LETTER OF INTENT 

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

o Descriptive title of the proposed research
o Name, address, and telephone and fax numbers of the Principal Investigator
o Names of other key personnel 
o Name and address of participating institutions
o Number and title of this PA 

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 CSR staff to estimate the potential review workload and plan 
the review.  Further information about this PA, including the answers to 
frequently asked questions, can be found at http://www.fic.nih.gov.  The letter 
of intent should be sent to:

Aron Primack, MD, MA
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220
Tel:  (301) 496-4596
Fax:  (301) 402-0779
Email:  [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact NIH GrantsInfo, Telephone (301) 710-0267, Email:  [email protected].

APPLICATION RECEIPT DATE:  Applications submitted in response to this program 
announcement will be accepted on the date listed on the first page of this 
announcement. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications must be 
submitted in a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  Section 
C of the research grant application instructions for the PHS 398 (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants 
is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 

SUPPLEMENTAL INSTRUCTIONS:  Applicants may request up to two modules, or 
$50,000, of direct costs per year and the application must be in modular format.  
The PI is expected to devote at least 50 percent of his/her total effort to this 
project.  The modular grant concept establishes specific modules in which direct 
costs may be requested, as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach. 

It is understood that writing an application for such an R01 grant may be 
difficult and time-consuming.  Therefore, it is encouraged that potential 
applicants seek assistance in such grant writing.  Those being trained via the 
D43 grant mechanism should seek such assistance at or from their training 
institutions.  Those within the NIH intramural program should seek such guidance 
within the NIH framework.  Although there is a limit of 25 pages for these R01 
applications, it is possible that applicants may only need 15 or fewer pages.  
The application should be complete and follow the format of the PHS 398.  Help 
for completing these applications can be found on the NIH website.  Examples of 
helpful information include:
o  http://www.niaid.nih.gov/ncn/grants/default.htm
o  http://www.nigms.nih.gov/funding/tips.html
o  http://www.niddk.nih.gov/fund/grants_process/grantwriting.htm
o  http://deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.htm
o  http://www.drugabuse.gov/Funding/Grantapps.html

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES with any questions regarding adherence to the guidelines of their 
proposed project to the goals of this PA.

Budget Instructions

Applicants will request direct costs in $25,000 modules, up to a total direct 
cost request of $50,000 per year.  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:
o  Under Personnel:  List all project personnel, including their names, percent 
of effort, and roles on the project.  The PI is expected to devote at least 50 
percent of his/her total effort to this project.  The PI may only request 
support of up to 50 percent of his/her effort on this project.  The PI's salary 
and any other salaries should be commensurate with the salary structure at the 
applicant institution.
o  Under Facilities and Administrative (F&A) Costs:  F&A costs of up to eight 
percent should be shown under the calculation section on the Checklist page of 
the PHS 398 application.  The F&A cost calculation may not exceed eight percent 
of total direct costs less equipment.  Applicants do not need to complete the 
section regarding agreements above the calculation section.  Applicants should 
mark the modified total direct costs base box below the calculation section.

Other Requirements

o  The applicant should list the date that he/she returned or expects to return 
to their home country.

o  The applicant must have a letter from the home institution describing its 
involvement in the ongoing research plan and the support of it including any 
financial and/or in-kind anticipated support.

o  For investigators associated with the D43 grants program:  include a letter 
from the U.S. mentor, outlining the nature of the future collaborative 
relationship, and how the NIH-supported laboratory or other program supported, 
and/or will support, a continued collaboration with the investigator, using all 
appropriate resources.  The letter should also indicate the dates of research 
training and a summary of the program.  

o  For applicants eligible through one year of research training and one year of 
significant mentored research:  letters outlining the nature of the future 
collaborative relationship from both mentors are required.  These letters should 
indicate the dates of such training and research.

o  In the application, either in the biosketch or as part of the background 
information, include the dates of the training program and, when applicable, the 
research effort, a description of the training and research programs including 
the courses taken, and a summary of the program and of the research.  Include 
evidence of at least two years of training or one year of training and one year 
of significant, well-documented research (e.g., the specific grant number).  

o  For NIH Visiting Fellows:  include the dates of the training as well as a 
letter from the NIH laboratory chief and Institute Scientific Director.  This 
letter should also outline the nature of the future collaborative relationships 
with the NIH mentors.

o  The investigator must describe current or previous training under the D43 or 
the NIH intramural program.  The applicant must provide a brief paragraph 
providing the grant number, the name and address of the NIH mentor or Principal 
Investigator of the D43 or other eligible grant, and a description of the 
training received.  The trainee must have at least two years of such training or 
one year of such training and one year of significant well-documented research 
experience.  If the latter, please include the grant number and a summary 
description of the research experience.

o  Include two further letters of reference relating to the abilities of the 
applicant investigator, specifically indicating the ability to become a leader 
in scientific pursuits.  These can be attached at the end of the grant but 
before any appendices.

o  Checklist:  This page should be completed and submitted with the application.  
Applications submitted by foreign or international institutions can request F&A 
costs up to a maximum of eight percent.  Please see the web site 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more 
information on the allowability of F&A costs for foreign and international 
organizations.  

Applications not conforming to these guidelines will be considered unresponsive 
to this PA and will be returned without further review.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the Checklist, and five signed photocopies, in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  208892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this PA.  If an application is received 
after that date, it will be returned to the applicant without review.  The 
Center for Scientific Review (CSR) will not accept any application in response 
to this PA that is essentially the same as one currently pending initial review, 
unless the applicant withdraws the pending application.  The CSR will not accept 
any application that is essentially the same as one already reviewed.  This does 
not preclude the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing the 
previous critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 
eight weeks.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the FIC.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration.  Applications that 
are complete and responsive to the PA will be evaluated for scientific and 
technical merit by an appropriate peer review group convened by the CSR in 
accordance with the review criteria stated below.  As part of the initial merit 
review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will 
be discussed and assigned a priority score
o  Receive a second level review by the FIC Advisory Board and possibly the 
Advisory Boards or Councils of co-sponsors.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written comments, reviewers will be asked to discuss the following aspects of 
the application in order to judge the likelihood that the proposed research will 
have a substantial impact on the pursuit of these goals including the career 
development of the Principal Investigator:  

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria in 
assigning the application's overall score, weighting them as appropriate for 
each application.  Your application does not need to be strong in all categories 
to be judged likely to have major scientific impact and thus deserve a 
meritorious priority score.  For example, you 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 health problem and is it 
specifically a priority health issue in your home country?  If the aims of the 
application are achieved, how will scientific knowledge be advanced and your 
research career be enhanced?  What will be the effect of these studies on the 
concepts or methods that drive this field?  

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?  Is your research hypothesis-driven or hypothesis-generating?  The 
NIBIB is also interested in technology driven research that may not specifically 
be hypothesis driven.

INNOVATION:  Does your project employ novel concepts, approaches or methods?  
Are the aims original and innovative?  Does your project challenge existing 
paradigms or develop new methodologies or technologies?  

INVESTIGATOR:  Are you appropriately trained and well-suited to carry out this 
work?  Is the work proposed appropriate to your experience level as the 
Principal Investigator and other researchers (if any)?  How will this award 
enhance your career development and help you achieve a position of scientific 
leadership in your home country?  Do the letters of support document a strong 
commitment to help you develop your career? 

ENVIRONMENT:  Does the scientific environment in which your work will be done 
contribute to the probability of success?  Has your home institution made a 
convincing commitment to you (e.g., to provide a research/academic appointment 
and partial salary support)?  Do the proposed experiments or studies take 
advantage of unique features of the scientific environment in your home country 
or employ useful collaborative arrangements?  Is there evidence of institutional 
support in the developing country?  What is the continuing commitment of the 
U.S. collaborating institution (e.g., the institution associated with the NIH 
D43, the NIH intramural program laboratory, or the research program) to further 
develop your career and research interests?

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

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 criteria included in the section 
on Federal Citations, below.)

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 Inclusion Criteria in the sections on Federal Citations, 
below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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.  Plans for the recruitment and retention of 
subjects will also be evaluated.  (See Inclusion Criteria included in the 
section on Federal Citations, below.)

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  July 25
Application Receipt Date:  September 21
Peer Review Date:  November
Council Review:  February
Earliest Anticipated Start Date:  March 15

AWARD CRITERIA

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

o  Quality of the proposed project, as determined by peer review
o  Availability of funds
o  Geographic balance
o  Programmatic priority, including funding interests of collaborating NIH, or 
other cosponsors
o  Level of need as measured by economic resources in the applicant developing 
country

Awards will not be made until applicants have actually returned to their home 
countries (or other developing countries).  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 Council/Board.

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against these 
risks, the potential benefits of the research to the subjects and others, and 
the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

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   
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on 
October 9, 2001 (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 a NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that:  a) all 
applications or proposals and/or protocols must provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable; and b) investigators 
must report annual accrual and progress in conducting analyses, as appropriate, 
by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  The 
NIH maintains a policy that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  This 
policy applies to all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.  

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 that is available at:  
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects.  
You will find this policy in the NIH Guide for Grants and Contracts, June 5, 
2000 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://grants.nih.gov/grants/stem_cells.htm 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 (see http://escr.nih.gov/).  
It is the responsibility of the applicant to provide 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.

PUBLIC 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 
public 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 date collected under this PA 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
"Standards for Privacy of Individually Identifiable Health Information," the 
"Privacy Rule," on August 14, 2002.  The Privacy Rule is a Federal regulation 
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 
that governs the protection of individually identifiable health information, and 
is administered and enforced by the DHHS Office for Civil Rights (OCR).  Those 
who must comply with the Privacy Rule (classified under the Rule as "covered 
entities") must do so by April 14, 2003 (with the exception of small health 
plans which have an extra year to comply).

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in a NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving 
the health promotion and disease prevention objectives of "Healthy People 2010," 
a PHS-led national activity for setting priority areas.  Because the 
applications are expected to cover many and varied areas, this PA will probably 
be related to many priority areas of this activity including general public 
health, cardiovascular disease, diabetes, and infectious diseases.  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 the 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 287b) and 
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards are 
subject to the terms and conditions, cost principles, and other considerations 
described in the NIH Grants Policy Statement.  The NIH Grants Policy Statement 
can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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