INTERNATIONAL TRAINING AND RESEARCH IN ENVIRONMENTAL AND OCCUPATIONAL HEALTH

Release Date:  December 8, 2000

RFA:  TW-01-002 (This RFA has been reissued, see RFA-TW-06-004)

Fogarty International Center
 (http://www.nih.gov/fic/)
National Institute of Environmental Health Sciences
 (http://www.niehs.nih.gov)
National Institute for Occupational Safety and Health of the Centers for Disease 
Control and Prevention
 (http://www.cdc.gov/niosh)

Letter of Intent Receipt Date: January 16, 2001
Application Receipt Date:      March 16, 2001

PURPOSE

The Fogarty International Center (FIC), in collaboration with the National 
Institute of Environmental Health Sciences (NIEHS) of the National Institutes 
of Health (NIH), and the National Institute for Occupational Safety and 
Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), 
invites applications from non-profit public or private institutions in the 
U.S. to continue or initiate international training and research support in 
environmental and occupational health-related sciences.  The program vision 
is to build global capacity and collaboration to better understand, 
investigate, control and prevent environmental and occupational health 
problems in developing countries and the United States.  During the first 
five years, the major emphasis of the program was on epidemiology, risk 
assessment and surveillance.  During the next five years the major emphasis 
will be on prevention and intervention research to reduce risks in 
participating collaborating countries.  Knowledge and experience from the 
first five years of training in the environmental and occupational health 
problems will be utilized.  The broad objectives are to:

1.  Train scientists from developing countries in a variety of disciplines 
necessary to identify and prevent environmental and occupational risks 
including but not limited to:
o  laboratory and toxicology research 
o  epidemiologic research and surveillance
o  environmental monitoring
o  workplace risk assessment
o  engineering control
o  hazardous waste assessment
o  disease prevention and control
2.  Develop and strengthen centers of research excellence in environmental 
and occupational health-related sciences in developing countries through 
long-term partnerships with U.S. institutions, with particular emphasis on 
research activities that will have the potential to benefit a whole region.
3.  Complement and reinforce environmental and occupational health research 
and training activities of the NIH and partner agencies.
4.  Facilitate the transition of trainees to positions of responsibility, 
authority, and influence in their home countries, regionally, and 
internationally
5.  Translate the results of research into public health practice.

This Request for Applications (RFA) was developed considering the 
recommendations of a program review committee chaired by Dr. John F. Finklea 
of the Centers of Disease Control and Prevention (CDC), and former Director 
of the National Institute for Occupational Safety and Health (NIOSH).  This 
committee report is available on the FIC webpage (http://www.nih.gov/fic/).

The program honors the memory of the late Dr. Irving Selikoff of the Mount 
Sinai School of Medicine, and Dr. Norton Nelson of New York University, in 
recognition of their lifelong commitment to the training of health 
professionals in the occupational and environmental health sciences.

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 RFA, “International 
Training and Research in Environmental and Occupational Health (ITREOH),” 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.

ELIGIBILITY REQUIREMENTS

The grantee institution must be a U.S. non-profit private or public 
institution capable of meeting the objectives in this RFA.  An increasing 
proportion of resources under this award (at least 25% by the end of the 
funding cycle) must be spent in-country, specifically to build research and 
public health capacity within the collaborating country(ies):  e.g. by 
strengthening medical informatics, Institutional Review Boards (IRBs) 
formation and ethical review, grants management, supporting advanced in-
country research, facilitating preparation of research grants or research 
coupled to intervention projects.  

Only one application from any U.S. institution will be allowed under 
this program.

Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigator (PI).  Participation in the 
program by investigators at minority institutions is strongly encouraged.

MECHANISM OF SUPPORT

This RFA will use the NIH international training grant (D43) mechanism, which 
limits facilities and administrative (F & A) costs to eight percent of 
allowable direct costs.  Applicants may request a project period of up to 
five years and a budget for total costs up to $300,000 per year for the first 
year for recompeting programs, and $200,000 for new starts.  Responsibility 
for planning, direction and execution of the proposed activities will be 
solely that of the applicant in collaboration with their foreign partners.  
The application should describe research and research training objectives to 
be pursued both in the U.S. and at collaborating institutions in the 
cooperating country or region.  Applications may incorporate cooperative 
activities with scientists from one or several developing countries or 
regions, based on the research and training objectives of the program.  
However, applicants are encouraged to focus their efforts on activities which 
provide maximum national and regional impact.

The applicant organization’s administration must provide the necessary 
management for the transfer of funds and material to the off-site component.  
Facilities and administrative (F & A) costs will not be paid on any expense 
incurred by the foreign institution(s), although expenses required to support 
in-country training and training-related research (such as access to 
facilities), establishing ethical review committees, supporting grant writing 
seminars, strengthening grants management, library services and the Internet, 
can be charged as direct expenses if well-justified and approved by the FIC 
program officer.  Travel, salaries, and fringe benefits will be subject to 
the applicant institution’s rules and regulations.

Continued support during this period depends on satisfactory performance as 
judged by:  annual progress reports, site visits, participation in annual 
meetings of program directors, career progress of trainees (e.g., positions 
occupied in home country), research undertaken and research awards received, 
first author publications and presentations by current and former trainees, 
and, development of institutional, national or regional capacity for 
environmental and occupational research and public health actions including 
the establishment or strengthening of model environmental and occupational 
health research centers of excellence in the home countries of trainees and 
in influencing policies that reduce environmental and occupational health 
risks.  Assessment of performance will be made jointly by FIC, NIEHS, and 
NIOSH.  Special program reviews may be conducted periodically by the FIC, 
NIEHS, and NIOSH.

FUNDS AVAILABLE

It is anticipated that about $3,000,000 (total costs) will be available for 
the first year of the recompeted program.  An estimated 12 awards will be 
made, with no single award exceeding $300,000 (in total costs).  Awards will 
be contingent upon availability of funds and receipt of a sufficient number 
of meritorious applications.  Requests for an administrative supplemental 
budget may be invited periodically by Program Staff and will be considered 
for increases of up to 20 percent of funded levels in a given budget year.  
These funds may be requested to meet special local or regional research or 
training needs and take advantage of unusual opportunities such as geographic 
expansion, field research, or emergency situations.  Such requests, which 
should be discussed with FIC program staff prior to submission, will be 
reviewed by FIC in consultation with NIEHS and NIOSH, and support will depend 
upon need, merit and availability of funds.

The grantee institution may request an F & A cost allowance based on eight 
percent of the total allowable direct costs, exclusive of tuition, insurance, 
related fees and expenditures for equipment.  Applicants should assume a 
budget increase of three percent per year for each succeeding year, 
contingent upon availability of funds.

The anticipated date of award is on or before September 30, 2001.

TYPES OF TRAINING

The FIC ITREOH program provides resources for U.S. institutions and 
collaborating foreign institutions to train scientists from developing 
countries, including those in Africa, Asia, Latin America, the Middle East, 
emerging democracies in Eastern Europe and Russia’s newly independent states.  
Research-related training programs in environmental and occupational health 
sciences for foreign scientists and health professionals may include the 
following types of training:

o  Long-term (more than nine months) training in pre- or post-doctoral 
programs.
o  Short-term (less than three months) training, to include focused workshops 
and technology transfer.
o  Intermediate-term training, including specialized activities in support of 
population-based studies, pilot trials or interventions.

While a range of short and long-term training is allowable, emphasis will be 
on intermediate to longer-term training, including mid-career training.  This 
approach will accelerate building an enduring research and public health 
capability at collaborating institutions in participating countries.  

Long-term training would generally take place in the U.S.  Short-term 
training could take place in the U.S. or in-country.  Training-related 
research and advanced in-country research would generally take place in the 
trainee’s home country.  The research activities are performed preferentially 
and predominantly in the trainees’ home country or region.

As part of the application, the applicant institution must describe in detail 
the recruitment and selection procedures for the foreign pre- and post-
doctoral scientists and other beneficiaries of the training program (short 
and intermediate term trainees, workshop participants, etc).  To a limited 
extent, U.S. trainees will be eligible for foreign research experiences under 
this program, with prior FIC approval, particularly if they are involved in 
training or research collaboration with developing country scientists.  

The ITREOH encourages directors to include foreign women as trainees and, if 
U.S. trainees are involved, to include women and minorities.

RESEARCH OBJECTIVES

Air, water, and soil pollution and hazardous wastes have been accelerating 
globally during the twentieth century.  This is due to expanding 
industrialization, use of newer technologies, including pesticides, and the 
resulting increased consumption of combustible fossil fuels, forests, and 
other natural resources.  Industrialization has also exposed workers to 
dangerous machinery, chemicals, and other conditions that are hazardous to 
health, livelihood, and life.  With the sequencing of the human genome new 
opportunities are presented to study gene-environment and occupational 
exposure interactions relevant to the expression or modification of genes 
that determine health and disease susceptibility.  Such studies are 
especially timely.  Scientific advances and economic progress have brought 
great benefits, but with these have come more complex environmental and 
occupational hazards, particularly in developing countries.  At the same 
time, there is growing recognition of the true global nature of the 
environment and the need for a global response to protect the world’s 
environment and people.

Through international research and training efforts, NIH, CDC, and other U.S. 
government and non-governmental agencies and organizations can play an 
important role in improving global response and increasing national capacity 
to identify and address health risks related to environmental change and 
degradation.  To this end, the ITREOH program supports capacity development, 
including training and research in laboratory research, epidemiologic 
methodologies, environmental and occupational hazard assessment, engineering 
control, intervention and control research and related policy development 
designed to facilitate and support prevention of environmental and 
occupational health risks.  Collaborations established through this program 
will help to facilitate standardized assessment and monitoring of 
environmental and occupational health hazards and prepare for the coordinated 
conduct of scientifically valid and ethically sound studies and interventions 
worldwide.  Most importantly, a new and larger cadre of scientists and public 
health specialists will understand, evaluate, and help control and prevent 
the many environmental and occupational dangers that we face globally in the 
twenty-first century.

Emphasis will be placed on collaborative activities in countries and regions 
where environmental and occupational health conditions adversely impact 
public health and economic progress. 

Examples of research and training priorities include, but are not limited to, 
the following:

o  Reduction in childhood environmental and adult occupational lead 
poisoning,
o  Reduction in traffic-related injury and deaths,
o  Hazardous waste management,
o  Safe drinking water programs,
o  Food sanitation and safety,
o  Environmental and occupational exposure surveillance,
o  Ambient air and drinking water monitoring,
o  Industrial hygiene, including measurement and engineering control,
o  Environmental hazard exposure and infectious disease interactions 
including vector-borne diseases,
o  Environmental hazard exposure and nutrition interactions.
o  Environmental hazard exposure and neurologic, pulmonary, and allergic 
(including asthma) interactions.
o  Reduction of personal environmental risk factors, including smoking and 
diet.  
o  Environmental and occupational health implications of climate change, 
deforestation, soil salinization, and/or reduction in arable land, and 
drinking and irrigation water resources.
o  Understanding gene-environmental interactions, including identification of 
biomarkers.

While applicants may choose from a wide range of activities, they are 
encouraged to focus on a limited number of scientific and geographic areas so 
as to make a real impact at collaborating institutions and in collaborating 
countries.  This pertains, in particular, to new starts.

SPECIAL REQUIREMENTS

o  Commitments:  Each awardee will have a U.S. PI and a Major Foreign 
Collaborator (MFC), if collaboration occurs in two or more countries, there 
will be a MFC in each country.  The PI and MFC will be responsible for the 
overall conduct of the ITREOH.  The institution of the PI and MFC must have 
entered into a long-term commitment in writing to build the capacity of the 
foreign institution through governmental-supported or other resources.

o  Recruitment and Selection Plan:  The applicant must include a detailed 
plan describing the recruitment and selection procedures for trainees and a 
detailed description of peer review for training-related and advanced in-
country research.  Degree candidates must meet all entrance requirements of 
the U.S. degree-granting institution or of the foreign degree-granting 
institution, if applicable.  The application should clarify and completely 
specify:  (a) criteria and procedures for the selection of trainees as, for 
example, by a committee composed of U.S. and foreign investigators at 
participating institution(s) and (b) a mechanism for internal peer review of 
applications to support U.S. and in-country research projects.

o  Establishing research priorities:  Applicants should assure that research 
priorities reflect those of the participating countries and should describe 
the procedures to assure this takes place.

o  Strategy for regional impact:  The application should emphasize capacity 
building at, and in collaboration with, institutions(s) in participating 
country(ies).  The application should also describe strategies to achieve a 
wider regional impact by strengthening of other institutions with the goal to 
become a national and regional center of excellence.

o  National support for the program:  Evidence should be provided in writing 
for national support of the program through cost-sharing by the host country 
and willingness of the host country to utilize trainees’ experience and 
knowledge gained from the program to reduce environmental and occupational 
risks.

o  Plans for continued collaboration with former trainees once they return 
home must be presented.  For PIs applying for a continuation of their ITREOH 
grant, detailed evidence of such continuing collaboration must be provided.

o  Tracking system for long-term impact.  As part of their obligations under 
this program, awardees are required to design initially as part of their 
application, implement and maintain, a system to track fully and document the 
long-term impact of this training program on:  (1) the career choices and 
progress of current and former trainees, if this is a reapplication, a table 
should be included with this information, (2) building research and public 
health capacity in the home institution and country of trainees, (3) types of 
positions the proposed trainees may assume upon completion of training and 
documentation of career progress, (4) the possible contributions to future 
NIH- and CDC- and other U.S. and non-U.S. government agency supported 
international environmental and occupational health research and public 
health efforts, (5) the establishment or strengthening of environmental and 
occupational research “centers of excellence” for training and referral in 
the home countries of trainees, and (6) the contributions of the program 
toward interventions or policies that reduce environmental and occupational 
health risks in the home country(ies) of trainees.

Impact will be an important criterion for assessing success in the 
recompetition of this program.  Detailed examples of past (or expected) 
impact should be included and address how training received under the program 
has allowed participants to assume more responsible positions upon returning 
home, how continuing collaborations with former trainees resulted in 
obtaining grants or other support by environmental and occupational health 
science investigators or co-investigators, publications in which trainees 
were first authors and which were based upon support under this program, and 
development and implementation of health policies that were based on work by 
returning trainees in their home countries.  

After awards have been made, but before tracking of impact is implemented, 
FIC will work with awardees to design a standardized web-based tracking 
system for individual trainees and reporting program impact and 
accomplishments.  This system will build upon an FIC experience in other 
research training programs and be compatible with them.  Once this 
standardized tracking system has been finalized, it will be implemented 
across all programs.  

o  Before any funds may be expended on in-country research, the grantee 
institution must show written evidence of formal approval from responsible 
authorities at the U.S.-based and foreign collaborating institutions, 
including an institutional (or ethical) review board or committee and the 
relevant government authority.  These approvals should be included in the 
application and must be available for review before any award can be made.

o  There will be annual program network meetings in Bethesda or other sites 
to exchange research and training experience and coordinate program 
activities.  PIs, MFCs, and selected trainees are expected to attend.  Funds 
for this activity (travel and per diem) should be included in the budgetary 
requests.

o  As part of  the proposed training program, the applicant must describe in 
detail how they propose to train students and investigators in the 
responsible conduct of research, consistent with NIH policies, updated July 
2000 and listed on the Office of Research Integrity, NIH website 
http://ori.dhhs.gov.  NIH requires that all staff at 
extramural institutions engaged in research or research training with NIH 
funds, or who work on NIH-supported research projects shall successfully 
complete a program of instruction in the responsible conduct of research.  An 
award will not be made unless such a plan is included.

ALLOWABLE COSTS

All budget items related to trainee participation in the program should be 
itemized on the PHS Form 398 (4/98), NRSA substitute budget pages OO and PP 
in the categories indicated in parentheses.  All budget items related to 
faculty participation in the program should be itemized on the PHS Form 398, 
budget pages DD and EE in the categories indicated in parentheses.

(Stipend/Salary/Honoraria)
o  Trainees (foreign graduate students and advanced degree participants) may 
be paid a stipend comparable to their professional experience, not exceeding 
$45,000 per year, in accordance with the U.S. institutional policies while 
involved in long-term training in the U.S.  Applicants should refer to the 
NRSA stipend levels described on the web site 
http://www.nih.gov/fic/opportunities/index.html  (NRSA substitute pages, pre- 
or postdoctoral stipends). 
o  Foreign trainees may be paid a stipend while conducting long-term 
training-related research in their home countries at levels comparable with 
the salary scales for similar professionals in that country, in accordance 
with the collaborating foreign institution’s policies, but not exceeding 
$45,000 per year  (NRSA substitute pages, pre- or postdoctoral stipends).
o  U.S. faculty, including the program director, who provide major program 
administration or who provide extended training and mentoring of students at 
the foreign site may receive salary and fringe benefits.  The total amount of 
salary and fringe benefits requested for all U.S. faculty cannot exceed 10% 
of direct costs.  The administrative, training, teaching and mentoring and 
collaborative research responsibilities and time commitment for personnel 
receiving salary must be completely described and justified for each faculty 
member  (Form 398, budget pages, personnel)
o  The applicant may request up to 10% of direct costs to provide salary and 
fringe benefits for clerical and administrative support staff for the 
program.  The responsibilities and time commitment for personnel receiving 
salary support must be completely described and justified (Form 398 pages, 
personnel).

o  Foreign institution faculty who provide major program administration at 
the foreign site or participate in training and mentoring and research, and 
U.S. faculty or foreign faculty who teach short courses, may receive an 
honorarium, not to exceed $2,000 per year, in accordance with their 
institution’s policies.  No more than 5% of direct costs may be used for 
honoraria.  The administrative, training or teaching responsibilities for 
each foreign faculty member must be completely described and justified  (NRSA 
substitute pages-training related expenses).

o  Tuition, Fees and Insurance:  Funds for tuition and academic fees at the 
U.S. institution can be requested.  In addition, family health insurance will 
be an allowable cost for trainees and fellows who have families and are 
eligible for family health insurance coverage at the sponsoring institution.  
Tuition, fees and insurance cannot exceed 20% of direct costs.  Programs are 
strongly encouraged to seek cost-sharing arrangements with the U.S. 
institutions (and foreign institutions where possible) to provide reduced 
tuition for long-term trainees and tuition-free short courses and indicate 
institutional commitment to the ITREOH program (NRSA substitute pages, 
tuition, fees, insurance).

o  Trainee Travel:  Funds may be requested for round-trip economy class 
airfares and/or ground transport on U.S. carriers, to the maximum extent 
possible, for long- or short-term trainees in the U.S., and, for foreign 
trainees to participate in short courses or attend scientific conferences to 
present their results.  One round-trip ticket to the host country per year 
for research purposes is allowed (NRSA substitute pages, trainee travel).

o  Funds may be requested for per diem and lodging for foreign trainees to 
participate in short courses or attend scientific conferences yearly to 
present their results (NRSA substitute pages, trainee travel).

o  Faculty Travel:  Funds may be requested for a round-trip economy airfare 
on U.S. carriers, to the maximum extent possible, for U.S. faculty providing 
extended training to go to the foreign site or teach short courses at the 
foreign site: (PHS 398 pages, travel).
o  Funds may be requested for per diem and lodging for U.S. faculty to teach 
short courses at the foreign site: (PHS 398 pages, travel).
o  Funds should be requested for airfare, per diem and lodging comparable to 
U.S. government rates 
(http://policyworks.gov/org/main/mt/homepage/mtt/perdiem/perd04d.html) for 
the program director to attend an annual network meeting in the Washington, 
DC area (PHS 398 pages, travel).

o  Training-related expenses:  Funds to support trainee research-related 
costs (such as reagents, lab supplies, computer access, small equipment, 
etc.) up to $600 per month per trainee may be requested (NRSA substitute 
pages, training- related expenses).
o  Funds (up to $10,000 per year) to support research at the foreign site 
associated with fulfilling requirements for an advanced degree may be 
requested (NRSA substitute pages, training-related expenses).
o  Research support up to $15,000 per trainee per year to facilitate 
conducting advanced research training (one time re-entry grants) in the home 
country by former long-term trainees usually at the post-doctoral level.  The 
applicant should describe in detail how proposals for re-entry projects will 
be selected by a competitive peer review process examining scientific merit 
and ethical concerns involving faculty from the U.S. and foreign institutions 
coordinated by the program director (NRSA substitute pages, training-related 
expenses).
o  Special research capacity building support at institutions in the 
participating country(ies):  Details can be submitted on medical informatics, 
operation of ethical review committees, grants writing seminars, etc., in 
support of the ITREOH and the center of excellence.  This includes 
appointment of trainees to receive long-term training in their home country 
with mentors who were former trainees in the program.
o  Equipment: list separately each item of equipment, including computers for 
trainees to take back to the host country, and justify each item (NRSA 
substitute page, training related expenses). 

PROTECTION OF HUMAN SUBJECTS AND LABORATORY ANIMALS

The new Office for Human Research Protections (OHRP) was created in on June 
6, 2000 at the Department of Health and Human Services to lead efforts for 
protecting human subjects in biomedical and behavior research.  In accordance 
with OHRP guidelines (ohrp@od.nih.gov) all investigators submitting NIH 
applications for grants, or receiving new or non-competing awards for 
research involving human subjects, will require education on the protection 
of human research participants.  Applicants should refer to NIH Guide Notice 
OD-00-039, dated June 5, 2000 and revised August 25, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  The new 
Office of Laboratory Animal Welfare will oversee the responsible treatment 
for animal subjects (olaw@od.nih.gov).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research 
involving human subjects should read the UPDATED " Guidelines for Inclusion 
of Women and Minorities as Subjects in Clinical Research," published in the 
NIH Guide for Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a 
complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, 
and is available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.  
Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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 an 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. Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by January 16, 2001, a letter of 
intent that includes a brief descriptive title, the name, address, and 
telephone number of the PI, the identities of other key personnel and 
participating institutions and foreign collaborators, and the number and 
title of the RFA in response to which the application may be submitted.  
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 staff to estimate the potential review workload and to plan 
the review.

The letter of intent is to be sent to:

Joel G. Breman, M.D., D.T.P.H.
Deputy Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Email:  joel_breman@nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and from the Center for Scientific Research, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 
20892-7910, telephone 301/435-0714, e-mail:  grants@nih.gov.  Application 
forms are also available on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Failure to use 
this label could result in delayed processing of the application such that it 
may not reach the review committee in time for review.  In addition, the RFA 
title and number must be typed on line two of the face page of the 
application form and the YES box must be marked.  The RFA number must be 
typed on the label as well.

A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf and has been 
modified to allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application and 
appendices must be sent to:
DR. LINDA BASS
NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
79 T. W. ALEXANDER DRIVE
BUILDING 4401, ROOM 118
RESEARCH TRIANGLE PARK, NC  27709

It is important to send these copies at the same time as the original and 
three copies are sent to the Center for Scientific Review.  These copies are 
used to identify conflicts of interest and to help ensure the appropriate and 
timely review of the application.

Applications must be received by March 16, 2001.  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 RFA 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.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by CSR.  Incomplete and/or 
non-responsive applications will be returned to the applicant without further 
consideration.  Applications that are complete will be evaluated for 
scientific and technical merit by an appropriate peer review group convened 
by the NIEHS in consultation with FIC and NIOSH in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, 
all applications will receive a written critique.  Applications may undergo a 
streamlined review process.  In this process, only those applications deemed 
to have the highest scientific merit, generally the top half of applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the FIC Advisory Board and other appropriate Advisory 
Councils.

REVIEW CRITERIA

Review criteria include those generally applicable to research training 
programs and research.  The scientific evaluation of each application will 
include assessment of the linkage between proposed training and environmental 
and occupational science-related research supported by FIC, NIEHS, NIOSH.  
Evidence of support for this program by collaborating institutions and 
foreign governments must be submitted in writing with the application.

1.  Significance:  
o  Does this training program address an important problem and do the program 
priorities reflect those of the collaborating country(ies)?  If the aims of 
the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of the training and studies on the concepts or 
methods that drive this field?
o  The expected public health and scientific contributions of the proposed 
activity at a country and regional level, and
o  The demonstrated capacity and/or potential to achieve sustained 
environmental and occupational health-related research and training efforts, 
and to build associated clinical and operational research and public health 
capacity within a country.

2.  Approach:  
o  Are the conceptual framework, design, methods, and analyses adequately 
developed, well-integrated, and appropriate to the aims of the research 
training?  Details of the training plan should be included.  Does the 
applicant recognize potential problem areas and consider alternative tactics?
o  Is there a balance in the proposed training program, to provide breadth of 
training opportunities in academic- and public health-based environmental and 
occupational research in biomedical and behavioral sciences?
o  Does the mix of long- and short-term training achieve the goals of this 
RFA, including focused efforts to build long-term biomedical, behavioral, 
clinical and operations research, and public health capacity at a model 
center of research excellence within a collaborating country?
o  Are the proposed procedures and criteria adequate for 1) recruitment, 
review and selection of trainees, and 2) peer review of research? 
o  Is there evidence of a long-term commitment by the U.S. institution to 
collaborate with its foreign partner(s) and a cost sharing by the U.S. and 
foreign institutions involved in the program?
o  Have the foreign institute(s) and government(s) expressed a willingness to 
take advantage of returning former trainees and information gained from the 
program to improve environmental and occupational health?
3.  Innovation:  
o  Does the research training program employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the program challenge 
existing paradigms or develop new methodologies or technologies?
o  Does the proposal include concrete plans for trainees to become involved 
in environmental and occupational health sciences, biomedical and behavioral 
research, and prevention projects conducted in their home countries?
o  Is there adequate and creative planning for the use of modern information 
technology to facilitate access to scientific information, distance learning, 
coordination and research collaboration?
o  Are there creative strategies to achieve a regional impact?
4.  Investigator:  
o  Are the Principal Investigator, co-Principal Investigators, and mentors in 
the U.S. and abroad, appropriately trained and well-suited to carry out this 
work?  Is the work proposed appropriate to the experience level of the PI and 
other researchers, if any?
o  Are the qualifications of the PI, MFC, and the named faculty adequate to 
lead and to productively participate in the proposed training and research 
program?
o  Do the PI, MFC, and participating faculty provide active and adequate 
research support?

5.  Environment:  
o  Does the scientific environment in which the training and research work 
will be done in the U.S. and abroad contribute to the probability of success?  
Do the proposed activities take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements?  Is there 
firm evidence of institutional support by the U.S. and foreign institutions?
o  Are there adequate mentoring and strength of resources and training 
environment in-country as evidenced by 1) the quality of teaching and the in-
country research facilities and other resources, 2) the availability and 
history of high-quality candidates chosen on merit, and 3) past history of 
success of former trainees returning to their home countries and their 
continued involvement in the program, for example, the participation of past 
trainees in advanced in-country research and as faculty and mentors for new 
trainees?
o  The initial review group will also examine the adequacy of the process for 
providing for the protection of human and animal subjects, the safety of the 
research environment, and, plans to include training in responsible conduct 
of research and training in the operation of Institutional Review Boards 
(IRBs), data and safety monitoring boards and community advisory boards as a 
part of the program.  IRBs in the home countries of trainees will be 
responsible for determining the adequacy of inclusion of women, minorities 
and children in research involving human subjects in their countries.

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

1.  Past research training record for both the PI and MFCs in the U.S. and 
abroad, and designated preceptors, in terms of tracking careers of their past 
U.S. and foreign trainees and the rate at which former trainees establish 
independent and productive research and public health careers, and, for 
foreign trainees, percent who return to their home country, please include 
tables with this information, including current status of foreign and other 
selected trainees for at least the past five years.

2.  Past research training record in terms of the success of former trainees 
in obtaining individual awards such as fellowships, career awards, and 
research grants for further development, major scientific breakthroughs by 
trainees should be highlighted.

3.  Recruitment and selection plans in detail for appointees and the 
availability of high quality candidates.

4.  The record of the research training program in retaining health 
professional postdoctoral trainees for at least two years in research 
training or other research activities.

5.  When appropriate, the concomitant training of health professional post-
doctorates (e.g., individuals with the M.D., D.O., D.D.S.) with basic science 
post-doctorates (e.g., individuals with a Ph.D., Sc.D.).

6.  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

7.  The reasonableness of the proposed budget and duration in relation to the 
proposed research and training.

8.  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.

Where specific research protocols are proposed, additional review criteria, 
applicable to research grants, will be as follows:

1.  Scientific, technical, medical and public health significance, and 
originality of proposed research.

2.  Appropriateness and adequacy of the experimental approach and methodology 
proposed to carry out the research.

3.  Qualifications and research experience of the Principal U.S. and Foreign
Investigator(s) and staff, particularly, but not exclusively, in the area 
of the proposed research.

4.  Availability of the resources necessary to perform the research.

5.  Appropriateness of the proposed budget and duration in relation to 
the proposed research.

SCHEDULE

Letter of Intent Receipt Date:  January 16, 2001
Application Receipt Date:       March 16, 2001
Date of Initial Review:         June/July, 2001
Review by Advisory Council:     September, 2001
Anticipated Award Date:         on or before September 30, 2001

AWARD CRITERIA

The most important factor to be considered in making funding decisions will 
be the quality of the proposed project as determined by initial scientific 
peer review.  The proposed instruction in the responsible conduct of research 
must be rated adequate for an award to be made.  Geographic and programmatic 
balance (e.g. the opportunities to have meritorious programs in Africa, Asia, 
Latin America, the Middle East and Russia/Eastern Europe) as well as input 
from the collaborating partners and the FIC Advisory Board will also be 
considered in making funding decisions.

Before any funds can be expended for in-country research, the grantee 
institution must show evidence of approval for collaborative research and 
training between the U.S. and foreign countries and institutions included in 
the program through written endorsements from the appropriate government 
official(s) as well as from the collaborating institutions.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome and prospective 
applicants are strongly encouraged to discuss their proposals with program 
staff prior to submission.

Direct inquiries regarding programmatic issues to:

Joel G. Breman, M.D., D.T.P.H.
Deputy Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email:  joel_breman@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Nancy Coulter
Program Specialist
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39 
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email: ncoulter@mail.nih.gov 

AUTHORITY AND REGULATIONS

Awards are made under authorization of the Public Health Service Act, Title 
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 
and 285) and administered under NIH grants policies and Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or to Health 
Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant recipients to 
provide a smoke-free workplace and promote the non-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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