RELEASE DATE:  October 18, 2002
PA NUMBER:  PA-03-012

Letter of Intent:  December 20, 2002; December 20, 2003; December 20, 2004

Application Deadline:  January 24, 2003; January 23, 2004; January 24, 2005 

EXPIRATION DATE:  June 23, 2005 (This PA has been reissued, see PAR-05-128) 

Fogarty International Center (FIC) 
National Institute of Allergy and Infectious Diseases (NIAID) 
National Institute of Dental and Craniofacial Research (NIDCR) 
Centers for Disease Control and Prevention (CDC) 


o Purpose of the PA
o Program Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


The purpose of this announcement is to invite applications from eligible 
institutions to train or expand the capabilities of scientists and health 
professionals from developing countries to engage in infectious diseases 
research and training not related directly to HIV/AIDS.  Proposals are 
requested for innovative, collaborative research-training programs that would 
contribute to the long-term goal of building sustainable research capacity in 
relevant infectious diseases at developing country institutions.  The intent 
is to harness scientific knowledge and skills to enhance prevention, 
treatment and control of infectious diseases causing major morbidity and 
mortality in endemic countries.

Previously, the Fogarty International Center (FIC) has supported several 
individual research-training programs for non-HIV/AIDS infectious diseases 
with major impact in developing countries through periodic Requests for 
Applications (RFAs).  These RFA-based programs included International 
Training and Research in Emerging Infectious Diseases (ITREID); Actions for 
Building Capacity in Support of International Centers for Infectious Disease 
Research (ABC/ICIDR); Tuberculosis International Training and Research; and 
International Malaria Research Training.  The FIC will now consolidate and 
standardize the requirements for all the non-HIV/AIDS infectious disease 
research-training programs under this program announcement (PA).  Competitive 
renewal applications for awards made in each of the individual programs 
mentioned above, as well as new applications, may be submitted in response to 
this announcement.  Developing country institutions may also apply for one-
year planning grants to support the development of research training 
proposals.  In addition, ongoing infectious disease research training 
awardees may apply for competing supplements to their award to expand their 



Despite eradication of many infectious diseases in the leading economic 
countries of the world, pathogens such as malaria and tuberculosis continue 
to impose a tremendous health burden in resource-poor countries throughout 
the world, claiming millions of lives annually and inflicting great morbidity 
that results in significant losses in economic productivity and social 
progress.  Infectious diseases anywhere in the world can be a potential 
threat to people in other countries, including those living in leading 
economic countries.  Attempts to control infectious diseases endemic to 
developing countries suffer due to an incomplete understanding of the 
pathogens, their disease manifestations and transmission mechanisms, 
inadequate preventive measures and interventions, and declines in health 
services and disease control efforts.  A major barrier to improved research, 
treatment and control of infectious diseases is the scarcity of scientists 
and health professionals in endemic countries with relevant infectious 
disease research expertise. 

Research Training Objectives

FIC will support research-training programs that focus on building 
sustainable infectious disease research capacity at an institution in an 
endemic developing country.  Sustainable research capacity depends on 
building a critical mass of scientists and health professionals with critical 
expertise and complementary skills that enable the institution to conduct 
independent, internationally recognized infectious disease research relevant 
to the health priorities of their country.  FIC will support research-
training programs that focus on major endemic or life-threatening emerging 
infectious diseases and are structured to provide a variety of short-, 
medium- and long-term training opportunities for participants from a 
developing country institution within the context of ongoing U.S. research 
collaborations.  Applications should present an assessment of the specific 
needs for infectious disease research training at the developing country 
institution and a proposed training plan to address those needs during the 
course of a five-year award.  It is expected that each grant awarded will:
1.  Substantially increase the expertise of trainees in relevant laboratory, 
clinical, epidemiological and/or social science research;
2.  Fill gaps and strengthen the sustainability of endemic infectious disease 
research training at a specified developing country institution;
3.  Expand and equalize collaborative scientific research interactions 
between U.S. and developing country scientists; 
4.  Provide data for evidence-based decision-making related to endemic 
infectious disease clinical treatment or prevention and control policies in 
the host developing country;
5.  Take advantage of other sources of research and training support in the 
foreign country; and
6.  Strengthen the capacity of developing country institutions by strategies 
that help insure trainees integrate into their home country institutions and 
pursue independently supported scientific careers.

Needs Assessment

Applicants should provide a detailed assessment of the specific needs at the 
developing country institution for the proposed training.  The assessment 
should identify specific gaps in laboratory, clinical, epidemiological, 
vector-related and social science research expertise and skills needed to 
address the infectious disease focus of the proposal.  The relevance of the 
infectious disease focus of the proposed training to the health of the host 
endemic country should be explained in detail.  The involvement of the 
developing country institution and training faculty in formulating clinical 
treatment and prevention policies locally, nationally or internationally 
should be noted.  The needs assessment should serve as a baseline against 
which progress can be evaluated in the future.

Training Plan

A) Focus of Training
The proposed research-training program may focus on one or more emerging or 
endemic infectious diseases of major health importance to the population of 
the host developing country.  Alternatively, research training may focus on 
multidisciplinary approaches to infectious pathogen transmission or disease 
risk factors such as nutrition, pathogen or vector resistance, or genetic, 
ecological, socio-cultural or economic determinants of one or more emerging 
or endemic infectious diseases of major health importance to the host 
developing country.  Trainee research may focus on analyzing the basic 
mechanisms of host-pathogen interaction, understanding disease transmission 
and pathology or developing new interventions, prevention measures or 
diagnostic methods.  

Trainee research projects may be part of a training faculty member's peer-
reviewed infectious disease research grant funded by NIH or other research 
support agencies.  All trainee research projects should be scientifically 
reviewed by one of the following processes.  Pre-doctoral or non-degree 
seeking trainee research projects that are not included as part of peer-
reviewed training faculty member's research grants must be scientifically 
reviewed by the proposed training advisory group (see below).  Post-doctoral 
trainee re-entry research projects at the developing country institution must 
be peer-reviewed at NIH as a competing supplement to an existing FIC 
infectious disease research training award (see below) or through 
applications to the Global Health Research Initiative Program for New Foreign 
Investigators ( or to the Fogarty 
International Research Collaboration Award program 

Applicants should also provide some training in skills needed at the host 
developing country institution to support sustainable independent research 
such as the use of scientific literature, scientific presentations, grant 
writing, bioinformatics, bioethics, good clinical practice, biosafety, data 
management, research administration, and the management of intellectual 

B) Types of Training
Applicants should propose a variety of research training options (degree-
related and non-degree training) to match the needs of the developing country 
institution.  Long-term research training may include studies leading to an 
advanced degree or a mentored post-advanced degree experience.  Long-term 
training may include academic courses related to infectious disease research 
(and English as a second language, if necessary).  Short- to medium-term 
training in short courses, workshops or practical experience of up to several 
months in specific research methods or other laboratory, clinical, social 
science or field skills related to infectious disease research may be 
proposed in addition to long-term training.

Training may occur in either the U.S. or developing country institution.  
However, applicants are strongly encouraged to provide support and mentoring 
by U.S. and developing country faculty for trainees to conduct the research 
related to their training in the host developing country to the greatest 
extent possible.  Applicants should include plans for the transfer of 
appropriate training options to the developing country institution during the 
course of the five-year award.  

C) Training in Responsible Conduct of Research 
Applicants are required to provide all long-term trainees with training in 
the responsible conduct of research.  For more information on this provision, 
see the NIH Guide for Grant and Contracts (volume 21, number 43  NIH does 
not require a specific curriculum or format for instruction but the following 
areas should be included:  conflict of interest, responsible authorship and 
institutional policies for handling scientific misconduct, human subjects, 
animal studies, data management and data sharing.  The inclusion of 
international perspectives on these topics is strongly encouraged.  The 
following information must be provided in the description of your plan:  
topics to be covered, format, faculty participating, instructional materials, 
frequency and duration of training and how trainee attendance will be 

D) Types of Trainees
Applicants should describe the characteristics of the trainees they plan to 
recruit for each type of training.  Training may be offered to a wide range 
of developing country scientists, including laboratory scientists, 
clinicians, and social scientists, and other health professionals, as well as 
technical and administrative staff.  The intent should be to build a critical 
mass of researchers and support staff with the combined expertise and skills 
to conduct independent infectious disease research.  Applicants are strongly 
encouraged to consider women and members of minority and socially 
disadvantaged populations in the developing country in the selection of 

E) Trainee Recruitment, Selection and Evaluation
Training plans should also describe the following processes:
o  Trainee recruitment
o  Trainee candidate evaluation and criteria for selection
o  Pre-training orientation and preparation
o  Training mentorship
o  Training evaluation
o  Post-training integration into the collaborating developing country 
institution's infectious disease research activities
o  Tracking and evaluation of long-term impact of training on the careers of 
the trainees and research capacity in the developing country institution.

F) Research Training Faculty and Environment
Applicants should describe in detail the U.S. and developing country training 
faculty and advisors and their developing country training records, as well 
as relevant infectious disease research support and scientific collaborations 
at the developing country institution.  Competitive renewal applications 
should contain detailed information about previous FIC-supported training 
efforts including:  the impact of short- and long-term training experience 
and a comprehensive list of all trainees; their status before training--
including position, country of residence and employment record; type and 
length of training provided in the U.S.; and developing country and the 
trainee's current position.

Applicants for competitive renewal awards should provide a list of 
publications in peer-reviewed scientific journals in which trainee research 
was supported by their previous FIC training award, i.e. publications in 
which trainees are authors and the FIC award is cited in the 

The application should also include letters from participating U.S. and 
developing country faculty defining their specific roles (such as mentoring 
and teaching) and time commitments in the proposed training program.

Pertinent research resources and the educational environment including the 
options available for distance learning for the proposed training at the U.S. 
and developing country institutions should be described.  Applicants are 
encouraged to describe their plans for dissemination of training materials, 
as well as other coordination efforts, to other FIC research training 
programs in developing countries.

G) Training Advisory Group
A training advisory group composed of expert U.S. and developing country 
faculty who are not directly involved in mentoring trainees should be 
established to conduct trainee selection, scientific review of trainee 
projects and evaluation of trainees and training program progress.  At least 
one member of the Training Advisory Group should be from an institution not 
involved in the training program.  Inclusion of women scientists from 
developed and developing country institutions is particularly encouraged.  
Applicants should describe the composition and expertise of the proposed 
training advisory group, the specific responsibilities of the group and the 
processes for it to accomplish its responsibilities.

H) Competing Supplements
Principal Investigators may apply for one competing supplement annually to an 
active FIC Global Infectious Disease Research Training Program, Actions for 
Building Capacity in Support of ICIDR Program, Tuberculosis International 
Training and Research Program, or International Malaria Research Training 
Program awards for the following purposes:  
o  Expanding their training programs geographically to other developing 
country institutions;
o  Adding new faculty in other infectious disease research training areas 
relevant to the developing country institution;
o  Taking advantage of new research or training opportunities;
o  Supporting U.S. minority or non-minority graduate or medical students and 
postdoctoral fellows for research training at the collaborating developing 
country institution;
o  Supporting research on other infectious diseases relevant to the 
collaborating country or HIV/AIDS-related interactions with the infectious 
disease focus of the program;  
o  Supporting expanded training in relevant research enhancing expertise such 
as bioethics, good clinical practice, medical informatics, research 
management, management of intellectual property, scientific grant writing, 
scientific manuscript preparation and data management;
o  Providing advanced re-entry support for developing country participants 
who have completed substantial mid- to long-term research training to 
establish independent research projects at the developing country institution 
upon their return home.

Competing supplement applications should include a detailed explanation of 
the scientific and administrative relationship between the supplemental 
research training proposed and the specific aims of the existing training 
award.  Competing supplement applications should include a needs assessment 
for the proposed training expansion and relevant training plan information as 
described above.

I) Planning Grants for Developing Country Institutions
Developing country institutions may apply for a one-year planning grant to 
develop an infectious disease research-training program with U.S. 
collaborators.  Planning grants should propose the following types of 
activities to organize and plan for a research-training program, and prepare 
and assemble an application to submit for support of that program the 
following year:
o  Consultation with U.S. and developing country faculty to assess the 
specific needs for infectious disease research training at the developing 
country institution;
o  Consultation with U.S. and developing country faculty to define the short-
, medium- and long-term training components to address the specific needs for 
infectious disease research training at the developing country institution in 
a stepwise plan;
o  Consultation with U.S. and developing country collaborators to define 
their roles and institutional commitments in the research training program;
o  Targeted training of developing country faculty to fill gaps in infectious 
disease research expertise, responsible conduct of research and human 
subjects education and other research support areas;
o  Training ethical review committee members of developing country 
institutions to obtain certification related to the U.S. Federal-wide 
Assurance for the developing country institution;
o  Planning grant program director training in grant writing.


This PA will use the NIH D43 international research training award mechanism.  
As an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  Under this PA, an applicant can submit: 
o  A new or competitive renewal award application; 
o  A competing supplement application to any of the following initiatives:  
Global Infectious Disease Research Training, Actions for Building Capacity in 
Support of ICIDR, Tuberculosis International Training and Research Program, 
or International Malaria Research Training award; or
o  A developing country applicant may apply for a one-year research training 
program planning grant.

An applicant for a Global Infectious Disease Research Training Program award 
may request a project period of up to five years and a budget for total costs 
of up to $150,000 per year maximum (including eight percent facilities and 
administrative (F & A) costs).  

An applicant for a competing supplement to current FIC award may request up 
to $50,000 per year total costs (including eight percent F & A costs) for a 
maximum project period equivalent to the remaining project period of the 
parent award.  

A developing country applicant for a planning grant may request up to $25,000 
total costs (including eight percent F & A costs) for one year.

Only one application may be submitted from an institution proposing research 
training on a particular infectious disease or working at a particular 
developing country institution.


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

o  Domestic or foreign developing country organizations
o  Nonprofit
o  Private or public institutions, such as universities, colleges, hospitals, 
and laboratories 

Eligible institutions are institutions from the developing foreign countries 
listed below or from domestic U.S. institutions with scientific 
collaborations with the developing countries listed below.  Eligible 
developing foreign countries include those low- and middle-income countries 
in the following regions:  Africa, Asia (except Japan, Singapore, South Korea 
and Taiwan), Central and Eastern Europe (Hungary, Poland, the Czech and 
Slovak Republics, Romania, Bulgaria, Albania, Turkey and the countries of the 
former Yugoslavia), Russia and the Newly Independent States of the former 
Soviet Union, Latin America and the Caribbean, the Middle East (except 
Israel), and the Pacific Ocean region (except Australia and New Zealand).


Any individual from an eligible institution with the skills, knowledge, and 
resources necessary to carry out the proposed international infectious 
disease research training is invited to work with their institution to 
develop an application for support.  U.S. applicants must apply with a 
developing country institution with which they have a demonstrable history of 
research collaboration.  Developing country applicants should apply in 
collaboration with U.S. institutions capable of enhancing their proposed 
training opportunities.  

Applicants must have a strong infectious disease research program in the 
scientific area proposed for research training and the requisite faculty and 
facilities to carry out the proposed training activities.  Applicants must be 
designated as the Principal Investigator of at least one active infectious 
disease research grant (with at least 18 months of support remaining at the 
time of application), from the NIH or other national or international 
research support organization, directly relevant to the research training 
proposed.  Priority will be given to applicants with NIH research grants with 
foreign components at the collaborating developing country institution or to 
foreign developing country applicants directly supported by NIH research 
awards.  Applicants should explain in detail how their relevant research 
grant support and activities are related to the proposed training plan.  

Individuals from underrepresented racial and ethnic groups, women, and 
individuals with disabilities are always encouraged to apply for NIH 


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

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

Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 402-9467
FAX:  (301) 402-0779

o Direct your questions about peer review issues to: 
Donald Schneider Ph.D.
Division of Molecular and Cellular Mechanisms
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5160
Bethesda, MD  20892-7842
Telephone:  (301) 435-1727
FAX:  (301) 480-1988

o 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
Bethesda, MD  20892-2220
Telephone:  (301) 496-1670
FAX:  (301) 594-1211


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 number of the Principal Investigator
o  Names of other key personnel
o  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 IC staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD  20892
Telephone:  (301) 402-9467
FAX:  (301) 402-0779


Applications must be prepared using the Institutional NRSA section of the PHS 
398 research grant application instructions and forms (rev. 5/2001).  The PHS 
398 is available at 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

Budget Preparation

Applicants should develop a budget that reflects the resources necessary to 
implement the components of the comprehensive developing country training 
plan included in their application.  The budgets may include costs to support 
the various types of training proposed (tuition, stipends, salary, travel, 
per diem) for trainees and faculty, and costs to support the administration 
of the program and grant.  Adequate resources to meet U.S. government 
requirements for training and training-related research should be included in 
the budget.


All expenses related to trainee participation in the program should be 
itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the 
appropriate categories.   All expenses related to faculty participation in 
the program should be itemized on the PHS Form 398 (budget form pages 4 & 5) 
in the appropriate categories.  The total direct costs of the trainee 
participation budget should be identified on PHS Form 398 (budget form pages 
4 & 5) in the "Other" category.  The combining of the budget figures will 
allow reviewers and FIC staff to review a composite budget of all costs.

Requested Salary Support
The salary for the Principal Investigator, other training faculty and 
administrative staff must be commensurate with the salary structure and 
benefits at the applicant institution.

Trainee Stipends
Trainees may be paid a stipend comparable to their professional experience in 
accordance with NRSA levels or grantee institutional policies while involved 
in long-term training at the grantee institution.  Current NRSA stipend 
levels are described on the web site  

Tuition, Fees and Insurance for Trainees
Funds for tuition, academic fees and self-only or family medical insurance 
may be requested.  Programs are encouraged to seek cost-sharing arrangements 
with the grantee institutions in order to provide reduced tuition for long-
term trainees and tuition-free short courses.

Network Meetings
Funds to support the attendance of the Principal Investigator and one or two 
faculty or trainees at the annual network meeting for the program in the 
Washington, D.C. area.

In-Country Activities
Before any funds can be expended for in-country research activities under 
this award, the grantee institution must notify FIC staff, documenting a 
collaborative research arrangement between the U.S. and foreign country 
institutions.  This can be documented through an endorsement from the 
Minister of Health or other appropriate foreign government official, as well 
as from the collaborating institutions. 

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  20892-7710
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 a substantial 
revision of an application already reviewed, but such application must 
include an introduction addressing the previous reviewers' comments.


An appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures ( will 
evaluate applications for scientific and technical merit.  

As part of the initial merit review, all applications will:
o Receive a written critique
o Receive a second level review by the Fogarty International Center Advisory 
Board and may receive review from the council of a co-sponsoring 


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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria 
in assigning your 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 training impact and 
thus deserve a meritorious priority score.  For example, you may propose to 
carry out important research training that, by its nature, is not innovative 
but is essential to move a field forward.


1.  The need for the specific infectious disease research training proposed 
to fill specific gaps in infectious disease research expertise at the 
developing country institution.
2.  The expected public health and scientific contributions related to the 
proposed infectious disease research training.
3.  The demonstrated capacity (for competing renewal applications) or 
expected potential (for new applications) to achieve independent and 
sustainable laboratory, clinical or public health infectious disease research 
capacity through the proposed training efforts. 


1.  The clarity and feasibility of the research training objectives.
2.  Adequacy of the research-training plan to achieve the proposed training 
objectives including:
a) A trainee recruitment and selection process that captures the most 
qualified individuals who could most benefit from the training proposed;
b) A process to include an adequate representation of women, ethnic 
minorities and socially disadvantaged groups among the developing country 
c) A plan for pre-training orientation and preparation for maximizing the 
training experience;
d) A process for matching trainees to appropriate mentors or instructors and 
research projects or needed research skills to fill recognized gaps in 
expertise at the developing country institution;
e) A process for scientific peer review of trainee research;
f) A plan to provide training in sustainable research enhancing areas such as 
laboratory safety, responsible conduct of research, scientific writing, grant 
writing, statistical methods, good clinical practice, medical informatics, 
data management, management of intellectual property, and English as a second 
language (if necessary);
g) A process for periodic evaluation of trainee progress in acquiring 
academic and research skills;
h) Approaches to support post-training integration into infectious disease 
research at the developing country institution to build sustainable research 
capacity; and
i) A method to monitor the long-term impact of the infectious disease 
research training experience on the subsequent careers of the trainees, the 
infectious disease research capacity at the developing country institution 
and public health in the developing country.


1.  The identification of innovative strategies for trainees to become 
actively involved in infectious disease laboratory studies, clinical or 
public health research studies or intervention trials relevant to national 
health priorities conducted at the developing country institution.
2.  Innovation in training strategies to produce a critical mass of 
independent infectious disease researchers and sustainable research training 
by trainees at the developing country institution at the end of the program.
3.  The creativity of plans to use modern information technology to 
facilitate trainee access to scientific information, distance learning and 
collaborative interaction.


1.  Qualifications of the program director to lead and the U.S. and 
developing country faculty to participate as mentors in the proposed research 
training program.
2.  Adequacy of the ongoing collaboration between the U.S. and developing 
country investigators and their institutions to provide a suitable framework 
in which the proposed training will occur.
3.  The extent and effectiveness of previous research training efforts made 
by applicants in the proposed developing country.
4.  Relevance of the sources of research support of the program directors and 
faculty to the research training plan proposed.


1.  The adequacy of the infectious disease teaching and research facilities 
and other resources, and ongoing research support related to the overall 
training environment at the U.S. and developing country institutions.
2.  The U.S. and developing country institutional commitments to the proposed 
infectious disease research training.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protections 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.)

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


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

o Scientific merit of the proposed project, as determined by peer review
o Availability of funds 
o Relevance to NIH and other co-funders' program priorities
o Geographic balance


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 AMENDMENT  "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 
(; a complete 
copy of the updated Guidelines are available at  
The amended policy incorporates:  the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the 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 

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

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 announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at

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

Applicants may wish to place data 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.

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.  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.  This 
PA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.989, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of the Public 
Health Service Act, as amended (42 USC 241 and 287b) and administered under 
Public Health Service (PHS) grants policies described at and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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