PHASE II COMPREHENSIVE ICOHRTA AIDS/TB

RELEASE DATE:  July 28, 2004

RFA Number:  RFA-TW-04-002 (This RFA has been reissued, see RFA-TW-06-005)
 
EXPIRATION DATE:  December 21, 2004

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH) 
(http://www.nih.gov)
United States Agency for International Development (USAID)  
(http://www.usaid.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
Fogarty International Center (FIC) 
(http://www.fic.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)  
(http://www.niaid.nih.gov) 
National Institute on Drug Abuse (NIDA)  
(http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH)  
(http://www.nimh.nih.gov/)
Office of Global Health United States Agency for International Development 
(USAID)  
(http://www.usaid.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.989, 93.242 (NIMH), 
93.855, 93.856 (NIAID)

LETTER OF INTENT RECEIPT DATE:  November 19, 2004
APPLICATION RECEIPT DATE:  December 20, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Training Objectives
o  Mechanism of Support
o  Funds Available
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  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The Fogarty International Center (FIC) and its co-sponsoring institutions 
invite Phase I International Clinical, Operational, and Health Services 
Research Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) Program 
awardees to submit applications for Phase II ICOHRTA-AIDS/TB awards to 
develop comprehensive international clinical, operational, and health 
services research training programs.  Co-sponsoring institutions are U.S. 
Government (USG) agencies contributing financial resources to the ICOHRTA-
AIDS/TB Program.

RESEARCH TRAINING OBJECTIVES

The International Clinical, Operational, and Health Services Research 
Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) program provides 
extended support for training to foster collaborative, multidisciplinary 
research in developing country sites where HIV/AIDS, tuberculosis (TB) or 
both are significant problems.  The first phase of the ICOHRTA-AIDS/TB 
program began in fiscal year 2002 (FY02), with one-year planning grants (PA-
02-022; PAR 03-072) to foreign institutions to organize and execute an 
application for a Phase II Comprehensive ICOHRTA-AIDS/TB Cooperative 
Agreement.  Only the recipients of the Phase I planning grants and their 
chosen U.S. (or pre-approved non-U.S.) collaborating partner institutions 
(together referred to as Research Training Units) are eligible to apply for 
Phase II Comprehensive ICOHRTA-AIDS/TB awards.  The Phase II awards to the 
Research Training Units will provide support to each partner institution.  
These applications should foster the development of the skills at the foreign 
institution needed to identify effective interventions pertinent to the 
global health crises created by HIV/AIDS and/or TB and to develop strategies 
to successfully implement these evidence-based interventions.

The training supported under Phase II of the ICOHRTA-AIDS/TB program will 
help to produce a cadre of experts who will facilitate integrated clinical, 
operational, and health services research for the benefit of developed and 
developing country populations.  These experts will comprise a resource that 
will facilitate additional training and research in the region.  The ICOHRTA-
AIDS/TB program will extend and intensify efforts to provide clinically 
appropriate and sustainable care to these individuals in a manner that 
supports continuing and expanding prevention activities.  This program will 
increase research training across the span of clinical science and public 
health practice and involve a wide range of health professionals (e.g. 
nurses, midwives, physicians, dentists, health care administrators and public 
health workers).

The program will also provide support for the development and extension of 
core research support capabilities necessary for long-term sustainability of 
the research capacity of the foreign institution.  Core research support 
capabilities are defined as those skills required by an institution to 
successfully compete for and conduct research.  The knowledge and ability to 
manage research grants require expertise in ethics and compliance issues, 
protection for human subjects, animal welfare, fiscal management, budgeting, 
program and grants administration, grant and report writing, preparation of 
scientific manuscripts, information technologies, technology transfer and 
management of intellectual property, data management, and Internet 
connectivity.

Clinical research, in the context of this RFA, includes studies of 
interventions intended to prevent transmission or to improve the quality of 
life for HIV- or TB-infected children, men or women.  This area of research 
involves, but is not limited to, clinical trials of biomedical, behavioral, 
or combination interventions, the development of new technologies, and new 
clinical methods to deliver, monitor, and sustain AIDS and/or TB care.

Operational research is defined as research that encompasses the translation 
of knowledge, practices, and technologies into clinical use.  Examples 
include assessment of how to successfully implement existing and new 
prevention interventions, therapeutic tools, and other care interventions for 
broad-based use, and the study of barriers to such translation and 
implementation.  When interventions have been shown to be successful on a 
small scale or in limited situations, operational research will help 
determine how best to generalize such interventions for widespread and 
sustainable use.  Operational research includes studies of factors that 
influence the effectiveness of interventions in "real world settings." 

Health services research includes studies that examine the organization, 
financing, management, and delivery of health services and how they impact a 
person's ability to utilize HIV and TB health services, including innovative 
strategies for providing therapy and care.  This research also includes 
studies of quality, cost, and effectiveness of proven therapeutic or 
prevention interventions.

The applications from both the foreign institution and its U.S. (or pre-
approved non-U.S.) collaborating partner must propose, in an integrated 
manner, a comprehensive training program that will strengthen the capacity in 
the foreign country to conduct integrated clinical, operational, and health 
services research focused on one or more of the following areas:

o  The application of clinical science and health care research to benefit 
those already infected with HIV and/or TB.  

o  The prevention and/or reduction of the spread of HIV and TB and related 
conditions, especially measures that can be implemented within the context of 
care.  

o  The study of strategies to scale-up and integrate effective therapeutic 
and preventive interventions into the local health care system.  

The approach and training plan for clinical, operational, and health services 
research training should be directly relevant to the needs of the people in 
the foreign country and be appropriate to local circumstances and most likely 
to affect public health policy.  Also implicit is the need to rapidly 
strengthen the research training capacity and infrastructure required for 
success by building on existing research and research training programs 
involved with the implementation of prevention and care interventions at the 
country level.  In addition, an important capacity building component is to 
strengthen core research support capabilities needed to manage research 
grants at the foreign site.

Each Phase II Comprehensive ICOHRTA-AIDS/TB program application should 
incorporate a number of long-, intermediate- and short-term training 
opportunities in a wide range of relevant disciplines and skills necessary to 
advance research objectives.  The proposed training should strengthen 
sustainable clinical, operational, and health services research and core 
research support capacity at the foreign site and include advanced in-country 
research.  Training will take place at the U.S. or foreign sites and 
training-related research will be carried out mainly at the foreign site.  
While a range of short-, intermediate- and long-term training is allowable, 
emphasis will be on intermediate- to longer-term training, including mid-
career training.  This approach will accelerate building enduring capability 
for clinical, operational, and health services research and core research 
support at the foreign institution.

In the context of this RFA, the following definitions are used for long-, 
medium-, and short-term training:

o  Long-term (greater than 12 months and up to four years, depending on 
resources) training for the full range of skills necessary to support 
research and research administration in masters or doctoral programs, with 
the understanding that the focus of thesis-related work will be in the 
developing country.  With prior FIC approval, pre-masters training will be 
allowed for individuals with demonstrated interest and capability, but whose 
prior professional education does not include a bachelor's level degree 
(e.g., nurses, midwives, laboratory technicians, administrative staff).

o  Short-term (less than three months) training or mentoring that focuses on 
research methodology, laboratory skills necessary to support clinical 
research, ethics and compliance issues, program and grants administration, 
accounting, financial management, grant writing, peer review, preparation of 
scientific manuscripts, data management, Internet connectivity, technology 
transfer, and medical informatics.

o  Intermediate-term (three to 12 months) training or mentoring, including 
specialized clinical, laboratory, research or administrative/business skills 
necessary to support clinical, operational, and health services research that 
is planned or ongoing.

o  Advanced in-country mentored research undertaken by the trainee in his/her 
home country upon completion of his/her initial period of training under the 
program (masters, Ph.D., post-doctoral or other significant training).

o  To a limited extent and with prior FIC approval, U.S. trainees will be 
eligible for foreign research experience under this cooperative agreement.  
To be eligible, they must have uniquely relevant expertise and skills that 
will contribute to the training, research, or administration at the foreign 
institution and/or have a major career commitment to international research.

The ICOHRTA-AIDS/TB program strongly encourages PIs to include women and 
individuals from underrepresented racial, ethnic or socially disadvantaged 
groups in the country as trainees and faculty at all sites.

MECHANISM OF SUPPORT

This RFA will use the NIH International Training Cooperative Agreement (U2R) 
award mechanism to provide funding to both the foreign research training 
institution and to its linked collaborating U.S. (or other pre-approved) 
institution.  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.  This RFA is a one-time 
solicitation.  The anticipated award date is April 2005. 

This program does not require cost sharing as defined in the current NIH 
Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.  

The NIH U2R is a cooperative agreement award mechanism.  In the cooperative 
agreement mechanism, the Principal Investigator retains the primary 
responsibility and dominant role for planning, directing, and executing the 
proposed project, with NIH and other United States Government (USG) staff 
being substantially involved as partners with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."  At this time, it is not known if this RFA will be reissued, but, 
subject to availability of funds and overall progress in the program, the 
intent is to reissue the RFA for at least one more competition, thus allowing 
recipients of Phase I planning grants to apply for Phase II awards, and for 
unsuccessful Phase II applicants to submit amended applications.

FUNDS AVAILABLE

FIC and its co-sponsoring partners intend to commit approximately $1.2-1.8 
million in FY05 to fund two to three applications from the Comprehensive 
ICOHRTA-AIDS/TB Research Training Units received, in response to this RFA and 
subject to availability of funds.  The two Phase II Comprehensive ICOHRTA-
AIDS/TB applicants in the Research Training Unit (which consists of a foreign 
institution application and its linked U.S. partner or pre-approved non-U.S. 
institution application) may request up to a total of $600,000 in total costs 
for each year.  Each of the applicants can request up to $300,000 total costs 
(that includes facilities and administrative (F & A) costs on subcontracts)  
in year one but the foreign institution application total cost budget must be 
at a total cost level equal to or greater than its linked U.S. partner or 
pre-approved non-U.S. institution partner.  The foreign institution's total 
cost budget should increase in years two through five to reflect the 
increased capacity of the foreign applicant to facilitate training and 
research.  The foreign institution's total cost budget may exceed $300,000 in 
years two through five but the total costs for the Research Training Unit may 
not exceed $600,000.  The total project period for an application may not 
exceed five years and F & A costs are limited to eight percent for both 
Research Training Unit partners.  Because the nature and scope of the 
proposed research training will vary from application to application, it is 
anticipated that the overall size of each linked award (and components) will 
also vary.  Although the financial plans of the ICs provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.

ELIGIBLE INSTITUTIONS  

Applications for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will only be 
accepted from foreign institutions that have been awarded a Phase I ICOHRTA-
AIDS/TB planning grant and their chosen linked collaborating U.S. (or other 
pre-approved) partners.  The foreign and U.S. (or other developed country) 
site must have achieved a strong record of receiving or being significantly 
involved in HIV/AIDS and/or TB international research.  Each site should 
provide a comprehensive list of these awards for at least the past five years 
to support its application.

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

o Non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations

With prior FIC approval, the designated collaborating institution may be a 
non-U.S. institution, provided it has special resources that uniquely 
contribute to this program.  Also with prior FIC approval, and concurrence 
from the foreign PI, the application from the collaborating U.S. (or other 
pre-approved) partner may involve additional institutions through a 
subcontract or consortium arrangement.

Only one application for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will 
be allowed from any foreign institution in response to this RFA.  In 
situations in which more than one planning grant has been awarded to 
institutions in close proximity in the same country, applicants will be 
strongly encouraged to submit a single, integrated application for a Phase II 
award.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The Principal Investigator (PI) in the Phase II application from the foreign 
institution is expected to be the PI from the Phase I award.  Any change will 
require pre-approval.  The foreign PI and the collaborating PI will be 
responsible for the overall conduct of the integrated research-training 
program.  Both the foreign and collaborating institutions must demonstrate 
the capacity and leadership necessary for the successful implementation and 
long-term productivity of the program.  The Principal Investigators at the 
foreign institution and at the collaborating partner institutions must have a 
track record of commitment and experience in related research and research 
training.  Both the foreign and collaborating PI must be directly involved in 
and funded to do research in resource-poor settings and there must be 
tangible evidence of very strong linkage to that ongoing research as 
collaborating partners.  The PIs must hold faculty or other long-term 
research positions at a public or private non-profit research institution 
that will allow them adequate time and provide appropriate facilities, salary 
support and resources, including access to patients or patient data, when 
necessary.  

Women, individuals from underrepresented racial, ethnic and socially 
disadvantaged groups in the country, as well as persons with disabilities are 
encouraged to apply as PIs.

SPECIAL REQUIREMENTS 

Guidance and Management Structure

The guidance and management of the ICOHRTA-AIDS/TB Program are provided by a 
Technical Advisory Group and a Steering Committee.

The Technical Advisory Group is a committee of advisors with relevant 
expertise from the USG co-sponsoring institutions (at least one from each co-
sponsor) and the Program and Grants Management Officers from the FIC.  The 
Technical Advisory Group:  1) reviews applications for responsiveness and, 
after the independent initial peer review, makes funding recommendations, and 
2) meets several times per year, as necessary, to review developments across 
the ICOHRTA-AIDS/TB program as well as the progress of individual ICHORTA-
AIDS/TB Research Training Units and the planning grant recipients.  The FIC 
Program Officer serves as the chair of the Technical Advisory Group.

The Steering Committee is composed of the Foreign Principal Investigator and 
the Collaborating Principal Investigator from each of the Research Training 
Units, the FIC Program Officer, and one additional representative from the 
Technical Advisory Group.  The FIC Grants Management Officer serves as a 
consultant to the Steering Committee on budget and grants-related issues.  
The Steering Committee provides oversight across the ICOHRTA AIDS/TB program 
and serves as the central point for communication and exchange of ideas 
regarding research training activities and resolution of any problems, as 
necessary.  A chairperson who is not a USG employee will be elected by the 
committee to serve a one-year term.  The Steering Committee will meet at 
least once annually and will participate in telephone, video or electronic 
conferences, as needed.  Each member of the Steering Committee will have one 
vote.

Each Research Training Unit in the ICOHRTA-AIDS/TB Program will have an 
advisory committee, composed of two or more USG scientific advisors 
designated by the Technical Advisory Group and a grants management expert, as 
needed.  The Research Training Unit Advisory Committees will assist the work 
of the ICOHRTA-AIDS/TB program by providing advice and assistance that is 
coordinated through the FIC Program Officer to the Research Training Unit.  
The advisory committees of the Research Training Units assists in such 
matters as reviewing the progress reports of each partner of the Research 
Training Unit and suggesting mid-course corrections and future directions.  
The membership of the individual advisory committee is determined by the 
Technical Advisory Group, with advice from the Steering Committee.  Research 
Training Unit advisory committee members maintain ongoing communication 
regarding the progress of the Research Training Unit, attend meetings of the 
ICOHRTA-AIDS/TB program, whenever possible, and meet as an advisory committee 
separately at least once per year.

The FIC Program Officer, as the program and scientific representative of the 
FIC, chairs the Technical Advisory Group and is a member of the Steering 
Committee.  The Program Officer has lead responsibility for day-to-day 
program decisions in coordination with the Technical Advisory Group and the 
Steering Committee. 

The FIC Grants Management Officer, as the grants management representative of 
the FIC, is a member of the Technical Advisory Group and a consultant to the 
Steering Committee.  The Grants Management Officer will serve as a resource 
in policies and issues related to NIH grants management to the planning grant 
awardees and the ICHORTA-AIDS/TB Research Training Units.
 
Cooperative Agreement Terms and Conditions of Award:

The administrative and funding instrument to be used for this program is a 
cooperative agreement, an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic and grants administration involvement with the awardee is 
anticipated during performance of the activity.  Under the cooperative 
agreement, the NIH purpose is to support and/or stimulate the recipient's 
activity by involvement in and otherwise working jointly with the award 
recipient in a partner role, but it is not to assume direction, prime 
responsibility, or a dominant role in the activity.  

The following special terms of award are in addition to, and not in lieu of, 
otherwise applicable OMB administrative guidelines, HHS grant administration 
regulations at 45 CFR Parts 74 and 92 [Part 92 is applicable when State and 
local Governments are eligible to apply], and other HHS, PHS, and NIH grant 
administration policies.

1. Awardee Rights and Responsibilities

Each partner institution will be responsible for implementation of its 
portion of the integrated research-training program.  Training will take 
place at the U.S. or foreign sites and mentored research will be carried out 
mainly at the foreign site.  The program should also provide support at the 
foreign site for training to develop and extend core research support 
capabilities necessary for long-term sustainability of the research capacity 
of the foreign institution.   The Principal Investigators will be expected to 
be active members of the Steering Committee.  Awardees are advised that they 
will retain custody of and primary rights to any research data developed 
under the award, subject to current Government policies regarding rights of 
access.

Each Research Training Unit in the ICOHRTA-AIDS/TB Program will have an 
advisory committee, composed of two or more USG scientific advisors 
designated by the Technical Advisory Group and a grants management expert, as 
needed.  The Research Training Unit Advisory Committees will assist the work 
of the ICOHRTA-AIDS/TB program by providing advice and assistance that is 
coordinated through the FIC Program Officer to the Research Training Unit.  

2. United States Government(USG) Staff Responsibilities

The FIC Program Officer/Collaborator, in consultation with co-sponsoring U.S. 
agencies, will have substantial scientific and programmatic involvement 
during the conduct of this activity, through technical assistance, advice and 
coordination above and beyond normal program stewardship for grants.  The FIC 
program officer/Collaborator will be familiar with the scientific agenda of 
FIC and co-sponsoring U.S. agencies and will facilitate coordination of 
training across these programs.  

The FIC Program Officer/Collaborator will:  
o  serve on the Steering Committee and chair the Technical Advisory Group; 
o  provide advice on the management of the training provided, technical 
content of the curriculum, and evaluation of the impact of the training; 
o  facilitate communication and exchange of information; and 
o  organize interactions with relevant co-sponsor and FIC staff to provide 
scientific and administrative technical assistance. 

The Technical Advisory Group is a committee of advisors with relevant 
expertise from the USG co-sponsoring institutions (at least one from each co-
sponsor) and the Program and Grants Management Officers from the FIC.  The 
Technical Advisory Group:  1) reviews applications for responsiveness and, 
after the independent initial peer review, makes funding recommendations, and 
2) meets several times per year, as necessary, to review developments across 
the ICOHRTA-AIDS/TB program as well as the progress of individual ICHORTA-
AIDS/TB Research Training Units and the planning grant recipients.  The FIC 
Program Officer/Collaborator serves as the chair of the Technical Advisory 
Group.

The Technical Advisory Group will provide guidance to the Research Training 
Units as part of the overall ICOHRTA AIDS/TB program.  The individual 
advisory committees of each Research Training Unit will provide guidance to 
that Research Training Unit.  The FIC Program Officer/Collaborator and one 
non-FIC member of the Technical Advisory Group will serve on the Steering 
Committee.  The FIC Program Officer/Collaborator, in consultation with co-
sponsoring organizations and the FIC Grants Management Officer, will oversee, 
advise, and assist the activities of the Research Training Units in support 
of the ICOHRTA-AIDS/TB programs.  The FIC Grants Management Officer will 
serve as a resource to the Research Training Units in policies and issues 
related to NIH grants management.

The FIC Program Official designated in the Notice of Grant Award will be 
responsible for the normal programmatic stewardship of the award and may be 
substantially involved as described above for the Program 
Official/Collaborator role.

3. Collaborative Responsibilities

The Steering Committee is composed of the Foreign Principal Investigator and 
the Collaborating Principal Investigator from each of the Research Training 
Units, the FIC Program Officer/Collaborator, and one additional 
representative from the Technical Advisory Group.  The FIC Grants Management 
Officer serves as a consultant to the Steering Committee on budget and 
grants-related issues.  The Steering Committee provides oversight across the 
ICOHRTA AIDS/TB program and serves as the central point for communication and 
exchange of ideas regarding research training activities and resolution of 
any problems, as necessary.  A chairperson who is not a USG employee will be 
elected by the committee to serve a one-year term.  The Steering Committee 
will meet at least once annually and will participate in telephone, video or 
electronic conferences, as needed.  Each member of the Steering Committee 
will have one vote.

The Principal Investigators will be members of the Steering Committee.  This 
committee together with the Technical Advisory Group will serve a 
consultative function and help to shape the agenda and facilitate the 
activities of the ICOHRTA AIDS/TB program.  

4. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award) between award recipient and the FIC may be brought to 
arbitration.  An arbitration panel will be composed of three members:  one 
selected by the Steering Committee (with the USG members not voting) or by 
the individual awardee in the event of an individual disagreement, a second 
member selected by FIC in consultation with the Technical Advisory Group, and 
the third member selected by the two prior selected members.  These special 
arbitration procedures in no way affect the awardee's right to appeal an 
adverse action in accordance with the PHS regulations at 42 CFR Part 50, 
Subpart D and HHS regulation at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

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

o  Direct your questions about scientific/programmatic issues to:

Jeanne McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center, National Institutes of Health
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone:  301-496-1492
Fax:  301-402-0779
Email:  mcdermoj@mail.nih.gov

o  Direct your questions about peer review issues to:

Sherry L. Dupere, Ph.D.Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
MSC 7840, Room 5136
Bethesda,MD  20892
(for express/courier service, use zip 20817 and remove MSC 7840)
Telephone:  301-435-1021
Fax:  301-480-3567
Email:  duperes@csr.nih.gov

o  Direct your questions about financial or grants management matters to:

Bruce Butrum
Grants Management Officer
Fogarty International Center, National Institutes of Health
Building 31, Room B2C29
Bethesda, MD  20892-2220
Telephone:  301-451-6830
Fax:  301-594-1211
Email:  butrumb@mail.nih.gov 

LETTER OF INTENT

Prospective applicants who receive Phase I planning grants and who intend to 
apply for a Phase II award under this RFA are asked to submit a letter of 
intent that includes the following information:

o  Descriptive title of the proposed program
o  Names, addresses, telephone numbers of the Principal Investigators
o  Names of other key personnel
o  Participating institutions
o  Number and title of this RFA

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 NIH 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 to:

Jeanne McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center, National Institutes of Health
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone:  301-496-1492
Fax:  301-402-0779
Email:  mcdermoj@mail.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:  Members of the proposed Research Training Unit 
must collaborate with each other to prepare similar or identical research 
training plans.  The two applications from the Research Training Unit 
partners should describe a comprehensive international clinical, operational, 
and health services research training program and should address the 
following areas in their applications, in place of the research plan: 

1.  Documentation by the institutions of a long-term commitment to build the 
clinical, operational, and health services research capacity of the foreign 
institution through governmental-support or other resources.  A copy of their 
agreement must be included with the Phase II applications.

2.  A description of plans for the integration of clinical, operational, and 
health services research capacity building at the collaborating foreign 
institution.

3.  A description of how resources from this award will be integrated with 
other resources at the foreign institution or within the country to achieve 
the overall goals of this program, building sustainable research capacity at 
the foreign institution.

4.  Evidence that both partners of the Research Training Unit collaborated in 
creating a research training development plan for the foreign site and 
demonstrated a description of how this plan supports the overall 
institutional development plan of the foreign site.  The U.S. (or other 
developed country site) must describe how its component of the linked program 
is designed to help build the research capacity at the foreign site.  The 
application should clarify the roles, responsibilities and commitments of the 
foreign and U.S. (or non-U.S.) collaborators and should state what the 
individuals listed would actually do and their time commitments to the 
program.

5.  Evidence of plans for linkage to and coordination with other sources of 
research and training support in the foreign country is required, including 
how these fit into the institutional development plans of the foreign 
institution.  Examples include:  

o  other FIC international research training and research programs; 
o  NIAID AIDS/TB-related programs; 
o  NICHD AIDS/TB-related programs; 
o  NIMH AIDS-related programs; 
o  NCI programs related to AIDS/TB; 
o  NIDA programs related to AIDS/TB; 
o  NIAAA programs related to AIDS/TB;
o  NINDS programs related to AIDS/TB;
o  AIDS/TB-related Programs of the Centers for Disease Control and 
Prevention; 
o  USAID AIDS/TB-related programs; 
o The President’s Emergency Plan for AIDS Relief
o The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria
o  AIDS/TB-related programs of other organizations/foundations involved in 
international control of and care for persons infected with HIV/AIDS and/or 
TB.

6. A description of how this program will serve as a bridge between academic 
research and public health communities to help to link the various HIV/AIDS 
and/or TB trials and care programs supported in the country by NIH and other 
sponsors.

7.  A description of how their programs will relate to any community advisory 
boards in the foreign country and how the training program will strengthen 
the capability of these community advisory boards 

8.  A description of strategies to achieve a wider regional impact.  This 
could be done by strengthening other institutions in the foreign PI's country 
or in neighboring countries ("south to south" training).  The ultimate goal 
is to become not only a national, but also a regional center of clinical, 
operational, and health services research excellence that is capable of 
offering training in these areas, and in introducing appropriate technology 
to scientists from other countries.

9.  Plans for strengthening core research support capabilities necessary for 
long-term sustainability.

10  Plans for meeting the requirements related to training-related research 
including advanced in-country research.  These include scientific and peer 
review procedures, written evidence of compliance with the required federal 
citations, approval for the research from an institutional (or ethical) 
review board or committee at both the U.S. or pre-approved non-U.S. and 
foreign institutions and from the relevant government authority, as required.  
Please see:  Procedures for Registering Institutional Review Boards and 
Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) 
(http://www.hhs.gov/ohrp/).  All training-related research protocols 
(including advanced in-country research) must be independently scientifically 
reviewed through expedited scientific review procedures established by the 
Research Training Unit.  For example, as the training programs are 
implemented, consideration will be given to mechanisms to support advanced 
in-country research proposals as either competing supplements to Phase II 
awards or as applications to the FIC Global Health Research Initiative 
Program for New Foreign Investigators.  Where appropriate, the design of 
training related research projects should take into account potential sex and 
gender differences that may affect the questions asked and the analyses 
performed.  These might include different responses to and impacts of health 
interventions, differences in physiology, and different behavioral bases for 
disease prevention strategies.

11. A description of how the proposed research training and capacity building 
supports the HIV/AIDS and/or TB-related clinical, operational, and health 
services research priorities of the participating foreign country.  
Applicants should describe the procedures to assure this takes place within 
the context of the collaborative relationship, including input from 
scientific and community advisory boards in the foreign country.  The 
applicant should identify areas of mutual interest between country and the 
co-sponsoring institutions (e.g., HIV-related opportunistic infections, HIV 
malignancies, neurological and mental health consequences, behavioral issues, 
cardiovascular disease, hematologic conditions, blood safety, pulmonary 
manifestations, ophthalmologic manifestations, gastrointestinal conditions, 
drug and alcohol usage, potential sex and gender differences in physiology 
and behavior, and oral health manifestations).

12. Evidence of sustained host-country support for the program is required.  
Such evidence of support should be provided in writing and should be in the 
form of the following:  (a) a statement of support from a senior 
administrator at the foreign PI's institution, evidence of contributions from 
the host-country and willingness of the host-country to utilize trainees' 
experience and knowledge gained from the program to build integrated 
clinical, operational, and health services research capacity at a center of 
research excellence in the foreign country; and (b) a formal letter of 
support from the Health Ministry and/or other senior government official that 
emphasizes the long-term commitment of the country to the goals of the 
proposed program.

13. Description of how the proposed training program will address the 
interest of the co-sponsoring institutions.

Budget Preparation 

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 pages 4 & 
5) in the "Other “ category to create a composite budget containing all 
direct costs for the applicant organization.  

Each applicant of the Research Training Unit should develop a budget that 
reflects the resources necessary to implement its components of the 
comprehensive training plan included in the application.  The total costs of 
the combined budgets should be within the guidelines provided in the FUNDS 
AVAILABLE section.  The budgets may include costs to support 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.

Requested Salary Support

The salary for the PIs and other faculty and staff must be commensurate with 
the salary structure or compensation package for similar professionals and 
staff at the applicant institution.

Trainees' Stipends

Trainees may be paid a stipend comparable to their professional experience 
similar to other equivalent trainees but not exceeding the NRSA stipend 
levels (http://grants.nih.gov/training/nrsa.htm) and in accordance with the 
grantee institutional policies while involved in long-term or intermediate-
term training at the grantee institution.  (Use the NRSA substitute pages, 
pre- or postdoctoral stipends.)

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 reduction 
arrangements with the grantee institutions in order to provide reduced 
tuition for long-term trainees and tuition-free short courses.  (Use the NRSA 
substitute pages, tuition, fees, insurance).

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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 2 of the face page of the application form 
and the YES box must be marked.  The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original, 
including the checklist, and five signed photocopies of the two applications, 
one from each partner, in a single package.  The two applications should be 
clearly bundled separately but sent together so that the two components of 
the Research Training Unit will be clearly identified and linked.  Submit the 
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 on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review.

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.

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.
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.

PEER REVIEW PROCESS 

For the Phase II Comprehensive ICOHRTA-AIDS/TB Awards, the applications 
specifying the roles and responsibilities of each of the partner institutions 
must be submitted together as a unit and the applications will be reviewed as 
a single unit.  Upon receipt, applications will be reviewed for completeness 
by CSR, and responsiveness by the Technical Advisory Group.  Incomplete 
and/or non-responsive applications will be returned to the applicant without 
further consideration.  Please see the Special Requirements section for a 
description of the documentation required for an application to be considered 
responsive. 

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by CSR in accordance with the review criteria stated below.  As part 
of the initial merit review, all applications will initially be reviewed to 
determine which are considered the most meritorious.  

CSR will conduct two peer review group meetings on the ICORHTA AIDS/TB 
applications in accordance with FIC's review criteria to determine which are 
considered the most meritorious.  The first meeting will be an initial merit 
review of all applications to evaluate the scientific and technical merit by 
an appropriate peer review group convened by CSR.  The second meeting will 
review those Phase II Comprehensive ICOHRTA-AIDS/TB applications deemed 
highly meritorious in the initial review and these applicants will have the 
opportunity to respond to questions that arose at the initial review.  The 
second review may include a site visit.  The results of both reviews will be 
considered by the review committee in determining the priority score.  Only 
applications that have received the second review will be eligible for 
funding, but all applicants will receive a written critique.  A second level 
review will be conducted by the FIC Advisory Board and possibly by the 
Councils or Advisory Boards of other co-sponsoring Institutes/Agencies.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
ICOHRTA-AIDS/TB program seeks to strengthen research capacity across the 
spectrum of clinical, operational, and health services research at specific 
foreign institutions to combat problems of HIV/AIDS, TB, and/or other 
HIV/AIDS-associated conditions relevant to that country's health.  In the 
written comments, reviewers will be asked to discuss these aspects of the 
application in order to judge the likelihood that the proposed program will 
have a substantial impact on the pursuit of each of these goals:

o  Significance
o  Approach
o  Innovation
o  Investigator and Institutions
o  Environment

The scientific review group will address and consider each of these criteria 
in reviewing your application and weighting them as appropriate for each 
application.  Note that the application does not need to be strong in all 
review categories to be judged likely to have major impact and thus deserve a 
meritorious priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

Review Criteria for Comprehensive ICOHRTA-AIDS/TB Award Applications

(1)  SIGNIFICANCE:

a) Expected contribution of the training program described in the 
applications of the Research Training Unit to the foreign institution's 
ability to conduct and manage integrated clinical, operational, and health 
services research.

b) Expected potential of the foreign institution to serve as a training site 
to advance a continuum of clinical, operational, and health services research 
and public health capacity within the country and within the region. 

(2)  APPROACH:

a) Adequacy of the described training program to provide breadth of training 
opportunities for the research trainees in all three of the research areas 
(clinical, operational, and health services).

b) Capability of the described training program to provide the trainees with 
the necessary administrative and management skills to compete for research 
support and conduct research.

c) Expected ability of the proposed training program to strengthen the 
capacity at the foreign institution over the life of the grant to develop 
degree programs and to provide opportunities for trainees and junior faculty 
to rise to scientific leadership positions in this or related programs.

d) Adequacy of the integrated application to demonstrate:
o  coordination between the research training activities of the linked 
applicants; and 
o  coordination and linkage with other related in-country research, training 
and public health programs.

(3)  INNOVATION:

a) Ability of the proposed training program to take advantage of the foreign 
institution's research infrastructure and of previous and current investments 
and support from FIC, NIH, CDC, USAID or other organizations.

b) Adequacy of the proposed training program to take advantage of relevant 
opportunities in other countries.

(4)  INVESTIGATOR:

a) Training and experience of the foreign PI, the collaborating PI and key 
personnel named in the integrated application to achieve the goals and 
implement the activities of the proposed training program.  Documentation 
should include:

o  Past research training record of the foreign PI, the collaborating PI and 
the designated preceptors in 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.  For foreign trainees, the 
percent whose professional activities are in the home country.  Please 
include tables with this information, including current status of foreign and 
other selected trainees for at least the past five years.

o  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 career development; major scientific 
breakthroughs and scientific leadership positions assumed by former trainees 
should be highlighted.

b) Documentation of a history of successful institutional and individual 
collaborations among the foreign PI, collaborating PI and key faculty of both 
institutions.  A successful history of collaborations is demonstrated by 
funded research or training grants that include the foreign PI at the foreign 
institution and the collaborating PI at the collaborating institution; by 
funded research or training grants that include both the faculty at the 
foreign institution and faculty at the collaborating institution; and by 
jointly authored publications in scientific peer-reviewed journals. 

(5)  ENVIRONMENT:

a) Documentation of written commitment by the foreign government and ministry 
of health and/or education or other officials to the long-term goals and 
activities of the program.  Examples include:  a statement of support from a 
senior administrator at the Foreign PI's institution; evidence of 
contributions by the host-country and willingness of the host-country to 
utilize trainees' experience and knowledge gained from the program to build 
integrated clinical, operational, and health services research capacity at a 
center of research excellence in the foreign country; and a formal letter of 
support from the Health Ministry and/or other senior government official in 
the foreign country that emphasizes the long-term commitment to the goals of 
the award.

b) Documentation of written commitment (agreement) by the foreign institution 
and its collaborating partners to cooperate to achieve the long-term goals 
and activities of the program. 

c) Plans for the proposed training program to take advantage of unique 
features of the scientific environment in the foreign country and to employ 
useful collaborative arrangements with other USG, other government and non-
governmental agencies active in addressing issues related to HIV/AIDS and/or 
TB and their associated conditions in the country, including how well the 
institutional development plan for the foreign site addresses these issues. 

d) The adequacy of mentoring resources and training environment in-country as 
evidenced by:  
o  the quality of teaching and the in-country research facilities; 
o the availability of high-quality candidates for training, chosen on merit;
o  the ability of the trainee recruiting and selection process to capture the 
most qualified individuals and to include an adequate representation of men, 
women and ethnic minorities or socially disadvantaged population groups among 
the developing country trainees; and  
o  a past history of success of former trainees contributing to their home 
countries and their programs by participation in advanced in-country research 
and as faculty and mentors for new trainees.
 
ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, in accordance 
with NIH policy, all applications will also be reviewed with respect to the 
following:

COLLABORATION WITH ICOHRTA AIDS/TB AWARDEES:  The adequacy of the proposed 
plan to work in collaboration with scientists at the ICOHRTA-AIDS/TB sites 
and associated NIH and USG scientists, health professionals and staff in 
proposed curriculum, training and evaluation activities. 

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.  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 REVIEW CONSIDERATIONS

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  November 19, 2004
Application Receipt Date:  December 20, 2004
Peer Review Date:  March 2004
Council Review:  May 2005
Earliest Anticipated Start Date:  July 1, 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review including a site visit, if 
conducted):  The most important factor to be considered in making funding 
decisions will be the quality of the proposed program, 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.

o  Availability of Funds

o  Programmatic priorities and geographic balance:  Geographic and 
programmatic balance, input from the collaborating partners and the FIC 
Advisory Board, and the adequacy of the commitment of the foreign country to 
the program, as well as the extent to which the program helps to integrate 
critical HIV/AIDS and/or TB efforts and related capabilities within the 
country, will also be considered in making funding decisions.  A 
consideration for funding will be whether the proposed research training and 
capacity building is integrated with or duplicates efforts in other FIC, NIH, 
and other international programs, and whether it supports a unique 
intervention opportunity not able to be accommodated by another FIC program.

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 

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.   (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.   
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the 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. 

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 ON 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 announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 data collected under this RFA 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 IDENTFIABLE 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).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
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 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

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


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