FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD (FIRCA)

RELEASE DATE:  February 6, 2002

PA NUMBER:  PA-02-057  (This PA has been modified, see PAR-05-072 and PAR-05-073. See also NOT-TW-05-004.)
                       (Notice of Extension, see NOT-TW-05-001)
                       (See NOT-TW-04-002)

EXPIRATION DATE:  March 18, 2005

PARTICIPATING INSTITUTES AND CENTERS (ICs):

Fogarty International Center (FIC)
 (http://www.nih.gov/fic)
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)
 
Application Receipt Dates:  March 25, 2005

THIS PA CONTAINS THE FOLLOWING INFORMATION:

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

PURPOSE OF THIS PA

The Fogarty International Research Collaboration Award (FIRCA) facilitates 
collaborative research between U.S. biomedical scientists supported by the 
National Institutes of Health (NIH) and investigators in the developing 
countries of Africa, Asia, Latin America and the Caribbean Region, as well as 
in countries of the former Soviet Union (FSU), and Central and Eastern Europe.  
The FIRCA will extend and enhance the research interests of both the U.S. 
scientist and the collaborating scientist, and will help to increase the 
research capacity of the foreign scientist and institution.  Awards are made 
to the U.S. applicant institution to support a collaborative research project 
that will be carried out mainly at the foreign collaborator"s research site.

Direct costs of $32,000 per year is available for up to three years to help 
cover purchase of supplies, equipment and for technical assistance at the 
foreign collaborator"s laboratory or research site, a small salary or 
consultant fee for the foreign investigator, and travel for the U.S. and 
foreign collaborators and their research associates, as justified by the needs 
of the collaborative research.

All biomedical and behavioral research topics supported by the NIH are 
eligible for inclusion under this program.  Investigators working on topics 
related to human immunodeficiency virus (HIV), acquired immunodeficiency 
syndrome (AIDS) or related illnesses should apply for the Fogarty 
International Center"s HIV/AIDS and Related Illnesses Collaboration Award 
(AIDS-FIRCA):  see the AIDS-FIRCA announcement in the NIH Guide and at the FIC 
web site (http://www.nih.gov/fic/programs/aidsfirc.html).

RESEARCH OBJECTIVES

An important role of the FIC is to foster discovery and reduce global health 
disparities through the support of international cooperation across the 
continuum of basic, clinical and applied biomedical, behavioral and health 
sciences. The opportunity to collaborate internationally provides a means of 
access to new information and perspectives, innovative concepts and methods, 
emerging research technologies, and unique populations and environments 
important for addressing global health problems.  The main objectives of the 
FIRCA program are:  1) to support collaborative research efforts between U.S. 
and foreign scientists on research of high scientific merit and mutual 
interest and benefit, and 2) to help build research capabilities at the 
foreign site and foster further sustained and productive research and research 
collaborations at the foreign site.

MECHANISM OF SUPPORT

The FIRCA will use the NIH small research project grant (R03) mechanism.  One 
module of $32,000 of direct costs per year for up to three years may be 
requested.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting format 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).  The modular 
grant concept establishes specific modules in which direct costs may be 
requested as well as a maximum level for requested budgets.  Only limited 
budgetary information is required under this approach.  The just-in-time 
concept allows applicants to submit certain information only when there is a 
possibility for an award.  It is anticipated that these changes will reduce 
the administrative burden for the applicants, reviewers and NIH staff.  

Continuation of the FIRCA project depends upon satisfactory research progress 
and availability of funds.  The FIRCA grant will remain active if the parent 
grant expires and is not renewed during the FIRCA project period

ELIGIBLE INSTITUTIONS

Only domestic U.S. organizations are eligible to apply.  You may submit (an) 
application(s) if your institution has any of the following characteristics:

o  For-profit and non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals 
(including Veteran"s Administration hospitals), and laboratories
o  Units of State and local governments
o  Domestic
o  Faith-based organizations

Eligible foreign collaborating 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 
(NIS) of the former Soviet Union (FSU), Latin America and the Caribbean, the 
Middle East, and the Pacific Ocean Islands (except Australia and New Zealand).  
Note:  Applicants should check 
http://www.nih.gov/fic/regional/CountryInstructions.html for special 
considerations relative to some potential collaborating countries.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research and who meets the other eligibility requirements 
below is invited to work with their institution to develop an application for 
support.  Individuals from underrepresented racial and ethnic groups, women 
and individuals with disabilities are always encouraged to apply for 
NIH programs.  

The U.S. scientist, who must have current NIH-funded research, will apply as 
Principal Investigator, with a colleague from a laboratory or research site in 
an eligible country.  Occasionally, scientific opportunities may arise that 
warrant a formal collaborative effort between the U.S. investigator and 
individuals from more than one country.  Such applications may be considered 
only after consultation with and pre-approval by FIC program staff.

The foreign collaborator must hold a position at an eligible public or private 
non-profit institution that will allow him or her adequate time and provide 
appropriate facilities to conduct the proposed research.

SPECIAL REQUIREMENTS

o  The U.S. applicant must be Principal Investigator or project director on a 
NIH research project grant (referred to as the "parent grant") that will be 
active and funded at the start of the proposed FIRCA budget period.  Eligible 
mechanisms are the R01, P01, or U01.  Principal Investigators of subprojects 
of a program project (P01) or Cooperative Agreement (U01 and U19) are 
eligible.  Other R, P and U mechanisms, and significant subprojects within 
these mechanisms, will be considered on a case by case basis after 
consultation with and pre-approval by the FIC FIRCA Program Officer. Among the 
mechanisms not accepted as parent grants are training grants and research 
contracts, Center Core Grants (P30), Small Business Innovative Research Awards 
(R43), STTR (R44) and Shannon Awards (R55).

o  The parent grant must have a minimum of 12 months of funding, which may 
include a no-cost extension, remaining at the time of application deadline to 
be eligible to apply for FIRCA funding.  

o  The FIRCA research proposal may be an extension or a new direction of the 
parent grant.  However, the proposed research must not overlap with research 
already supported by the U.S. investigator"s parent grant or by other sources.  
If the proposal is for work that is not an obvious extension of the parent 
grant, the research must be clearly within the expertise and field of interest 
of both the U.S. and foreign collaborators, as indicated by the general area 
of science in the parent grant and other research support and published work.  
Such research should ideally make use of the comparative strengths of the U.S. 
and foreign investigators. Special consideration may be given to proposed 
research which addresses significant global health problems, particularly 
those of high relevance to the foreign country or region, and to research that 
makes use of unique or special resources, circumstances or environment of the 
foreign site.

o  There is no limit to the number of distinct FIRCA grants an applicant may 
be awarded over time and applicants may already be FIRCA grantees at the time 
of application.  However, only one FIRCA application may be submitted by the 
same U.S. investigator per review cycle.

o  Applicants may apply for only one competitive renewal for an additional 
three years of a given FIRCA award, providing the above-mentioned criteria are 
satisfied at the time of application for the renewal. Current grantees may 
want to consider whether their collaboration has developed to the point where 
they can submit an R01 research grant.  

o  The research under the FIRCA award is to occur mainly at the foreign site 
and the major portion of the funds and items purchased must be used at the 
foreign site to support this research.

WHERE TO SEND INQUIRIES

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 issues.

o  Direct your questions about scientific/research issues to:

FIC:
Dr. Kathleen Michels
Program Officer
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  301-496-1653
Fax:  301-402-0779
Email:  FIRCA@nih.gov

Ms. Janice Solomon
Program Specialist
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  301-496-1653
Fax:  301-402-0779
Email:  solomonj@mail.nih.gov

Direct your questions about financial or grants management matters to:

Mr. Randolph Williams
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  301-496-5710
Fax:  301-594-1211
Email:  willrand@mail.nih.gov

NIEHS:
Christopher Schonwalder, Ph.D.
Director, Office of International Programs
National Institute of Environmental Health Sciences
111 Alexander Drive
Research Triangle Park, NC  27709
Telephone:  919-541-4794
Fax:  919-541-2260
Email:  cs64c@nih.gov

The NIEHS (http://www.niehs.nih.gov/) is interested in co-funding FIRCAs that 
are relevant to its mission and are selected to be paid by FIC.  Through the 
use of the FIRCA grant mechanism, FIC and NIEHS wish to develop collaborative 
programs between established environmental health researchers and 
investigators in developing countries with access to unique research 
opportunities.  This includes laboratory- and population-based studies on the 
effects of exposures to pollutants in air, water, food, and through 
occupation, as well as studies of susceptibility factors due to genetics, age, 
or nutritional status.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001) along with the supplemental instructions 
below.  The PHS 398 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.  Additional important information and 
clarifications may be found under the Frequently Asked Questions section of 
the FIC FIRCA web-site http://www.nih.gov/fic/programs/fircin2.html.

SUPPLEMENTAL INSTRUCTIONS

Under the Description Section: 
Please include the name of the foreign country and institution, the foreign 
collaborator and the grant number in your description.  (e.g., "This research 
will be done primarily in Peru at Lima University in collaboration with Jorge 
Smith as an extension of NIH grant # R01HL98765.")

Performance Site Section: 
Provide full name and address of the foreign institution where the research 
will be performed.  Also provide the full number of the NIH parent grant and 
the dates of the award (e.g., R01HL98765-01, 9/30/2000 - 9/29/2003). 

Research Plan - special instructions:
Follow the instructions for the PHS 398 except as described below (and note 
that the research plan must not exceed ten pages for sections a-d):

Introduction:  
Original FIRCA applications should have a one-page introduction in which you 
describe the nature of the proposed collaboration, and discuss any relevant 
previous collaborative arrangement(s).  In cases where the Principal 
Investigator has previously served as a mentor to the foreign collaborator, 
address the independence of the foreign collaborator in regards to the 
proposed FIRCA research.  In particular, address respective contributions to 
the preparation of the research proposal.

Specific Aims: 
List the specific aims of the parent grant exactly as written in the parent 
grant.  If these are longer than one page, you may summarize them and indicate 
that you have done so.  If the FIRCA is more closely related to another funded 
(but not FIRCA-eligible) grant, please be sure to give the specific aims of 
that grant here also.  Then, list the specific aims of the FIRCA proposal.  
Finally, discuss how the specific aims of the FIRCA relate to the aim(s) of 
the parent grant, and other relevant grant, if applicable. 

Research Design and Methods:  
Follow the instructions described in PHS Form 398 instructions, however at the 
end of this section outline the proposed contributions of the U.S. Principal 
Investigator and the foreign collaborator to the study.  Describe exactly 
where and when each aspect of the work will be carried out and by whom.  This 
will allow reviewers to assess the contributions of each laboratory and 
predict the likelihood for success.

Collaborator Assurance:  
Attach a letter (on institutional letterhead) from the foreign collaborator 
confirming his/her role in the project.  Also, provide a statement confirming  
the foreign collaborating organization"s willingness to comply with all 
pertinent U.S. Federal regulations and policies.  For example, the institution 
must be willing to support the collaboration with time and resources for the 
foreign collaborator, to provide necessary documentation to the U.S. 
institution for tracking expenditures, and provide necessary documentation to 
OHRP for human or animal involvement, if necessary.  The letter must be 
cosigned by the Head of a department, Dean, or other academic official.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Section C, item 3, of 
the research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Follow the modular 
grant directions except that FIRCA, applications must be submitted as one 
module of $32,000 in direct costs.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.

Budgetary Restrictions:
Applications will be submitted using the modular grant process but FIRCA 
grants will have the following budget restrictions that must be considered in 
the development of the modular budget:  

1.  Travel funds for the Principal Investigator, foreign collaborator, or 
colleagues to visit the research sites must not exceed $7,000 annually.
2.  Travel funds for the foreign collaborator to attend scientific conferences 
must not exceed $2,000 annually.
3.  Consultant fees for the foreign collaborator(s) must not exceed a total of 
$5,000 annually.
4.  Salary for the Principal Investigator, or any other staff at the U.S. 
site, is not allowed.

Checklist: 
Facilities and Administrative costs:  Facilities and Administrative (F&A) 
Costs must be calculated on the basis of the off-site rate of the U.S. 
sponsoring institution.

For applications that have foreign subcontracts, F&A costs of up to eight 
percent can be requested by the foreign institutions.  F&A costs for a foreign 
subcontract are considered direct costs on the applicant"s application and 
should be included as part of the $32,000 that can be requested.  Please see 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more 
information on the F&A costs allowed for foreign institutions and 
international organizations.

SENDING AN APPLICATION TO THE NIH:  The application, along with all required 
supplemental information, must be submitted as a single package by the U.S. 
grantee"s institution.  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)
Telephone:  301-435-0715

APPLICATION PROCESSING:  Applications must be received by the receipt dates 
described on the first page of this PA.  If the receipt date falls on a 
weekend or holiday, the deadline is automatically extended to the following 
Monday or business day.  The Center for Scientific Review (CSR) will not 
accept applications that are submitted after the pertinent deadline. 

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.  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 critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned to FIC. The research 
proposals will be reviewed for scientific and technical merit and quality of 
the collaboration by the International and Cooperative Projects study section, 
a broadly multidisciplinary review group in the Center for Scientific Review 
(CSR), NIH, convened in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm).

As part of the initial merit review, all applications:

o  Will receive a written critique
o  May undergo a selection process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed and assigned a priority score
o  Will receive a second level review by the appropriate national advisory 
council or board.

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 
FIRCA program also addresses important factors associated with international 
collaborative research and research capacity building at the foreign research 
site.  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 goals:

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment
o  Research Capacity Building

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 impact on the scientific field 
and/or research capacity building of the foreign collaborator, their country 
or institution, and may thus deserve a high priority score.  For example, you 
may propose to carry out important work that, by its nature, is not innovative 
but is essential to move a field forward.  In one example, an investigator may 
propose research on an important topic in a developing country with 
underdeveloped research infrastructure but with unique resources, environment 
or knowledge not readily available in the U.S. or other developed nations.  
Such projects may be slower to achieve their scientific goals but may receive 
special consideration for their potential to build research capacity along 
with significant scientific impact in the long-term.  The criteria are 
as follows:

(1) SIGNIFICANCE:  Does your study address an important problem?  If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that drive 
this field?  

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider 
alternative tactics?

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

(4) INVESTIGATOR:  Are you and the foreign collaborator appropriately trained 
and well suited to carry out this work?  Is the foreign collaborator able to 
undertake and direct the foreign research efforts?  Is the work proposed 
appropriate to your experience level as the Principal Investigator and to that 
of the foreign collaborator and other researchers?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional support?

(6) RESEARCH CAPACITY BUILDING:  Does the collaboration have the potential to 
enhance the research capability of the foreign collaborator and the foreign 
site?  Does the research constitute a substantial scientific endeavor for the 
foreign collaborator, including creative and scientific input to the research 
proposal?  The foreign site and investigator should not be used merely to 
gather biological samples (clinical, plants, etc), or behavioral data 
(interviews, surveys, etc).  In all cases, the foreign investigator should be 
actively involved in analyzing and interpreting the data.  Is the research on 
a problem of particular relevance for the foreign country involved?  Are the 
resources necessary to perform the research available or obtainable?

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

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated.  (See Inclusion Criteria included in the 
section on Federal Citations, below.)

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

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

AWARD CRITERIA

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 program priorities
o  Participation/interest of other NIH Institute, Center or Office 

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and 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 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 
(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 a NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that:  a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups, if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION 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.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for Federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned 
without review.  

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place 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 a NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
PA, the Fogarty International Research Collaboration Award, 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 No. 
93.989 and is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.  Awards made under 
authorization of Sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241and 284 and administered under NIH grants policies 
described at http://grants.nih.gov/grants/policy/policy.htm 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, and 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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