DEVELOPMENTAL GRANTS FOR COLLABORATIVE INTERNATIONAL PROJECTS

Release Date:  December 20, 2000

PA NUMBER:  PAR-01-038

National Institute on Alcohol Abuse and Alcoholism

THIS PROGRAM ANNOUNCEMENT (PAR) USES THE "MODULAR GRANT" AND "JUST-IN-TIME" 
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION 
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO 
THIS PA.

This Program Announcement (PA) replaces PA-96-033, which was published in NIH 
Guide March 8, 1996 and will expire three years from the date of issuance, 
unless reissued.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting 
applications for exploratory/developmental grants for collaborative 
international projects.  The goal of this program announcement is to 
establish new or strengthen existing cooperative relationships between U.S. 
and foreign alcohol research scientists.  While awards under this program are 
intended to enhance and extend the research of the U.S. scientist, it is 
expected that the projects supported will be mutually beneficial to advancing 
research on alcohol abuse and alcoholism in the collaborating nation.

The objective of the exploratory/developmental grant mechanism (R21) is to 
encourage 
applications from individuals who are interested in testing innovative or 
conceptually creative ideas that are scientifically sound and may advance our 
understanding of alcohol abuse and alcoholism.  Another objective is to 
encourage necessary initial development to provide a basis for important 
future research.  Investigators are encouraged to use this mechanism to 
explore the feasibility of an innovative research question or approach, which 
may not be justifiable through extant research, or competitive as a standard 
research project grant (R01).

The issues related to alcohol use, abuse, alcoholism, and the reduction of 
alcohol-related problems are global.  Much has been learned from the 
international exchange of research findings and observations on the etiology, 
prevention and treatment of alcohol abuse and alcoholism.  While much is 
gained from the exchanges that occur at international meetings and workshops, 
there is a need to assure that some exciting and potentially seminal findings 
reported by foreign investigators are more fully explored and developed 
through mutually beneficial collaborative research.

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 Program Announcement 
(PA), Developmental Grants for Collaborative International Projects  is 
related to one or more of the priority areas.   Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal Government.  The U.S. scientist must apply as principal 
investigator with a colleague or colleagues from foreign laboratories or 
research sites.  It is recognized that scientific opportunities may arise 
that warrant a formal collaborative effort between the U.S. investigator and 
individuals from more than one country.  The foreign collaborator(s) must 
hold a position at a public or private non-profit institution that will allow 
him or her adequate time and provide appropriate facilities to conduct the 
proposed research.  The linkages for international collaborative efforts may 
be between institutions in the United States and those in industrialized 
nations or developing countries.  Simultaneous submissions of both an 
exploratory/developmental and regular research grant application on the same 
topic will not be accepted.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH), 
exploratory/developmental grant (R21)  mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely 
that of the applicant. These are short-term awards with limited funding.  
Normally, grants under this PA will be for $50,000 or $75,000 per year for 
direct costs for two years.  If strongly justified, grants can be considered 
up to the $100,000 (direct costs per year) and three year maximum levels. 

Facilities and Administrative (F&A) costs will be awarded based on the 
negotiated rate at the time of the award. These awards are not renewable; 
however, a no-cost extension of up to one year may be granted to the grantee 
institution prior to expiration of the project period.  Investigators are 
encouraged to seek continued support for their research projects through a 
research project grant (R01).

Awards are made to the U.S. applicant institution to support a collaborative 
research project that will be performed, in part, at the foreign 
collaborator’s research site.  F&A costs will not be allocated to any funds 
sent for collaborative purposes to another country.  Funds may be included to 
purchase supplies for the foreign collaborator’s laboratory and to support 
travel for both the U.S. and foreign collaborators, as justified by the needs 
of the research proposed.  Annual awards will be made subject to progress 
achieved and continued availability of funds.
Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm. 

RESEARCH OBJECTIVES

The NIAAA Exploratory/Developmental Grant (R21) Program provides limited 
financial support for exploring the feasibility of innovative or creative 
research questions within the research interests of the NIAAA.  This includes 
basic and applied research on biochemical, physiological, genetic, and 
behavioral mechanisms leading to pathological drinking behavior; mechanisms 
of alcohol-induced organ damage, including fetal injury; and clinical, 
behavioral, and epidemiological approaches to more effective diagnosis, 
prevention, and treatment of alcoholism, alcohol abuse and alcohol-related 
problems.   This Program Announcement also requests research applications 
that address epidemiology, behavior and biomedical research in alcohol abuse 
and infectious disease with a specific focus on the global epidemic of HIV 
infection. Such research studies could include: the impact of alcohol abuse 
and dependence on the progression of  infection; epidemiology of alcohol 
problems and infectious disease; and the effect of alcohol abuse and 
dependence on compliance with medical therapies. 

While applications may involve a wide variety of biomedical, behavioral, 
clinical, social, cultural, or other disciplines, relevance to the mission of 
the NIAAA must be clear.  The Institute's mission statement, extramural 
research program descriptions, list of special emphasis areas, and active 
program announcements may be found at the NIAAA's Internet web site: 
http://www.niaaa.nih.gov.

The purpose of this program announcement is to encourage 
exploratory/developmental studies that would complement U.S. alcohol research 
efforts.  The program will allow the accumulated knowledge and experience of 
U.S. alcohol research scientists to enhance collaboration with their 
colleagues on a global basis to address common issues and problems.

While the problems and issues around alcohol use, abuse and alcoholism are 
universal, cross-national comparisons of research findings have been 
difficult.  Differences in terminology and definition, study design, research 
methodology, and data analysis often yield reports which are inconsistent.  
Differences in drinking patterns, alcohol policies, the type of alcohol 
(alcoholic beverage) consumed, or differences in the social and medical 
consequences of abuse present obstacles to cross national comparisons.  
Because the United States is a multi-cultural, multi-ethnic nation with 
variations in the patterns, trends and practices around alcohol use and 
abuse, much can be gained from international research partnerships in this 
field where the experience of other cultures and availability of unique 
research opportunities will be helpful.

It is anticipated that this program will provide support to pursue or verify 
intriguing research observations reported in foreign literature using 
different technologies or methodologies; to collaboratively pilot-test a 
hypothesis before a larger more complex project is developed; to develop new 
technology or to assure the study of appropriate comparison groups.  The 
intent is to advance global understanding, contribute meaningfully to the 
international literature, and to significantly advance alcohol research 
efforts in the United States.

Although international meetings and workshops have led to an increase in 
collaborative projects and constructive dialogue, more joint project planning 
and implementation would be beneficial. It is anticipated that collaborative 
efforts established through this program would facilitate the following:
 
a) standardized assessments of epidemiological, biomedical, behavioral, 
treatment, prevention, and policy research observations;

 b) studies to explore more fully intriguing observations and innovations 
which might be critical to the advancement of the field;

c) the development of unique methods or resources; and

d) development of the foundation for the coordinated conduct of  
scientifically sound studies and interventions on an international basis.

Applications may be made for support of research in any scientific area 
relevant to alcohol abuse.  While applications may involve a wide variety of 
biomedical, biobehavioral, or clinical disciplines, relevance to the mission 
of the Institute must be clear. Applications for studies aimed at problems 
outside these areas will be returned without review. 

Areas of interest to NIAAA are described in program announcements, which can 
be obtained on the Internet (http://www.niaaa.nih.gov) or from the National 
Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, 11426-28 
Rockville Pike, Suite 200, Rockville, MD 20852, telephone (301) 468-2600.

Travel costs must be for collaborative research purposes only and should be 
kept to a minimum.  Travelers must use economy class airfare on a U.S. 
carrier.  Per diem costs should be reduced for visits exceeding two weeks.

Foreign collaborators must submit a signed letter from their institution 
and/or Public Health authority, as appropriate, stating approval to conduct 
the research.  The foreign collaborator must also submit a signed letter 
describing his/her commitment to the collaborative effort.

Domestic applicants should also be aware of the program announcements for the 
NIAAA Small Grant (R03) Program PA-99-098 and the NIAAA Behavioral Science 
Track Awards for Rapid Transition (B-START) PA-99-043.  These two programs 
are for Small grants (R03) for pilot studies for up to $50,000 per year for 
direct costs for up to two years. The two NIAAA R03 programs limit the 
Research Plan (Sections A-D) to a total of 10 pages and also provide for 
expedited review and funding in a six or seven month period.  This is two to 
three months
shorter than the normal funding cycle for regular research grants (R01).  The 
Small Grant (R03) and B-START program announcements are also available on the 
NIAAA Home Page.  Foreign Institutions are not eligible for Small Grants or 
B-START awards.

Applicants are requested to contact appropriate program staff at NIAAA for 
assistance in preparation of an application. Appropriate staff contacts are 
listed under INQUIRIES.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

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

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit. Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email: GrantsInfo@nih.gov.

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 Institute 
staff. The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $100,000 per year.  The total direct costs 
must be requested in accordance with the program guidelines and the 
modifications made to the standard PHS 398 application instructions described 
below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $100,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the initial 
budget period Items 8a and 8b should be completed indicating the Direct and 
Total Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398. It is not required and will not be accepted with the 
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398. It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.) At the top of the page, enter the total direct costs requested 
for each year. This is not a Form page.

o Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000. List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project. Indicate whether the collaborating institution 
is foreign or domestic. The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount. 
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team. A biographical sketch is required for 
all key personnel, following the instructions below. No more than three pages 
may be used for each person. A sample biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing
   or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

CHECKLIST - This page should be completed and submitted with the application. 
If the F&A rate agreement has been established, indicate the type of 
agreement and the date. All appropriate exclusions must be applied in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

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)
REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened in accordance with 
the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the National Advisory Council on Alcohol Abuse and Alcoholism.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high 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.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field? What is the potential of the proposed study as a building 
block in the development of future research, particularly international 
collaboration?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Does the collaboration present opportunities for 
furthering alcohol research through the use of unusual talents, resources, 
populations, or environmental conditions in other countries which are not 
readily available in the United States or which provide augmentation of 
existing U.S. resources?

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

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?   What is 
the extent of past international collaboration, research, research training, 
scientific exchange, and joint publications and extent of prior research 
support from NIH or other Federal, State or private funding organizations?  
Does the foreign investigator have the ability to undertake and direct the 
foreign research activities of the project?

(5) Environment:  Does the scientific environment in which the 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?  At the foreign institution?

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

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

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

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.

In addition, applications will be evaluated by criteria specifically related 
to the intentions of this Program Announcement as outlined above.

Additional consideration pertinent to the review of Exploratory/Developmental 
Grant (R21) applications:

Pilot/feasibility studies may contain little or no preliminary data.  Review 
should focus on  whether  the rationale for the study is well developed and 
whether the proposed research is likely to generate data that will lead to a 
regular research project grant or full-scale clinical trial.  Adequate 
justification for the proposed work may be provided through literature 
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions: 
scientific merit of the proposed project as determined by peer review, 
availability of funds, and program priorities.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Margaret M. Murray, M.S.W.
Coordinator International Research and Training
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-2594
Fax: (301) 443-7043
E-mail: pmurray@willco.niaaa.nih.gov

Faye J. Calhoun, D.P.A., M.S.
Director 
Office of Collaborative Research 
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-1269
Fax: (301) 443-7043
E-mail: fcalhoun@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to: 

Ms. Judy Simons 
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone: (301) 443-2434
Fax: (301) 443-3891
E-mail: js182a@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.273.  Awards are made under authorization of sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, 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.


Return to Volume Index

Return to NIH Guide Main Index


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


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.