Full Text PA-96-033
NIH GUIDE, Volume 25, Number 7, March 8, 1996
PA NUMBER:  PA-96-033
P.T. 34

  Disease Prevention+ 
  Population Studies 

National Institute on Alcohol Abuse and Alcoholism
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.
Exploratory/developmental grants (R21) are intended to develop new
research activities that could serve as the foundation for the
development of more intensive and larger research studies.  Grants
supported under this program announcement will be limited to a
two-year effort and a maximum of $70,000 in direct costs per year.
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.
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of Healthy People 2000, a
PHS-led national activity for setting priority areas.  This program
announcement, Developmental Grants for Collaborative International
Projects, is related to the priority areas of alcohol abuse reduction
and alcoholism treatment.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report: Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325
(telephone: 202-512-1800).
Applications may be submitted by domestic non-profit and for-profit,
public and private, institutions such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  The U.S. scientist must
be a U.S. citizen or permanent resident of the United States, and
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.
Research support mechanisms are limited to exploratory/developmental
grants (R21) for up to $70,000 in direct costs per year for up to two
years.  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.  Indirect 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.
Although awards may be up to $70,000 in direct costs per year for two
years, the NIAAA estimates that the majority of
awards will be much smaller.  It is estimated that in Fiscal Year
1997 approximately four awards will be made depending on the quality
of applications, program priorities and the availability of funds.
Second year budgets should conform to current NIH cost-containment
policy of a four percent increase for recurring costs.  Support for
subsequent years may be requested through the regular research grant
programs of NIAAA.  Although the financial plans of NIAAA provide for
the support of this program, the award of grants pursuant to this
program announcement is contingent upon the availability of funds for
this program.
The purpose of this program announcement is to encourage
exploratory/developmental studies that would complement U.S. alcohol
research efforts.  The establishment of this 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 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 will facilitate:
a) standardized assessments of epidemiologic, 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
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.
Potential applicants with questions concerning acceptability of their
proposed study may contact NIAAA staff listed under INQUIRIES.
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 is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(concerning the Inclusion of Women in Study Populations), which have
been in effect since 1990. The new policy contains some provisions
that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email:  girg@drgpo.drg.nih.gov.
The title and number of the program announcement must be typed in
section 2 on the face page of the application.
Special Instructions for the Preparation of the Application are as
a)  Under key personnel: list the U.S. Principal Investigator,
foreign collaborator, including complete organizational address, and
key research collaborators.
b)  Travel must be well justified and include economy class airfare
on a U.S. carrier and subsistence.  Travel expenses may not exceed 15
percent of the total direct costs in each budget period.  Travel
funds to attend scientific meetings exclusively are not allowed.  Per
diem costs should be reduced for visits exceeding two weeks.
c) The foreign collaborator's biographical sketch and bibliography
may not exceed two pages.  Relevant positions and all publications
from at least the last three years should be listed.  Thoroughly
describe the current position of the foreign collaborator.
d) Foreign collaborators must include evidence of approval to conduct
the research from their institution and/or Public Health authority as
e) Foreign collaborators must include a signed letter describing
their commitment to the collaborative effort.
f) Human Subjects and Animal Welfare Assurances: If human subjects
and/or vertebrate animals will be used as part of the project at the
foreign site, then appropriate assurances from both the U.S. and the
foreign institution must be filed with and approved by the Office of
Protection of Research Risks (OPRR), NIH as a precondition for award.
These assurances must comply with U.S. regulations.  The assurances
from the U.S. institution must have been filed and approved by OPRR
(phone:301-496-7041 for human subjects; 301-496-7163 for laboratory
animals) at the time of submission.  Applicants will receive specific
information for obtaining the foreign assurances following the
initial review of the application.
The completed original application and five legible copies must be
sent or delivered to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817-7710 (for express/courier service)
Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer 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 the applications under review will be discussed, assigned a
priority score, and receive a second level review by the appropriate
national advisory council.
Review Criteria
Criteria to be used in the scientific and technical merit review of
exploratory/developmental (R21) applications will include the
1.  The scientific, technical, health or medical significance, and
innovativeness or promise of the proposed research.
2.  The degree to which the proposed collaboration presents
opportunities for furthering research programs 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 United States
3.  The potential of the proposed study as a building block in the
development of future research, particularly international
4.  The appropriateness and adequacy of the research design and
methodology proposed to implement the research plan.
5.  The adequacy of the qualifications (including level of education
and training) and relevant research experience of the principal
investigator, key personnel, and the ability of the foreign
collaborator to undertake and direct the foreign research activities
of the project.  Extent of past international collaboration,
research, research training, scientific exchange, and joint
publications and a extent of prior research support from NIH or other
Federal, State or private funding organizations.
6.  The availability of adequate facilities and general environment
for the conduct of the proposed research and other resources, as well
as collaborative arrangements.
7.  The appropriateness of budget estimates and duration in relation
to plans for the research.
8.  Adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will
also be evaluated.
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.  Final assurances will be required as a
condition of award.
Applications recommended for approval by the National Advisory
Council on Alcohol Abuse and Alcoholism will be considered for
funding on the basis of the overall scientific and technical merit of
the proposal as determined by peer review, NIAAA program needs and
balance, geographical considerations, cost effectiveness of the
planned research, and the availability of funds.
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding potential research to:
Faye J. Calhoun, D.P.A., M.S.
Office of Collaborative Research Activities
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 400 - MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2593
FAX:  (301) 443-7043
Email:  fcalhoun@willco.niaaa.nih.gov
Peggy Murray, M.S.W.
Office of Collaborative Research Activities
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 400 - MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2593
FAX:  (301) 443-7043
Email:  pmurray@willco.niaaa.nih.gov
Direct inquiries regarding fiscal matters to:
Linda Hilley
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0915
FAX:  (301) 443-3891
Email:  lhilley@willco.niaaa.nih.gov
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.273. Awards are made under the authorization of
the Public Health Service Act, Sections 301 and 464H, and
administered under the PHS policies and Federal Regulations at Title
42 CFR Part 52 and 45 CFR Part 74.  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 recipients to provide a
smoke-free workplace and promote the non-use of 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 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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