From: kristoff@NET.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 40, pt. 2, 6 November 1992
Date: 5 Nov 92 18:50:48 GMT
Distribution: bionet


$$XID NIHGUIDE 19921106 V21N40 P2O2 ************************************
production of Interleukin-6 and the effects of corticosteroids
following stress and trauma.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and 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.
Applications from minority individuals and women are encouraged.
Applicants for K- and F-series awards must be U.S. citizens, non-
citizen nationals, or have been lawfully admitted for permanent
residence at the time of award.

MECHANISMS OF SUPPORT

o  Research grant (R01)

o  Program Project grant (P01)

o  First Independent Research Support and Transition (FIRST) award
(R29)

o  Career grants, which include:  Research Career Development Award
(K04); Clinical Investigator Award (K08); Physician Scientist Award
(individual K11)

o  Fellowships (F32, F33)

Deadlines for applications are as follows:

F-series grants:                     Jan 10, May 10, Sep 10
New R, K, and P-series:              Feb 1, Jun 1, Oct 1
Competing continuation and revised:  Mar 1, Jul 1, Nov 1

Foreign institutions are not eligible to apply for Program Project
(P01) awards, or FIRST awards (R29).

RESEARCH OBJECTIVES

The NIA invites researchers to submit applications for research grants,
career development awards, and postdoctoral fellowships for studies on
the role of DHEA/DHEAS and their metabolic products as they interface
with fundamental aging.  Of particular interest is the pathway of
action and its possible role as a biomarker of aging, including the
decline of the immune system and the propensity for increased disease
in aging.  Of interest also are potential intervention methods to delay
and control the aging process with respect to the susceptibility to
diseases of the immune, endocrine, and other physiologic systems.

Although the interaction of DHEA/DHEAS and their metabolic products and
analogs with components of the immune system and various
pathophysiologic processes is of primary interest in this Program
Announcement, other relevant areas of investigation exploring the
communication between the immune and endocrine systems in aging mammals
are also of interest and are included within the scope of this Program
Announcement.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women in
study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis must be placed on the need for inclusion of minorities
and women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply to
males and females of all ages. If women or minorities are excluded or
inadequately represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale must be
provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study. This information must be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 3,
Recruitment of Individuals from Underrepresented Racial/Ethnic Groups,
and Section 5, Human Subjects.  Applicants are urged to assess
carefully the feasibility of including the broadest possible
representation of minority groups. However, NIH recognizes that it may
not be feasible or appropriate in ALL research projects to include
representation of the full array of United States racial/ethnic
minority populations (i.e., Native Americans  including American
Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,
Hispanics). The rationale for studies on single minority population
groups must be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply. Basic research or clinical studies in which human tissues cannot
be identified or linked to individuals are excluded. However, every
effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the review will be deferred until the information is provided.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies. If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies. NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398
(rev. 9/91) and will be accepted at the standard application deadlines
as indicated in the application kit.  The receipt dates for
applications for AIDS-related research are found in the PHS 398
instructions.  National Research Service Award (NRSA) (F32, F33)
applications are to be submitted on grant application Form PHS 416
(rev. 10/91).

Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Westwood Building, Room  449, Bethesda, MD 20892, telephone
301/496-7441.  The title and number of this announcement must be typed
in Section 2a on the face page of the application.

Applications from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator could be included with the
application.

The completed original application and five legible copies must be sent
or delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

REVIEW PROCEDURES

All applications in response to this Program Announcement will be
assigned to Initial Review Groups on the basis of the PHS Referral
Guidelines and reviewed by the usual Public Health Service Peer Review
(Study Section) procedures.  They will also be given appropriate
primary and secondary Institute assignments in accordance with
established PHS Referral Guidelines.  The review criteria are the
traditional criteria appropriate to each mechanism.  In accordance with
the standard NIH peer review procedures, research project grant (R01
and R29) applications, fellowships (F32, F33) and research career
development awards (K04) will be reviewed for scientific and technical
merit by appropriate study sections in the Division of Research Grants.
All other applications will be reviewed by review groups of the
appropriate Institute.  Following the Study Section review, the
applications will receive a second-level review by appropriate advisory
councils.  Funding decisions will be based on the above evaluations and
on the availability of funds.

AWARD CRITERIA

Applications compete for available funds on the basis of scientific
merit with other applications.  The following will be considered in
making funding decisions:

o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement

INQUIRIES

Researchers considering an application in response to this announcement
are strongly encouraged to discuss the projects and the range of grant
mechanisms available, with NIA staff.  This can be done either through
a telephone conversation or a brief letter. Applications related to the
health of women and minorities are particularly encouraged.

Correspondence and inquiries may be directed to:

Dr. David Lavrin
Immunology Program Administrator
Biology of Aging Program
National Institute on Aging
Gateway Building, Room 2C231
Bethesda, MD  20892
Telephone:  (301) 496-6402

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.855.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 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.

$$P2 END ************************************************************


$$XID RFA DK9312 DK-93-12 P1O1 *****************************************

RESEARCH USING THE UNITED STATES RENAL DATA SYSTEM

NIH GUIDE, Volume 21, Number 40, November 6, 1992

RFA:  DK-93-12

P.T. 34; K.W. 0785095, 0755018

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  April 19, 1993
Application Receipt Date:  May 18, 1993

PURPOSE

The purpose of this initiative is to invite grant applications for
biomedical research questions that can be answered using the United
States Renal Data System (USRDS) database.  Awarded funds will be used
to generate the data file through the USRDS Coordinating Center and to
support the investigator's analysis of the data.

HEALTHY PEOPLE 2000

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 Request
for Applications (RFA), Research Using the United States Renal Data
System, is related to the priority area of diabetes and chronic
disabling conditions. Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign organizations,
public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible
agencies of the Federal government.  Minority individuals and women are
encouraged to submit as Principal Investigators.

MECHANISM OF SUPPORT

Support of this program will be through the investigator initiated
research project grant (R01) mechanism.  Each grant award will not be
more than $50,000 total cost (including direct and indirect costs).
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  Awards will be
administered under PHS grants policy as stated in the PHS Grants Policy
Statement.

This RFA is a one-time solicitation.  Generally, future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  The total requested project period
for each applications submitted in response to this RFA may not exceed
two years.  The earliest possible award date will be January 1994.

FUNDS AVAILABLE

It is anticipated that approximately ten awards will be made; however,
this funding level is dependent upon the receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), the award of grants
pursuant to this RFA is also contingent upon the availability of funds
designated for this purpose.

RESEARCH OBJECTIVES

End-stage renal disease (ESRD) treatment is costly, and the number of
patients being treated has been increasing steadily in this country
since 1977.  The total number of patients with treated ESRD in 1989 was
190,862.  The 1989 estimated federal Medicare payments for ESRD
patients averaged $30,900 per patient.  The estimated total 1989 direct
medical payments for ESRD by public and private payers is $5.99
billion.

The USRDS database, designed to serve as a resource to the academic and
clinical medicine communities, has been operational since 1988.  The
USRDS database contains information on approximately 420,000 Medicare
patients who have had ESRD therapy at any time since 1976.  For each
patient, the database includes information on basic demographics, the
primary medical diagnosis that led to renal failure, dialysis records,
hospital records, and transplant information.  In addition, the
database contains details on the 2,492 institutions that provide ESRD
treatment services.  Limited information is available on non-Medicare
funded ESRD patients who are treated by the Department of Veterans
Affairs (excluding billing data and social security information).  The
USRDS database is supplemented by data from the U.S. Census Bureau.

Since 1989, the USRDS Coordinating Center has produced an annual data
report containing descriptive and analytic epidemiologic data on ESRD
patients.  However, as yet, few investigators outside of the USRDS
Coordinating Center have utilized the database to answer biomedical
research questions.  It is the purpose of this RFA to solicit
applications that will pose and answer questions relevant to ESRD in
the United States.

Specific questions that would be considered responsive to this RFA
include, but are not limited to, the following examples:

o  the relative incidence, prevalence, mortality and survival
associated with various comorbid conditions, causes of ESRD, modes of
ESRD treatment, or subgroups of the treated ESRD population in the
United States;

o  examination of the relative burden of disease in various minority
groups;

o  ecologic analyses that relate prevalence of predisposing diseases to
incidence and prevalence of treated and untreated ESRD in various
subgroups of the population.

Creativity in using the data to develop descriptive, analytic, and
hypothesis generating studies is encouraged.  Questions primarily of an
economic focus would not be considered responsive to this RFA, although
such issues may be included as secondary aims.

The USRDS data release policy includes the following provisions:  The
sole purpose of providing the data is the conduct of legitimate
biomedical research by the Principle Investigator (PI).  The
investigator will not use the data to identify individuals on the file.
The investigator will not combine or link the data provided with any
other collection or source of information that may contain information
specific to individuals on the file, except specific, written
authorization has been obtained through the approval process.  The
investigator will not use the data for purposes that are not related to
biomedical research.  The investigator will not publish or otherwise
disclose the data in the file to any person unless the data have been
aggregated (that is, combined into groupings of data such that the data
are no longer specific to any individual within each grouping) and no
cells (aggregates of data) contain information on fewer than 10
individuals.  A copy of any aggregation of data intended for
publication will be submitted to the USRDS Project Officer for review
prior to publication; if the publication is not in conformity with the
Privacy Act, it will not be published until revised to adhere to the
Privacy Act provisions.  Appropriate administrative, technical,
procedural, and physical safeguards shall be established by the
investigator to protect the confidentiality of the data and to prevent
unauthorized access to it.  The safeguards will provide a level of
security outlined in OMB Circular No. A-130, Appendix III-- "Security
of Federal Automated Information Systems," which sets forth guidelines
for security plans for automated information systems in Federal
agencies.

The investigator is encouraged to contact the USRDS Project Officer,
Dr. Lawrence Agodoa, (KUH/NIDDK, Westwood Building, Room 3A-06, 5333
Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7571), to
discuss the data request and to request a copy of the USRDS Data
Release Policy and the USRDS Agreement for Data Release Form.  The
USRDS database may be contacted at any time.  The USRDS process of
reviewing a written request for data, generating the data, and
releasing the data takes approximately three months.

STUDY POPULATIONS

It is NIH policy that women and minorities must be included in clinical
study populations unless there is a good reason to exclude them.  The
study design must seek to identify any pertinent gender or minority
population differences.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women in
study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis must be placed on the need for inclusion of minorities
and women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply to
males and females of all ages.  If women or minorities are excluded or
inadequately represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale must be
provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in the form PHS 398 (rev. 9/91) in
Item 4 (Research Design and Methods) of the Research Plan AND
summarized in Item 5, Human Subjects.  Applicants are urged to assess
carefully the feasibility of including the broadest possible
representation of minority groups.  However, NIH recognizes that it may
not be feasible or appropriate in all research projects to include
representation of the full array of United States racial/ethnic
minority populations; i.e., Native Americans (including American
Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,
Hispanics.  The rationale for studies on single minority population
groups should be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
[and preventive strategies], diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.
The usual NIH policies concerning research on human subjects also
apply.  For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned without review.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and reflected in assigning
the priority score to the application.  All applications for clinical
research submitted to NIH are required to address these policies.  NIH
funding components will not award grants or cooperative agreements that
do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by April 19, 1993, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal Investigator,
the identities of other key personnel and participating institutions,
and the number and title of the RFA in response to which the
application may be submitted.  Although a letter of intent is not
required, is not binding, and does not enter into the review of
subsequent applications, the information that it contains is helpful in
planning for the review of applications.  It allows NIDDK staff to
estimate the potential review workload and to avoid possible conflict
of interest in the review.

The letter of intent is to be sent to the Chief, Review Branch,
Division of Extramural Activities at the address provided below.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301/496-7441.

The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page.  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 2a of the face page of the application
form and check the YES box.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by May 18, 1993.  If an application is
received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  However, it is allowable to submit the same
project as both an R01 and as a component project of a program project.
The DRG will not accept any application that is essentially the same as
one already reviewed.  This does not preclude the submission of
substantial revisions of applications previously reviewed.  Such
applications must not only include an introduction addressing the
previous critique but also be responsive to this RFA.

REVIEW CONSIDERATIONS

Upon receipt, applications will be initially reviewed by the DRG for
completeness. Incomplete applications will be returned to the applicant
without further consideration.  Evaluation for responsiveness to the
program requirements and criteria stated in the RFA is an NIDDK staff
function.  If the application is not responsive to the RFA, NIDDK staff
will return it to the applicant.

Those applications that are complete and responsive will be evaluated
in accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the NIDDK.
Applications may be subjected to triage by an NIDDK peer review group
to determine their scientific merit relative to other applications
received in response to this RFA.  If the number of applications is
large compared to the number of awards to be made, a preliminary
scientific peer review may be conducted and applications withdrawn from
further competition when they are not competitive for the award.  The
NIDDK will notify the applicant and institutional official of this
action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the usual NIH peer
review procedures by an initial review group specifically convened for
this RFA.  Following this review, the applications may be given a
second level review by the NIDDK Advisory Council unless not
recommended for further consideration by the initial review group.

Review criteria for this RFA are as follows:

o  Scientific/medical significance of the proposed research.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research.

o  Requested data elements are already contained in the database.  (New
data collection and purchase of equipment will not be covered by this
RFA.)

o  Realistic cost estimates for generating and analyzing the data.

o  Availability of resources necessary to perform the research.

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

o  Qualifications and research experience of the Principal Investigator
and staff in doing epidemiologic analyses.

o  If the researcher is from a foreign country, the uniqueness of
research such that it can only be performed outside of the United
States must be demonstrated.

AWARD CRITERIA

The anticipated date of award is January 1994.

Applications will compete for available funds with all other
applications recommended by the initial review group.  The following
will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review.

o  Availability of funds.

o  Programmatic balance among the studies recommended for funding.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:

Camille A. Jones, M.D., M.P.H.
Director, Epidemiology Program
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-06
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7571

Inquiries regarding fiscal matters may be directed to:

Ms. Trude McCain
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7467

Schedule

Letter of Intent:     April 19, 1993
Application Receipt:  May 18, 1993
Initial Review:       October - November 1993
Second Level Review:  January 1994
Anticipated Award:    January 1994

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.849.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 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.


$$XID RFA CA9306 CA-93-06 P1O1 *****************************************

DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS

NIH GUIDE, Volume 21, Number 40, November 6, 1992

RFA:  CA-93-06

P.T. 34, FB; K.W. 0715035, 0795003, 0745027

National Cancer Institute

Letter of Intent Receipt Date:  December 4, 1992
Application Receipt Date:  January 25, 1993

PURPOSE

The National Cancer Program is mandated to address the unique cancer
prevention, early detection, and treatment needs of all populations
within the U.S. and its territories.  An excerpt from the FY 1992
Committee on Appropriations to the U.S. Department of Health and Human
Services stated:

"The Committee also urges NCI to expand its efforts to develop an
appropriate response to the needs of American Samoans.  Access to
timely treatment intervention is especially important for this native
American population...."   (Senate Report No. 102-104, page 86)

Therefore, the Division of Cancer Prevention and Control (DCPC) of the
National Cancer Institute (NCI) invites applications from various
organizations for developmental studies that:  (1) assess cancer
control need, (2) determine barriers to cancer control, and/or (3)
validate intervention methods and assessment instruments in native
Pacific populations; i.e., American Samoans, Guamanians (Chamorros),
Palauians, and Northern Marianians.  This initiative will define the
cancer prevention and control needs of native Pacific populations and
those of similar ancestry located in the Pacific as well as the U.S.
mainland.

HEALTHY PEOPLE 2000

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 Request
for Applications (RFA), Developmental Research in Native Pacific
Populations, is related to the priority area of cancer.  Potential
applicants may obtain a copy of Healthy People 2000 (Full Report:
Stock No. 017-001-00474-0) or Healthy People 2000 (Summary Report:
Stock No. 017-001- 00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202/783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic (including U.S. Territorial
possessions) public and private, for-profit and non-profit
organizations serving native Pacific populations such as universities,
public health departments, voluntary organizations, research centers,
hospitals, consortia of health providers, units of State and local
governments and eligible agencies of the Federal government.  Teams of
applicants are encouraged.  Among a team of applicants, one institution
must be proposed as the lead institution to serve as the applicant and
to assume responsibility for the conduct and administration of the
project.  Note that awards will not be made to foreign institutions and
that applications from domestic organizations may not include
international components.

MECHANISM OF SUPPORT

The mechanism of support for this RFA will be the National Institutes
of Health (NIH) research project grant (R01).  Responsibility for the
planning, direction, and execution of the proposed research will be
solely that of the applicant.  In addition to the requirements stated
in this RFA, awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 90-50,000, revised October 1, 1991.  This RFA is
a one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications
and be reviewed according to the customary peer review procedures.  It
is anticipated that four awards will be made at approximately $300,000
total costs per year.

FUNDS AVAILABLE

Approximately $1.2 million in total costs per year for three years will
be set-aside to specifically fund applications that are submitted in
response to this RFA.  It is anticipated that up to four awards will be
made.  The total project period of these awards may not exceed three
years.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific merit.  Although
this program is provided for in the financial plans of the NCI, the
award of a grant pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

The National Cancer Program is mandated to address the unique cancer
prevention, early detection, and treatment needs of all populations
within the U.S. and its territories.  The cancer control objectives for
the nation are aimed at (1) reducing the cancer death rates for all
Americans and (2) eliminating differentials in cancer rates between
population segments.  The means to obtain these objectives include the
development and implementation of cancer control and prevention
strategies directed at the general U.S. population and targeted
initiatives directed at minority and medically underserved populations
that are differentially affected by cancer.  These populations include
those who experience high cancer incidence/mortality rates or low
survival rates, or who are underserved in terms of cancer prevention
and control programs that include the native Pacific populations.

The paucity of data on effective cancer prevention and control
intervention methods in the target populations reflect both a dearth of
such programs and of validated instruments to evaluate their
effectiveness.  The need for the development of sensitive intervention
methods and assessment instruments has to be established in many areas
of health (e.g., mental health, cardiovascular diseases) and other
sectors (e.g., education).

In recent years, the Division of Cancer Prevention and Control (DCPC)
has carried out intervention research initiatives directed at the
American Indian/Alaska Native, Black, Native Hawaiian, and Hispanic
populations.  These experiences, combined with information gathered
through external working groups and experts in the cancer prevention
and control needs of minority and medically underserved populations and
extensive conversations with experienced investigators, has clarified
the need for Phase I and Phase II cancer control studies for native
Pacific populations.  It is clear that the concepts of health and
healing vary significantly, and this diversity is not captured by a
single design, method, or instrument.

Studies conducted under this RFA will seek to define cancer prevention
and control needs/services of the native Pacific population segments
(Phase I). Studies to test ways in which existing intervention methods
can be used or adapted for the target populations (Phase II); studies
of new methods designed to be sensitive to the needs of the target
populations (Phase II); and methodologic research on validation of
assessment instruments in target populations (Phase II) are eligible
for consideration under the RFA.  This "developmental cancer control
research" (Phase I and Phase II) is absolutely essential to future
development of cancer prevention and control research for native
Pacific populations.

The following definitions apply to this RFA:

1.  Native Pacific Populations -- The term "native Pacific populations"
refers to those population segments indigenous to the Pacific region
and/or populations of similar ancestry located within the U.S.
mainland, such as American Samoan populations.

2.  Cancer Control -- Cancer control is defined as the reduction of
cancer incidence, morbidity, and mortality through an orderly sequence
from research on interventions and their impact in defined populations
to the broad, systematic application of the research results.

3.  Phases of Cancer Control -- Cancer control research studies are
classified in the five phases that represent the orderly progression
noted in the above definition:  (I) Hypothesis development; (II)
Intervention methods development and testing; (III) Controlled
intervention trials to establish cause and effect relationships; (IV)
Research in defined human populations; and (V) Demonstration and
implementation studies.

The research of interest in this RFA falls into either Phase I or Phase
II studies.  Hypothesis development (Phase I) studies should focus on
the assessment of cancer prevention and control needs in communities or
organizations within native Pacific populations, or studies that
identify barriers to cancer prevention and control within these
indigenous populations.  Methods development and testing studies, Phase
II, should focus on:  (1) validating the use of existing intervention
methods (e.g., dietary modification, health services, tobacco
cessation) as applied in the target populations described above; (2)
developing and pilot testing unique methods that are sensitive to the
needs of the target populations described above, or (3) developing and
validating assessment instruments to measure the cancer control related
needs of the target populations or for use in evaluating the
effectiveness of intervention methods in the target populations.

It is the interest of this RFA that the projects should be
multidisciplinary in design.  Applicable disciplines may include
epidemiology, oncology, public health, pathology, health services
research, behavioral, and social sciences.  The research team should
include individuals with knowledge of the culture and language of the
native Pacific populations.

Because validation and intervention studies may depend on the review of
case records, investigators should assure in the application that a
mechanism to access pertinent records has been identified.

A.  Goals and Objectives

The goals of this program initiative are to identify cancer control
needs, to determine barriers to cancer control, and to validate
intervention methods and assessment instruments.  The objectives
relating to Phases I and II are described below:

Phase I Studies

1.  Assess cancer prevention and control needs/services in communities
with native Pacific populations.

2.  Identify barriers to cancer prevention and control in native
Pacific population communities.

Phase II Studies

1.  Validate the use of existing intervention methods (e.g., dietary
modification, health services, tobacco cessation) applied in the target
populations.

2.  Develop and pilot test unique intervention methods sensitive to the
needs of the target populations.

3.  Develop and validate assessment instruments (e.g., dietary intake,
risk factor surveys) to measure the cancer control related needs of the
target populations and to evaluate the effectiveness of intervention
methods in the target populations.

B.  Project Approach

It is important that applicants describe fully and in detail all
aspects of the proposed project in the application, including cancer
sites to be studied, the target population for which the research is
being conducted, available population data bases, hypotheses to be
considered, the planned intervention approaches, methods of assessment
and validation, and the overall research design approach to the
proposed study.  It is essential to select and justify in the
application, cancer sites on the basis of the significance in the
target population and the potential for reduction of mortality rates.
It is also essential that the population for which the study(ies) will
be carried out be specified and characterized using population-based
estimates of the demographic characteristics of the target population.
All collaborative arrangements that are planned should be described in
detail, including areas of responsibility, coordinating, decision-
making authority, and financial relationships.  Letters of commitment
from each participating organization should be included in the
application.

C.  Research Plan

The applicant should include a detailed protocol outlining the proposed
project methods for determining outcome effects.  The protocol should
detail the research project as conceived and should provide the
complete methodological approach to the problem under investigation.
The design for the project should provide enough information to
determine an adequate "test" of the concepts, whether validation or
intervention outcomes.  It is important that the design permits
statistically valid results to be achieved within the period of award.

D.  Options in Project Design

Applicants must choose from the three types of projects described
below:

o  Type One - Validation study of an existing intervention method for
use in a native Pacific population group.

o  Type Two - Develop and pilot test a "unique" intervention method
that is sensitive to the needs of the target population.

o  Type Three - Develop and validate needs assessment instruments or
assessment instruments that could be used to measure effectiveness of
cancer control methods in the target population.

Applicants must specify which type they have selected in the first line
of section 2(a), "Specific Aims", in the application.

E.  Time Schedule

A detailed time schedule should be presented in the application.  This
schedule is important because it will provide the milestones against
which progress will be validated.

SPECIAL REQUIREMENTS

Awardees should include in the proposed budgets travel to the NCI for
up to two persons to attend two meetings of Principal Investigators and
NCI program staff to discuss such issues as the validation of stated
hypotheses, determination of population characteristics/size relative
to the intervention specified, research progress, and results.  These
meetings will be held approximately three months prior to the scheduled
completion of years 01 and 03, respectively.

Awardees should anticipate that NCI staff may conduct a site visit as
a part of program management in order to assure that projects are
proceeding according to the plans specified in the application.  This
anticipated site visit is not intended to reduce the requirements for
the customary detailed progress report in accordance with the
instructions appearing in form PHS 2590.

STUDY POPULATIONS

The targeted population intended under this RFA is the native Pacific
populations and those of similar ancestry located in the Pacific as
well as the U.S. mainland; i.e., American Samoans, Guamanians
(Chamorros), Palauians, and North Marianians.  Applicants responding to
this RFA are expected to successfully access a significant portion of
this population to decrease cancer incidence and mortality, increase
cancer survival, and increase the diagnosis of cancers at earlier
stages.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and women
in study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders, and conditions
which disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population-based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects.  Applicants are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans [including American Indians or Alaska Natives], Asian/Pacific
Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes biomedical
and behavioral studies of etiology, epidemiology, prevention (and
preventive strategies), diagnosis, or treatment of diseases, disorders
or conditions, including but not limited to clinical trials.

The usual policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every
effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and reflected in assigning
the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 4, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the
identities of other key personnel and participating institutions, and
the number and title of the RFA in response to which the application
may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is extremely helpful in planning for the review of
applications.  It allows NCI staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

In addition, if it appears that the potential applicant has
misunderstood the objectives of the RFA or opted for an inappropriate
funding mechanism, NCI staff will respond to such letters.  The NCI
would like to emphasize the benefits to the applicant and to staff of
having a Principal Investigator submit a letter of intent.  The letter
establishes communication between the potential applicant and program
staff initiating the RFA.  Program staff may be able to assist
prospective applicants in several areas, i.e., scientific content and
objectives of an application, size and focus of a research program,
organization of an application, and appropriate use of core components
and consultants.

The letter of intent is to be sent to:

George A. Alexander, M.D.
Chief, Special Populations Studies Branch
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 240
Bethesda, MD  20892-4200
Telephone:  (301) 496-8589
FAX:  (301) 496-8675

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892;
telephone 301/496-7441.

The RFA label available in the application form PHS 398 must be affixed
to the bottom of the face page.  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 should be typed on line 2a 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 three signed, exact photocopies in one package to the
Division of Research Grants at the address below.  The photocopies must
be clear and single-sided.

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Ms. Toby Friedberg, Referral Officer
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by January 25, 1993.  If an application
is received after that date, it will be returned to the applicant
without review. The Division of Research Grants (DRG) will not accept
any application in response to this announcement that is essentially
the same as one currently pending initial review, unless the applicant
withdraws the pending application.  The DRG will not accept any
application that is essentially the same as one already reviewed.  This
does not preclude the submission of a substantial revision of an
application already reviewed, but the revised application must include
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed (initially) by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for responsiveness
to the RFA is an NCI program staff function.  If an application is
judged to be non-responsive, the applicant will be contacted and given
an opportunity to withdraw the application or have it considered with
other unsolicited applications received by NIH in the next review
cycle.  Questions concerning responsiveness to the RFA may be directed
to NCI program staff listed under INQUIRIES.

If the number of applications submitted is large compared to the number
of awards to be made, the NCI may conduct a preliminary scientific peer
review to eliminate those that are clearly not competitive.  The NCI
will remove from competition those applications judged to be
noncompetitive for award and notify the applicant and institutional
business official.

Those applications that are complete and responsive will be initially
evaluated in accordance with the review criteria stated below for
scientific/technical merit by an ad hoc review committee convened by
the Division of Extramural Activities, NCI.  The second level of review
will be provided by the National Cancer Advisory Board.

Responsiveness Criteria

Applicants must be responsive to this RFA in the sense of being
directed towards the attainment of the stated programmatic goals.  Five
considerations are of paramount importance to this RFA:

1.  Descriptions of the cancer problem with justification for the
selection of specific cancer site(s) in terms of potential for
reduction of mortality rates, cancer control intervention strategy,
research method, procedures, analysis plans, and time schedule must be
clearly delineated.

2.  Studies must be limited to Phase I and/or Phase II only.

3.  Assurance of access to a community with characteristics appropriate
for the proposed intervention: written documentation must be included.

4.  The target population must be a native Pacific population
indigenous to the U.S. Pacific territorial region, i.e., American
Samoa, Guam, Palau, Northern Marianas; or of similar ancestry located
in Hawaii and the U.S. mainland, i.e., American Samoans.

5.  Agreements with communities, organizations, agencies, or
institutions that are critical to ensure access to appropriate records
and to the implementation of the research plan must be included.

Review Criteria

Each application will be reviewed on its own merit.  All applicants
must clearly define the target population and geographic location where
the program efforts will be demonstrated as well as the project team's
ability to access the target population.  All applicants should include
in the application a succinct discussion of previous relevant efforts
and plans to meet the terms of award.

Applicants are encouraged to submit and describe the approach that they
think would best meet the goals of this RFA and to identify in-kind
contributions and/or co-sponsors for specific personnel, activities,
and facilities.  Each application will be reviewed according to the
following criteria:

1.  Scientific merit of the research approach, design, and methodology.

2.  Scientific and technical significance and originality of the
proposed research.

3.  Experience (research or clinical or service) and/or competence of
the Principal Investigator and staff.

4.  Adequacy of time (effort) that the Principal Investigator and staff
would devote to the proposed project.

5.  Characterization of the native Pacific population to be used
(cultural, spiritual or language considerations) in the proposed project.

6.  Adequacy of the approaches to produce valid assessment instruments
for use in larger community intervention studies for cancer control.

7.  Likelihood of intervention (Phase II studies) to be readily
accepted and feasible in terms of cost.

8.  Potential for generalizability of the findings and adaptability of
the intervention approaches and assessment instruments in other
communities with similar cancer control problems.

9.  Adequacy of the plans for inclusion of women.

The ad hoc review group will recommend an appropriate budget for each
approved application.

AWARD CRITERIA

The anticipated date of award is July 1, 1993.  Applicants will compete
for funding based on the quality and merit of the proposed research
study as determined by peer review, availability of funds, and
programmatic priorities, as well as geographic location.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The
opportunity to clarify any issues or questions from potential
applicants is
welcome.

Direct inquiries regarding programmatic issues to:

George A. Alexander, M.D.
Chief, Special Populations Studies Branch
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 240
Bethesda, MD  20892-4200
Telephone:  (301) 496-8589

Direct inquiries regarding fiscal issues to:

Crystal Elliott
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 Ext. 19

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.399, Cancer Control Science Program.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A.
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 285) and
administered under PHS grants policies and Federal Regulations 42 CFR
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.