From: kristoff@GENBANK.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 31, pt. 4, 28 August 1992
Date: 3 Sep 92 02:01:47 GMT
Distribution: bionet


$$XID RFA DA9301 DA-93-01 P1O1 *****************************************

DEVELOPMENT OF INNOVATIVE METHODS TO IDENTIFY MEDICATIONS FOR TREATING
COCAINE ABUSE

NIH GUIDE, Volume 21, Number 31, August 28, 1992

RFA:  DA-93-01

P.T. 34; K.W. 0404009, 0710085, 0710100

National Institute on Drug Abuse

PURPOSE

The Medications Development Division of the National Institute on Drug
Abuse (NIDA) invites the submission of research applications to develop
innovative preclinical (nonhuman) methods for the identification of
potential treatment agents for the entire spectrum of cocaine abuse,
from pre-addiction through abstinence, relapse, and recovery.  The
methods may be based on behavioral, neurophysiological, neurochemical,
or other approaches as long as a strong case is made that they will be
relevant to human cocaine abuse and its pharmacologic treatment.  These
methods should be novel, or they should expand other underdeveloped or
unrecognized methods as tools for evaluating pharmacotherapies for drug
abuse disorders.

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), Development of Innovative Methods to Identify
Medications for Treating Cocaine Abuse, is related to the priority area
of health promotion (alcohol and other drugs).  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 20492-9325 (telephone 202-783-3238).

ELIGIBILITY

Applications may be submitted by foreign and domestic, non-profit and
for-profit, public and private organizations such as universities,
colleges, hospitals, laboratories, research institutions, units of
State and local governments, and eligible agencies of the Federal
Government.  Applications from minority individuals and women are
encouraged.  Foreign applicants are not eligible for First Independent
Research Support and Transition (FIRST) Awards (R29).

MECHANISMS OF SUPPORT

Support mechanisms include Research Projects (R01) and the FIRST award
(R29).  Most investigator-initiated research is supported by
independent research grants (R01).  A research grant is awarded to an
institution on behalf of a Principal Investigator (PI) who has designed
and will direct a specific project or set of projects.  For information
on the special requirements of the FIRST awards, please contact the
program staff listed at the end of the announcement.

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.

FUNDS AVAILABLE

Applications submitted in response to this announcement will compete
for approximately $1,000,000 that has been made available for this
purpose in Fiscal Year 1993.  It is expected that approximately four to
five grants will be supported.  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 NIDA, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Several behavioral models of drug abuse have been useful in studying
important variables in the laboratory.  Perhaps the most widely
recognized of these is the self-administration model in which an animal
presses a lever to inject an abused drug intravenously.  This
methodology has been an invaluable research tool in many ways,
especially in the preclinical evaluation of the abuse potential of
compounds.

The drug discrimination model is a second method that has proven
useful.  In this method, an animal is trained, on the basis of internal
(interoceptive) cues, to make one response when a particular drug is
injected and to make a different response when a different drug (or
placebo) is injected.  This procedure has proved valuable in assessing
the subjective effects (e.g., the "high") of cocaine, as well as the
likelihood that an unknown compound produces a similar interoceptive
cue.

Little is known about the predisposing factors involved in drug-seeking
behavior in humans or in the animal models that are used to study this
human trait.  Furthermore, these models (when they are available) are
limited in that they may apply only to a particular phase of cocaine
abuse.  For example, the self-administration model may be predictive of
the drug-seeking portion of addictive behavior.  But having an animal
in a cage pressing a lever for a drug reinforcement may not be
predictive of an individual on a street corner considering whether or
not to take cocaine.  Furthermore, there are no models of pre-addictive
use in which the individual administers cocaine frequently but
nondependently.  This lack of a preclinical method restricts the study
of the variables that may cause escalation to drug dependence.  Thus,
it is difficult to identify a new medication that may be useful in this
early phase of drug abuse.

Just as there are no models of pre-addiction to study factors that may
engender the acquisition of drug abuse, there are no validated methods
to represent the recovery phase following treatment in which the addict
is striving not to avoid relapse to drug use.  This lack of suitable
methods restricts the study of variables that contribute to relapse.
Even though clinicians who treat drug abuse maintain that relapse
prevention is the most important and the most difficult phase of drug
abuse treatment, there is no model for "slips" or relapses.

The presently available methodology (self-administration, cocaine
discrimination) has not proven useful in identifying and developing new
chemical entities that are useful in the clinics to combat cocaine
abuse.  The lack of a set of laboratory methods to study the phases of
cocaine abuse from pre-addiction through recovery limits the
identification and development of new medications that may be useful in
treating cocaine abuse.  For the identification and development of a
wider range of medications, the selection and development of new
methods relevant to a broader spectrum of drug abuse, especially
cocaine abuse, will be an important advance.

Methods to study compounds that may be potentially useful in combatting
drug abuse via brain reward mechanisms have not been adequately
developed.  The areas of the brain that probably mediate reward
(nucleus accumbens, striatum, prefrontal cortex) have been identified.
It appears that, in terms of modern neurophysiological and
electrophysiological methodologies, research has not focused on the
discovery of potential pharmacotherapies.  One such example is the in
vivo microdialysis technique, in which extracellular levels of
neurotransmitters can be monitored in brain areas of freely moving
animals.  Thus, the development and application of neurophysiological
methods to identify useful treatment agents are needed.

Areas of Interest

The areas of research interest that may be funded include those that
are innovative, that develop new methods of drug discovery for cocaine
abuse pharmacotherapies, and that will advance the development of a new
medication for the treatment of cocaine abuse.  In general, these may
include:

o  an innovative behavioral model of craving that does not employ the
standard self-administration paradigms;

o  models of behavioral toxicity that look at attenuation of important
adverse effects of cocaine through a new approach;

o  techniques to study post-addictive behavior as experimental models
of recovery and possible relapse;

o  neurophysiological techniques which utilize the putative underlying
mechanisms of cocaine abuse to identify new medications; and

o  electrophysiological methods which will identify and develop new
pharmacotherapeutic agents.

These areas of research interest are not intended to be all-inclusive.
However, experimental animal models to develop therapeutic
interventions for cocaine abuse are extremely limited.  Therefore, a
major research effort is required to design creative approaches to
expand the current methods and models to those that have not been
explored.  Well-known models of drug abuse to study cocaine are of
interest only insofar as their application constitutes an innovative
approach.  It is anticipated that no single method will be definitive.
It is anticipated that both behavioral and non-behavioral techniques
will be identified and developed.

STUDY POPULATIONS

This RFA is targeted for preclinical studies in intact non-human
species, including rodents and monkeys, as well as cell preparations
from non-human sources.  The PHS Policy on Humane Care and Use of
Laboratory Animals by Awardee Institutions requires that applicant
organizations establish and maintain appropriate policies and
procedures to ensure that humane care and use of live vertebrates
involved in research, research training, and biological testing
activities supported by PHS.  All institutions are required to comply,
as applicable, with the Animal Welfare Act as amended (7 USC 2131 et
sec.).  These documents are available from the Office for Protection
from Research Risks (OPRR), National Institutes of Health, Bethesda, MD
20892.

An applicant organization proposing to use vertebrate animals in
PHS-funded studies must file an Animal Welfare Assurance Form with
OPRR.  As part of the Assurance, which commits the applicant
organization to comply with PHS policy, the applicant organization must
appoint an Institutional Animal Care and Use Committee (IACUC) which is
required to review and approve those sections of application for PHS
support that involve vertebrate animals.  IACUC approval should be
submitted at the time of application for studies that involve animal
subjects.

If animal subjects will be involved at sites other than the applicant
organization, the applicant must identify, within the application, the
assurance status of each participant and must arrange the appropriate
certifications and verifications.

APPLICATION PROCEDURES

Applicants are to use the grant application form PHS 398 (rev. 9/91).
The number and abbreviated title of this RFA, DA-93-01, "METHODS TO
IDENTIFY MEDICATIONS FOR TREATING COCAINE ABUSE," should be typed in
item number 2a on the face page of the PHS 398 application form.

Applicants must affix the RFA label available in the 398 application 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.

Application kits containing the necessary forms and instructions for
regular research grants may be obtained from business offices or
offices of sponsored research at most universities, colleges, medical
schools, and other major research facilities.  If such a source is not
available, the following office may be contacted for the necessary
application material:

Division of Research Grants
Office of Grants Inquiries
Westwood Building, Room 449
Bethesda, MD  20892
Telephone:  (301) 496-7441

Submit a signed, typewritten original of the application, including the
Checklist, and four photocopies, and for R29 applicants, three letters
of reference, in one package, to:

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

At the time of submission, one additional copy of the application
should also be sent to:

Heinz Sorer, Ph.D.
Medications Development Division
National Institute on Drug Abuse
Parklawn Building, Room 11A-55
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6270

Applications must be received by the special receipt date of December
11, 1992.  Applications received after date will be returned to the
applicant without review.  The receipt and review schedule follows:

                  Initial           Advisory Council   Earliest Award
Receipt Date      Review                 Review             Date

Dec 11, 1992      Feb/Mar 1993      May 1993           Jun 1993

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.  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 already reviewed, but such applications must conform to
the requirements for revised applications in the Form PHS 398
instructions.

REVIEW CONSIDERATIONS

The Division of Research Grants serves as a central point of receipt of
applications for most discretionary PHS grant programs.  Applications
received under this announcement will be assigned to an initial review
group in the NIDA.  The review group, consisting primarily of
non-Federal scientific and technical experts, will review the
applications for scientific and technical merit.  Notification of the
review recommendations will be sent to the applicant after this initial
review.  Applications will receive a second-level review by the
National Advisory Drug Abuse Council whose review may be based on
policy considerations as well as scientific merit.  Only applications
recommended for further consideration by the Council may be considered
for funding.

REVIEW CRITERIA

Criteria for scientific/technical merit review of the applications will
include the following:

o  Relevance of objectives to the goal of this program as stated in
this RFA including:

a) Is the method innovative?
b) Is the method workable as either a screening technique or as an
evaluation technique?
c) Will the method identify potential treatment agents?

o  Adequacy of the research design and methodology;

o  Applicability of the project to clinical situations covering
specific aspects of the addictive process from pre-addiction through
craving, abstinence, relapse, and recovery;

o  Potential contribution to the development of medications to treat
cocaine abuse;

o  Demonstrated scientific expertise of the PI and other key personnel;

o  Availability of adequate facilities, other resources, and
collaborative arrangements necessary for the research; and

o  Appropriateness of budget estimates for the proposed research
activities.

AWARD CRITERIA

Award criteria include:

o  Availability of funds;

o  Potential contribution to the medications development program;

o  Overall scientific and technical merit as determined by peer review;

o  Needs and balances of the medications development portfolio;

o  Relevance to program goals and objectives, as stated in this RFA
under RESEARCH OBJECTIVES; and

o  Preference in funding under this RFA will be given to applications
for innovative methods to identify medications for treating cocaine
abuse.  Applications relevant to abused drugs other than cocaine may be
submitted and considered under the NIDAs general program announcement.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Heinz Sorer, Ph.D.
Medications Development Division
National Institute on Drug Abuse
Parklawn Building, Room 11A-55
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6270

Direct inquiries regarding fiscal matters to:

Shirley A. Denney
Chief, Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-55
Rockville, MD  20857
Telephone:  (301) 443-6710

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Section 301 and 515 (42 USC 241 and 290cc)
and administered under PHS grants policies and Federal Regulations 42
CFR 92 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 DK9303 DK-93-03 P1O1 *****************************************

CAREER DEVELOPMENT AWARDS FOR UNDERREPRESENTED MINORITY
CLINICIAN-INVESTIGATORS

NIH GUIDE, Volume 21, Number 31, August 28, 1992

RFA:  DK-93-03

P.T. 34, FF; K.W. 0785035, 0710030

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  November 4, 1992
Application Receipt Date:  December 3, 1992

PURPOSE

The purpose of this solicitation is to increase the number of
underrepresented minority clinicians who can conduct high-quality
independent research and provide leadership in the areas of diabetes,
endocrinology, metabolism and metabolic diseases (including cystic
fibrosis), nutrition, eating disorders, obesity, organ systems and
components associated with the gastrointestinal tract, renal and
urological diseases, and hematology.

This Request for Applications (RFA) is limited to the Clinical
Investigator Award (CIA/K08) and the Physician Scientist Award
(PSA/K11).  Each of these mechanisms is tailored to a particular stage
of the investigator's career.  Each is designed to equip the developing
physician-scientist to become an independent investigator capable of
designing and executing rigorous research protocols, carefully crafted
to examine a clearly stated and focused hypothesis.  Ideally, such
investigators should be able to integrate patient-oriented and
laboratory-oriented research methods to address specific questions.

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 RFA,
Career Development Awards for Underrepresented Minority Clinician-
Investigators, is related to the priority area of nutrition and
diabetes and chronic disabling disorders.  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 202-783-3238).

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.

Applicants for the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) CIA must:

o  Hold an M.D., D.O., or other appropriate clinical degree;

o  Have had approximately four to eight years of postdoctoral
experience, both clinical and research (a minimum of two years of
each), by the projected start of the award;

o  Not have been a Principal Investigator (PI) on a PHS-supported
research project; and

o  Commit at least 75 percent time to CIA activities.

Applicants for the NIDDK PSA must:

o  Hold an M.D., D.O., or other appropriate clinical degree;

o  Have completed at least one postgraduate year of clinical training
by the time the award is made;

o  Not have been a PI on a PHS-supported research project; and

o  Commit at least 75 percent time to PSA activities.

Potential candidates must be citizens or non-citizen nationals of the
United States or its possessions and territories or must have been
lawfully admitted to the United States for permanent residence at the
time of the application and must be a member of a minority group that
is underrepresented in biomedical or behavioral science.

Applicants applying for the CIA or the PSA under this solicitation must
have completed, by the time an award would be activated, a residency in
internal medicine, surgery, or pediatrics.

MECHANISMS OF SUPPORT

The mechanisms of support will be the Clinical Investigator Award (K08)
and the Physician Scientist Award (K11).  While these two mechanisms
are summarized in this announcement, detailed guidelines may be
obtained from the office of sponsored programs at most research
institutions or from the Office of Grants Inquiries, Division of
Research Grants, NIH, (301) 496-7441.

Awards will be administered under PHS grants policy as stated in the
PHS Grants Policy Statement.  This RFA is a one time solicitation.  The
total requested project period for applications submitted in response
to this RFA may not exceed five years.

Clinical Investigator Award

The CIA is offered to provide the opportunity for promising
clinically-trained individuals with demonstrated aptitude in research
to develop into independent investigators.  Provisions of the CIA
include:

o  Five years of support, nonrenewable;

o  Salary up to $50,000 per year plus fringe benefits; and

o  Up to $20,000 per year for research supplies, equipment, technical
assistance, and travel.

Physician Scientist Award

The PSA is designed to encourage the newly trained clinician to develop
independent research skills and experience in a fundamental biomedical
or behavioral science.  This is a five year award that is divided into
two phases.  During Phase I, which may last two to three years, the
candidate is expected to develop independent research skills and
experience and may elect to work toward a Ph.D. degree.  The primary
sponsor must be an accomplished basic science investigator.  Phase II
entails intensive basic or clinical research activity, applying the
skills learned during Phase I.  Provisions of the PSA include:

o  Five years of support, nonrenewable;

o  Salary up to $50,000 per year plus fringe benefits; and

o  Up to $10,000 (Phase I) and $20,000 (Phase II) per year for research
supplies, equipment, technical assistance, and travel.

Grant funds awarded under the CIA and the PSA mechanisms are for
research development only and may not be used for the support of
clinical training or clinical services.  Such activities must be
supported from other funding sources.

FUNDS AVAILABLE

Up to eight awards will be made in support of applications submitted
for this RFA, dependent upon the receipt of a sufficient number of
highly meritorious applications.  Although this program is provided for
in the financial plans of the NIDDK, the award of grants pursuant to
this RFA is also contingent upon the availability of funds for this
purpose.

RESEARCH OBJECTIVES

The proportion of physicians among all first-time PIs has been
declining since 1977, and the number of physicians and other
professional doctorates participating in NIH research training programs
has declined since 1975.  The limited number of minority clinicians in
research is a matter of critical concern.  The Institute of Medicine's
Committee on National Needs for Biomedical and Behavioral Research
Personnel, in their 1983 report, predicted that a potential no-growth
situation in medical schools would decrease the flow of qualified new
entrants into the field of clinical investigation, particularly in the
face of declining opportunities in the academic sector.  The
maintenance of such a flow, particularly for minority scientists, is
vital to the future of biomedical and behavioral research in this
country.

The NIDDK is a focal point at the NIH for research on diabetes,
endocrinology, metabolism and metabolic diseases, including cystic
fibrosis; nutrition, eating disorders, obesity, organ systems and
components associated with the gastrointestinal tract; renal and
urological diseases and hematology.  Advances in knowledge in the
scientific areas served by the NIDDK requires a steady supply of
rigorously trained individuals.  To this end, the NIDDK wishes to
encourage research training and career development in areas related to
the mission of the NIDDK that utilize the most current scientific
disciplines such as molecular biology, cell biology, structural
biology, immunology, neurology, developmental biology, genetics,
biochemistry, organic chemistry, physiology, and epidemiology, to name
a few.  Applicants are encouraged to acquire proficiency in
technologies at the forefront of current biomedical and behavioral
research and should seek mentors in the areas served by the NIDDK.
Minority populations and women must be included in all proposed
clinical studies, unless sufficient justification is provided for their
exclusion.

Potential applicants are encouraged to read the guidelines for each
mechanism to identify the mechanism most appropriate for their needs
and experience.

SPECIAL REQUIREMENTS

Awardees will be asked to inform the NIH for each of five years
following the completion of the award about academic status,
publications, and research grants and contracts received.

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

It is NIH and ADAMHA policy that clinical research studies include
women and minorities 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 women and minorities in studies of diseases, disorders,
and conditions which disproportionately affect them.  This policy is
intended to apply to females and males of all ages.  If women or
minorities are excluded or inadequately represented in a clinical
research project, 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 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, the 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, and
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.  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 to the applicant 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 November 4, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the applicant, the
name of the sponsor, the names of all participating institutions, and
the number and title of the RFA in response to which the application is
being 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 conflicts of interest in the review.

The letter of intent is to be sent to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892
Telephone:  (301) 496-7083
FAX:  (301) 402-1277

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for the K awards.  Special instructions for preparing CIA
and PSA applications can be found in the booklet "The K Awards,"
October 1991.  These forms and "The K Awards" booklet are available
from most institutional business offices 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 of the application.  Failure to use this
label could result in delayed processing of an application such that it
may not reach the review committee in time for review.  In addition,
the RFA number and title, RFA DK-93-03, Career Awards for
Underrepresented Minorities, must be typed on line 2a of the face page
of the application form, and the YES box must be checked on the face
page.

Applicants must 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 should
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
Bethesda, MD  20892

Applications must be received by December 3, 1992.  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 RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application.  The DRG also will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of applications previously reviewed that have since been
substantially revised.  Such applications must not only include an
introduction addressing the previous critique, but also must be
responsive to this RFA.

REVIEW CONSIDERATIONS

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 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 contact the applicant to determine whether it should be
returned to applicant or be held until the next regular receipt date
and reviewed in competition with all other unsolicited applications.

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, the NIDDK may
conduct a preliminary scientific peer review (triage) and withdraw
applications from further competition if they are not competitive for
the award.  The NIDDK will notify the applicant and institutional
official of any such action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit by an NIDDK initial review group (IRG).
Following this review, applications will be given a secondary review by
the National Diabetes and Digestive and Kidney Diseases Advisory
Council.  Applications not recommended for further consideration by the
IRG will not undergo secondary review.

The review criteria for applications received in response to this RFA
are the same as those for unsolicited K08 and K11 applications.
Generally stated, these include:

o  Applicant's potential for and commitment to a research career in the
areas specified by this RFA;

o  Scientific merit of the proposed research;

o  Potential of the proposed research in developing the applicant as an
independent investigator;

o  Qualifications, research expertise, and training experience of the
sponsor along with adequate institutional commitment to ensure
completion of the proposed training; and

o  Adequacy of the proposed means for protecting against or minimizing
such effects, for those applications involving activities that could
have an adverse effect upon humans, animals, or the environment.

AWARD CRITERIA

Applications will compete for available funds with all other
recommended applications received in response to this RFA.  The
following will be considered in making funding decisions:

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

o  Availability of funds; and

o  Program balance among the research areas of this RFA.

Schedule

Letter of Intent:           Nov 4, 1992
Application Receipt:        Dec 3, 1992
Initial Review:             Feb/Mar 1993
Second Level Review:        May/Jun 1993
Anticipated Award:          Jul 1, 1993

INQUIRIES

Written and telephone inquiries about this RFA and the opportunity to
clarify any issues or questions from potential applicants are
encouraged.

Direct inquiries regarding programmatic issues to:

Lois F. Lipsett, Ph.D.
Director, Research Training and Career Development Programs
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 620
Bethesda, MD  20892
Telephone:  (301) 496-7433

Direct inquiries regarding fiscal matters to:

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

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
Nos. 93.847, 93.848, and 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 66 and
45 CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.