Full Text DK-92-19

RESEARCH TRAINING AND CAREER DEVELOPMENT AWARDS IN NUTRITION AND
OBESITY RESEARCH

NIH GUIDE, Volume 21, Number 18, May 15, 1992

RFA:  DK-92-19

P.T. 34, 44

Keywords: 
  Nutrition/Dietetics 
  Obesity 
  Clinical Medicine, General 


National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  September 18, 1992
Application Receipt Date:  October 16, 1992

PURPOSE

The Division of Digestive Diseases and Nutrition of the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the
National Institute of Child Health and Human Development (NICHD) invite
applications:

(1) for post-doctoral Individual National Research Service Awards
(NRSA) (F32s) from individuals trained in the clinical or basic
sciences and

(2) for Clinical Investigator Awards (K08s) and Physician Scientist
Awards (K11s) from individuals with doctoral degrees in the clinical
sciences.

Proposed projects must be in the broad areas of nutrition, nutrient
metabolism, obesity, and related research.  The intent of this Request
for Applications (RFA) is to provide research training and career
development support for individuals with a strong commitment to a
research career in the areas of nutrition, nutrient metabolism,
obesity, eating disorders, energy metabolism/regulation, and
maternal-fetal, infant, and childhood nutrition.

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,
Research Training and Career Development Awards in Nutrition and
Obesity Research, is related to the priority area of nutrition.
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 any 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.  Women and minority
investigators are encouraged to apply.

Applicants applying for Physician Scientist (K11) and Clinical
Investigator (K08) awards must have completed, by the time an award
would be activated, a residency in internal medicine, surgery, or
pediatrics.  While physicians may be enrolled in a medical or surgical
subspeciality training program that relates to the nutrition/obesity
program of the NIDDK and the NICHD, a full-time commitment to research
training is required.  Grant funds are for research training and career
development only, and may not be used for the support of clinical
training or clinical services.  Such clinical subspeciality activities
must be supported from other funding sources.

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.

Applicants applying for an individual NRSA fellowship (F32) must have
received the Ph.D, M.D., or equivalent degree prior to the beginning
date of the appointment.

MECHANISMS OF SUPPORT

Support of this program will be through the Individual NRSA (F32), the
Physician Scientist Award (K11), and the Clinical Investigator Award
(K08).

Complete information pertaining to the K08 and K11 awards is given in
the pamphlet "The K Awards."  These publications are available 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.

Responsibility for the planning, direction, and execution of the
proposed project will be that of the applicant in conjunction with
his/her sponsor(s).  Except as otherwise stated in this announcement,
awards will be administered under PHS grants policy as stated in the
PHS Grants Policy Statement.  F32 applicants should be aware that,
prior to an award being made, they must sign an agreement that they
will fulfill the legislatively mandated payback requirements.  More
information on payback may be obtained from the Program Directors
listed below. (see INQUIRIES)

Grant funds are for research training and career development only, and
may not be used for the support of clinical training or clinical
services.  Such subspeciality activities must be supported from other
funding sources.

This RFA is a one-time solicitation.  The total requested project
period for F32 applications submitted in response to this RFA may not
exceed three years; the total requested project period for K08 and K11
applications may not exceed five years.  The earliest possible award
date will be July 1, 1993.

FUNDS AVAILABLE

For FY 1993, the NIDDK and the NICHD each plan to make two to three K08
and/or K11 awards and four to six F32 awards for applications submitted
in response to this RFA.  However, this funding level is dependent upon
the receipt of a sufficient number of highly meritorious applications.
Stipend levels for the NRSA awards are in accordance with those
established by the PHS.  Salary support for K08 and K11 awards is
limited to $50,000 per year plus either $10,000 or $20,000 per year for
other expenses, depending upon the mechanism.  Although this program is
provided for in the financial plans of the NIDDK and the NICHD, the
award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

The objective of this solicitation is to increase the number of
physicians and basic scientists who can conduct high-quality research
in the areas of nutrition and obesity, compete for NIH grant support,
and provide leadership in the areas of clinical nutrition/obesity
research.  It is particularly important to increase the number of
underrepresented minority persons and women being trained to pursue
research careers and provide leadership in the areas of nutrition and
obesity.

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

SPECIAL REQUIREMENTS

Investigators receiving support under any of the award mechanisms
offered here also may be enrolled in a medical or surgical
subspeciality training program that relates to the nutrition/obesity
program of the NIDDK and the NICHD. However, a full-time commitment to
research training is required.

STUDY POPULATIONS

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

It is NIH and ADAMHA policy that clinical research studies 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 women and minorities 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 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 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, 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, 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 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 September 18, 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

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for the K awards.  The fellowship application form PHS
416-1 (rev. 4/89) must be used in applying for the F32 awards.  These
forms 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 K08 and K11 applications.  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 title and number must be typed on line 2a of the face
page of the application form, and the YES box must be checked.  NRSA
applications must indicate the RFA number on the face page under item
3.

For K award applications, 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 also
must 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

For F32 applications, submit a signed, typewritten original of the
application and two signed, exact, clear, single-sided photocopies in
one package along with the Checklist, the Personal Data form, appendix
material, and sealed reference reports to:

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

No copies should be sent to the Review Branch.

Applications must be received by October 16, 1992.  If an application
is received after that date, it will be returned to the applicant.  The
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 Division
of Research Grants (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 the applicant, or whether it
should be held until the next 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 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)
specifically convened for this RFA.  Following this review, NRSA
applications will be given a secondary review by committees of NIDDK
and NICHD program staff; K08 and K11 applications will be given a
secondary review by the National Diabetes and Digestive and Kidney
Diseases Advisory Council and the National Child Health and Human
Development 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 F32, 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;

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

Schedule

Letter of Intent:          September 18, 1992
Application Receipt:       October 16, 1992
Initial Review:            Feb/Mar 1993
Second Level Review:       May/Jun 1993
Anticipated Award:         July 1, 1993

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
o  program balance among the research areas of this RFA.

INQUIRIES

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

Direct requests for the RFA and inquiries regarding programmatic issues
to:

Judith M. Podskalny, Ph.D.
Director, Research Training and Career Development Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A15
Bethesda, MD  20892
Telephone:  (301) 496-7455

or

Ephraim Y. Levin, M.D.
Medical Officer
National Institute of Child Health and Human Development
Executive Plaza North, Room 637
Bethesda, MD 20892
Telephone: (301) 496-5593

Direct inquiries regarding fiscal matters to:

Mrs. Nancy Dixon
Supervising 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
No. 93-848 and 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, 42 CFR 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.

.

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