Full Text DK-94-016


NIH GUIDE, Volume 23, Number 6, February 11, 1994

RFA:  DK-94-016



National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  April 20, 1994
Application Receipt Date:  May 20, 1994


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 a tailored data file through the USRDS Coordinating
Center, and to support the independent analysis of the data file by
the investigator.


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).


Applications may be submitted by domestic and foreign organizations,
both 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.


Support of this program will be through the investigator initiated
research project grant (R01) mechanism.  Each grant award will be
capped at $100,000 total cost (including direct and indirect cost)
per year for a maximum of two years.  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 earliest possible award date will be
April 1, 1995.


It is anticipated that approximately five 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.  A total of
$500,000 dollars have been set aside for this RFA in FY 1995.


The number of patients being treated for End-stage renal disease
(ESRD) in the United States has increased steadily since 1977.  The
total number of U.S. patients with treated ESRD was over 210,000 in
1990.  End-stage renal disease treatment is costly.  The 1990
estimated federal Medicare payments for ESRD patients averaged
$36,600 per patient.  The estimated total 1990 direct medical
payments for ESRD by public and private payers was $7.26 billion.
ESRD is a very serious condition, with high hospitalization rates and
death rates.  Thus, research to decrease the morbidity and mortality
due to ESRD is urgently needed.

The USRDS is a database with information on treated end stage renal
disease patients and their treatment facilities in the United States.
It is designed to serve as a resource to the academic and clinical
medicine communities.  The database contains information on
approximately 462,000 Medicare patients who have had ESRD therapy at
any time since 1976, including basic demographics, the primary
medical diagnosis that led to renal failure, dialysis records,
hospital records, and transplant information.  For patients included
in any of the USRDS special data collection studies, the specially
collected information can be linked with their master file.  In
addition to patient-specific information, the database contains
details on the 2,646 institutions that provide ESRD treatment
services.  Limited information is also available on non-Medicare
funded ESRD patients who are being treated by the Department of
Veterans Affairs.  The USRDS database is supplemented by data from
the U.S. Census Bureau.

All release of data will be in compliance with the U.S. Privacy Act
of 1974, and other relevant legislation. This information on patients
may be supplied in encrypted form, so that identification of
individuals is precluded. In addition, investigators seeking to use
the data must supply written assurances that they will not use the
data to attempt to identify individuals.

Since 1989, the USRDS Coordinating Center has produced an annual data
report which contains descriptive and analytic epidemiologic data on
ESRD patients.  The USRDS database has been very successful in
providing data on several important issues in the biomedical research
and clinical nephrology community.  However, there are many other
important questions that could be posed, and there is a multitude of
data that can be analyzed.

The purpose of this RFA is to solicit applications from investigators
to pose and answer important biomedical and health research 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, morbidity, and
survival associated with various co-morbid 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

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

o  Analyses combining a biomedical research question and a health
services research question.

Creativity in using the data to develop descriptive, analytic, and
hypothesis generating studies is encouraged.  Applications proposing
to investigate issues with a large impact on the health, well being,
morbidity and mortality of treated ESRD patients will be considered
responsive to this RFA.

Investigators are urged to become familiar with the structure and
data elements currently contained in the USRDS database, including
data elements from relevant special studies.  This information
(including data dictionary, structure of the database, special
studies data collection instruments) can be obtained from the
Director, Epidemiology Program, Division of Kidney, Urologic and
Hematologic Diseases, NIDDK, (301) 594-7586 (see INQUIRIES Section
below).  In addition, copies of the USRDS Annual Data Reports may be
useful.  The United States Renal Data System Annual Data Reports may
usually be found in dialysis units, nephrology department libraries,
and medical libraries; a copy of the 1993 Annual Data Report can be
ordered through the National Technical Information Service (703)
487-4600, order number PB 93 202 786, for $77.

The USRDS data release policy includes the following provisions:  The
sole purpose of providing the data is the conduct of legitimate
biomedical and health services research by the Principal Investigator
(PI).  The investigator will not use the data to identify individual
persons or institutions represented 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, unless 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 or
health services 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 Dr. Camille Jones
(301-594-7586) or the USRDS Project Officer, Dr. Lawrence Agodoa
(301-594-7553) to discuss the data request and to request a copy of
the USRDS Data Release Policy and the USRDS Agreement for Data
Release Form.  Both may be reached via mail at the following address:
KUH/NIDDK, Westwood Building, Room 3A-06, 5333 Westbard Avenue,
Bethesda, MD 20892.  The USRDS database Coordinating Center may also
be contacted for information about the database (313-998-6610).

The official request to the USRDS for USRDS data can be submitted at
any time and must be done separately from submitting an application
to the NIH in response to this RFA.  If the only way that the
investigator will be able to do the analysis is with funding from
this RFA, the investigator should submit the request for USRDS data
after the application has been approved.  The USRDS process of
reviewing a written request for data and generating and releasing the
data takes approximately three months.



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.


Prospective applicants are asked to submit, by April 20, 1994, 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.  The letter of intent is to
be sent to the Chief, Review Branch, Division of Extramural
Activities at the address listed under INQUIRIES.  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 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 Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/710-0267.

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

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
Bethesda, MD  20892

Applications must be received by May 20, 1994.  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.  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.


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.  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 review if 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 further 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

Review criteria for this RFA are as follows:

o  Scientific/medical/public health significance of the proposed

o  Adequate justification and rationale for the project. Knowledge of
literature with respect to the topic of interest.

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

o  Realistic cost estimates for generating and analyzing the data.
Appropriateness of the proposed budget and duration in relation to
the proposed research.

o  Availability of resources necessary to perform the proposed

o  Qualifications and experience of the Principal Investigator and
staff in epidemiologic research and clinical nephrology.

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.


The anticipated date of award is April 1, 1995.  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.


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

Camille A. Jones, M.D., M.P.H.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A-06
Bethesda, MD  20892
Telephone:  (301) 594-7586
FAX:  (301) 594-7501

Inquiries regarding fiscal matters may be directed to:

Ms. Trude McCain
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD  20892
Telephone:  (301) 594-7543


Letter of Intent Receipt Date:  April 20, 1994
Application Receipt Date:       May 20, 1994
Initial Review:                 Fall 1994
Second Level Review:            January 1995
Anticipated Date of Award:      April 1, 1995


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


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