Full Text DK-93-12


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

RFA:  DK-93-12

P.T. 34

  Data Management/Analysis+ 

National Institute of Diabetes and Digestive and Kidney Diseases

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


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.


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,
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 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

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.


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.


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

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

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

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.


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.


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

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

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 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.


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

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.


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

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

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.


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.


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


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


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.


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