Subject: NIH GUIDE - RFA DK-92-11 - V20(46) 12/13/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Cc: [email-masked], [email-masked], [email-masked]
Date: Tue, 17 Dec 91 10:29 EST

Hi Paul,
      Please post this to the NIH Listserver as:
    RFADK-92-11.911213
            Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA DK9211 DK-92-11 P1O1 *****************************************
 
THE BIOLOGY OF KIDNEY DISEASE AND HYPERTENSION IN BLACKS
 
RFA:  DK-92-11
 
P.T. 34, FC; K.W. 0715115, 0411005, 0765035, 0710095, 1002019
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Heart, Lung, and Blood Institute
 
Letter of Intent Receipt Date:  February 13, 1992
Application Receipt Date:  March 13, 1992
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the Division of Heart and Vascular Diseases (DHVD) of the
National Heart, Lung, and Blood Institute (NHLBI) announces a Request
for Applications (RFA) for research project grants The biology of
Kidney Disease and Hypertension in Blacks.
 
PURPOSE
 
This grant program will support fundamental research on the biology
of kidney disease and hypertension in Blacks.  An emphasis of this
initiative, however, is to foster extensive collaboration between
individuals in the basic sciences, including biochemistry, cell
biology, genetics, molecular biology, pathology, pharmacology, renal
physiology, and pathophysiology.  It is the intent of this
solicitation to engage investigators with diverse research interests
who wish to apply their expertise to better understand kidney disease
and hypertension in Blacks.
 
RESEARCH OBJECTIVES AND SCOPE
 
End-stage renal disease (ESRD) associated with hypertension is a
major health problem among Black Americans.  In 1989, the incidence
of ESRD with a diagnosis of hypertension was nearly six and one-half
times greater in Blacks compared to Whites.  For Blacks aged 20-44,
the rate was greater than 18 times that of Whites.  A number of
factors have been proposed to be responsible for this increased
disease burden in Blacks, including greater prevalence of
hypertension, more severe and uncontrolled hypertension, lack of easy
accessibility to adequate health care, and greater susceptibility of
the kidney to the effects of high blood pressure.
 
During the past two decades, a number of morphologic and physiologic
differences in the kidneys of hypertensive Blacks and Whites have
been identified.  These include differences in microscopic pathology
of arterioles from patients with malignant hypertension and more
severe nephrosclerotic changes among Black hypertensives with normal
renal function when compared to White hypertensives with similar
renal function.  In addition, it has been suggested that Blacks have
lower renal blood flow and higher vascular resistance, attenuated
sodium excretion, reduced urinary excretion of kallikrein, and
greater blood pressure response to saline loading, compared to
Whites.  These observations suggest that there may be a renal
vascular differences in Blacks that is involved in initiating
hypertension and that the renal vasculature may be uniquely
susceptible to the damaging effects of high blood pressure.  There is
increasing evidence for a genetic basis for many of these observed
differences in Blacks.  Therefore, it is the objective of this RFA to
encourage increased research activity directed toward the structure
and function of the kidney in Blacks with hypertension and
elucidation of the biologic basis for derangements in blood pressure
homeostasis.
 
This RFA is targeted toward Blacks, therefore, the study populations
must reflect this designation.  However, if other racial groups are
to be used for control purposes, appropriate justification must be
included in the study design.
 
The following are some of the areas of investigation that would be
considered responsive to this solicitation:
 
o  Circulatory and target organ pathophysiology including the use of
polymerase chain reaction and receptor-binding techniques to study
specific tissues and relevant receptors in patients with kidney
disease and hypertension.
 
o  Study of known factors and mediators of kidney disease and
hypertension utilizing appropriate methodology.
 
o  Dietary mechanisms, including the role of monovalent and divalent
cations in the genesis and maintenance of renal dysfunction and
hypertension.
 
o  Neural and other humoral factors, including kinins, the
renin-angiotensin- aldosterone system, atrial natriuretic peptide
(ANP), dopamine, and eicosanoids, and their role in renal dysfunction
and hypertension.
 
o  The role played by intrinsic morphological and physiological
aberrations of the kidney resulting in hypertension.
 
o  Examination of gender-related mechanisms associated with the
development of kidney disease and hypertension in Blacks.
 
o  Studies in genetics and immunogenetics, including the
identification thereof, and studies in demonstration families and
appropriate animal models, using state-of-the-art methods.  This
approach would include studies to select and identify Black family
configurations (such as sibling pairs or pedigrees); to
phenotypically characterize their members; to collect, analyze,
immortalize, and store cell lines from these individuals; and use the
DNA to identify markers and genes for kidney disease and
hypertension.
 
o  Polycystic kidney disease in blacks:  the genetics and basic
physiology and pathophysiology of kidney disease and hypertension in
Blacks with polycystic kidney disease, including functional
adaptation and morphogenesis.
 
The above are examples only and are not all inclusive.
 
MECHANISM OF SUPPORT
 
Support for this program will be through the individual research
project (R01) grant and will be governed by the current policies of
grant programs of the National Institutes of Health.  Under this
mechanism the applicants will plan, direct, and conduct the research
programs.  The project period requested should accurately reflect the
time that would be required to accomplish the stated goals.  Support
will be provided for up to five years (renewable for subsequent
periods) subject to the availability of funds and progress achieved.
 
With respect to post-award administration, the current policies and
requirements that govern research project grants of the NIH, as
described in the PHS Grants Policy Statement, will prevail.
 
FUNDS AVAILABLE
 
For FY 1992, $1.5 million in total costs will be allocated by NIDDK
and NHLBI to fund applications submitted in response to this RFA.  It
is anticipated that six to eight awards will be made.  However, this
funding level is dependent upon the receipt of a sufficient number of
applications of high scientific merit.  The total project period for
applications submitted in response to this RFA may not exceed five
years.  Although this program is provided for in the financial plans
of the NIDDK and the NHLBI, the award of grants pursuant to this RFA
is contingent upon appropriated funds for this purpose. Applicants
must limit the budget requests to no more than $160,000 in direct
costs for the first year.  The earliest award date will be September
30, 1992.
 
SPECIAL INSTRUCTIONS TO APPLICANTS
 
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,
"The Biology of Kidney Disease and Hypertension in Blacks," is
related to the priority areas of heart disease and stroke, and
diabetes and other chronic disabling conditions.  The PHS urges
applicants to submit work plans that address specific objectives of
"Healthy People 2000."  Copies of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report:
Stock No. 017-001-00473-1) may be obtained through the Superintendent
of Documents, Government Printing Office, Washington, DC  20402-9325
(Telephone 202-783-3238).
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH policy is that applicants for clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder, or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders,
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale
for its choice.  In addition, gender and racial/ethnic issues should
be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study.  This
information should be included in the form PHS 398 in Section 2, A-D
of the Research Plan AND summarized in Section 2, E. Human Subjects.
Data available at present shows that end stage renal disease
associated with hypertension occurs in Blacks to a greater extent
than any other racial group in the U.S.  Therefore, for the purposes
of this RFA, minorities are limited to Blacks.  If other racial
groups are used as control, appropriate justification must be
included in the study design.
 
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 when
it is important to apply the results of the study broadly, and this
should be addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.
 
If the required information is not contained within the application,
the application will be returned.
 
Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women in a study design is inadequate to answer the scientific
question(s) addressed AND the justification for the selected study
population is inadequate, it will be considered a scientific weakness
or deficiency in the study design and will be reflected in assigning
the priority score to the application.
 
All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants that do not comply with these policies.
 
ELIGIBILITY
 
Research grant applications may be submitted by both non-profit and
for-profit organizations and institutions, State and local
governments and their agencies, and eligible agencies of the Federal
Government.  Applications from foreign institutions will be
considered according to the PHS Grants Policy.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or Principal Investigator must be included with
the application.
 
REVIEW PROCEDURES
 
Applications in response to this RFA will be reviewed in accordance
with the customary NIH peer review procedures.  Upon receipt,
applications will be reviewed by the Division of Research Grants
(DRG) for completeness.  Incomplete applications will be returned to
the applicant without further review. Applications will then be
reviewed by program staff for responsiveness to the objectives of
this RFA.  If an application is considered unresponsive, the
applicant will be contacted and given an opportunity to withdraw the
application or have it considered for the grant program of the NIH.
Complete and responsive applications will be given a primary
assignment either to the NIDDK or the NHLBI, depending upon the
subject matter.
 
If an application submitted in response to this RFA is found to be
substantially identical to a grant application already submitted to
the NIH for review, but has not yet been reviewed, the applicant will
be asked to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be
allowed, nor will essentially identical applications be reviewed by
different review committees.  Therefore, an application cannot be
submitted in response to this RFA that is essentially identical to
one that has already been reviewed.  This does not preclude the
submission of substantial revisions of applications already reviewed,
but such applications must include an introduction addressing the
previous critique.
 
If the number of applications submitted is large compared to the
number of anticipated awards, the NIH may conduct a preliminary
scientific peer review to eliminate those applications that are
clearly not competitive.  The NIH will withdraw from competition
those submissions judged to be noncompetitive and will notify the
applicant and the institutional business official.
 
Applications will be reviewed for scientific and technical merit by
an Initial Review Group that will be convened by the Review Branch,
Division of Extramural Activities, NIDDK.  This group will be
composed primarily of non-Federal scientific consultants.  The
applications will then be reviewed by the National Diabetes and
Digestive and Kidney Disease Advisory Council and the National Heart,
Lung, and Blood Advisory Council.
 
REVIEW CRITERIA
 
The review criteria for this solicitation will include:
 
o  extent of relevance and/or contribution of the proposed research
to the overall goals and objectives of the RFA, including the
scientific, technical, or medical significance and originality of the
proposed research;
 
o  novelty, originality, feasibility of the approach and the adequacy
of the experimental design;
 
o  training, experience, and research competence of the
investigators;
 
o  suitability of the facilities and availability of resources
necessary to perform the research;
 
o  appropriateness of the requested budget to the work proposed; and
 
o  if an application involves activities that could have an adverse
effect upon humans, animals, or the environment, the adequacy of the
proposed means for protecting against or minimizing such effects.
 
METHOD OF APPLYING
 
Applications must be submitted using form PHS 398 (rev. 10/88).  that
is available in the business office or grants office of most academic
or research institutions and from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Bethesda, MD  20892, telephone 301/496-7441.  In
order to ensure proper identification of the application, line 2 of
the application form must state "DK/HL-92-11, Kidney Disease and
Hypertension in Blacks" and check the "YES" box.  The receipt date
for applications is March 13, 1992; the IRG review will be in the
Summer of 1992; and the National Advisory Council review will be
September 10-11, 1992, for the NHLBI and September 23-24, 1992, for
the NIDDK.  The earliest requested start-date will be September 30,
1992.
 
The RFA label, found in form PHS 398, must be affixed to the bottom
of the face page of the original copy of the application.  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.
 
The original and four copies of the application are to be sent to:
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Two additional copies of the application must be sent under separate
cover to:
 
Robert D. Hammond, Ph.D.
Chief, Review Branch, DEA
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 603
Bethesda, MD  20892
 
THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING
ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.  APPLICANTS WHO USE
EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE ADDRESS FOR THE
WESTWOOD BUILDING IS:
 
5333 Westbard Avenue
Bethesda, Maryland 20816
 
LETTER OF INTENT
 
Prospective applicants are encouraged to submit a letter of intent
that includes a descriptive title of the grant application, the name
of the Principal Investigator, the institutional affiliation of the
Principal Investigator, and any other participating institutions.
Since such letters are requested only for the purpose of obtaining an
indication of the number and scope of applications likely to be
received, their receipt will not be acknowledged.  A letter of intent
is not binding, and will not enter into the review of the application
subsequently submitted, nor is it required for application.  This
letter of intent, is requested by February 13, 1992, and is to be
sent to:
 
Robert D. Hammond, Ph.D.
Chief, Review Branch, DEA
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 603
Bethesda, MD 20892
FAX:  (301) 402-1277
 
INQUIRIES
 
Applicants are encouraged to contact either of the following
individuals below prior to submitting applications:
 
Lawrence Y. Agodoa, M.D.
Director of Clinical Affairs
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A11
Bethesda, MD  20892
Telephone:  (301) 496-7572
FAX:  (301) 402-0223
 
OR
 
Paul A. Velletri, Ph.D.
Program Administrator, HKDB/DHVD
National Heart, Lung, and Blood Institute
Federal Building, Room 4C10
Bethesda, MD  20892
Telephone:  (301) 496-1857
FAX:  (301) 496-9882
 
For fiscal and administrative matters, contact:
 
Mrs. Helen Ling
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 639
Bethesda, MD  20892
Telephone:  (301) 496-7467
FAX:  (301) 496-9721
 
OR
 
Ms. Jane R. Davis
Chief, Blood Diseases and Resources Grants Management Section
Grants Operation Branch, DEA
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A15B
Bethesda, MD  20892
Telephone:  (301) 496-7257
FAX: (301) 402-1200
 
SCHEDULE
 
Letter of Intent:        February 13, 1992
Application Receipt:     March 13, 1992
Initial Review:          June-July 1992
Second Level Review:     September 1992
Anticipated Award:       September 30, 1992
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849, (Kidney, Urologic and Hematologic Diseases)
and 93.837 (Heart and Vascular Diseases).  Grants will be awarded
under the authority of the Public Health Service Act, Title III,
Section 301 (Public Law 78-410, as amended; 42 USC 241) and
administered under PHS grants policies and Federal Regulations at 42
CFR Part 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.