Subject: RFA DK-9l-l0 Full text
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Tue, 02 Apr 91 13:16 EST

Hi Paul,
    Please post this to the NIH Listserver as:
      RFADK-91-10.910329
                        Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$FT BEGIN DK-91-10 **************************************************** P1O1
 
INTERSTITIAL CYSTITIS DATA BASE:  CLINICAL CENTERS AND DATA
COORDINATING CENTER
 
RFA:  DK-91-10
 
P.T. 34; K.W. 0755018, 0785220, 0413001, 0780005
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  May 17, 1991
Application Receipt Date:  June 14, 1991
 
PURPOSE
 
The Division of Kidney, Urologic and Hematologic Diseases
invites cooperative agreement applications for investigators
to design and implement a data base for patients with
interstitial cystitis (IC).  The primary purpose of this
program is to determine the natural history of this
disorder.  Clinical centers will prospectively obtain
uniform demographic and diagnostic information as well as
clinical samples, such as bladder biopsies, from patients
with interstitial cystitis.  Data will be transmitted and
samples sent to a central data coordinating center for
analysis.  The Data Coordinating Center (DCC) will collect,
maintain, and analyze data and assess patient samples
provided by the Clinical Centers.  The primary objectives of
this investigation are:  1) to establish and maintain a data
base of uniformly and accurately collected information,
including results of testing clinical samples, from patients
with interstitial cystitis; 2) to study the natural history
of this disorder; and 3) to make available the data base and
patient samples for other interested investigators to
conduct epidemiological and clinical studies.  The
assistance mechanism used to support this study is the
cooperative agreement, which is similar to the traditional
NIH research grant.  It differs from a research grant in the
extent and nature of NIH staff involvement.
 
The Public Health Service is committed to achieving the health
promotion and disease prevention objectives of Healthy People
2000, a Public Health Service-led national activity for setting
priority areas.  This Request for Applications (RFA),
"Interstitial Cystitis Data Base:  Clinical Centers and Data
Coordinating Center", is related to the priority area of Diabetes
and Chronic Disabling Diseases.  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, D.C. 20402-9325
(telephone 202-783-3238).
 
DISCIPLINE AND EXPERTISE
 
The expertise appropriate for a clinical center includes
advanced training in urology and knowledge of the clinical
and epidemiological aspects of interstitial cystitis as well
as experience in recruiting and following patients with
this disorder.  In addition, experience in collaborative
studies, with special reference to development and
implementation of common protocols and ability to ensure
uniform collection and submission of patient data and
samples, is required.  Participants must also possess skills
and interest in the analysis of data and preparation of
scientific reports on the collected data in cooperation with
other components of the study.  Skills in data base
management; biostatistics; collection and assessment of
patient samples, such as bladder biopsies; and development
of collaborative studies are appropriate for the Data
Coordinating Center.  An institution may apply for both a
Clinical Center and a Data Coordinating Center.  However, a
specific plan on how the independent operation (i.e.,
confidentiality of study-wide data) of each unit will be
maintained is required.  Separate applications are
required for institutions applying for both a Clinical
Center and a Data Coordinating Center.
 
ELIGIBILITY REQUIREMENTS
 
Domestic universities, medical colleges, hospitals, and other
public or private research institutions, including State and
local government units, are eligible.  Applications from
minority investigators and women are encouraged.  Applications
from foreign institutions will not be considered since only a
small number of centers will be selected to participate in this
program.
 
BACKGROUND
 
Interstitial cystitis is a chronic, painful, and variably
incapacitating disorder that manifests a symptom complex
consisting of pain in the region of the urinary bladder and
associated pelvic musculature, and variable motor and
sensory dysfunctions of the urinary bladder.  It affects a
significant percentage of the adult population,
predominately women.  Although the symptom complex was
described nearly a century ago, there has been little
research into this disorder until recently, and the existing
data contain many conflicting and incongruous findings.
The factors that have inhibited advances in the
understanding of this disorder include:  the lack of specific
diagnostic criteria, the lack of specific tissue changes at
the histological level, and the unpredictable and variable
remission and recrudescence of symptoms.
 
A first step in better understanding the nature of this
disorder is the establishment of a data base of well
characterized patients with interstitial cystitis whose
disease course will be carefully documented during the
period of follow-up.
 
This RFA is in response to Senate Report 101-516 for the
Departments of Labor, Health and Human Services and Related
Agencies Appropriations Bill, 1991, that provided funds for
the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) to establish a national IC registry.
 
GOALS AND SCOPE OF THE ACTIVITY
 
The primary purpose of this RFA is to initiate a
collaborative study to develop an interstitial cystitis data
base through the collection and analysis of information and
clinical samples from patients with the disorder.  A
protocol and manual of operations will be designed by a
Steering Committee, consisting of members of the Clinical
Centers, Data Coordinating Center, and the NIDDK Project
Coordinator.  It is expected that investigators from the
Clinical Centers, in conjunction with the Data Coordinating
Center, will have lead responsibility in developing the
protocol; the NIDDK Project Coordinator will provide
assistance in this phase of the study.  Patients recruited
and admitted into the study after having met agreed upon
diagnostic entry criteria, will have standard demographic
information, symptoms related to interstitial cystitis, and
clinical samples collected from them at established
intervals.
 
The primary objectives of this patient data base include the
following:
 
1.  To identify the age, sex, race, and other demographic
characteristics of patients with interstitial cystitis.
 
2.  To determine the natural history of this disorder.
 
3.  To collect and distribute patient samples and to analyze
bladder biopsies.
 
4.  To act as a data and patient sample repository for use
by other investigators wishing to conduct epidemiological
and clinical studies.
 
The protocol will be subject to review by an uninvolved
expert group, the External Advisory Committee.  The study
will move into its operational phase following concurrence
by awardees and the NIDDK.
 
It is expected that data and patient sample collection will
take place in three Clinical Centers.  Each Clinical Center
is expected to recruit a minimum of 50 patients with the
diagnosis of IC per year for 4 years or
a total of 200 patients.  Applicants for Clinical Centers
must provide a detailed estimate of the number of patients
that could be recruited over the course of the study based
on their current patient population and potential referral
population.  Because of difficulty in diagnosis of this
disorder, uniform diagnostic criteria have been established
and published (Journal of Urology 142(1): 139, 1989 and
American Journal of Kidney Diseases 8(4):353, 1989).  It is
expected that there will be an initial 5-month period of
collaborative protocol development prior to patient
enrollment, 48 months of patient recruitment, and 6 months
of final data analysis and reporting of results at the
conclusion of recruitment.
 
It is planned that the NIDDK will support the function of a
separate Data Coordinating Center (DCC) for the study as
outlined in this RFA.  The DCC will have primary
responsibility for collecting, editing, and analyzing data
generated by the Clinical Centers and collection and
distribution of bladder biopsy material and other patient
samples.  The DCC will assume a key role in protocol
development, design of the data and patient sample
collection system, and quality control.
 
Each Clinical Center applicant should indicate what data and
patient samples they propose for collection in this study.
Information and samples to be collected should be chosen
to address the natural history of the disorder in the
study population.  All centers must be willing to
participate fully in the development and implementation of
the data and sample collection procedures as members of the
Steering Committee.  They must also agree to supply their
data and patient samples to the Data Coordinating Center for
analysis.  The DCC and Clinical Centers will have primary
access and rights to data and patient samples.  Study
investigators will be responsible for establishing
procedures for reviewing requests for use of data and
samples from researchers not directly participating in the
study.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION
OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES
IN CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applications for NIH/ADAMHA
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.
 
Applicants/offerors 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 includes
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.
 
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
will be reflected in assigning the priority score to the
application.
 
All applications for clinical research submitted to NIH are
required to address the policies.  NIH funding components
will not award grants or cooperative agreements that do not
comply with these policies.
 
STUDY COMPONENTS
 
1.  Clinical Centers
 
A Clinical Center is an institution that is actively
involved in the recruitment, evaluation, and follow-up of
study patients.  It should consist of a small team of
researchers, including part-time effort from a Principal
Investigator, research/nurse coordinator, and clerical
staff.  Applications for Clinical Centers must provide
evidence that they will be capable of recruiting 50 patients
into the study during each year of the 4-year period of
recruitment.  Clinical Centers will be required to submit
data and patient samples expeditiously.  The Principal
Investigator in each Clinical Center should be skilled in
clinical investigation with IC patients.  There should be
evidence of strong institutional support for the Clinical
Center, including adequate space in which to conduct clinic
activities.
 
2.  Data Coordinating Center
 
The DCC will have primary
responsibility for collecting, editing, storing, and
analyzing data and assessing patient samples provided by the
Clinical Centers.  The DCC should be prepared to assume a
key role in protocol development, designing a data and
patient specimen collection system, assuring quality control
and providing appropriate detailed data reports to the
Steering Committee at regular intervals.  The DCC will be
expected to provide appropriate biostatistics; data
management; handling of patient samples, interpretation, and
distribution; and study-wide coordination expertise.  They
will also make a major contribution to the development of
the study protocol and manual of operations.  The
DCC will also be expected to provide
appropriate detailed data reports to the Steering Committee
and to the External Advisory Committee at regular intervals
and will be responsible for the logistics and planning of
meetings of these committees.
 
Applicants for the Data
Coordinating Center must provide a detailed description of
prior experience in multicenter studies.  DCC applicants
must identify in their applications a collaborating Central
Laboratory (or laboratories) for testing patient samples,
including bladder biopsies.  The Central Laboratory will be
responsible for establishing procedures for collection of
patient samples, testing these samples and reporting results
to the DCC and Clinical Centers, maintaining laboratory
quality control procedures, developing guidelines for
obtaining bladder biopsies and other patient samples, and
providing periodic training in specimen collection and
transport procedures.  For a Central Laboratory supported by
a subcontract from the DCC, all NIH policies and procedures
governing consortium grants must be adhered to.
 
3.  Steering Committee
 
A Steering Committee including the Principal
Investigators of the Clinical Centers and the
DCC will be responsible for making the major
scientific decisions governing the conduct of the study,
with assistance from the NIDDK Project Coordinator.  Each
member of the Steering Committee will have one vote.  The
Chairman of the Steering Committee will be selected by
members of the Steering Committee.
 
It is anticipated that the Steering Committee will meet on a
monthly basis during protocol development, or more often if
required, and on a quarterly basis thereafter.  During
protocol development, the Steering Committee will define
rules for accessing patient data and samples by non-study
investigators.
 
4.  External Advisory Committee
 
An External Advisory Committee composed of experts in
relevant medical, statistical, and bioethical fields will be
established to periodically review the progress of the study
and provide advice regarding this progress to the Steering
Committee and NIDDK.  The Chairman of the Steering
Committee, the Principal Investigator of the DCC, and the
NIDDK Project Coordinator may participate as ex-officio non-
voting members of this Committee.  External Advisory
Committee members will be selected by members of the
Steering Committee.
 
5.  Project Coordinator
 
The NIDDK will name the Urology Program Director within the
Division of Kidney, Urologic and Hematologic Diseases, to be
the Project Coordinator, to assist the Steering Committee
and External Advisory Committee in carrying out the study.
The Project Coordinator will provide scientific support to
awardees' activities including:  protocol development, quality
control, interim data monitoring, final data analysis and
interpretation, preparation of publications, and performance
monitoring.
 
STUDY PHASES
 
The entire study will consist of three sequential phases as
follows:
 
Phase I    Development of Protocol (5 months)
Phase II   Recruitment of Study Sample and
           Interim Data Analysis (48 months)
Phase III  Final Data Analysis and Reporting (6 months)
 
STUDY RESPONSIBILITIES, GOVERNANCE, AND FUNDING
 
The primary governing body of the study will be the Steering
Committee composed of the Principal Investigators of the
study centers, the Chairman of the Committee, and the
NIDDK Project Coordinator.  All major scientific decisions
concerning protocol development will be determined by vote
of the Steering Committee.  The Committee will have primary
responsibility for the development of the study protocol,
facilitating the conduct of the study, and reporting of
study results.
 
It is expected that data and patient samples will be
submitted centrally and that the protocol will define rules
regarding access to data, patient samples, and
publications.  Study investigators have primary access to
patient data and samples and responsibility for deciding
upon their distribution.  Formal, written requests for use
of study data and samples by non-study investigators will be
required.  These requests will be reviewed and acted upon by
the Steering Committee or one of its subcommittees.
Criteria for this review will be developed as part of the study
protocol.  An External Advisory Committee will review
progress at least semi-annually and provide advice to the
investigators and the NIDDK regarding progress of the study.
 
MECHANISM OF AWARD
 
It is anticipated that four awards (three Clinical Centers
and one Data Coordinating Center) will be made under this
RFA, at a funding level of approximately $200,000 - $250,000
in total costs, for the Data Coordinating Center, and
approximately $125,000 in total costs for each Clinical
Center.  Funding is expected to begin in Fiscal Year 1991;
total support for the project will be for approximately 5
years.  However, based on recommendations from the Steering
Committee and the External Advisory Committee, the NIDDK may
wish to extend follow-up of study participants recruited in
the latter half of the study for an additional 1-2 years.
This extension in follow-up would also be supported under
the cooperative agreement mechanism.  Applications from
foreign institutions will not be considered since only a
small number of centers will be selected to participate in
this program.
 
The administrative and funding mechanism to be used to
undertake this program will be cooperative agreements (UO1).  The
cooperative agreement is an award instrument establishing an
assistance relationship between NIH and a recipient, in
which substantial programmatic involvement is anticipated
between NIH and the recipient during performance of the
contemplated activity.  NIH assists, supports, and/or
stimulates, and is involved substantially with recipients in
conducting projects similar in program intent to those for
grants, facilitating performance of the effort in a
"partner" role.
 
TERMS AND CONDITIONS OF AWARD
 
The tasks or activities in which awardees will have
substantial and lead responsibilities include protocol
development, patient recruitment and follow-up, data and
patient sample collection, quality control, final data
analysis and interpretation, control of publications, and
collaboration with other awardees.  The awardees will have
primary access and rights to data and samples collected in
this study.  The NIDDK Project Coordinator will assist in
protocol development, quality control, interim data
monitoring, final data analysis and interpretation,
preparation of publications, and performance monitoring.
 
The NIDDK reserves the right to terminate or curtail the
study (or an individual award) in the event of a substantial
shortfall in (a) patient recruitment, follow-up, data
reporting, quality control, or other major breach of the
protocol; or (b) substantial changes in the agreed-upon
protocol to which the NIDDK does not agree; or (c) human
subject ethical issues that may dictate a premature
termination.
 
Any disagreement that may arise in scientific-programmatic
matters between award recipients and NIDDK may be brought to
arbitration.  An arbitration panel will be composed of three
members---one selected by the Steering Committee (with NIDDK
member not voting) or by the individual awardee in the event
of an individual disagreement, a second member selected by
NIDDK, and the third member selected by the two prior
members.  This special arbitration procedure in no way
affects the awardees' right to appeal an adverse action that
is otherwise appealable in accordance with the PHS
regulations at 42 CFR part 50, subpart D and HHS regulations
at 45 CFR part 16.
 
These special terms of award are in addition to, and not in
lieu of, otherwise applicable OMB administration guidelines,
HHS Grant Administration Regulations at 45 CFR part 74, and
other HHS, PHS, and NIH grant administration policy
statements.
 
Review Procedures and Criteria
 
Upon receipt, applications will be reviewed by NIDDK staff
for responsiveness to the objectives of this RFA.  If
an application is judged unresponsive, the applicant will be
contacted and given the opportunity to withdraw the
application, or have it considered for the regular NIH grant
program.
 
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 to eliminate those
applications that are clearly not competitive.  The NIDDK
will withdraw from further competition those applications
judged to be noncompetitive and notify the applicant and
institutional official.
 
Those applications judged to be both responsive and
competitive will be further evaluated according to the review
criteria stated below for scientific and technical merit by
an appropriate peer review group convened by the Division of
Extramural Affairs, NIDDK.  Subsequently, they will be
reviewed by the National Diabetes and Digestive and Kidney
Diseases Advisory Council.
 
If the application submitted in response to this RFA is
substantially similar to a research 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.
 
Review Criteria
 
The evaluation of applications for both Clinical Centers and
the Data Coordinating Center will be based primarily on the
scientific merit of the proposed study.  If an institution
wishes to apply both as a Clinical Center and Data
Coordinating Center, separate applications must be
prepared.  Specific criteria for review of applications will
be as follows.
 
For Clinical Centers:
 
1.  Scientific merit of the proposed study design including
diagnostic criteria for patient selection, plans for
recruitment of patients, proposed data and patient sample
collection during follow-up, and techniques for maintaining
continued contact with patients during the course of the
study.
 
2.  Documentation of the specific competence and previous
experience of professional, technical, and administrative
staff pertinent to the operation of a Clinical Center in the
proposed study.  Evaluation will include the following:
familiarity and experience in recruiting
IC patients for clinical studies; working in
collaboration with other investigators under a common
protocol; and careful and expeditious handling of study
data.
 
3.  Documentation of a well-established practice and
experience in the treatment of persons with
IC or, alternatively, detailed knowledge about
IC and a referral source of patients.
This includes documentation of a sufficient patient
population from which to recruit in order to meet individual
Clinical Center goals for the number of study participants.
 
4.  Understanding and awareness of the scientific, ethical,
and practical issues underlying the proposed study and
appropriateness of plans to deal with them.  This includes
an organizational structure that will allow follow-up of
patients.
 
5.  Appropriateness of the budget for the work proposed.
 
6.  Adequacy of the proposed facility and space.
 
7.  Evidence of the degree of institutional commitment and
support for the proposed program.
 
8.  A willingness to work cooperatively with other centers
in a manner summarized in the RFA.
 
For the Data Coordinating Center:
 
1.  Documentation of the specific competence and previous
experience of professional, technical, and administrative
staff pertinent to the operation of a Data Coordinating
Center for a collaborative study, as well as available on-
site medical consultation, and the time these professionals
will devote to the project.  Prior experience in similar
studies in the collection of data from multiple clinical
sites, as well as experience in monitoring the quality and
timeliness of such data, must be demonstrated.  Experience
in collection and testing of patient samples from multiple
clinic sites should also be documented.
 
2.  The approach to soliciting cooperation from the
participating Clinical Centers and exercising appropriate
leadership in matters of study design and direction and of
data acquisition, management, and analysis.
 
3.  Ability to identify and enlist the cooperation of a
central laboratory or laboratories for processing patient
samples and bladder biopsy material.
 
4.  Suitability of the proposed data management and data
analysis plans.
 
5.  Suitability of proposed plans for collection and testing
of patient samples.
 
6.  Appropriateness of the budget for the proposed work.
 
7.  The adequacy of the proposed facility, technical
hardware, and space.
 
8.  The organizational and administrative structure of the
proposed program.
 
9.  Evidence of the degree of commitment and support of the
organization/institution for the proposed program, including
the relative position of the proposed project staff within
the applicant's organizational structure.
 
Study Phases
 
Each applicant must submit an adequately justified budget
for the entire anticipated project period of approximately 5
years.  The budgets for each budget period of the study
should be clearly delineated.  The 01 budget period of the
grant will be for an 11-month period, September 30, 1991
through August 31, 1992, that includes 5 months of protocol
development (Phase I) and 6 months of recruitment (Phase
II).  Recruitment will continue for an additional 42 months
during Phase II (September 1, 1992 through February 29,
1996).  Phase III is the last 6 months of the study (March
1, 1996 through August 30, 1996) which will be for final
data analysis and reporting of results.  The 02, 03, 04, and
05 budget periods for which individual budgets should be
prepared will be for the following 12-month time periods:
September 1, 1992-August 30, 1993; September 1, 1993-August
30; 1994; September 1, 1994-August 30, 1995; and September
1, 1995-August 30, 1996, respectively.
 
METHOD OF APPLYING
 
Letter of Intent
 
Prospective applicants are requested, but not required, to submit
a letter of intent to apply to the RFA as a Clinical Center
and/or Data Coordinating Center.  This letter should include
the name, telephone number and mailing address of the
Principal Investigator, the names of other key personnel,
the name of the applicant institution, and the number and
title of this RFA.  Such a letter of intent is not binding
and it will not enter into the review of any application
subsequently submitted, nor is it a necessary requirement
for application.  Letters of intent are requested solely for
planning purposes.  The NIDDK staff will not provide
responses to such letters.  Letters of intent to apply to
this RFA, must be received no later than May 17, 1991, and
must be addressed to:
 
Dr. Robert D. Hammond
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 406
Bethesda, MD  20892
 
Format for Applications
 
Submit applications on form PHS 398 (revised 10/88,
reprinted 9/89), the application form for the traditional
NIH research project grant.  Copies of this form are
available in the applicant institution's office of sponsored
research, and may be obtained from the following:
 
Office of Grants Inquiries
Division of Research Grants
Westwood Building, Room 449
National Institutes of Health
Bethesda, MD  20892
 
Use the conventional format for research project grant
applications and ensure that the points identified in the
section above on "Review Procedures and Criteria" are
fulfilled.  To identify the application as a response to the
RFA, CHECK "YES" on item 2 of page 1 of the application and
enter the title "Interstitial Cystitis Data Base:  Clinical
Centers and Data Coordinating Center" and enter the RFA
number DK-91-10 in the space provided.
 
THE RFA LABEL FOUND IN THE FORM PHS 398 (REVISED 10/88,
REPRINTED 9/89) APPLICATION KIT MUST BE AFFIXED TO THE
BOTTOM OF THE FACE PAGE OF THE ORIGINAL COMPLETED
APPLICATION FORM PHS-398.  FAILURE TO USE THIS LABEL COULD
RESULT IN DELAYED PROCESSING OF YOUR APPLICATION SUCH THAT
IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW.
 
Application Procedure
 
Send or deliver the completed, signed application and four
(4) complete photocopies to the following, making sure
that the original application with the RFA label attached is
on top:
 
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD  20892**
 
SEND TWO ADDITIONAL COPIES OF THE APPLICATION TO DR. HAMMOND
AT THE ADDRESS LISTED UNDER  "LETTER OF INTENT."  IT IS
IMPORTANT TO SEND THESE TWO COPIES AT THE SAME TIME AS THE
ORIGINAL AND FOUR COPIES ARE SENT TO THE DIVISION OF
RESEARCH GRANTS, OTHERWISE THE NIDDK CANNOT GUARANTEE THAT
THE APPLICATION WILL BE REVIEWED IN COMPETITION FOR THE RFA.
 
Applications must be received by June 14, 1991.  An
application not received by this date will be considered
ineligible and returned to the applicant.
 
Timetable
 
Letter of Intent:  May 17, 1991
Application receipt date:  June 14, 1991
Initial Review:  July/August 1991
Review by the National Diabetes and Digestive and Kidney
Diseases Advisory Council:  September 1991
Anticipated Award Date:  September 30, 1991
 
Inquiries:  Inquiries regarding this announcement may
directed to the following:
 
John W. Kusek, Ph.D.
Clinical Trials Program Director
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 621
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7133
FAX:  (301) 496-9721
 
For fiscal and administrative matters, contact:
 
Thomas Turley
Grants Management Office
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 653B
Bethesda, MD  20892
Telephone:  (301) 496-7467
 
These programs are described in the Catalog of Federal
Domestic Assistance No. 93.849 - Kidney, Urologic and
Hematologic Diseases Research.  Awards will be made under
the authority of the Public Health Service Act, Title III,
Section 301 (Public Law 78-4110, as amended:  42 USC 241)
and administered under PHS Grant Policies and Federal
Regulations 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.
 
$$FT END ***************************************************************