Full Text DK-94-010


NIH GUIDE, Volume 23, Number 1, January 7, 1994

RFA:  DK-94-010

P.T. 34

  Viral Studies (Virology) 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  March 9, 1994
Application Receipt Date:  April 20, 1994


The Division of Kidney, Urologic, and Hematologic Diseases of the
National Institute of Diabetes and Digestive and Kidney Diseases
solicits research project (R01) and FIRST (R29) grant applications
for support of studies focused on infections of Human
Immunodeficiency Viruses (HIV) and the effects of such infections on
the kidneys of patients undergoing treatment with dialysis and/or
patients with a renal allograft.


The 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, Effects of HIV
Infections in the Kidney, and in Dialysis and Renal Transplant
Patients, is related to the priority area of HIV infections.
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 for-profit or nonprofit
organizations, whether public or private, such as universities,
colleges, hospitals, laboratories, units of State or local
governments, and eligible agencies of the Federal Government.
Minority individuals and women are encouraged to submit as principal


Support of this program will be through the NIH and grant-in-aid
research project grant (R01) award or the FIRST (R29) award.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  Awards will
be administered under Public Health Service (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 total requested project period
for applications submitted in response to this RFA may not exceed 5
years.  The earliest possible award date will be
July 1, 1994.


For FY 1994, $500,000 will be committed to fund applications
submitted in response to this RFA.  It is anticipated that 3 new
awards will be made.  However, this funding level is dependent upon
the receipt of a sufficient number of applications of high scientific
merit.  Applicants must limit their requests to not more than
$160,000 direct costs for the initial budget period.  Although this
program is provided for in the financial plans of the NIDDK, the
award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.


The purpose of this announcement is to solicit applications in order
to support cellular and molecular studies that focus on the effects
of the HIV infection  on renal structure and function.  Studies that
focus on the pathogenesis of the nephropathy associated with HIV
infections are especially sought.  The various factors that influence
the renal manifestations of the HIV  infections need to be elucidated
as well as the effects  on renal function as a result of the various
treatment modalities for HIV.

Studies that focus on the clinical course of the HIV infection in
dialysis patients are encouraged.  Studies could include for example:
(1) factors that modulate progression from initial infection and
seropositive response to HIV to the development of ARC and/or AIDS;
(2) effects of blood transfusions, immunizations and vaccinations;
(3) effects of co-infection with the hepatitis virus; (4) treatment
of anemia and the effects of HIV treatments modalities.

Studies involving renal transplant recipients who have the HIV
infection are encouraged.  Such studies might focus on factors such
as:  immunosuppression; histocompatibility; co-infections;  patient
survival, and the immunosuppression regimen.

Applications for clinical studies in dialysis and/or with renal
transplant patients not infected with HIV are not applicable.
Program project grant applications (P01) are not suited to this


Applicants who receive an award through this announcement are
expected to attend a yearly meeting (convened by the NIDDK) of
investigators to discuss progress and exchange research information.
Funds to support the travel to these meetings may be included in the
proposed budget.


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 go 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 is 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/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 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

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


Prospective applicants are asked to submit, by March 9, 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.

A letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications.

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) 594-7515
FAX:  (301) 594-7503


The research grant application form PHS 398 (rev. 9/91) must be used
in applying for these grants.  The form is available from most
institutional business  offices  of sponsored research or from the
Office of Grants Inquiries, Division of Research Grants, National
Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD

Applications must be received at the NIH by April 20, 1994.  For
developing programs that deal with clinical populations, applicants
may wish to consider utilization of General Clinical Research Center
(GCRC) facilities.  More information on the GCRC program may be
obtained from the National Center for Research Resources, telephone:
(301) 594-7945.

The RFA label available in the 9/91 revision of 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 your 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
should 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 April 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 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.

For investigators applying for support through the FIRST award
mechanisms (R29), three letters of references must be submitted with
the application.  An applicant submitting a revised R29 application
in response to this RFA must again submit reference letters.


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 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 held until the next regular receipt date and reviewed
in competition with all other 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.  In
cases where 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 action.

Those applications judged to be competitive will be reviewed for
scientific and technical merit in accordance with the NIH peer review
procedures by an initial review group specifically convened for this
RFA.  Following this review, the applications will be given a
secondary review by the NIDDK Advisory Council unless not recommended
for further consideration by the initial review group.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

o  scientific/technical merit criteria specific to the objectives of
the RFA;

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly but not exclusively in the area
of the proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; 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.


Factors that will be taken into consideration in making awards
include the scientific merit of the proposed research as determined
by peer review and the availability of funds.


Written and telephone inquiries concerning this RFA are encouraged.

Direct inquiries regarding programmatic issues to:

Ralph L. Bain, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Suite 3A-05
Bethesda, MD  20892
Telephone:  (301) 594-7556

Direct inquiries regarding fiscal matters 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:       March 9, 1994
Application Receipt:    April 20, 1994
Initial Review:         July , 1994
Second Level Review:    September 20-21, 1994
Anticipated Award:      September 30, 1994


This program is described in the Catalog of Federal Domestic
Assistance No. 93.849.  Awards are 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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