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Full Text DK-94-009


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

RFA:  DK-94-009

P.T. 34

  Urogenital System 
  Biology, Cellular 
  Biology, Molecular 
  Medical/Diagnostic Imaging 

National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development

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
(NIDDK) and the Center for Population Research of the National
Institute of Child Health and Human Development (NICHD) solicit
regular research (R01) and First Independent Research Support and
Transition (R29) grant applications for support of studies focused on
infections of the Human Immunodeficiency Viruses (HIV) and the
effects of such infections on the genitourinary tract.


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, Research on HIV
Infections in the Genitourinary Tract, 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 grant-in-aid research
project grant (R01) and 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 and in this announcement.

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 September 30, 1994.


For FY 1994, $500,000 will be committed by the NIDDK and $300,000 by
the NICHD to fund applications submitted in response to this RFA.  It
is anticipated that 3 new awards will be made by the NIDDK and an
additional 2 new awards by the NICHD; 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 and the NICHD, 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 to
support cellular and molecular studies that focus on the effects of
the HIV infection on the genitourinary tract.  Such studies might
include for example: tissues/fluid/secretions involving the urine,
semen, bladder, urethra, prostate, testes, seminal vesicles, and
epididymides.  Broad areas for investigation could include the
location of the HIV in such tissues and the effect(s) of the HIV
infection on the cellular structure/function of these tissues.  It is
also of interest to study the effectiveness of pharmacological
therapy on eradicating HIV infection in these tissues and to study
the pathogenesis and treatment of urological disorders secondary to
HIV infection. Studies that focus on the effect(s) of HIV infections
on the physiology of the genitourinary tract as monitored by
established clinical methodologies such as urodynamics, radiographic,
and sonographic technologies are encouraged. The various factors that
influence the genitourinary manifestations of HIV infections need to
be elucidated as well as the effects on the function(s) of the
genitourinary tract as a result of the various treatment modalities
for HIV.

Applications for clinical studies in urodynamics and urinary tract
infections that have no relationship to HIV infection are not
requested.  Program project grant applications (P01) are not suited
to this announcement.


Applicants who receive an award through this announcement are
expected to attend a yearly meeting (convened by the NIDDK and the
NICHD) 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 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

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 is being 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:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 605
Bethesda, MD  20892
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 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 20892.

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 is available from Dr. Bernard Talbot at 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
5333 Westbard Avenue
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 or R29 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.

FIRST Award applications must include at least three sealed letters
of reference attached to the face page of the original application.
FIRST Award applications submitted without the required number of
reference letters will be considered incomplete and will be returned
without review.


Upon receipt, applications will be initially reviewed by 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 and NICHD staff function.  If the application is not
responsive to the RFA, the staff will contact the applicant to
determine whether it should be returned to the applicant, or whether
it should be 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.
Applications may be triaged by an NIDDK peer review group if the
number of applications is large compared to the number of awards to
be made.  Applications may be withdrawn from further competition if
they are judged to be non-competitive.  The NIDDK and the NICHD staff
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 usual 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 or NICHD 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.


Funding decisions will be made based on the initial review group and
national advisory council recommendations, program relevance and
balance, and availability of funds.

The anticipated date of award is September 30, 1994.


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

Donna Vogel, M.D., Ph.D.
Reproductive Medicine Unit
National Institute of Child Health and Human Development
6100 Building, Room 8B01
Bethesda, MD  20892
Telephone: (301) 496-6515

Inquiries regarding fiscal matters should 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

Ms. Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Building, Room 8A17
Bethesda, MD  20892
Telephone:  (301) 496-5481


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 (NIDDK) and 93.864 (NICHD). 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 review.


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