Full Text PA-96-063
NIH Guide, Volume 25, Number 22, July 5, 1996
PA NUMBER:  PA-96-063
P.T. 34

  Biology, Cellular 
  Biology, Molecular 

National Institute of Diabetes and Digestive and Kidney Diseases
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites grant applications for support of research addressing
the infections of the Human Immunodeficiency Viruses (HIV) and the
effects of such infections on the kidney, on patients undergoing
treatment with dialysis, and/or patients with a renal allograft.
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.  Potential
applicants may obtain a copy of "Healthy People 2000 (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock
No.017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
Applications may be submitted by domestic and foreign for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government. Foreign
institutions are not eligible for First Independent Research Support
and Transition (FIRST) (R29) awards. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.
This PA will use the National Institutes of Health (NIH) individual
research project grant (R01) and FIRST (R29) award mechanisms.
Responsibility for planning, direction, and execution of the proposed
project will be solely that of the applicant.  Because the nature and
scope of the research proposal in response to this PA may vary, it is
anticipated that the size of an award will vary also; however, the
support of requests exceeding the NIDDK average grant size of
$160,000 direct cost for R01 grants would be unusual and require
ample justification.  FIRST (R29) awards are limited to $350,000
direct cost over the five year period.
The purpose of this program 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 infection 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 treatment 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
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
Animal Welfare Considerations
Investigators are encouraged to consider alternative methods and
approaches in their research grant applications that do not require
the use of whole animals, use alternative species such as nonmammals
or invertebrates, reduce the number of animals required, and
incorporate refinements to procedures that will result in the
elimination or further minimization of pain and distress in animals.
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email: asknih@odrockm1.od.nih.gov.
The program announcement title and number must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application. FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
Potential R29 applicants should refer to the notice on Just-in-Time
Procedures for FIRST and Career Awards (NIH Guide for Grants and
Contracts, Vol. 25, No. 10, March 29, 1996) for information on recent
changes in guidelines for FIRST award format.
The completed original application and five legible copies must be
sent or delivered to:
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
Applications will be assigned on the basis of established Public
Health Service referral guidelines. Applications that are complete
will be evaluated for scientific and technical merit by an
appropriate peer review group convened in accordance with NIH peer
review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in
which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the appropriate national advisory council or board.
Review Criteria
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 the resources necessary to perform the research;
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
The initial review group will also examine the provisions for the
protection of human and animal subjects, and the safety of the
research environment.
For Applications from Foreign Organizations:
o  availability of special opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions in other countries that are not readily
available in the United States or that provide augmentation of
existing U.S. resources.
Applications will compete for available funds with other approved
applications assigned to the National Institute of Diabetes and
Digestive and Kidney Diseases.  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  Program priority.
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome. 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
45 Center Drive, Room 6AS-19B MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  Ralph_Bain@nih.gov
Inquiries regarding fiscal matters may be directed to:
Trude Hillard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AN-44J, MSC 6600
Bethesda, MD  20892-6600
Telephone: (301) 594-8859
Email:  HillardT@ep.niddk.nih.gov
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
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children. This is consistent with PHS
mission to protect and advance the physical and mental health of the
American people.

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