Subject: NIH Guide 2/l5/9l Part 2
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 13 Feb 91 13:09 EST

Hi Paul,
   Please post this to the NIH Listserver as:
    NIHGUIDE1.910215
This looks like the last one today.
     Thanks.  Have a fine evening.
                                  Dottie
 ---------------------------- Text of forwarded message -----------------------
 
X-comment: NIH Guide (including TOC) contained 23 pages (1840 lines)
X-comment: RFAS described:  CA-91-07, AR-91-02, AR-91-03, AHCPR-91-01, AG-91-
                           07, CA-91-08, AG-91-05
clinical trials, studies of mechanisms underlying treatment response, and
cost-effectiveness/health care utilization studies.  The Research Development
Core will also support pilot research projects on topics related to the
activities of the OAIC.
 
DEMONSTRATION AND INFORMATION DISSEMINATION PROJECTS:  OAICs must include
activities to translate findings from their research into health care
practice.
 
LEADERSHIP/ADMINISTRATIVE CORE:  Applicants may request funds for the OAIC
Director, OAIC Administrator, and support staff.  The OAIC Director should be
a scientist who can provide effective administrative and scientific leadership
and coordination with OAIC intervention studies.  An OAIC Administrator who
will assist the Director in managing the Center, addressing issues of fiscal
management and compliance with institutional, PHS, NIH, and NIA policies, must
be identified.
 
MECHANISM AND SCALE OF SUPPORT:  Older Americans Independence Centers will be
supported through comprehensive center grants (P60).  The total costs (direct
 
           NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 17
plus indirect) requested per application for the first year may not exceed
$1,500,000.  Plans are to make up to 3-4 awards depending upon availability of
funds.  Up to $3.9 million (total cost) for first-year expenses, and
additional approved expenses for up to five years, will be committed in Fiscal
Year 1991 to fund applications submitted in response to this RFA, subject to
receipt of high-quality applications and availability of funds.
 
REVIEW PROCEDURES AND CRITERIA, AND METHOD OF APPLYING:  Applications will be
received by the NIH Division of Research Grants and assigned to NIA.
Responsive applications will be assigned to a special institute review group
for review.  Customary scientific review criteria will be applied, including
significance of the research project to the goals of the RFA.  A complete copy
of the RFA and program guidelines may be obtained from the NIA contact listed
below.  Applications must be submitted on the standard PHS 398 (rev. 10/88,
reprinted 10/89) application form.  The deadline for receipt of applications
is May 17, 1991.  On item 2 of the face page of the application, applicants
should enter:  NIA RFA--Claude Pepper Older Americans Independence Center,
AG-91-05.  The RFA label available in the application form PHS 398 must be
affixed to the bottom of the face page and placed on top of the entire
package.  Failure to use this label could result in delayed processing of the
application and prevent it from reaching the review committee in time for
review.
 
A complete copy of the RFA and program guidelines may be obtained from:
 
Stanley L. Slater, M.D.
Geriatrics Program, NIA
Building 31, Room 5C27
Bethesda, MD  20892
Telephone:  (301) 496-6761

                        ONGOING PROGRAM ANNOUNCEMENTS

MECHANISMS OF HIV PATHOGENESIS IN PEDIATRIC POPULATIONS
 
PA:  PA-91-25
 
P.T. 34; K.W. 0715008, 0765033, 0745027, 0770005, 0715125, 0710070
 
National Institute of Allergy and Infectious Diseases
 
Application Receipt Dates:  May 1, September 1, January 2
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases (NIAID) is
designated as the lead institute for the investigation of the pathogenesis,
prevention, and treatment of the human immunodeficiency virus (HIV)
responsible for the acquired immunodeficiency syndrome (AIDS).  HIV-infected
women as well as children born to HIV-infected women are the fastest growing
populations of AIDS patients.  The clinical manifestations of pediatric AIDS
differ from those seen in adults.  Recurrent bacterial infections, lymphocytic
interstitial pneumonitis and encephalopathy, as well as neurological and
physical growth deficits, are commonly observed in children with HIV
infection.  Immune dysfunction is found in children with greater than 1500 CD4
T cells/mm3.  Compared to adults, opportunistic infections and AIDS symptoms
appear much earlier after infection in most children, with 50 percent
diagnosed before one year of age and 82 percent within the first three years.
Little is known concerning the mechanisms of pathogenesis of HIV infection in
the immature host, and this lack of knowledge makes it difficult to define
effective treatment strategies.
 
RESEARCH OBJECTIVE
 
The objective of this program announcement is to stimulate research on the
mechanisms of HIV pathogenesis in hosts with developing immune and
neurological systems.
 
Applications that focus on specific strategies to determine the mechanisms of
HIV pathogenesis in pediatric populations are encouraged.  These strategies
may include, but are not limited to, the following areas:
 
1.  Determine the cells/organs harboring HIV, the time and mode of infection
(in utero, perinatal, breast milk), the route and mechanisms of viral spread,
cell tropism, and genetic variation in pediatric HIV infection.

           NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 18
2.  Determine if there is transfer of maternal immunity to the fetus, and if
so, define the parameters (e.g., viral load, time, mechanism).  Identify
strategies to induce or amplify protective immune response(s) in
immunosuppressed individuals.
 
3.  Define the mechanisms for the immunologic abnormalities in pediatric
populations.
 
  A. Abnormalities in humoral immunity:  Which regulatory mechanism(s)
     are impaired?  Which regulatory mechanisms determine whether
     immunoglobulin levels are elevated or deficient?
 
  B. Abnormalities in cellular immunity.
 
  C. Abnormalities in antigen presenting cells.
 
  D. Abnormalities in regulation, production, and/or expression of
     cytokines and/or lymphokines.
 
4.  Define the cellular factors in the immature host that interact with viral
regulatory elements.
 
5.  Define the mechanisms for neurologic abnormalities and neuropathology in
pediatric populations.
 
6.  Define the factors and co-factors influencing/causing lymphocytic
interstitial pneumonitis and the mechanisms of pathogenesis.
 
7.  Define the pathogenic mechanisms that allow recurrent bacterial
infections, viral infections (e.g., EBV, CMV, JC), fungal, and other
opportunistic infections in children with HIV infection.
 
8.  Define the host and viral factors that determine the accelerated course of
HIV disease progression in some infants and children and that allow latency in
other children for many years.
 
9.  Define appropriate animal models for the study of pediatric AIDS.
 
The approaches outlined above are not intended to be comprehensive nor are
they required.  All research strategies that will lead to insights into the
mechanism of pathogenesis in pediatric HIV infection are encouraged under this
program announcement.
 
MECHANISM OF SUPPORT
 
The NIAID encourages investigator-initiated research on topics relevant to
pediatric AIDS.  This program announcement invites R01 applications from
investigators who wish to play an active role in defining the direction of
such research.  Although no funds are specifically set aside for funding
grants submitted in response to this program announcement, the NIH regards
high quality research in pediatric AIDS as an area of high priority.  The
total project period for applications submitted in response to this program
announcement should not exceed five years for domestic institutions and three
years for foreign institutions.
 
ELIGIBILITY
 
Applications may be submitted by nonprofit or for-profit organizations and by
public or private entities 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
apply.  Both foreign and domestic institutions are eligible to apply.
 
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 applicants 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.

           NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 19
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
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.
 
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 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 these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.
 
REVIEW PROCEDURES
 
Although most applications in response to this announcement are expected to be
assigned to the NIAID, whenever there is inter-institute programmatic overlap
in the proposed research, the PHS Referral Guidelines will prevail in
assignment of applications to the institutes.  Applications will be reviewed
for scientific and technical merit in accordance with the usual NIH peer
review procedures by the Division of Research Grants (DRG) study sections
specially constituted to review AIDS grant applications.  Following study
section review, the applications will receive a second-level review by an
appropriate national advisory council.  The earliest award date for successful
applications will be no more than six months from the receipt date.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  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  Balance among research areas
 
Applications from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may identify
the GCRC as a resource for conducting the proposed research by including a
letter of agreement from either the GCRC program director or Principal
Investigator.

 
 
           NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 20
METHOD OF APPLYING
 
Applications must be submitted on the grant application form PHS 398 (rev.
10/88) and will be accepted at the regular application deadlines as indicated
below.  The relevant dates for applications for AIDS-related research are:
 
Receipt Date      Initial Review          Council Review - Earliest Award
 
May 1             June/July               September/October - Nov. 1
September 1       October/November        January/February - March 1
January 2         February/March          May/June - July 1
 
Application kits are available at most institutional business and
grant/contract offices and may be obtained from the Office of Grants
Inquiries, Division of Research Grants, Westwood Building, Room 449, National
Institutes of Health, Bethesda, Maryland 20892.  The title and number of this
announcement, MECHANISMS OF HIV PATHOGENESIS IN PEDIATRIC POPULATIONS,
PA-91-25, must be typed in item 2 on the face page of the application.
 
The completed original application and twenty-three copies must be sent or
delivered to:
 
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
5333 Westbard Avenue
Bethesda, MD  20892**
 
INQUIRIES
 
Requests for further information may be directed to:
 
Gregory Milman, Ph.D., Chief
Pathogenesis Branch/DAIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Blvd., Room 242P
Bethesda, MD  20892
Telephone:  (301) 496-8378
FAX:  (301) 480-5703
 
This program is described in the Catalog of Federal Domestic Assistance No.
93.856 - Microbiology and Infectious Disease Research and 93.855 - Allergy,
Immunology and Transplantation Research.  Grants are awarded under the
authority of the Public Health Service Act, Title IV, Section 301 as amended,
Public Law 78-410, Public Law 97-219; Public Law 99-158; Public Law 99-500;
and Report 99-711 to accompany HR 5233 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.

                                   ERRATUM

MULTICENTER COOPERATIVE AGREEMENT FOR STUDYING NEURAL TUBE DEFECTS IN MUTANT
MICE
 
RFA:  HD-91-09
 
P.T. 34; K.W. 0710030, 1002004, 1002019, 1002059, 0755030
 
National Institute of Child Health and Human Development
 
The number assigned to the above RFA (RFA HD-91-01), which appeared in the
February 1 issue of the NIH Guide for Grants and Contracts (Vol. 20, No. 5),
is in error.  It should be changed to 'RFA 91-HD-09'.

**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF 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

           NIH GUIDE - Vol. 20, No. 7, February 15, 1991 - Page 21