Full Text PA-97-017
 
HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM
 
NIH GUIDE, Volume 25, Number 44, December 20, 1996
 
PA NUMBER:  PA-97-017
 
P.T. 34

Keywords: 
  Nervous System 
  AIDS 
  Pathogenesis 
  Treatment, Medical+ 

 
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute on Drug Abuse
National Institute of Child Health and Human Development
 
PURPOSE
 
The National Institute of Mental Health (NIMH), the National
Institute of Neurological Disorders and Stroke (NINDS), the National
Institute on Drug Abuse (NIDA), and the National Institute of Child
Health and Human Development (NICHD) invite research grant
applications through this Program Announcement (PA) to support
research focused on determining the pathogenic mechanisms involved in
HIV-1 associated neurobehavioral and neurological dysfunction in
adults and children.  The objective of this cooperative effort is to
foster investigations that will provide the foundation for the rapid
development of therapeutic interventions to prevent and treat the
effects of HIV-1 on the central nervous system (CNS).  Applications
ranging from basic research to clinical diagnosis and treatment
studies are being solicited.  Multidisciplinary research teams and
collaborative alliances are encouraged but not required.
 
HEALTHY PEOPLE 2000
 
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.  This PA,
HIV-1 Infection of the Central Nervous System, is related to the
priority area of HIV infection.  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 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Eligibility and requirements for different funding mechanisms vary.
Applicants are advised to contact the relevant program staff listed
under INQUIRIES for additional information and specific application
procedures.
 
Applications may be submitted by foreign and domestic, 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 small grants (R03), First
Independent Research Support and Transition (FIRST) (R29) awards,
program projects (P01), or fellowships (F32).  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
 
Grant funds may be used for expenses clearly related and necessary to
conduct the proposed research, including both direct and allowable
indirect costs.  Grant funds may not be used to operate a treatment,
rehabilitation, or other service program.  Prospective applicants
should contact NIH staff to ascertain the dollar and time limitations
associated with each program mechanism.
 
Information specific to the Individual Postdoctoral Training Awards
(F32):
 
Individuals must be, at time of application, citizens or noncitizen
nationals of the United States, or have been lawfully admitted to the
United States for permanent residence and have in their possession an
Alien Registration Receipt Card (I-151 or I-551).  Noncitizen
nationals are persons who, although not citizens of the United
States, owe permanent allegiance to the United States.  They are
generally persons born in lands that are not States, but are under
United States sovereignty, jurisdiction, or administration (e.g.,
American Samoa).  Individuals on temporary or student visas are not
eligible. Individuals must have received, as of the beginning date of
the National Research Service Award (NRSA) appointment, a Ph.D.,
M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr.P.H., or
D.N.S., or equivalent degree from an accredited domestic or foreign
institution.  Certification by an authorized official of the degree
granting institution that all degree requirements have been met is
also acceptable.  Individuals may receive up to three years of
aggregate NRSA support at the postdoctoral level including any
combination of support from institutional training grants and
individual fellowship awards.  For additional eligibility criteria,
see the NIH Guide, Vol. 25, No. 31, September 20, 1996.
 
MECHANISM OF SUPPORT
 
The mechanisms for support by the in this program announcement are:
investigator initiated research project grants (R01), FIRST awards
(R29), program project grants (P01), individual postdoctoral
fellowship programs (F32) and small research grants (R03).
 
NINDS does not accept applications for the R03 award.
 
Because certain grants have special eligibility requirements (e.g.,
small grants, program project grants and FIRST awards), application
formats, and review criteria; applicants are strongly encouraged to
consult with program staff listed under INQUIRIES and obtain the
appropriate additional announcements for those grant mechanisms.
 
An applicant planning to submit a new (Type 1) investigator-initiated
grant application requesting $500,000 or more in direct costs for any
year is advised that he or she must contact Institute program staff
before submitting the application, i.e, as plans for the study are
being developed.  Furthermore, the applicant must obtain agreement
from the staff that the Institute will accept the application for
consideration for award.  Finally, the applicant must identify, in
the cover letter that is sent with the application, the staff member
and Institute who agreed to accept assignment of the application.
Any application subject to this policy that does not contain the
required information in the cover letter sent with the application
will be returned to the applicant without review.  For additional
information concerning large grant applications, see the NIH Guide,
Vol. 25, No. 14 (May 3, 1996).
 
For FIRST (R29) awards, Just-in-Time procedures will be used.  These
modified procedures are described in full in the NIH Guide, Volume
25, Number 10, March 29,1996.
 
RESEARCH OBJECTIVES
 
Studies of the neuropathogenesis of HIV-1 infection have enhanced our
understanding of the profound impact of HIV disease on both the
central and peripheral nervous systems. These effects are common and
can result in considerable morbidity and mortality.  The recent
Report of the NIH AIDS Research Program Evaluation Task Force
described neuro-AIDS as "one of the most prominent and dreaded
manifestations of HIV infection."  Steady progress in the field of
neuro-AIDS research has been made.  However, answers to critical
questions that can be translated into clinical applications are
needed.  This program announcement is intended to encourage and
foster investigations that will address research questions that will
provide the foundation for the rapid development of therapeutic
interventions to prevent and treat the effects of HIV-1 on the
central and peripheral nervous systems.
 
In an effort to intensify the depth, focus and coordination of
efforts to address key neuro-AIDS issues, the NIMH, NINDS, NIDA, and
NICHD are jointly issuing this Program Announcement.  Applicants are
encouraged to contact program staff of the appropriate Institute
regarding programmatic specific issues.  The following are research
topics identified by the Institutes, the Office of AIDS Research
(OAR), as well as experts in the field to be the most pressing
scientific priorities and are provided as examples of research topics
pertinent to this Program Announcement.
 
o  Research that will determine the pathogenic mechanisms involved in
HIV-1 associated neurobehavioral and neurological dysfunction such
as:
 
- Determining how HIV enters, establishes infection and persists in
the CNS
 
- Determining the molecular and cellular changes underlying
HIV-associated  CNS dysfunction and their role in CNS dysfunction
 
- Determining the mechanisms and consequences of cellular trafficking
between the CNS, CSF and blood in the context of HIV-1 infection
 
- Determining the consequences of the biological activity of
cytokines, chemokines and neurotrophins on neurobehavioral and
neurological dysfunction associated with HIV-1 infection
 
o  Research that will determine the impact of HIV-1/CNS infection on
systemic disease progression; and the role of the CNS as a reservoir
for HIV infection
 
o Research leading to the development and expansion of methods to
diagnose and monitor HIV-1 associated cognitive and motor dysfunction
 
o Research to develop HIV-1 therapeutic agents capable of penetrating
the blood-brain-barrier or delivery systems that enhance uptake
across the blood-brain-barrier
 
o Research that will determine the mechanisms and consequences of
HIV-1 infection that influence the developing nervous system
 
o Research which employs appropriate animal models of HIV-1/CNS
disease to test hypotheses regarding the neuropathogenesis of HIV-1
infection and/or test therapeutic interventions
 
o Research to determine the impact of anti-HIV-1 treatments on
neurobehavioral and neurological complications of HIV-1 infection
 
o Research to determine the role of opportunistic infections in
neurobehavioral and neurologic complications of HIV-1 infection
 
o Research investigating biological, environmental and nutritional
factors that impact nervous system function in the context of HIV-1
infection
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
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.
 
APPLICATION PROCEDURES
 
Applications (with the exception of F32) are to be submitted on the
grant application form PHS 398 (rev. 5/95) and will be accepted at
standard deadlines for AIDS applications as indicated on page 21 of
the application kit.  Applications for fellowships (F32) are to be
submitted on form PHS 416-1 (rev. 8/95); the standard receipt dates
for these applications are April 5, August 5, and December 5.  Both
application kits are available at most institutional offices of
sponsored research and may be obtained from Office of Extramural
Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910; telephone 301/435-0714; fax 301/480-0525;
Email: ASKNIH@ODROCKM1.OD.NIH.GOV. The title, "HIV-1 Infection of the
Central Nervous System," and number of the program announcement must
be typed on the face page of the application.
 
Applications for the FIRST award (R29) must include at least three
sealed reference letters 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.  Applications for individual
postdoctoral NRSAs (F32) must submit at least three completed
reference forms. These forms are enclosed in the PHS 416-1 (rev.
8/95) kit used for individual NRSA applications.
 
The completed original application and five legible copies of the PHS
398 or the original and two copies of the PHS 416-1 must be sent or
delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight mail service)
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications that are complete will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with the standard NIH peer review
procedures.  As part of the initial merit review, applications may
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, when applicable.
 
Review Criteria for R01 and R29:
 
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
evaluated.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.
 
For foreign applications, availability of special opportunities for
furthering research programs through the use of unusual talent,
resources, populations, or environmental conditions not readily
available in the United States, or that provide enhancement of
existing U.S. resources, must be addressed.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions: quality of the proposed project as determined by peer
review, potential impact and relevance to the field, availability of
funds and program priority.
 
INQUIRIES
 
Inquiries regarding this PA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Walter L. Goldschmidts, Ph.D.
Office on AIDS
National Institute of Mental Health
Parklawn Building, Room 10-75
Bethesda, MD  20857
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  wgoldsch@nih.gov
 
A. P. Kerza-Kwiatecki, Ph.D.
Division of Convulsive, Infectious and Immune Disorders
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 804
Bethesda, MD  20892
Telephone:  (301) 496-1431
FAX:  (301) 402-2060
Email:  ak45w@nih.gov
 
Lynda Erinoff, Ph.D.
Office on AIDS
National Institute on Drug Abuse
Parklawn Building, Room 9A30
Bethesda, MD 20857
Telephone:  (301) 443-6046
FAX:  (301) 443-4100
Email:  le30q@nih.gov
 
Anne Willoughby, M.D., MPH
Pediatric, Adolescent and Maternal AIDS Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11H
Bethesda, MD  20892
Telephone:  (301) 496-7339
FAX:  (301) 496-8678
Email:  willouga@hd01.nichd.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Bethesda, MD  20857
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov
 
Dianna Jessee
Division of Extramural Activities
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
FAX:  (301) 402-0219
Email:  dj35j@nih.gov
 
Gary P. Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
Parklawn Building, Room 8A54
Bethesda, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov
 
Edgar D. Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17
Bethesda, MD  20892
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  shawverd@hd01.nichd.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.242, 93.281, and 93.282 for NIMH, Nos. 93.853 and
93.854 for NINDS,. No. 93.279  for NIDA and 93.865 for NICHD. 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 66, and 45 CFR Part 74.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.  Awards
will be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement (April 1, 1994).
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the nonuse 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 the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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