Full Text PAR-96-060
 
ACUTE INFECTION AND EARLY DISEASE RESEARCH NETWORK
 
NIH GUIDE, Volume 25, Number 20, June 21, 1996
 
PA NUMBER:  PAR-96-060
 
P.T. 34

Keywords: 
  AIDS 
  Pathogenesis 
  INTERVENTION, TYPES OF 

 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  August 1, 1996
Application Receipt Dates:  October 11, 1996; September 1, 1997;
September 1, 1998
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases (NIAID)
gives special consideration for funding to scientifically meritorious
applications in response to Program Announcements (PA).  Program
Announcements identify areas of ongoing research emphasis for the
NIAID.  In this PA, The Division of AIDS (DAIDS), National Institute
of Allergy and Infectious Diseases (NIAID), solicits applications to
study the pathogenesis of acute/early HIV-1 infection in adult
humans, and to develop and evaluate the impact of therapeutic
interventions at this early stage of HIV-1 infection on HIV disease.
 
The goal of this initiative is to build a network of three to five
HIV-1 Acute Infection and Early Disease Research Units through
cooperative agreements (U01) during the first year, with additional
units funded over the next several years as this emerging area of
science matures.  Each awarded unit will perform innovative,
integrated, investigator-initiated pathogenesis and clinical research
on acute (i.e, within one month post initial infection) and early
(i.e., up to 12 months post initial infection) HIV-1 infection and
will be part of the Acute Infection and Early Disease Research
Network (AIEDRN).  The multi-unit format (Network) is required to
enroll sufficient numbers of these hard-to-identify patients for
study.
 
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,
Acute Infection and Early Disease Research Network, 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
 
Applications may be submitted by domestic non-profit and for-profit
organizations, public and private organizations, such as
universities, colleges, hospitals, laboratories, units of State and
local governments, and eligible agencies of the Federal government.
While foreign organizations are not eligible to apply, domestic
organizations may include foreign components.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.
 
MECHANISM OF SUPPORT
 
The administrative and funding mechanism to be used to undertake this
program will be the cooperative agreement (U01), an "assistance"
mechanism in which substantial NIH scientific and/or programmatic
involvement is anticipated.  Under the cooperative agreement, the NIH
purpose is to support and/or stimulate the recipient's activity by
involvement in and otherwise working jointly with the award recipient
in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Cooperative
agreements may include a combination of academic, non-profit
research, and commercial organizations; applications that include
collaborations with domestic or international organizations with
access to larger numbers of people with acute infection and early HIV
disease are strongly encouraged.
 
RESEARCH OBJECTIVES
 
Background
 
Approximately 40,000 individuals are newly infected with HIV in the
United States each year.  Nonetheless, acute HIV infection is an
under-diagnosed entity because it is often asymptomatic and because
risk behavior associated with HIV infection is not identified.  Acute
infection is characterized by high levels of viral
replication/dissemination to lymphoid tissues and immunologic
activation.  Observations from several small cohorts suggest that:
(a) the concentration of HIV circulating in the blood (viral load)
reaches a peak in the first two to four weeks of HIV infection and
subsequently declines, and (b) the CD4+ T cell count of acutely
infected individuals declines precipitously during the first days of
HIV infection, however this rapid decline reverses itself, with a
subsequent rebound in the CD4+ T cell count.  Individuals with high
levels of plasma HIV-1 RNA within six months from seroconversion
experience more than tenfold increase in the risk for AIDS
development, suggesting that inadequate suppression of viremia during
the acute infection may be a critical factor in disease progression.
The identification of both host and viral factors that influence the
early establishment of a chronic HIV reservoir will facilitate the
development, selection and administration of treatment and prevention
modalities.  Antiviral and/or immunological interventions during
acute/early infection may have a great impact on the rate of disease
progression and survival in HIV+ individuals.  Preliminary results of
a placebo controlled European- Australian study of ZDV are promising
as CD4+ lymphocytes counts were higher in individuals receiving ZDV.
Because of the difficulties associated with identifying individuals
at this stage of infection, there have been few studies to analyze
the associated viral and immunological changes as well as the effect
of therapeutic interventions.
 
Scope of Research
 
This initiative will support innovative, integrated pathogenesis and
clinical research for acute (up to one month post initial infection)
and early (up to 12 months post initial infection) HIV-1 infection in
adult humans.  It will support single-unit and multi-unit clinical
research and conduct in-depth studies of HIV pathogenesis and factors
that influence response to interventions.  The treatment strategies
will be based on state-of-the-art concepts of early disease
pathogenesis.
 
The goal of this initiative is to build a network of three to five
HIV-1 Acute Infection and Early Disease Research Units through
cooperative agreements (U01) in the first year.  Each unit will
comprise basic and clinical scientists coordinated under the
direction of a single Principal Investigator, and each unit will be
part of the Acute Infection and Early Research Disease Network.
Unlike many other major NIH cooperative research projects, the
structure of the groups and funding are not linked to a specific
experiment or clinical trial.  Thus this mechanism has the potential
for considerable flexibility in resource allocation which will
facilitate the rapid testing of hypotheses about the pathogenesis of
HIV-1 infection and early phase clinical trials of promising
treatments of acute/early HIV infection.  The multi year nature of a
program announcement provides additional and necessary flexibility to
allow the support for the scientific capability to expand and keep
pace, as warranted, with this emerging, rapidly developing and high
priority area of HIV-related research.
 
In order to address these scientific needs, each unit should:
 
o  identify, accrue and retain acute/early HIV-1 positive individuals
for pathogenesis studies and clinical trials.  This requires strong
linkages with and intense screening from unique referral sources such
as Sexually Transmitted Diseases (STD) Clinics, emergency rooms,
blood banks, and primary care centers, as well as close collaboration
with centers and investigators studying existing natural history
cohorts.  The projected enrollment in the application should be at
least 30 to 50 patients per year. Of the total number of subjects, a
minimum of 10 to 15 subjects per year should be acutely infected,
i.e., within one month post initial infection. Applicants may include
studies on ways to improve detection and recruitment of new infected
individuals.
 
o  conduct independent and collaborative (both through the Network
and with outside investigators) studies of the in vivo pathogenesis
of early HIV disease.
 
o  evaluate and optimize therapeutic interventions in small, focused
clinical studies; perform extensive virologic and immunologic
evaluation that will provide new insights into the pathogenesis of
acute/early HIV infection and the efficacy of therapeutic approaches.
The identification and use of existing resources (such as the Centers
For AIDS Research, CFAR) should be maximized.  The banking and
storage of specimens for later analyses and for use in collaboration
with investigators outside the network is encouraged.
 
o  have the potential capability of supporting, through participation
in the Network activities, multi-unit evaluation (Phase I/II and
Phase II clinical studies) of novel therapeutic interventions for
acute infection and/or early HIV disease.
 
The Network will include the awarded units' clinical sites and
laboratories. In order to facilitate interpretation of data across
the network, central quality assurance and data management of the
laboratories can be provided by the Division of AIDS as needed. The
Network activities will be coordinated by a Steering Committee formed
by the Unit Principal Investigators.  The Network serves to
facilitate information exchange, foster collaboration and coordinate
activities to minimize duplication. Additionally, the Network should
have the capability and flexibility to conduct multi-unit clinical
trials involving a larger number of patients (Phase II studies) as
scientific opportunities become available.  These studies may also
require international collaboration.
 
In summary, the primary objective of this PA is to conduct intense
pathogenesis research and single- and multi-unit early phase clinical
intervention studies into acute infection and early HIV disease.
 
SPECIAL REQUIREMENTS
 
Terms and Conditions of Award
 
A.  Applicability.
 
These special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR part 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.
 
The administrative and funding instrument used by the NIAID to award
research projects involving (1) clinical trials, (2) prevention,
education and control studies, and (3) epidemiological studies in
excess of $500,000 direct cost per year at a single institution or in
the aggregate for studies proposing multi-institution collaborative
arrangements submitted either as subcontracts to a single application
or as separate applications shall be a cooperative agreement (U01),
an "assistance" mechanism (rather than an "acquisition" mechanism),
in which substantial NIAID scientific and/or programmatic involvement
with the awardee is anticipated during the performance of the
activity.  For single applications, the dollar limit excludes
indirect costs of any subcontracts that are reported as a direct cost
on the application budget page summary.
 
Under the cooperative agreement, the NIAID purpose is to support
and/or stimulate the recipient's activity by involvement in and
otherwise working jointly with the award recipient in a partner role,
but it is not to assume direction, prime responsibility, or a
dominant role in the activity.
 
Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardees for the
project as a whole, although specific tasks and activities in
carrying out the study will be shared among the awardees and the
NIAID Program Officer or designee.
 
Under the cooperative agreement, a relationship will exist between
the award recipient(s) and the NIAID in which the performers of the
activities (1) are responsible for the requirements and conditions
described below and (2) agree to accept program assistance from a
named NIAID Program Officer in achieving project objectives.
 
Failure of an awardee to meet the performance requirements, including
these special terms and conditions of award, or significant changes
in the level of performance, may result in a reduction in budget,
withholding of support, or suspension and/or termination of the
award.
 
B.  Awardee Rights and Responsibilities
 
The awardee is responsible for:
 
1.  Research design and protocol development, including definition of
objectives and approaches, planning, implementation, participant
recruitment and follow-up, data collection, quality control, interim
data and safety monitoring, final data analysis and interpretation,
and publication of results.
 
2.  Establishing with the other Principal Investigators a mandatory
AIEDRN Steering Committee to facilitate information exchange, foster
collaboration and coordinate activities to minimize duplication.  The
Steering Committee should designate a single Protocol Chairperson for
each multi-unit clinical trial protocol within the research plan and
define core data collection strategies, methods and cross-study
analyses.
 
3.  Functioning as the scientific coordinator for protocols (Protocol
Chairpersons) and assuming responsibility for developing protocols
and monitoring study performance for their protocols.  All proposed
protocols will be submitted by the Protocol Chair through the
Principal Investigator to the NIAID Program Officer for review.
Multi-unit clinical studies will be submitted to the NIAID Program
Officer for review and approval, subject to negotiation with the
awardees.
 
4.  Implementing the core data collection strategy and methods for
multi-unit studies and cross-study analyses collectively decided upon
by the Steering Committee.  For each study involving multiple
institutions, it is the responsibility of each awardee/site to ensure
that data will be collected and submitted in a timely way following
such procedures as agreed to by the Steering Committee.
Additionally, individual investigators/sites must demonstrate the
ability to implement the strategy specifically designed for their
individual study population.
 
5.  Establishing mechanisms for internal quality control and
monitoring. Awardees are responsible for ensuring the accurate and
timely assessment of the progress of studies, including development
of procedures to ensure that data collection and management are:  (a)
adequate for quality control and analysis; (b) for clinical trials,
as simple as appropriate in order to encourage maximum participation
of clinicians and other providers and study subjects and to avoid
unnecessary expense; and (c) sufficiently staffed across the
participating institutions.
 
6.  Preparing and submitting interim progress reports, when
requested, to the NIAID Program Officer including, as a minimum,
summary data on performance of multi-unit studies.  The Steering
Committee may require additional information on multi-unit studies
from the individual awardees/sites.  Such reports are in addition to
the annual awardee noncompeting continuation progress reports.
 
7.  Establishing procedures, where applicable, for all participating
institutions in coordinated awards to comply with FDA regulations for
studies involving investigational agents or devices and to comply
with the requirements of 45 CFR Part 46 for the protection of human
subjects.
 
8.  Cooperating in the reporting of the study findings.  The NIAID
will have access to and may periodically review all data generated
under an award.  Where warranted by appropriate participation, plans
for joint publication with NIAID of pooled data and conclusions, are
to be developed by the Principal Investigator or Steering Committee,
as applicable.  NIH policies governing possible co-authorship of
publications with NIAID staff will apply in all cases.
 
C.  NIAID Staff Responsibilities
 
It is expected that the dominant role and prime responsibility for
the activity will reside with the awardee(s) for the project as a
whole. However, specific tasks and activities will be shared among
the awardee(s) and the NIAID Program Officer and/or Scientific
Coordinator(s).  The Scientific Coordinator(s) will be the contact
for all facets of the scientific interaction with the awardee(s),
while the Program Officer will be the contact for issues such as
administration and budget.  As required for the coordination of
activities and to expedite progress, the NIAID Program Officer may
designate additional scientific coordinator(s) to provide advice or
assistance to the awardee on specific scientific, technical or
management issues.  The NIAID Program Officer shall retain overall
programmatic responsibility for the award(s) and will clearly specify
to the awardee(s) the name(s) and role(s) of any such additional
individuals and the lines of reporting authority.
 
NIAID Extramural Program staff responsibilities will include:
 
1.  Interacting with the Principal Investigator(s) on a regular basis
to monitor study progress.  Monitoring may include:  (a) regular
communications with the Principal Investigator and staff, (b)
periodic site visits for discussions with awardee research teams, (c)
observation of field data collection and management techniques,
quality control, fiscal review, and other relevant matters, as well
as (d) attendance at and participation in Steering Committee and
other meetings.  The NIAID retains, as an option, periodic external
review of progress.
 
2.  For multi-unit protocols, convening the first meeting of and
subsequent participation in the Steering Committee that oversees
study conduct.  The NIAID Program Officer will be a full participant
and voting member of the Steering Committee and, if applicable,
subcommittees.
 
3.  Serving as a resource with respect to ongoing NIAID activities
that may be relevant to the research to facilitate compatibility and
avoid unnecessary duplication.
 
4.  Substantial assistance in the design and coordination of research
activities for awardees including:
 
a.  Assisting by providing advice on the management and technical
performance of the investigations.
 
b.  Providing access to and use of, when appropriate, reagents and
assays, and other resources available through NIAID contractors and
awardees.
 
c.  Technical advice and assistance with meeting FDA requirements for
investigational drugs.
 
d.  For multi-unit protocols, through participation on the Steering
Committee and with the agreements of the Principal Investigator(s),
the NIAID Program Officer may coordinate activities among awardees by
assisting in the design, development, and coordination of a common
research or clinical protocol and statistical evaluations of data; in
the preparation of questionnaires and other data recording forms; and
in the publication of results.
 
e.  Reviewing and approving multi-unit clinical trial protocols to
insure that they are within the scope of peer review and for adequacy
of safety, human subjects, and representation of women and
minorities, as required by Federal regulations.  The NIAID Program
Officer will monitor protocol progress, and may request that a
protocol be closed to accrual for reasons including:  (1) accrual
rate insufficient to complete study in a timely fashion; (2) accrual
goals met early; (3) poor protocol performance; (4) patient safety,
human subjects, and women/minority recruitment concerns; (5) study
results that are already conclusive; and (6) emergence of new
information that diminishes the scientific importance of the study.
The NIAID will not permit further expenditure of NIAID funds for a
study after requesting closure (except for patients/subjects on-study
and final data analysis and reporting).
 
f.  Reviewing and providing advice regarding the establishment of
mechanisms for quality control and study monitoring for multi-center
clinical trials.
 
5.  Making recommendations for continued funding based on: (a)
overall study progress, including study subject and/or data accrual;
(b) cooperation in carrying out the research (e.g., attendance at
Steering Committee meetings, implementation of group decisions,
compliance with terms of award and reporting requirements); and/or
(c) maintenance of a high quality of research which will allow
pooling of data and comparisons across multiple cooperative agreement
awards for common data elements.
 
D.  Collaborative Responsibilities
 
In addition to the interactions defined above, awardees and NIAID
staff shall share responsibility for the following activities:
 
1.  Steering Committee.  A Steering Committee will have primary
responsibility to facilitate information exchange, foster
collaboration and coordinate activities to minimize duplication.  For
multi-unit clinical trials the committee will establish scientific
priorities, develop (through appropriate designees) common protocols
and manuals, questionnaires and other data recording forms, establish
and maintain quality control among awardees, review progress, monitor
patient/subject accrual, coordinate and standardize data management
and cooperate on the publication of results. Major scientific
decisions regarding the core data of multi-unit clinical trials will
be determined by the Steering Committee.  The Steering Committee will
document progress in written reports to the NIAID Program Officer and
will provide periodic supplementary reports upon NIAID request.
 
The Steering Committee will be composed of all Principal
Investigators and, as deemed necessary, co-investigators and the
NIAID Program Officer (or designee).  An initial meeting of the
Steering Committee will be convened early after award by the NIAID
Program Officer.  The final structure of the Steering Committee will
be established at the first meeting.  The NIAID Program Officer or
designee will have voting membership on the Steering Committee and,
as appropriate, its subcommittees.  The Steering Committee usually
will meet at least twice yearly.
 
A Chairperson, other than the NIAID staff, will be selected by vote
of the members.  The Chairperson is responsible for coordinating the
Committee activities, for preparing meeting agendas, and for
scheduling and chairing meetings.
 
E.  IND Responsibilities
 
For pilot studies, either the Principal Investigator or a
pharmaceutical company may file an Investigational New Drug (IND)
application to the United States Food and Drug Administration.  The
sponsor of the IND has responsibility for the conduct of trials under
that IND, which includes adhering to applicable Federal regulations.
For larger scale, multi center (Phase II) studies, NIAID will retain
the option to cross-file or independently file an IND.  Reports of
data generated by the Network or any of its members required for
inclusion in INDs and Clinical Brochures and for cross-filing
purposes will be submitted by the Principal Investigator to the NIAID
Program Officer upon request.  Such reports will be in final draft
form and include background information, methods, results, and
conclusions.  They will be subject to approval and revision by NIAID
and may be augmented with test results from other
Government-sponsored projects prior to submission to the appropriate
regulatory agency.
 
If NIAID holds the IND for a trial, a DAIDS Program Officer will
monitor the safety of the treatment(s) being evaluated.  Regulatory
responsibilities will be the responsibility of NIAID.  Standard
procedures (e.g., registration of sites participating in clinical
trials) will apply.  Interim and final reports on toxicity for all
sponsored clinical trials will be routinely provided to the DAIDS
Scientific Coordinator.
 
F.  Arbitration
 
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and the
NIAID may be brought to arbitration.  An arbitration panel will be
composed of three members -- one selected by the Steering Committee
(with the NIAID member not voting) or by the individual awardee in
the event of an individual disagreement, a second member selected by
the NIAID, and the third member selected by the two prior members.
This special arbitration procedure in no way affects the awardee's
rights to appeal an adverse action that is otherwise appealable in
accordance with the PHS regulations at 42 CFR part 50, subpart D and
HHS regulation at 45 CFR part 16.
 
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 sub-populations 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 printed 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.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by August 1, 1996, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Principal Investigator, and the number and title of this PA.
Although the letter of intent is not required, is not binding, does
not commit the sender to submit an application, and does not enter
into the review of subsequent applications, the information that it
contains allows NIAID staff to estimate the potential review workload
and to avoid conflict of interest in the review.  The letter of
intent is to be sent to Dr. Tingley at the address listed under
INQUIRIES.
 
APPLICATION PROCEDURES
 
Applicants are strongly encouraged to contact NIAID program staff
with any questions regarding the responsiveness of their proposed
project to the goals of this PA.  Applications are to be submitted on
the grant application form PHS 398 (rev. 9/95).  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone 301/435-0714, e-mail:
asknih@odrockm1.od.nih.gov.
 
The NIH policy ypdate on acceptance for review of unsolicited
applications that requires more than $500,000 direct cost for any one
year applies to applications to become part of the Acute Infection
and Early Disease Research Network.  The policy update was published
in the NIH Guide, Vol. 25, No. 14, May 3, 1996, and is effective June
1, 1996.  The policy requires the applicant to contact, in writing or
by telephone, NIAID program staff (see INQUIRIES) when the
application development process begins.  If the NIAID is willing to
accept assignment of the application for consideration of funding,
the staff will notify the Division of Research Grants before the
application is submitted.  The applicant Principal Investigator must
identify, in a cover letter sent with the application, the NIAID
program staff member who agreed to accept assignment of the
application.  An application received without indication of prior
staff concurrence and identification of that contact will be returned
to the applicant without review.
 
For purposes of identification and processing, mark "YES" in item 2
on the face page of the application and type in the PA number
PA-96-060 and the title "Acute Infection And Early Disease Research
Network".
 
Applications that are not received as a single package on a receipt
date or that do not conform to the instructions contained in PHS 398
(rev 9/95) Application Kit (as modified in, and superseded by, the
NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS
FOR MULTI-PROJECT AWARDS"), will be judged not responsive and will be
returned to the applicant.
 
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or Principal Investigator could be included
with the application. Applicants from an institution receiving
government funds under Center for AIDS Research (CFAR), Strategic
Program For Innovative Research On AIDS Treatment (SPIRAT), AIDS
Clinical Trial Unit (ACTU), AIDS Vaccine Evaluation Unit (AVEU),
DATRI, and CPCRA programs, should describe how these programs are
integrated with the proposed studies, if applicable, and ensure that
no scientific and budget overlap exists with the proposed project.
 
Submit a signed, typewritten original of the application, including
the checklist, and three signed, exact, single-sided photocopies, in
one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD 20817 (for express/courier service)
 
At the time of submission, two additional exact copies of the grant
application and all five sets of any appendix material must be sent
to Dr. Tingley at the address listed under INQUIRIES.
 
REVIEW CONSIDERATIONS
 
Review Procedures
 
Upon receipt, applications will be reviewed for completeness by the
NIH Division of Research Grants (DRG) and for responsiveness by NIAID
staff.  Incomplete and/or non-responsive applications will be
returned to the applicant without further consideration.
 
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAID in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the PA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.  The second
level of review will be provided by the National Advisory Allergy and
Infectious Diseases Council.
 
Review Criteria
 
The review criteria for this PA are essentially the same as those for
unsolicited research project grant applications, with specific areas
of emphasis as noted below:
 
A.  Scientific, technical, or clinical significance and originality
of the proposed research.
 
B.  Appropriateness and adequacy of the experimental approach and the
methodology proposed to carry out the research, specifically
including the adequacy and feasibility of the applicant's plans,
methods, approaches and problem solving strategies to:  (1) identify,
screen and recruit into research projects individuals with acute or
early HIV-1 infection; (2) follow subjects for the long term and
retain them in research studies; and (3) perform and quality assure
laboratory assays in support of these studies. The applicant should
demonstrate the ability to enroll and retain an adequate number of
subjects given the size of the unit and the proposed scientific
agenda.  The Network will be encouraged to develop mechanisms, when
appropriate, to assure comparability and standardization of
laboratory testing across Units.
 
C.  Qualifications and research experience of the Group Leader and
key staff in the area of the proposed research, specifically:  (1)
the scientific ability and track record of the applicants in
conducting research on the pathogenesis of HIV; (2) the experience,
leadership scientific ability and administrative competence of the
applicant for the development, implementation and management of pilot
Phase I/II clinical trials; and (3) experience of the applicants in
performing virologic, immunologic and pharmacologic assays in support
of state-of-the-art pathogenesis research and AIDS clinical trials.
 
D.  Availability of necessary resources to conduct the research.
 
E.  Adequacy of the proposed means for protecting against adverse
effects of the research upon humans, animals or the environment,
where such are involved.
 
F.  In clinical studies, if there is inadequate representation of
women and/or minorities in a study design AND this affects the
potential to answer the scientific question(s) addressed, such
inadequacy will be considered to be a weakness or deficiency in the
study design.  This weakness will be reflected in the priority score
assigned to the project, unless a convincing justification is
provided by the investigator to explain the inadequate
representation.
 
AWARD CRITERIA
 
Funding decisions will be based on scientific and technical merit as
determined by peer review, the availability of funds and program
priority. However, the predominant criteria for funding priorities
will be the scientific and technical merit of the applications.
 
Schedule
 
Application Receipt Date:  September 1, 1996
Scientific Review Date:    November 1996
Earliest Date of Award:    February 1997
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues:
 
Michael Hedderman, R.N., M.P.H
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2B30
Bethesda, MD  20892
Telephone:  (301) 496-8214
FAX:  (301) 480-4582
Email: mh33a@nih.gov
 
Direct inquiries regarding scientific issues to:
 
Carla B. Pettinelli, M.D. Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2C14
Bethesda, MD  20892
Telephone:  (301) 496-0700
FAX:  (301) 402-3171
Email: cp22n@nih.gov
 
Direct Inquiries regarding review issues:
 
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C07
Bethesda, MD  20892
Telephone:  (301) 496-2550
FAX:  (301) 402-2638
Email:  dt15g@nih.gov
 
Direct inquiries regarding fiscal matters and the special
instructions for preparation of the grant application to:
 
Linda Shaw
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B31
Bethesda, MD  20892-7610
Telephone:  (301) 402-6611
FAX:  (301) 480-3780
Email:  ls15k@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is supported under authorization of the Public Health
Service Act, Sec. 301 (c), Public Law 78-410, as amended.  The
Catalogue of Federal Domestic Assistance Citation is (Sec. 93.856,
Microbiology and Infectious Diseases Research, or No. 93.855 -
Immunology, Allergy, and Transplantation Research, or both, as
appropriate).  Awards will be administered under PHS grants 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 review.
 
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 the PHS
mission to protect and advance the physical and mental health of the
American people.
 
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