and Human Services (HHS)
EXPIRED
This is a one time solicitation. This PA expires after June 27, 2001.
INTEGRATED PRECLINICAL/CLINICAL PROGRAM FOR HIV TOPICAL MICROBICIDES
Release Date: March 29, 2001
Receipt Date: June 27, 2001
PA NUMBER: PA-01-075
National Institute of Allergy and Infectious Diseases
(http://www.niaid.nih.gov/)
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov/)
APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE
PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC
INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS.
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID) and
the National Institute of Child Health and Human Development (NICHD),
National Institutes of Health (NIH) invite multi-project, multi-
disciplinary applications whose goal is to advance novel topical
microbicides and microbicide combination strategies to prevent the
sexual transmission of HIV from preclinical to clinical studies. For
the purposes of this Program Announcement (PA), topical microbicides
are defined as vaginally or rectally applied biomedical products with
or without contraceptive activity that directly or indirectly
inactivate HIV or prevent HIV infection or spread from initial target
cells. The Integrated Preclinical/Clinical Program for HIV Topical
Microbicides (IPCP-HTM) described in this PA links research with
product development and initial clinical evaluation by supporting
diverse research activities from multidisciplinary groups spanning
advanced preclinical optimization and development through early
clinical trials. Applications that aim to further an innovative
topical microbicide may propose to initiate research at one of the
following points: (1) preclinical optimization of a lead microbicide
candidate/combination and advanced preclinical development, (2)
preclinical research that transitions to iterative clinical/laboratory
research directed toward refinement of the microbicide
candidate/combination during the award period, or (3) iterative
clinical/laboratory research in which a pilot clinical trial will be
implemented within the first year of award. In combining these
activities into a single PA, the IPCP-HTM provides a spectrum of
research opportunities for collaborative groups pursuing any aspect of
advanced development of new topical microbicides. For applications in
which clinical studies are proposed, the participation of industry is
required. For applications limited to advanced preclinical
optimization and development, participation of industry is strongly
urged. Responsive applications will advance microbicide development
with innovative microbicide research. Excluded from this PA is
research on, or development of, marketed spermicidal products and/or
discovery of potential microbicides.
HEALTHY PEOPLE 2010
The PHS is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS led national
activity for setting priority areas. This PA, Integrated
Preclinical/Clinical Program for HIV Topical Microbicides, is related
to the focus area of HIV Infection and Sexually Transmitted Diseases.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by 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. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators (PIs).
The involvement of industry is required for applications proposing
clinical studies and strongly urged for preclinical applications
because of the established and proven infrastructure and capital
resources it brings to the program and its proficiency in rapidly
mobilizing resources and expertise to move promising leads through the
development pathway. Investigators from the private sector are
eligible to participate as PIs, Project or Core Leaders (PLs or CLs),
or as collaborators.
MECHANISM OF SUPPORT
Program Project grants (P01) will be used to support projects in
response to this announcement. Program Project grants support broadly
based, multi-disciplinary research programs that have a well-defined,
central research focus or objective. An important feature is that the
integrated approach of the individual scientifically meritorious
projects will result in a greater contribution to the overall program
goals than if each project were pursued independently. Normally, the
program project grant consists of a minimum of three interrelated
individual research projects that contribute to the program objective.
However, for the purposes of this PA, the minimum number of individual
research projects is two. It is important to note that applications for
programs consisting of only 2 projects must have 2 fundable projects
remaining as recommended for consideration for funding after the review
is complete. This type of award also can provide support for certain
common resources termed cores. Such resources should be utilized by two
or more projects within the award. Examples of cores include
administrative, formulation or animal model cores. The total project
period for an application submitted in response to this PA that
proposes clinical studies at any time during the award period may not
exceed 5 years. The total project period for an application limited to
advanced preclinical optimization and development may not exceed 4
years.
NIAID and NICHD intend to support the following research groups through
this PA: (1) groups focusing exclusively on advanced preclinical
optimization and IND-directed development of new topical microbicides
[i.e., appropriately synthesized and manufactured microbicide products
that will undergo safety testing as per U.S. Food and Drug
Administration (FDA) Investigational New Drug (IND) guidelines], and
(2) groups positioned to implement a pilot clinical study during the
award period. Pilot clinical studies are defined as early Phase I
studies with small numbers of participants, exclusive of formal Phase I
through Phase III clinical trials. P01 applications submitted in
response to this PA may not request in excess of $750,000 first-year
direct costs for research involving preclinical studies, or $1,300,000
first-year direct costs, exclusive of Facilities & Administrative (F &
A) costs for consortium arrangements for translational research
involving clinical studies. Budgets exceeding these levels must be
strongly justified and pre-approved for submission by the Program
contact person listed under INQUIRIES. Applications with budgets
exceeding these levels that are submitted without prior Program
approval will be returned without review. Groups proposing to
transition from preclinical to clinical studies during the award period
should submit a budget for each phase that reflects the limits given
above.
The level of support for clinical research under this PA may be
insufficient to provide all the funds necessary to conduct the proposed
clinical study. Prospective groups are encouraged therefore to develop
plans to use existing infrastructure and organizational support to
complement the award [including NIH-sponsored General Clinical Research
Centers (GCRC), Centers for AIDS Research (CFAR), the HIV Prevention
Trials Network (HPTN), the Adolescent Medicine Trials Network (ATN),
the Contraceptive Clinical Trials Network (CCTN) and the Comprehensive
International Program for Research on AIDS (CIPRA)]. These plans
should be included in the application.
Responsibility for the planning, direction, and execution of the
proposed research for all applicable mechanisms of support will be
solely that of the applicant.
Applicants for P01 grants must follow special application guidelines in
the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS (August 2000); this brochure is available via the WWW
at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.
RESEARCH OBJECTIVES
Background
In the absence of a fully effective HIV vaccine, topical microbicides
represent an important potential strategy for preventing the
transmission of HIV through sexual intercourse, the predominant mode by
which HIV is transmitted worldwide. In particular, the number of women
with HIV infection and AIDS has been increasing steadily worldwide and
according to the World Health Organization (WHO), 15.7 million women
are living with HIV/AIDS worldwide, accounting for 46 percent of the
32.4 million adults living with HIV/AIDS. The vulnerability of women
of all ages for acquiring HIV infection - including older,
postmenopausal women as well as adolescents - demands the development
of effective and acceptable female-controlled chemical and physical
barrier methods, including topical microbicides, to reduce HIV
transmission. In addition, recent statistics from several major cities
in the U.S. show an increase in unsafe sexual practices as indicated by
an increase in rectal gonorrhea. Yet no effective anti-HIV topical
microbicide is currently available. Few products have been entered
into clinical trials and only nonoxynol-9 (N-9)-containing products
have advanced to efficacy trials. Results from Phase III trials of
vaginal N-9-containing products have indicated that N-9 does not
provide protection against the sexual transmission of HIV. Candidate
microbicides currently under investigation include products that kill
or inactivate HIV nonspecifically, those that inhibit HIV entry and
cell fusion, and those that inhibit post-fusion events early in the
viral replication cycle. The nonspecific candidate products fall
predominantly into the category of surfactants and detergents, whereas
most products targeted against specific steps in the HIV life cycle
have been developed exclusively as potential therapeutics. In
addition, no combination of microbicides has yet been evaluated in
animal or human trials. Therefore, there is a critical need to promote
the advanced development of novel microbicides and combinations and to
provide support for translational studies to advance existing/new
candidates and combinations into early clinical trials. This PA will
support multi-project, multi-disciplinary research groups whose goal is
to advance topical microbicides and microbicide combination strategies
from preclinical to clinical studies by assembling the diverse
scientific expertise and ancillary resources needed to translate basic
discoveries to innovative applied entities.
Scope
The purpose of the IPCP-HTM is: 1) to encourage advanced optimization
and development of lead topical microbicide candidates and
combinations, and 2) to foster translation of new
microbicides/combinations from preclinical studies to pilot clinical
studies. The ultimate goal of this research is the development and
exploratory clinical evaluation of new and potentially effective
microbicides for the prevention of HIV sexual transmission. Such
research is expected to increase the array of approaches and
availability of potential candidates and combinations suitable for
evaluations of safety and effectiveness in human clinical studies. In
line with this objective, the PA will support diverse and creative
microbicides/combinations with sound scientific rationale that are new
and innovative or understudied. The PA provides a continuous spectrum
of research opportunities for interdisciplinary research groups to
conduct, from preclinical to pilot clinical studies.
Examples of microbicide candidates of interest to the IPCP-HTM include,
but are not limited to:
o Development of combination microbicides containing a cocktail of
active agents with diverse mechanisms of action, including those
addressed below.
o Development of microbicides that target viral or host elements
essential for (i) HIV entry, including attachment, receptor engagement
or fusion; (ii) early post-entry events in the HIV life cycle prior to
and including reverse transcription, such as uncoating or translocation
of the pre-integration complex into the nucleus; and/or (iii) HIV
capture by, and dissemination from, initial target cells
o Development of microbicides that enhance or stimulate naturally
occurring healthy mucosal defense mechanisms
o Development of innovative virucidal agents that inactivate
infectious HIV-1 particles or HIV-1-infected cells in the absence of
host cell toxicity.
Preclinical Research
The preclinical component of the IPCP-HTM supports the advanced
optimization and development of topical microbicides and combination
microbicide approaches. A new microbicide or combination, including
pre-existing non-detergent microbicides, should have relevance and
future application to clinical evaluation. Advanced optimization may
involve identification of the most favorable formulation for delivery
or determination of the optimum concentrations of individual active
agents in a candidate combination microbicide. As part of an
integrated approach to the critical path development of a specific
candidate product and advancement into pilot clinical trials,
applications may incorporate research in the areas of formulation
science and development of new and/or improved ex vivo (e.g., tissue
explants) and in vivo animal models for evaluating the safety and
efficacy of new microbicides, including models for reproductive
toxicity. In addition, IND-enabling preclinical studies must comply
with Good Laboratory Practice (GLP) regulations, as well as production
and manufacture of microbicide products according to Good Manufacturing
Practice (GMP) regulations, to be considered responsive to this PA. A
successful group proposing preclinical studies would move a candidate
microbicide, or combination, through advanced preclinical development
where it would be poised for clinical evaluation during the course of
the award period.
Applicants seeking to transition from preclinical to clinical research
during the award period must detail the goals and milestones considered
necessary to enter the clinical phase. These goals and milestones
should also include plans and a timetable for obtaining the required
institutional and government approvals [Institutional Review Board
(IRB), Office of Human Research Protection (OHRP), FDA]. The peer
review group will review the appropriateness of the goals and
milestones. When a request to transition to the clinical phase is
made, these goals and milestones will also be used to determine the
successful completion of the preclinical development phase. Release of
funds for clinical research will be contingent upon the documented
successful completion of the proposed and peer-reviewed goals and
milestones.
Clinical studies
The clinical portion of the IPCP-HTM exploits interdependent, iterative
clinical/laboratory research designed to evaluate and optimize a
microbicide. Research in the areas of identification of markers to
establish product use compliance and assessment of state-of-the-art
technologies to measure bio-adhesive and bio-dispersion characteristics
may be included as part of an integrated approach to advance a specific
microbicide candidate. Examples of other scientific areas appropriate
for pilot clinical studies include, but are not limited to, evaluation
of pharmacokinetics and tissue distribution of the proposed microbicide
candidate, and preliminary evaluation of potential activity on viral
load (if relevant to the proposed mechanism of action) recovered in
vaginal and rectal mucosal specimens. Proposals with projects focusing
on new strategies that exploit pre-existing non-detergent microbicides,
especially as combination microbicides, would also be considered
responsive. A successful application proposing clinical studies would
develop and optimize a microbicide candidate to the point of
determining its merits for further clinical evaluation.
A clinical application must be based on a strategy in an advanced stage
of preclinical development that is suitable for evaluation in a small
number (6-12) of subjects in a pilot clinical study. [When merited by
the study, a larger number of subjects may be considered; prior
approval by the Program Officer (see INQUIRIES, below) is required.]
Conventional Phase I through Phase III clinical trials are not
supported by this Program Announcement. The application should include
(1) a detailed plan of the iterative clinical and laboratory research
to be conducted to optimize the proposed strategy, (2) a timetable to
be followed, (3) plans for clinical studies, including a clinical
concept, outline of a clinical protocol, or the clinical protocol, and
(4) institutional and government approvals (IRB, FDA, OHRP), where
applicable.
SPECIAL REQUIREMENTS
IPCP-HTM Group Scientific Advisory Panel
Each IPCP group will establish a Scientific Advisory Panel ("Panel") of
2-3 investigators not affiliated with any of the institutions
comprising the group. Applicants must not name the prospective
Advisory Panel members in their applications nor should prospective
members be contacted by applicants prior to completion of review of
applications. However, a proposal should include identification of the
proposed expertise to be represented on the panel. The Panel will
attend one or more of the IPCP group meetings each year, review the
group's activities, and evaluate progress, adherence to the original
time frame of activities, and the continued relevance of each project
to the group's overall goals. The Panel will recommend new directions
as appropriate and will provide the PI with a comprehensive written
evaluation of the group's activities and recommendations after each
meeting. A copy of the report is to be sent to the NIAID or NICHD
Coordinator, as appropriate, within 30 days of the meeting. [The
Coordinator for each group will be the equivalent of a Program Officer,
having medical and/or scientific research expertise depending on the
preclinical and/or clinical focus of the project.]
Meetings and travel
All awardees will be strongly encouraged to attend a scientific
conference of IPCP-HTM investigators, organized by NIH and held every
12-18 months in the Washington, D.C. area. Applicants should include
estimated travel expenses for one such meeting per year to the
applicant organization or the Washington, D.C. metropolitan area in the
application budget. Estimated expenses for travel of the Scientific
Advisory Panel members should be based on one group meeting per year
and should also be included in the budget. No additional travel funds
will be provided to attend other domestic or foreign meetings.
TERMS AND CONDITIONS OF AWARD
Patent Coverage
Since an application may include several institutions, including the
private sector, complex patent situations may arise. To avoid delays
related to intellectual property issues, each multi-project group is
required to provide, as part of the application, a plan detailing (1)
the approach agreed to by all parties for obtaining patent coverage and
licensing, where appropriate; and (2) procedures to be followed for the
resolution of legal problems that potentially may develop. Attention
is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and
37 CFR Part 401 or FAR 55.227-11 for intellectual property issues.
Instructions were also published in the NIH GUIDE FOR GRANTS AND
CONTRACTS, Vol. 19, No. 23, June 22, 1990. Note that non-profit
organizations (including universities) and small business firms retain
the rights to any patent resulting from Government grants or
cooperative agreements.
It is also noted that a Presidential memorandum of February 18, 1983
extended to all business concerns, regardless of size, the first option
to the ownership of rights to inventions as provided in P.L. 96-517.
As a result of this memorandum, the relationships among industrial
organizations and other participants are simplified, since all group
members can now be full partners in the research and in any inventions
resulting there from. The specific patenting arrangements among the
institutions may vary and could include joint patent ownership,
exclusive licensing arrangements, etc. Applicants are encouraged to
develop an arrangement that is most suitable for the group’s particular
circumstances.
The patent agreement among the institutions comprising the group,
signed and dated by the organizational officials authorized to enter
into patent arrangements for each group member and member institution,
should be submitted to Dr. Roberta Black (listed under INQUIRIES) prior
to review. The patent agreement should not be submitted with the
application. If the group wishes to place all inventions and
discoveries resulting from these studies within the public domain, a
letter to that effect must be submitted to Dr. Black in lieu of the
patent agreement. The letter must be co-signed by the PI, each of the
PLs, and each of the business officials representing the respective
institutions.
Awards Including Clinical Studies
When clinical studies or trials are a component of the research
proposed, NIAID policy requires that studies be monitored commensurate
with the degree of potential risk to study subjects and the complexity
of the study. Terms and Conditions of Award will be included with
awards. NIAID policy was announced in the NIH Guide on February 24,
2000 and is available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.
The full policy including terms and conditions of award is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf
Groups seeking to transition from preclinical to clinical studies
during the award period must include a long-range development plan that
details the preclinical, transitional, and clinical phases of the
proposed studies, and a budget appropriate to each phase. Funds to
accommodate the potentially more costly clinical study should be
budgeted in the application. The group must articulate a set of
objectives and milestones to be completed prior to transition to
clinical research and include the clinical site(s) and clinical
investigators to be involved. For purposes of peer review, the
application must include, at a minimum, a clinical concept for a future
protocol or an outline of a clinical protocol (as an Appendix to the
application) based on research findings available at the time of
submission (although it is understood that the concept/protocol may
evolve as work progresses). The concept/outline must contain
information regarding the design of the protocol including objectives
and rationale, the size and characteristics of the patient population,
medical (including safety) and site monitoring plans, statistical
analysis, if appropriate, and a list and time course for associated
laboratory evaluations. All the above components - the development
plan, objectives and milestones, clinical concept/protocol outline,
clinical site and clinical investigators - will be essential elements
of the initial review by the peer review group. The NIAID and NICHD
will review requests to transition to clinical research and will use
the Division of AIDS (DAIDS) Prevention Sciences Review Committee
(PSRC) to review the clinical protocol and budget and to assist in
determining whether the group requesting transition is positioned to
proceed to clinical studies.
Release of funds for clinical research will be contingent on successful
accomplishment of milestones and criteria stated in the original
application as reviewed and approved by the peer review group, and
include compliance with all applicable laws and regulations. To
initiate clinical studies awardees must have IRB, FDA, and OHRP
approvals. Funds for clinical studies will be withheld until the
required approvals are obtained and copies provided to NIAID (Dr.
Roberta Black, listed under INQUIRIES) or NICHD (Dr. Patricia
Reichelderfer, listed under INQUIRIES), as appropriate.
Additional details for applications that include a clinical component
are listed as follows.
The PI is responsible for:
o Assuming responsibility for developing protocols and monitoring
study performance; participant recruitment and follow-up; interim data
and safety analysis and monitoring. All protocols will be submitted by
the PI to the NIAID (Dr. Roberta Black, listed under INQUIRIES) for
review for safety issues by the DAIDS PSRC prior to implementation.
The PI will be responsible for reporting recruitment, retention, and
other similar information to DAIDS, NIAID (or Center for Population
Research, NICHD, as appropriate) at six-month intervals, on January 1
and July 1 of each year. Adverse event reports will be forwarded to
Dr. Black or Dr. Reichelderfer at the same time as to the FDA.
o Establishing procedures to comply with FDA regulations for studies
involving investigational agents and strategies and to comply with the
requirements of 45 CFR Part 46 for the protection of human subjects.
Terms of award for any human clinical trial component will be developed
to ensure volunteer safety and monitoring of compliance with
regulations and Good Clinical Practices. NIAID and NICHD staff will
provide guidance and technical advice on meeting FDA requirements for
investigational agents.
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 policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should
read the UPDATED "NIH Guidelines For Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.
The revisions relate to the NIH-defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects" that was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and is
available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may obtain copies from these sources or from Dr. Roberta
Black (listed in INQUIRIES below) who may also provide additional
relevant information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained
within specified page limitations. Unless otherwise specified in an
NIH solicitation, internet addresses (URLs) should not be used to
provide information necessary to the review because reviewers are under
no obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
APPLICATION PROCEDURES
Applicants for P01 grants must follow special application guidelines in
the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS (August 2000); this brochure is available via the WWW
at: http://www.niaid.nih.gov/ncn/grants/multibron.htm
Applications are to be submitted on the grant application form PHS 398
(rev. 4/98) and will be accepted up to and including the application
receipt date as indicated in this PA. Application kits are available
at most institutional offices of sponsored research and may be obtained
from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone 301/710-0267, email:
[email protected]. In addition, applications are available at the
following URL: http://grants.nih.gov/grants/forms.htm.
Applications that are not received as a single package on the receipt
date or that do not conform to the instructions contained in PHS 398
(rev. 4/98) Application Kit (as modified in, and superseded by, the
NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS"), will be judged non-responsive and will be returned to
the applicant.
For purposes of this PA, the following procedures and policies will
apply. Applicants planning to submit a grant application requesting in
excess of $750,000 in direct costs if preclinical research is proposed,
or in excess of $1,300,000 in direct costs if a clinical trial is
proposed, for any year, are advised that he or she must contact the
Institute or Center (IC) program staff listed in INQUIRIES below,
before submitting the application, i.e., as plans for the study are
being developed. Furthermore, the applicant must obtain agreement from
the IC staff that the IC will accept the application for consideration
for award. Finally, the applicant must identify, in a cover letter
sent with the application, the staff member and Institute or Center who
agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of
both any such application and any such subsequent amendment. Refer to
the NIH Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
For purposes of identification and processing, item 2a on the face page
of the application must be marked YES , and the PA number and the
words, INTEGRATED PRECLINICAL/ CLINICAL PROGRAM FOR HIV TOPICAL
MICROBICIDES must be typed in.
Submit a signed, typewritten original of the application, including the
checklist, and three signed, exact, single-sided photocopies in one
package to:
CENTER FOR SCIENTIFIC REVIEW
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. Vassil St. Georgiev at the address listed under INQUIRIES.
Concurrent submission of an R01 and a Component Project of a Multi-
project Application: Current NIH policy permits a component research
project of a multi-project grant application to be concurrently
submitted as a traditional individual research project (R01)
application. If, following review, both the multi-project application
and the R01 application are found to be in the fundable range, the
investigator must relinquish the R01 and will not have the option to
withdraw from the multi-project grant. This is an NIH policy intended
to preserve the scientific integrity of a multi-project grant, which
may be seriously compromised if a strong component project(s) is
removed from the program. Investigators wishing to participate in a
multi-project grant must be aware of this policy before making a
commitment to the PI and awarding institution.
Applicants from institutions that have a GCRC funded by the NIH
National Center for Research Resources or an HIV Prevention Trials Unit
(HPTU), a CFAR, or a CIPRA award funded by NIAID or an ATN or CCTN
award funded by NICHD may wish to identify the GCRC, HPTU, CFAR, ATN,
CCTN or CIPRA as a resource for conducting the proposed research. If
so, a letter of agreement from either the GCRC program director or PI
for the other relevant program(s) should be included with the
application.
REVIEW CONSIDERATIONS
Review Procedures
Upon receipt, applications will be reviewed for completeness by the NIH
Center for Scientific Review. Incomplete applications will be returned
to the applicant without further consideration.
P01 applications that are complete and responsive to this PA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAID.
Review Criteria
Applicants should see the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS
FOR MULTI-PROJECT AWARDS (August 2000) for review criteria for P01
applications. Additional review criteria specific to this PA that the
initial review group will also examine are: the adequacy of plans to
include children, and both genders and minorities and their subgroups,
as appropriate for the scientific goals of the research, and plans for
the recruitment and retention of subjects; the provisions for the
protection of human and animal subjects; and the safety of the research
environment. It may be beneficial to contact staff for advice
regarding human subjects concerns prior to submission.
The reviewers will be asked to comment on specific criteria as detailed
in the brochure for multi-project applications in order to judge the
likelihood that the proposed research will have a substantial impact on
the pursuit of these goals. These specific criteria are:
o The biomedical significance and originality of the project.
o The likelihood that the research will open new directions in the
prevention of HIV sexual transmission or containment of HIV infection,
demonstrate a capacity to be translated to clinical practice, or merit
evaluation in IND-directed clinical trials for safety and proof-of-
concept.
o Appropriateness of the experimental approach, development plan, and
methodology proposed, including laboratory capabilities (preclinical
and/or clinical).
o The PI's and PLs' commitment to devote substantial time and effort
to the program. [Due to the complexity and time required to maintain a
well coordinated and productive research effort, a minimum 20% (time)
commitment by the PI and PLs is strongly suggested.]
Each of these review criteria will be addressed and considered by the
reviewers in assigning the overall score, weighting them as appropriate
for each application. Note that the application does not need to be
strong in all categories to be judged likely to have a major scientific
impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature
is not innovative but is essential to move a field forward.
In addition to (not in lieu of) the review criteria detailed in the
instruction brochure (see above), review criteria specific to this PA
(mainly bearing to the review of the individual preclinical and
clinical projects) include an evaluation of the following:
For groups focusing on preclinical research:
o Choice of the microbicide target or strategy, its contribution to
the diversity of potential microbicides, and the likelihood that the
microbicide candidate can be developed (e.g., following a prescribed
preclinical development plan; selecting a clinical candidate) during
the award period.
o Likelihood that work will progress through advanced development
during the award period
For groups proposing clinical research:
o Adequacy and validity of the proposed milestones for determining the
readiness of the group to transition to clinical research; iterative
research plan to develop and optimize the proposed microbicide
candidate; protocol design (clinical and scientific); short and long
term development plans; contingency plans addressing the specific
objectives; plans to guard the safety of subjects; plans to evaluate
outcome even if unanticipated; and provisions to obtain the required
institutional and regulatory approvals (IRB, FDA, OHRP) to conduct the
clinical study.
o Experience of the PI and PLs in the planning, design, and conduct of
small pilot clinical studies in healthy individuals and/or in the
conduct of topical microbicide clinical trials, availability of a GCRC,
CFAR, CIPRA, HPTN clinical site, ATN site, CCTN site or other
additional source of institutional support and/or statistical support;
the infrastructure required for the conduct of safe and efficient
clinical research; and short and long range plans that will result in
the successful implementation of clinical studies during the award
period.
In addition to evaluating the scientific merit of the application, all
multi-project applications are also assessed for the soundness of the
administrative and organizational structure that facilitates attainment
of the objective(s) of the program.
Thus, the Administrative Core should detail the short and long term
management of the Program such as: communication, group meetings,
sharing and transmission of information and reagents, awareness of
development of other projects within the program, progress, problems
and how will they be addressed, engagement of the Scientific Advisory
Panel and NIAID and NICHD, as appropriate, in the group's research
activities/meetings, consideration and integration of scientific
input/recommendation from the Scientific Advisory Panel and NIAID and
NICHD, as appropriate, into scientific direction and decision-making,
timely reporting as required in the Terms of Award (provided at the
time of award), Health and Human Services, NIH Office of Biotechnology
Activities - Recombinant Advisory Committee (OBA-RAC), and FDA as
applicable, and other aspects relevant to the cohesiveness and
interactive nature of group activities.
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The reasonableness of the proposed budget and duration in relation
to the proposed research
AWARD CRITERIA
The following will be considered in making funding decisions: quality
of the proposed project as determined by peer review, program balance
among research areas of the announcement, balance of preclinical and
clinical studies, and availability of funds.
INQUIRIES
Written and telephone inquiries are encouraged. The opportunity to
clarify any issues or questions from potential applicants is welcome.
Requests for the NIAID brochure INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS as well as inquiries regarding programmatic
(research scope, eligibility and responsiveness) issues may be directed to:
Roberta Black, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4110, MSC-7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628
Telephone: (301) 496-8199
FAX: (301) 402-3684
Email: [email protected]
Requests for inquiries related to the NICHD contraceptive microbicide
research interests may be directed to:
Patricia Reichelderfer, Ph.D.
Contraception and Reproductive Health Branch (CRH)
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13G, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1661
FAX: (301) 480-1972
Email: [email protected]
Direct inquiries regarding review issues to:
Vassil St. Georgiev, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2102, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-8206
FAX: (301) 402-2638
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Ms. Celeste Kerner
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2248, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-6213
FAX: (301) 480-3780
Email: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.856 and 93.864. Awards are made under authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and
284) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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