and Human Services (HHS)
EXPIRED
COOPERATIVE RESEARCH FOR THE DEVELOPMENT OF VACCINES, ADJUVANTS, THERAPEUTICS,
IMMUNOTHERAPEUTICS, AND DIAGNOSTICS FOR BIODEFENSE
RELEASE DATE: August 2, 2002
RFA: AI-02-026
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
Letter of Intent Receipt Date: October 25, 2002
Application Receipt Dates: November 26, 2002
MULTI-PROJECT APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA)
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" WHICH IS AVAILABLE AT
THE FOLLOWING LINK: http://www.niaid.nih.gov/ncn/grants/multibron.htm
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
The National Institute of Allergy and Infectious Diseases (NIAID) invites
investigator-directed cooperative research grant applications that will lead to
the development of new Vaccines, Adjuvants, Therapeutics, Immunotherapeutics or
Diagnostics focused on NIAID category A-C pathogens. In addition, NIAID has
identified specific products for biodefense that are of highest priority for
rapid development. The objective of this program is to support research in the
early stages of product development, however, for the area of immunotherapeutics
more basic research is also appropriate. Research conducted through this
program may fall anywhere along a broad spectrum of activities, from target
identification, design of compounds, validation and testing, production scale-up
and validation, through advanced preclinical evaluation. Applications should
define the proposed project goal, interim objectives (development milestones)
and potential ultimate product, and provide a schedule or timeline for milestone
and goal attainment. Applications that include collaborations between
researchers from different disciplines and/or with the private sector (e.g.
pharmaceutical, chemical or biotechnological companies) are strongly encouraged.
Clinical trials are supported by distinct programs and are not included in this
initiative
RESEARCH OBJECTIVES
Background
The National Institutes of Health and other agencies in the DHHS are currently
supporting extramural and intramural projects to develop new products to protect
the public from the health consequences resulting from the use of biological
agents in acts of terrorism or war. "The NIAID Blue Ribbon Panel" convened on
February 4-5, 2002 (the full report can be found at:
http://www.niaid.nih.gov/dmid/pdf/biotresearchagenda.pdf) identified the
development of new Vaccines, Adjuvants, Therapeutics, Immunotherapeutics and
Diagnostics for Category A pathogens as one of the highest priority. These
recommendations have now been extended to include Category B and C pathogens. A
complete listing of NIAID Category A-C pathogens is available at
http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm.
In response to this need, it is imperative that promising findings are
translated rapidly into new approaches and strategies for product development.
The involvement of diverse disciplines (e.g., biochemists, structural
biologists, protein chemists, pharmacologists, immunologists, molecular
biologists, engineers and clinicians) within academia and industry in early
stage product development is needed to bring sufficient knowledge to bear on the
development of well-designed candidates for Vaccines, Adjuvants, Therapeutics,
Immunotherapeutics and Diagnostics.
Research Goals and Objectives
Applications should address research that will advance the development of a
Vaccine, Adjuvant, Therapeutic, Immunotherapeutic or Diagnostic that is an NIAID
priority biodefense product
(http://www2.niaid.nih.gov/Biodefense/Research/high_priority.htm) or any other
Vaccine, Adjuvant, Therapeutic, Immunotherapeutic or Diagnostic specific for an
NIAID Category A, B or C pathogen
(http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm).
VACCINES
The objective of this RFA is to stimulate original, novel and innovative
research of sound scientific rationale, requiring comprehensive team and
multidisciplinary effort that is likely to result in the progression of
promising vaccines through the product development pathway. Applications should
define the proposed project goal, interim objectives (development milestones)
and potential ultimate product, and provide a schedule or timeline for milestone
and goal attainment.
Research approaches may include target identification, developmental studies,
scale-up and production, evaluation in laboratory animals, evaluation in the
context of specific delivery platforms and/or adjuvants, protection of
appropriate species from infection or disease following virulent challenge
(where appropriate), and other considerations that relate to the acceptability
and utility of candidate vaccines for clinical trials.
Applications for vaccines against any NIAID Category A-C pathogen are invited.
Those applications that address development of: smallpox vaccine, tularemia
vaccine, plague vaccine, Rift Valley fever vaccine, pandemic flu vaccine, or
Clostridium botulinum, botulinum toxin vaccine are particularly encouraged.
Projects may include, but are not limited to, one or more of the following
areas:
o Identification and validation of protective epitopes for the development of
recombinant or sub-unit vaccine candidates;
o Optimization of production of vaccine components;
o Optimization of delivery platforms, antigen and adjuvant
combinations/formulations;
o Optimization of dose and route of delivery in pre-clinical evaluation;
o Evaluation of safety, toxicity and immunogenicity in animals;
o Evaluation of efficacy in challenge models where appropriate animal models
are available; and/or
o Performance of required benchmarks for moving vaccine candidate into phase I
clinical trials (http://www.fda.gov/cber/vaccine/vacappr.htm).
Approaches should consider the potential feasibility of products for use in
civilian populations, which may include pediatric, elderly, or immune
compromised populations, as well as the vaccines potential to quickly induce
safe and protective responses.
ADJUVANTS
Applications for development of novel adjuvants that could be used as stand
alone immunostimulants or in conjunction with specific pathogen components are
invited. Those applications that address development of new immunostimulatory
agents or products to induce enhanced innate immune protection in the lungs,
gastrointestinal tract or systemically are particularly encouraged. Applications
should define the proposed project goal, interim objectives (development
milestones) and potential ultimate product, and provide a schedule or timeline
for milestone and goal attainment.
Generation of safer vaccines, such as those composed of defined antigens or DNA,
will require administration with additional substances, termed adjuvants, in
order to stimulate effective immune responses. Adjuvants are broadly separated
into two classes based upon their primary mechanism of action: vaccine delivery
systems (e.g., emulsions, microparticles, iscoms, and liposomes) that target
associated antigens to antigen presenting cells, and immunostimulatory adjuvants
(e.g., LPS, MLP, or CpG DNA) that directly activate innate immune responses.
Recent knowledge that receptors of the innate immune system mediate the
stimulatory effects of adjuvants opens many new possibilities for the
development of new, safer, and more effective adjuvants. In order to advance
the development of vaccine adjuvants against NIAID category A-C agents of
bioterrorism, this solicitation focuses on optimization and preclinical testing
of prospective lead compounds, including particulate materials (vaccine delivery
systems), cytokines, chemokines, or costimulatory molecule expression, and
innate immune receptor/ligand leads (immunostimulatory adjuvants), that
previously showed promise in early stages of discovery and development. It is
expected that adjuvants defined in this program will be considered as candidates
for future Phase I-II-III testing in clinical trial programs that may be
supported by NIAID solicitations or other sources.
This program will encompass:
o Analysis of lead compounds with a high potential as adjuvant candidates based
upon previous studies of their antigen targeting capability, receptor binding
capacity, and effect on immune signaling;
o Testing of previously-evaluated adjuvants for their capacity to stimulate
desired immune responses toward specific NIAID category A, B or C
pathogens/toxins;
o Testing mixtures of adjuvants to evaluate additive or synergistic potential to
stimulate desired immune responses;
o Scale-up production under GMP to provide sufficient quantities for pre-
clinical FDA-required animal studies;
o Pre-clinical testing for safety and stimulatory capacity in animals, and/or
o Performing required benchmarks for moving candidate into phase I clinical
trials (http://www.fda.gov/cber/therapies.htm).
THERAPEUTICS
The need for safe and effective, broad-spectrum and specific, antimicrobials for
biodefense against threats by highly pathogenic agents or their toxins is a key
national priority. Applications for development of drugs against any NIAID
Category A-C pathogen are invited; however, those applications that address
development of: antivirals, especially against smallpox and viral hemorrhagic
fevers; antitoxins to B. anthracis and C. botulinum; narrow-spectrum
antibiotics, especially for anthrax; and broadly reactive antimicrobial drugs
are particularly encouraged.
Applicants should submit a research plan, including timelines and specific
milestones, to identify and confirm targets, as well as to design, synthesize,
and test drug candidates in model systems. These should be specified in the
research plan and may include:
o Identify new targets for drug discovery or develop previously identified
targets for drugs by examining microbial gene products expressed during
infection and/or host gene products expressed as a consequence of infection;
o Identify initial lead compounds by molecular modeling and/or library screening
and synthesize sufficient quantities for in vitro analysis and/or explore the
use of active components of natural products as potential drug sources for
development;
o Perform reiterative design, chemical synthesis and in vitro analysis to
develop a "mature" lead compound;
o Perform preliminary pharmacokinetics and pharmacodynamics assessing
bioavailability and mechanism of action;
o Evaluate the potential for the emergence of drug resistance in model systems;
o Synthesize, purify, and test drugs/inhibitors for efficacy and toxicity in
model assays and preclinical in vivo systems;
o Determine drug interactions in host molecular processes; and/or
o Perform required benchmarks for moving drug candidate into phase I clinical
trials (http://www.fda.gov/cder/regulatory/default.htm).
IMMUNOTHERAPEUTICS
Applications to discover and/or improve immune-based therapeutics including both
broad-spectrum (innate immunity) and pathogen-specific (antibodies) approaches
are invited. Major applications for products generated in the research program
include prevention of infection in the face of an immediate threat, protection
of immunocompromised individuals, or post-exposure treatment to suppress
infection and disease. Research on compounds that directly affect pathogens as
well as on approaches to stimulate non-specific immunity are encouraged.
Passive treatments may be especially valuable during the acute emergence of
infectious diseases and may complement the use of antimicrobial drugs or
vaccination programs to optimize protection.
Research may focus on fundamental mechanisms of immune protection by the
therapeutic agents and need not require use of NIAID Category A-C pathogens.
Applicants may submit a research plan, including timelines and specific
milestones that addresses, but is not limited to, one or more of the following
areas:
Innate immunity:
o Discovery and characterization of novel antimicrobial peptides, lectins, or
immune modulators with broadly protective or pathogen-specific potential;
o Development of candidate compounds to optimize in vivo activity, including
improving the therapeutic index and specificity for NIAID Category A-C
pathogens;
o Testing and validation of efficacy;
o GMP production;
o Preclinical testing for safety and efficacy in animal models; and/or
o Performing required benchmarks for moving product into Phase I clinical trials
(http://www.fda.gov/cber/therapies.htm).
Antibodies:
o Discovery and characterization of novel antibodies with high specificity for
pathogen antigens;
o Methods to modify existing reagents to improve economy of production, half
life in vivo, affinity for target antigens, neutralization potency, microbial
clearance rates, or tissue accessibility; or to decrease adverse side effects of
administration (e.g. production of humanized or fully human antibodies);
o Testing and validation of efficacy;
o GMP production;
o Preclinical testing for safety and efficacy in animal models; and/or
o Performing required benchmarks for moving product into Phase I clinical trials
(http://www.fda.gov/cber/therapies.htm).
DIAGNOSTICS
There is an urgent need for rapid, sensitive, specific, and cost-effective
diagnostics for public health laboratories and point-of-care use to identify or
diagnose individuals exposed to agents and toxins of category A-C pathogens.
This RFA includes agent detection in or on symptomatic or exposed individuals.
Applications for the development of diagnostics specific for NIAID Category A-C
pathogens are invited. Applications should define the proposed project goal,
interim objectives (development milestones) and potential ultimate product, and
provide a schedule or timeline for milestone and goal attainment.
Tests for use on human samples may consider benchmarks required for approval
(http://www.fda.gov/cber/devices.htm). Applications that focus on the following
areas are encouraged:
o Protocols for the rapid preparation of samples for testing;
o Methods demonstrating the highest performance of specificity, sensitivity,
rapidity and cost when applied to relevant clinical samples;
o Tests capable of detecting an infectious or toxic doses of agent;
o Tests capable of resolving engineered or otherwise acquired genetic traits,
such as patterns of microbial resistance or enhanced virulence;
o Tests capable of identifying characteristic microbial genetic signature
profiles;
o Tests capable of high or ultrahigh throughput, robotics, and automated data
analyses;
o Tests that target multiple agents simultaneously in a single sample;
o Tests that distinguish viable (or active) from non-viable (or inactive)
agents;
o Non-destructive tests that permit subsequent confirmation and forensic
characterizations;
o Tests based on the minimum number of platforms for the maximum number of
targets; and
o Clinical diagnostic tools for human eczema are particularly encouraged.
Examples include:
o Microchip-based platforms exploiting functional genomic tools and the
determination of multi-locus genetic signature profiles;
o Novel assays based on human immune or other physiological responses,
identification of novel or improved biomarkers for human immune activation, in
vivo imaging methods, and the development of contrast reagents for the
visualization of pathogens or host responses in vivo; and,
o Development of a flexible or expandable platform possessing potential spin-off
applications in the detection in remote settings of naturally-occurring and
deliberately released emerging threats.
Diagnostics should be easy to produce, inexpensive and translatable to field
conditions, where applicable. The latter condition is likely to exclude cell-
based technologies. Preliminary data should be presented to support the basis
of the method. Capabilities of the diagnostics should be described. Plans for
determining the sensitivity, specificity and validation of the diagnostic should
be included in the application.
MECHANISM OF SUPPORT
This RFA will use the single project (U01) or multi-project (U19) cooperative
agreement(s).
The U01 and U19 are cooperative agreement award mechanisms in which the
Principal Investigator retains the primary responsibility and dominant role for
planning, directing and executing the proposed project, with NIH staff being
substantially involved as a partner with Principal Investigator, as described
under "Cooperative Agreement Terms and Conditions of Award".
Essential elements of the U19 multi-project cooperative agreement mechanism
include: (1) a minimum of three interrelated individual research projects
organized around a central theme; (2) collaborative efforts and interaction
among independent projects and their investigators to achieve a common goal; (3)
a single Principal Investigator who will be scientifically and administratively
responsible for the group effort; (4) a single applicant institution that will
be legally and financially responsible for the use and disposition of funds
awarded; and (5) support provided, as necessary, for "Core" resources or
facilities, each of which is expected to be utilized by at least two research
projects in order to facilitate the research effort.
This RFA is a one-time solicitation. Future unsolicited, competing-continuation
applications based on this project will compete with all investigator-initiated
applications and will be reviewed according to the customary peer review
procedures.
The total project period for applications submitted in response to this RFA may
not exceed five years.
FUNDS AVAILABLE
The NIAID intends to commit approximately $50M in FY 2003 to fund approximately
12 to 25 new grants in response to this RFA. An applicant may request a project
period of up to 5 years. Applicants may request up to $500,000 for significant
alterations and renovations and/or up to $300,000 for major equipment to ensure
that research aims can be met and biohazards can be contained. Prior approval
from program staff must be obtained for requests that exceed these amounts.
Funds for these purposes must be included in the first year's requested budget
Because the nature and scope of the proposed research will vary from application
to application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NIAID provide support for this
program, awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
At this time, the NIAID has not determined whether or how this solicitation will
be continued beyond the present RFA.
ELIGIBILE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of U.S. State and local governments
o Eligible agencies of the U.S. Federal government
o Domestic or foreign
Institutions must be in compliance with U.S. laws and regulations and DHHS and
NIH policies in effect at the time of grant award and during the period of
performance of the research.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out
the proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH programs.
SPECIAL REQUIREMENTS
Each application must propose a research and development project whose goal is
to advance a Vaccine, Adjuvant, Therapeutic, Immunotherapeutic or Diagnostic
specific for an NIAID Category A, B or C pathogen through the product
development process.
Single project U01 and multi-project U19 applications must define the proposed
project goal, interim objectives (development milestones) and potential ultimate
product, and provide a schedule or timeline for milestone and goal attainment.
Due to the possible complexity of multi-project cooperative agreements it is
suggested, but not required, that the Principal Investigator and the Project
Leaders contribute a minimum of 20% (time) effort to the study.
Mandatory Meetings:
Single project awards: The Principal Investigator, one or two key personnel
designated by the Principal Investigator and NIAID Scientific Coordinator will
meet once a year to review progress, aid program development, and foster
collaborations among the programs. This meeting will likely be held at the NIH
in Bethesda, MD and applicants should include requests for travel funds
(airfare, and per diem) specifically for this meeting.
Multi-project awards: The Principal Investigator, Project Leaders, NIAID
Scientific Coordinator, and where applicable, Scientific Advisors will meet once
per year to review progress, plan and design research activities, and establish
priorities. This meeting will likely be held at the NIH. Applicants should
include requests for travel funds specifically for the above meeting in their
budget requests.
Informal meetings. A critical determinant of success will be the degree of
communication among its members. Therefore, in addition to the one meeting
listed above, additional meetings, which may be necessary for coordination of
activities, may be scheduled if justified and should be included in the budget.
Regular telephone and written communication will be important and are
encouraged.
External advisors may be appointed by the Principal Investigator in consultation
with the NIAID Scientific Coordinator to assist in progress review. This
activity is likely to apply to large multi-project programs.
Where scientifically appropriate NIAID may ask recipients to collaborate or
cooperate with other NIAID funded projects and/or US government agencies, for
example Centers for Disease Control, Food and Drug Administration and United
States Department of Agriculture.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The following terms and conditions will be incorporated into the award statement
and provided to the Principal Investigator as well as the institutional official
at the time of award.
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 for this program is the single
project or multiproject cooperative agreement (U01 or U19), an "assistance"
mechanism (rather than an "acquisition" mechanism), in which substantial NIH
scientific and/or programmatic involvement with the awardee is anticipated
during the performance of the activity. 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
partnership 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
research will be shared among the awardees and the NIAID Scientific Coordinator.
The interaction of academic and non-profit research institutions with commercial
organizations and the Government is strongly encouraged and is expected to favor
expeditious preclinical development of Vaccines, Adjuvants, Therapeutics,
Immunotherapeutics, and Diagnostics.
1. Monitoring 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. AN UPDATED
NIAID policy was published in the NIH Guide on July 8, 2002 and is available at:
http://grants2.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full
policy, including terms and conditions of award, is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
2. Awardee Rights and Responsibilities
Awardees will have primary responsibility for defining the research objectives,
approaches and details of the projects within the guidelines of the RFA and for
performing the scientific activity. Specifically, awardees have primary
responsibility as described below.
The Principal Investigator retains primary responsibility for the performance of
the scientific activity, and agrees to accept close assistance in coordination,
cooperation and participation of NIAID staff in scientific and technical
management of the project in accordance with the terms formally and mutually
agreed upon prior to the award. The responsibility for the planning, direction,
and execution of the proposed project will be solely that of the Principal
Investigator.
o Meetings: One mandatory progress review meeting of the awardees will be held
annually at the NIH or at a site designated by the NIH during which the
Principal Investigator and Project Leaders will present significant findings.
The NIAID Scientific Coordinator and External Advisors (when applicable) will be
present. A critical determinant of success will be the degree of communication
between the Principal Investigator, Project Leaders and other significantly
involved parties. Therefore, in addition to the one meeting listed above,
additional meetings, which may be necessary for coordination of cooperative
agreement activities, may be scheduled if justified. Regular telephone and
written communication will be important and are encouraged.
o Publications: The Principal Investigator will be responsible for the timely
submission of all abstracts, manuscripts and reviews (co)authored by members of
the grant and supported in part or in total under this Agreement. The Principal
Investigator and Project Leaders are requested to submit manuscripts to the
Scientific Coordinator within two weeks of acceptance for publication so that an
up-to-date summary of program accomplishments can be maintained and joint press
conferences prepared. Publications or oral presentation of work done under this
Agreement is the responsibility of the Principal Investigator and appropriate
Project Leaders and will require appropriate acknowledgement of NIAID support.
Timely publication of major findings is encouraged.
o Data: While the NIAID Scientific Coordinator has a right of access to the data
(see NIAID staff responsibilities below) the applicant will retain custody of
and right to the data. For more information on data sharing go to:
http://grants.nih.gov/grants/policy/data_sharing/index.htm.
o Intellectual Property: Because an application may include several
institutions, including the private sector, complex intellectual property-
related situations may arise. To avoid delays related to intellectual property
issues, each multi-project application is required to provide, as part of the
application, a plan detailing (1) the approach agreed to by all parties for
disposition of intellectual property, including but not limited to obtaining
patent coverage and licensing, where appropriate; and (2) procedures to be
followed for the resolution of legal problems that potentially may develop.
o Human Subjects: Although this funding will not support clinical trials,
awardees that intend to use clinical samples in their studies shall be in
compliance with all Federal regulations, and NIH policies applying to the
conduct of research involving human subjects. These include but are not limited
to: Title 21 CFR 50, 56, 312 and Title 45 CFR 46. For research conducted in
foreign countries, the Awardee must assure compliance with the host country
regulations for human subjects, and must assure that the internationally
recognized standards for the protection of human subjects are observed.
3. NIAID Staff Responsibilities
NIAID staff assistance will be provided by Katherine Taylor who will serve as
NIAID's Scientific Coordinator. The NIAID Scientific Coordinator will have
substantial scientific/programmatic involvement during the conduct of this
activity through technical assistance, advice and coordination above and beyond
normal program stewardship for grants, as described below.
During performance of the award, the NIAID Scientific Coordinator may provide
appropriate assistance, advice, and guidance by: participating in the design of
the activities; advising in the selection of sources or resources (e.g.,
determining where a particular reagent can be found); coordinating or
participating in the collection and/or analysis of data; advising in management
and technical performance; or participating in the preparation of publications.
However, the role of NIAID will be to facilitate and not to direct the
activities. It is anticipated that decisions in all activities will be reached
by consensus and the NIAID staff will be given the opportunity to offer input
into this process. The manner of reaching this consensus and the final decision-
making authority will rest with the Principal Investigator.
Based on the research topic of the applications to be funded, relevant program
staff will be assigned to assist in scientific coordination of projects in the
areas of research specified. An NIAID Program Official will be assigned to
perform normal program stewardship responsibilities for this award.
4. Collaborative Responsibilities
The specific timelines, interim objectives and funding levels agreed to by the
Principal Investigator and the NIAID shall be included in the terms and
conditions of award. Given the nature of product development, it is recognized
that timelines and interim objectives may require revision and renegotiation
during the course of the project period. The Principal Investigator and NIAID
must agree to all such revisions. Release of each funding increment by NIAID
will be based on a NIAID review of progress towards achieving the previously
agreed upon interim objective. Where scientifically appropriate NIAID may ask
recipients to collaborate or cooperate with other NIAID funded projects and/or
US government agencies, for example CDC, FDA and USDA.
5. Arbitration
Any disagreement that may arise on scientific or 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 or by the individual awardee in the event of
an individual disagreement, a second member selected by the NIAID, and the third
member with expertise in the relevant area and selected by the two prior members
will be formed to review any scientific or programmatic issue that is
significantly restricting progress. While the decisions of the Arbitration
Panel are binding, these special arbitration procedures will in no way affect
the awardee's right to appeal an adverse action in accordance with PHS
regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues on VACCINE RESEARCH to:
Dr. Katherine Taylor
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 6003
Bethesda, MD 20892-7630
Telephone: (301) 496-7051
FAX: (301) 480-1456
E-Mail: kt148o@nih.gov
o Direct your questions about scientific/research issues on ADJUVANTS RESEARCH
to:
Dr. Charles Hackett
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 5139, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640
Telephone: (301) 496-7551
FAX: (301) 402-2571E-Mail: chackett@niaid.nih.gov
o Direct your questions about scientific/research issues on IMMUNOTHERAPEUTICS
RESEARCH to:
Dr. Alison Deckhut
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 5138, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640
Telephone: (301) 496-7551
FAX: (301) 402-2571
E-Mail: ad122x@nih.gov
o Direct your questions about scientific/research issues on THERAPEUTICS
RESEARCH to:
Dr. Catherine Laughlin
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 3105, MSC-7630
6700-B Rockledge Drive
Bethesda, MD 20892-7630
Telephone: (301) 496-7453
FAX: (301) 480-1594
E-Mail: cl28r@nih.gov
o Direct your questions about scientific/research issues on DIAGNOSTICS RESEARCH
to:
Dr. Robert Hall
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 6008
Bethesda, MD 20892-7630
Telephone: (301) 496-5305
FAX: (301) 496-8030
E-Mail: rhall@niaid.nih.gov
o Direct your questions about peer review issues; address the letter of intent;
mail two copies of the application and all five sets of appendices to:
Dr. Dianne Tingley
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-0818
FAX: (301) 402-2638
E-Mail: dt15g@nih.gov
o Direct your questions about financial or grants management matters to:
Lesia A. Norwood
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2117, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-7146
Fax: (301) 480-3780
E-mail: ln5t@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-0818
FAX: (301) 402-2638
E-Mail: dt15g@nih.gov
SUBMITTING AN APPLICATION
Applicants for U19 grants must follow special application guidelines in the
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS;
this brochure is available via the Internet at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS:
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and number must
be typed on line 2 of the face page of the application form and the YES box must
be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the Checklist, and three signed, 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:
Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express mail or courier service)
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. 5/01)
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.
It is highly recommended that the appropriate NIAID program contact be
consulted before submitting the letter of intent and during the early stages of
preparation of the application. (See program contact under INQUIRIES).
SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA:
Applicants for U19 cooperative agreements must follow special application
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under
INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.
This brochure presents specific instructions for sections of the PHS 398 (rev.
5/01) application form that should be completed differently than usual. For all
other items in the application, follow the usual instructions in the PHS 398.
APPLICATION PROCESSING: Applications must be received by the application receipt
date listed in the heading of this RFA. If an application is received after
that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The CSR
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
Introduction addressing the previous critique.
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 Principal Investigator
and awarding institution.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIAID.
Incomplete and/or non-responsive applications will be returned to the applicant
without further consideration.
Applications that are complete and responsive to the RFA 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, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Institute of Allergy and
Infectious Diseases Council
REVIEW CRITERIA
The general review criteria for U19 multi-project cooperative agreement
applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR
APPLICATIONS FOR MULTI-PROJECT AWARDS" at
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
In addition, the following review criteria specific to this RFA will be used in
evaluation of applications:
The criteria to be used in the evaluation of grant applications are listed
below. To put those criteria in context, the following information is contained
in instructions to the peer reviewers.
The reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of the RFA goals. Each of these
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 product forward.
(1) SIGNIFICANCE: Is this project likely to significantly advance the
development of a Vaccine, Adjuvant, Immunotherapeutic, Drug or Diagnostic
against a NIAID Category A, B or C pathogen?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Is the likelihood of successful project completion high
given the current state of research and development and the technical approach?
Are the proposed timeline and interim milestones appropriate, feasible and
technically sound?
(3) INNOVATION: Many aspects of vaccine, adjuvant, therapeutics,
immunotherapeutics and diagnostics development are not inherently innovative.
However, each project will be judged on whether the proposed research leverages
multi-disciplinary involvement to accelerate product development. In addition,
the approach should represent the best use of current technology and appropriate
collaborations to achieve the research objectives.
(4) INVESTIGATOR: Is the research and development team appropriately trained and
experienced and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the principal investigator and other
researchers (if any)?
(5) ENVIRONMENT: Does the environment in which the work will be done contribute
to the probability of success? Do the proposed experiments take advantage of
unique features of the scientific environments including partnerships with
industry or employ useful collaborative arrangements? Is there adequate evidence
of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application
will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the section
on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 25, 2002
Application Receipt Date: November 26, 2002
Scientific Peer Review Date: March, 2003
Advisory Council Review: May, 2003
Earliest Anticipated Start Date: July 1, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for assessment
of patient eligibility and status, rigorous data management, quality assurance,
and auditing procedures. In addition, it is NIH policy that all clinical trials
require data and safety monitoring, with the method and degree of monitoring
being commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and
compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete
copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must 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) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy 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 is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
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. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (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 RFA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalogue of Federal Domestic Assistance in the
following citations: No. 93.855, Immunology, Allergy, and Transplantation
Research and No. 93.856, Microbiology and Infectious Diseases Research. 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 NIH Grants Policy Statement is available at
http://grants.nih.gov/grants/policy/policy.htm. This document includes general
information about the grant application and review process; information on the
terms and conditions that apply to NIH Grants and cooperative agreements; and a
listing of pertinent offices and officials at the NIH.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the 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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