and Human Services (HHS)
EXPIRED
COOPERATIVE RESEARCH FOR THE DEVELOPMENT OF VACCINES, ADJUVANTS,
THERAPEUTICS, IMMUNOTHERAPEUTICS, AND DIAGNOSTICS FOR BIODEFENSE AND SARS
RELEASE DATE: June 16, 2003
RFA: AI-03-017
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
LETTER OF INTENT REFCEIPT DATE: September 22, 2003
APPLICATION RECEIPT DATES: October 22, 2003
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. These products should be focused on the
toxins or pathogens listed in the NIAID Categories A, B and C list of
priority pathogens
(http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm), or their
arthropod vectors. Products focused on the newly recognized SARS Coronavirus
are also responsive. The objective of this program is to support research in
the early stages of product development (i.e., beyond basic research);
however, for the area of immunotherapeutics more basic research is also
appropriate. Research may include, but is not limited to, target
identification, the adaptation of platform technologies or products to
biodefense or SARS applications, optimization of products, process
development, early validation and testing, preclinical evaluation, scale-up,
and production of quantities sufficient for preclinical regulatory
requirements and clinical Phase I testing or field trials. Phase I, II, and
III clinical trials and field studies are not supported by this initiative.
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.
The NIAID recognizes that the inherent nature and demands of the product
development process may require funding large, complex grants with
interdependent specific aims. Furthermore, some aspects of the product
development process (e.g., production of GLP and cGMP product) are inherently
not innovative. Recognizing that product development is often an iterative
and sequential process, and that steps early in the process may not be
successful and may need to be modified or reworked, NIAID staff, through the
cooperative agreement grant mechanism, will be actively involved in
evaluating the milestones of awardees and determining whether additional
investment in the development is warranted.
RESEARCH OBJECTIVES
Background
The National Institutes of Health (NIH) and other agencies in the Department
of Health and Human Services (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 biological agents deemed to pose the greatest threat
to civilian populations have been prioritized in the NIAID Category A, B, and
C priority pathogens and toxins list, which is available at
http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm. NIAID
convened three Blue Ribbon Panels to address the research priorities for
Category A pathogens and toxins, Category B and C pathogens and toxins, and
immunology research. The research agendas that resulted from these three
meetings are published at:
http://www.niaid.nih.gov/biodefense/research/biotresearchagenda.pdf,
http://www.niaid.nih.gov/biodefense/research/categorybandc.pdf
and http://www.niaid.nih.gov/publications/pdf/biodimmunpan.pdf.
In addition to the NIAID research agendas, the DHHS has identified the
highest priority products for bioterror preparedness
(http://www2.niaid.nih.gov/Biodefense/Research/high_priority.htm).
The recent emergence of SARS, its relative ease of transmission, disease
severity, and potential for epidemic spread require the rapid development of
interventions by the research community and the private sector. To this end,
NIAID is interested in supporting the early stages of development of specific
high priority products against the newly recognized SARS Coronavirus. High
priority products against the SARS Coronavirus include the development of
vaccines, therapeutics, and diagnostics.
In response to these needs, it is imperative that promising findings are
translated rapidly into new approaches and strategies for product
development. The involvement of experts from 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
specific for an NIAID Category A, B or C priority toxin, pathogen, or their
arthropod vector; or the SARS Coronavirus. Research is not required to
result in a "final" product but must advance the development of a candidate
product.
One objective of this RFA is to stimulate scientifically sound, original, and
innovative research requiring comprehensive team and multidisciplinary effort
that is likely to advance promising candidate products or platform
technologies through the product development pathway. All applications
should define the proposed project goal, interim objectives (development
milestones), a general description of the potential ultimate product (a
specific product profile that is defined by licensing indication is not
requested), and provide a schedule or timeline for milestone and goal
attainment. When appropriate, research plans should include an awareness of
guidelines that govern GLP (as defined by 21 CFR(58)) and GMP (as defined by
21 CFR(211)) manufacturing and/or IND enabling studies that will be performed
with this award as they would be applicable to eventual product licensure in
the U.S.
Phase I, II, and III clinical trials and field trials are not supported by
this RFA. However, the use of human tissues and samples, as well as
appropriate human cell lines, is encouraged.
More advanced stages of biodefense product development that include
significant industry participation are supported by a parallel mechanism
"Partnership Challenge Grants for Product Development: Vaccines, Adjuvants,
Therapeutics, Diagnostics, and Resources". This is also a cooperative
agreement mechanism and includes funding for Phase I and II clinical trials.
VACCINES
Applications for vaccines against any of the NIAID Category A-C pathogens or
toxins, or the SARS Coronavirus, are invited. Approaches should consider the
ultimate potential of candidate vaccines to quickly induce safe and
protective responses in a diverse civilian population. 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 subunit vaccine candidates;
o Process development for the production of vaccine components, including
QA/QC, methods for product recovery, characterization, purification,
identity, stability etc.;
o Manufacturing GLP or cGMP product in quantities sufficient for pre-
clinical and early clinical evaluation;
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
o Performance of required benchmarks for successful submission and review of
an Investigational New Drug application by the Food and Drug Administration
(FDA) (http://www.fda.gov/cber/vaccine/vacappr.htm).
ADJUVANTS
Applications for development of novel adjuvants that could be used in
conjunction with specific pathogen components are invited. 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. In order to advance the development of
vaccine adjuvants against NIAID category A-C agents of bioterrorism and the
SARS Coronavirus, this solicitation focuses on optimization and preclinical
testing of prospective lead compounds that previously showed promise in early
stages of discovery and development. Note: Applications proposing the
development of an adjuvant in conjunction with a pathogen that is not on the
NIAID Category A, B, or C priority pathogen list, with the exception of the
SARS Coronavirus, will be deemed unresponsive and returned without review to
the applicant.
Projects may include, but are not limited to, one or more of the following
areas:
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 Reiterative design, synthesis, and analysis to improve adjuvant
performance;
o Testing of previously-evaluated adjuvants for their capacity to stimulate
desired immune responses toward specific NIAID Category A, B or C pathogens
or toxins; or the SARS Coronavirus;
o Testing mixtures of adjuvants to evaluate additive or synergistic potential
to stimulate desired immune responses;
o Process development for the manufacturing of adjuvant components, including
QA/QC methods for product recovery, characterization, purification, identity,
stability etc.;
o Scale-up production under GLP or cGMP to provide sufficient quantities for
preclinical FDA-required animal studies and Phase I clinical trials;
o Pre-clinical testing for safety and stimulatory capacity in animals, and
o Performance of required benchmarks for successful submission and review of
an Investigational New Drug application by the (FDA)
(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 priority pathogens or the SARS Coronavirus are invited.
Projects may include, but are not limited to, one or more of the following
areas:
o Perform molecular modeling, library screening, and medicinal
chemistry/structural activity analysis to optimize candidate compounds for
preclinical studies
o Identify and validate 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 Synthesize sufficient quantities of candidate drug for in vitro analysis
and/or explore the use of active components of natural products as potential
drug sources for development;
o Process development for the manufacturing of drugs, including QA/QC,
methods for product recovery, characterization, purification, identity,
stability etc.;
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
o Performance of required benchmarks for successful submission and review of
an Investigational New Drug application by the FDA
(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 or toxin-specific
(antibodies) approaches are invited. Major objectives for products generated
in this research program include prevention of infection or intoxication in
the face of an immediate threat, protection of immunocompromised individuals,
and 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
or the SARS Coronavirus. Projects may include, but are 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 or the SARS Coronavirus;
o Testing and validation of efficacy;
o Process development for the manufacturing of product, including QA/QC,
methods for product recovery, characterization, purification, identity,
stability etc.;
o GMP production to generate sufficient product to conduct pre-clinical
studies and Phase I clinical studies;
o Preclinical testing for safety and efficacy in animal models; and
o Performance of required benchmarks for successful submission and review of
an Investigational New Drug application by the FDA
(http://www.fda.gov/cber/therapies.htm).
Antibodies:
o Discovery and characterization of novel antibodies with high specificity
for pathogen antigens or toxins;
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. improved purification methods, production of
humanized or fully human antibodies);
o Testing and validation of efficacy;
o Process development for the manufacturing of antibody product, including
QA/QC methods for product recovery, characterization, purification, identity,
stability etc.;
o GLP or cGMP production to generate sufficient product to conduct pre-
clinical and Phase I clinical studies;
o Preclinical testing for safety and efficacy in animal models; and/or
o Performance of required benchmarks for successful submission and review of
an Investigational New Drug application by the Food and Drug Administration
(FDA) (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, hospital-based clinical
laboratories and point-of-care use to identify infectious agents or toxins so
that rapid diagnostics and appropriate therapeutic intervention can be
executed. Simultaneous detection and identification of a broad range of
infectious agents in clinical samples is highly desirable. Research for the
development of diagnostics that can detect, or indicate exposure to,
infectious agents or toxins in individuals that are symptomatic, pre-
symptomatic, or exposed with non-specific symptoms is invited.
This initiative does not support environmental detection research, which is
supported by other institutes and agencies such as the National Institute for
Environmental Health Sciences, the Centers for Disease Control and Prevention
(CDC), the Environmental Protection Agency, and the Department of Energy.
All applications should include:
o Description of the capabilities of the method, technology, or assay.
o Plans for determining the sensitivity, specificity, and validation of the
technology, assay, and diagnostic.
Applications for the development of medical diagnostics specific for NIAID
Category A-C pathogens and toxins or the SARS Coronavirus are invited.
Applications may include, but are not limited to, one or more of the
following areas:
o Rapid, hospital-based tests that differentiate the common pathogens from
the Category A, B, and C priority pathogens in blood;
o Methods for rapid sample preparation, processing, and concentration;
o Methods demonstrating the highest performance of specificity, sensitivity,
rapidity, and cost when applied to relevant clinical samples to detect an
infectious agent and/or toxin;
o Technologies capable of resolving engineered or otherwise acquired genetic
traits in microorganisms, such as patterns of microbial resistance or
enhanced virulence;
o Technologies capable of identifying characteristic microbial genetic
signature profiles;
o Methods capable of high throughput, robotics, and automated data output and
analyses;
o Tests that target multiple agents simultaneously in a single sample;
o Technologies that are capable of simultaneously detecting two parameters in
a clinical sample such as both DNA and protein.
o Process development for the manufacturing of diagnostic components,
including QA/QC methods for reagent recovery, characterization, purification,
identity, stability etc.;
Tests for use on human samples may consider benchmarks required for approval
(http://www.fda.gov/cber/devices.htm).
VECTOR CONTROL
Many of the pathogens on NIAID's priority organism list are transmitted by
arthropod vectors, including mosquitoes of the genera Culex and Aedes, ixodid
ticks, and fleas. Vector control is one means to prevent disease
transmission. Applications to develop novel vector control products will also
be considered under this announcement. Applicants are strongly encouraged to
consult NIAID staff for details.
MECHANISM OF SUPPORT
This RFA will use the single project (U01) or multi-project (U19) cooperative
agreement(s), an "assistance" mechanism, rather than an "acquisition"
mechanism. The NIH 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 the Principal
Investigator, as described under the section "Cooperative Agreement Terms and
Conditions of Award."
Essential elements of the U01 include: (1) a single research project that may
include consortium agreements, but does not include "Core" resources and
facilities as defined for U19 applications; (2) a single Principal
Investigator who will be scientifically and administratively responsible for
research project; and (3) a single applicant institution that will be legally
and financially responsible for the use and disposition of funds awarded.
Essential elements of the 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 these 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.
Lack of synergy and interaction among the projects and cores will adversely
affect the priority score of a multi-project application, even if the merit
of individual projects is high.
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 $40 million per year (total costs),
beginning in FY 2004, to fund 12 to 25 new grants in response to this RFA.
An applicant may request a project period of up to 5 years. The yearly
direct costs that can be requested are not limited but must be justified by
the proposed research and will be evaluated by the review panel and program
staff. Domestic 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 for renovations
and/or equipment 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.
Foreign Organizations:
Several special provisions apply to applications submitted by foreign
organizations.
o Funds for alterations or renovations cannot be requested.
o Charge back of customs and import fees is not allowed.
o Format: every effort should be made to comply with the format
specifications, which are based upon
a standard US paper size of 8.5" x 11."
o Funds for up to 8% administrative costs can now be requested,
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
o Organizations must comply with federal/NIH policies on human subjects,
animals, and biohazards.
o Organizations must comply with federal/NIH biosafety and biosecurity
regulations.
o Proposed research should provide a unique research opportunity, not
available in the U.S.
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 priority toxin, pathogen,
or their arthropod vector; or the SARS Coronavirus, through the product
development process. It is not necessary to propose to complete the product
development process up to the point of readiness for clinical trials within
the time frame of this project. Applications that would significantly
advance a specific product toward clinical or field usefulness are
responsive.
Single project U01 and multi-project U19 applications must define the
proposed project goal, interim objectives (development milestones) and
potential ultimate product (a specific product profile that is defined by
licensing indication is not requested), and provide a schedule or timeline
for milestone and goal attainment.
When appropriate, research plans should include an awareness of guidelines
that govern GLP, as defined by 21 CFR(58), and GMP, as defined by 21
CFR(211), manufacturing and/or IND enabling studies performed with this award
as they would be applicable to eventual product licensure in the U.S.
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.
Select Agents:
All participating organizations whether domestic or foreign, must comply with
Select Agent regulations (http://www.cdc.gov/od/sap/)
and NIH Guidelines for Research Involving Recombinant DNA Molecules
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). Applicants must
document their ability and willingness to comply.
Intellectual Property:
Intellectual property rights are likely to play an important role in
achieving the goals of this program. To this end, the NIAID requires that at
the time of the application all applicants must provide a letter (Proprietary
Rights Assurance Letter" containing the following assurances, which is signed
by a representative who is duly authorized to provide such assurances on
behalf of the applicant organization:
o. Applicant is solely responsible for the timely acquisition of all
proprietary rights, including intellectual property rights, and all materials
needed for applicant to perform the project
o. Applicant acknowledges that prior to, during, and subsequent to the award,
the U.S. Government is not required to obtain for applicant any proprietary
rights, including intellectual property rights, or any materials needed by
applicant to perform the project.
o. Applicant acknowledges the requirement to report to the U.S. Government
all inventions made in the performance of the project, as specified at 35
U.S.C. Sect. 202.
Apart from the Proprietary Rights Assurance Letter, applicants are expected
to exercise their Bayh-Dole rights in a manner that does not conflict with
the goals of this award or the intent of the Bayh-Dole Act to promote the
utilization, commercialization and availability of the U.S. Government-funded
inventions for public benefit. In addition, applicants are expected to make
new information and materials known to the research community in a timely
manner through publications, web announcements, and reports to the NIAID or
other mechanisms.
Mandatory Meetings:
Single project awards: The Principal Investigator, one or two key personnel
designated by the Principal Investigator and NIAID program staff 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, and NIAID
program staff 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
(airfare, and per diem) 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.
External advisors should be identified and appointed only after the funding
award is made.
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 multi-project 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 or other designated NIAID scientific program staff.
1. Monitoring Clinical Studies
Note that phase I, II, and III clinical trials are not supported by this
initiative. However, the use of clinical samples, when appropriate, is
acceptable and will be governed by NIAID policy. When clinical studies 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://grants.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 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 NIAID program staff 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 and program staff have a right
of access to the data (see NIAID staff responsibilities below) the applicant
will retain custody of and right to the data. In accordance with this NIH
policy a data-sharing plan should be included in the application. For more
information on data sharing go to:
http://grants.nih.gov/grants/policy/data_sharing/index.htm.
3. NIAID Staff Responsibilities
NIAID staff assistance will be provided by Clare Schmitt who will serve as
NIAID's Scientific Coordinator. The NIAID Scientific Coordinator will have
substantial scientific/programmatic involvement during the conduct of awarded
activities 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, with
assistance from other scientific program staff who are designated based on
the research topic and their relevant expertise, 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. The NIAID Scientific Coordinator will serve as a liaison
/facilitator between the awardee, pharmaceutical and biotech industries, and
other government agencies (e.g., FDA, USDA, CDC) will serve as a resource of
scientific and policy information related to the goals of the awardee's
research. 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.
An NIAID Program Official will be assigned to perform normal program
stewardship responsibilities for this award. The Program Official may serve
as the Scientific Coordinator.
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 (with the NIAID
representation not voting) or by the individual awardee in the event of an
individual disagreement, a second member selected by NIAID, and the third
member selected by the two prior selected members. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with the PHS regulations at 42 CFR
Part 50, Subpart D and HHS regulation at 45 CFR Part 16.
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. Clare Schmitt
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4005, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-7051
FAX: (301) 402-1456
E-Mail: cs453y@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 1127, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640
Telephone: (301) 496-7551
FAX: (301) 480-2381
E-Mail: ch187q@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 4099, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-7453
FAX: (301) 480-1594
E-Mail: cl28r@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 1126, MSC-7640
6700-B Rockledge Drive
Bethesda, MD 20892-7640
Telephone: (301) 496-7551
FAX: (301) 480-2381
E-Mail: ad122x@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
Room 4013, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-7051
FAX: (301) 4021456
E-Mail: rh277v@nih.gov
o Direct your questions about scientific/research issues on VECTOR CONTROL
PRODUCTS to:
Dr. Kathryn S. Aultman
Division of Microbiology and Infectious Diseases
National Institute of Allergy & Infectious Diseases
Room 5097, MSC-6603
6610 Rockledge Blvd
Bethesda, MD 20892-6603
Telephone: (301) 435 2854
FAX: (301) 402 0659
E-Mail: ka6z@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) 496-2550
FAX: (301) 402-2638
E-Mail: dt15g@nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Sharie Bernard
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 3219, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-402-5540
FAX: 301-493-0597
E-Mail: sb34k@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) 496-2550
FAX: (301) 402-2638
E-Mail: dt15g@nih.gov
SUBMITTING AN APPLICATION
Applicants for U01 or U19 grants must follow the forms and standard
guidelines in the NIH public Health Service grant application (PHS 398, rev.
5/2001, Sections I-III) available at
http://grants.nih.gov/grants/funding/phs398/phs398.html.
In addition, 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. Revisions of applications
previously submitted in response to RFA-AI-02-026 must contain a special
introduction to the Research Plan identifying changes from the former
application, in accordance with instructions for Revised Application in PHS
398, Section I.8. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
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)
The Center for Scientific Review now accepts delivery of applications only by
mail or courier service. Personal deliveries of applications will not be
accepted (http://grants.nih.gov/grants/funding/phs398/instructions2/
p1_mailing_address.htm). 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 or before October
22, 2003 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, Sections I-III.
APPLICATION PROCESSING: Applications must be received on or before 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 (P01 or U19) to be concurrently submitted as
a traditional individual research project (R01) or SBIR application. If,
following review, both the multi-project application and the R01 or SBIR
application are found to be in the fundable range, the investigator must
relinquish the R01 or SBIR 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. Applicants to this RFA may not submit a U01 proposal
containing a project identical to a project in a U19 proposal.
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 Advisory 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.
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.
SIGNIFICANCE: Is this project likely to significantly advance the development
of a vaccine, adjuvant, therapeutic, immunotherapeutic, or diagnostic against
an NIAID Category A, B or C priority toxin, pathogen, or associated arthropod
vector; or the SARS Coronavirus?
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?
INNOVATION: Many aspects of vaccine, adjuvant, therapeutics,
immunotherapeutics, and diagnostics product 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 or emerging technologies and appropriate collaborations to achieve
the research objectives.
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)?
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, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
DATA SHARING: The adequacy of the proposed plan to share data.
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: September 22, 2003
Application Receipt Date: October 22, 2003
Scientific Peer Review Date: February, 2004
Advisory Council Review: May, 2004
Earliest Anticipated Start Date: July, 2004
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
MONITORING PLAN AND DATA AND SAFETY 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://stemcells.nih.gov/index.asp 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes
involving the review, funding, and progress monitoring of grants, cooperative
agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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 at
http://www.cfda.gov/ 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. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
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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