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CHALLENGE GRANTS: BIODEFENSE PRODUCT DEVELOPMENT

Published on AidPage by IDILOGIC on Jun 24, 2005
Administered by:

Department of Health and Human Services, National Institutes of Health, National Institutes of Health
(see all US Federal Agencies)

Explore all postings for this grant program:
  • Original Grant - Jun 21, 2004
Applications Due:

Jan 18, 2005

total funding: Not Available
max award: none
min award: none
cost sharing, matching: No
number of awards: Not Available
type of funding: Cooperative Agreement
Description:

Research supported and conducted by the National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health, strives to
understand, treat and ultimately prevent the myriad infectious, immunologic,
and allergic diseases that threaten millions of human lives. The NIAID
Division of Microbiology and Infectious Diseases (DMID) and the Division of
Allergy, Immunology and Transplantation (DAIT) support extramural research to
control and prevent diseases caused by virtually all infectious agents. This
includes basic biomedical research, such as studies of microbial physiology
and antigenic structure; immunity; applied research, including the
development of diagnostic tests; and clinical trials to evaluate experimental
drugs and vaccines.

In response to growing concerns about the use of biological agents in acts of
terrorism, the further clinical development of new vaccines, therapeutics,
adjuvants, and diagnostics against NIAID Category A, B, and C priority
pathogens (see http://www.niaid.nih.gov/biodefense/bandc_priority.htm) is a
high priority. This program, CHALLENGE GRANTS: BIODEFENSE PRODUCT
DEVELOPMENT, will support further development of previously identified
products against NIAID Category A, B, and C high priority pathogens including
vaccines, adjuvants, therapeutics, and diagnostics. To be responsive to this
program for the development of biodefense products, the applicant must have
already demonstrated proof-of-principle for a candidate vaccine, therapeutic,
adjuvant, or diagnostic method for biodefense. Phases of further development
eligible for support include, but are not limited to: early validation; pre-
clinical stages; scale-up; production; and fulfilling regulatory
requirements.

NOTE: While clinical development strategies may be included within an overall
development plan, this RFA will NOT support clinical trials; applications
requesting support for clinical trials will be viewed as unresponsive to this
RFA and will be returned without review. Utilization of human derived
material in pre-clinical studies in support of complying with regulatory
requirements is considered responsive.

NOTE: Applications to support basic research or the "discovery" of new
targets or the identification and validation of protective epitopes for NIAID
Category A, B, and C priority pathogens will NOT be supported under this RFA,
but are supported by other NIAID programs (see
http://www.niaid.nih.gov/biodefense/research/funding.htm). In addition,
ancillary research studies that are not directly relevant to development of
the selected product will not be supported.

Challenge Grants

Under this program, Challenge (UC1) grant awards will be performance based
for a period of up to three years. That is, funds can be requested and will
be awarded in increments based on the attainment of interim research
objectives (milestones) defined by the applicant and approved following peer
review by the NIAID. Because funding will be tied to the attainment of
interim research objectives (milestones), funding will not be provided
annually as is traditional for NIH grants, but will be linked to project
timelines and interim objectives. Initial release of funds will be to
support achievement of the first interim objective/milestone. Release of the
next funding increment will be based on the achievement of the previous
interim objective, as determined by NIAID staff.

Partnerships

A key component of this initiative is the development of partnerships between
the government and industry. For the purpose of this program, "industry" is
defined as large and small, domestic or foreign, pharmaceutical,
biotechnology, bioengineering, and chemical companies. Since academic
organizations are often the source of new candidate products, this program
can also support a partnership between industry and collaborator(s) as
necessary from academic and non-profit research organizations. The
involvement of an academic or non-profit research organization is NOT a
requirement; therefore, industry does not need an academic collaborator to
submit an application to this program.

All projects must demonstrate substantive investment by industry
participant(s). "Substantive investment" is defined, for the purposes of this
program, as substantive commitment of any one or more of the following
resources: personnel, in kind contributions of materials and/or reagents,
including but not limited to chemical libraries, innovative biotechnology
platforms (i.e., for screening of drugs and inhibitors), scale up of GMP
chemical synthesis or production, provision of animal or other laboratory
models for evaluation, subcontracts, data management resources, regulatory
support, and alterations/renovations of facilities or provision of equipment
to address biohazard concerns.

The Principal Investigator of the project may be affiliated with either
industry or an academic organization (if academia is part of a partnership
with industry). See information under ELIGIBLE INSTITUTIONS below.

Who can apply:

Anyone/General Public
City Or Township Governments
County Governments
Federally Recognized Indian Tribal Governments
Independent School Districts
Individual/Family
Minority Group
Native American Organization
Non-Government - General
Nonprofits Having A 501(C)(3) Status With The IRS, Other Than Institutions Of Higher Education
Nonprofits That Do Not Have A 501(C)(3) Status With The IRS, Other Than Institutions Of Higher Education
Other Private Institution/Organization
Private Institutions Of Higher Education
Private Nonprofit Institution/Organization (Includes Institutions Of Higher Education, Hospitals)
Profit Organization
Public And State Controlled Institutions Of Higher Education
Public Housing Authorities/Indian Housing Authorities
Small Business (Less Than 500 Employees
Special District Governments
State (Includes District Of Columbia; Includes Institutions Of Higher Education And Hospitals)
U.S. Territories And Possessions (Includes Institutions Of Higher Education, Hospitals)

Eligible functional categories:
Funding Sources:

Allergy, Immunology and Transplantation Research
Microbiology and Infectious Diseases Research

More Information:

http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-029.html

If you have problems accessing the full announcement, please contact: NIH OER Webmaster

Address Info:

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