SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID)
Release Date: July 26, 2000
PA NUMBER: PAR-00-126
National Institute of Allergy and Infectious Diseases
Application Receipt Dates: December 1, 2000
April 1, August 1, December 1, 2001
April 1, August 1, December 1, 2002
April 1, August 1, 2003
PURPOSE
This Program Announcement, SBIR-AT-NIAID, invites grant applications for
Small Business Innovation Research (SBIR) projects with award duration and
amounts greater than those routinely allowed under the SBIR program. This
program announcement replaces PAR-98-073 that appeared in the May 22, 1998
issue of the NIH Guide and was updated in the August 16, 1999 issue of the
NIH Guide. August 1, 2000 is final receipt date for application in response
to PAR-98-073. This new program announcement includes changed receipt dates
(see above), new URL links, modified instructions (consistent with current
SBIR application instructions), and a modified Research Objectives and Scope.
SBIR-AT-NIAID applications are a parallel option for advanced technology
related SBIR proposals and are not intended as an alternative for other SBIR
proposals.
Advanced technology projects are defined as those that include high-cost
advanced technology or high-cost long-term clinical studies in human or non-
human primates. NIAID invites applications for SBIR-AT-NIAID awards in the
research areas identified in Research Objectives and Scope below.
This PA must be read in conjunction with the Omnibus Solicitation of the
Public Health Service for Phase I SBIR Grant Applications found at
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm and the instructions
for Phase II Grant Applications found at
http://grants.nih.gov/grants/funding/sbir2/index.htm. Except as noted below,
all instructions and information in these documents also apply to SBIR-AT-
NIAID applications.
This PA provides examples of advanced technology areas in which NIAID will
entertain SBIR applications and provides NIAID"s interpretation and
clarification of instructions relating to total cost, dates of project
period, and page limitations for these applications.
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 PA, SBIR-AT-NIAID, is
related to the priority areas of immunization and infectious diseases, HIV
infection, sexually transmitted diseases, clinical preventive services,
maternal and infant health, diabetes and chronic disabling conditions, and
surveillance and data systems. Potential applicants can find "Healthy People
2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY
Eligibility requirements for Phase I and Phase II grants are found at
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm and
http://grants.nih.gov/grants/funding/sbir2/index.htm respectively.
MECHANISM OF SUPPORT - PHASE I
Phase I applications in response to this PA will be funded as Phase I SBIR
Grants (R43) with modifications as described below. Responsibility for the
planning, direction, and execution of the proposed research will be solely
that of the applicant. Applications for Phase I grants should be prepared
following the instructions at
http://grants.nih.gov/grants/funding/sbirsttr1/11instructions.htm.
o Project Period and Amount of Award.
Because the length of time and cost of research involving advanced technology
projects often exceeds that routinely awarded for SBIR grants, NIAID will
entertain well justified Phase I applications for an SBIR-AT-NIAID award with
a project period up to two years and a budget not to exceed a total cost of
$300,000 per year. See section, BUDGET REQUESTS GREATER THAN $100,000 TOTAL
COSTS, in http://grants.nih.gov/grants/funding/sbirsttr1/11instructions.htm
o Consultant and contractual costs.
The total amount of all consultant costs and contractual costs normally may
not exceed 33% of the total costs requested for Phase I SBIR applications.
However, NIAID will entertain well-justified Phase I applications for an
SBIR-AT-NIAID award with greater than 33% contractual costs when those costs
are necessary to support clinical studies and trials.
o Page Limitations.
The 25-page limitation for Phase I applications apply. Supplementary or
corrective material pertinent to the review of an application after the
receipt date may be submitted only if it is specifically solicited by or
agreed to through prior discussion with the Scientific Review Administrator
of the scientific peer review group.
MECHANISM OF SUPPORT - PHASE II
Phase II applications in response to this PA will be awarded as Phase II SBIR
grants (R44) with modifications as described below. Phase II applications in
response to this PA will only be accepted as competing continuations of
previously funded NIH Phase I SBIR awards. The previously funded Phase I
award need not be an SBIR-AT-NIAID award, but the Phase II proposal must be a
logical extension of the Phase I research.
Phase II applications should be prepared using instructions at
http://grants.nih.gov/grants/funding/sbir2/index.htm.
o Project Period and Amount of Award.
Because the length of time and cost of research involving advanced technology
projects often exceeds that routinely awarded for SBIR grants, NIAID will
entertain well-justified Phase II applications for an SBIR-AT-NIAID award
with a project period up to three years and a budget not to exceed $1 million
per year total cost.
o Consultant and contractual costs.
The total amount of all consultant costs and contractual costs normally may
not exceed 50% of the total costs requested for Phase II SBIR applications.
However, NIAID will entertain well-justified Phase II applications for an
SBIR-AT-NIAID award with greater than 50% contractual costs when those costs
are necessary to support clinical studies and trials.
RESEARCH OBJECTIVES
The SBIR program consists of the following three phases:
o Phase I.
The objective of Phase I is to establish the technical merit and feasibility
of proposed research or R&D efforts and to determine the quality of
performance of the small business grantee organization prior to providing
further federal support in Phase II.
o Phase II.
The objective of this phase is to continue the research or R&D efforts
initiated in Phase I.
o Phase III.
The objective of this phase, where appropriate, is for the small business
concern to pursue the commercialization of the results of the research or R&D
funded in Phases I and II. Normally, Phase III occurs without additional
Federal funding. However, NIAID may support some Phase III studies, with
non-SBIR funds, through resources such as NIAID clinical trial networks.
Research Objectives and Scope.
SBIR applications often do not request support for the length of time or the
funding required for advanced technology projects. Advanced technology
projects are defined as those that include high-cost advanced technology or
high-cost long-term clinical studies in human or non-human primates. NIAID
invites applications for SBIR-AT-NIAID awards in four areas:
A. Development of vaccines, biologics, drugs and prevention strategies for
infectious and immunologic diseases, allergy, and transplantation.
B. Development of vaccine, biologic and drug delivery systems.
C. Development of assays and therapeutic monitoring systems for clinical and
vaccine trials and for improved diagnosis of infectious, allergic, and
immunologic diseases.
Examples include, but are not limited to, the following:
o Kits, reagents and/or out-source services that provide reproducible
measurements of human immune responses in preclinical and clinical trials of
vaccines for HIV and other infections such as those caused by
cytomegalovirus, hepatitis C virus, enteroviruses, B. burgdorferii (Lyme
agent), aspergillus, candida, P. falciparum, STD agents, C. pneumoniae, N.
meningitidis, respiratory syncytial virus, Group A streptococcus and drug-
resistant microbes.
o Detection and quantitative measurement of neutralizing antibodies,
cytotoxic T lymphocytes, chemokine receptor assays, CD4+ helper cell
activity, CD8+ suppressor cell activity, and in vitro infectivity of virus.
Currently, many of these assays are not standardized among laboratories and
results are difficult to compare.
o Development and clinical evaluation of targeted therapies, novel vaccine
constructs, diagnostic tests and tests for the monitoring of clinical
response to an intervention for infectious diseases caused by pathogens such
as those listed above.
o Drug and therapeutic delivery systems directed towards special
populations, special targets or special problems. Special populations
include patient groups such as newborns, young children, pregnant women and
others needing other than oral delivery. Special targets include specific
physiological sites such as the genital, pulmonary, gastrointestinal tract,
red blood cells, brain, etc. Special problems include prolonged release, and
timed or sequential delivery of one or more components, and delivery with
improved pharmokinetic factors such as oral bioavailability or protein
binding.
o Application of rapid and highly sensitive DNA chip technology to any of
the following: kinetics of specific gene expression in different cell types
under different stimulatory conditions, comparison of immune response gene
expression during allograft or xenograft acceptance and rejection in humans,
non-human primates, and rodents, comparison of pathogenic and non-pathogenic
strains or different organisms which share the same mechanisms of
pathogenesis, and correlation of gene expression with disease progression.
o Protein-protein interaction chips to extend such genetic analyses to the
more relevant level of functional protein expression.
o Bioinformatics programs and centralized databases for analysis of data
generated from new technologies, in particular gene and protein chips. These
databases should also provide the means to model and understand entire
systems both at the level of the cell and the whole organism.
o High resolution magnetic resonance imaging (MRI) and other imaging
techniques to localize and monitor in vivo any of the following: immune
cells, pathogens, disease progression or remission.
o New reagents that identify antigen-specific T cells to follow the course
of a specific immune response, identify the responding T cell subset and
cytokine profile at different times during the response, and predict the
outcome of the response.
o Development and clinical evaluation of topical microbicides
o Development and field evaluation of methods for controlling vector-borne
infections
NIAID Policy on Monitoring Clinical Trials and Studies.
On February 24, 2000, NIAID published its policy requiring that all clinical
trials and studies supported by NIAID be monitored commensurate with the
degree of potential risk to study subjects. When SBIR-AT-NIAID applications
are for clinical trials or studies, applicants must meet the requirements of
this policy available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear,
compelling rationale, and justification are provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research", published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,
1994 which is available at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and which is available at the following
URL address:http://grants.nih.gov/grants/guide/notice-files/not98-024.html
APPLICATION PROCEDURES
Applicants should follow the instructions for SBIR Phase I or Phase II
submission with the modifications as noted in this PA.
Advice on Submitting Applications. Potential applicants are strongly
encouraged to contact program staff for pre-application guidance and/or for
more specific information on the research topics described in this PA.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
Mailing Instructions
The original application and two single-sided copies must be mailed to the
NIH Center for Scientific Review. For purposes of identification and
processing, the title and number of this PA must be shown in item 2 on the
face page of the SBIR Phase I applications and in item 1A of the face page of
Phase II grant applications (i.e., "SBIR-AT-NIAID,"). Follow the mailing
instructions in the Omnibus Solicitation for Phase I applications. Follow
the mailing instructions in the Phase II application package for Phase II
applications.
REVIEW CONSIDERATIONS
Review Procedures
Applications will be assigned on the basis of established PHS referral
guidelines. Upon receipt, applications will be reviewed for completeness by
the NIH Center for Scientific Review. Incomplete applications will be
returned to the applicant without further consideration.
Applications will be reviewed for scientific and technical merit by study
sections of the Center for Scientific Review, NIH, in accordance with the
standard NIH peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit,
generally the top half of the applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council.
Review Criteria
Review criteria are described in Phase I and Phase SBIR websites listed
above. The Phase I application should specify clear, measurable goals
(milestones) that should be achieved prior to initiating Phase II. Failure
to provide clear, measurable goals may be sufficient reason for the study
section to judge the application non-competitive.
AWARD CRITERIA
The following will be considered when making funding decisions: quality of
the proposed project as determined by peer review, program balance among
research areas of the announcement, and the availability of funds.
Applications will compete for available funds with all other favorably
recommended SBIR applications. Note that applicants may achieve all Phase I
goals and milestones and still not receive Phase II funding.
INQUIRIES
Written and telephone inquiries are encouraged. The opportunity to clarify
any issues or questions from potential applicants is welcome.
Inquiries regarding programmatic issues may be directed to:
Allan Czarra
Deputy Director
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 2144 - MSC 7610
Bethesda, MD 20892-7610
Bethesda, MD 20817-7610 (for express/courier service)
Telephone: (301) 496-7291
FAX: (301) 402-0369
Email: aczarra@niaid.nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Pam Fleming
Grants Management Specialist
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive
Rm. 2119, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-6580
FAX: (301) 480-3780
Email: pf49e@nih.gov
AUTHORITY AND REGULATIONS
This program is supported under authorization of the Public Health Service
Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue of Federal
Domestic Assistance Citations are No. 93.855, Immunology, Allergy, and
Transplantation Research, and No. 93.856, Microbiology and Infectious Disease
Research. Awards will be administered under PHS grants policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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