This Program Announcement (PA) has been superceded by the PA dated July 26, 2000.

SMALL BUSINESS INNOVATION RESEARCH ADVANCED TECHNOLOGY: NIAID (SBIR-AT-NIAID)

Release Date:  May 21, 1998

PA NUMBER:  PAR-98-073

P.T.

National Institute of Allergy and Infectious Diseases

Application Receipt Dates:  April 15, August 15, and December 15

PURPOSE

This Program Announcement (PA), 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.

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.

This PA must be read in conjunction with the Omnibus Solicitation of the
Public Health Service (Omnibus Solicitation) for Phase I SBIR Grant
Applications (PHS 98-2) and the instructions for Phase II Grant Applications
revised March 1998.  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 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," 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 may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No. 017-
001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (Telephone 202-512-1800).

ELIGIBILITY

Eligibility requirements are described in the Omnibus Solicitation.

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 directions for Phase I SBIR applications as described in the
Omnibus Solicitation.  The Omnibus Solicitation is available on the Internet
at:  http://www.nih.gov/grants/funding/sbir1/sbir.htm

A limited number of hard copies of the Omnibus Solicitation are available
from:

PHS SBIR/STTR Solicitation Office
13685 Baltimore Avenue
Laurel, MD  20707-5096
Telephone:  (301) 206-9385
FAX:  (301) 206-9722
Email:  [email protected]

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.

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 in academic institutions.

o  Page Limitations.

The 25-page limitation for Phase I applications apply (see Omnibus
Solicitation).  If the allowed number of pages is not sufficient for an SBIR-
AT-NIAID application, applicants should contact the Scientific Review
Administrator (SRA) after receipt and assignment of the application to request
approval for submission of supplementary information for review.

MECHANISM OF SUPPORT - PHASE II

Phase II applications in response to this PA will be awarded as Phase II SBIR
grants (R44) or contracts (N44) 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.

Applications for Phase II awards should be prepared following the instructions
for NIH Phase II SBIR applications. The Phase II SBIR instructions and
application may be found on the Internet at: 
http://www.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 in academic institutions.

o  Applications over $500,000.

Applicants who plan to submit a Phase II SBIR application requesting $500,000
or more in total cost for any one year are advised that they must contact
NIAID program staff as they begin to develop plans. Furthermore, applicants
must obtain agreement from NIAID that the application will be accepted for
consideration for award.  Finally, the applicant must identify in a cover
letter that is sent with the application, the staff member who agreed to
accept assignment of the application.  Applications received without prior
staff contact may be delayed in the review process or returned to the
applicant without review (see NIH GUIDE, March 20, 1998).

RESEARCH OBJECTIVES

o  Background.

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.

o  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 three 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.

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 cytomeaglovirus,
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 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


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 and
compelling rationale and justification are provided that inclusion is
inappropriate with respect to the health of the subjects of 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", which have been 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.

Investigators may obtain copies from these sources or from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

NIH POLICY AND GUIDELINES ON THE 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 is scientific or ethical reasons not to include them.  This
applies to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

o  Applicants should follow the instructions for SBIR Phase I or Phase II
submission with the modifications as noted in this PA.

o  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.  They
are also encouraged to read the advice and information on SBIR and STTR
programs located on the Internet at:
http://www.nih.gov/grants/funding/sbirsttradvice.htm

o  Mailing Instructions.

The original application and two single-sided copies must be mailed both to
the NIH Center for Scientific Review and to the NIAID Division of Extramural
activities.  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," PAR-98-073).  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

o  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.

o  Review Criteria.

Review criteria are described in the Omnibus Solicitation.  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.

o  Release of Grant Application Review Information.

Following evaluation of grant applications by the study section but prior to
National Advisory Council or Board action, summary statements will be sent
automatically to principal investigators.  A "summary statement" documents the
evaluation of an application by the study section and conveys the group's
recommendations to the awarding component and its Council or Board. No one
other than the Principal Investigator may receive the summary statement and
evaluation rating.

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, the availability of funds, and the
commercialization status where the small business concern has received more
than 15 Phase II awards in the prior five (5) fiscal years, if applicable (see
this application requirement under "Prior SBIR Phase II Awards" found in the
"Introduction and Application Instructions" portion of the Omnibus
Solicitation).

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:

Gregory Milman, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2C06
Bethesda, MD  20892
Telephone: (301) 496-8666
FAX:  (301) 402-3211
Email:  [email protected]

Mr. Allan Czarra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C23
Bethesda, MD  20892
Telephone:  (301) 496-7291
FAX:  (301) 402-0369
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Pam Fleming
Grants Management Specialist
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4C25
Bethesda, MD 20892-7610
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  [email protected]

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 Citation is (No. 93.855 - Immunology, Allergy, and
Transplantation Research and No. 93.856 - Microbiology and Infectious Disease
Research [or] both of the preceding.  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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