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:  [email protected]
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:  [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 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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