SMALL BUSINESS BIODEFENSE PROGRAM

RELEASE DATE:  August 15, 2002

PA NUMBER: PAS-02-149 

RECEIPT DATES: 
 (http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm)

EXPIRATION DATE:  August 2, 2005

National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov)

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements (if included)
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

To support SBIR/STTR grants to develop therapeutics, vaccines, 
diagnostics, adjuvants/immunostimulants, and selected resources for 
biodefense.  

This PA provides instructions relating to total cost and dates of 
project period for these applications.

RESEARCH OBJECTIVES

NIAID has identified specific products for biodefense that are of 
highest priority for rapid development. These products are listed at: 
http://www2.niaid.nih.gov/Biodefense/Research/high_priority.htm. The list 
may be updated regularly based on changing priorities.

Due to the urgent need to advance research involving Biodefense and 
concern that the time and cost of these projects may exceed that 
routinely awarded for SBIR or STTR grants, NIAID will entertain well-
justified applications focused on NIAID High Priority Biodefense 
Products with the following expanded duration and award limits:

1) SBIR and STTR Phase I applications up to 2 years and $500,000 total 
cost per year.  

2) SBIR and STTR Phase II applications up to 3 years and $2,000,000 
total cost per year.  

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 Biodefense award with greater than 50% 
contractual costs when those costs are necessary to support clinical 
studies and trials or product development.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH Small Business Innovation Research (SBIR   
R43/R44) and Small Business Technology Transfer (STTR   R41/R42) 
applications to stimulate technological innovations in areas that are 
within its mission.  The total requested project period for an 
application submitted in response to this PA may not exceed two years 
for Phase I (R43 or R41) grant and three years for a Phase II (R44 or 
R42) grant.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  

This PA must be read in conjunction with the Omnibus Solicitation of the 
Public Health Service for Phase I SBIR/STTR Grant Applications found at 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf 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 apply. 

FUNDS AVAILABLE

The estimated budget available for support of SBIR/STTR grants in 
Biodefense and Emerging Infectious Diseases is $35,000,000 for Fiscal 
Year 2003. Future year amounts will depend on annual appropriations.

ELIGIBLE INSTITUTIONS 

Eligibility requirements for Phase I and Phase II grants are found at 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and 
http://grants.nih.gov/grants/funding/sbir2/index.htm respectively. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Eligibility criteria for principal investigators can be found at 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and 
http://grants.nih.gov/grants/funding/sbir2/index.htm

SPECIAL REQUIREMENTS 

MILESTONES

As consistent with the Omnibus Solicitation, Phase II SBIR and STTR 
applications must be performance based, and include a critical path and 
scientific milestones for product development to be completed during the 
project period.  A milestone is defined as a specific area of research 
that must be completed before additional research endeavors can be 
started.  Examples of milestones include, but are not limited to: 
completion of a prototype of a diagnostic tool; submission of an IND to 
FDA; initiation of a clinical trial.     

CLINICAL TERMS OF AWARD

When clinical studies or trials 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.  Terms and Conditions of Award will be included with 
awards.  When clinical studies or trials 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://grants2.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.

A mandatory milestone is the approval of the final clinical protocol by 
NIAID prior to the start of the clinical trial. Phase I applicants, who 
anticipate that their Phase I application will contain or comprise a 
clinical trial, can include a budget item in the Phase I application to 
assist in the preparation of the clinical protocol for the Phase II 
application. Phase II applications that contain or comprise a clinical 
trial should also include a budget item for preparation of a clinical 
protocol.  Protocol development must be consistent with Federal and 
NIAID specific regulations governing the conduct of human subjects 
research (http://www.hhs.gov/ohrp/assurances/assurances_index.html).  Potential 
applicants are encouraged to contact appropriate NIAID program staff 
concerning this policy.

WHERE TO SEND INQUIRIES

We strongly encourage your inquiries concerning this PA and welcome the 
opportunity to clarify any issues or questions from potential 
applicants. 

o Direct inquires regarding scientific, technical and programmatic 
issues to:

Dr. Barbara Mulach
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 3266, MSC-7630
6700-B Rockledge Drive
Bethesda, MD  20892-7630
Telephone:  (301) 496-1884
FAX:  (301) 480-4528
Email:  bmulach@niaid.nih.gov 

o Direct inquires regarding fiscal matters to:

Ms. Theresa Mercogliano
Grants Management Specialist
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Rm. 2261, MSC 7614
Bethesda, MD  20892-7614
Bethesda, MD  20817-7614 (for express/courier service)
Telephone:  (301) 402-5512
FAX:  (301) 480-3780
Email:  tmercoglia@niaid.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format. Please refer to Chapter VI of the PHS 398 
instructions when preparing an SBIR or STTR application. PHS 398 forms 
specific to SBIR/STTR applications are available at: 
http://grants.nih.gov/grants/funding/phs398/398_SBIRSTTRforms.doc.  For 
further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be received by or mailed on 
or before the receipt dates described at 
http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm. The 
CSR will not accept any application in response to this PA 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 a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.  

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 an appropriate National Advisory 
Council (there is no guarantee that all will be assigned to NIAID, 
hence "assigned on the basis of established PHS guidelines" above)
	
REVIEW CRITERIA

The review criteria for SBIR and STTR applications are found at:
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_SBIR
_STTR_app.htm.

PHASE I APPLICATION REVIEW CRITERIA
SIGNIFICANCE 
Does the proposed project have commercial potential to lead to a 
marketable product or process? Does this study address an important 
problem? 
What may be the anticipated commercial and societal benefits of the 
proposed activity? 
If the aims of the application are achieved, how will scientific 
knowledge be advanced? 
Does the proposal lead to enabling technologies (e.g., instrumentation, 
software) for further discoveries?  
Will the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs? 
APPROACH 
Are the conceptual framework, design, methods, and analyses adequately 
developed, well-integrated, and appropriate to the aims of the project? 
Is the proposed plan a sound approach for establishing technical and 
commercial feasibility 
Does the applicant acknowledge potential problem areas and consider 
alternative strategies?  
Are the milestones and evaluation procedures appropriate? 
INNOVATION 
Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies? 
Are the aims original and innovative? 
INVESTIGATORS 
Is the Principal Investigator capable of coordinating and managing the 
proposed SBIR/STTR?  
Is the work proposed appropriate to the experience level of the 
Principal Investigator and other researchers, including consultants and 
subcontractors (if any)? 
Are the relationships of the key personnel to the small business and to 
other institutions appropriate for the work proposed?" 
ENVIRONMENT 
Is there sufficient access to resources (e.g., equipment, facilities)?  
Does the scientific and technological 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 environment or employ useful collaborative arrangements? 
IN ACCORDANCE WITH NIH POLICY, THE FOLLOWING CRITERIA WILL BE APPLIED TO 
ALL APPLICATIONS: 

BIOHAZARDS 
Is the use of materials or procedures that are potentially hazardous to 
research personnel and/or the environment proposed?  
Is the proposed protection adequate? 
ANIMAL WELFARE 
If vertebrate animals are involved, are adequate plans proposed for 
their care and use?  
Are the applicant's responses to the five required points appropriate? 
Will the procedures be limited to those that are unavoidable in the 
conduct of scientifically sound research? 
BUDGET  
For all applications, is the percent effort listed for the PI 
appropriate for the work proposed? 
On applications requesting up to $100,000 total costs, is the overall 
budget realistic and justified in terms of the aims and methods 
proposed? 
On applications requesting over $100,000 in total costs, is each budget 
category realistic and justified in terms of the aims and methods?  
In accordance with NIH policy, all applications will also be reviewed 
with respect to the following: 
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS - for all studies 
involving human subjects. See "Guidance for Preparing the Human Subjects 
Research Section."  
If an exemption is claimed, is it appropriate for the work proposed? If 
no exemption is claimed, are the applicant's responses to the six 
required points appropriate? 
Are human subjects placed at risk by the proposed study? If so, are the 
risks reasonable in relation to the anticipated benefits to the subjects 
and others? Are the risks reasonable in relation to the importance of 
the knowledge that reasonably may be expected to be gained? 
Are the plans proposed for the protection of human subjects adequate? 
INCLUSION OF WOMEN PLAN - for clinical research only. See instructions. 
Does the applicant propose a plan for the inclusion of both genders that 
will provide their appropriate representation? Does the applicant 
provide appropriate justification when representation is limited or 
absent? 
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants? 
INCLUSION OF MINORITIES PLAN - for clinical research only. See 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html 
Does the applicant propose a plan for the inclusion of minorities that 
will provide their appropriate representation? Does the applicant 
provide appropriate justification when representation is limited or 
absent?  
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants? 
INCLUSION OF CHILDREN PLAN- for all studies involving human subjects 
Does the applicant describe an acceptable plan in which the 
representation of children of all ages (under the age of 21) is 
scientifically appropriate and recruitment/retention is addressed 
realistically? 
If not, does the applicant provide an appropriate justification for 
their exclusion? 
DATA AND SAFETY MONITORING PLAN - for clinical trials only 
Does the applicant describe a Data and Safety Monitoring Plan that 
defines the general structure of the monitoring entity and mechanisms 
for reporting Adverse Events to the NIH and the IRB? 
PHASE II APPLICATION REVIEW CRITERIA
In addition to the above criteria: 
How well did the applicant demonstrate progress toward meeting the Phase 
I objectives, demonstrating feasibility, and providing a solid 
foundation for the proposed Phase II activity? 
Did the applicant submit a concise Product Development Plan that 
adequately addresses the four areas described in Section I, item 9, J? 
Does the project carry a high degree of commercial potential, as 
described in the Product Development Plan? 
AMENDED APPLICATIONS 
In addition to the above criteria, the following criteria will be 
applied to revised applications. 
Are the responses to comments from the previous SRG review adequate? 
Are the improvements in the revised application appropriate? 
PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA 
For Phase I/Phase II Fast Track applications, the following criteria 
also will be applied: 
Does the Phase I application specify clear, appropriate, measurable 
goals (milestones) that should be achieved prior to initiating Phase II? 
Did the applicant submit a concise Product Development Plan that 
adequately addresses the four areas described in Section I, item 9, J? 
To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private sector 
or non-SBIR/STTR funding sources that would enhance the likelihood for 
commercialization? 
Does the project carry a high degree of commercial potential, as 
described in the Product Development Plan? 
Phase I and Phase II Fast-Track applications that satisfy all of the 
review criteria will receive a single rating. Failure to provide clear, 
measurable goals may be sufficient reason for the scientific review 
group to exclude the Phase II application from Fast-Track review.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND 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://grants.nih.gov/grants/stem_cells.htm 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.

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 PA 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 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.

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.

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