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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