and Human Services (HHS)
EXPIRED
SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID)
Release Date: February 13, 2001 (replaced by PA-04-127)
(see addendum NOT-AI-03-049)
PA NUMBER: PA-01-052
National Institute of Allergy and Infectious Diseases
Application Receipt Dates: 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-00-126 that
appeared in the July 26, 2000 issue of the NIH Guide. This program
announcement includes instructions for applications for funds in excess
of $500,000 annual total cost and new contact listings for inquiries.
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.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 also apply
to SBIR-AT-NIAID applications.
This PA 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.pdf 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 (Appendix A)
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf
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/index.pdf
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. SBIR-AT-NIAID Phase I applications may not exceed
25 single-spaced standard size (8 " x 11") pages, excluding Cover
letters; One-page "Introduction" required when submitting a revised
(amended) application; Biographical sketches (no more than 3 pages per
person); Letters of commitment from collaborators and consultants;
"Checklist" (Form Page 5);"Personal Data on Principal Investigator"
Form Page; and, if applicable, Second Year Budget Page (see below) and
Page(s) furnishing information required under "Prior SBIR/STTR Phase II
Awards. " Items A-D of the Phase I Research Plan are limited to 15
pages. The 25-page limit includes all other Form Pages and
"continuation" pages.
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.
o Page limitations. Items 1-4 of the Phase II RESEARCH PLAN are
limited to 25 pages. There is no further limitation on the total number
of pages for the entire Phase II application
http://grants.nih.gov/grants/funding/sbir2/index.htm.
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 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 and for improved diagnosis of infectious,
allergic, and immunologic diseases.
POLICY ON HUMAN SUBJECTS AND 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.
On October 1, 2000, NIH required education on the protection of human
research participants for all investigators submitting NIH applications
for grants or proposals for contracts or receiving new or non-competing
awards for research involving human subjects. Information about this
policy may be found at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Frequently asked questions regarding this
policy may be found at
(http://grants.nih.gov/grants/policy/hs_educ_faq.htm).
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
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 research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
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
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.
APPLICATION PROCEDURES
Applicants should follow the instructions for SBIR Phase I or Phase II
submission with the modifications as noted in this PA.
SBIR-AT-NIAID are NOT modular grant applications or awards. Complete
budget information must be submitted on the SBIR application forms.
Phase I SBIR Applicants requesting a budget period of more than 1 year
should follow the following procedures:
o Photocopy Form Page 3 "Budget for Phase I-Direct Costs Only", number
it Form Page "3a"
o Use Form Page 3 for the first year budget and title Form Page 3a
"Phase I - 2nd year budget." This page will not be counted against the
"25-page" total.
o Provide the appropriate/requested information in the narrative
justification (Form Page 4) for years 1 and 2
o Indicate on the Phase I Face page in Field 6, Dates of Project
Period, the dates for the entire project period (e.g., Nov, 15, 2000-
Nov. 15, 2002)
o Indicate on the Phase I Face Page in Field 7, the requested Direct
Costs for the entire project period and the Total Costs for the entire
project period (e.g. 2 years)
o The summary statement will reflect the recommended budget for the -01
year and -02 year.
Advice on Submitting Applications--Potential applicants are encouraged
to contact program staff for pre-application guidance and/or for more
specific information on the research topics described in this PA.
MAILING INSTRUCTIONS
The original application and five 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 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 the 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 unscore the application. AN APPLICANT FOR SBIR-AT-NIAID
FUNDING MUST JUSTIFY WHY THE PROPOSED PROJECT REQUIRES FUNDS IN EXCESS
OF THOSE NORMALLY PROVIDED FOR SBIR PROJECTS.
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:
Gregory Milman, Ph.D.
Director Office of Innovation and Special Programs
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, Room 2140 - MSC 7610
Bethesda, MD 20892-7610
Bethesda, MD 20817-7610 (for express/courier service)
Telephone: (301) 496-8666
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
Bethesda, MD 20817-7614 (for express/courier service)
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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