SBIR ADVANCED TECHNOLOGY - NIAID (SBIR-AT-NIAID)

Release Date:  February 13, 2001 

PA NUMBER:  PA-01-052 (replaced by PA-04-127)
                      (see addendum NOT-AI-03-049)

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 ½" 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: gmilman@niaid.nih.gov 

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: pf49e@nih.gov

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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.