NIDDK EXPANDED AWARDS FOR SBIR-AT-NIDDK

Release Date:  May 10, 2001

PA NUMBER:  PA-01-093

National Institute of Diabetes and Digestive and Kidney Diseases

PURPOSE

The NIDDK encourages the small business community to participate in the 
research and development of cutting-edge approaches, technologies, 
tools, methods, devices, cells, biomolecules and biomaterials that can 
be used in the study and/or treatment of diseases in the mission of the 
NIDDK.  The NIDDK supports research pertaining to diabetes; endocrine 
and metabolic diseases; nutritional disorders, obesity, and digestive 
diseases; and kidney, urologic and hematologic diseases.  Because the 
length of time and cost of research involving the development of 
advanced technologies may exceed those normally awarded for SBIR 
grants, this announcement serves to expand the allowable time and 
funding level requested for SBIR grants assigned to NIDDK (SBIR-AT-
NIDDK).

SBIR-AT-NIDDK applications are not appropriate for all SBIR 
applications, but are an option for projects proposing the development 
of advanced technologies as defined below.

Advanced technology projects, for the purpose of the SBIR-AT-NIDDK 
program are defined as those that are aimed at developing cutting-edge 
therapeutic or diagnostic devices, tests, and reagents, as well as 
projects that involve testing of diagnostics, drugs or therapeutic 
devices in humans and non-human primates.  NIDDK invites applications 
for SBIR-AT-NIDDK 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-NIDDK applications.

This PA provides examples of advanced technology areas in which NIDDK 
will entertain SBIR applications and provides NIDDK's interpretation 
and clarification of instructions relating to total cost, and dates of 
project period.
   
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-NIDDK), is related to one or more the priority areas including 
Diabetes and other Chronic Disabling Conditions.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

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 
http://grants.nih.gov/grants/funding/phs398/phs398.html

o Project Period and Amount of Award.

Because the length of time and cost of research involving advanced 
technology projects often exceed those routinely awarded for SBIR 
grants, NIDDK will entertain well justified Phase I applications for an 
SBIR-AT-NIDDK award with a project period up to two years and a budget 
not to exceed a total cost of $250,000 per year (direct costs, indirect 
costs and fixed fee).  See section, BUDGET REQUESTS GREATER THAN 
$100,000 TOTAL COSTS, in 
http://grants.nih.gov/grants/funding/phs398/phs398.html 

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, NIDDK will entertain well-justified Phase I 
applications for an SBIR-AT-NIDDK award with greater than 33% 
contractual costs when those costs are necessary to support clinical 
studies and trials.

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/STTR awards.  The 
previously funded Phase I award need not be an SBIR-AT-NIDDK 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, NIDDK will entertain well-justified Phase II applications for 
an SBIR-AT-NIDDK award with a project period up to three years and a 
budget not to exceed total costs of $650,000 per year (direct costs, 
indirect costs and fixed fee).

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, NIDDK will entertain well-justified Phase II 
applications for an SBIR-AT-NIDDK award with greater than 50% 
contractual costs when those costs are necessary to support clinical 
studies and trials.

MECHANISM OF SUPPORT-FAST TRACK

Applications for fast track SBIR grants should be prepared following 
the instructions for Phase I applications at
http://grants.nih.gov/grants/funding/phs398/phs398.html, 
Phase II applications at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and the 
additional instructions at 
http://grants.nih.gov/grants/funding/sbirsttr1/sbirsttrft-rs.pdf

The total duration of Phase I and Phase II cannot exceed 5 years for 
fast track applications, and the budget levels described above for 
Phase I and Phase II applications apply. 

RESEARCH OBJECTIVES AND SCOPE

Background

The SBIR program consists of the following three phases.  Only the 
first two phases will be considered for support:

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.  Phase III occurs without 
additional Federal funding.
Objective and Scope
  
The time and budget guidelines for SBIR applications can be prohibitive 
for projects where advanced technologies are developed and/or applied 
to treatment and research on diseases in NIDDK’s mission. Advanced 
technology projects are defined as those that develop or employ high-
cost new technologies or carry out high-cost, long-term toxicity or 
efficacy studies in animals, or clinical studies in human.  NIDDK 
invites applications for SBIR-AT-NIDDK awards in the following areas:

o Identification, isolation, characterization and propagation of adult 
human stem/progenitor cells of the endocrine and exocrine pancreas, 
liver, gut, kidney, bladder, prostate, and hematopoietic lineages.

o Development of resources for progenitor cell research, including 
reliable and convenient clonegenic assays for stem cell populations in 
pancreas, liver, stomach/intestine, kidney, bladder, bone, and 
hematopoietic tissues.  Development of broadly applicable methods for 
amplifying mRNAs from single or small numbers of recovered progenitor 
cells so that gene expression profiling can be performed, as well as 
protein profiling.  Development of methods for manipulating gene 
expression in progenitor cells and their immediate descendents.

o Development of surrogate markers for identification of disease states 
and disease progression, hepatotoxicity, or for use as endpoints in 
clinical studies of diseases within NIDDK’s mission.

o Identification, generation and characterization of new receptor 
ligands and/or partial receptor agonists or antagonists with 
therapeutic potential for treatment of the diseases within NIDDK’s 
mission.  For example, use of rational drug design or high throughput 
screening methods to develop agents that interact with L-type calcium 
channels and can be used to treat diseases of the bowel.    

o Development or application of imaging techniques to assess 
physiologic or functional changes in liver, kidney, gut, prostate, 
bladder or pancreas during disease progression or acute environmental 
insult to these organs.  For example, the NIDDK encourages development 
of methods to measure pancreatic beta cell mass, inflammation or 
perfusion; to measure iron content of the liver and to allow non-
invasive detection of fibrotic, necrotic and fatty tissue in this 
organ; to measure progression of kidney disease; and to develop methods 
to differentiate between benign and malignant parenchymal diseases.

o Initiation and/or enhancement of research in tissue engineering for 
the development of pancreas or pancreatic islets, liver, gut and 
kidney.  The NIDDK encourages research to ascertain angiogenic, 
adhesion or other factors necessary to promote the development of these 
organs or tissues in vitro and in vivo.  In addition, the requirements 
of other types of cells must be examined.  For example, endothelial 
cells or exocrine cells may synergize with the protein factors or 
endocrine cells to establish a pancreas or islet “organ” independent of 
or contained within the pancreas of a person with diabetes.
  
o Development of devices to aid in the diagnosis and treatment of 
diabetes, endocrine and metabolic diseases; nutritional disorders, 
liver and digestive diseases, motility disorders; and kidney, urologic 
and hematologic diseases.  The NIDDK encourages development and testing 
of the following: non-invasive or minimally invasive methods of 
monitoring blood glucose; improved and miniaturized insulin delivery 
systems; integration of sensor and delivery systems to create an 
artificial pancreas (closed-loop system); devices to accurately assess 
energy intake and/or energy expenditure; and non-invasive measures of 
hepatotoxicity.    

o Development of rapid and sensitive DNA chip technology and protein-
protein interaction chip technology to help understand the physiology 
of disease conditions, and for ultimate use in the diagnosis and 
treatment of diabetes and other endocrine disorders, and diseases of 
the blood, kidney, genitourinary and digestive tract, and their 
complications.  For example, the NIDDK encourages the development of 
methods to do the following:  measure the kinetics and levels of gene 
transciption and protein in beta cells, hepatocytes and cell 
populations present in the kidney, urinary bladder and prostate under 
different stimulatory condition, or in disease states; correlation of 
gene and protein expression with disease progression in humans and non-
human primates and rodent models of diabetes and obesity or during 
differentiation of stem/progenitor cells into differentiated cell types 
such as a beta cell, hepatocyte, hematopoietic cells, prostate urinary 
bladder and kidney.  Development, propagation and distribution of novel 
genes promoters and transgenic knock-out animals targeting processes 
involved in the development and/or function of pancreas, liver, 
intestine, urinary bladder, prostate, blood, and kidney.

Other advanced technology topics may be of interest to the NIDDK and 
may be appropriate for SBIR-AT-NIDDK.  

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 is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applicants should follow the instructions for SBIR Phase I, Phase II or 
fast-track submissions with the modifications as noted in this PA.

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.

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 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, SBIR-AT-NIDDK, PA—01-
072, 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.  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 
Scientific Review Groups (SRG) 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 II 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.
Applications for the SBIR-AT-NIDDK must justify why the project 
requires longer duration and a larger budget than 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 the research areas of the announcement, and the 
availability of funds. Applications will compete for available funds 
with all other favorably recommended SBIR applications assigned to the 
NIDDK.  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:

Dr. Carol Renfrew Haft
National Institute of Diabetes and Digestive and Kidney Diseases
Division of Diabetes, Endocrinology and Metabolic Diseases
6707 Democracy Blvd., Room 605 MSC-5460
Bethesda, MD  20892-5460
Bethesda, MD  20817 (for express/courier service)
Telephone:  (301) 594-7689
FAX:  (301) 480-3503
Email: haftC@extra.niddk.nih.gov

Dr. Judith Podskalny
National Institute of Diabetes and Digestive and Kidney Diseases
Division of Digestive Diseases and Nutrition
6707 Democracy Blvd., Room 667 MSC-5460
Bethesda, MD  20892-5460
Bethesda, MD  20817 (for express/courier service)
Telephone:  (301) 594-8876
FAX:  (301) 480-8300
Email:  jp53s@nih.gov

Dr. M. James Scherbenske
National Institute of Diabetes and Digestive and Kidney Diseases
Division of Kidney, Urologic and Hematologic Diseases
6707 Democracy Blvd., Room 613 MSC-5460
Bethesda, MD  20892-5460
Bethesda, MD  20817 (for express/courier service)
Telephone:  (301) 594-7719
FAX:  (301) 480-3510
Email:  js255f@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. David Mineo
Chief, Grants Management Officer
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 731 MSC-5460
Bethesda, MD 20892-5460
Telephone:  (301) 594-8854
FAX:  (301) 480-3504
Email: mineod@extra.niddk.nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.847, 93.848 and 93.849.  Awards are under authorization of the 
Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) 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 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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