SBIR - DEVELOPMENT OF NEW TECHNOLOGIES AND PRODUCTS FOR DENTAL CLINICAL 
INFECTION CONTROL

RELEASE DATE:  March 21, 2002

PA NUMBER:  PA-02-089

EXPIRATION DATE:  March 31, 2004, unless reissued. 

National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov)

THIS 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 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

This announcement is to encourage small businesses to participate in the 
research and development of new approaches, tools, methods, devices, and 
biomaterials for dental clinical infection control. 

RESEARCH OBJECTIVES

Infectious diseases are now the world"s leading killer of children and young 
adults, accounting for more than 13 million deaths a year.  Infectious 
diseases in the general population directly impact dental patients and 
healthcare workers.  Cleanliness and proper sterilization techniques have 
been a part of dental practices for many years, but recently a number of 
disease-causing organisms such as HIV/AIDS, hepatitis B and C, and herpes 
viruses have made these techniques even more important.  While universal 
precautions are now standard in traditional dental practice, practitioners 
and patients would still benefit from new products and technologies that are 
more effective, more cost-effective and more convenient.  

In addition, health care providers in the military, as well as those in 
governmental and private relief organizations, must provide urgent and 
essential healthcare to underserved populations in a wide variety of non-
traditional settings.  Efforts to prevent infections among patients and 
healthcare workers in these non-traditional settings can be compromised by a 
host of factors including local disease prevalence (e.g. tuberculosis, HIV, 
HBV), lack of clean water, absence of modern facilities, equipment and 
supplies, and inadequate sanitation.  Medical and dental teams operating 
under field conditions must balance the need for adequate infection control 
and healthcare worker protection against the urgent needs of the population 
they seek to assist.  Stringent limitations on the size and weight of 
supplies and equipment - including sterilizers and liquid chemical germicides 
are often a fact of life for these care providers.

The development of new approaches, tools, methods, devices, and biomaterials 
for infection control and safe practice   in both traditional and non-
traditional settings   is the goal of this announcement.    

The following objectives would make appropriate topics for proposed projects. 
Areas of emphasis might include but are not limited to:

o  Develop low-cost effective devices and methodologies for the prevention 
and control of biofilms in dental unit water lines, 
o  Develop low-cost effective devices and methodologies for consistent 
delivery of water with microbial levels below 200 CFUs/ml,
o  Develop and test new chemical germicides that can be used in settings 
where there is no potable water, inconsistent electrical power and/or 
limited sterilization equipment,
o  Develop improved comfort and safety of eyewear and masks adequate to 
prevent exposure to infectious agents and particulate debris,
o  Develop a safety syringe which helps to protect dental healthcare workers 
from needlestick injuries,
o  Assess contents of and develop a basic health emergency kit for 
needlestick injuries,
o  Develop and test educational programs that can be accessed via the 
internet and other modes of current technology,
o  Develop and pilot-test curriculum regarding safety and infection control 
for oral health care volunteers and others who work in less than ideal 
conditions.

Applicants can propose other projects that are relevant to the purpose of 
this PA.

MECHANISM OF SUPPORT 

This PA will use the NIH SBIR award mechanism.  The objectives of the SBIR 
Program include stimulating technological innovation in the private sector, 
strengthening the role of small business in meeting Federal R/R&D needs, 
increasing private sector commercialization of innovations developed through 
Federal SBIR R&D, increasing small business participation in Federal R/R&D, 
and fostering and encouraging participation by socially and economically 
disadvantaged small business concerns and women-owned business concerns in 
the SBIR program.  

This PA must be read in conjunction with the current Omnibus Solicitation of 
the National Institutes of Health, Small Business Innovation Research (SBIR) 
and Small Business Technology Transfer (STTR) Grant Applications 
(http://grants.nih.gov/grants/
funding/sbirsttr1/index.pdf).  An SBIR 
application responding to this PA may be submitted as a Phase I, Phase II or 
Fast Track (Phase I/Phase II) application.  The Fast Track applications will 
benefit from expedited evaluation of progress following the Phase I 
feasibility study for transition to Phase II funding for expanded 
developmental work.

Support under the SBIR program is normally provided for six months/$100,000 
for Phase I and for two years/$750,000 for Phase II projects.

As an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.

ELIGIBLE INSTITUTIONS

Each organization submitting a grant application under the SBIR program must 
qualify as a small business concern. In determining whether an applicant is a 
small business concern, an assessment will be made of several factors, 
including whether or not it is independently owned and operated and whether 
or not it is an affiliate of a larger organization whose employees, when 
added to those of the applicant organization, exceed 500. In conducting this 
assessment, all appropriate factors will be considered, including common 
ownership, common management, and contractual relationships.

The following requirements must be met:
o Organized for profit
o At least 51% U.S.- owned and independently operated.
o Small Business located in the U.S.
o Principal Investigator"s primary employment with small business during 
project.
o 500 or fewer employees.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The primary employment of the Principal Investigator must be with the small 
business concern at the time of award and during the conduct of the proposed 
project. Primary employment means that more than one half of the Principal 
Investigator"s time is spent in the employ of the small business concern. 
Primary employment with a small business concern precludes full-time 
employment at another organization.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues.

o Direct your questions about scientific/research issues to:

Kevin S. Hardwick, DDS, MPH
Office of International Health 
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS13
Bethesda, MD  20892
Telephone:  301-594-2765
FAX:  301-402-7033
Email: kevin.hardwick@nih.gov

Eleni Kousvelari, DDS, DSc
Chief, Cellular and Molecular Biology, Physiology and
Biotechnology Branch
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN 18A
Bethesda, MD  20892
Phone:  (301) 594-2427
Email:  kousvelari@de45.nidr.nih.gov

o Direct your questions about financial or grants management matters to:

George Hausch, PhD
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44F
Bethesda, MD  20892-6402
Telephone:  301-594-2904
FAX:  301-480-8303
Email:  hauschg@de45.nidr.nih.gov

SUBMITTING AN APPLICATION

Detailed information regarding submitting SBIR grant applications is 
available on the NIH website at 
http://grants.nih.gov/grants/
funding/sbirsttr1/index.pdf

SBIR/STTR applicants must use the PHS 398 instructions and forms for all 
Phase I and Phase II applications. See http://grants.nih.gov/grants/forms.htm 
for links to the PHS 398 Application Instructions and new Fillable Forms. 
IMPORTANT NOTE: Applicants should refer to Chapter VI 
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing_SBIR_STTR_app.htm of the PHS 398 
instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html)
prior to preparing an SBIR or STTR application. 
Please note that Phase I applications with budgets of $100,000 or less total 
costs should use the Modular Budget Page and omit Form Pages 4 and 5. See   
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_SBIRSTTR_general_instructions.htm. For 
answers to frequently asked questions about using the new fillable forms, see 
FAQs: Revised PHS 398 and PHS 2590 Forms and Instructions at 
http://grants.nih.gov/grants/forms_faq.pdf.

For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 
GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on the standard SBIR application deadlines 
(April 1, August 1, December 1).  See http://grants.nih.gov/grants/dates.htm.  
Application deadlines are also indicated in the PHS 398 application kit.

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/submissionschedule.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 the appropriate national advisory council 
or board
	
REVIEW CRITERIA

See Specific SBIR Review Criteria at 
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_peer_review.htm#Research_Project.

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  

a. Does the proposed project have commercial potential to lead to a 
marketable product or process? Does this study address an important problem?
b. What may be the anticipated commercial and societal benefits of the 
proposed activity?
c. If the aims of the application are achieved, how will scientific knowledge 
be advanced?
d. Does the proposal lead to enabling technologies (e.g., instrumentation, 
software)for further discoveries?
e. Will the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs?
	
(2) APPROACH:  

a. Are the conceptual framework, design, methods, and analyses adequately 
developed, well-integrated, and appropriate to the aims of the project?
b. Is the proposed plan a sound approach for establishing technical and 
commercial feasibility
c. Does the applicant acknowledge potential problem areas and consider 
alternative strategies? 
d. Are the milestones and evaluation procedures appropriate?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR:
 
a. Is the Principal Investigator capable of coordinating and managing the 
proposed SBIR/STTR? 
b. Is the work proposed appropriate to the experience level of the 
Principal Investigator and other researchers, including consultants and 
subcontractors (ifany)?
c. Are the relationships of the key personnel to the small business and to 
other institutions appropriate for the work proposed?"

(5) ENVIRONMENT:
  
a. Is there sufficient access to resources (e.g., equipment, facilities)?
b. Does the scientific and technological environment in which the work will be 
done contribute to the probability of success?
c. Do the proposed experiments take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

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 

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.ht
m.  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.

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 Catalog of 
Federal Domestic Assistance No. 93.121, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.
http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html. 

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