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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



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