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MANUFACTURING PROCESSES OF MEDICAL, DENTAL, AND BIOLOGICAL TECHNOLOGIES (SBIR/STTR) RELEASE DATE: September 29, 2004 PA NUMBER: PA-04-161 EXPIRATION DATE: October 1, 2007, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Center for Disease Control and Prevention (CDC) (http://www.cdc.gov) Food and Drug Administration (FDA) (http://www.fda.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Eye Institute (NEI) (http://www.nei.nih.gov/) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute of Nursing Research (NINR) (http://www.nih.gov/ninr/) National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov) National Library of Medicine (NLM) (http://www.nlm.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.394 (NCI); 93.867 (NEI); 93.233, 93.837,93.838, 93.839 (NHLBI); 93.866 (NIA); 93.273 (NIAAA); 93.856; (NIAID); 93.286, 93.287 (NIBIB); 93.173 (NIDCD); 93.121; (NIDCR); 93.849, 93.848 and 93.847 (NIDDK); 93.279 (NIDA); 93.113, 93.114, 93.115 (NIEHS); 93.859 (NIGMS); 93.242 (NIMH); 93.853 (NINDS); 93.361 (NINR); 93.879 (NLM); 93.103 (FDA); 93.061 (CDC) APPLICATION RECEIPT DATE(S): Applications submitted in response to this program announcement will be accepted at the standard application deadlines [April 1, August 1, December 1] THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Funds Available (include for PAS only) o Project Period and Amount of Award o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Receipt and Review Schedule o Required Federal Citations NOTICE: This program announcement (PA) must be read in conjunction with the current Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications. The solicitation (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions and review criteria within the current SBIR/STTR Omnibus Solicitation apply. PURPOSE OF THE PA On February 26, 2004, Executive Order 13329 (http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov /2004/pdf/04-4436.pdf)was signed by President George W. Bush requiring SBIR/STTR agencies, to the extent permitted by law and in a manner consistent with the mission of the Department, to give high priority within the SBIR and STTR programs to manufacturing-related research and development (R&D;). In response to this Executive Order, NIH, CDC, and the FDA are expanding their foci by encouraging biomedical research related to advanced processing, manufacturing processes, equipment and systems, and manufacturing workforce skills and protection. RESEARCH OBJECTIVES The NIH, CDC, and FDA encourage research related to advanced processing in the manufacture of biomedical products and the implementation of new technologies in medical care. New methods, procedures, measures, and controls are needed for manufacturing a broad range of technologies and products with unsurpassed quality and to lower manufacturing costs for existing and/or new processes. Research is also encouraged that can contribute to the containment and reduction of health care costs and that can improve the cost effectiveness, quality, and accessibility of the health care system. Manufacturing-related R&D; is defined as: Manufacturing innovation is fostered by research and development of technologies that are aimed at increasing the competitive capability of manufacturing concerns. Broadly speaking, manufacturing-related R&D; encompasses improvements in existing methods or processes, or wholly new processes, machines or systems. Four main areas include: Unit process level technologies that create or improve manufacturing processes, including (1) fundamental improvements in existing manufacturing processes that deliver substantial productivity, quality, or environmental benefits, and (2) development of new manufacturing processes, including new materials, coatings, methods, and practices associated with these processes. Machine level technologies that create or improve manufacturing equipment, including (1) improvements in capital equipment that create increased capability (such as accuracy or repeatability), increased capacity (through productivity improvements or cost reduction), or increased environmental efficiency (safety, energy efficiency, environmental impact), and (2) new apparatus and equipment for manufacturing, including additive and subtractive manufacturing, deformation and molding, assembly and test, semiconductor fabrication, and nanotechnology. Systems level technologies for innovation in the manufacturing enterprise, including (1) advances in controls, sensors, networks, and other information technologies that improve the quality and productivity of manufacturing cells, lines, systems, and facilities; (2) innovation in extended enterprise functions critical to manufacturing, such as quality systems, resource management, supply chain integration, and distribution, scheduling and tracking; and (3) technologies that enable integrated and collaborative product and process development, including computer-aided and expert systems for design, tolerancing, process and materials selection, life-cycle cost estimation, rapid prototyping, and tooling. Environment or societal level technologies that improve workforce abilities and manufacturing competitiveness, including (1) technologies for improved workforce health and safety, such as human factors and ergonomics; and (2) technologies that aid and improve workforce manufacturing skills and technical excellence, such as educational systems incorporating improved manufacturing knowledge and instructional methods Because manufacturing-related R&D; is extremely broad in scope, the following examples of research topics may be of interest but are not meant to be exhaustive. o Flexible computer-assisted integrated manufacturing equipment and intelligent processing equipment adaptable to the varied needs of biomedical research and medical care device and material production. o Systems engineering and management tools needed for the development of biomedical product manufacturing plants with particular emphasis on the requirements to meet GMP requirements for FDA approvals. o Technology for the manufacture of research instrumentation, such as highly sensitive, high resolution spectrometers, highly selective electrodes, microarray devices, and microfluidic devices. o Technology for the manufacture of clinical diagnostic devices and reagents. Technology for the manufacture of novel diagnostic imaging devices for both invasive and non-invasive techniques. o Technology for the manufacture and delivery of therapeutic drugs, including for example, synthetic process chemistry, separations methods, formulation, and dosage delivery. o Technology for the manufacture of implantable devices and materials, including drug delivery pumps, prosthetic organs, artificial tissues, electronic sensors and electrical stimulators. o Technology for the production of natural products derived from plant, animal, and microbial sources, such as antibiotics, anticancer drugs, and other therapeutic agents, and useful synthetic starting materials. o Technology for the production and isolation of biotechnology products, such as proteins, antibodies, nucleic acids, vaccines, and vectors for genetic engineering and gene therapy. o Technology for the production of new materials relevant to biomedical research and medical care delivery, including nanomaterials, carbon fibers, polymeric materials, self-assembled monolayers, controlled size, shape, and porosity particles, filters, membranes, silicon substrates for microarrays, superconducting materials for NMR and MRI magnets, and implantable magnetic materials for external magnetic manipulation. o Technology for manufacture of medical device power sources, such as high energy density, long life-time batteries, solar cells, and fuel cells. o Technology for the fabrication of medical care instruments and devices such as minimally invasive and magnetic field tolerant surgical instruments, orthopedic implants, prostheses, and enabling devices for the injured and disabled. o Rapid prototyping and manufacture technology suitable for remote site and on demand production processes. o Technology to promote the recovery, reuse, and remanufacture (recycling) of medical materials and equipment. o Technology for the manufacture of biomedically specialized computational and information technology equipment and software. o Development of innovative products that facilitate the safety and health training of hazardous materials workers, emergency responders, and skilled support personnel. (See also NIEHS Worker Education and Training Program at http://www.niehs.nih.gov/wetp/home.htm. Many specific topics listed in Part II of the NIH SBIR/STTR Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration (http://grants.nih.gov/grants/funding/sbirsttr1/2004-2_SBIR-STTR-topics.pdf) could also be considered relevant to manufacturing. Potential applicants are encouraged to review this material for additional indications of NIH areas of interest. MECHANISM(S) OF SUPPORT This PA uses the SBIR and STTR mechanisms, which are set-aside programs. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing- continuation applications based on this project will compete with all SBIR/STTR applications and will be reviewed according to the customary peer review procedures. This PA uses just-in-time concepts. It also uses the modular budgeting format. Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A; and fee) or less, use the modular format and instructions as described in the current SBIR/STTR Omnibus Solicitation. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#matching_or _cost_sharing Applications may be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus Solicitation. 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 Phase II application must be a logical extension of the Phase I research but not necessarily a Phase I project supported in response to this PA. PROJECT PERIOD AND AMOUNT OF AWARD The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of funding support and project duration periods for SBIR and STTR Phase I and Phase II awards. ELIGIBLE INSTITUTIONS: Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the SBIR/STTR Omnibus Solicitation. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. On an SBIR application, the principal investigator must have his/her primary employment (more than 50%) with the small business at the time of award and for the duration of the project. The PI on an STTR application may be employed with the small business concern or the participating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to 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: Michael-David Kerns, Ph.D. National Institute on Aging Gateway Building, Room 2C218, 7201 Wisconsin Avenue, Bethesda, MD 20892-9205; Telephone: (301) 496-9322 FAX: (301) 402-2945 Email: kernsm@mail.nih.gov Karen P. Peterson, Ph.D. National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, MSC 9304 Bethesda, MD 20892-9304 Telephone: (301) 451-3883 FAX: (301) 443-7043 Email: kpeterso@mail.nih.gov Gregory Milman, Ph.D. National Institute of Allergy and Infectious Diseases Division of Extramural Activities Room 2153, MSC-7610 6700-B Rockledge Drive Bethesda, MD 20892-7610 Telephone (301) 496-8666 FAX: (301) 402-0369 Email: gm16s@nih.gov Todd Merchak National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Blvd., MSC 5477 Bethesda, MD 20892-5477 Telephone: (301) 496-8592 FAX: (301) 480-1614 Email: merchakt@mail.nih.gov Greg Downing, Ph.D. National Cancer Institute Office of Technology and Industrial Relations 31 Center Drive; Room 10A52, MSC 2580 Bethesda, MD 20852 Telephone: (301) 496-1550 FAX: 496-7807 Email: downing@mail.nih.gov Cathrine Sasek, Ph.D. National Institute on Drug Abuse 6001 Executive Blvd, MSC 9591 Bethesda, MD 20892-9591 Telephone: (301) 443-6071 FAX: (301) 443-6277 Email: csasek@nih.gov Lynn E. Luethke, Ph.D. National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd., MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: lynn_luethkel@nidcd.nih.gov Rosemarie Hunziker, Ph.D. National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4An.24K Bethesda, MD 20892-6402 Telephone: (301) 451-3888 FAX: (301) 480-8318 E-mail: hunzikerr@nidcr.nih.gov Sanford A. Garfield, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 685 Bethesda, MD 20892 Telephone: (301) 594-8803 FAX: (301) 402-6271 Email: sg50o@nih.gov Jerry Heindel, Ph.D. National Institute of Environmental Health Sciences 79 T.W. Alexander Drive,4401 Bldg, 3rd Floor Research Triangle Park, NC, 27709 Telephone: (919) 541-0781 FAX (919)541-5064 Email: heindelj@niehs.nih.gov Ralph J. Helmsen, Ph.D. National Eye Institute Suite 1300, 5635 Fishers Lane, MSC 9300 Bethesda, MD 20892-9300 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: rjh@nei.nih.gov Peter Preusch, Ph.D. National Institute of General Medical Sciences 45 Center Drive; Room 2As.43j; MSC 6200 Bethesda, MD 20892 Telephone: (301) 594-5938 FAX: (301) 480-2802 Email: preuschp@nigms.nih.gov Bishow Adhikari, Ph.D. National Heart, Lung and Blood Institute 6701 Rockledge Dr, Room 9161; MSC 7940 Bethesda, MD 20892 Telephone: (301) 435-0513 FAX: 301-480-1335 Email: adhikarb@mail.nih.gov Margaret Grabb, Ph.D. National Institute of Mental Health 6001 Executive Blvd., Room 7204, MSC 9645 Bethesda, MD 20892 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mgrabb@mail.nih.gov Thomas Miller, Ph.D. National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2139 Bethesda, MD 20892-9527 Telephone: (301) 496-1779 FAX: (301) 402-1501 Email: millert@ninds.nih.gov Yvonne Bryan, Ph.D. National Institute of Nursing Research 6701 Democracy Blvd., Room 710; MSC 4870 Bethesda, MD 20892-0001 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: bryany@mail.nih.gov Amy L. Swain, Ph.D. National Center for Research Resources 6701 Democracy Blvd., MSC 4874 Bethesda, MD 20879-4874 Telephone: (301) 435-0752 FAX: 301-402-3659 Email: swaina@mail.nih.gov Shan S. Wong, Ph.D. National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 496-7498 FAX: (301) 480-3621 Email: sw196c@nih.gov. Charles Friedman, Ph.D. National Library of Medicine 6705 Rockledge Drive, Room 301 Bethesda, MD 20892 Telephone: (301) 594-4927 FAX: 301-402-2951 Email: friedmc1@mail.nih.gov Curtis L. Bryant Centers for Disease Control and Prevention Procurement & Grants Office 2920 Brandywine Road Atlanta, GA 30341 Telephone: (770) 488-2806 FAX: (770) 488-2828 Email: ckb9@cdc.gov Rosemary Springer Food and Drug Administration Division of Contracts and Grants Management 5600 Fishers Lane, HFA-531 Rockville, MD 20857 Telephone: (301) 827-7182 FAX: (301) 827-7101 Email: rspringe@oc.fda.gov o Direct your questions about financial or grants management matters to: Ms. Linda Whipp National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippl@mail.nih.gov Ms. Judy Fox National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane, MSC 9304 Bethesda, MD 20892-9304 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: jfox@mail.nih.gov Ms. Pamela Fleming National Institute of Allergy and Infectious Diseases Division of Extramural Activities Room 2119, MSC 7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-6580 FAX: (301) 480-3780 Email: pf49e@nih.gov Ms. Florence Turska National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Blvd., MSC 5469 Bethesda, MD 20892-5469 Telephone: (301) 496-9314 FAX: (301) 480-5735 Email: turskaf@mail.nih.gov Mr. Ted Williams National Cancer Institute 6120 Exec Blvd, Room 243; MSC 7150 Bethesda, MD 20892 Telephone: (301) 496-8785 FAX: (301) 496-8601 Email: williate@mail.nih.gov Mr. Gary Fleming National Institute on Drug Abuse 6101 Executive Blvd, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov. Mr. Christopher Myers National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd., Room 400B, MSC 7180 Bethesda, MD 20892 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: myers@mail.nih.gov Ms. Mary Daley National Institute of Dental and Craniofacial Research 45 Center Drive Bldg. 45, Rm. 4AN44B; MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4808 FAX: (301) 480-3562 Email: md74u@nih.gov Ms. Helen Y. Ling National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 732 Bethesda, MD 20892 Telephone: (301) 594-8857 FAX: (301) 480-3504 Email: lingh@extra.niddk.nih.gov Mr. Dwight Dolby National Institute of Environmental Health Sciences 79 T.W. Alexander Drive, 4401 Bldg, 3rd Floor Research Triangle Park, NC, 27709 Telephone: (919) 541-7824 FAX: (919) 541-2860 Email: dolby@niehs.nih.gov Mr. William Darby National Eye Institute Suite 1300, 5635 Fishers Lane, MSC 9300 Bethesda, MD 20892-9300 Telephone: (301) 451-2020 FAX: (301) 496-9997 Email: wwd@nei.nih.gov Ms. Patrice Molnar National Institute of General Medical Sciences 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 534-5136 FAX: (301) 480-2554 E-Mail: molnarp@nigms.nih.gov Ms. Suzanne White National Heart, Lung and Blood Institute 6701 Rockledge Dr.; MSC 7926 Bethesda, MD 20892 Telephone: (301) 435-0144 FAX: (301) 480-3310 Email: sw52h@nih.gov Mr. Brian Albertini National Institute of Mental Health 6001 Executive Blvd., MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: albertib2@mail.nih.gov Ms. Kathleen Howe National Institute of Neurological Disorders and Stroke 6001 Exec Blvd.; MSC 9531 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: howek@ninds.nih.gov Ms. Teresa Farris Marquette National Institute of Nursing Research 6701 Democracy Blvd, Room 710; MSC 4870 Bethesda, MD 20892 Telephone: (301) 594-2177 FAX: (301) 402-4502 Email: tm275a@nih.gov Ms. Alice Chi National Center for Research Resources 6701 Democracy Blvd., MSC 4874 Bethesda, MD 20879-4874 Telephone: (301) 435-0857 FAX: (301) 435-480-3777 Email: ChiA@mail.nih.gov Mr. George Tucker National Center for Complementary and Alternative Medicine 6707 Democracy Blvd.; MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-9102 FAX: (301) 480-1552 Email: gt35v@nih.gov. Mr. Dwight Mowery National Library of Medicine 6705 Rockledge Drive, Suite 301 Bethesda, MD 20892 Telephone: (301) 496-4221 FAX 301 402-0421 Email: moweryd@mail.nih.gov Ms. Sharron Orum Centers for Disease Control and Prevention 2920 Brandywine Road Atlanta, GA 30341 Telephone: (770) 488-2716 FAX: (770) 488-2777 Email: sorum@cdc.gov Ms. Rosemary Springer Food and Drug Administration Division of Contracts and Grants Management 5600 Fishers Lane, HFA-531 Rockville, MD 20857 Telephone: (301) 827-7182 FAX: (301) 827-7101 Email: rspringe@oc.fda.gov SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for all SBIR/STTR Phase I, Phase II and Fast-Track applications (new and revised.) Effective October 1, 2003, applications must have a DUN and Bradstreet (D&B;) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information for advice and preparation of the application can be obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will return applications that are not submitted on the 5/2001 version of the PHS 398. For further assistance contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the face page of the application. 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 (FOR USPS EXPRESS or REGULAR MAIL) Bethesda, MD 20817 (FOR EXPRESS/COURIER NON-USPS SERVICE) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described on the first page of this program announcement. 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA that are complete will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 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 written critique o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA 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 the 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 ALL SBIR/STTR APPLICATIONS 1. Significance: Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? 3. Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? 4. Investigators: Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? 5. Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? 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, the following items will be applied to ALL applications in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See additional information and criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 additional information and Inclusion Criteria in the sections on Federal Citations, below). Human Subjects: 1. Protection of Human Subjects from Research Risks - for all studies involving human subjects. See instructions and "Guidance for Preparing the Human Subjects Research Section.” If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate? Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained? Are the plans proposed for the protection of human subjects adequate? 2. Inclusion of Women Plan - for clinical research only. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 3. Inclusion of Minorities Plan - for clinical research only. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 4. Inclusion of Children Plan- for all studies involving human subjects. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion? 5. Data and Safety Monitoring Plan – for clinical trials only. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB? CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the required five items described under Vertebrate Animals (section f of the Research Plan instructions) will be assessed. BIOHAZARDS: Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate? ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be considered by reviewers but will not be included in the determination of scientific merit. SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (http://grants.nih.gov/grants/policy/data_sharing) BUDGET: The reasonableness of the proposed budget may be considered. For all applications, is the percent effort listed for the PI appropriate for the work proposed? On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed? On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods? PERIOD OF SUPPORT: The appropriateness of the requested period of support in relation to the proposed research. PHASE II APPLICATIONS: In addition to the above review criteria: 1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? 2. Did the applicant submit a concise Commercialization Plan that adequately addresses the seven areas described in the Research Plan item J? 3. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? AMENDED APPLICATIONS In addition to the above criteria, the following criteria will be applied to revised applications. 1. Are the responses to comments from the previous SRG review adequate? 2. Are the improvements in the revised application appropriate? PHASE I/PHASE II FAST-TRACK APPLICATION REVIEW CRITERIA For Phase I/Phase II Fast Track applications, the following criteria also will be applied: 1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? 2. Did the applicant submit a concise Commercialization Plan that adequately addresses the seven areas described in the Research Plan, item J? 3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/ STTR funding sources that would enhance the likelihood for commercialization? 4. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended SBIR and STTR 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 For FAST-TRACK applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved. RECEIPT AND REVIEW SCHEDULE See http://grants1.nih.gov/grants/funding/sbirsttr_receipt_dates.htm REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 "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.htm. 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. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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.
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