MEASUREMENT TOOLS FOR ALTERED AUTONOMIC FUNCTION IN SPINAL CORD INJURY AND DIABETES: SBIR/STTR RELEASE DATE: July 1, 2004 RFA NUMBER: RFA-HD-04-018 EXPIRATION DATE: October 22, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865, 93.847 LETTER OF INTENT RECEIPT DATE: September 21, 2004 APPLICATION RECEIPT DATE: October 21, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Project Period and Amount of Award o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations NOTICE: This Request for Application (RFA) 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 within the SBIR/STTR Omnibus Solicitation apply with the following exceptions: o Special receipt date o Initial review convened by the NICHD Division of Scientific Review PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite small business grant applications to conduct research on measurement tools or devices for altered autonomic functions in persons with spinal cord injury (SCI) or diabetes mellitus. Critical disruptions or imbalances of autonomic function can result from SCI and diabetes and lead to serious, long- term conditions that negatively impact on survival, quality of life and neuronal repair after SCI. Although there has been an ongoing need for improved measurement tools or devices for changes in autonomic function, productive research in this area has been both difficult and nominal. Scientists and/or engineers are encouraged to address this underserved area with innovative research and technology for the development of user-friendly and reasonably priced tools and devices that are specifically designed for the clinic, laboratory and/or residence and will enable detection and/or assessment of changes in autonomic functions. These measurement tools could also be used for clinical trials and for the detection or assessment of other medical conditions. Approaches may include animal or human subject models and may focus on one or more specific autonomic functions. Applicants are strongly encouraged to include appropriate bioengineering and clinical collaborations to achieve clinically relevant tools or devices. Personnel with appropriate expertise should be involved in all phases of the proposed effort, including development of initial concepts and approaches, design of the tool or device, and fabrication and construction or validation of useful clinical measurement tools or devices for individuals with autonomic neuropathy. RESEARCH OBJECTIVES Background The autonomic nervous system (ANS) innervates every organ and regulates a vast array of functions, such as blood flow and pressure, body temperature, stress responses, and control for reflex responses via sensory messages from the skin and internal organs to the brain. Dysfunction of ANS can, therefore, manifest in the cardiovascular system as orthostatic hypotension, hypertension, and silent myocardial ischemia, in the gastrointestinal system as nausea, vomiting, constipation, and diarrhea, and in the genitourinary system as bladder and erectile dysfunction. Both spinal cord injury and diabetes can lead to autonomic dysfunction from different etiologies, but with overlapping signs and symptoms. The incidence of spinal cord injuries (SCI) is approximately 10,000 cases per year in the United States, with an increasing prevalence as persons with SCI survive longer and reach older ages. The spinal cord is an important regulator of the ANS and its injury can lead to an imbalance between the "fight or flight" activities of the sympathetic system and the "rest and digest" activities of the parasympathetic systems. SCI can result in secondary complications that include potentially life-threatening conditions such as autonomic dysreflexia with increased blood pressure, sweating, and other elevated autonomic reflexes. The responsiveness and timeliness of acute and chronic medical management of secondary complications can greatly affect patient outcome and the severity of the disabilities over time. Improved and more appropriate tools and devices that are designed for use in the clinic or residence could enable this medical management. An example of a beneficial tool would be a device designed for the clinic to accurately measure blood flow within the spinal cord for the purpose of assessing the environmental milieu over time and the changes in conditions that may affect dynamic processes such as neuronal repair and degeneration. Over 18 million Americans have diabetes and are at risk of developing complications from hyperglycemia and associated conditions. A common complication of diabetes is autonomic neuropathy which can produce symptoms of delayed gastric emptying, diarrhea, constipation, urine retention, and erectile dysfunction. For cardiac manifestations, diabetic autonomic neuropathy can be relatively asymptomatic, yet its presence can increase the five-year mortality rate by five fold for individuals with diabetes. However, despite its negative effect on survival and quality of life, diabetic autonomic neuropathy is poorly understood, under diagnosed and inadequately treated. One cause for this situation is the deficiency of objective measures of autonomic function. Standardization of most tests for genitourinary or gastrointestinal function or sweating, sympathetic skin responses or pupillary reflexes is lacking. Tests for cardiovascular autonomic neuropathy have been developed, but only for parasympathetic responses. Clinical studies to better understand this condition and clinical trials to test therapeutics need reliable, objective outcome measures. Although new or improved measurement tools are needed for autonomic dysfunction, the amount of productive research in this area is very small as reflected by the sparse literature and scarcity of NIH-funded projects. This initiative addresses the need for tools and technologies for clinicians (e.g., neurologists, endocrinologists, physiatrists, etc.) and researchers to collect meaningful measurements of autonomic functions in the clinical setting. Scope SBIR or STTR grant applications responsive to this initiative may include, but are not limited to, research projects with innovative designs or approaches for the development of measurement assessment tools or devices. Potential products should be capable of reliable and accurate detection, measurement, and/or data correlations of autonomic function(s) that are important for the care management and treatment of persons with SCI or diabetes. An important objective is for the proposed device to be affordable, user friendly, and designed for use in an unsupervised environment such as the home or extended care facility, a clinic, a medical office, or in a research laboratory. The proposed measurement tool may be developed to interface with an existing piece of equipment but should be specifically designed to address the needs of persons with SCI or diabetes. The scope of possible project areas may be broad due to the complexity of SCI or diabetes medical issues, but the proposed objectives must be feasible within the framework of the SBIR/STTR mechanism. It is acknowledged that to meet the objectives for some types of projects, studies may need to address complex physiological and technical issues. The design and development of a prototype device may require further research on the functional properties to be detected or measured, as well as extensive assessment and evaluation of the device. The long-range objectives may include approaches using animal models and/or human subjects. Proposed products may be directed toward the clinic, the home residence, or to the research laboratory with goals that will ultimately lead to useful clinical devices. Applications with multidisciplinary research projects should demonstrate the potential for integrative collaboration/consultation among a team of investigators such as bioengineer(s) and clinician(s) with an understanding of the complex and dynamic interactions of the autonomic nervous system in persons with SCI or diabetes. An informed justification of why and how the proposed tool or device could be beneficial for assessing the autonomic dysfunction or changes in persons with acute and/or chronic SCI or diabetes is expected. Essential to Phase I feasibility applications are adequate descriptions and rationale for the identified problem and objectives of the proposal, and clearly defined Phase I milestones and prospective Phase II goals. Responsive applications will include thorough and detailed descriptions and justifications for the chosen approaches, assessment criteria, evaluation procedures, and outcome measures for the tool or device. Consideration of alternative options for high-risk approaches is recommended. When animal or human subjects research is proposed, the application must thoroughly and completely address all of the pertinent issues described in the PHS 398 application instructions. An adequately focused project will have an expected scope and completion time that will be compatible with the NIH SBIR/STTR program. The following are examples of possible measurement tools and focus areas for consideration. This list is not meant to be a comprehensive or restrictive list of appropriate responses to this RFA, but merely examples of research and development needs: o Systems that include wearable devices that are specifically designed to monitor autonomic functions of individuals in unsupervised environments, such as the home and extended care facilities in order to identify clinically significant events. o Smart, wearable or implantable devices that remotely monitor important changes or dysfunction of the autonomic systems and/or provide data for an early prediction of pathophysiological changes or clinical outcomes. o Novel devices (e.g., imaging tools) or innovative modifications to existing technology that can detect and measure incremental blood flow changes in regions of the spinal cord and/or to correlate blood flow data with other physiological changes due to chronic or sporadic autonomic dysfunction. o Innovative tools that monitor and assess changes in autonomic functions, such as postural blood pressure or galvanic skin response, and correlate these changes with other physiological parameters during different states of stress, activity, spasticity, etc. o Innovative devices that measure and assess pain during variable states of activity, spasticity, or autonomic dysfunction and provide data that can be correlated with changes in other autonomic responses. o Innovative technologies for detecting and monitoring incremental changes in sensory function such as progressive gain or loss of sensation, or development of musculoskeletal, visceral or neuropathic pain symptoms. o Novel designs for measurement tools or devices that identify changes in a person's condition and indicate ongoing pathophysiological processes as he/she develops or ages over time. o Quantitative tests of autonomic dysfunction that can readily be used in an outpatient setting. These tests should give reliable results that are not only useful for determining progression in individual patients, but also for assessing dysfunction based on standardized results. Development of these tests or reliable surrogates for autonomic dysfunction is critical as outcome measures for drug trials to gain FDA approval of treatments for this condition. o Tests for detection and/or assessment of early signs of autonomic dysfunction. These tests are particularly needed for bladder dysfunction, which occurs in 37-50 percent of diabetic individuals, and gastrointestinal dysfunction, which has a large range of manifestations. Yet, for both of these complications, only complex, specialized tests that measure gross functional changes are available. o A measurement tool for rapid pre-operative screening for cardiovascular autonomic neuropathy to identify patients at risk for cardiovascular lability and hypothermia. Note: Although an ideal measurement tool for the clinic might have a universal design, it may be more feasible or appropriate to target the device with regard to specific conditions that may affect autonomic function, such as the level or severity of the SCI and the age range of the subjects. MECHANISM OF SUPPORT This RFA 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. The anticipated award date is July 1, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW SBIR/STTR applications using the standard receipt dates for NEW applications described in the current SBIR/STTR Omnibus Solicitation. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats. Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A and fee) or less, use the modular budget format. For applications requesting more than $100,000, use the non-modular budget format. Instructions for both are described in the current SBIR/STTR Omnibus Solicitation. 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. Except as otherwise stated in this RFA, awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, December 2003, available at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Applications may be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants. This RFA does NOT include the SBIR/STTR Fast-Track option as described in the SBIR/STTR Omnibus Solicitation and does not support Phase II SBIR or STTR mechanism. Upon successful completion of Phase I research funded by this RFA, the Phase II application must be a logical extension of the Phase I research and will be submitted using the standard receipt dates for new and competing continuation applications described in the current SBIR/STTR Omnibus Solicitation (http://grants.nih.gov/grants/funding/sbir.htm#sol). 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 awards. For this RFA, Phase I budgets up to $150,000 total costs per year and time periods up to one year for Phase I may be requested. Total costs include direct costs, F & A, and fee/profit. FUNDS AVAILABLE The NICHD intends to commit approximately $600,000 and the NIDDK intends to commit approximately $400,000 in FY 2005 to support five to eight new Phase I applications under the SBIR/STTR set-aside funding mechanism. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit SBIR/STTR 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 current 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 percent) 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 inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Nancy Shinowara, Ph.D. Spinal Cord & Musculoskeletal Disorders & Assistive Devices Program National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6838 FAX: (301) 402-0832 Email: shinowan@mail.nih.gov Teresa L. Z. Jones, M.D. Program Director for Diabetes Complications Division of Diabetes, Endocrinology and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 651, MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 435-2996 FAX: (301) 480-3503 Email: jonest@extra.niddk.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: John Chris Robey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6996 FAX: (301) 451-5510 Email: robeyj@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Nancy Shinowara, Ph.D. Spinal Cord & Musculoskeletal Disorders & Assistive Devices Program National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6838 FAX: (301) 402-0832 Email: shinowan@mail.nih.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) 710-0267, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.doc or http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) To expedite the review process, at the time of submission, send two additional copies of the application to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) RECEIPT OF APPLICATIONS: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Research (CSR) will not accept any application in response to this RFA 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 and assigned a priority score o Receive a written critique o Receive a second level review by the NICHD or NIDDK National Advisory Council. 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals within the context of the SBIR/STTR Program. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score: o Significance o Approach o Innovation o Investigator o Environment (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 considered in the determination of scientific merit and the priority score: o If the application includes a multidisciplinary team of investigators, does it demonstrate the potential for integrative collaboration/consultation among these investigators and an understanding of the complex and dynamic interactions of the autonomic nervous system in persons with SCI and/or diabetes? o Is there appropriate and informed justification of why and how the proposed tool or device could be beneficial for assessing the autonomic dysfunction or changes for persons with acute and/or chronic SCI or diabetes? 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.) 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. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 21, 2004 Application Receipt Date: October 21, 2004 Peer Review Date: March 2005 Council Review: June 2005 Earliest Anticipated Start Date: July 01, 2005 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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). 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 is 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. 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 RFA 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://grants.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 RFA 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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