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EXPANDING ACCESS TO MTBI TREATMENT FOR VETERANS AND SERVICE MEMBERS WITH CO-OCCURRING SUBSTANCE USE

LINE EXTENSION AND EXPANDED PRECLINICAL EVIDENCE FOR NERVE TAPE, A SUTURELESS NERVE REPAIR COAPTATION DEVICE - PROJECT SUMMARY WE WILL FINALIZE DEVELOPMENT OF A MICROHOOK-BASED DEVICE FOR QUICK AND CONSISTENTLY EFFECTIVE REPAIR OF NERVE INJURIES. THIS “MICROHOOK NERVE TAPE” CONSISTS OF AN ARRAY OF MICROSCALE HOOKS, DISTRIBUTED ACROSS A FINE, FLEXIBLE MESHWORK AND EMBEDDED IN A BIOLOGIC BACKING. THIS DEVICE WILL BE USED DURING NERVE REPAIR SURGERIES IN PLACE OF MICROSUTURES TO WRAP AROUND AND BIND THE APPROXIMATED ENDS OF A SEVERED NERVE (OR THE ENDS OF A NERVE GRAFT). THE SHORT MICROHOOKS PENETRATE ONLY INTO THE OUTER, CONNECTIVE TISSUE LAYERS OF THE NERVE, FORMING AN EFFECTIVE MECHANICAL ATTACHMENT AND DISTRIBUTING TENSION EVENLY ACROSS THE DEVICE. MICROHOOK NERVE TAPE CAN BE APPLIED EASILY AND LOWERS SURGERY TIME AND COMPLEXITY AS COMPARED TO THE CURRENT CLINICAL STANDARD OF MICROSUTURE REPAIR. THE EASE AND INTUITIVENESS OF MICROHOOK NERVE TAPE APPLICATION WILL ENABLE CONSISTENT HIGH-QUALITY REPAIRS TO OPTIMIZE RECOVERY AFTER NERVE INJURIES. IN PHASE I, WE REFINED THE DEVICE DESIGN TO PRODUCE A SET OF PROTOTYPES CONSISTING OF A STAINLESS STEEL-BASED MICROHOOK MESH LAMINATED WITHIN A BIOLOGIC LAYER OF PORCINE SMALL INTESTINAL MUCOSA (SIS). IN BIOMECHANICAL TESTING, NERVES WERE HELD TOGETHER BY THE DEVICE WITH STRENGTH COMPARABLE TO THAT OF MICROSUTURE REPAIRS. IN IN VIVO RABBIT TESTING, THE DEVICE WAS WELL TOLERATED BY THE SURROUNDING TISSUE, AND NERVES THAT WERE CUT AND REPAIRED WITH MICROHOOK NERVE TAPE REGENERATED COMPARABLY VS. MICROSUTURE REPAIRED NERVES. WE SUBSEQUENTLY DEVELOPED AN ENHANCED NITINOL- BASED VERSION OF THE DEVICE MORE SUITABLE TO CLINICAL TRANSLATION, AND WE DEMONSTRATED THE SUPERIOR PERFORMANCE OF THIS DEVICE IN BIOMECHANICAL TESTING. IN PHASE II WE WILL FINALIZE THE DESIGN OF THE MICROHOOK NERVE TAPE DEVICE WITH NITINOL-BASED MICROHOOKS, AND WE WILL DEVELOP EFFICIENT MANUFACTURING AND PRODUCTION METHODS. WE WILL CONDUCT EXTENSIVE VALIDATION TESTING OF SAFETY AND EFFICACY IN COMPREHENSIVE RABBIT STUDIES AND APPLY FOR FDA 510(K) CLEARANCE. THE FINAL COMMERCIALIZATION-READY PRODUCT WILL BE AN FDA- APPROVED NERVE REPAIR DEVICE THAT CAN BE STORED ON THE SHELF FOR USE DURING NERVE REPAIR PROCEDURES. MICROHOOK NERVE TAPE WILL REDUCE THE TECHNICAL DEMANDS AND TIME COSTS OF NERVE REPAIR, WHILE IMPROVING REPAIR CONSISTENCY AND OVERALL QUALITY.

SPINAL REFLEX CONDITIONING SYSTEM FOR ENHANCING MOTOR FUNCTION RECOVERY AFTER INCOMPLETE SPINAL CORD INJURY - PROJECT SUMMARY SPINAL CORD INJURY (SCI) AFFECTS ~300,000 PEOPLE IN THE US, WITH 11,000 NEW CASES/YEAR. AFTER SCI, SPINAL REFLEX FUNCTION BECOMES ABNORMAL, CONTRIBUTING TO MOTOR IMPAIRMENTS AND SPASTICITY THAT AFFECTS 65-78% OF PEOPLE WITH SCI. THUS, RESTORING THE FUNCTION OF SPINAL REFLEX PATHWAYS IS A MAJOR THERAPEUTIC GOAL. CURRENT THERAPIES ARE ONLY MODERATELY SUCCESSFUL; MOTOR FUNCTION OFTEN DOES NOT RETURN TO PRE-INJURY LEVELS. RESEARCH LED BY DR. WOLPAW AT THE NATIONAL CENTER FOR ADAPTIVE NEUROTECHNOLOGIES (NCAN) AND DR. THOMPSON AT THE MEDICAL UNIVERSITY OF SOUTH CAROLINA (MUSC) HAS DEVELOPED A NOVEL NONINVASIVE THERAPY THAT TARGETS BENEFICIAL CHANGE TO SPECIFIC SPINAL REFLEX PATHWAYS. THE PATIENT LEARNS, THROUGH OPERANT CONDITIONING, TO MODIFY THE BRAIN’S CONTROL OVER THE PATHWAY. THIS MODIFIED CONTROL GRADUALLY CHANGES THE PATHWAY, AND TRIGGERS FAVORABLE PLASTICITY IN OTHER PATHWAYS AS WELL. IN PEOPLE WITH SCI, SPINAL REFLEX CONDITIONING REDUCES SPASTICITY, ELIMINATES LIMPING, AND INCREASES WALKING SPEED. THE BENEFITS PERSIST; AND THEY ARE APPARENT TO PEOPLE IN THEIR DAILY LIVES. CLINICAL TRANSLATION OF THIS POWERFUL NEW THERAPY IS NOW IMPRACTICAL BECAUSE THE REFLEX CONDITIONING SYSTEM IS COMPLEX AND REQUIRES A HIGHLY-TRAINED OPERATOR. TO REALIZE ITS THERAPEUTIC POTENTIAL, REFLEX CONDITIONING NEEDS AN INTEGRATED HARDWARE/SOFTWARE SYSTEM THAT CAN BE MASTERED QUICKLY AND USED EFFECTIVELY BY THERAPISTS. BIOCIRCUIT TECHNOLOGIES HAS THE ESSENTIAL HARDWARE; NCAN AND MUSC HAVE THE ESSENTIAL SOFTWARE AND CLINICAL EXPERTISE. BIOCIRCUIT HAS A STRONG RECORD IN TRANSFORMING COMPLEX TECHNOLOGY INTO TURNKEY SYSTEMS. WORKING TOGETHER, BIOCIRCUIT, NCAN, AND MUSC PROPOSE TO CREATE A REFLEX CONDITIONING SYSTEM SUITABLE FOR WIDESPREAD CLINICAL USE. PHASE I - AIM 1 WILL INTEGRATE HARDWARE TO RECORD EMG FROM MULTIPLE SITES AND STIMULATE THE PERIPHERAL NERVE WITH SOFTWARE TO CONTROL RECORDING AND STIMULATION AND PROVIDE REAL-TIME VISUAL FEEDBACK TO THE PATIENT AND RESULTS TO THE THERAPIST. THIS NEW SYSTEM WILL COMBINE BIOCIRCUIT’S RECORDING/STIMULATION PLATFORM, NCAN’S AUTOMATED ALGORITHMS, AND MUSC’S CLINICAL METHODS. THROUGH FORMAL CLINICIAN USABILITY TESTS, WE WILL OPTIMIZE THE SYSTEM AND CONFIRM ITS ROBUSTNESS AND USABILITY. AIM 2 WILL ESTABLISH THE DEVICE COMPLIANCE AND REGULATORY PATHWAY BASED ON FDA FEEDBACK, BRING DEVELOPMENT UNDER DESIGN AND QUALITY SYSTEM CONTROL, ENSURE REGULATORY COMPLIANCE, AND GUIDE THE PHASE II CLINICAL STUDY AND THE PATHWAY TO A FUTURE FDA 510(K) SUBMISSION. PHASE II - AIM 1 WILL VALIDATE THE EFFECTIVENESS OF THE NEW SYSTEM IN PEOPLE WITH CHRONIC INCOMPLETE SCI. WE EXPECT THAT REFLEX CONDITIONING WITH THE NEW SYSTEM WILL EQUAL OR EXCEED THAT OF THE OLD SYSTEM. AIM 2 WILL ASSESS THE IMPACT OF THE NEW SYSTEM ON MOTOR FUNCTION, QUALITY OF LIFE, AND COMMUNITY PARTICIPATION. WE EXPECT THAT ITS BENEFITS WILL EQUAL OR EXCEED THOSE OF THE OLD SYSTEM. THESE STUDIES WILL IDENTIFY METRICS FOR A LARGE POST-PHASE II STUDY. AIM 3 WILL GATHER INITIAL DATA ON SAFETY FOR AN FDA 510(K) SUBMISSION FOR USE IN SCI. THIS PROJECT WILL PRODUCE A ROBUST CLINICALLY PRACTICAL REFLEX CONDITIONING SYSTEM THAT ENABLES THIS NONINVASIVE NEW THERAPY TO COMPLEMENT TRADITIONAL THERAPIES AND ENHANCE RECOVERY FOR PEOPLE WITH SCI AND OTHER DISORDERS.

LINE EXTENSION AND EXPANDED PRECLINICAL EVIDENCE FOR NERVE TAPE, A SUTURELESS NERVE REPAIR COAPTATION DEVICE - PROJECT SUMMARY BIOCIRCUIT TECHNOLOGIES’ NERVE TAPE® IS A BIOLOGIC WRAP WITH INTEGRATED MICROHOOKS FOR SUTURELESS REPAIR OF INJURED NERVES. THIS SBIR PHASE IIB PROJECT COMPRISES ACTIVITIES CRITICAL FOR PROMOTING ADOPTION OF NERVE TAPE UPON COMMERCIAL LAUNCH. NERVE INJURIES ARE COMMON AND RESULT IN PARALYSIS, SENSORY LOSS, AND CHRONIC PAIN. IN CURRENT REPAIR TECHNIQUES, THE ENDS OF A CUT NERVE ARE MICROSUTURED BACK TOGETHER UNDER HIGH MAGNIFICATION BY A SPECIALIZED SURGEON. MICROSUTURE REPAIR TECHNIQUES ARE TECHNICALLY CHALLENGING AND TIME INTENSIVE, AND REPAIR QUALITY IS NOT CONSISTENT. NERVE TAPE WAS DEVELOPED AS A SIMPLE AND EASY-TO-USE ALTERNATIVE TO MICROSUTURE REPAIR. THE DEVICE CONSISTS OF FLEXIBLE COLUMNS OF MICROSCALE NITINOL HOOKS EMBEDDED IN A BIOLOGIC WRAP. THE DEVICE EASILY WRAPS TO ALIGN AND HOLD TOGETHER THE TWO ENDS OF A SEVERED NERVE. THE MICROHOOKS ARE DESIGNED FOR SAFE, SHALLOW PENETRATION INTO OUTER CONNECTIVE TISSUE LAYERS OF THE NERVE, EVENLY DISTRIBUTING TENSION FOR A FIRM HOLD. NERVE TAPE IS EASILY AND QUICKLY APPLIED, RELIABLY AND SAFELY ALIGNING NERVE ENDS FOR CONSISTENT, HIGH-QUALITY REPAIRS. TO PROMOTE ADOPTION OF NERVE TAPE UPON COMMERCIAL LAUNCH, THE PROPOSED WORK WILL 1) EXTEND THE SIZE RANGE OF THE DEVICE FOR GREATER MARKET CAPTURE AND 2) GATHER KEY PRECLINICAL DATA TO GUIDE SURGEON PERCEPTION AND SUPPORT KEY MARKETING CLAIMS. TO ADDRESS COMMONLY INJURED NERVES SUCH AS SMALL DIGITAL, FACIAL, AND BRANCHED MOTOR NERVES, THE NERVE TAPE SIZE RANGE WILL BE EXPANDED TO INCLUDE 1-2MM NERVE DIAMETERS. ADDITION OF THE NEW SIZE REQUIRES DESIGN OPTIMIZATION AND SUBSEQUENT VERIFICATION AND VALIDATION TESTING TO SUPPORT REGULATORY CLEARANCE OF THE SMALLER SIZED DEVICE. SEPARATELY, PERFORMANCE DATA IN SPECIFIC SCENARIOS WILL BE COLLECTED TO PROACTIVELY DISPEL PERCEIVED CLINICIAN CONCERNS THAT MIGHT HINDER ADOPTION. SPECIFICALLY, NERVE TAPE’S PERFORMANCE WILL BE DEMONSTRATED IN AREAS OF FLEXION (USING A RABBIT KNEE FLEXION MODEL) AND IN LONG-TERM IMPLANT SCENARIOS (USING A 9-MO. PIG MODEL). FINALLY, WE WILL GATHER EVIDENCE OF NERVE TAPE’S SUPERIOR EFFICIENCY AND REPAIR QUALITY CONSISTENCY. THESE ADVANTAGES WILL BE DEMONSTRATED THROUGH A RABBIT TRANSECTED NERVE REPAIR STUDY COMPARING SURGICAL TIME AND REGENERATION OUTCOMES ACHIEVED BY SURGEONS OF VARIED MICROSURGERY EXPERIENCE USING NERVE TAPE OR CONVENTIONAL MICROSUTURE-BASED REPAIR. THE STEPS PROPOSED IN THIS PROJECT WILL POSITION NERVE TAPE FOR MAXIMAL MARKET PENETRATION AFTER COMMERCIAL LAUNCH, ENABLING WIDESPREAD ADOPTION AS A NERVE REPAIR DEVICE THAT REDUCES SURGICAL TIME AND COMPLEXITY FOR CONSISTENT, HIGH-QUALITY REPAIRS AND IMPROVED RECOVERY OUTCOMES.

SOUTHEASTERN REGIONAL SPINAL CORD INJURY MODEL SYSTEMS (SR-SCIMS) - ABSTRACT THE SOUTHEASTERN REGIONAL SPINAL CORD INJURY MODEL SYSTEM (SER-SCIMS) OFFERS MULTIDISCIPLINARY REHABILITATION SPECIFICALLY DESIGNED FOR THE NEEDS OF INDIVIDUALS WITH SCI ACROSS THE CONTINUUM OF CARE. IN THIS COMING 5-YEAR SCIMS CYCLE, OUR GOAL IS TO CONTRIBUTE 500 NEW CASES TO THE SCIMS DATABASE, AND ~1,500 INTERVIEWS OF FORMER PATIENTS AT PRESCRIBED POST-INJURY TIMEPOINTS. BEYOND PROVIDING OUTSTANDING CLINICAL CARE, OUR GOAL IS TO CONDUCT INNOVATIVE RESEARCH TO IMPROVE OUTCOMES IN THE HEALTH AND FUNCTION DOMAIN. AN ADVISORY BOARD COMPRISED OF INDIVIDUALS WITH A BROAD SKILL SET AND EXPERIENCES REPRESENTING THE DIVERSITY OF THE COMMUNITY IN TERMS OF RACE, ETHNICITY, GENDER, DISABILITY, AND AGE WILL PROVIDE CRITICAL FEEDBACK AND INSIGHTS ON ALL ASPECTS OF OUR SCIMS PROJECTS, AS WELL AS OUR DISSEMINATION, KNOWLEDGE TRANSLATION, AND CONSUMER ENGAGEMENT ACTIVITIES. THE OBJECTIVE OF OUR SITE-SPECIFIC PROJECT IS TO EVALUATE THE EFFECTS OF MOTOR SKILL TRAINING PLUS NON-INVASIVE SPINAL STIMULATION; ANTICIPATED OUTCOMES ARE IMPROVED WALKING ABILITY, BALANCE, STRENGTH, AND REDUCED SPASTICITY. THE OBJECTIVE OF OUR COLLABORATIVE PROJECT IS TO IDENTIFY RISK FACTORS FOR UNINTENTIONAL INJURIES IN THE FIRST YEAR AFTER SCI; THE ANTICIPATED OUTCOME IS KNOWLEDGE ABOUT HOW THESE INJURIES OCCUR, ASSOCIATED RISK FACTORS, AND TOOL DEVELOPMENT TO INFORM EDUCATION/PREVENTION PROGRAMS. WE WILL COLLABORATE WITH OTHER SCIMS CENTERS AND THE MODEL SYSTEMS KNOWLEDGE TRANSLATION CENTER. THE EXPECTED PRODUCTS ARE SCIENTIFIC RESULTS AND INFORMATION FOR DISSEMINATION TO OUR VARIOUS STAKEHOLDER COMMUNITIES, INCLUDING PEOPLE WITH SCI, FAMILIES/CARE PARTNERS; CLINICIANS; RESEARCHERS; POLICY MAKERS; ADVOCACY GROUPS; INDUSTRY REPRESENTATIVES; AND THE GENERAL PUBLIC. WE WELCOME THE OPPORTUNITY TO CONDUCT THIS PROJECT WITH THE VALUED INPUT OF INDIVIDUALS FROM THE DISABILITY AND MINORITY COMMUNITIES.

SOUTHEASTERN REGIONAL SPINAL CORD INJURY MODEL SYSTEMS (SR-SCIMS) - ABSTRACT THE SOUTHEASTERN REGIONAL SPINAL CORD INJURY MODEL SYSTEM (SER-SCIMS) OFFERS MULTIDISCIPLINARY REHABILITATION SPECIFICALLY DESIGNED FOR THE NEEDS OF INDIVIDUALS WITH SCI ACROSS THE CONTINUUM OF CARE. IN THIS COMING 5-YEAR SCIMS CYCLE, OUR GOAL IS TO CONTRIBUTE 500 NEW CASES TO THE SCIMS DATABASE, AND ~1,500 INTERVIEWS OF FORMER PATIENTS AT PRESCRIBED POST-INJURY TIMEPOINTS. BEYOND PROVIDING OUTSTANDING CLINICAL CARE, OUR GOAL IS TO CONDUCT INNOVATIVE RESEARCH TO IMPROVE OUTCOMES IN THE HEALTH AND FUNCTION DOMAIN. AN ADVISORY BOARD COMPRISED OF INDIVIDUALS WITH A BROAD SKILL SET AND EXPERIENCES REPRESENTING THE DIVERSITY OF THE COMMUNITY IN TERMS OF RACE, ETHNICITY, GENDER, DISABILITY, AND AGE WILL PROVIDE CRITICAL FEEDBACK AND INSIGHTS ON ALL ASPECTS OF OUR SCIMS PROJECTS, AS WELL AS OUR DISSEMINATION, KNOWLEDGE TRANSLATION, AND CONSUMER ENGAGEMENT ACTIVITIES. THE OBJECTIVE OF OUR SITE-SPECIFIC PROJECT IS TO EVALUATE THE EFFECTS OF MOTOR SKILL TRAINING PLUS NON-INVASIVE SPINAL STIMULATION; ANTICIPATED OUTCOMES ARE IMPROVED WALKING ABILITY, BALANCE, STRENGTH, AND REDUCED SPASTICITY. THE OBJECTIVE OF OUR COLLABORATIVE PROJECT IS TO IDENTIFY RISK FACTORS FOR UNINTENTIONAL INJURIES IN THE FIRST YEAR AFTER SCI; THE ANTICIPATED OUTCOME IS KNOWLEDGE ABOUT HOW THESE INJURIES OCCUR, ASSOCIATED RISK FACTORS, AND TOOL DEVELOPMENT TO INFORM EDUCATION/PREVENTION PROGRAMS. WE WILL COLLABORATE WITH OTHER SCIMS CENTERS AND THE MODEL SYSTEMS KNOWLEDGE TRANSLATION CENTER. THE EXPECTED PRODUCTS ARE SCIENTIFIC RESULTS AND INFORMATION FOR DISSEMINATION TO OUR VARIOUS STAKEHOLDER COMMUNITIES, INCLUDING PEOPLE WITH SCI, FAMILIES/CARE PARTNERS; CLINICIANS; RESEARCHERS; POLICY MAKERS; ADVOCACY GROUPS; INDUSTRY REPRESENTATIVES; AND THE GENERAL PUBLIC. WE WELCOME THE OPPORTUNITY TO CONDUCT THIS PROJECT WITH THE VALUED INPUT OF INDIVIDUALS FROM THE DISABILITY AND MINORITY COMMUNITIES.

PURPOSE: THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD), OFFICE OF MULTIFAMILY HOUSING PROVIDES RENEWALS OF PROJECT-BASED SECTION 8 HOUSING ASSISTANCE PAYMENTS (HAP) CONTRACTS DIRECTLY WITH OWNERS. THE PURPOSE OF THE HAP CONTRACTS IS TO PROVIDE RENTAL ASSISTANCE TO LOW (80% IF AREA MEDIAN INCOME), VERY LOW (50% OF AREA MEDIAN INCOME AND EXTREMELY LOW (30% OF AREA MEDIAN INCOME)-INCOME HOUSEHOLDS ENABLING THEM TO LIVE IN AFFORDABLE, DECENT, SAFE, AND SANITARY HOUSING. FOR ADDITIONAL INFORMATION ABOUT THESE AWARDS SEE THE MULTIFAMILY ASSISTANCE & SECTION 8 DATABASE AT: HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/HOUSING/MFH/EXP/MFHDISCL.; ACTIVITIES TO BE PERFORMED: APPROXIMATELY 16,400 SECTION 8 HOUSING ASSISTANCE PAYMENTS (HAP) CONTRACTS PROVIDE RENTAL ASSISTANCE ANNUALLY TO 1.19 MILLION HOUSEHOLDS UNDER PROGRAM ACTIVITY CODE 001 FOR ASSISTANCE LISTING 14.195. OWNERS RECEIVE FEDERAL FUNDS FROM HUD TO ADMINISTER THE SECTION 8 PROJECT BASED RENTAL ASSISTANCE PROGRAM THROUGH THE HAP CONTRACTS. THE OWNERS ACCEPT A FAMILY’S APPLICATION FOR RENTAL ASSISTANCE, CONFIRMS THE FAMILY’S ELIGIBILITY FOR ASSISTANCE AND SELECTS THE FAMILY FOR ADMISSION IN ACCORDANCE WITH THE OCCUPANCY HANDBOOK 4350.3 REV-1 (HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/HANDBOOKS/HSGH/4350.3). THE FAMILY THEN MOVES INTO THE PROPERTY AND EXECUTES THE LEASE AND AGREES TO SECTION 8 PROGRAM REQUIREMENTS INCLUDING ANNUAL RECERTIFICATION. THE OWNER SUBMITS FOR PAYMENT OF THE RENTAL ASSISTANCE SUBSIDY MONTHLY ON BEHALF OF THE PARTICIPATING FAMILY. THE FAMILY PAYS 30% OF THEIR ADJUSTED INCOME IN RENT AND UTILITIES AND THE HAP CONTRACT PAYS THE BALANCE OF THE CONTRACT RENT TO THE OWNER.; EXPECTED OUTCOMES: APPROXIMATELY 1.19 MILLION HOUSEHOLDS CONTINUE TO LIVE IN AFFORDABLE HOUSING PAYING 30% OF THEIR ADJUSTED INCOME IN RENT AND UTILITIES IN HOUSING THAT IS DECENT, SAFE AND SANITARY FOR AS LONG AS THEY CHOOSE, AND THE OWNER REMAINS IN COMPLIANCE WITH THE HAP CONTRACT.; INTENDED BENEFICIARIES: INDIVIDUALS AND FAMILIES WHO MEET THE ELIGIBILITY CRITERIA OF THE PROGRAM AND PROPERTY AS NOTED IN THE OCCUPANCY HANDBOOK, 4350.3 REV-1, CHAPTER 3 (HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/HANDBOOKS/HSGH/4350.3) AND SUMMARIZED BELOW ARE THE INTENDED BENEFICIARIES OF THIS PROGRAM. • PROGRAM ELIGIBILITY DETERMINES WHETHER APPLICANTS ARE ELIGIBLE FOR ASSISTANCE. PROGRAM REQUIREMENTS INCLUDE INCOME LIMITS, DISCLOSURE OF SOCIAL SECURITY NUMBERS, CONSENT FORMS, RESTRICTION ON ASSISTANCE TO NONCITIZENS, RESTRICTIONS ON ELIGIBILITY OF STUDENTS FOR SECTION 8 ASSISTANCE, MANDATORY USE OF ENTERPRISE INCOME VERIFICATION SYSTEM (EIV). • PROJECT ELIGIBILITY ESTABLISHES WHETHER APPLICANTS ARE ELIGIBLE TO RESIDE IN A SPECIFIC PROJECT TO WHERE THEY HAVE APPLIED. THREE THINGS MY AFFECT THE MATCH BETWEEN AN APPLICANT AND THE APPLICANT’S ELIGIBILITY FOR OCCUPANCY IN A PARTICULAR PROJECT: 1. THE EXTENT TO WHICH ALL OR SOME OF THE UNITS IN A PROJECT ARE DESIGNATED FOR SPECIFIC FAMILY TYPES, SUCH AS THOSE WHO ARE ELDERLY OR DISABLED; 2. THE PROJECT-SPECIFIC OCCUPANCY STANDARDS ESTABLISHED BY THE OWNER, THE FAMILY SIZE, AND THE UNIT SIZES AVAILABLE IN THE PROJECT; AND 3. IN SOME INSTANCES, A FAMILY’S INTENTION TO LEASE USING A HOUSING-CHOICE VOUCHER SUBSIDY THAT MAY BE USED IN SOME PROJECTS AND NOT IN OTHERS.; SUBRECIPIENT ACTIVITIES: THE RECIPIENT DOES NOT INTEND TO SUBAWARD FUNDS.

GEORGIA MODEL BRAIN INJURY SYSTEM (GAMBIS) - THE SHEPHERD CENTER AND THE GEORGIA VOCATIONAL REHABILITATION AGENCY (GVRA) ARE PARTNERING TO LEAD THE GEORGIA MODEL BRAIN INJURY SYSTEM (GAMBIS). THE MISSION OF GAMBIS IS TO IMPROVE THE EMPLOYMENT, FINANCIAL, HEALTH, AND COMMUNITY PARTICIPATION OUTCOMES OF INDIVIDUALS WITH TBI, AND PARTICULARLY FOR MINORITY AND UNDERSERVED POPULATIONS. THE GOAL OF OUR SITE-SPECIFIC PROJECT, “IMPROVING EMPLOYMENT OUTCOMES OF PERSONS WITH MODERATE/SEVERE TBI,” IS TO VALIDATE NOVEL VOCATIONAL REHABILITATION (VR) INTERVENTIONS THAT ARE COORDINATED BETWEEN HOSPITAL-BASED (I.E., SHEPHERD CENTER) AND STATE VR PROGRAMS (I.E., GVRA). THE GAMBIS OBJECTIVES ARE TO: (1) ENROLL 35+ PARTICIPANTS IN THE TBIMS NDB ANNUALLY AND CONDUCT FOLLOW-UP ASSESSMENTS; (2) IDENTIFY THE MOST CLINICALLY AND FINANCIALLY EFFECTIVE VR SERVICES FOR INDIVIDUALS WITH THE MOST SIGNIFICANT TBIS (I.E., SITE-SPECIFIC PROJECT); (3) IDENTIFY PREDICTORS OF SUCCESSFUL REHABILITATION OUTCOMES THAT ARE AMENABLE TO TREATMENT (I.E., PERSONAL RESOURCES, COMMUNITY RESOURCES, SOCIOCULTURAL VARIABLES) FOR INDIVIDUALS WITH TBI FROM MINORITY AND UNSERVED POPULATIONS (I.E., COLLABORATIVE PROJECT); AND (4) TRANSLATE KNOWLEDGE AND DEVELOP MATERIALS TAILORED FOR EACH STAKEHOLDER. THE ANTICIPATED OUTCOMES INCLUDE: (A) IMPROVED EMPLOYMENT AND FINANCIAL OUTCOMES FOR INDIVIDUALS WITH THE MOST SIGNIFICANT TBIS; (B) DECREASED STATE FINANCIAL EXPENDITURES (I.E., VR COSTS, SSDI EXPENDITURES); (C) A NATIONAL MODEL FOR COORDINATED HOSPITAL- AND STATE VR PROGRAMS; (D) EVIDENCE TO SUPPORT FINANCIAL REIMBURSEMENT OF HOSPITAL-BASED VR SERVICES (E.G., PRIVATE INSURANCE; MEDICARE/ MEDICAID); AND 5) SUPPORT FOR INCREASED ON-THE-JOB-TRAINING INTERVENTIONS BY STATE VR PROGRAMS. ANTICIPATED PRODUCTS WILL INCLUDE ACADEMIC PUBLICATIONS IN PEER-REVIEWED JOURNALS, PROFESSIONAL PRESENTATIONS AT REHABILITATION CONFERENCES (WITH OUR PARTNER, THE NATIONAL COUNCIL FOR VOCATIONAL REHABILITATION ADMINISTRATORS), AND VR INTERVENTION MANUALS FOR STATE VOCATIONAL REHABILITATION PROGRAM PROVIDERS.

GEORGIA MODEL BRAIN INJURY SYSTEM (GAMBIS) - THE SHEPHERD CENTER AND THE GEORGIA VOCATIONAL REHABILITATION AGENCY (GVRA) ARE PARTNERING TO LEAD THE GEORGIA MODEL BRAIN INJURY SYSTEM (GAMBIS). THE MISSION OF GAMBIS IS TO IMPROVE THE EMPLOYMENT, FINANCIAL, HEALTH, AND COMMUNITY PARTICIPATION OUTCOMES OF INDIVIDUALS WITH TBI, AND PARTICULARLY FOR MINORITY AND UNDERSERVED POPULATIONS. THE GOAL OF OUR SITE-SPECIFIC PROJECT, “IMPROVING EMPLOYMENT OUTCOMES OF PERSONS WITH MODERATE/SEVERE TBI,” IS TO VALIDATE NOVEL VOCATIONAL REHABILITATION (VR) INTERVENTIONS THAT ARE COORDINATED BETWEEN HOSPITAL-BASED (I.E., SHEPHERD CENTER) AND STATE VR PROGRAMS (I.E., GVRA). THE GAMBIS OBJECTIVES ARE TO: (1) ENROLL 35+ PARTICIPANTS IN THE TBIMS NDB ANNUALLY AND CONDUCT FOLLOW-UP ASSESSMENTS; (2) IDENTIFY THE MOST CLINICALLY AND FINANCIALLY EFFECTIVE VR SERVICES FOR INDIVIDUALS WITH THE MOST SIGNIFICANT TBIS (I.E., SITE-SPECIFIC PROJECT); (3) IDENTIFY PREDICTORS OF SUCCESSFUL REHABILITATION OUTCOMES THAT ARE AMENABLE TO TREATMENT (I.E., PERSONAL RESOURCES, COMMUNITY RESOURCES, SOCIOCULTURAL VARIABLES) FOR INDIVIDUALS WITH TBI FROM MINORITY AND UNSERVED POPULATIONS (I.E., COLLABORATIVE PROJECT); AND (4) TRANSLATE KNOWLEDGE AND DEVELOP MATERIALS TAILORED FOR EACH STAKEHOLDER. THE ANTICIPATED OUTCOMES INCLUDE: (A) IMPROVED EMPLOYMENT AND FINANCIAL OUTCOMES FOR INDIVIDUALS WITH THE MOST SIGNIFICANT TBIS; (B) DECREASED STATE FINANCIAL EXPENDITURES (I.E., VR COSTS, SSDI EXPENDITURES); (C) A NATIONAL MODEL FOR COORDINATED HOSPITAL- AND STATE VR PROGRAMS; (D) EVIDENCE TO SUPPORT FINANCIAL REIMBURSEMENT OF HOSPITAL-BASED VR SERVICES (E.G., PRIVATE INSURANCE; MEDICARE/ MEDICAID); AND 5) SUPPORT FOR INCREASED ON-THE-JOB-TRAINING INTERVENTIONS BY STATE VR PROGRAMS. ANTICIPATED PRODUCTS WILL INCLUDE ACADEMIC PUBLICATIONS IN PEER-REVIEWED JOURNALS, PROFESSIONAL PRESENTATIONS AT REHABILITATION CONFERENCES (WITH OUR PARTNER, THE NATIONAL COUNCIL FOR VOCATIONAL REHABILITATION ADMINISTRATORS), AND VR INTERVENTION MANUALS FOR STAT E VOCATIONAL REHABILITATION PROGRAM PROVIDERS.

SECTION 8 HOUSING ASSISTANCE PAYMENTS PROGRAM

CALIBRATING TRANSCUTANEOUS SPINAL STIMULATION FOR SPASTICITY, PAIN, AND MOTOR FUNCTION IN SCI - PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): FIELD-FOTE, EDELLE CARMEN PROJECT SUMMARY / ABSTRACT WHILE THE INCIDENCE OF SPINAL CORD INJURY (SCI) MAY NOT BE AS HIGH AS OTHER NEUROLOGICAL DISORDERS SUCH AS STROKE, MANY WITH SCI ARE YOUNG ADULTS WHO CAN EXPECT TO LIVE WITH DISABILITY FOR 35 – 50 YEARS. FOR THIS REASON, EVEN SMALL REDUCTIONS OF IMPAIRMENT AND IMPROVEMENTS IN FUNCTION CAN HAVE A SIGNIFICANT IMPACT ON HEALTH, QUALITY OF LIFE, AND SOCIAL PARTICIPATION AFTER SCI. SPASTICITY CAN BE A SIGNIFICANT PROBLEM FOR PERSONS WITH SCI, FOR EXAMPLE, THE MUSCLE SPASMS ASSOCIATED WITH SPASTICITY CAN BE SO STRONG THAT, DESPITE HAVING SUFFICIENT MOTOR FUNCTION TO USE A LIGHTWEIGHT MANUAL WHEELCHAIR, SOME INDIVIDUALS MUST BE SECURED IN A CUMBERSOME POWER CHAIR TO AVOID BEING THROWN FROM THE CHAIR BY THEIR SPASMS. MANAGEMENT OF SPASTICITY IS CHALLENGING; IT IS TYPICALLY TREATED WITH ANTISPASMODICS THAT ACT AS CENTRAL NERVOUS SYSTEM DEPRESSANTS, WITH NEGATIVE SIDE-EFFECTS SUCH AS DROWSINESS, LETHARGY, AND MUSCLE WEAKNESS. IN ADDITION TO SPASTICITY, MANY INDIVIDUALS WITH SCI HAVE NEUROPATHIC PAIN. THE PROBLEMS OF SPASTICITY AND PAIN ARE IN ADDITION TO THE MUSCLE PARESIS THAT IS THE HALLMARK OF SCI. TSS OFFERS AN ACCESSIBLE APPROACH TO ACHIEVING ACTIVATION OF MULTIPLE SPINAL LEVELS SIMULTANEOUSLY, MODULATING THE SPINAL NEURAL CIRCUITS THAT UNDERLIE SPASTICITY, PAIN, AND MOTOR FUNCTION. THE PROPOSED STUDIES CALIBRATING TRANSCUTANEOUS SPINAL STIMULATION (TSS) FOR SPASTICITY, PAIN, AND MOTOR FUNCTION IN SCI HAVE THE POTENTIAL TO MAKE A MEANINGFUL IMPACT ON THESE PROBLEMS. IT IS POSSIBLE THAT TSS CAN OFFER A VALUABLE, AND CLINICALLY ACCESSIBLE FORM OF NEUROMODULATION WITH THE BENEFITS OF PROVIDING A: 1) NON-PHARMACOLOGICAL APPROACH FOR MANAGING SPASTICITY, 2) NON-PHARMACOLOGICAL INTERVENTION FOR MANAGEMENT OF PAIN, AND 3) STRATEGY TO IMPROVE VOLITIONAL MOTOR FUNCTION IN PERSONS WITH SCI. HOWEVER BEFORE TSS CAN BE CONSIDERED A VIABLE FORM OF CLINICALLY ACCESSIBLE NEUROMODULATION, MUCH NEEDS TO BE LEARNED ABOUT DOSE-RESPONSE RELATIONSHIPS REGARDING INTENSITY, FREQUENCY, AND PATTERN OF STIMULATION, AND HOW THESE INFLUENCE SPASTICITY, NOCICEPTIVE RESPONSES, AND VOLITIONAL MOTOR OUTPUT. THESE STUDIES WILL BE THE FOUNDATION FOR LARGER STUDIES COMPARING TSS TO COMMONLY PRESCRIBED PHARMACEUTICALS, AFTER COMPLETION OF THE FOLLOWING AIMS: SPECIFIC AIM 1 (PHASE 1; YEAR 1) QUANTIFY EARLY AND LATE WITHIN-SESSION EFFECTS ON SPASTICITY OF 50HZ TSS APPLIED AT EACH OF 3 DIFFERENT INTENSITIES (0.8XRT, 0.8XRT-BURST, 1.2XRT) TO INFORM PHASE 2. SPECIFIC AIM 2 (PHASE 2; YEARS 2–5) QUANTIFY EARLY, LATE, CUMULATIVE AND PERSISTENT MULTI-SESSION EFFECTS ON SPASTICITY OF 3 DIFFERENT TSS FREQUENCY CONDITIONS (30HZ, 50HZ, 80HZ; AT THE INTENSITY/PATTERN) SPECIFIC AIM 3 (PHASE 2; YEARS 2–5) QUANTIFY EARLY, LATE, AND PERSISTENT EFFECTS ON NOCICEPTION OF 3 DIFFERENT TSS FREQUENCY CONDITIONS (30HZ, 50HZ, 80HZ) SPECIFIC AIM 4 (PHASE 2; YEARS 2–5) QUANTIFY PER-STIMULATION, EARLY, AND PERSISTENT EFFECTS ON LOWER EXTREMITY MUSCLE STRENGTH AND MOTOR CONTROL OF 3 DIFFERENT TSS FREQUENCY CONDITIONS (30HZ, 50HZ, 80HZ) OMB NO. 0925-0001/0002 (REV. 01/18 APPROVED THROUGH 03/31/2020) PAGE 1 CONTINUATION FORMAT PAGE

SECTION 8 HOUSING ASSISTANCE PAYMENTS PROGRAM

PURPOSE: THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD), OFFICE OF MULTIFAMILY HOUSING PROVIDES RENEWALS OF PROJECT-BASED SECTION 8 HOUSING ASSISTANCE PAYMENTS (HAP) CONTRACTS DIRECTLY WITH OWNERS. THE PURPOSE OF THE HAP CONTRACTS IS TO PROVIDE RENTAL ASSISTANCE TO LOW (80% IF AREA MEDIAN INCOME), VERY LOW (50% OF AREA MEDIAN INCOME AND EXTREMELY LOW (30% OF AREA MEDIAN INCOME)-INCOME HOUSEHOLDS ENABLING THEM TO LIVE IN AFFORDABLE, DECENT, SAFE, AND SANITARY HOUSING. FOR ADDITIONAL INFORMATION ABOUT THESE AWARDS SEE THE MULTIFAMILY ASSISTANCE & SECTION 8 DATABASE AT: HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/HOUSING/MFH/EXP/MFHDISCL.; ACTIVITIES TO BE PERFORMED: APPROXIMATELY 16,400 SECTION 8 HOUSING ASSISTANCE PAYMENTS (HAP) CONTRACTS PROVIDE RENTAL ASSISTANCE ANNUALLY TO 1.19 MILLION HOUSEHOLDS UNDER PROGRAM ACTIVITY CODE 001 FOR ASSISTANCE LISTING 14.195. OWNERS RECEIVE FEDERAL FUNDS FROM HUD TO ADMINISTER THE SECTION 8 PROJECT BASED RENTAL ASSISTANCE PROGRAM THROUGH THE HAP CONTRACTS. THE OWNERS ACCEPT A FAMILY’S APPLICATION FOR RENTAL ASSISTANCE, CONFIRMS THE FAMILY’S ELIGIBILITY FOR ASSISTANCE AND SELECTS THE FAMILY FOR ADMISSION IN ACCORDANCE WITH THE OCCUPANCY HANDBOOK 4350.3 REV-1. THE FAMILY THEN MOVES INTO THE PROPERTY AND EXECUTES THE LEASE AND AGREES TO SECTION 8 PROGRAM REQUIREMENTS INCLUDING ANNUAL RECERTIFICATION. THE OWNER SUBMITS FOR PAYMENT OF THE RENTAL ASSISTANCE SUBSIDY MONTHLY ON BEHALF OF THE PARTICIPATING FAMILY. THE FAMILY PAYS 30% OF THEIR ADJUSTED INCOME IN RENT AND UTILITIES AND THE HAP CONTRACT PAYS THE BALANCE OF THE CONTRACT RENT TO THE OWNER.; EXPECTED OUTCOMES: APPROXIMATELY 1.19 MILLION HOUSEHOLDS CONTINUE TO LIVE IN AFFORDABLE HOUSING PAYING 30% OF THEIR ADJUSTED INCOME IN RENT AND UTILITIES IN HOUSING THAT IS DECENT, SAFE AND SANITARY FOR AS LONG AS THEY CHOOSE, AND THE OWNER REMAINS IN COMPLIANCE WITH THE HAP CONTRACT.; INTENDED BENEFICIARIES: INDIVIDUALS AND FAMILIES WHO MEET THE ELIGIBILITY CRITERIA OF THE PROGRAM AND PROPERTY AS NOTED IN THE OCCUPANCY HANDBOOK, 4350.3 REV-1, CHAPTER 3 AND SUMMARIZED BELOW ARE THE INTENDED BENEFICIARIES OF THIS PROGRAM. • PROGRAM ELIGIBILITY DETERMINES WHETHER APPLICANTS ARE ELIGIBLE FOR ASSISTANCE. PROGRAM REQUIREMENTS INCLUDE INCOME LIMITS, DISCLOSURE OF SOCIAL SECURITY NUMBERS, CONSENT FORMS, RESTRICTION ON ASSISTANCE TO NONCITIZENS, RESTRICTIONS ON ELIGIBILITY OF STUDENTS FOR SECTION 8 ASSISTANCE, MANDATORY USE OF ENTERPRISE INCOME VERIFICATION SYSTEM (EIV). • PROJECT ELIGIBILITY ESTABLISHES WHETHER APPLICANTS ARE ELIGIBLE TO RESIDE IN A SPECIFIC PROJECT TO WHERE THEY HAVE APPLIED. THREE THINGS MY AFFECT THE MATCH BETWEEN AN APPLICANT AND THE APPLICANT’S ELIGIBILITY FOR OCCUPANCY IN A PARTICULAR PROJECT: 1. THE EXTENT TO WHICH ALL OR SOME OF THE UNITS IN A PROJECT ARE DESIGNATED FOR SPECIFIC FAMILY TYPES, SUCH AS THOSE WHO ARE ELDERLY OR DISABLED; 2. THE PROJECT-SPECIFIC OCCUPANCY STANDARDS ESTABLISHED BY THE OWNER, THE FAMILY SIZE, AND THE UNIT SIZES AVAILABLE IN THE PROJECT; AND 3. IN SOME INSTANCES, A FAMILY’S INTENTION TO LEASE USING A HOUSING-CHOICE VOUCHER SUBSIDY THAT MAY BE USED IN SOME PROJECTS AND NOT IN OTHERS.; SUBRECIPIENT ACTIVITIES: THE RECIPIENT DOES NOT INTEND TO SUBAWARD FUNDS.

DRRP PROJECT FOR ADVANCING COLLABORATIVE TRANSLATION FOR MHEALTH APPS TO SUPPORT HEALTH AND FUNCTION OF PEOPLE WITH DISABILITIES - SHEPHERD CENTER, IN PARTNERSHIP WITH MASSACHUSETTS GENERAL BRIGHAM/SPAULDING REHABILITATION HOSPITAL (MGB/SRH) AND THE UNIVERSITY OF MICHIGAN, PROPOSE THIS 5-YEAR GRANT TO 1) CONDUCT TRANSLATION ACTIVITIES FOR THREE MOBILE HEALTH (MHEALTH) APPS TO SUPPORT THE HEALTH AND FUNCTION OF PEOPLE WITH DISABLING CONDITIONS (BURN INJURY, SCLERODERMA AND TRAUMATIC BRAIN INJURY) DEVELOPED WITH SUPPORT FROM RECENT GRANTS FROM THE NATIONAL INSTITUTE ON DISABILITY, INDEPENDENT LIVING AND REHABILITATION RESEARCH (NIDILRR), AND 2) CONDUCT RESEARCH ON TRANSLATION STRATEGIES FOR MHEALTH APPS FOR PEOPLE WITH DISABILITIES. THE GOAL IS TO EXPAND UTILIZATION OF THE FUNDED MHEALTH APPS TO GREATER NUMBERS OF TARGET USERS AND NEW SETTINGS AND EXPAND UNDERSTANDING OF TRANSLATION STRATEGIES FOR MHEALTH APPS FOR PEOPLE WITH DISABILITIES. OBJECTIVES: 1) IDENTIFY TRANSLATION NEEDS FOR 3 NIDILRR FUNDED MHEALTH APPS FOR USERS WITH TARGET DISABLING CONDITIONS IN DIVERSE SETTINGS; 2) DEVELOP TRANSLATION PLANS FOR 3 MHEALTH APPS, 3) DEVELOP MEASURES TO EVALUATE ADOPTION/USE; 4) DOCUMENT AND DISSEMINATE TRANSLATION METHODS UTILIZED; AND 5) ENHANCE PARTNERSHIP WITH TARGET USERS AND STAKEHOLDERS. MEASURABLE OUTCOMES: 1) EXPANDED USE OF MHEALTH APPS BY TARGET USERS WITH DISABILITIES; 2) IMPROVED HEALTH AND FUNCTION OUTCOMES BY TARGET USERS; 3) CHANGES IN PRACTICE AND SYSTEMS TO IMPROVE OUTCOMES FOR TARGET USERS; 4) EXPANDED NETWORKS OF TARGET MHEALTH APP USERS, CLINICIANS AND COLLABORATING ORGANIZATIONS; 5) ENHANCED UNDERSTANDING OF TRANSLATION METHODS FOR MHEALTH APPS. PRODUCTS WILL INCLUDE 1) TRANSLATION PLANS CO-DEVELOPED WITH COLLABORATORS AND TARGET USERS, 2) INFORMATION PRODUCTS (TRAINING MATERIALS, WEBSITE, PEER-REVIEWED ARTICLES AND PRESENTATIONS) TO SUPPORT TRANSLATION OF SELECTED MHEALTH APPS FOR TARGET USERS, 3) RESEARCH PRODUCTS ON TRANSLATION STRATEGIES FOR MHEALTH APPS.

COMMERCIALIZATION READINESS FOR NERVE TAPE: A NERVE REPAIR COAPTATION AID - PROJECT SUMMARY THIS SBIR COMMERCIALIZATION READINESS PILOT PROJECT WILL PREPARE AND ACHIEVE THE COMMERCIAL LAUNCH OF BIO- CIRCUIT TECHNOLOGIES’ NERVE TAPE® DEVICE FOR SUTURELESS NERVE REPAIR. NERVE INJURIES ARE COMMON AND RESULT IN PARALYSIS, SENSORY LOSS, AND CHRONIC PAIN. IN CURRENT REPAIR TECHNIQUES, THE ENDS OF A CUT NERVE ARE MICROSUTURED BACK TOGETHER UNDER HIGH MAGNIFICATION BY A SPECIALIZED SURGEON. MICROSUTURE REPAIR TECHNIQUES ARE TECHNICALLY CHALLENGING AND TIME INTENSIVE, AND REPAIR QUALITY IS NOT CONSISTENT. NERVE TAPE WAS DEVELOPED AS A SIMPLE AND EASY-TO-USE ALTERNATIVE TO MICROSUTURE REPAIR. NERVE TAPE CONSISTS OF FLEXIBLE COLUMNS OF MICROSCALE NITINOL HOOKS EMBEDDED IN A BIOLOGIC WRAP. THE DEVICE EASILY WRAPS TO ALIGN AND HOLD TOGETHER THE TWO ENDS OF A SEVERED NERVE. THE MICROHOOKS ARE DESIGNED FOR SAFE, SHALLOW PENETRATION INTO OUTER CONNECTIVE TISSUE LAYERS OF THE NERVE, EVENLY DISTRIBUTING TENSION FOR A FIRM HOLD. NERVE TAPE IS EASILY AND QUICKLY APPLIED, RELIABLY AND SAFELY ALIGNING NERVE ENDS FOR HIGH-QUALITY REPAIRS. TO ACHIEVE INITIAL COMMERCIALIZATION LAUNCH OF THE NERVE TAPE PRODUCT, BIOCIRCUIT MUST COMPLETE SEVERAL KEY STEPS. A STRATEGIC SWITCH IN THE 510(K) CLEARED DEVICE TO A NEW BIOLOGIC MATERIAL SUPPLIER REQUIRES SOME VERIFICATION AND VALIDATION TESTING STEPS TO BE REPEATED. THIS TESTING WILL SUPPORT A NEW REGULATORY SUBMISSION TO GAIN CLEARANCE FOR THE UPDATED DEVICE. PRIOR TO PRODUCTION OF DEVICES FOR CLINICAL USE, A FORMAL DESIGN TRANSFER PROCESS MUST BE COMPLETED. THIS PROCESS INCLUDES ENSURING ALL VENDORS AND SUPPLIERS ARE CERTIFIED AND/OR QUALIFIED, AND ALL SUPPLIER AGREEMENTS ARE IN PLACE. TOOLING FOR FABRICATING THE FULL RANGE OF DEVICE SIZES MUST ALSO BE BUILT AND QUALIFIED. MANUFACTURING PROCESSES THAT WERE PREVIOUSLY DEVELOPED AND REFINED MUST NOW BE TRANSFERRED TO A CERTIFIED CONTRACT MANUFACTURER, AND ALL PRODUCTION PROCESSES MUST TO BE QUALIFIED TO MEET PRODUCT SPECIFICATIONS. AFTER COMPLETING THE DESIGN TRANSFER PROCESS AND DOCUMENTING THIS PROCESS IN BIOCIRCUIT’S QUALITY MANAGEMENT SYSTEM, PRODUCTION RUNS WILL BUILD ENOUGH DEVICES TO SUPPORT AN INITIAL COMMERCIAL LAUNCH PHASE. TO PREPARE FOR SUCCESSFUL COMMERCIAL LAUNCH, MARKET RESEARCH AND ANALYTICS WILL GUIDE PLANS FOR INITIAL LAUNCH AND SUBSEQUENT GROWTH. CLINICAL AFFAIRS ACTIVITIES WILL INCLUDE PLANS FOR GATHERING EVIDENCE TO SUPPORT KEY CLAIMS AND PREPARATIONS FOR A CLINICAL REGISTRY AS PART OF A BROADER EVIDENCE STRATEGY. A STRATEGICALLY LIMITED “SOFT LAUNCH” WILL BE CONDUCTED AT SELECT ACCOUNTS TO ESTABLISH AND OPTIMIZE COMMERCIAL PROCEDURES, OBTAIN CLINICAL FEEDBACK, AND POSITION NERVE TAPE FOR MARKET PENETRATION FOLLOWING FULL LAUNCH. DUE TO ITS SIMPLE, EFFICIENT, AND RELIABLE USAGE, NERVE TAPE WILL BE AN ATTRACTIVE TOOL FOR SURGEONS AND COULD EXPAND FUTURE TREATMENT STRATEGIES FOR NERVE REPAIR.

SECTION 8 HOUSING ASSISTANCE PAYMENTS PROGRAM

SECTION 8 HOUSING ASSISTANCE PAYMENTS PROGRAM

SECTION 8 HOUSING ASSISTANCE PAYMENTS PROGRAM

INTENSIVE REHABILITATION RESEARCH GRANT WRITING WORKSHOPS IN THE UNITED STATES (TIGRR) - .PROJECT SUMMARY. REHABILITATION RESEARCH IS CRITICAL TO HEALTH, PARTICULARLY FOR OUR AGING POPULATIONS AND THOSE WITH DISABILITY, BUT THE FIELD OF REHABILITATION RESEARCH REMAINS UNDERDEVELOPED RELATIVE TO OTHER AREAS OF BIOMEDICAL RESEARCH. CONDUCTING THE STUDIES THAT ARE NEEDED TO INNOVATE REHABILITATION CARE FOR THE LARGE AND GROWING POPULATION OF OLDER ADULTS AND PERSONS WITH DISABILITY REQUIRES REHABILITATION SCIENTISTS WITH THE SKILLS NEEDED TO SUCCESSFULLY COMPETE FOR EXTRAMURAL FUNDING AND MANAGE THEIR FUNDED PROPOSALS. IN ADDITION, ADVANCEMENTS IN REHABILITATION RESEARCH REQUIRES PEER-REVIEWERS WHO ARE ABLE TO PROVIDE CRITICAL REVIEW OF REHABILITATION RESEARCH FUNDING APPLICATIONS. IN THIS RENEWAL APPLICATION, WE PROPOSE CONTINUATION AND FURTHER DEVELOPMENT OF INTENSIVE REHABILITATION RESEARCH GRANT WRITING WORKSHOPS IN THE UNITED STATES MORE COMMONLY KNOWN AS TIGRR (TRAINING IN GRANTSMANSHIP IN REHABILITATION RESEARCH). THIS YEAR-LONG (12-MONTH) RESEARCH EDUCATION PROGRAM ENGAGES EARLY STAGE INVESTIGATORS (ESI) IN ONE-ON-ONE EXPERT MENTORSHIP IN GRANTSMANSHIP, GRANTS MANAGEMENT, CAREER DEVELOPMENT, AND DEVELOPMENT OF PEER-REVIEW SKILLS FOR REHABILITATION RESEARCH. THE NEED FOR THIS IMMERSIVE RESEARCH TRAINING PROGRAM ARISES FROM THE REALITY THAT PRACTICE IN REHABILITATION SPECIALTIES IS OFTEN BASED ON EXPERT OPINION, PRIOR EXPERIENCE, AND TRADITION RATHER THAN ON SCIENTIFICALLY DERIVED EVIDENCE. THERE IS A NEED TO DEVELOP AND TEST INTERVENTIONS AND DEVICES THAT HAVE A SOUND SCIENTIFIC BASIS – BUT THIS REQUIRES A WORKFORCE OF PROFESSIONALS WHO ARE WELL-PREPARED TO COMPETE FOR EXTRAMURAL FUNDING. WHILE, FOR MOST AREAS OF BIOMEDICAL RESEARCH, TRAINING BEGINS IN THE POST-BACCALAUREATE AND POSTDOCTORAL YEARS, MANY INVESTIGATORS IN REHABILITATION RESEARCH BEGIN THEIR CAREERS AS CLINICIANS. THESE CLINICAL EXPERIENCES PROVIDE THEM WITH ESSENTIAL INSIGHTS ABOUT POTENTIALLY BENEFICIAL REHABILITATION APPROACHES, BUT THEY OFTEN LACK EXPOSURE TO INTENSIVE GRANTWRITING OPPORTUNITIES AND THE PREPARATION TO BE SUCCESSFUL FOLLOWING A GRANT AWARD. THE TIGRR PROGRAM IS INTENDED TO ADDRESS THIS NEED THROUGH A 12-MONTH RESEARCH EDUCATION EXPERIENCE THAT INCLUDES A WEEK-LONG WORKSHOP AS ITS NUCLEUS. UNLIKE MOST GRANTWRITING COURSES THAT ARE COMPLETELY DIDACTIC, TIGRR MENTEES ARE ASSIGNED A PRIMARY AND SECONDARY MENTOR WHO PROVIDE DETAILED, ITERATIVE CRITIQUING OF THEIR PROPOSALS, AND THEY PARTICIPATE IN INTENSIVE ONE-ON-ONE MENTORSHIP PRIOR TO AND FOLLOWING THE WORKSHOP. IN THE WORKSHOP, MENTEES MEET WITH MULTIPLE MENTORS WHO REFLECT A WIDE RANGE OF EXPERTISE AND PERSPECTIVES, AND ARE IMMERSED IN THE DEVELOPMENT OF THEIR PROPOSAL. FOLLOWING THE WORKSHOP, THEY CONTINUE TO MEET WITH THEIR PRIMARY MENTOR, AND ALSO APPLY KNOWLEDGE GAINED THROUGH NIH-STYLE PEER-REVIEW PANELS WHEREIN THEY HAVE THE OPPORTUNITY TO HAVE THEIR APPLICATIONS REVIEWED, DEVELOP THEIR CRITICAL EVALUATION SKILLS THROUGH PEER-REVIEW, AND RECEIVE MENTOR FEEDBACK ON THEIR REVIEWS. THROUGH TIGRR, WE WILL DEVELOP A WORKFORCE OF WELL-TRAINED, REHABILITATION RESEARCHERS WHOSE EXPERTISE WILL FOSTER BETTER REHABILITATION RESEARCH. IMPORTANTLY, WE ALSO WORK TO INCREASE THE REPRESENTATION OF WOMEN, PERSONS WITH DISABILITY, AND UNDERSERVED MINORITIES IN THIS WORKFORCE.

INTENSIVE REHABILITATION RESEARCH GRANT WRITING WORKSHOPS IN THE UNITED STATES (TIGRR) - .PROJECT SUMMARY. REHABILITATION RESEARCH IS CRITICAL TO HEALTH, PARTICULARLY FOR OUR AGING POPULATIONS AND THOSE WITH DISABILITY, BUT THE FIELD OF REHABILITATION RESEARCH REMAINS UNDERDEVELOPED RELATIVE TO OTHER AREAS OF BIOMEDICAL RESEARCH. CONDUCTING THE STUDIES THAT ARE NEEDED TO INNOVATE REHABILITATION CARE FOR THE LARGE AND GROWING POPULATION OF OLDER ADULTS AND PERSONS WITH DISABILITY REQUIRES REHABILITATION SCIENTISTS WITH THE SKILLS NEEDED TO SUCCESSFULLY COMPETE FOR EXTRAMURAL FUNDING AND MANAGE THEIR FUNDED PROPOSALS. IN ADDITION, ADVANCEMENTS IN REHABILITATION RESEARCH REQUIRES PEER-REVIEWERS WHO ARE ABLE TO PROVIDE CRITICAL REVIEW OF REHABILITATION RESEARCH FUNDING APPLICATIONS. IN THIS RENEWAL APPLICATION, WE PROPOSE CONTINUATION AND FURTHER DEVELOPMENT OF INTENSIVE REHABILITATION RESEARCH GRANT WRITING WORKSHOPS IN THE UNITED STATES MORE COMMONLY KNOWN AS TIGRR (TRAINING IN GRANTSMANSHIP IN REHABILITATION RESEARCH). THIS YEAR-LONG (12-MONTH) RESEARCH EDUCATION PROGRAM ENGAGES EARLY STAGE INVESTIGATORS (ESI) IN ONE-ON-ONE EXPERT MENTORSHIP IN GRANTSMANSHIP, GRANTS MANAGEMENT, CAREER DEVELOPMENT, AND DEVELOPMENT OF PEER-REVIEW SKILLS FOR REHABILITATION RESEARCH. THE NEED FOR THIS IMMERSIVE RESEARCH TRAINING PROGRAM ARISES FROM THE REALITY THAT PRACTICE IN REHABILITATION SPECIALTIES IS OFTEN BASED ON EXPERT OPINION, PRIOR EXPERIENCE, AND TRADITION RATHER THAN ON SCIENTIFICALLY DERIVED EVIDENCE. THERE IS A NEED TO DEVELOP AND TEST INTERVENTIONS AND DEVICES THAT HAVE A SOUND SCIENTIFIC BASIS – BUT THIS REQUIRES A WORKFORCE OF PROFESSIONALS WHO ARE WELL-PREPARED TO COMPETE FOR EXTRAMURAL FUNDING. WHILE, FOR MOST AREAS OF BIOMEDICAL RESEARCH, TRAINING BEGINS IN THE POST-BACCALAUREATE AND POSTDOCTORAL YEARS, MANY INVESTIGATORS IN REHABILITATION RESEARCH BEGIN THEIR CAREERS AS CLINICIANS. THESE CLINICAL EXPERIENCES PROVIDE THEM WITH ESSENTIAL INSIGHTS ABOUT POTENTIALLY BENEFICIAL REHABILITATION APPROACHES, BUT THEY OFTEN LACK EXPOSURE TO INTENSIVE GRANTWRITING OPPORTUNITIES AND THE PREPARATION TO BE SUCCESSFUL FOLLOWING A GRANT AWARD. THE TIGRR PROGRAM IS INTENDED TO ADDRESS THIS NEED THROUGH A 12-MONTH RESEARCH EDUCATION EXPERIENCE THAT INCLUDES A WEEK-LONG WORKSHOP AS ITS NUCLEUS. UNLIKE MOST GRANTWRITING COURSES THAT ARE COMPLETELY DIDACTIC, TIGRR MENTEES ARE ASSIGNED A PRIMARY AND SECONDARY MENTOR WHO PROVIDE DETAILED, ITERATIVE CRITIQUING OF THEIR PROPOSALS, AND THEY PARTICIPATE IN INTENSIVE ONE-ON-ONE MENTORSHIP PRIOR TO AND FOLLOWING THE WORKSHOP. IN THE WORKSHOP, MENTEES MEET WITH MULTIPLE MENTORS WHO REFLECT A WIDE RANGE OF EXPERTISE AND PERSPECTIVES, AND ARE IMMERSED IN THE DEVELOPMENT OF THEIR PROPOSAL. FOLLOWING THE WORKSHOP, THEY CONTINUE TO MEET WITH THEIR PRIMARY MENTOR, AND ALSO APPLY KNOWLEDGE GAINED THROUGH NIH-STYLE PEER-REVIEW PANELS WHEREIN THEY HAVE THE OPPORTUNITY TO HAVE THEIR APPLICATIONS REVIEWED, DEVELOP THEIR CRITICAL EVALUATION SKILLS THROUGH PEER-REVIEW, AND RECEIVE MENTOR FEEDBACK ON THEIR REVIEWS. THROUGH TIGRR, WE WILL DEVELOP A WORKFORCE OF WELL-TRAINED, REHABILITATION RESEARCHERS WHOSE EXPERTISE WILL FOSTER BETTER REHABILITATION RESEARCH. IMPORTANTLY, WE ALSO WORK TO INCREASE THE REPRESENTATION OF WOMEN, PERSONS WITH DISABILITY, AND UNDERSERVED MINORITIES IN THIS WORKFORCE.