BAA_FY2023_Awards_SAM.pdf

Center Awardee Name Description

75F40122A00018 $252,728.90 $252,728.90 OC DELOITTE CONSULTING

DELOITTE CONSULTING LLP

1919 N 1919 N LYNN ST

Conversion of labeling currently not in PLR/PLLR format to PLR/PLLR format

75F40123C00060 $468,771.00 $468,771.00 OC BATTELLE MEMORIAL INSTITUTE

BATTELLE/James R. Gridley 505

KING AVE COLUMBUS OH

432011268

This is a cost reimbursement contract to acquire services for Development of a Parenteral Challenge Model of Systemic Botulinum

Neurotoxin Intoxication in Rabbits to Support the Advancement of Candidate Therapeutic

Medical Countermeasures.

75F40123C00103 $1,592,348.00 $4,548,811.00 OC STANFORD UNIVERSITY 217691

Jennifer Scerri 485 BROADWAY

THIRD FLOOR REDWOOD CITY

CA 94063

“Development of neuroblastoma tissue diagnostic utility through deep learning-based image analytics and targeted multiplex proteomics”.

75F40123C00113 $447,337.00 $911,251.00 CDER JOHNS HOPKINS UNIVERSITY

3400 N CHARLES ST, W-400

WYMAN PARK BALTIMORE MD

212182685

“Improving the Efficiency and Rigor of Pharmacovigilance at Food and Drug

Administration: Developing a Cognitive Framework for Case Series Evaluation and

Integrating it in the Information Visualization Platform to Support Decision-Making”.

75F40123C00128 $249,478.00 $249,478.00 CDER UNIVERSITY OF SOUTHERN CALIFORNIA 3720 S. Flower St. LOS

ANGELES CA 900890701

Characterizing azithromycin efficacy against carbapenem-resistant Gram-negative bacteria in bicarbonate containing culture media.

75F40123C00132 $906,628.80 $906,628.80 CDER UNIVERSITAT ST.GALLEN DUFOURST DUFOURSTRASSE

50NST. GALLEN SG 9000

Predictive Continous Improvement Acceleration (PCIA) - Towards Performance Based

Regulations and Oversight

75F40123C00133 $441,597.00 $441,597.00 CDRH COLLABORATIVE COMMUNITY ON

OPHTHALMIC IMAGING

11190 SUNRISE VALLEY DR, STE

300 RESTON VA 20191

“Enhancing Visual Health Equity via Novel, Real- World Underserved Population Health Data Sets

Utilizing Ophthalmic Imaging & Artificial Intelligence”.

75F40123C00137 $249,582.00 $249,582.00 CDER UNIVERSITY OF SOUTHERN CALIFORNIA 3720 S FLOWER ST FL 3 LOS

ANGELES CA 90089

"Characterizing beta-lactam efficacy against metallo-beta lactamase producing bacteria in zinc-limited culture media"

75F40123C00143 $598,674.00 $598,674.00 CDER UNIVERSITY OF WISCONSIN SYSTEM 750 UNIVERSITY AVE MADISON

WI 537066141

“Development of In vivo Pharmacometric Approaches to Guide Antifungal Dosing and

Susceptibility Breakpoint Determination for Drug Resistant Aspergillus”.

75F40123C00186 $439,681.00 $439,681.00 CDER APTARGROUP, INC. 1504104

APTARGROUP INC 250 N

ROUTE 303 CONGERS NY

10920

“BAA RESEARCH CHALLENGES RELATED TO

ENVIRONMENTALLY FRIENDLY PROPELL”.

75F40123C00187 $167,270.00 $167,270.00 CDRH SAGE BIONETWORKS 1236306

2901 3RD AVE STE 330

MAILSTOP M1-C108 SEATTLE

WA 98121

“BraTS 2023 Data Centric Challenge

75F40123C00191 $633,660.92 $633,660.92 OO THE UNIVERSITY OF LIVERPOOL

William Henry Duncan Building 6 West Derby Street Liverpool

L7 8TX, United Kingdom

“Development of a rabbit model to characterise antifungal drug resistance.”

75F40123C00192 $1,211,682.00 $655,810.00 OO AKINA, INC

KINAM PARK 3495 KENT AVE

STE A 200 WEST LAFAYETTE IN

479061074

“New PLGA analytical methods for mini-size complex long-acting injectable formulations.”

75F40123C00196 $552,931.00 $876,368.00 CDER VIRGINIA COMMONWEALTH UNIVERSITY

164539

VIRGINIA COMMONWEALTH

UNIVERSITY RICHMOND VA

23298-0568

“In Vitro and In Vivo Assessment of Buprenorphine Extended Release Injections for

Generic Product Equivalence ”

75F40123C00199 $2,949,902.00 $2,949,902.00 OC

MCKESSON SPECIALTY HEALTH

PHARMACEUTICAL & BIOTECH SOLUTIONS

LLC

BIOTECH SOLUTIONS LLC

10101 WOODLOCH FOREST

DRIVE THE WOODLANDS TX

77380

“Leveraging Real-World Data (RWD) to Investigate the Natural History of Rare Cancers Treated in the US Community Oncology Setting to Provide Clinical Context to Inform Future Research”

75F40123C00201 $687,062.00 $687,062.00 CDER UNIVERSITY OF SYDNEY 1618776

NICOLEMAKOVINEY, LEVEL 3 ,

ADMINISTRATION BUILDING

F23, THE UNIVERSITY OF

SYDNEY NSW 2006

Development of a laser-based testing platform for generic dry powder inhaler DPI evaluation and in-silico model validation”.

75F40123C00211 $437,576.00 $1,721,851.00 CDER TRUSTEES OF COLUMBIA UNIVERSITY IN

THE CITY OF NEW YORK

722 W 168TH STREET 4TH

FLOOR NEW YORK NY

100323702

“Health and Neurodevelopmental Outcomes in Infants at Risk for Neonatal Opioid Withdrawal

Syndromes (NOWS): Effects of Timing and Duration of Prenatal Opioid Exposure (POE) &

Postnatal Management with Eat�Sleep-Console

(ESC).”

75F40123C00213 $324,472.00 $964,769.00 CDER RUTGERS, THE STATE UNIVERSITY OF NEW

JERSEY

3 RUTGERS PLAZA NEW

BRUNSWICK NJ 089018559

“Role of excipients and excipient substitution in topical semi-solid formulations and their effect on product performance and quality”.

75F40123P00138 $21,480.00 $748,888.56 CDRH ARRAY STAR INC 1365876

9430 KEY WEST 9430 KEY WEST

AVE, STE 128 ROCKVILLE MD

208506345

Transfer RNA Sequencing (tRNAs) Service

75F40123C00185 $399,988.00 $399,988.00 CDER MONASH UNVIERSITY 1635407

DAVID ROBSON MONASH

UNIVERSITY WELLINGTON R

WELLINGTON RD CLAYTON VIC

Bridging the gap between urinary tract infection pharmacokinetic/pharmacodynamic in vitro models and the optimization of antibiotic selection, dosing strategies, clinical breakpoints, and novel drug development.”

75F40123C00195 $523,227.89 $523,227.89 CDER AMERICAN COLLEGE OF EMERGENCY

PHYSICIANS

4950 West Royal Lane, Irving

TX 75063-2524

“Naloxone Usage, Safety, And Efficacy in Prehospital Environment for Conventional and

Emerging Synthetic Opioids and Other Co-mixtures”

75F40123C00184 $996,392.00 $4,553,525.00 CDER AMERICAN COLLEGE OF MEDICAL

TOXICOLOGY INC 429654

AMERICAN COLLEGE OF

MEDICAL TOXICOL 5431 E

CHERYL DR PARADISE VALLEY

AZ 85253

“Real-world Examination of Naloxone d for Drug Overdose Reversal (RENDOR)”

Contract Number Amount Obligated Total Estimated Contract Value

Awardee Address

FY23 FDA BAA Awards

75F40123C00198 $190,246.00 $518,363.00 CDRH PPD DEVELOPMENT, LP 1228530

PPD DEVELOPMENT LP 929 N

FRONT ST WILMINGTON NC

28401

“Assessing , Clinical Site Readiness: A Framework to Support Enrollment of Under-Represented

Minorities in Medical Device Clinical Trials

75F40123C00204 $119,006.00 $507,625.00 CDER THE CORPORATION OF MERCER

UNIVERSITY 292546

THE CORPORATION OF

MERCER UNIVERSIT 1501

MERCER UNIVERSITY DR

MACON GA 31207

“In vitro tests to support bioequivalence determination when generic dermatological formulation has differences from the brand product formulation”.

75F40123C00140 $263,016.10 $263,016.10 OO INSTITUTE FOR CLINICAL

PHARMACODYNAMICS

242 BROADWAY STE 101 ,

SCHENECTADY NY 12305

“Development of Modernized Susceptibility Guidance for Ampicillin and Vancomycin for Enterococcus Species Using Pharmacometric

Approaches”.

75F40123C00197 $1,151,037.00 $1,151,037.00 CDER THE REGENTS OF THE UNIVERSITY OF

MICHIGAN

1058 WOLVERINE TOWER -

DRDA 3003 S. STATE ST. ANN

ARBOR MI 481091274

“Seamless Design for Multicomponent Endpoints for Drug , Development in Rare

Diseases”.

75F40123C00202 $811,680.97 $811,680.97 CDRH RESEARCH TRIANGLE INSTITUTE 105107

RESEARCH TRIANGLE

INSTITUTE 30 , 3040 E

CORNWALLIS RD , RESEARCH

TRIANGLE PARK NC 2770

“Patient Experience and Preference Research to Genitourinary Syndrome of Menopause”

75F40123C00183 $748,779.00 $748,779.00 CDRH DUKE UNIVERSITY 132317

OFFICE OF SPONSORED

PROGRAMS 2200 WEST MAIN

STREET SUITE 300 DURHAM

NC 27705

“Meaningful Changes in Patient Reported Outcomes – Identifying Changes That Matter to

Patients”.

75F40123C00138 $748,888.56 $1,206,589.24 CDRH DUKE UNIVERSITY 0 DUKE UNIVERSITY DURHAM

NC 277088990

“Quantifying patient priorities for clinical evidence on the impact of osseointegrated limb prostheses.”

75F40123C00209 $1,567,108.00 $1,567,108.00 CDER DUKE UNIVERSITY 132317 2200 W MAIN ST DURHAM NC 27705

“Medicare Advantage for Real World Evidence in Cardiovascular Disease”

75F40123C00208 $500,000.00 $800,000.00 OC THE RESEARCH FOUNDATION OF

STATEUNIV. OF NY 117615

RESEARCH FOUNDATION FOR

THE STATE U 4400 VESTAL

PKWY E BINGHAMTON NY

13902

"build human lactation PBPK 0.00 +models

75F40123C00118 $303,245.00 $1,530,889.00 CDER UNIVERSITY OF CONNECTICUT 297690

UNIVERSITY OF CONNECTICUT

438 438 WHITNEY RD

EXTENSION UNIT 1133 STORRS

CT 06269

“Investigating the Impact of API Purity, Excipient Source and Manufacturing Process on

Performance and Quality of Complex siRNA Lipid Nanoparticles”

75F40123C00188 $845,834.00 $845,834.00 CDRH RESEARCH TRIANGLE INSTITUTE 105107

3040 East Cornwallis Rd PO

BOX 12194 RESEARCH

TRIANGLE PARK NC 27709

“Project Titled Incorporating Patients' Experiences and Prioritization of Treatment

Outcomes into Regulatory Decision Making for Medical Devices: Application of Patient

Experience and Preference Research to Tricuspid Valve Disease”

75F40123C00200 $1,928,198.00 $4,714,475.00 CBER MASSACHUSETTS INSTITUTE OF

TECHNOLOGY

VIVIAN M HOLMES 77,

MASSACHUSETTS AVE NE18-

901 , CAMBRIDGE MA 02139

“Mechanistic Modeling and Process Analytical “Technology for Exosome Production”.

75F40123C00205 $415,700.00 $415,700.00 CDER UNIVERSITY OF EASTERN FINLAND

1642371

Arto Urtti PL 1627 KUOPIO 70211

“Understanding Preservative Effects on Bioequivalence of Topical Ocular Product”

75F40123C00210 $555,292.00 $1,233,980.00 CDER KAISER FOUNDATION HOSPITALS 157119

1 KAISER PLAZA 22ND FLOOR

OAKLAND CA 94612

Reducing the Use and Harms of Benzodiazepine Treatment through Health Systems

Interventions

75F40123C00142 $248,198.00 $248,198.00 CDER Universirty of Connecticut 438 whitney RD Extension Unit

1133 , Storrs CT 06269

“Impact of API CQAs on In Situ Forming Implants and Understanding In Vitro and In Vivo

Performance Differences”.

75F40123C00072 $179,898.00 $950,450.00 CDER CFD Research Corporation 6820 Moquin Drive

HUNTSVILLE AL 358062923

An CFD_PBPK Framework for Supporting Bioequivalence Evalutation of Ophthalmic Drugs Used FY23 funds for applications from FY22 BAA soliciatation

75F40123C00207 $400,000.00 $798,000.00 CDER CLINICAL DATA INTERCHANGE STANDARDS

CONSORTIUM

401 W 15TH ST STE 800

AUSTIN TX 78701

CDMH Phase III to Extend the Value of Common Data Model Harmonization and FHIR in the Generation of Clinical Evidence from Real World Data Sufficient to Support Regulatory Use Used FY23 funds for applications from FY22 BAA soliciatation

75F40123C00039 $594,609.00 $1,429,670.00 OC Battelle Memorial Institute

505 KING AVE

COLUMBUS OH 432011268

Development of a Ferret Nerve Agent Exposure Model For Chemical Warfare Agent Countermeasue Evaluation Used FY23 funds for applications from FY22 BAA soliciatation

$26,123,205.14 $43,690,919.38 Total Obligated in FY23 Total Contract Values

Sheet1