FY22 BAA Award Announcement.pdf

Contract Number

Amount Obligated

Total Estimated Contract Value Center Awardee Name Awardee

Address

BAA WP

Number Description

75F40122C00146 $2,014,369.00 $2,014,369.00 CTP Georgia Tech Research Corp

926 Dalney Street NW, Atlanta, GA

30332

TOXWP

In Vitro Assessment of Chemical Mixture-induced Airway Inflammation in Healthy and Diseased

Lungs.

75F40122C00128 $353,326.00 $353,326.00 CDER University of

Wisconsin 21 N Park Street, Suite 6301, Madison, WI 53715

PMWP 186 Development of Modernized Susceptibility Guidance for Oral Cephalosporin Antimicrobial Agents Using Pharmacometric Approaches

75F40122C00147 $400,000.00 $400,000.00 CDER The Regents of the University of Michigan

3003 S. State Street, Ann Arbor, MI 48109

PMWP 190 Advancing Methods to Optimize Antimicrobial Dosing in Patients with Obesity

75F40122c00180 $291,618.00 $291,618.00 CDER Institute for Clinical Pharmacodynamics

242 Broadway

STE 101,

Schenectady, NY 12305

PMWP 191 Combatting Antibiotic Resistant Bacteria (CARB) Program

75F40122C00184 $1,550,000.00 $2,942,329.00 OC Alliance NCTN Foundation

125 S Wacker Drive, STE 1600, Chicago, IL 60606

PMWP 194 Real World Collection of Radiographic Images and Treatment Emergent Adverse Event Data Next Phase Development of ICAREdata Research Institute

75F40122C00174 $291,142.00 $291,142.00 CDER Institute for Clinical Pharmacodynamics

242 Broadway

STE 101,

Schenectady, NY 12305

PMWP 195 A study in the "Development Of Modernized Susceptibility Guidance for Oral Sulfamethoxazole- Trimethoprim Using Pharmacometrics Approaches

75F40122C00138 $246,617.00 $246,617.00 CDER University of Southern California

3720 S Flower Street, FL 3, Los Angeles, CA 90007

PMWP 198 A study into modified susceptibility testing protocol for predicting polymyxin in vivo efficacy

75F40122C00187 $100,000.00 $100,000.00 OC University of Oklahoma

PO BOX 26901

URP865, Suite 490, Oklahoma City, OK 73126

PMWP 213 Analyzing clinical outcomes and genomic data of American Indian patient population treated with immune checkpoint inhibitors for various cancers

75F40122C00112 $1,783,975.93 $3,177,482.71 CDRH Synensys, LLC 145 Governors Square, Suite D, Peachtree City, GA 30269

PMWP 214 Improving the Reliability, Interoperability, Agility, and Quality of Laboratory Data Exchanges using System Safety Engineering and High Reliability Organization Methods

75F40122C00179 $1,000,000.00 $3,470,544.66 CDRH College of American Pathologists

325 Waukegan Road, Northfield, IL 60093

PMWP 216 In Vitro Diagnostic (IVD) Encoded Test Result Data Validation and Quality Improvement

75F40122C00143 $9,999,920.00 $9,999,920.00 CDRH Deloitte Consulting L.L. P

1919 N. Lynn Street, Arlington, VA 22209

PMWP 217 Optimizing Knowledge Management Processes that Enable a Highly Reliable Laboratory Data Life Cycle

75F40122C00130 $407,720.00 $407,720.00 CDER Hartford Hospital 80 Seymour Street, Hartford, CT 06102

PMWP 218 Ex Vivo Modeling, Simulation, and In Vivo Pharmacokinetic Validation to Guide Antimicrobial Dosing Recommendations for Patients on Continuous Renal Replacement Therapy

75F40122C00134 $399,991.00 $399,991.00 CDER Midwestern University

555 31st Street, Downers

PMWP 219 Development and Validation of CRRT-specific

Grove, IL 60515

Beta-Lactam Population Pharmacokinetic Models to Guide Treatment for Patients with Hospital- Acquired Pneumonia

75F40122C00161 $3,795,000.00 $3,795,000.00 CDRH Safe Health Systems INC.

1475 N Scottsdale Road, STE 200, Scottsdale, AZ 85257

PMWP 229 Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcome

75F40122C00139 $265,368.00 $527,318.00 CDER Uppsala Universitet

Dag Hammarskjolds Vag 7, 752 37, Uppsala, Sweden

PMQWP

Model-integrated strategies for bioequivalence evaluation of drugs with high variability and/or long half-life

75F40122C00163 $709,554.00 $709,554.00 CDER DigiM Solution 2 Chestnut Street, Winchester, MA 01890

PMQWP

Correlative 3D Imaging and AI Analysis to Establish Critical Performance Attributes of Polymeric Microsphere Products in Support of Performance Evaluation

75F40122C00019 $447,513.00 $997,996.00 CDER University of Texas 110 Inner Campus Drive, Austin, TX 78712

PMQWP

Correlation Between Material properties, Manufacturing process, Structural properties, and Quality Attributes of Long-acting, Biodurable Implants

75F40122C00123 $300,255.00 $300,255.00 CVM Texas A&M University System

8441 Riverside Parkway, BLDG 1, STE 3, Bryan, TX 77807

PMQWP

In-Vitro Quality Metrics Approach for Bioequivalence Demonstration Between Intramammary Infusion Products of Animals

75F40122C00197 $408,329.00 $408,329.00 CDER Inhalation Sciences Halsovagen 7, Huddinge SE 141 57

PMQWP

A study in "DissolvIt an in vitro test model built to resemble relevant lung physiology for evaluating the dissolution-and absorption of drugs administered via the inhalation route

75F40122C00202 $764,285.00 $764,285.00 CDER University of Sydney

The University of Sydney NSW

PMQWP

Identification of Drug Distribution in Aerosols: A Nanospectroscopy and NanoThermal Analysis

75F40122C00121 $160,376.00 $494,060.00 CDER Drexel University 3141 Chestnut Street, Philadelphia, PA 19104

PMQWP

Machine-Learning based Heterogeneous Treatment Effect Models for Prioritizing Product-Specific Guidance Development

75F40122C00192 $3,000,000.00 $3,000,000.00 CDER National Institute for Pharmaceutical Technology and Education

717 Delaware Street SE, STE 482, Minneapolis, MN 55414

PMQWP

Continuous drug substance manufacturing from biomass-derived building blocks

75F40122C00182 $1,844,289.00 $1,844,289.00 CDER University of Florida

1523 Union Road, Rm 207

PMQWP

Advancing In Vitro and (patho)Physiology-Based Pharmacokinetics Models to Understand and Predict Pulmonary Absorption and Tissue Retention of Inhaled Drugs

75F40122C00200 $82,182,000.00 $82,182,000.00 CBER Massachusetts Institute of Technology

Massachusetts Ave, Cambridge, MA 02139

PMQWP

To Development of an Integrated Continue cGMP Facility for mRNA Manufacturing

75F40122C00186 $2,692,771.30 $2,692,771.30 CBER Trustees of Princeton University

1 Nassau Hall, Princeton, NJ 08544

PMQWP

An Integrated Platform for Continuous RNA Nanoparticle Formulation and Drying

75F40122C00122 $2,701,518.97 $4,999,953.00 CDER National Institute for Pharmaceutical Technology and Education

717 Delaware Street SE, STE 482, Minneapolis, MN 55414

PMQWP

A Model-Based Systems Engineering Approach to End-to-End Pharmaceutical Manufacturing of Liquid

75F40122C00155 $224,632.00 $393,716.00 CDRH American Academy of Ophthalmology

655 Beach Street, Floor 3, San Francisco, CA 94109

EETWP 59 A study in Leveraging the real-world data from the American Academy of Ophthalmology's IRIS Registry to evaluate the use and impact of approved medical devices and software algorithms

75F40122C00183 $943,192.00 $943,192.00 CDRH University of Missouri

5100 Rockhill Road, Kansas City, MO 64110

EETWP 60 KCCQ Validation in Tricuspid Valve

75F40122C00196 $937,737,91 $3,694,735.47 CDER Critical Path Institute

1730 E River Road, STE 200, Tucson, AZ 85718

EETWP 63 A standardized framework to support FDA qualification of complex in vitro models for use in regulatory submissions

75F40122C00116 $753,973.00 $3,518,377.00 CDER The Regents of the University of California

1855 Folsom Street, STE 425, San Francisco, CA 94103

EETWP 65 Community Uses of Psychedelics and Safety Study (CUPS)

75F40122C00203 $6,523,977.04 $47,223,589.66 CDRH Nanobiosym INC. 245 First Street, STE 18, Cambridge, MA 02142

EETWP 66 Gene-RADAR Mobile Device & Nanobiosym Digital Dx Platform for Precision Mobile Diagnosis

75F40122C00154 $2,032,775.00 $2,032,775.00 CDER Brigham and Women’s Hospital

INC.

75 Francis Street, Boston, MA 02115

HDDISWP

Real-world evidence to support labeling expansions for effectiveness claims using a two-stage trial emulation process

75F40122C00181 $2,708,850.00 $2,708,850.00 OC Brigham and Women’s Hospital

INC.

75 Francis Street, Boston, MA 02115

HDDISWP

Calibrating RWE Studies in Oncology Against Randomized Trials

75F40122C00193 $2,044,056.00 $3,077,090.00 CDER University of North Carolina

104 Airport Drive, CB# 1350, Chapel Hill, NC 27599

HDDISWP

Opioid Data Lab:

Understanding Overdose Through Scientific Innovation

75F40122C00165 $1,353,024.00 $1,353,024.00 CDER Denver Health and Hospital Authority

777 Bannock Street, Denver, CO 80204

HDDISWP

General Online Longitudinal Drug Survey: A novel approach to combining surveillance and longitudinal designs for investigating drug use trajectories

75F40122C00185 $119,160.00 $549,175.31 CDER American College of Emergency Physician’s

4950 W Royal Lane, Irving, TX 75063

HDDISWP

Analysis of Naloxone Usage, Safety, and Efficacy in the Emergency Department and Prehospital Environment During the COVID-19 Pandemic

75F40122C00168 $400,756.00 $400,756.00 CFSAN Texas Tech University

Broadway, Lubbock, TX 79409

FSSWP 19 Improving detection of plant contaminants in mixed samples with targeted sequencing of 353 nuclear protein coding genes

75F40122C00051 $559,428.00 $2,275,305.00 OC The Children’s Hospital of Los Angeles

4650 Sunset Blvd, Lost Angeles, CA 90027

MCMWP

Development of a model that integrates inflammation and tissue injury to predict and mitigate the post-acute sequelae of COVID19

75F40122C00169 $623,991.00 $623,991.00 NCTR The University of Tennessee

62 S Dunlap Street, Memphis, TN 38163

MCMWP

Longitudinal Quantitative Evaluation of Clinical, Immunological, and Virological Characteristics of COVID-19 in Mucosal, Blood, and Fecal Specimens from Adults, Children, and Exposed Household Members

75F40122C00023 $317,349.00 $607,510.00 CDER University of North Carolina

104 Airport Drive, STE 2200, Chapel Hill, NC 27599

SSBSWP

Reducing Preventable Medication Errors through Minimizing Work Distractions: Evaluating Data from Smart Pump Usage in Health Systems across the Midwest

75F40122C00137 $855,584.00 $855,584.00 OC Americans for Indian Opportunity

Marquette Ave

NW,

Albuquerque, NM 87102

SSBSWP

Increasing Participation in Clinical Trials and Research inTribal and Urban Indigenous Communities

75F40122C00111 $230,000.00 $230,000.00 OC National Minority Quality Forum, INC.

1201 15th Street NW, STE 340, Washington, DC 20005

SSBSWP

Strengthening FDA’s Ability to Communicate Health and Safety Information to Minority Populations About Pediatric COVID-19 Vaccines and Vaccine Boosters Utilizing Social Media Platforms

75F40122C00145 $575,451.00 $575,451.00 CDER Anticoagulation Forum, INC.

17 Lincoln Street, Floor 2, Newton, MA 02461

SSBSWP

Oral Anticoagulation Surveillance and Improvement through Stewardship (OASIS)

75F40122C00148 $1,997,031.00 $1,997,031.00 CBER New York Medical College

40 Sunshine Cottage Road, Valhalla, NY 10595

SSBSWP

Long-term Outcomes of COVID-19 Vaccine-associated Myocarditis

75F40122C00191 $1,184,520.00 $2,656,207.00 CDER Northwestern University

750 N. Lake Shore Drive, Rubloff 7th Floor, Chicago, IL 60611

SSBSWP

Assessing the Effectiveness of Text Enhancements to Prevent Drug Name Confusion Errors

Totals $141,557,687.24 $202,527,229.11