FY21 BAA Award Announcement-FINAL-UPDATED_ (003).pdf

Contract Number

Amount Obligated Total Estimated Contract Value

Center Awardee Name Awardee Address Awardee Zip Code

Description of Requirement

75F40121C0008

8 $ 224,478.00 $ 224,478.00 CDER

UNIVERSITY OF

MARYLAND103087

3112 LEE BLDG 7809 REGENTS DR

COLLEGE PARK

MD 20742-

Combating the COVID-19 Infodemic Through Evidence- Based Misinformation Strategies

75F40121C0014

4 $ 2,053,902.00 $ 3,761,678.00 OC

COMMONWEALTH

SCIENTIFIC AND INDUSTRIAL

RESEARCH ORGANIZATION

1595438

CLUNIES ROSS ST BLACK MOUNTAIN ACT

2601 AUSTRALIA AU 2601

Procure a scientific research study entitled: Strengthening COVID-19 animal models and regulatory science using a systems biologyapproach

75F40121C0016

7 $ 1,992,223.00 $ 5,930,261.00 OC

EMBLEEMA INC.

1592090 16 PEARL ST STE 110 METUCHEN NJ NJ 08840-1847

Development and maintenance of FDA-ARGOS 2 containing regulatory grade reference genomes for diagnostic use and regulatory science

75F40121C0018

$ 926,349.00 $ 926,349.00 CDER JOHNS HOPKINS UNIVERSITY

299008

3400 N CHARLES ST BALTIMORE MD MD 21218-

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

Administration

75F40121C0017

$ 373,488.00 $ 645,896.00 NCTR GEORGIA TECH RESEARCH

CORPORATION 160612

926 DALNEY ST NW ATLANTA GA 30332 Quantitative, Label-Free Chemical Imaging for Mechanistic Discovery, Identification and Stratification of Disease

75F40121C0015

4 $ 378,839.00 $ 378,839.00 NCTR

UNIVERSITY OF TENNESSEE

103423 62 S DUNLAP STREET STE 103 MEMPHIS TN 38103-4903

Evaluation of Small Animal Models for COVID-19 and their Application in Nonclinical Safety and Efficacy Studies of

Investigational Therapeutics

75F40121C0015

3 $ 237,550.00 $ 1,237,710.00 CDER

GEORGIA TECH RESEARCH

CORPORATION 160612 926 DALNEY ST NW ATLANTA GA 30332

Real time microfluidic cell sensing and sorting to evaluate drug resistance in leukemia cells

75F40121C0019

$ 2,294,544.00 $ 14,255,253.00 CBER ZATA PHARMACEUTICALS

INC. 1596760

60 PRESCOTT ST. WORCESTER MA 016052661 Universal Closed Systems for Pathogen Reduction in Donated Whole Blood Units

75F40121C0016

$ 350,353.00 $ 350,353.00 OC NORTHWESTERN UNIVERSITY

317125

633 CLARK ST. EVANSTON IL 60208-0001 Evaluation of a Global Item for Side Effect Bother

75F40121C0009

2 $ 3,095,955.00 $ 3,095,955.00 OC

ST JUDE CHILDRENS

RESEARCH HOSPITAL 354326 262 DANNY THOMAS PL MEMPHIS TN 38105-3678

Modeling Pediatric Solid Tumors and the Tumor Microenvironment

75F40121C0013

4 $ 749,361.96 $ 749,361.96 OC

CARDINAL HEALTH 127

INC. 1596241 7400 W 110TH ST OVERLAND PARK KS 66210-2358

Validation of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real- World Studies

75F40121C0012

9 $ 198,408.00 $ 198,408.00 OC

MEDICAL COLLEGE OF

WISCONSIN 405286

8701 WATERTOWN PLANK RD

MILWAUKEE WI 53226-3548

Commensurate prior models accommodating historical controls for clinical trials with matched and/or intervalcensored

75F40121C0013

$ 1,048,942.00 $ 1,048,942.00 OC

THE CHILDRENS

HOSPITAL OF PHILADELPHIA

356961

3401 CIVIC CENTER BLVD PHILADELPHIA PA 19104-4319 Pediatric High-Risk Cancer Preclinical Model Resource

75F40121C0014

3 $ 100,000.00 $ 100,000.00 OC

MEDICAL COLLEGE OF

WISCONSIN 405286

8701 WATERTOWN PLANK RD

MILWAUKEE WI 53226-3548

Estimation of Casual Treatment Effects in Hematologic Oncology (HO) Trials in the Presences of Multiple Subsequent Therapies

75F40121C0013

1 $ 2,565,626.00 $ 2,565,626.00 CBER

MASSACHUSETTS INSTITUTE

OF TECHNOLOGY 100706 77 MASSACHUSETTS AVE CAMBRIDGE MA 02139-4301

study entitled, “Technologies to enable continuous production of rAAV from Sf9 baculovirus culture”

75F40121C0013

$266,809.00 $ 480,183.00 CDRH IDAHO STATE UNIVERSITY

152474

921 S 8TH AVE STOP 8219 POCATELLO ID 83209-0002 study entitled, “Artificial Intelligence in healthcare understanding patient perspectives and improving patient experiences”

75F40121C0013

2 $ 309,976.92 $ 309,976.92 CDER

THE UNIVERSITY OF

AUCKLAND 1432701 24 PRINCES STREET AUCKLAND NZ 1010

study entitled, “Applying a robotic soft esophagus (RoSE) to assess the swallowability of opioid drugs”

75F40121C0013

$ 1,193,782.00 $ 1,310,263.00 CDER UNIVERSITY OF

CONNECTICUT 297690

438 WHITNEY RD EXTENSION UNIT 1133

STORRS

CT 06269-1133

study entitled, “Enhancement and Validation of In Vitro

- In Vivo Correlation Method for Long Acting Injectable

Drug Products to Accelerate Their Generic Development”

75F40121C0018 9 $ 667,142.00 $ 667,142.00 CDER PURDUE UNIVERISTY 311033 155 S GRANT ST WEST LAFAYETTE IN 47907-2114 study entitled “Characterization of Carboxymaltose Variability and Interactions in Ferric Carboxymaltose Complexes”

75F40121C0014 5 $ 580,000.00 $ 580,000.00 CDER F2G LTD 1595441 F2G LTD LANKRO WAY MANCHESTER LANCASHIRE M30 study entitled, “Creation and validation of a patient reported outcome (PRO) instrument for the assessment of health-related quality of life (HRQOL) in patients with coccidioidomycosis”

75F40121C0012

8 $ 249,975.00 $ 249,975.00 CDER

HARTFORD HOSPITAL

1364439 80 SEYMOUR ST HARTFORD CT 06102-8000

study entitled, “A critical look at cefepime breakpoints in vivo an assessment of cefepime activity against carbapenemase-producing

Enterobacterales with unexpected cefepime”

75F40121C0012

7 $ 307,205.00 $ 307,205.00 CDER

JOHNS HOPKINS UNIVERSITY

299008 3400 N CHARLES ST BALTIMORE

MD 21218-

study entitled, “To Provide Evaluating the Impact of Extended-Infusion ?-lactam Administration Strategies on Improving

Clinical Outcomes and Reducing the Subsequent Emergence of Antimicrobial Resistance”

75F40121C0012

6 $ 388,347.00 $ 388,347.00 CDER

THE UNIVERSITY OF

QUEENSLAND 1249762

LEVEL 8, UQ CENTER FOR CLINICAL

RESEARCH ROYAL BRISBANE AND

WOMENS HOSTPITAL

AU QLD 4029

study entitled, “Continuous vs intermittent infusion of beta-lactam antibacterial drugs impact on resistance and outcomes in sepsis”

75F40121C0015 8 $ 299,924.00 $ 299,924.00 CBER DUKE UNIVERSITY 132317 2200 W MAIN ST STE 710 DURHAM NC 27708-4677

Using simulation modeling and real-world data to monitor the effectiveness of the COVID-19 vaccine

75F40121C0014

8 $ 316,471.00 $ 1,487,081.00 CDER

REGENTS OF THE

UNIVERSITY OF MICHIGAN

221536

503 THOMPSON ST ANN ARBOR MI 48109-1340 BAA SSBSWP 189

75F40121C0014

9 $ 683,353.00 $ 1,156,751.00 CDER

UNIVERSITY OF CALIFORNIA

158384

1855 FOLSOM ST STE 425 SAN

FRANCISCO CA 94143-4249 BAA SSBSWP 179

75F40121C0010

$ 2,814,105.00 $ 2,814,105.00 CBER REGENTS OF THE UNIVERISTY

OF CALIFORNIA 228475

10889 WILSHIRE BLVD STE 700 LOS

ANGELES

CA 90024-4201 BAA GLOBWP 60

75F40121C0015

$ 499,445.00 $ 499,445.00 CDER UNVERSITY OF FLORIDA

147908

1523 UNION RD RM 207 GAINSVILLE FL 32611-1941 BAA PMWP 148

study entitled, “A Mosaic Approach for Understanding Stimulant Use, Misuse and Use Disorder Trajectories” conduct a study entitled, “A Multidisciplinary Approach to Understanding Stimulant Use Disorders: Use Trajectories, Medical

Consequences and Treatment Goals” study entitled, “Strengthening Pharmacovigilance Systems and Adverse Events Reporting for Maternal Immunization Safety in the

Democratic Republic of Congo” conduct a study entitled, “Beta-lactam continuous versus intermittent infusion and associated bacterial resistance and therapy outcomes in critically ill patients with severe pneumonia”

BAA PMWP 154

BAA PMWP 156

BAA PMWP 173

BAA PMWP 170

BAA PMWP 172

BAA PMQWP 312

BAA EETWP 54

BAA PMQWP 294

BAA PMQWP 304

BAA PMQWP 329

BAA PMWP 160

BAA PMWP 176

BAA PMWP 147

BAA PMWP 143

BAA PMWP 146

BAA MCMWP 104

BAA MCMWP 101

BAA PMWP 135

BAA EETWP 58

BAA HDDISWP 149

BAA WP Number

BAA SSBSWP 175

BAA MCMWP 110

BAA MCMWP 117

BAA HDDISWP 134

75F40121C0018

$ 249,999.00 $ 249,999.00 CDER HARTFORD HOSPITAL

1364439

80 SEYMOUR ST HARTFORD CT 06102-8000 BAA PMWP 166

75F40121C0013

$ 794,004.00 $ 794,004.00 CDER PURDUE UNIVERISTY 311033 155 S GRANT ST WEST LAFAYETTE IN 47907-2114 BAA PMQWP 298

75F40121C0009

6 $ 63,081.00 $ 63,081.00 OC

HAPATITIS B FOUNDATION

1592041 3805 OLD EASTON TD DOYLESTOWN PA 18902-8400 BAA HDDISWP 132

75F40121C0011

1 $ 3,572,685.00 $ 4,999,325.00 CDER

MASSACHUSETTS UNSTITUTE

OF TECHNOLOGY 100706 77 MASSACHUSETTS AVE CAMBRIDGE MA 02139-4301 BAA PMQWP 324

75F40121C0013

8 $ 700,000.00 $ 700,000.00 CDER

ACADEMISCH ZIEKENHUIS

LEIDEN 1139836 ALBINUSDREEF 2 LEIDEN ZUID- HOLLAND

LEIDEN ZUID

HOLLAND 2333 BAA PMWP 142

75F40121C0010

6 $ 2,279,621.00 $ 4,198,914.00 CDER

RUTGERS, THE STATE

UNIVERSITY 299012 3 RUTGETS PLAZA NEW BRUNSWICK NJ 08901-8559 BAA PMQWP 309

75F40121C0011

9 $ 600,000.00 $ 1,200,000.00 CDER

THE UNIVERSITY OF

MISSISSIPPI 354320 113 FALKNER MS 38677-9704 BAA PMQWP 338

75F40121C0016

$ 391,759.25 $ 391,759.25 CDER UNIVERSITAT ST.GALLEN

1592134

DUFOURSTRASSE 50 ST. GALLEN ST. GALLEN SG 9000 BAA PMQWP 336

75F40121C0009

$ 5,000,001.00 $ 5,000,001.00 CDER

MASSACHUSETTS

INSTITUTE OF TECHNOLOGY

100706

77 MASSACHUSETTS AVE CAMBRIDGE MA 021394301 BAA PMQWP 314

75F40121C0015

0 $ 1,399,298.00 $ 1,399,298.00 CDER

UNIVERSITY OF

CONNECTICUT 297690

438 WHITNEY RD EXTENSION

UNIT 1133

STORRS

CT 06269-1133 BAA EETWP 56

75F40121C0017

7 $ 500,000.00 $ 500,000.00 OC

HOWARD UNIVERSITY

347586 2400 6TH ST NW WASHINGTON DC 20059-0001 BAA MCMWP 111

75F40121C0018

$ 749,980.00 $ 749,980.00 CDER UNIVERSITY OF FLORIDA

147908

1523 UNION RD RM 207 GAINSVILLE FL 32611-1941 BAA SSBSWP 173

75F40121C0002

0 $ 272,553.00 $ 386,781.00 CDER

JOHANNES GUTENBER-

UNIVERSITAT MAINZ

1585755

JOHANNES GUTENBER- UNIVERSITAT

MAIN SAARSTR. 21

MAINZ RHEINLAND-

PFLAZ 55122 BAA PMQWP 259

75F40121C0008 7 $ 2,696,737.00 $ 5,504,916.00 OC AETION INC 1591094 5 PENN PLZ FL 7 NEW YORK NY 100011837 BAA MCMWP 97

75F40121C0008

$ 393,043.00 $ 393,043.00 OC MEDSTAR RESEARCH

INSTITUTE 283696

6525 BELCREST RD STE

HYATTSVILLE

MD 207822031 BAA SSBSWP 184

75F40121C001

$ 599,723.00 $ 599,723.00 CDER OREGON HEALTH & SCIENCE

UNIVERSITY 160276

3181 SW SAM JACKSON PARK RD

PORTLAND OR 97239-3011 PMWP 183

75F40121C000

$ 683,910.00 $683,910.00 CDER AUBURN UNIVERSITY 280440 107 SAMFORD HALL AUBURN AL 36849-0001 SSBSWP 165

Totals $46,112,948.13 $73,834,242.13

Study entitled, “Assessment of a pharmacist-led transitions of care service utilizing an admission-enhanced patient risk evaluation approach”

Study entitled, "Teratogenic Risk Impact and Mitigation (TRIM): An Evidence-based Decision Framework”

Study entitled, “Disintegration and dissolution of solid dosage forms and influence of food induced viscosity on its kinetics, tools and methodologies for bioequivalence and substitutability evaluation” study entitled, “Real-world evidence for rapid, systematic assessmentof COVID-19 countermeasures? safety and effectiveness in inpatientsettings” study entitled: "Artificial Intelligence (AI) Supported Annotation of FAERS Reports”

Study entitled, “Development of pulmonary nontuberculous mycobacterial disease symptom scale (NTM-SS) pulmonary NTM infection”

Study entitled, "Preventable Harm from Pediatric Outpatient Medication Errors:

Conduct a study entitled, “RiskSurve - Towards a Holistic Risk-based Site Surveillance An approach for remote, data- based site risk identification and inspection preparation in a (Post-) COVID-

19Environment” study entitled, “Application of Smart Data Analytics for Biomanufacturin”

Study entitled, "Comparative Trial of Different Packaging Components of an Opioid Packaging Solution on Opioid Safety Outcomes” study entitled, “Bridging Gaps: Recruiting African and Asian American Participants in Clinical Trials and Creating Culturally Competent

Messages” study entitled, " Assessment tools for surveillance and monitoring fo real-world data systems and processes to ensure product quality" study entitled “Improving clinical trial diversity and participation among people living with chronic hepatitis B Perceptions and challenges”

Controlled Protein Capture via Continuous Crystallization and Precipitation for Monoclonal Antibody Manufacturing

Study entitled, "Reversal of Opioid-induced respiratory depression with opioid antagonists A Study in opioid individuals and chronic opioid users under real-life conditions”

Study entitled, "Integrated toolbox for digital design, scale- up, control, and optimization of advanced API manufacturing processes” study entitled, “Ampicillin-Sulbactam against Acinetobacter baumannii infections:

Pharmacokinetic/Pharmacodynamic Appraisal of Current Susceptibility Breakpoints and Dosing

Recommendations” https://worksmarter.appiancloud.com/suite/sites/ars-prism-document-view/page/prism-documents/record/lsB67hqAUmdqmYT-iRY4XReLhBlkbJzbAqmDfZ5s0TzJYeV12wQHdDjoUNZwEnGontxHtufIjPYXR1xjGlAChD785J9oMdI3pTxrs1S-GG8vltMXxuZE8vDk5C_/view/summary https://worksmarter.appiancloud.com/suite/sites/ars-prism-document-view/page/prism-documents/record/lsB67hqAUmdqmYT-iRY4XReLhBlkbJzbAqmDfZ5s0TzJYeV12wQHdDjoUNZwEnGontxHtufIjPYXR1xjGlAChD785J9oMdI3pTxrs1S-GG8vltMXxuZE8vDk5C_/view/summary

Table 1