FY18_BAA_FBO_Award_Announcement.pdf

Contract Number Amount Obligated Total Estimated Contract Value Vendor Name Description of Requirement

1 HHSF223201810187C $324,410.00 $1,482,306.00 Regents of the University of Michigan

Influence of raw materials, manufacturing variables, and storage conditions on release performance of long‐acting release microsphere products

2 HHSF223201810189C $106,664.00 $106,664.00 American Society of Nephrology, Inc.

Identification and Assessment of Patient‐Reported Outcome Measures (PROMs) for Novel Renal Devices

3 HHSF223201810188C $458,014.00 $888,097.00

The Research Foundation for the State Univeristy of New York

Physiologically‐based model of the female reproductive tract:

vaginal and intrauterine delivery components – Support New Approaches to Improve Product Manufacturing and Quality

4 HHSF223201810172C $942,075.00 $2,283,839.00 The Broad Institute, Inc.

Comprehensive Spatio‐Temporal Map of Gene Expression During Lethal Ebola Virus Disease

5 HHSF223201810123C $406,408.00 $406,408.00 EDJ Analytics, LLC Develop Data Analysis Techniques and Perform Data Profiling in Order to Improve Overall Regulatory Data Quality

6 HHSF223201810186C $500,076.20 $1,072,328.42 CUBRC, Inc.

Immunogenicity Risk of Peptide Drug Generics and their Impurities: In Silico and In Vitro Assessment and Validation Methods

7 HHSF223201810182C $159,903.00 $499,761.00 CFD Research Corporation A Multiscale Computational Framework for Bioequivalence of Orally Inhaled Drugs

8 HHSF223201810158C $401,691.88 $401,691.88 UserWise, Inc.

Training Decay Selection for Medical Product Usability Validation Testing

9 HHSF223201810136C $120,000.00 $120,000.00 Brigham and Womens Hospital, Inc

Confidence in Decision‐Making: Evaluating a Structured Reporting Template to Increase Transparency and reduce Review Time for Healthcare Database Studies

10 HHSF223201810184C $569,688.00 $2,590,422.00 The Critical Path Institute

Developing novel kidney transplant drug development tools to enhance regulatory decision making and enable innovation in medical product development

11 HHSF223201810175C $1,454,560.00 $1,454,560.00 University of Mississippi

Holistic Approach for Potential Drug Interactions with Botanical Drugs ‐ importance of Chemical Fingerprinting and Bio‐Similarity

12 HHSF223201810201C $5,733,684.00 $5,733,684.00 Kaiser Foundation Hospitals Effects of Medical Products on Suicidal Ideation and Behavior

– Real World Evidence

13 HHSF223201810326P $247,954.00 $949,307.00 Conceptant, Inc. Visualizing Interconnected Projects

14 HHSF223201810150C $30,404.00 $98,946.00

Sharp Mary Birch Hospital For Women and Newborns

Conduct a study entitled, "Manganese Contamination in Neonatal Parenteral Nutrition.

15 HHSF223201810208C $249,000.00 $249,000.00 WebMD Health Corp. Lupus clinical research participation study

16 HHSF223201810148C $218,000.00 $218,000.00 WebMD Health Corp.

Understanding of Safe Medication Use By Women's Health Special Populations

Contract Value Vendor Name Description of Requirement

17 HHSF223201810146C $1,604,165.00 $1,604,165.00 Brigham and Womens Hospital, Inc

Effectiveness research with Real World Data to support FDA's regulatory decision making: A Real World Evidence Demonstration Project

18 HHSF223201810151C $159,922.00 $159,922.00 CFD Research Corporation An Integrated Multiscale‐Multiphysics Framework for Evaluation of Generic Ophthalmic Drug Products

19 HHSF223201810169C $374,884.00 $374,884.00 University of Texas at Austin Evaluating Batch to Batch Variability and its Origins in Dry Powder Inhalers

20 HHSF223201810163C $699,201.00 $699,201.00 Duke University Patient Preference Information: Bridging Regulatory Decisions and Clinical Practice

21 HHSF223201810044C $289,719.00 $289,719.00 AntiCoagulation Forum Inc. Core Elements of Anticoagulation Stewardship

22 HHSF223201810128C $192,364.00 $192,364.00

The Regents of the University of California, San Francisco

21st Century Cures ‐ DEVELOPMENT, ASSESSMENT AND

VALIDITY COMPARISON OF APPROACHES TO ELICITING

PATIENT PREFERENCES ACROSS RISK GROUPS: A CASE STUDY

ON INNOVATIVE PREFERENCE SENSITIVE TREATMENTS (TYPE

1 DIABETES OR HEREDITARY RETINAL DYSTROPHY OR

OSTEOARTHRITIS)

23 HHSF223201810129C $364,781.00 $364,781.00 Research Triangle Institute Center for Biologics Evaluation and Research's (CBER) Patient Preference Study

24 HHSF223201810114C $385,768.00 $1,141,038.00 University of Connecticut In Vitro and In Vivo Assessment of Ophthalmic Ointments for Generic Product Equivalence

25 HHSF223201810113C $118,578.00 $277,849.00 Research Triangle Institute

Formative Research Study to Understand the Impact of Generic Drug‐Device Substitutes for Various Patient and Caregiver Populations

26 HHSF223201810209C $651,762.00 $1,122,452.00

Trustees of the University of Pennsylvania

A scalable, patient‐centered approach for "right sizing" opioid prescribing study

27 HHSF223201810115C $245,419.00 $245,419.00 University of Connecticut Impact of Polymer Source Variations on Parenteral Microsphere Drug Product Performance

28 HHSF223201810127C $1,408,195.00 $3,445,344.00 Regent of the University of Colorado Toxicity and Carcinogenicity Profiling of Tobacco Products via Organ Microengineering and Systems Biology

29 HHSF223201810083C $329,475.00 $329,475.00 University of Florida Safety of Gadolinium‐Enhanced MRI Exposure During Pregnancy on Adverse Fetal Outcomes

30 HHSF223201810084C $1,992,737.48 $1,992,737.48 Deloitte Consulting, LLP Regulatory Decision Making through the Use of High Quality and Standardized Data

31 HHSF223201810116C $880,000.00 $880,000.00 Medical Device Innovation Consortium Framework for Incorporating Patient Input into Medical Device Clinical Trials

32 HHSF223201810082C $228,760.00 $228,760.00 National Academy of Sciences Updating Labels for Generic Oncology Drugs

33 HHSF223201810077C $499,483.99 $499,483.99 Conceptant, Inc.

Healthy Citizen ‐ Enhancing Public Health Through Citizen‐ Centric Communications

Contract Value Vendor Name Description of Requirement

34 HHSF223201810194C $896,696.00 $896,696.00 Research Triangle Institute Identification and Validation of a Biomarker of Electronic Cigarette Exposure

35 HHSF223201810144C $521,920.00 $521,920.00

Virginia Commonwealth University

(VCU)

Evaluating Relationships Between In Vitro Nasal Spray Characterization Test Metrics for Bioequivalence and Nasal Deposition In Silico and In Vitro

36 HHSF223201810112C $254,902.00 $254,902.00 University of Birmingham UK Better Understanding Risk Mitigation in the Evaluation of Relative Bioavailability of Pediatric Generic Products

37 HHSF223201810051C $70,473.00 $139,502.00

ANN & ROBERT H. LURIE CHILDREN'S

HOSPITAL

Comparative Safety of Complex Feeding Device Types among NICU graduates

38 HHSF223201810183C $3,205,422.00 $6,584,713.00 University of North Carolina Methodological Advances In Evaluating Abuse Deterrent Opioid Analgesics

39 HHSF223201810171C $933,606.00 $986,328.00 University of Louisville

Development of a Mouse Model for Preclinical Screening of Investigational Drugs Against Pseudomonas Aeruginosa and Acinetobacter Baumannii

$28,230,765.55 $41,786,669.77