BAA_Amendment_2.pdf

AMENDMENT TO FDA BROAD AGENCY ANNOUNCEMENT FOR THE ADVANCE

RESEARCH AND DEVELOPMENT OF REGULATORY SCIENCE AND

INNOVATION

Broad Agency Announcement Number: FDA BAA-16-00122 Amendment Number: Two (2)

Amendment Posting Date: August 29, 2016

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions & Grants Service, 5630 Fishers Lane, Rockville, MD 20857

Point of Contact: Sean Wybenga, Contracting Officer Sean.Wybenga@fda.hhs.gov

SUMMARY OF CHANGES

PURPOSE: The purpose of this amendment is to add two (2) additional sub areas of research interest to “Part I: Research Areas of Interest:

Research Area 2 – Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes

Research Area 4 - Ensure FDA Readiness to Evaluate Innovative Emerging Technologies

The following research areas are hereby added to Part I of FDA’s Broad Agency Announcement No. FDABAA-16-00122.

Research Area 2

2.4 Facilitate Antibacterial Drug Development and Address Antibacterial Drug Resistance

Antibacterial drug resistance is a major threat to public health. FDA’s roles in combatting antibacterial drug resistance are to : (1) facilitate the development of new antibacterial drugs to treat patients and (2) advance the science of clinical trial design. FDA is interested in the following topic areas:

2.4.1 Evaluate potential innovations in clinical trial design for new antibacterial drugs such as enrollment strategies, data collection streamlining, drug development tools, clinical endpoints, and new statistical analytic approaches

2.4.2 Conduct in-vitro, animal model, and/or pharmacokinetic studies to facilitate antibacterial drug development, including studies focused on special populations such as children and patients with renal or hepatic dysfunction mailto:Sean.Wybenga@fda.hhs.gov

2.4.3 Evaluate strategies to enrich enrollment in clinical trials for new antibacterial drugs such as the use of rapid diagnostic tests

2.4.4 Advance the science of antibacterial drug susceptibility testing

Research Area 4

4.2 Develop assessment tools to evaluate packaging, storage, delivery and disposal solutions, as well as product formulations, designed to prevent or deter misuse and abuse of opioid analgesics.

4.2.1. Perform research to enhance FDA’s understanding of the features of existing and emerging packaging, storage, delivery and disposal solutions, how they fit into the continuum of opioid misuse and abuse, and the evidence available to support these features.

4.2.1.1. Evaluate whether any existing data requirements in other fields may be applicable for packaging, storage, delivery and disposal solutions to prevent or deter misuse and abuse of opioid analgesics. Exploratory research should include abuse deterrent packaging, medication adherence packaging, or child resistant packaging.

4.2.1.2. Research whether there are any existing data requirements in other countries to have packaging, storage, delivery and disposal solutions approved or labeled as being able to prevent or deter misuse and abuse of opioid analgesics.

4.2.1.3. Identify and evaluate appropriate endpoints for studies undertaken to support packaging, storage, delivery and disposal solutions approved or labeled as being able to prevent or deter misuse and abuse of opioid analgesics.

4.2.2. Combine findings from 4.2.1.1 and 4.2.1.2 and work with FDA to define what the data needs and guiding principles should be for industry to follow to have their packaging, storage, delivery and disposal solutions approved or labeled as being able to prevent or deter misuse and abuse of opioid analgesics. Draft and provide to FDA a Final Report for its use.

4.2.3. Perform research to enhance FDA’s understanding of the uptake and use of abuse deterrent opioid product formulations after approval and their impact on patterns of misuse, abuse, addiction, overdose and death in communities, improve our knowledge about the data systems and methods available to study their impact, and develop new data resources and methods in this area.

4.2.3.1. Perform research to enhance FDA’s understanding of the relationship between the number of dispensed prescriptions and abuse rates for opioid products. Relevant activities would include qualitative and/or quantitative research to better understand the reasons for decreases in prescription volume that often occur after the marketing of opioid products reformulated with abuse deterrent properties. Other relevant activities would include qualitative and/or quantitative research to better understand how well local, state, or national drug utilization data reflect availability of, or access to, various opioid products for misuse and abuse in communities.

4.2.3.2. Perform research to enhance FDA’s understanding of existing data systems used to evaluate the impact of abuse deterrent formulations.

Relevant activities would include research to better understand factors influencing the use of poison control call centers in settings of drug misuse, abuse, and overdose, and how these factors may drive overall or drug-specific trends in poison control center utilization over time. Other relevant activities would include research to better understand the accuracy of information collected on abuse of specific opioid products and formulations in poison center data or in self-reported data collected from individuals entering or being assessed for substance abuse treatment.

4.2.3.3. Develop new data resources, methods, and linkages to advance the science of evaluating of abuse-deterrent opioid products and their impact on misuse, abuse, addiction, overdose and death in communities in the U.S.

Examples might include novel methods of collecting, linking, and analyzing data from prescription drug monitoring programs, emergency department and other medical records, administrative claims, surveys, substance abuse treatment programs, syringe exchange programs, and medical examiner databases.