(FOA)-Food
and Drug Administration (FDA) - Broad Agency Announcement (BAA) for the Advanced
Research and Development of Regulatory Science; March 13,
2020
Agency
Department
of Health and Human Services
Food
and Drug Administration
Description
Food
and Drug Administration (FDA) solicits for advanced research and development
proposals to support regulatory science and innovation. The FDA anticipates
that research and development activities awarded under this BAA will serve to
advance scientific knowledge to accomplish its mission to protect and promote
the health of our nation through the following technical objectives:
1.
Modernize
Toxicology to Enhance Product Safety
a.
Develop
better models of human and animal (where applicable) adverse response; Identify
and evaluate biomarkers and endpoints that can be used in nonclinical and
clinical evaluations; Use and develop computational methods and in silico
modeling:
2.
Stimulate
Innovation in Clinical Evaluations and Personalized Medicine to Improve Product
Development and Patient Outcomes
a.
Develop
and refine clinical trial designs, endpoints and analysis methods; Leverage
existing and future data; Identify and qualify biomarkers and study endpoints;
Facilitate Antibacterial Drug Development and Address Antibacterial Drug
Resistance; Facilitate Drug Development and Appropriate Use for Patients with
Serious Mental Illness; Facilitate Development of Drug Therapies for Youth
Tobacco Cessation; Immuno-oncology
3.
Support
New Approaches to Improve Product Manufacturing and
Quality
a.
Enable
development and evaluation of novel and improved materials and manufacturing
methods; Develop new analytical methods; Develop assessment tools to support
facility and product surveillance and monitoring of quality systems and
processes; Reduce risk of microbial contamination of products; Improve
scientific approaches to evaluate generic drugs; Identify and Qualify
Pain-Associated Biomarkers that are Associated with Therapeutic Control of Pain
in Food Producing Animals; Develop a Regulatory Database for Species
Identification; Develop methods to improve the cybersecurity of medical
devices
4.
Ensure
FDA Readiness to Evaluate Innovative Emerging Technologies;
a.
Develop
assessment tools for novel therapies; 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; FDA is interested in trending drug use over time to provide a
context for evaluating drug safety in pediatric populations;
5.
Harness
Diverse Data through Information Sciences to Improve Health
Outcomes
a.
Develop
and apply simulation models for product life cycles, risk assessment, and other
regulatory science uses; Develop and analyze large scale clinical and
nonclinical data sets; Computer Modeling and Simulation to Assess Product Risk;
Collect and use patient input in regulatory decision-making; Systems Modeling
of the Opioid Crisis;
6.
Implement
a New Prevention-Focused Food Safety System to Protect Public
Health
a.
Establish
and implement centralized planning and performance measurement processes;
Maintain mission critical science capabilities:
7.
Facilitate
Development and Availability of Medical Countermeasures (MCMs) to Protect
Against Threats to U.S. and Global Health and Security
a.
Develop,
characterize, and qualify tools to support MCM development under the Animal
Rule or Accelerated Approval Provisions; Modernize tools to evaluate MCM
product safety, efficacy, and quality; and improve/ensure MCM supply chain;
8.
Strengthening
Social and Behavioral Science at FDA by Enhancing Audience
Understanding
a.
Assess
awareness and understanding of FDA communications, especially among diverse
audiences and populations, and identify methods to improve the comprehension of
content, including numerical information; Explore ways that FDA communications
can best complement those communicated by industry to enhance audience
comprehension; Assess public understanding of regulatory terms; Evaluate timing
of release of recall or warning messages, how and when these messages can
enhance impact, and how to communicate the end of a recall or warnings; Studies
to increase the safety of post-approval drug use; Studies to evaluate the
safety of approved drug products
9.
Strengthening
the Global Product Safety Net
a.
Advancing
Global Public Health; Analyzing and Utilizing Global Data to Manage Risks;
Announcement
Number:
FDABAA-20-00123
Closing
Date:
Offerors are encouraged to
submit white papers no later than March 13, 2020
Link
to Full Announcement
Contact
Information
Richard
Robinson
(301)-796-6508