Search Grant Opportunities

Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed

ID: RFA-FD-23-029 • Type: Posted

Description

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER)/Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.

The goals of this Cooperative Agreement are to: continue the development of the Compounding Quality Center for Excellence Training Program, providing education and training for the Outsourcing Facility (OF) industry and other stakeholders with the capacity to expand into other program areas as directed; research and assess stakeholder training needs; and revise, develop and deliver and evaluate new and existing Current Good Manufacturing Practice (CGMP) training courses to stakeholders nationwide (Outsourcing Facility (OF), compounders, federal and state, regulators). This training and research program is intended to improve compounding quality to protect patients from unsafe, ineffective, and poor-quality drugs that may cause serious health consequences, impairment, harm, or death.

Through a Congressional appropriation, FDA is directed to increase direct engagement and provide education and training to outsourcing facilities, compounders, federal and state regulators.

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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Consumer Protection
Science and Technology and other Research and Development
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 4/27/23 Food and Drug Administration posted grant opportunity RFA-FD-23-029 for Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed. The grant will be issued under grant program 93.103 Food and Drug Administration Research. It is expected that one grant will be made worth between $500,000 and $5.5 million.

Timing

Posted Date
April 27, 2023, 12:00 a.m. EDT
Closing Date
June 30, 2023, 12:00 a.m. EDT Past Due
Last Updated
April 27, 2023, 9:04 p.m. EDT
Version
1
Archive Date
July 30, 2023

Eligibility

Eligible Applicants
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Info
Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Nonprofits with 501(c)(3) IRS Status Nonprofits without 501(c)(3) IRS Status For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations

Award Sizing

Ceiling
$5,500,000
Floor
$500,000
Estimated Program Funding
Not Provided
Estimated Number of Grants
1

Contacts

Contact
Shashi Malhotra Grants Management Specialist
Contact Email
shashi.malhotra@fda.hhs.gov   Profile
Contact Phone
(240) 402-7592
Additional Information
FULL ANNOUNCEMENT
Additional Information Site
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-029.html

Documents

Posted documents for RFA-FD-23-029

Grant Awards

Grants awarded through RFA-FD-23-029

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