Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional

The summary for the Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional: The goal of this program is to support the advancement of regulatory science to facilitate the implementation and the assessment of continuous manufacturing and similar innovative monitoring and control techniques in the pharmaceutical sector. This will be accomplished by making awards to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products (e.g., monoclonal antibodies and therapeutic enzymes). Examples of activities could include the development or modification of a novel manufacturing process (e.g., design, scale-up, and/or commercial scale), control method, and/or testing technology. Awards made under this FOA may be funded in part by appropriations received under the 21st Century Cures Act, section 3016.
Federal Grant Title: Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional
Federal Agency Name: Food and Drug Administration (HHS-FDA)
Grant Categories: Agriculture Consumer Protection Food and Nutrition
Type of Opportunity: Discretionary
Funding Opportunity Number: PAR-19-216
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Information not provided
Current Application Deadline: April 5th, 2021
Original Application Deadline: April 5th, 2021
Posted Date: March 13th, 2019
Creation Date: March 13th, 2019
Archive Date: May 5th, 2021
Total Program Funding: $6,000,000
Maximum Federal Grant Award: $6,000,000
Minimum Federal Grant Award: $1,000,000
Expected Number of Awards: 2
Cost Sharing or Matching: No
Last Updated: March 13th, 2019
Applicants Eligible for this Grant
Public and State controlled institutions of higher education - Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education - Private institutions of higher education - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility
Eligible OrganizationsHigher Education InstitutionsPublic/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 Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
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Shashi Malhotra
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