Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)

The summary for the Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01) 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 Drug Administration, which is the U.S. government agency offering this grant.
Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01): The goal of this program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be viewed as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology.
Federal Grant Title: Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: PAR-15-187
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Apr 30, 2019 This announcement has multiple deadl
Original Application Deadline: Apr 30, 2019 This announcement has multiple deadl
Posted Date: Apr 20, 2015
Creation Date: Apr 20, 2015
Archive Date: May 30, 2019
Total Program Funding: $2,000,000
Maximum Federal Grant Award: $1,000,000
Minimum Federal Grant Award: none
Expected Number of Awards: 2
Cost Sharing or Matching: No
Applicants Eligible for this Grant
State governments
Small businesses
Public and State controlled institutions of higher education
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Public housing authorities/Indian housing authorities
County governments
Native American tribal governments (Federally recognized)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Special district governments
Independent school districts
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Additional Information on Eligibility
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Link to Full Grant Announcement
Full Announcement of PAR-15-187 on NIH Guide for Grants and Contracts
Grant Announcement Contact
Lisa Ko Grants Management Specialist
lisa.ko@fda.hhs.gov

Food & Drug Administration 301-443-5869
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