Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01)

The summary for the Advancing Regulatory Science through Novel Research and Science-Based 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 National Institutes of Health, which is the U.S. government agency offering this grant.
Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01): Purpose. This FOA, issued by the National Institutes of Health, encourages applications from institutions/organizations that propose to study the applicability of novel technologies and approaches towards the development and regulatory review of medical products (including drugs, biologics, and devices). This regulatory science initiative will foster the development, evaluation and availability of new or improved tools, methods, standards, and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle. This area of science has knowledge gaps that deserve special emphasis and would benefit from strategic coordination and planning by NIH and FDA. Advances in this area depend on the incorporation of cutting-edge science and evidence-based knowledge into regulatory decision making. Support through this FOA for regulatory science research will facilitate the translation of biomedical discoveries to improve prevention, treatment, and diagnosis of human health problems. Mechanism of Support. This FOA will utilize the NIH Research Project Cooperative Agreement (U01) (http://grants1.nih.gov/grants/funding/funding_program.htm) award mechanism. Funds Available and Anticipated Number of Awards. The total amount of funds available for these awards is approximately $6.75 million total costs for FY2010-2012, of which $750 thousand will be contributed by the FDA and $6 million will be contributed by the NIH Common Fund, contingent upon receiving scientifically meritorious applications. Two-three awards are anticipated from this solicitation, or more depending upon the size of the applications.
Federal Grant Title: Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01)
Federal Agency Name: National Institutes of Health
Grant Categories: Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-RM-10-006
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.310
CFDA Descriptions: Trans-NIH Research Support
Current Application Deadline: Apr 27, 2010
Original Application Deadline: Apr 27, 2010
Posted Date: Feb 24, 2010
Creation Date: Feb 24, 2010
Archive Date: May 28, 2010
Total Program Funding: $6,750,000
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching: No
Applicants Eligible for this Grant
State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - 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 - For profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Eligible Agencies of the Federal Government; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Link to Full Grant Announcement
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