This grant from the National Institutes of Health (NIH), in partnership with the FDA, aims to advance regulatory science. It encourages institutions to apply novel technologies and approaches to the development and review of medical products (drugs, biologics, and devices). The initiative seeks to create and evaluate new tools, methods, and applied science that improve product safety, quality, effectiveness, and manufacturing. This facilitates translating biomedical discoveries into better human health outcomes. Approximately $6.75 million is available from NIH and FDA, supporting two to three awards.
Opportunity ID: 52081
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-RM-10-006 |
| Funding Opportunity Title: | Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.310 — Trans-NIH Research Support |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 24, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Apr 27, 2010 |
| Current Closing Date for Applications: | Apr 27, 2010 |
| Archive Date: | May 28, 2010 |
| Estimated Total Program Funding: | $6,750,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities State governments Small businesses 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 For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Independent school districts Private institutions of higher education County governments City or township governments |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-10-006.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
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