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

Post Date

February 24th 2010

Application Due Date

April 27th 2010

Funding Opportunity Number

RFA-RM-10-006

CFDA Number(s)

93.310

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Health

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

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.

Funding

• Estimated Total Funding:

  $6750000

• Award Range:

  $None - $None

Grant 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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  National Institutes of Health

• Agency Contact:

  NIH OER Webmaster
  FBOWebmaster@OD.NIH.GOV
  

• Agency Mailing Address:

  If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

• Agency Email Address:

  FBOWebmaster@OD.NIH.GOV

• More Information:

  http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-10-006.html