Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non - inferiority of Generic Transdermal Products (U01)

Post Date

April 1st 2016

Application Due Date

May 31st 2016

Funding Opportunity Number

RFA-FD-16-010

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

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

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.

Funding

• Estimated Total Funding:

  $250000

• Award Range:

  $None - $250000

Grant Description

Use of Яtrained observersН for clinical evaluation of transdermal irritation has the potential for observer bias and variability in assessment since the various transdermal systems that are applied on subjects for such studies are usually visually dissimilar. Use of digital images and image analysis software/s has the potential to enhance consistency and reliability of the measurements compared to visual assessment. The purpose of this study is to help evaluate if digital imaging can be used to quantify transdermal irritation and for non-inferiority analysis of generic transdermal systems.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Eric Bozoian
  Grants Management Specialist
  Phone 2404027623

• Agency Mailing Address:

  eric.bozoian@fda.hhs.gov

• Agency Email Address:

  eric.bozoian@fda.hhs.gov

• More Information:

  Full Announcement of RFA-FD-16-010