Post-market Surveillance of Generic Modified Release Products (U01)

Post Date

April 20th 2015

Application Due Date

June 29th 2015

Funding Opportunity Number

RFA-FD-15-015

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:

  $500000

• Award Range:

  $None - $500000

Grant Description

The purpose of this study is to analyze use, substitution patterns, safety and effectiveness of generic modified release products, and compare them with their respective brand name drug products and other generic drugs with different formulation design characteristics. The outcome(s) of this study will help determine if there are differences in the patterns of use, substitution, and safety and effectiveness associated with the studied generic modified release products, and to provide further evidence regarding their substitutability for brand name drugs.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist
  

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  Full Announcement of RFA-FD-15-015 on NIH Guide for Grants and Contracts