Generic Drug Substitution in Special Populations (U01)

Post Date

April 1st 2016

Application Due Date

June 3rd 2016

Funding Opportunity Number

RFA-FD-16-011

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

2

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:

  $400000

• Award Range:

  $None - $200000

Grant Description

The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDAмs regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.

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-16-011