Generic Drug Substitution in Special Populations (U01)
The summary for the Generic Drug Substitution in Special Populations (U01) grant is detailed below.
This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants.
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Generic Drug Substitution in Special Populations (U01): 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 FDA’s regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.
| Federal Grant Title: | Generic Drug Substitution in Special Populations (U01) |
| Federal Agency Name: | Food and Drug Administration |
| Grant Categories: | Consumer Protection Food and Nutrition Health |
| Type of Opportunity: | Discretionary |
| Funding Opportunity Number: | RFA-FD-16-011 |
| Type of Funding: | Cooperative Agreement |
| CFDA Numbers: | 320580 |
| CFDA Descriptions: | Food and Drug Administration_Research |
| Current Application Deadline: | Jun 3, 2016 |
| Original Application Deadline: | Jun 3, 2016 |
| Posted Date: | Apr 1, 2016 |
| Creation Date: | Apr 1, 2016 |
| Archive Date: | Jul 3, 2016 |
| Total Program Funding: | $400,000 |
| Maximum Federal Grant Award: | $200,000 |
| Minimum Federal Grant Award: | none |
| Expected Number of Awards: | 2 |
| Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- State governments
Special district governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Small businesses
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
County governments
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
Public and State controlled institutions of higher education - Additional Information on Eligibility
- 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. - Link to Full Grant Announcement
- Full Announcement of RFA-FD-16-011
- Grant Announcement Contact
- Eric Bozoian
Grants Management Specialist
Phone 2404027623
[email protected]
Food and Drug Administration 240-402-7592