The FDA is offering this grant to analyze practice patterns in special populations and identify barriers to generic substitution, including assessing safety and effectiveness concerns. The study aims to compare clinical practices with labeled information, analyze factors affecting generic drug substitution, and support FDA’s efforts for ensuring successful generic substitution. Ultimately, the research outcomes will help address research needs, enhance FDA’s regulatory science capabilities, and provide evidence to assure the public about the safety and effectiveness of generic drugs. Closing date for applications is Jun 03, 2016.
Opportunity ID: 282689
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-011 |
| Funding Opportunity Title: | Generic Drug Substitution in Special Populations (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 03, 2016 |
| Current Closing Date for Applications: | Jun 03, 2016 |
| Archive Date: | Jul 03, 2016 |
| Estimated Total Program Funding: | $400,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Public housing authorities/Indian housing authorities Private institutions of higher education Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Native American tribal governments (Federally recognized) Small businesses |
| 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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 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. |
| Link to Additional Information: | Full Announcement of RFA-FD-16-011 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Eric Bozoian
Grants Management Specialist Phone 2404027623 Email:eric.bozoian@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Eric Bozoian Grants Management Specialist Phone 2404027623 Email: eric.bozoian@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00222277 | Apr 04, 2016 | Jun 03, 2016 | View |
Package 1
Mandatory forms
282689 RR_SF424_2_0-2.0.pdf
282689 PHS398_CoverPageSupplement_3_0-3.0.pdf
282689 RR_OtherProjectInfo_1_3-1.3.pdf
282689 PerformanceSite_2_0-2.0.pdf
282689 RR_KeyPersonExpanded_2_0-2.0.pdf
282689 RR_Budget_1_3-1.3.pdf
282689 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282689 RR_SubawardBudget30_1_3-1.3.pdf
282689 PHS_Inclusion_Enrollment_Report-1.0.pdf
282689 PHS_AssignmentRequestForm-1.0.pdf
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