The Food and Drug Administration is offering a grant to conduct a study analyzing the use, safety, and effectiveness of generic modified release products compared to brand name drugs. The study aims to determine if there are differences in use patterns, substitution, and safety between generic and brand name drugs, providing important evidence for their substitutability. Researchers will investigate the outcomes to better understand the impacts and performance of these generic products in the market.
Opportunity ID: 276024
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-015 |
| Funding Opportunity Title: | Post-market Surveillance of Generic Modified Release Products (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: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 20, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 29, 2015 |
| Current Closing Date for Applications: | Jun 29, 2015 |
| Archive Date: | Jul 29, 2015 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits having 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) Small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts County governments Native American tribal governments (Federally recognized) Private institutions of higher education State governments Special district governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | Full Announcement of RFA-FD-15-015 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 276024 Other Supporting Documents-SF424 R&R VersionC Instructions 1 -> sf424_rr_guide_general_adobe_verc.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@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 | PKG00216320 | Apr 27, 2015 | Jun 29, 2015 | View |
Package 1
Mandatory forms
276024 RR_SF424_2_0-2.0.pdf
276024 PHS398_ResearchPlan_2_0-2.0.pdf
276024 PHS398_CoverPageSupplement_2_0-2.0.pdf
276024 RR_Budget_1_3-1.3.pdf
276024 RR_KeyPersonExpanded_2_0-2.0.pdf
276024 RR_OtherProjectInfo_1_3-1.3.pdf
276024 PerformanceSite_2_0-2.0.pdf
Optional forms
276024 PlannedReport-1.0.pdf
276024 PHS398_CumulativeInclusionReport-1.0.pdf
276024 RR_SubawardBudget30_1_3-1.3.pdf
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