Opportunity ID: 233482
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-015 |
| Funding Opportunity Title: | In vitro release tests for transdermal drug delivery systems (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 7 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 07, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 01, 2013 |
| Current Closing Date for Applications: | Jun 01, 2013 |
| Archive Date: | Jul 01, 2013 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Eligible Agencies of the Federal Government; U.S. Territory or Possession; Native American Tribal Organizations (other than Federally recognized tribal governments); Faith-based or Community-based Organizations; Regional Organizations; Non-domestic (non-U.S.) Entitites (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Background
Many transdermal delivery systems (TDDS) are labeled to warn against applying heat to the TDDS as it may increase the rate of drug release. When the reference product contains these warnings, the generic product must also have the same labeling. As part of its review FDA does require evidence that the formulation of a generic product is not less safe than the RLD. It is possible that different transdermal formulations of the same drug may have different responses to heat. To ensure that the RLD labeling with respect to heat is applicable to the ANDA product, the ANDA applicant should provide information about the formulation performance to ensure that the sensitivity to heat of the generic product is not more pronounced than that of the RLD. Because the identified concern is specifically related to differences in product formulation, in vitro data provides a direct measure of the formulation properties and thus is more appropriate than in vivo studies for this evaluation. Objectives This project will investigate in vitro – in vivo correlations of transdermal systems. The goal is to identity in vitro release test conditions that best identify heat effects on transdermal system release. These in vitro tests would be used in the review process to ensure that the performance of the proposed generic products does not introduce any additional safety risk. Detailed Description This project will investigate in vitro – in vivo correlations of transdermal systems. The project has several phases 1) Identification or generation of an in vivo data set of heat effects on transdermal products. The in vivo data set may be obtained from the literature or generated as a part of this grant. It may include identification of approved transdermal systems with in vivo heat effects on systemic exposure mentioned in the approved labeling. 2) Evaluation of these transdermal systems in a range of different in vitro test conditions to identify the in vitro conditions and study design that best identify the effect of heat on transdermal systems. These studies should be in-vitro skin flux permeation studies and include comparative in vitro release data at normal and elevated temperatures. 3) Evaluation of approved generic products with no in vivo heat effect data using the optimal in vitro conditions from phase 2. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Officer/Specialist Phone 301-827-7175 Email: gladys.bohler@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| PKG00178197 | May 15, 2013 | Jul 02, 2013 | View |
Package 1
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