This grant from the National Institutes of Health aims to fund research on topical semisolid drug products to understand the link between quality attributes and functional properties. Researchers will explore how the arrangement of matter and rheological characterizations relate to sensorial differences perceived by individuals. The goal is to predict if compositionally different products have comparable qualities such as grittiness, smoothness, and cooling effects. Applications for this grant are open until April 11, 2019.
Opportunity ID: 312818
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-009 |
| Funding Opportunity Title: | Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| 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: | Feb 11, 2019 |
| Last Updated Date: | Feb 11, 2019 |
| Original Closing Date for Applications: | Apr 11, 2019 |
| Current Closing Date for Applications: | Apr 11, 2019 |
| Archive Date: | May 11, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,000,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public housing authorities/Indian housing authorities For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses State governments Public and State controlled institutions of higher education County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Higher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSmall Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of this funding opportunity is to support research relevant to topical semisolid drug products that will help elucidate the relationship between a product’s quality attributes and its functional properties. A specific purpose is to elucidate how characterizations of the arrangement of matter, including rheological characterizations (e.g., texture analysis, tribology) may correlate with and/or be predictive of sensorial differences perceived by human subjects (or patients). Upon the successful completion of this research, it should be possible to predict, based upon product quality characterizations, whether test and reference products that may be compositionally different are likely to have a comparable look and feel, including comparable perceptions of grittiness, silky-smoothness, and cooling sensation. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@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 | RFA-FD-19-009 | FORM E | PKG00248261 | Feb 11, 2019 | Apr 11, 2019 | View |
Package 1
Mandatory forms
312818 RR_SF424_2_0-2.0.pdf
312818 PHS398_CoverPageSupplement_4_0-4.0.pdf
312818 RR_OtherProjectInfo_1_4-1.4.pdf
312818 PerformanceSite_2_0-2.0.pdf
312818 RR_KeyPersonExpanded_2_0-2.0.pdf
312818 RR_Budget_1_4-1.4.pdf
312818 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
312818 RR_SubawardBudget30_1_4-1.4.pdf
312818 PHS_AssignmentRequestForm_2_0-2.0.pdf
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