FDA’s CDER is offering a grant to analyze intersubject variability in small airway delivery using computational modeling for orally inhaled drug products. The study focuses on factors like airway segment dimensions, constriction patterns, and inhalation techniques. The goal is to provide deposition data for asthma drugs, determining if they effectively target small airways and identifying key product attributes influencing deposition. Applications close on May 16, 2016.
Opportunity ID: 282340
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-16-024 |
| Funding Opportunity Title: | Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug 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: | Mar 18, 2016 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 16, 2016 |
| Current Closing Date for Applications: | May 16, 2016 |
| Archive Date: | Jun 15, 2016 |
| Estimated Total Program Funding: | $200,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education City or township governments For profit organizations other than small businesses Small businesses Native American tribal organizations (other than Federally recognized tribal governments) County governments 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 Public and State controlled institutions of higher education Independent school districts Special district governments Public housing authorities/Indian housing authorities State governments 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) |
| 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: | FDA’s CDER is seeking depositional data obtained with a computational modeling approach for small airway delivery to adults with orally inhaled drug products (OIDPs) that are indicated for management of asthma. Possible sources of intersubject variability include lengths and diameters of various airway segments, heterogeneous or homogeneous constriction, and inhalation patterns. An expected outcome is regional deposition data for reference listed drugs that can indicate whether or not the drug product targets small airways in asthmatic patients and the key product attributes that affects the deposition. |
| Link to Additional Information: | Full announcement of RFA-FD-16-024 |
| 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 | PKG00221711 | Mar 17, 2016 | May 16, 2016 | View |
Package 1
Mandatory forms
282340 RR_SF424_2_0-2.0.pdf
282340 PHS398_CoverPageSupplement_3_0-3.0.pdf
282340 RR_OtherProjectInfo_1_3-1.3.pdf
282340 PerformanceSite_2_0-2.0.pdf
282340 RR_KeyPersonExpanded_2_0-2.0.pdf
282340 RR_Budget_1_3-1.3.pdf
282340 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
282340 RR_SubawardBudget30_1_3-1.3.pdf
282340 PHS_Inclusion_Enrollment_Report-1.0.pdf
282340 PHS_AssignmentRequestForm-1.0.pdf
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