This grant is for advancing Quality by Design (QbD) in the Chemistry, Manufacturing, and Controls (CMC) of orally inhaled drugs, particularly dry powder inhalers (DPIs). Its purpose is to ensure product quality and consistency through rigorous management of active pharmaceutical ingredient (API) crystal manufacturing. This involves defining critical quality attributes, understanding their link to micronized material quality, and investigating post-micronization relaxation effects on performance. The research will establish best practices for laagering and quarantining micronized API, optimizing manufacturing to improve drug product variability and efficacy.
Opportunity ID: 106035
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-11-029 |
| Funding Opportunity Title: | Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection 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: | Jul 18, 2011 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Aug 15, 2011 |
| Current Closing Date for Applications: | Aug 15, 2011 |
| Archive Date: | Sep 14, 2011 |
| Estimated Total Program Funding: | $160,000 |
| Award Ceiling: | $160,000 |
| Award Floor: | $1 |
Eligibility
| Eligible Applicants: | City or township governments Independent school districts Native American tribal governments (Federally recognized) 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The project highlights the following important areas in chemistry, manufacturing and controls of dry powder inhaler (DPI) drug products:
-Controlling the manufacturing of API crystals in order to obtain micronized API materials with low variability and consistency; -Defining the critical quality attributes of the API crystals that must be measured and controlled to ensure quality in the final drug product; -Emphasizing the relationship between the properties of the API crystals and the quality of micronized API materials to be in included in the final drug product; -Exploring the effects of post-micronization relaxation of micronized API on product performance, with an aim to understand the requirements for laagering and quarantining of micronized API materials. |
| Link to Additional Information: | NIH Guide Announcement Link |
| 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 106035 Full Announcement-1 -> rfa-fd-11-029.pdf
Folder 106035 Other Supporting Documents-SF424_RR_Guide_General_Adobe_VerB 1 -> sf424_rr_guide_general_adobe_verb.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 | ADOBE-FORMS-B1 | ADOBE-FORMS-B1 | PKG00064890 | Jul 15, 2011 | Aug 15, 2011 | View |
Package 1
Mandatory forms
106035 RR_SF424_1_2-1.2.pdf
106035 RR_OtherProjectInfo_1_3-1.3.pdf
106035 RR_KeyPersonExpanded_1_2-1.2.pdf
106035 PerformanceSite_1_4-1.4.pdf
106035 PHS398_ResearchPlan_1_3-1.3.pdf
106035 PHS398_CoverPageSupplement_1_4-1.4.pdf
106035 PHS398_Checklist_1_3-1.3.pdf
Optional forms
106035 RR_Budget-1.1.pdf
106035 RR_SubawardBudget-1.2.pdf
106035 PHS_CoverLetter_1_2-1.2.pdf
106035 PHS398_ModularBudget-1.1.pdf
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