The Department of Health is offering a grant to support projects focusing on enhancing chemistry, manufacturing, and controls of dry powder inhaler drug products. This grant aims to address key areas such as controlling API crystal manufacturing for consistent quality, defining critical quality attributes, exploring API crystal properties, and studying post-micronization effects. Applicants can contribute to understanding product performance and requirements for micronized API materials. Deadline for applications is August 15, 2011.
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:: | |
| Category of Funding Activity:: | Agriculture |
| Category Explanation:: | |
| Expected Number of Awards:: | 1 |
| Assistance Listings Number(s):: | 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:: | County governments |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | ADOBE-FORMS-B1 |
| Competition Title: | ADOBE-FORMS-B1 |
| Opportunity Package ID: | PKG00064890 |
| Opening Date: | Jul 15, 2011 |
| Closing Date: | Aug 15, 2011 |
| Agency Contact Information:: | Lisa Ko |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Project/Performance Site Location(s) [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Cover Page Supplement [V1.4] PHS 398 Checklist [V1.3] |
| optional_forms |
Research & Related Budget [V1.1] R & R Subaward Budget Attachment(s) Form [V1.2] PHS Cover Letter [V1.2] PHS 398 Modular Budget [V1.1] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Agency Contact Information: | Who Can Apply: |
|---|---|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-B1 | ADOBE-FORMS-B1 | PKG00064890 | Jul 15, 2011 | Aug 15, 2011 | View | Lisa Ko | Organization Applicants |