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The National Institute of Health is offering the U01 grant for researchers to utilize population pharmacokinetic modeling of systemic pharmacokinetic data for enhancing bioequivalence specifically in regional lung exposure. This grant does not support clinical trials and the closing date for applications is Feb 28, 2023.
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Opportunity ID: 344257
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General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | RFA-FD-23-017 |
| Funding Opportunity Title:: | Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Consumer Protection |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 1 |
| Posted Date:: | Dec 01, 2022 |
| Last Updated Date:: | Dec 01, 2022 |
| Original Closing Date for Applications:: | Feb 28, 2023 |
| Current Closing Date for Applications:: | Feb 28, 2023 |
| Archive Date:: | Mar 30, 2023 |
| Estimated Total Program Funding:: | $ 1,000,000 |
| Award Ceiling:: | $500,000 |
| Award Floor:: | $50,000 |
Eligibility
| Eligible Applicants:: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility:: | Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian 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 BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions) |
Additional Information
| Agency Name:: | Food and Drug Administration |
| Description:: | |
| 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 | Dec 01, 2022 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | |
| Competition ID: | RFA-FD-23-017 |
| Competition Title: | FORMS H |
| Opportunity Package ID: | PKG00278731 |
| Opening Date: | Nov 30, 2022 |
| Closing Date: | Feb 28, 2023 |
| Agency Contact Information:: | Shashi Malhotra |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget 10YR [V3.0] PHS 398 Research Plan [V5.0] PHS Human Subjects and Clinical Trials Information [V3.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 10 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0] |
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Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| RFA-FD-23-017 | FORMS H | PKG00278731 | Nov 30, 2022 | Feb 28, 2023 | View | Shashi Malhotra | Organization Applicants |
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