This grant opportunity from the FDA aims to establish an information-sharing system for state regulators and FDA to enhance oversight of compounding pharmacies that distribute across state lines. The system will improve information availability, support better regulation, and reduce risks to patients. The grant focuses on conducting research to utilize the information obtained for more targeted regulation and oversight. Applicants will contribute to facilitating state information reporting to FDA for compounded drugs distributed interstate. Closing date for applications is July 17, 2019.
Opportunity ID: 316037
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-025 |
| Funding Opportunity Title: | Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed |
| 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 3 |
| Posted Date: | May 16, 2019 |
| Last Updated Date: | May 16, 2019 |
| Original Closing Date for Applications: | Jul 17, 2019 |
| Current Closing Date for Applications: | Jul 17, 2019 |
| Archive Date: | Aug 16, 2019 |
| Estimated Total Program Funding: | $1,600,000 |
| Award Ceiling: | $1,600,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | 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 Small businesses City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Independent school districts County governments |
| 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: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 BusinessesFor-Profit Organizations (Other than Small Businesses)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 Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this cooperative agreement is to establish an information-sharing system and conduct research on the information obtained by this system to improve the information available to state regulators and FDA about compounding pharmacies that distribute interstate and support better and more targeted regulation and oversight to reduce risk to patients. In part, this system will facilitate state information reporting to FDA under future agreements between the states and FDA addressing interstate distribution of compounded drugs. |
| 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 |
|---|---|---|
| description added | May 16, 2019 | |
| May 16, 2019 | ||
| May 16, 2019 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-025 |
| Funding Opportunity Title: | Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed |
| 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 3 |
| Posted Date: | May 16, 2019 |
| Last Updated Date: | May 16, 2019 |
| Original Closing Date for Applications: | Jul 17, 2019 |
| Current Closing Date for Applications: | Jul 17, 2019 |
| Archive Date: | Aug 16, 2019 |
| Estimated Total Program Funding: | $1,600,000 |
| Award Ceiling: | $1,600,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | 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 Small businesses City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Public and State controlled institutions of higher education Independent school districts County governments |
| 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: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 BusinessesFor-Profit Organizations (Other than Small Businesses)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 Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The purpose of this cooperative agreement is to establish an information-sharing system and conduct research on the information obtained by this system to improve the information available to state regulators and FDA about compounding pharmacies that distribute interstate and support better and more targeted regulation and oversight to reduce risk to patients. In part, this system will facilitate state information reporting to FDA under future agreements between the states and FDA addressing interstate distribution of compounded drugs. |
| 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 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-025 |
| Funding Opportunity Title: | Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed |
| 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 2 |
| Posted Date: | May 16, 2019 |
| Last Updated Date: | May 16, 2019 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 17, 2019 |
| Archive Date: | Aug 16, 2019 |
| Estimated Total Program Funding: | $1,600,000 |
| Award Ceiling: | $1,600,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses |
| 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: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 BusinessesFor-Profit Organizations (Other than Small Businesses)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 Organizations |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | – |
| 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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-19-025 |
| Funding Opportunity Title: | Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed |
| 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: | May 16, 2019 |
| Last Updated Date: | May 16, 2019 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 17, 2019 |
| Archive Date: | Aug 16, 2019 |
| Estimated Total Program Funding: | $1,600,000 |
| Award Ceiling: | $1,600,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses |
| Additional Information on Eligibility: | Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Small Businesses State Governments Independent School Districts |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | – |
| 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 |
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-19-025 | FORM E | PKG00251045 | May 16, 2019 | Jul 17, 2019 | View |
Package 1
Mandatory forms
316037 RR_SF424_2_0-2.0.pdf
316037 PHS398_CoverPageSupplement_4_0-4.0.pdf
316037 RR_OtherProjectInfo_1_4-1.4.pdf
316037 PerformanceSite_2_0-2.0.pdf
316037 RR_KeyPersonExpanded_2_0-2.0.pdf
316037 RR_Budget_1_4-1.4.pdf
316037 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
316037 RR_SubawardBudget30_1_4-1.4.pdf
316037 PHS_AssignmentRequestForm_2_0-2.0.pdf
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