Opportunity ID: 315776

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-19-026
Funding Opportunity Title: Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials 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 09, 2019
Last Updated Date: May 09, 2019
Original Closing Date for Applications: Jul 10, 2019
Current Closing Date for Applications: Jul 10, 2019
Archive Date: Aug 09, 2019
Estimated Total Program Funding: $1,000,000
Award Ceiling: $1,000,000
Award Floor: $500,000

Eligibility

Eligible Applicants: State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Small businesses
City or township governments
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Independent school districts
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations

Additional Information

Agency Name: Food and Drug Administration
Description:

FDA is currently developing a comprehensive systems model of the opioid’s crisis. The model will serve as a tool to help FDA assess and communicate the complex issues underlying the crisis and the potential impacts of possible policy actions. The primary objective of this funding opportunity is to provide supporting research that will help FDA enhance its systems model. The results of this supporting research will help FDA improve and expand the model and generate new insights that can better inform policy making by FDA, and others.

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
May 09, 2019
May 09, 2019

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-19-026
Funding Opportunity Title: Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials 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 09, 2019
Last Updated Date: May 09, 2019
Original Closing Date for Applications: Jul 10, 2019
Current Closing Date for Applications: Jul 10, 2019
Archive Date: Aug 09, 2019
Estimated Total Program Funding: $1,000,000
Award Ceiling: $1,000,000
Award Floor: $500,000

Eligibility

Eligible Applicants: State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Small businesses
City or township governments
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
Independent school districts
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on Eligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The 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 Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations

Additional Information

Agency Name: Food and Drug Administration
Description:

FDA is currently developing a comprehensive systems model of the opioid’s crisis. The model will serve as a tool to help FDA assess and communicate the complex issues underlying the crisis and the potential impacts of possible policy actions. The primary objective of this funding opportunity is to provide supporting research that will help FDA enhance its systems model. The results of this supporting research will help FDA improve and expand the model and generate new insights that can better inform policy making by FDA, and others.

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-19-026
Funding Opportunity Title: Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials 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 09, 2019
Last Updated Date: May 09, 2019
Original Closing Date for Applications:
Current Closing Date for Applications: Jul 10, 2019
Archive Date: Aug 09, 2019
Estimated Total Program Funding: $1,000,000
Award Ceiling: $1,000,000
Award Floor: $500,000

Eligibility

Eligible Applicants: Small businesses
Special district governments
Public and State controlled institutions of higher education
State governments
County governments
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
City or township governments
Native American tribal governments (Federally recognized)
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Independent school districts
Public housing authorities/Indian housing authorities
Additional Information on Eligibility: Eligible Organizations
Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The 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 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)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
U.S. Territory or Possession
Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional 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

Related Documents

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-19-026 FORM E PKG00250824 May 09, 2019 Jul 10, 2019 View

Package 1

Mandatory forms

315776 RR_SF424_2_0-2.0.pdf

315776 PHS398_CoverPageSupplement_4_0-4.0.pdf

315776 RR_OtherProjectInfo_1_4-1.4.pdf

315776 PerformanceSite_2_0-2.0.pdf

315776 RR_KeyPersonExpanded_2_0-2.0.pdf

315776 RR_Budget_1_4-1.4.pdf

315776 PHS398_ResearchPlan_4_0-4.0.pdf

Optional forms

315776 RR_SubawardBudget30_1_4-1.4.pdf

315776 PHS_AssignmentRequestForm_2_0-2.0.pdf

2025-07-09T16:03:54-05:00

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