Opportunity ID: 328024
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-002 |
| Funding Opportunity Title: | Renewal-Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health Science and Technology and other Research and Development |
| 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: | Jul 08, 2020 |
| Last Updated Date: | Jul 08, 2020 |
| Original Closing Date for Applications: | Oct 13, 2020 |
| Current Closing Date for Applications: | Oct 13, 2020 |
| Archive Date: | Nov 12, 2020 |
| Estimated Total Program Funding: | $2,500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Eligible Organizations International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Additional Information on Eligibility:Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The Food and Drug Administration announces its intention to consider and accept a renewal application for award to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this program is to provide support in convening regional pharmaceutical regulatory authorities and pharmaceutical industry associations representing regions and jurisdictions from around the world to achieve greater harmonization of scientific and technical standards for pharmaceuticals. This is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner, to be available to patients globally. The outcome of this effort will be a series of internationally recognized guidelines for pharmaceutical product registration, adopted by regulators in regions around the world. |
| Link to Additional Information: | Full Announcement RFA-FD-21-002 |
| 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 |
|---|---|---|
| Update | Jul 08, 2020 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-21-002 |
| Funding Opportunity Title: | Renewal-Harmonization of Technical Requirements for Pharmaceuticals for Human Use (U01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health Science and Technology and other Research and Development |
| 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: | Jul 08, 2020 |
| Last Updated Date: | Jul 08, 2020 |
| Original Closing Date for Applications: | Oct 13, 2020 |
| Current Closing Date for Applications: | Oct 13, 2020 |
| Archive Date: | Nov 12, 2020 |
| Estimated Total Program Funding: | $2,500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Eligible Organizations International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Additional Information on Eligibility:Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The Food and Drug Administration announces its intention to consider and accept a renewal application for award to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The purpose of this program is to provide support in convening regional pharmaceutical regulatory authorities and pharmaceutical industry associations representing regions and jurisdictions from around the world to achieve greater harmonization of scientific and technical standards for pharmaceuticals. This is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner, to be available to patients globally. The outcome of this effort will be a series of internationally recognized guidelines for pharmaceutical product registration, adopted by regulators in regions around the world. |
| Link to Additional Information: | Full Announcement RFA-FD-21-002 |
| 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-21-002 | FORMS F | PKG00262475 | Jul 13, 2020 | Oct 13, 2020 | View |
Package 1
Mandatory forms
Optional forms
Share This Post, Choose Your Platform!
About the Author: osnqt
