FDA’s grant aims to assess quality metrics for monitoring pharmaceutical manufacturing, aiding in the transition to quantitative quality oversight. This project supports ensuring availability of quality drugs to the public and developing risk-based inspections for drug establishments domestically and internationally.
Opportunity ID: 276601
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-036 |
| Funding Opportunity Title: | Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 14, 2015 |
| Last Updated Date: | Jun 12, 2015 |
| Original Closing Date for Applications: | Jul 02, 2015 |
| Current Closing Date for Applications: | Jul 02, 2015 |
| Archive Date: | Aug 01, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses State governments Private institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts |
| 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 goal of this project is to evaluate a set of potential quality metrics for their utility in monitoring quality across the pharmaceutical manufacturing sector. This project aids to support FDA’s efforts in transforming quality oversight from a qualitative to a quantitative and expertise-based assessment in order to assure that quality drugs are available to the American public. The outcomes of the project could also be used to assist in the development of a risk-based inspection approach for domestic and foreign drug establishments. |
| Link to Additional Information: | Full Announcement of RFA-FD-15-036 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Updated award information. | Jun 12, 2015 | |
| Jun 12, 2015 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-036 |
| Funding Opportunity Title: | Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 14, 2015 |
| Last Updated Date: | Jun 12, 2015 |
| Original Closing Date for Applications: | Jul 02, 2015 |
| Current Closing Date for Applications: | Jul 02, 2015 |
| Archive Date: | Aug 01, 2015 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses State governments Private institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts |
| 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 goal of this project is to evaluate a set of potential quality metrics for their utility in monitoring quality across the pharmaceutical manufacturing sector. This project aids to support FDA’s efforts in transforming quality oversight from a qualitative to a quantitative and expertise-based assessment in order to assure that quality drugs are available to the American public. The outcomes of the project could also be used to assist in the development of a risk-based inspection approach for domestic and foreign drug establishments. |
| Link to Additional Information: | Full Announcement of RFA-FD-15-036 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-036 |
| Funding Opportunity Title: | Evaluating Quality Metrics for Risk-Based Surveillance of Drug Manufacturing Operations and Facilities (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 12, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 02, 2015 |
| Archive Date: | Aug 01, 2015 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses County governments Special district governments Private institutions of higher education City or township governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 goal of this project is to evaluate a set of potential quality metrics for their utility in monitoring quality across the pharmaceutical manufacturing sector. This project aids to support FDA’s efforts in transforming quality oversight from a qualitative to a quantitative and expertise-based assessment in order to assure that quality drugs are available to the American public. The outcomes of the project could also be used to assist in the development of a risk-based inspection approach for domestic and foreign drug establishments. |
| Link to Additional Information: | Full Announcement of RFA-FD-15-036 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Related Documents
Folder 276601 Other Supporting Documents-SF424 R&R VersionC Instructions 1 -> sf424_rr_guide_general_adobe_verc.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@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 | PKG00216917 | May 29, 2015 | Jul 02, 2015 | View |
Package 1
Mandatory forms
276601 RR_SF424_2_0-2.0.pdf
276601 PHS398_ResearchPlan_2_0-2.0.pdf
276601 PHS398_CoverPageSupplement_2_0-2.0.pdf
276601 RR_Budget_1_3-1.3.pdf
276601 RR_KeyPersonExpanded_2_0-2.0.pdf
276601 RR_OtherProjectInfo_1_3-1.3.pdf
276601 PerformanceSite_2_0-2.0.pdf
Optional forms
276601 PlannedReport-1.0.pdf
276601 PHS398_CumulativeInclusionReport-1.0.pdf
276601 RR_SubawardBudget30_1_3-1.3.pdf
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