This grant, offered by the FDA, aims to establish Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). These centers will advance Regulatory Science – the development of new tools, standards, and approaches to assess FDA-regulated product safety, efficacy, quality, and performance. The CERSI program will foster innovation to support effective product development and evaluation. This includes training, applied collaborative science, professional development, and scientific exchanges. Applicants, whether single institutions or consortia, should be internationally recognized for their expertise. They are encouraged to include plans for sustained operation as FDA-partnering scientific expert centers beyond initial funding.
Opportunity ID: 235074
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-034 |
| Funding Opportunity Title: | Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | May 17, 2013 |
| Last Updated Date: | Jun 25, 2013 |
| Original Closing Date for Applications: | Jul 08, 2013 |
| Current Closing Date for Applications: | Jul 08, 2013 |
| Archive Date: | Aug 07, 2013 |
| Estimated Total Program Funding: | $1,400,000 |
| Award Ceiling: | $1,400,000 |
| Award Floor: | $700,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | FDA is announcing this FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). Regulatory Science is defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSIs will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (e.g., Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA’s Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI’s should be internationally recognized for the outstanding expertise in the respective field(s). CERSI’s candidates may apply either as single institutions or as consortia of more than one institution and are encouraged to include plans and business models which describe how the entity would continue its role and function as FDA-partnering scientific expert center beyond the funding provide with this CERSI mechanism. |
| Link to Additional Information: | NIH Guide For Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| This notice is to inform potential applicants that the FDA has revised RFA-FD-13-034, | Jun 25, 2013 | |
| This notice is to inform potential applicants that the FDA has revised RFA-FD-13-034, | Jun 25, 2013 | |
| This notice is to inform applicants that the FDA has revised RFA-FD-13-034, | Jun 25, 2013 | |
| Jun 25, 2013 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-034 |
| Funding Opportunity Title: | Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | May 17, 2013 |
| Last Updated Date: | Jun 25, 2013 |
| Original Closing Date for Applications: | Jul 08, 2013 |
| Current Closing Date for Applications: | Jul 08, 2013 |
| Archive Date: | Aug 07, 2013 |
| Estimated Total Program Funding: | $1,400,000 |
| Award Ceiling: | $1,400,000 |
| Award Floor: | $700,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | FDA is announcing this FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). Regulatory Science is defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSIs will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (e.g., Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA’s Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI’s should be internationally recognized for the outstanding expertise in the respective field(s). CERSI’s candidates may apply either as single institutions or as consortia of more than one institution and are encouraged to include plans and business models which describe how the entity would continue its role and function as FDA-partnering scientific expert center beyond the funding provide with this CERSI mechanism. |
| Link to Additional Information: | NIH Guide For Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-034 |
| Funding Opportunity Title: | Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Jun 25, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 08, 2013 |
| Archive Date: | Aug 07, 2013 |
| Estimated Total Program Funding: | $1,400,000 |
| Award Ceiling: | $1,400,000 |
| Award Floor: | $700,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | FDA is announcing this FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). Regulatory Science is defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSIs will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (e.g., Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA’s Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI’s should be internationally recognized for the outstanding expertise in the respective field(s). CERSI’s candidates may apply either as single institutions or as consortia of more than one institution and are encouraged to include plans and business models which describe how the entity would continue its role and function as FDA-partnering scientific expert center beyond the funding provide with this CERSI mechanism. |
| Link to Additional Information: | NIH Guide For Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-034 |
| Funding Opportunity Title: | Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| 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: | Jun 25, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 08, 2013 |
| Archive Date: | Aug 07, 2013 |
| Estimated Total Program Funding: | $1,400,000 |
| Award Ceiling: | $1,400,000 |
| Award Floor: | $700,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | FDA is announcing this FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). Regulatory Science is defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSIs will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (e.g., Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA’s Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI’s should be internationally recognized for the outstanding expertise in the respective field(s). CERSI’s candidates may apply either as single institutions or as consortia of more than one institution and are encouraged to include plans and business models which describe how the entity would continue its role and function as FDA-partnering scientific expert center beyond the funding provide with this CERSI mechanism. |
| Link to Additional Information: | NIH Guide For Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-034 |
| Funding Opportunity Title: | Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Business and Commerce Consumer Protection Education Employment, Labor and Training Environment Food and Nutrition Health Information and Statistics Science and Technology and other Research and Development |
| 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 25, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 08, 2013 |
| Archive Date: | Aug 07, 2013 |
| Estimated Total Program Funding: | $1,400,000 |
| Award Ceiling: | $1,400,000 |
| Award Floor: | $700,000 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Private institutions of higher education |
| Additional Information on Eligibility: | Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | FDA is announcing this FOA to provide support for one or more Collaborating Centers of Excellence in Regulatory Science and Innovation (CERSI). Regulatory Science is defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. The CERSIs will be established to foster an innovative and thematically coherent approach to advance the field of Regulatory Science (e.g., Regulatory Science encompasses laboratory, population, behavioral and manufacturing sciences, as well as other scientific programmatic areas, including those outlined in FDA’s Strategic Plan for Regulatory Science, accessible at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm267719.htm) and the Critical Path Initiative toward more effective and efficient product development and evaluation. CERSI efforts will focus on promoting innovation in support of the development and evaluation of safe and effective products through training, applied collaborative science, professional development and scientific exchanges. The CERSI’s should be internationally recognized for the outstanding expertise in the respective field(s). CERSI’s candidates may apply either as single institutions or as consortia of more than one institution and are encouraged to include plans and business models which describe how the entity would continue its role and function as FDA-partnering scientific expert center beyond the funding provide with this CERSI mechanism. |
| Link to Additional Information: | NIH Guide For Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Vieda Hubbard
Grants Management Specialist Phone 301-827-7177 Email:vieda.hubbard@fda.hhs.gov |
Related Documents
Folder 235074 Full Announcement-1 -> sf424_rr_guide_general_adobe_verb.pdf
Folder 235074 Revised Full Announcement-1 -> final not-fd-13-017.pdf
Folder 235074 Revised Full Announcement-1 -> rfa-fd-13-034 gm005062013 final.pdf
Packages
| Agency Contact Information: | Vieda Hubbard Grants Management Specialist Phone 301-827-7177 Email: vieda.hubbard@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 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00178270 | May 17, 2013 | Jul 08, 2013 | View |
Package 1
Mandatory forms
235074 RR_SF424_1_2-1.2.pdf
235074 PerformanceSite_1_4-1.4.pdf
235074 RR_OtherProjectInfo_1_3-1.3.pdf
235074 RR_KeyPersonExpanded_1_2-1.2.pdf
235074 RR_Budget-1.1.pdf
235074 PHS398_CoverPageSupplement_1_4-1.4.pdf
235074 PHS398_ResearchPlan_1_3-1.3.pdf
235074 PHS398_Checklist_1_3-1.3.pdf
Optional forms
235074 RR_SubawardBudget30-1.2.pdf
235074 PHS_CoverLetter_1_2-1.2.pdf
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