The FDA is offering this grant to support the development of regulatory science to aid in the evaluation and adoption of new manufacturing technologies in the pharmaceutical industry. This grant aims to enhance processes and technologies that can modernize pharmaceutical manufacturing and improve efficiency. Eligible projects may focus on innovative product manufacturing technologies, manufacturing processes, or testing methods. Applications must align with the goal of advancing regulatory science for emerging manufacturing technologies in the pharmaceutical sector. Applications are due by Apr 30, 2019.
Opportunity ID: 276023
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-15-187 |
| Funding Opportunity Title: | Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| 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: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 20, 2015 |
| Last Updated Date: | Jun 12, 2015 |
| Original Closing Date for Applications: | Apr 30, 2019 This announcement has multiple deadline dates.
June 30, 2015, by 11:59 PM Eastern Time. April 29, 2016, by 8:00 PM Eastern Time. April 28, 2017, by 8:00 PM Eastern Time. April 30, 2018, by 8:00 PM Eastern Time. April 30, 2019, by 8:00 PM Eastern Time. Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process. For the June 30, 2015 application due date, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. For all subsequent application due dates, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 8:00 PM Eastern Time on the application due date. Late applications will not be accepted for this FOA. |
| Current Closing Date for Applications: | Apr 30, 2019 This announcement has multiple deadline dates.June 30, 2015, by 11:59 PM Eastern Time. April 29, 2016, by 8:00 PM Eastern Time.April 28, 2017, by 8:00 PM Eastern Time.April 30, 2018, by 8:00 PM Eastern Time.April 30, 2019, by 8:00 PM Eastern Time.Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process.For the June 30, 2015 application due date, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. For all subsequent application due dates, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 8:00 PM Eastern Time on the application due date. Late applications will not be accepted for this FOA. |
| Archive Date: | May 30, 2019 |
| Estimated Total Program Funding: | $6,000,000 |
| Award Ceiling: | $3,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal governments (Federally recognized) 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 State governments Public housing authorities/Indian housing authorities Private institutions of higher education City or township governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses |
| 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 program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be viewed as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology. |
| Link to Additional Information: | Full Announcement of PAR-15-187 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: | PAR-15-187 |
| Funding Opportunity Title: | Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| 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: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 20, 2015 |
| Last Updated Date: | Jun 12, 2015 |
| Original Closing Date for Applications: | Apr 30, 2019 This announcement has multiple deadline dates.
June 30, 2015, by 11:59 PM Eastern Time. April 29, 2016, by 8:00 PM Eastern Time. April 28, 2017, by 8:00 PM Eastern Time. April 30, 2018, by 8:00 PM Eastern Time. April 30, 2019, by 8:00 PM Eastern Time. Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process. For the June 30, 2015 application due date, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. For all subsequent application due dates, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 8:00 PM Eastern Time on the application due date. Late applications will not be accepted for this FOA. |
| Current Closing Date for Applications: | Apr 30, 2019 This announcement has multiple deadline dates.June 30, 2015, by 11:59 PM Eastern Time. April 29, 2016, by 8:00 PM Eastern Time.April 28, 2017, by 8:00 PM Eastern Time.April 30, 2018, by 8:00 PM Eastern Time.April 30, 2019, by 8:00 PM Eastern Time.Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process.For the June 30, 2015 application due date, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. For all subsequent application due dates, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 8:00 PM Eastern Time on the application due date. Late applications will not be accepted for this FOA. |
| Archive Date: | May 30, 2019 |
| Estimated Total Program Funding: | $6,000,000 |
| Award Ceiling: | $3,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal governments (Federally recognized) 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 State governments Public housing authorities/Indian housing authorities Private institutions of higher education City or township governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Small businesses |
| 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 program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be viewed as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology. |
| Link to Additional Information: | Full Announcement of PAR-15-187 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: | PAR-15-187 |
| Funding Opportunity Title: | Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Technologies (U01) |
| 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: | 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: | Apr 30, 2019 This announcement has multiple deadline dates.
June 30, 2015, by 11:59 PM Eastern Time. April 29, 2016, by 8:00 PM Eastern Time. April 28, 2017, by 8:00 PM Eastern Time. April 30, 2018, by 8:00 PM Eastern Time. April 30, 2019, by 8:00 PM Eastern Time. Applicants are encouraged to apply early to allow adequate time to make any corrections by the due date to errors found in the application during the submission process. For the June 30, 2015 application due date, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. For all subsequent application due dates, Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 8:00 PM Eastern Time on the application due date. Late applications will not be accepted for this FOA. |
| Archive Date: | May 30, 2019 |
| Estimated Total Program Funding: | $2,000,000 |
| Award Ceiling: | $1,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Public housing authorities/Indian housing authorities Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) 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 Small businesses Special district governments City or township governments Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| 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 program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be viewed as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, and/or cost-effective processes and with which the FDA has limited review or inspection experiences, due to its relative novelty. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology. |
| Link to Additional Information: | Full Announcement of PAR-15-187 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 276023 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 | PAR-15-187 | FORMS-E | PKG00241590 | Apr 30, 2016 | Apr 30, 2019 | View |
Package 1
Mandatory forms
276023 RR_SF424_2_0-2.0.pdf
276023 PHS398_CoverPageSupplement_4_0-4.0.pdf
276023 RR_OtherProjectInfo_1_4-1.4.pdf
276023 PerformanceSite_2_0-2.0.pdf
276023 RR_KeyPersonExpanded_2_0-2.0.pdf
276023 RR_Budget_1_4-1.4.pdf
276023 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
276023 RR_SubawardBudget30_1_4-1.4.pdf
276023 PHS_AssignmentRequestForm_2_0-2.0.pdf
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