FDA’s Office of Orphan Products Development (OPD) offers the Research Project Grant (R01) to support clinical studies on the safety and effectiveness of orphan products. This grant is for advancing treatments for rare diseases or conditions affecting fewer than 200,000 people in the U.S. The primary goal is to facilitate market approval or provide crucial data for products where no current therapy exists, or where the product significantly improves existing treatments. Research institutions/organizations apply, with Project Directors/Principal Investigators defining the scientific focus. Proposals must document disease prevalence and demonstrate how the study will contribute to product approval or development, aligning with FDA’s mission to promote the development of these vital therapies.
Opportunity ID: 57180
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Education Health Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan.
Cl;ose Date Explanation Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. |
| Expected Number of Awards: | 60 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 5 |
| Posted Date: | Sep 09, 2010 |
| Last Updated Date: | Oct 18, 2010 |
| Original Closing Date for Applications: | Oct 16, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Current Closing Date for Applications: | Oct 18, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Archive Date: | Nov 17, 2010 |
| Estimated Total Program Funding: | $41,400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities State governments Native American tribal governments (Federally recognized) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VII, Other Information – Required Federal Citations, for policies related to this announcement. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
Senior Grants Management Spec Phone 301-827-7162 Email:Marc.Pitts@FDA.HHS.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Please Note: This FOA’s Application Submission Date has been extended through the Close of Business October 18th 2010 due to A Grants.gov Hardwire Failure. For clarification, the Introduction page for this FOA has been reduced from a three page limit to a one page limit per Adobe Forms B Guidelines. | Oct 18, 2010 | |
| Please Note: This FOA’s Application Submission Date has been extended through the Close of Business October 18th 2010 due to A Grants.gov Hardwire Failure. For clarification, the Introduction page for this FOA has been reduced from a three page limit to a one page limit per Adobe Forms B Guidelines. | Oct 18, 2010 | |
| Please Note: This FOA’s Application Submission Date has been extended through the Close of Business October 18th 2010 due to A Grants.gov Hardwire Failure.
For clarification, the Introduction page for this FOA has been reduced from a three page limit to a one page limit per Adobe Forms B Guidelines. |
Oct 18, 2010 | |
| Please Note: This FOA’s Application Submission Date has been extended through the Close of Business October 18th 2010 due to A Grants.gov Hardwire Failure.
For clarification, the Introduction page for this FOA has been reduced from a three page limit to a one page limit per Adobe Forms B Guidelines. |
Oct 18, 2010 | |
| Oct 18, 2010 |
DISPLAYING: Synopsis 5
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Education Health Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan.
Cl;ose Date Explanation Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. |
| Expected Number of Awards: | 60 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 5 |
| Posted Date: | Sep 09, 2010 |
| Last Updated Date: | Oct 18, 2010 |
| Original Closing Date for Applications: | Oct 16, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Current Closing Date for Applications: | Oct 18, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Archive Date: | Nov 17, 2010 |
| Estimated Total Program Funding: | $41,400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities State governments Native American tribal governments (Federally recognized) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VII, Other Information – Required Federal Citations, for policies related to this announcement. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
Senior Grants Management Spec Phone 301-827-7162 Email:Marc.Pitts@FDA.HHS.GOV |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Education Health Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan.
Cl;ose Date Explanation Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. |
| Expected Number of Awards: | 60 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Oct 18, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 16, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Archive Date: | – |
| Estimated Total Program Funding: | $41,400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) 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 |
| Additional Information on Eligibility: | Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VII, Other Information – Required Federal Citations, for policies related to this announcement. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
Senior Grants Management Spec Phone 301-827-7162 Email:Marc.Pitts@FDA.HHS.GOV |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Education Health Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan.
Cl;ose Date Explanation Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. |
| Expected Number of Awards: | 60 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Oct 18, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 16, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Archive Date: | – |
| Estimated Total Program Funding: | $41,400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Native American tribal governments (Federally recognized) Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) 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 |
| Additional Information on Eligibility: | Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VII, Other Information – Required Federal Citations, for policies related to this announcement. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
Senior Grants Management Spec Phone 301-827-7162 Email:Marc.Pitts@FDA.HHS.GOV |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Education Health Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan.
Cl;ose Date Explanation Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. |
| Expected Number of Awards: | 60 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Oct 18, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 16, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Archive Date: | Oct 17, 2010 |
| Estimated Total Program Funding: | $41,400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) 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 |
| Additional Information on Eligibility: | Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VII, Other Information – Required Federal Citations, for policies related to this announcement. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
Senior Grants Management Spec Phone 301-827-7162 Email:Marc.Pitts@FDA.HHS.GOV |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-09-001 |
| Funding Opportunity Title: | Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Education Health Other (see text field entitled “Explanation of Other Category of Funding Activity” for clarification) Science and Technology and other Research and Development |
| Category Explanation: | OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan.
Cl;ose Date Explanation Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. |
| Expected Number of Awards: | 60 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 18, 2010 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Oct 16, 2010 Resubmission Application Due Dates: Application Resubmission/Receipt Date: October 15, 2009, and October 15, 2010 Please note that there is only one receipt date for FY 2010 and one receipt date for FY 2011 for new and resubmitted applications. Resubmissions and applications that were submitted previously but were deemed non-responsive to the RFA due to technical or IND issues will be allowed to resubmit October 15, 2009 and October 15, 2010. Resubmissions will also be accepted in the February receipt dates in both Fiscal years. On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). |
| Archive Date: | Oct 17, 2010 |
| Estimated Total Program Funding: | $41,400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Special district governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) 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 |
| Additional Information on Eligibility: | Eligible Organizations: The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. For-profit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c) (4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. The following are also included: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Non-domestic (non-U.S.) Entity; Small Business; For-Profit Organization (Other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Other: Eligible agencies of the Federal government; Faith-based or community based organizations. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Research Objectives The Research Project Grant (R01) is an award to support a discrete, specified, circumscribed project to be performed by named Project Directors/Principal Investigators (PDs/PIs) in areas representing the investigators specific interests and competencies based on the mission of FDA. FDA awards R01 grants to institutions/organizations of all types. This mechanism allows the PDs/PIs to define the scientific focus or objective of the research based on particular areas of interest and competence. Although the PDs/PIs write the grant application and are responsible for conducting and supervising the research, the actual applicant is the research institution/organization.OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and foods for medical purposes that are indicated for a rare disease or condition (that is, one with a prevalence, not incidence, of fewer than 200,000 people in the United States). Diagnostic tests and vaccines will qualify only if the U.S. population of intended use is fewer than 200,000 people a year. Additional information regarding OPD and the FOA tips page are available on FDA’s Web site at www.fda.gov/orphan. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product will improve the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition and an explanation of how the proposed study will either help gain product approval or provide essential data needed for product development. All funded studies are subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331 et seq.), regulations issued under it, and applicable Department of Health and Human Services (HHS) statutes and regulations.For specific information about the mission of each FDA Center, see About FDA. See Section VII, Other Information – Required Federal Citations, for policies related to this announcement. |
| Link to Additional Information: | Full Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Marc Pitts
Senior Grants Management Spec Phone 301-827-7162 Email:Marc.Pitts@FDA.HHS.GOV |
Related Documents
Folder 57180 Full Announcement-1 -> rfa-fd-09-001 clinical studies of safety and effectiveness of orphan products research project grant (r01).pdf
Folder 57180 Full Announcement-1 -> not-od-09-003 new nih policy on resubmission (amended) applications.pdf
Folder 57180 Full Announcement-1 -> sf424_rr_guide_general_adobe_verb.pdf
Folder 57180 Full Announcement-1 -> era registration tips.pdf
Packages
| Agency Contact Information: | Marc Pitts Senior Grants Management Spec Phone 301-827-7162 Email: Marc.Pitts@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-B | ADOBE-FORMS-B | PKG00020916 | Sep 09, 2010 | Oct 19, 2010 | View |
Package 1
Mandatory forms
57180 RR_SF424_1_2-1.2.pdf
57180 PerformanceSite_1_3-1.3.pdf
57180 RR_OtherProjectInfo_1_2-1.2.pdf
57180 RR_KeyPersonExpanded_1_2-1.2.pdf
57180 PHS398_CoverPageSupplement_1_4-1.4.pdf
57180 PHS398_ResearchPlan_1_3-1.3.pdf
57180 PHS398_Checklist_1_3-1.3.pdf
Optional forms
57180 PHS_CoverLetter_1_2-1.2.pdf
57180 PHS398_ModularBudget-1.1.pdf
57180 RR_Budget-1.1.pdf
57180 RR_SubawardBudget-1.2.pdf
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