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2016-05-04
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Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)
Notices
D09002ee1c2bb69f1
D09002ee1c2bb6a72
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OOPD) Natural History Grants Program. The goal of the Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
81 FR 26803
https://www.govinfo.gov/app/details/FR-2016-05-04/2016-10398
2016-10398
fr04my16-63
4164-01-P
Docket No. FDA-2016-N-0012
https://www.govinfo.gov/app/details/FR-2016-05-04/2016-10398
https://www.govinfo.gov/content/pkg/FR-2016-05-04/html/2016-10398.htm
https://www.govinfo.gov/content/pkg/FR-2016-05-04/pdf/2016-10398.pdf
2 p.
26803
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81 FR 26803
Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01); Federal Register Vol. 81, Issue
NOTICE
2016-10398
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-N-0012
4164-01-P
2016-10398
Notice.
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OOPD) Natural History Grants Program. The goal of the Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products. Applicants must include in the application's Background and Significance section documentation to support that the estimated prevalence of the orphan disease or condition in the United States is less than 200,000 (or in the case of a vaccine or diagnostic, information to support that the product will be administered to fewer than 200,000 people in the United States per year), and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Important dates are as follows:
Funding Availability:
Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)
,
daniel.lukash@fda.hhs.gov
katherine.needleman@fda.hhs.gov
Grants.gov
http://grants.nih.gov/grants/guide
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458485.pdf
http://www.fda.gov/orphan
http://www.grants.gov
http://www07.grants.gov/applicants/organization_registration.jsp
https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp
Federal Register
Vol. 81, no. 86
Office of the Federal Register, National Archives and Records Administration
2016-05-04
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2016-05-04
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https://www.govinfo.gov/app/details/FR-2016-05-04
https://www.govinfo.gov/content/pkg/FR-2016-05-04/pdf/FR-2016-05-04.pdf
https://www.govinfo.gov/content/pkg/FR-2016-05-04/xml/FR-2016-05-04.xml
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