Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. 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 proposed product will be superior to 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 assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2012-N-0011] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. 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 proposed product will be superior to 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 assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. DATES: Important dates are as follows: 1. The application due dates are February 6, 2013; February 5, 2014. The resubmission due dates are October 15, 2013; October 15, 2014. 2. The anticipated start dates are November 2013; November 2014. 3. The opening date is December 6, 2013. 4. The expiration date is February 6, 2014; October 16, 2014 (resubmission). For Further Information and Additional Requirements Contact:…
Other Federal Register documents from the same docket.
Establish a Patient-Based Registry To Evaluate the Association of Gadolinium Based Contrast Agents Exposure and Nephrogenic Systemic Fibrosis
Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24)
Citation: 77 FR 46764
