Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is making available the summary report of the public comments received during the open period from November 4 to December 4, 2014, on FDA activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. The purpose of this notice is to announce the public availability of the report on stakeholder views based on the comments received in the docket.
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-2014-N-1698] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is making available the summary report of the public comments received during the open period from November 4 to December 4, 2014, on FDA activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. The purpose of this notice is to announce the public availability of the report on stakeholder views based on the comments received in the docket. ADDRESSES: An electronic copy of the summary report is available at http://www.fda.gov/​ForPatients/​About/​ucm483931.htm . The summary report is also available in Docket No. FDA-2014-N-1698. FOR FURTHER INFORMATION CONTACT: Andrea Furia-Helms, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5319, Silver Spring MD 20993-0002, Andrea.Furia@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Background On July 9, 2012, the President signed into law FDASIA ( Pub. L. 112-144 ). FDASIA expands FDA's authorities and strengthens the Agency's ability to safeguard and advance public health in several areas including increasing stakeholder involvement in FDA regulatory processes. Specifically, section 1137 of FDASIA directs the Secretary of Health and Human Services to develop and implement strategies to solicit t…
Other Federal Register documents from the same docket.
Citation: 81 FR 8503