[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Page 8503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03479]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1698]
Food and Drug Administration Activities for Patient Participation
in Medical Product Discussions; Report on Stakeholder Views;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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, [email protected].
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 the views of patients during the medical product development
process and consider the perspectives of patients during regulatory
discussions, including by fostering participation of a patient
representative who may serve as a special government employee in
appropriate Agency meetings with medical product sponsors and
investigators and exploring means to provide for identification of
patient representatives who do not have any, or have minimal, financial
interests in the medical products industry.
FDA formed an Agency-wide working group to explore approaches and
procedures as well as to align strategies across the Agency for patient
participation in accordance with the statute.
Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03479 Filed 2-18-16; 8:45 am]
BILLING CODE 4164-01-P