81 FR 8503 - Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Report on Stakeholder Views; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 33 (February 19, 2016)

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.

[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Page 8503]
From the Federal Register Online  [www.thefederalregister.org]
[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