Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Report on Stakeholder Views; Availability, 8503 [2016-03479]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: AADPAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the docket (see ADDRESSES) on or before August 31, 2016, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 10:30 a.m. on September 16, 2016. Those individuals interested in making formal oral presentations should notify the VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 23, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 24, 2016. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Stephanie L. Begansky at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 16, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–03468 Filed 2–18–16; 8:45 am] BILLING CODE 4164–01–P 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. The Food and Drug Administration (FDA or Agency) is SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 8503 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. An electronic copy of the summary report is available at https:// www.fda.gov/ForPatients/About/ ucm483931.htm. ADDRESSES: 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 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 E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[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.

-----------------------------------------------------------------------

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 
https://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 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

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