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)
Food and Drug Administration
Federal Register Volume 81, Issue 33 (February 19, 2016)
| Page Range | 8503-8503 | |
| FR Document | 2016-03479 |
[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] ----------------------------------------------------------------------- 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 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
![Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 8503
to a disability, visitor parking, and contact person and submit a brief making available the summary report of
transportation may be accessed at: statement of the general nature of the the public comments received during
http://www.fda.gov/ evidence or arguments they wish to the open period from November 4 to
AdvisoryCommittees/ present, the names and addresses of December 4, 2014, on FDA activities
AboutAdvisoryCommittees/ proposed participants, and an under the Food and Drug
ucm408555.htm. indication of the approximate time Administration Safety and Innovation
Contact Person: Stephanie L. requested to make their presentation on Act (FDASIA), Patient Participation in
Begansky, Center for Drug Evaluation or before August 23, 2016. Time allotted Medical Product Discussions. The
and Research, Food and Drug for each presentation may be limited. If purpose of this notice is to announce
Administration, 10903 New Hampshire the number of registrants requesting to the public availability of the report on
Ave., Bldg. 31, Rm. 2417, Silver Spring, speak is greater than can be reasonably stakeholder views based on the
MD 20993–0002, 301–796–9001, FAX: accommodated during the scheduled comments received in the docket.
301–847–8533, email: AADPAC@ open public hearing session, FDA may
fda.hhs.gov, or FDA Advisory conduct a lottery to determine the ADDRESSES:An electronic copy of the
Committee Information Line, 1–800– speakers for the scheduled open public summary report is available at http://
741–8138 (301–443–0572 in the hearing session. The contact person will www.fda.gov/ForPatients/About/
Washington, DC area). A notice in the notify interested persons regarding their ucm483931.htm.
Federal Register about last minute request to speak by August 24, 2016. The summary report is also available
modifications that impact a previously Persons attending FDA’s advisory in Docket No. FDA–2014–N–1698.
announced advisory committee meeting committee meetings are advised that the
cannot always be published quickly Agency is not responsible for providing FOR FURTHER INFORMATION CONTACT:
enough to provide timely notice. access to electrical outlets. Andrea Furia-Helms, Food and Drug
Therefore, you should always check the FDA welcomes the attendance of the Administration, 10903 New Hampshire
Agency’s Web site at http:// public at its advisory committee Ave., Bldg. 32, Rm. 5319, Silver Spring
www.fda.gov/AdvisoryCommittees/ meetings and will make every effort to MD 20993–0002, Andrea.Furia@
default.htm and scroll down to the accommodate persons with disabilities. fda.hhs.gov.
appropriate advisory committee meeting If you require accommodations due to a
link, or call the advisory committee SUPPLEMENTARY INFORMATION:
disability, please contact Stephanie L.
information line to learn about possible Begansky at least 7 days in advance of Background
modifications before coming to the the meeting.
meeting. FDA is committed to the orderly On July 9, 2012, the President signed
Agenda: The purpose of this public into law FDASIA (Pub. L. 112–144).
conduct of its advisory committee
advisory committee meeting is to FDASIA expands FDA’s authorities and
meetings. Please visit our Web site at
discuss the appropriate development strengthens the Agency’s ability to
http://www.fda.gov/
plans for establishing the safety and safeguard and advance public health in
AdvisoryCommittees/
efficacy of prescription opioid several areas including increasing
AboutAdvisoryCommittees/
analgesics for pediatric patients, stakeholder involvement in FDA
ucm111462.htm for procedures on
including obtaining pharmacokinetic regulatory processes. Specifically,
public conduct during advisory
data and the use of extrapolation. section 1137 of FDASIA directs the
committee meetings.
FDA intends to make background Secretary of Health and Human Services
material available to the public no later Notice of this meeting is given under
the Federal Advisory Committee Act (5 to develop and implement strategies to
than 2 business days before the meeting. solicit the views of patients during the
If FDA is unable to post the background U.S.C. app. 2).
medical product development process
material on its Web site prior to the Dated: February 16, 2016.
and consider the perspectives of
meeting, the background material will Jill Hartzler Warner,
patients during regulatory discussions,
be made publicly available at the Associate Commissioner for Special Medical including by fostering participation of a
location of the advisory committee Programs.
patient representative who may serve as
meeting, and the background material [FR Doc. 2016–03468 Filed 2–18–16; 8:45 am]
a special government employee in
will be posted on FDA’s Web site after BILLING CODE 4164–01–P appropriate Agency meetings with
the meeting. Background material is
medical product sponsors and
available at http://www.fda.gov/
investigators and exploring means to
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND
default.htm. Scroll down to the provide for identification of patient
HUMAN SERVICES
appropriate advisory committee meeting representatives who do not have any, or
link. Food and Drug Administration have minimal, financial interests in the
Procedure: Interested persons may medical products industry.
[Docket No. FDA–2014–N–1698]
present data, information, or views, FDA formed an Agency-wide working
orally or in writing, on issues pending Food and Drug Administration group to explore approaches and
before the committees. All electronic Activities for Patient Participation in procedures as well as to align strategies
and written submissions submitted to across the Agency for patient
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Medical Product Discussions; Report
the docket (see ADDRESSES) on or before on Stakeholder Views; Availability participation in accordance with the
August 31, 2016, will be provided to the statute.
committees. Oral presentations from the AGENCY: Food and Drug Administration, Dated: February 16, 2016.
public will be scheduled between HHS.
Leslie Kux,
approximately 8:30 a.m. and 10:30 a.m. ACTION: Notice of availability.
on September 16, 2016. Those Associate Commissioner for Policy.
individuals interested in making formal SUMMARY: The Food and Drug [FR Doc. 2016–03479 Filed 2–18–16; 8:45 am]
oral presentations should notify the Administration (FDA or Agency) is BILLING CODE 4164–01–P
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Document Created: 2018-02-02 14:32:03
Document Modified: 2018-02-02 14:32:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Contact | Andrea Furia-Helms, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5319, Silver Spring MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 8503 |
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