Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee; Notice of Meeting, 8502-8503 [2016-03468]
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Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Daniela Verthelyi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–7450.
SUPPLEMENTARY INFORMATION:
Weight Heparin.’’ It finalizes the draft
guidance entitled ‘‘ImmunogenicityRelated Considerations for the Approval
of Low Molecular Weight Heparin for
New Drug Applications and
Abbreviated New Drug Applications’’
that published on April 9, 2014 (79 FR
19621). FDA has considered the
comments submitted to the public
docket and modified statements and
added terms for clarity.
This guidance provides
recommendations to applicants for new
drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) regarding impurities and their
potential effect on immunogenicity for
LMWH. This guidance also includes
recommendations for ANDA applicants
on meeting the requirement for active
ingredient sameness, because a
demonstration of active ingredient
sameness helps to address
immunogenicity considerations in this
context. In addition, this guidance
discusses how to address changes in the
source material or other component, or
when there are modifications to the
manufacturing process after completion
of supporting clinical studies, either
before or after approval of the
application.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the Agency’s
current thinking on immunogenicity
considerations for low molecular weight
heparin. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
I. Background
Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
FDA is announcing the availability of
a guidance for industry entitled
‘‘Immunogenicity-Related
Considerations for Low Molecular
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II. The Paperwork Reduction Act
This guidance refers to a previously
approved collection of information that
is subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in 21 CFR part 314 has been
approved under OMB control number
0910–0001.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
[FR Doc. 2016–03461 Filed 2–18–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0584]
Anesthetic and Analgesic Drug
Products Advisory Committee, the
Drug Safety and Risk Management
Advisory Committee, and the Pediatric
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
This notice announces a forthcoming
meeting of public advisory committees
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Names of Committees: Anesthetic and
Analgesic Drug Products Advisory
Committee, the Drug Safety and Risk
Management Advisory Committee, and
the Pediatric Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 15, 2016, from 8 a.m.
to 5 p.m. and September 16, 2016, from
8 a.m. to 5 p.m.
Addresses: FDA is opening a docket
for public comment on this meeting.
The docket number is FDA–2016–N–
0584. The docket will open for public
comment on February 19, 2016. The
docket will close on September 30,
2016. Interested persons may submit
either electronic or written comments
regarding this meeting. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments received will be posted
without change, including any personal
information provided. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Comments received on or before August
31, 2016, will be provided to the
committee before the meeting.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
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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
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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]
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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.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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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]
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]]>Agencies
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8502-8503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03468]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0584]
Anesthetic and Analgesic Drug Products Advisory Committee, the
Drug Safety and Risk Management Advisory Committee, and the Pediatric
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of public advisory
committees of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Names of Committees: Anesthetic and Analgesic Drug Products
Advisory Committee, the Drug Safety and Risk Management Advisory
Committee, and the Pediatric Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 15, 2016, from
8 a.m. to 5 p.m. and September 16, 2016, from 8 a.m. to 5 p.m.
Addresses: FDA is opening a docket for public comment on this
meeting. The docket number is FDA-2016-N-0584. The docket will open for
public comment on February 19, 2016. The docket will close on September
30, 2016. Interested persons may submit either electronic or written
comments regarding this meeting. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. All comments received will be posted
without change, including any personal information provided. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Comments received on
or before August 31, 2016, will be provided to the committee before the
meeting.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Answers to commonly asked questions including information
regarding special accommodations due
[[Page 8503]]
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 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]
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