81 FR 8502 - Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee; Notice of Meeting
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 | 8502-8503 | |
| FR Document | 2016-03468 |
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)] [Notices] [Pages 8502-8503] From the Federal Register Online [www.thefederalregister.org] [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 http://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: http://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: [email protected], 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 http://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 http://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 http://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
![8502 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
submission. You should submit two Weight Heparin.’’ It finalizes the draft DEPARTMENT OF HEALTH AND
copies total. One copy will include the guidance entitled ‘‘Immunogenicity- HUMAN SERVICES
information you claim to be confidential Related Considerations for the Approval
with a heading or cover note that states of Low Molecular Weight Heparin for Food and Drug Administration
‘‘THIS DOCUMENT CONTAINS New Drug Applications and [Docket No. FDA–2016–N–0584]
CONFIDENTIAL INFORMATION’’. The Abbreviated New Drug Applications’’
Agency will review this copy, including that published on April 9, 2014 (79 FR Anesthetic and Analgesic Drug
the claimed confidential information, in 19621). FDA has considered the Products Advisory Committee, the
its consideration of comments. The comments submitted to the public Drug Safety and Risk Management
second copy, which will have the docket and modified statements and Advisory Committee, and the Pediatric
claimed confidential information added terms for clarity. Advisory Committee; Notice of Meeting
redacted/blacked out, will be available This guidance provides
for public viewing and posted on http:// recommendations to applicants for new AGENCY: Food and Drug Administration,
www.regulations.gov. Submit both drug applications (NDAs) and HHS.
copies to the Division of Dockets abbreviated new drug applications ACTION: Notice; request for comments.
Management. If you do not wish your (ANDAs) regarding impurities and their
potential effect on immunogenicity for This notice announces a forthcoming
name and contact information to be
LMWH. This guidance also includes meeting of public advisory committees
made publicly available, you can
recommendations for ANDA applicants of the Food and Drug Administration
provide this information on the cover
on meeting the requirement for active (FDA). The meeting will be open to the
sheet and not in the body of your
ingredient sameness, because a public.
comments and you must identify this Names of Committees: Anesthetic and
information as ‘‘confidential.’’ Any demonstration of active ingredient
Analgesic Drug Products Advisory
information marked as ‘‘confidential’’ sameness helps to address
Committee, the Drug Safety and Risk
will not be disclosed except in immunogenicity considerations in this
Management Advisory Committee, and
accordance with 21 CFR 10.20 and other context. In addition, this guidance
the Pediatric Advisory Committee.
applicable disclosure law. For more discusses how to address changes in the
General Function of the Committees:
information about FDA’s posting of source material or other component, or
To provide advice and
comments to public dockets, see 80 FR when there are modifications to the
recommendations to the Agency on
56469, September 18, 2015, or access manufacturing process after completion
FDA’s regulatory issues.
the information at: http://www.fda.gov/ of supporting clinical studies, either Date and Time: The meeting will be
regulatoryinformation/dockets/ before or after approval of the held on September 15, 2016, from 8 a.m.
default.htm. application. to 5 p.m. and September 16, 2016, from
Docket: For access to the docket to This guidance is being issued
8 a.m. to 5 p.m.
read background documents or the consistent with FDA’s good guidance Addresses: FDA is opening a docket
electronic and written/paper comments practices regulation (21 CFR 10.115). for public comment on this meeting.
received, go to http:// This guidance represents the Agency’s The docket number is FDA–2016–N–
www.regulations.gov and insert the current thinking on immunogenicity 0584. The docket will open for public
docket number, found in brackets in the considerations for low molecular weight comment on February 19, 2016. The
heading of this document, into the heparin. It does not establish any rights docket will close on September 30,
‘‘Search’’ box and follow the prompts for any person and is not binding on 2016. Interested persons may submit
and/or go to the Division of Dockets FDA or the public. You can use an either electronic or written comments
Management, 5630 Fishers Lane, Rm. alternative approach if it satisfies the regarding this meeting. Submit
1061, Rockville, MD 20852. requirements of the applicable statutes electronic comments to http://
Submit written requests for single and regulations. www.regulations.gov. Submit written
copies of this guidance to the Division II. The Paperwork Reduction Act comments to the Division of Dockets
of Drug Information, Center for Drug Management (HFA–305), Food and Drug
Evaluation and Research, Food and This guidance refers to a previously
approved collection of information that Administration, 5630 Fishers Lane, Rm.
Drug Administration, 10001 New 1061, Rockville, MD 20852. All
Hampshire Ave., Hillandale Building, is subject to review by the Office of
Management and Budget (OMB) under comments received will be posted
4th Floor, Silver Spring, MD 20993– without change, including any personal
0002. Send one self-addressed adhesive the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of information provided. It is only
label to assist that office in processing necessary to send one set of comments.
your requests. See the SUPPLEMENTARY information in 21 CFR part 314 has been
approved under OMB control number Identify comments with the docket
INFORMATION section for electronic number found in brackets in the
access to the guidance document. 0910–0001.
heading of this document. Received
FOR FURTHER INFORMATION CONTACT: III. Electronic Access comments may be seen in the Division
Daniela Verthelyi, Center for Drug Persons with access to the Internet of Dockets Management between 9 a.m.
Evaluation and Research, Food and may obtain the guidance at either http:// and 4 p.m., Monday through Friday.
Drug Administration, 10903 New www.fda.gov/Drugs/Guidance Comments received on or before August
Hampshire Ave., Silver Spring, MD 31, 2016, will be provided to the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ComplianceRegulatoryInformation/
20993, 240–402–7450. Guidances/default.htm or http:// committee before the meeting.
SUPPLEMENTARY INFORMATION: www.regulations.gov. Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
I. Background Dated: February 16, 2016. 31 Conference Center, the Great Room
FDA is announcing the availability of Leslie Kux, (Rm. 1503), Silver Spring, MD 20993–
a guidance for industry entitled Associate Commissioner for Policy. 0002. Answers to commonly asked
‘‘Immunogenicity-Related [FR Doc. 2016–03461 Filed 2–18–16; 8:45 am] questions including information
Considerations for Low Molecular BILLING CODE 4164–01–P regarding special accommodations due
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![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 14:31:59
Document Modified: 2018-02-02 14:31:59
| 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; request for comments. | |
| FR Citation | 81 FR 8502 |
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