81_FR_14501 81 FR 14449 - Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

81 FR 14449 - Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 52 (March 17, 2016)

Page Range14449-14450
FR Document2016-06017

Federal Register, Volume 81 Issue 52 (Thursday, March 17, 2016) 
[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14449-14450]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Anesthetic and Analgesic Drug Products Advisory Committee and the 
Drug Safety and Risk Management Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committees: Anesthetic and Analgesic Drug Products Advisory 
Committee and the Drug Safety and Risk Management 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 June 7, 2016, from 8 
a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due 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://

[[Page 14450]]

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 committees will be asked to discuss new drug 
application (NDA) 207975, hydrocodone bitartrate extended-release 
tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., 
with the proposed indication of management of pain severe enough to 
require daily, around-the-clock, long-term opioid treatment and for 
which alternative treatment options are inadequate. The product is an 
extended-release formulation intended to have abuse-deterrent 
properties based on its physicochemical properties. The committees will 
be asked to discuss whether the data submitted by the Applicant are 
sufficient to support labeling of the product with the properties 
expected to deter abuse.
    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: On June 7, 2016, from 9:30 a.m. to 4 p.m., the meeting 
is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committees. Written submissions may be made to the contact person 
on or before May 23, 2016. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. 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 May 13, 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 May 16, 2016.
    Closed Committee Deliberations: On June 7, 2016, from 8 a.m. to 
9:30 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). During this session, the committees will discuss the drug 
development program of an investigational abuse-deterrent opioid 
product.
    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: March 14, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-06017 Filed 3-16-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices 14449 ACTION: Notice. be made publicly available at the Dated: March 11, 2016. location of the advisory committee Jill Hartzler Warner, This notice announces a forthcoming meeting, and the background material Associate Commissioner for Special Medical meeting of a public advisory committee Programs. will be posted on FDA’s Web site after of the Food and Drug Administration the meeting. Background material is [FR Doc. 2016–05959 Filed 3–16–16; 8:45 am] (FDA). The meeting will be open to the available at http://www.fda.gov/ BILLING CODE 4164–01–P public. Name of Committee: Endocrinologic AdvisoryCommittees/Calendar/ and Metabolic Drugs Advisory default.htm. Scroll down to the appropriate advisory committee meeting DEPARTMENT OF HEALTH AND Committee. HUMAN SERVICES General Function of the Committee: link. To provide advice and Procedure: Interested persons may Food and Drug Administration recommendations to the Agency on present data, information, or views, FDA’s regulatory issues. [Docket No. FDA–2016–N–0001] orally or in writing, on issues pending Date and Time: The meeting will be before the committee. Written held on May 25, 2016, from 8 a.m. to 5 Anesthetic and Analgesic Drug submissions may be made to the contact Products Advisory Committee and the p.m. person on or before May 10, 2016. Oral Location: FDA White Oak Campus, Drug Safety and Risk Management presentations from the public will be Advisory Committee; Notice of Meeting Building 31 Conference Center, the Great Room (Rm. 1503), 10903 New scheduled between approximately 1 p.m. and 2 p.m. Those individuals AGENCY: Food and Drug Administration, Hampshire Ave., Silver Spring, MD HHS. 20993–0002. Answers to commonly interested in making formal oral presentations should notify the contact ACTION: Notice. asked questions including information regarding special accommodations due person and submit a brief statement of This notice announces a forthcoming to a disability, visitor parking, and the general nature of the evidence or meeting of a public advisory committee transportation may be accessed at: arguments they wish to present, the of the Food and Drug Administration http://www.fda.gov/ names and addresses of proposed (FDA). At least one portion of the AdvisoryCommittees/ participants, and an indication of the meeting will be closed to the public. AboutAdvisoryCommittees/ approximate time requested to make Name of Committees: Anesthetic and ucm408555.htm. their presentation on or before May 2, Analgesic Drug Products Advisory Contact Person: LaToya Bonner, 2016. Time allotted for each Committee and the Drug Safety and Risk Center for Drug Evaluation and presentation may be limited. If the Management Advisory Committee. Research, Food and Drug number of registrants requesting to General Function of the Committees: Administration, 10903 New Hampshire speak is greater than can be reasonably To provide advice and Ave., Bldg. 31, Rm. 2417, Silver Spring, accommodated during the scheduled recommendations to the Agency on MD 20993–0002, 301–796–9001, FAX: open public hearing session, FDA may FDA’s regulatory issues. 301–847–8533, EMDAC@fda.hhs.gov, or conduct a lottery to determine the Date and Time: The meeting will be FDA Advisory Committee Information speakers for the scheduled open public held on June 7, 2016, from 8 a.m. to 4 Line, 1–800–741–8138 (301–443–0572 hearing session. The contact person will p.m. in the Washington, DC area). A notice in Location: FDA White Oak Campus, notify interested persons regarding their the Federal Register about last minute 10903 New Hampshire Ave., Bldg. 31 request to speak by May 3, 2016. Conference Center, the Great Room (Rm. modifications that impact a previously announced advisory committee meeting Persons attending FDA’s advisory 1503), Silver Spring, MD 20993–0002. cannot always be published quickly committee meetings are advised that the Answers to commonly asked questions enough to provide timely notice. Agency is not responsible for providing including information regarding special Therefore, you should always check the access to electrical outlets. accommodations due to a disability, Agency’s Web site at http:// FDA welcomes the attendance of the visitor parking, and transportation may www.fda.gov/AdvisoryCommittees/ public at its advisory committee be accessed at: http://www.fda.gov/ default.htm and scroll down to the meetings and will make every effort to AdvisoryCommittees/ appropriate advisory committee meeting accommodate persons with physical AboutAdvisoryCommittees/ link, or call the advisory committee ucm408555.htm. disabilities or special needs. If you information line to learn about possible Contact Person: Stephanie L. require special accommodations due to Begansky, Center for Drug Evaluation modifications before coming to the a disability, please contact LaToya and Research, Food and Drug meeting. Agenda: The committee will discuss Bonner at least 7 days in advance of the Administration, 10903 New Hampshire the safety and efficacy of new drug meeting. Ave., Bldg. 31, rm. 2417, Silver Spring, application (NDA) 208583 for insulin FDA is committed to the orderly MD 20993–0002, 301–796–9001, Fax: degludec and liraglutide injection, conduct of its advisory committee 301–847–8533, email: AADPAC@ submitted by Novo Nordisk Inc., for the meetings. Please visit our Web site at fda.hhs.gov, or FDA Advisory proposed indication: Adjunct to diet http://www.fda.gov/ Committee Information Line, 1–800– and exercise to improve glycemic 741–8138 (301–443–0572 in the asabaliauskas on DSK3SPTVN1PROD with NOTICES AdvisoryCommittees/ control in the treatment of adults with AboutAdvisoryCommittees/ Washington, DC area). A notice in the type 2 diabetes mellitus. ucm111462.htm for procedures on Federal Register about last-minute FDA intends to make background public conduct during advisory modifications that impact a previously material available to the public no later committee meetings. announced advisory committee meeting than 2 business days before the meeting. cannot always be published quickly If FDA is unable to post the background Notice of this meeting is given under enough to provide timely notice. material on its Web site prior to the the Federal Advisory Committee Act (5 Therefore, you should always check the meeting, the background material will U.S.C. app. 2). Agency’s Web site at http:// VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1

14450 Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public Tabulation Data Definition Specification default.htm and scroll down to the hearing session. The contact person will (Define.xml) and an update to the FDA appropriate advisory committee meeting notify interested persons regarding their Data Standards Catalog. Use of link, or call the advisory committee request to speak by May 16, 2016. Define.xml Version 2.0, which has been information line to learn about possible Closed Committee Deliberations: On available since March 2013, is the newer modifications before coming to the June 7, 2016, from 8 a.m. to 9:30 a.m., standard supported by FDA. FDA meeting. the meeting will be closed to permit support for Define.xml Version 1.0 will Agenda: The committees will be discussion and review of trade secret end for studies that start 12 months after asked to discuss new drug application and/or confidential commercial March 15, 2017. (NDA) 207975, hydrocodone bitartrate information (5 U.S.C. 552b(c)(4)). DATES: Submit either electronic or extended-release tablets, submitted by During this session, the committees will written comments at any time. Teva Branded Pharmaceutical Products discuss the drug development program ADDRESSES: You may submit comments R&D, Inc., with the proposed indication of an investigational abuse-deterrent of management of pain severe enough to as follows: opioid product. require daily, around-the-clock, long- Persons attending FDA’s advisory Electronic Submissions term opioid treatment and for which committee meetings are advised that the Submit electronic comments in the alternative treatment options are Agency is not responsible for providing following way: inadequate. The product is an extended- access to electrical outlets. release formulation intended to have • Federal eRulemaking Portal: http:// FDA welcomes the attendance of the abuse-deterrent properties based on its www.regulations.gov. Follow the public at its advisory committee physicochemical properties. The instructions for submitting comments. meetings and will make every effort to committees will be asked to discuss Comments submitted electronically, accommodate persons with disabilities. whether the data submitted by the including attachments, to http:// If you require accommodations due to a Applicant are sufficient to support www.regulations.gov will be posted to disability, please contact Stephanie L. labeling of the product with the the docket unchanged. Because your Begansky at least 7 days in advance of properties expected to deter abuse. comment will be made public, you are the meeting. FDA intends to make background FDA is committed to the orderly solely responsible for ensuring that your material available to the public no later conduct of its advisory committee comment does not include any than 2 business days before the meeting. meetings. Please visit our Web site at confidential information that you or a If FDA is unable to post the background http://www.fda.gov/ third party may not wish to be posted, material on its Web site prior to the AdvisoryCommittees/ such as medical information, your or meeting, the background material will AboutAdvisoryCommittees/ anyone else’s Social Security number, or be made publicly available at the ucm111462.htm for procedures on confidential business information, such location of the advisory committee public conduct during advisory as a manufacturing process. Please note meeting, and the background material committee meetings. that if you include your name, contact will be posted on FDA’s Web site after Notice of this meeting is given under information, or other information that the meeting. Background material is the Federal Advisory Committee Act (5 identifies you in the body of your available at http://www.fda.gov/ U.S.C. app. 2). comments, that information will be AdvisoryCommittees/Calendar/ posted on http://www.regulations.gov. Dated: March 14, 2016. default.htm. Scroll down to the • If you want to submit a comment Jill Hartzler Warner, with confidential information that you appropriate advisory committee meeting Associate Commissioner for Special Medical do not wish to be made available to the link. Programs. public, submit the comment as a Procedure: On June 7, 2016, from 9:30 a.m. to 4 p.m., the meeting is open to [FR Doc. 2016–06017 Filed 3–16–16; 8:45 am] written/paper submission and in the the public. Interested persons may BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper present data, information, or views, Submissions’’ and ‘‘Instructions’’). orally or in writing, on issues pending DEPARTMENT OF HEALTH AND Written/Paper Submissions before the committees. Written submissions may be made to the contact HUMAN SERVICES Submit written/paper submissions as person on or before May 23, 2016. Oral follows: Food and Drug Administration presentations from the public will be • Mail/Hand delivery/Courier (for scheduled between approximately 1 [Docket No. FDA–2014–N–1840] written/paper submissions): Division of p.m. and 2 p.m. Those individuals Dockets Management (HFA–305), Food interested in making formal oral Electronic Study Data Submission; and Drug Administration, 5630 Fishers presentations should notify the contact Data Standards; Support End Date for Lane, Rm. 1061, Rockville, MD 20852. person and submit a brief statement of Case Report Tabulation Data Definition • For written/paper comments the general nature of the evidence or Specification Version 1.0 submitted to the Division of Dockets arguments they wish to present, the AGENCY: Food and Drug Administration, Management, FDA will post your names and addresses of proposed HHS. comment, as well as any attachments, participants, and an indication of the ACTION: Notice. except for information submitted, approximate time requested to make marked and identified, as confidential, asabaliauskas on DSK3SPTVN1PROD with NOTICES their presentation on or before May 13, SUMMARY: The Food and Drug if submitted as detailed in 2016. Time allotted for each Administration’s (FDA or Agency) ‘‘Instructions.’’ presentation may be limited. If the Center for Biologics Evaluation and Instructions: All submissions received number of registrants requesting to Research (CBER) and Center for Drug must include the Docket No. FDA– speak is greater than can be reasonably Evaluation and Research (CDER) are 2014–N–1840 for ‘‘Electronic Study accommodated during the scheduled announcing the end of support for Data Submission; Data Standards; open public hearing session, FDA may Version 1.0 of Clinical Data Interchange Support End Date for Case Report conduct a lottery to determine the Standards Consortium Case Report Tabulation Data Definition Specification VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1


Document Created: 2016-03-17 00:58:02
Document Modified: 2016-03-17 00:58:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation81 FR 14449 
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