81_FR_14503 81 FR 14451 - Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

81 FR 14451 - 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 Range14451-14452
FR Document2016-05999

Federal Register, Volume 81 Issue 52 (Thursday, March 17, 2016) 
[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14451-14452]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05999]


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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 8, 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://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) 207621, oxycodone hydrochloride and naltrexone 
hydrochloride extended-release capsules, submitted by Pfizer, 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 the

[[Page 14452]]

presence of naltrexone, an opioid antagonist, in the formulation. 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 8, 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 24, 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 16, 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 17, 2016.
    Closed Committee Deliberations: On June 8, 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 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05999 Filed 3-16-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices 14451 Version 1.0.’’ Received comments will MD 20993–0002, 240–402–8187, ACTION: Notice. be placed in the docket and, except for jack.zhang@fda.hhs.gov. those submitted as ‘‘Confidential This notice announces a forthcoming SUPPLEMENTARY INFORMATION: Submissions,’’ publicly viewable at meeting of a public advisory committee http://www.regulations.gov or at the I. Background of the Food and Drug Administration Division of Dockets Management (FDA). At least one portion of the On December 17, 2014, FDA between 9 a.m. and 4 p.m., Monday meeting will be closed to the public. published final guidance for industry Name of Committees: Anesthetic and through Friday. ‘‘Providing Regulatory Submissions in Analgesic Drug Products Advisory • Confidential Submissions—To Electronic Format—Standardized Study Committee and the Drug Safety and Risk submit a comment with confidential Data’’ (eStudy Data) posted on FDA’s Management Advisory Committee. information that you do not wish to be Study Data Standards Resources Web General Function of the Committees: made publicly available, submit your page at http://www.fda.gov/forindustry/ To provide advice and comments only as a written/paper datastandards/studydatastandards/ recommendations to the Agency on submission. You should submit two default.htm. The eStudy Data guidance FDA’s regulatory issues. copies total. One copy will include the implements the electronic submission Date and Time: The meeting will be information you claim to be confidential requirements of section 745A(a) of the held on June 8, 2016, from 8 a.m. to 4 with a heading or cover note that states Federal Food, Drug, and Cosmetic Act p.m. ‘‘THIS DOCUMENT CONTAINS (21 U.S.C. 379k–1(a)) for study data Location: FDA White Oak Campus, CONFIDENTIAL INFORMATION.’’ The contained in new drug applications, 10903 New Hampshire Ave., Bldg. 31 Agency will review this copy, including abbreviated new drug applications, Conference Center, the Great Room (Rm. the claimed confidential information, in biologics license applications, and 1503), Silver Spring, MD 20993–0002. its consideration of comments. The investigational new drug applications Answers to commonly asked questions second copy, which will have the submitted to CDER or CBER by including information regarding special claimed confidential information specifying the format for electronic accommodations due to a disability, redacted/blacked out, will be available submissions. The eStudy Data guidance visitor parking, and transportation may for public viewing and posted on states that a Federal Register notice will be accessed at: http://www.fda.gov/ http://www.regulations.gov. Submit specify the transition date for updates to AdvisoryCommittees/ both copies to the Division of Dockets standards (with the month and day for AboutAdvisoryCommittees/ Management. If you do not wish your the transition date corresponding to ucm408555.htm. name and contact information to be March 15). Contact Person: Stephanie L. made publicly available, you can The transition date for the end of FDA Begansky, Center for Drug Evaluation provide this information on the cover support for Define.xml Version 1.0 is and Research, Food and Drug sheet and not in the body of your March 15, 2017. Therefore, FDA support Administration, 10903 New Hampshire comments and you must identify this for Define.xml Version 1.0 will end for Ave., Bldg. 31, Rm. 2417, Silver Spring, information as ‘‘confidential.’’ Any studies that start after March 15, 2018. MD 20993–0002, 301–796–9001, FAX: information marked as ‘‘confidential’’ The FDA Data Standards Catalog (see 301–847–8533, email: AADPAC@ will not be disclosed except in http://www.fda.gov/forindustry/ fda.hhs.gov, or FDA Advisory accordance with 21 CFR 10.20 and other datastandards/studydatastandards/ Committee Information Line, 1–800– applicable disclosure law. For more default.htm) will be updated to list 741–8138 (301–443–0572 in the information about FDA’s posting of March 15, 2018, as the ‘‘date support Washington, DC area). A notice in the comments to public dockets, see 80 FR ends.’’ Federal Register about last minute 56469, September 18, 2015, or access II. Electronic Access modifications that impact a previously the information at: http://www.fda.gov/ announced advisory committee meeting regulatoryinformation/dockets/ Persons with access to the Internet cannot always be published quickly default.htm. may obtain the referenced material at enough to provide timely notice. http://www.fda.gov/forindustry/ Therefore, you should always check the Docket: For access to the docket to datastandards/studydatastandards/ read background documents or the Agency’s Web site at http:// default.htm. www.fda.gov/AdvisoryCommittees/ electronic and written/paper comments received, go to http:// Dated: March 10, 2016. default.htm and scroll down to the www.regulations.gov and insert the Leslie Kux, appropriate advisory committee meeting docket number, found in brackets in the Associate Commissioner for Policy. link, or call the advisory committee heading of this document, into the [FR Doc. 2016–05958 Filed 3–16–16; 8:45 am] information line to learn about possible ‘‘Search’’ box and follow the prompts BILLING CODE 4164–01–P modifications before coming to the and/or go to the Division of Dockets meeting. Agenda: The committees will be Management, 5630 Fishers Lane, Rm. DEPARTMENT OF HEALTH AND asked to discuss new drug application 1061, Rockville, MD 20852. HUMAN SERVICES (NDA) 207621, oxycodone FOR FURTHER INFORMATION CONTACT: hydrochloride and naltrexone Fatima Frye, Center for Drug Evaluation Food and Drug Administration hydrochloride extended-release and Research, Food and Drug capsules, submitted by Pfizer, Inc., with asabaliauskas on DSK3SPTVN1PROD with NOTICES Administration, 10903 New Hampshire [Docket No. FDA–2016–N–0001] the proposed indication of management Ave., Bldg. 51, Rm. 1192, Silver Spring, Anesthetic and Analgesic Drug of pain severe enough to require daily, MD 20993–0002, 301–796–5333, Products Advisory Committee and the around-the-clock, long-term opioid fatima.frye@fda.hhs.gov; or Jack Zhang, Drug Safety and Risk Management treatment and for which alternative Center for Biologics Evaluation and Advisory Committee; Notice of Meeting treatment options are inadequate. The Research, Food and Drug product is an extended-release Administration, 10903 New Hampshire AGENCY: Food and Drug Administration, formulation intended to have abuse- Ave., Bldg. 71, Rm. 7318, Silver Spring, HHS. deterrent properties based on the VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1

14452 Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices presence of naltrexone, an opioid FDA welcomes the attendance of the risk of losing their hospital. The day antagonist, in the formulation. The public at its advisory committee will conclude with a period of public committees will be asked to discuss meetings and will make every effort to comment at approximately 5:00 p.m. whether the data submitted by the accommodate persons with disabilities. The Committee will break into Applicant are sufficient to support If you require accommodations due to a Subcommittees and depart for site visits labeling of the product with the disability, please contact Stephanie L. Tuesday morning, April 19, at properties expected to deter abuse. Begansky at least 7 days in advance of approximately 8:30 a.m. Subcommittees FDA intends to make background the meeting. will visit the Beaufort County material available to the public no later FDA is committed to the orderly Department of Social Services and the than 2 business days before the meeting. conduct of its advisory committee Keyserling Cancer Center. The day will If FDA is unable to post the background meetings. Please visit our Web site at conclude at the Keyserling Cancer material on its Web site prior to the http://www.fda.gov/ Center with a period of public comment meeting, the background material will AdvisoryCommittees/ at approximately 5:00 p.m. be made publicly available at the AboutAdvisoryCommittees/ The Committee will meet to location of the advisory committee ucm111462.htm for procedures on summarize key findings and develop a meeting, and the background material public conduct during advisory work plan for the next quarter and the will be posted on FDA’s Web site after committee meetings. following meeting on Wednesday the meeting. Background material is Notice of this meeting is given under morning, April 20, at 8:30 a.m. at the available at http://www.fda.gov/ the Federal Advisory Committee Act (5 Keyserling Cancer Center. AdvisoryCommittees/Calendar/ U.S.C. app. 2). FOR FURTHER INFORMATION CONTACT: default.htm. Scroll down to the Dated: March 11, 2016. Steve Hirsch, MSLS, Administrative appropriate advisory committee meeting Jill Hartzler Warner, Coordinator, National Advisory link. Associate Commissioner for Special Medical Committee on Rural Health and Human Procedure: On June 8, 2016, from 9:30 Programs. Services, Health Resources and Services a.m. to 4 p.m., the meeting is open to [FR Doc. 2016–05999 Filed 3–16–16; 8:45 am] Administration, Parklawn Building, the public. Interested persons may BILLING CODE 4164–01–P 17W61, 5600 Fishers Lane, Rockville, present data, information, or views, MD 20857, Telephone (301) 443–0835, orally or in writing, on issues pending Fax (301) 443–2803. before the committees. Written DEPARTMENT OF HEALTH AND Persons interested in attending any submissions may be made to the contact HUMAN SERVICES portion of the meeting should contact person on or before May 24, 2016. Oral Pierre Joseph at the Federal Office of presentations from the public will be Health Resources and Services Rural Health Policy (FORHP) via scheduled between approximately 1 Administration telephone at (301) 945–0897 or by email p.m. and 2 p.m. Those individuals at PJoseph@hrsa.gov. Individuals who interested in making formal oral National Advisory Committee on Rural plan to attend and need special presentations should notify the contact Health and Human Services; Notice of assistance, such as sign language person and submit a brief statement of Meeting interpretation or other reasonable the general nature of the evidence or In accordance with section 10(a)(2) of accommodations, should notify the arguments they wish to present, the the Federal Advisory Committee Act contact person listed above at least 10 names and addresses of proposed (Pub. L. 92–463), notice is hereby given days prior to the meeting. The participants, and an indication of the of the following meeting: Committee meeting agenda will be approximate time requested to make Name: National Advisory Committee posted on the Committee’s Web site at their presentation on or before May 16, on Rural Health and Human Services. http://www.hrsa.gov/ 2016. Time allotted for each Date And Time: April 18, 2016, 8:30 advisorycommittees/rural/. presentation may be limited. If the a.m.–5:00 p.m., April 19, 2016, 8:30 number of registrants requesting to Jackie Painter, a.m.–5:15 p.m., April 20, 2016, 8:30 speak is greater than can be reasonably Director, Division of the Executive Secretariat. a.m.–11:00 a.m. accommodated during the scheduled [FR Doc. 2016–05998 Filed 3–16–16; 8:45 am] Place: Keyserling Cancer Center, open public hearing session, FDA may 1680b Ribaut Road, Port Royal, SC BILLING CODE 4165–15–P conduct a lottery to determine the 29935, (843) 522–7800. speakers for the scheduled open public Status: The meeting will be open to hearing session. The contact person will the public. DEPARTMENT OF HEALTH AND notify interested persons regarding their Purpose: The National Advisory HUMAN SERVICES request to speak by May 17, 2016. Committee on Rural Health and Human Request for Comments on National Closed Committee Deliberations: On Services provides counsel and Bioethics Advisory Bodies June 8, 2016, from 8 a.m. to 9:30 a.m., recommendations to the Secretary with the meeting will be closed to permit respect to the delivery, research, AGENCY: Presidential Commission for discussion and review of trade secret development, and administration of the Study of Bioethical Issues, Office of and/or confidential commercial health and human services in rural the Secretary, Department of Health and information (5 U.S.C. 552b(c)(4)). areas. Human Services. asabaliauskas on DSK3SPTVN1PROD with NOTICES During this session, the committees will Agenda: The meeting on Monday, ACTION: Notice. discuss the drug development program April 18, will be called to order at 8:30 of an investigational abuse-deterrent a.m. by the Chairperson of the SUMMARY: The Presidential Commission opioid product. Committee, the Honorable Ronnie for the Study of Bioethical Issues is Persons attending FDA’s advisory Musgrove. The Committee will examine requesting public comment on the role committee meetings are advised that the the issue of Opioid Abuse Disorder in of past, present, and future national Agency is not responsible for providing rural areas and alternatives for bioethics bodies, such as this one, in the access to electrical outlets. emergency care in rural communities at United States and elsewhere. VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1


Document Created: 2016-03-17 00:58:35
Document Modified: 2016-03-17 00:58:35
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 14451 
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