81_FR_42489 81 FR 42364 - Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

81 FR 42364 - 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 125 (June 29, 2016)

Page Range42364-42365
FR Document2016-15361

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

Federal Register, Volume 81 Issue 125 (Wednesday, June 29, 2016) 
[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42364-42365]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15361]


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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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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Anesthetic and Analgesic Drug 
Products Advisory Committee and the Drug Safety and Risk Management 
Advisory Committee. The general function of the committees is to 
provide advice and recommendations to the Agency on FDA's regulatory 
issues. At least one portion of the meeting will be closed to the 
public.

DATES: The meeting will be held on August 4, 2016, from 8 a.m. to 5 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31

[[Page 42365]]

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.

FOR FURTHER INFORMATION CONTACT: Philip A. Bautista, 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 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.

SUPPLEMENTARY INFORMATION: Agenda: The committees will discuss new drug 
application (NDA) 208630, morphine sulfate extended-release tablets, 
submitted by Egalet U.S., Inc., with the proposed indication of the 
management of pain severe enough to require daily, around-the-clock, 
long-term opioid treatment and for which alternative treatment options 
are inadequate. It has been formulated with the intent to provide 
abuse-deterrent 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 August 4, 2016, from 9:30 a.m. to 5 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 July 21, 2016. Oral presentations from the public will be 
scheduled between approximately 1 p.m. to 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 July 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 July 14, 2016.
    Closed Committee Deliberations: On August 4, 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 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 
Philip Bautista 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: June 23, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-15361 Filed 6-28-16; 8:45 am]
 BILLING CODE 4164-01-P

42364 Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices if submitted as detailed in Submit written requests for a single advisory committee meeting to ‘‘Instructions.’’ hard copy of the draft guidance entitled voluntarily publicly disclose Instructions: All submissions received ‘‘Procedures for Evaluating Appearance authorization. The Agency will consider must include the Docket No. FDA– Issues and Granting Authorizations for these comments in developing the final 2016–D–1399 for ‘‘Procedures for Participation in FDA Advisory guidance document. Evaluating Appearance Issues and Committees; Guidance for the Public, Granting Authorizations for II. Significance of Guidance FDA Advisory Committee Members, and Participation in Food and Drug FDA Staff’’ to the Advisory Committee This draft guidance is being issued Administration Advisory Committees; Oversight and Management Staff, Office consistent with FDA’s good guidance Draft Guidance for the Public, Food and of Special Medical Programs, Food and practices regulation (21 CFR 10.115). Drug Administration Advisory Drug Administration, 10903 New The draft guidance, when finalized, will Committee Members, and Food and Hampshire Ave., Bldg. 32, Rm. 5103, represent the Agency’s current thinking Drug Administration Staff; Silver Spring, MD 20993–0002. Send on the processes for evaluating Availability.’’ Received comments will one self-addressed adhesive label to appearance issues and granting an be placed in the docket and, except for assist that office in processing your authorization. It does not create or those submitted as ‘‘Confidential request. confer any rights for or on any person Submissions,’’ publicly viewable at and does not operate to bind FDA or the FOR FURTHER INFORMATION CONTACT: http://www.regulations.gov or at the public. An alternative approach may be Division of Dockets Management Michael Ortwerth, Advisory Committee Oversight and Management Staff, Office used if such approach satisfies the between 9 a.m. and 4 p.m., Monday requirements of the applicable statute through Friday. of Special Medical Programs, Food and Drug Administration, 10903 New and regulations. • Confidential Submissions—To submit a comment with confidential Hampshire Ave., Bldg. 32, Rm. 5103, III. Electronic Access information that you do not wish to be Silver Spring, MD 20993–0002, 301– Persons interested in obtaining a copy made publicly available, submit your 796–8220. of the draft guidance may do so by comments only as a written/paper SUPPLEMENTARY INFORMATION: downloading an electronic copy from submission. You should submit two I. Background the Internet at either http:// copies total. One copy will include the www.fda.gov/RegulatoryInformation/ information you claim to be confidential Advisory committees provide Guidances/ucm122044.htm or http:// with a heading or cover note that states independent, expert advice to FDA on a www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS range of issues affecting the public health. To protect the credibility and Dated: June 23, 2016. CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including integrity of advisory committee advice, Leslie Kux, the claimed confidential information, in FDA screens advisory committee Associate Commissioner for Policy. its consideration of comments. The members carefully for two categories of [FR Doc. 2016–15384 Filed 6–28–16; 8:45 am] second copy, which will have the potentially disqualifying interests or BILLING CODE 4164–01–P claimed confidential information relationships: (1) Current financial redacted/blacked out, will be available interests that may create a recusal for public viewing and posted on http:// obligation under Federal conflict of DEPARTMENT OF HEALTH AND www.regulations.gov. Submit both interest laws (18 U.S.C. 208) and (2) HUMAN SERVICES copies to the Division of Dockets other interests and relationships that do Management. If you do not wish your not create a recusal obligation under Food and Drug Administration name and contact information to be financial conflict of interest laws but [Docket No. FDA–2016–N–0001] made publicly available, you can may create the appearance that the provide this information on the cover member lacks impartiality (5 CFR Anesthetic and Analgesic Drug sheet and not in the body of your 2635.502). This draft guidance Products Advisory Committee and the comments and you must identify this addresses FDA’s process for evaluating Drug Safety and Risk Management information as ‘‘confidential.’’ Any whether an advisory committee member Advisory Committee; Notice of Meeting information marked as ‘‘confidential’’ has potentially disqualifying interests or relationships that fall into the second AGENCY: Food and Drug Administration, will not be disclosed except in accordance with 21 CFR 10.20 and other category of interests, which are known HHS. applicable disclosure law. For more as appearance issues, under 5 CFR ACTION: Notice. information about FDA’s posting of 2635.502. It also describes FDA’s process for determining whether to SUMMARY: The Food and Drug comments to public dockets, see 80 FR authorize a member with an appearance Administration (FDA) announces a 56469, September 18, 2015, or access issue to participate in an advisory forthcoming public advisory committee the information at: http://www.fda.gov/ committee meeting under 5 CFR meeting of the Anesthetic and Analgesic regulatoryinformation/dockets/ 2635.502. Drug Products Advisory Committee and default.htm. Docket: For access to the docket to In addition, FDA is seeking comment the Drug Safety and Risk Management read background documents or the regarding public disclosure of such Advisory Committee. The general electronic and written/paper comments authorizations. Under Federal laws function of the committees is to provide received, go to http:// protecting the confidentiality of advice and recommendations to the mstockstill on DSK3G9T082PROD with NOTICES www.regulations.gov and insert the information, FDA may not itself disclose Agency on FDA’s regulatory issues. At docket number, found in brackets in the confidential information provided by least one portion of the meeting will be heading of this document, into the advisory committee members related to closed to the public. ‘‘Search’’ box and follow the prompts appearance issues. FDA is soliciting DATES: The meeting will be held on and/or go to the Division of Dockets comment on whether the agency should August 4, 2016, from 8 a.m. to 5 p.m. Management, 5630 Fishers Lane, Rm. ask members with appearance issues ADDRESSES: FDA White Oak Campus, 1061, Rockville, MD 20852. who are authorized to participate in an 10903 New Hampshire Ave., Bldg. 31 VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

Federal Register / Vol. 81, No. 125 / Wednesday, June 29, 2016 / Notices 42365 Conference Center, the Great Room (Rm. Procedure: On August 4, 2016, from Dated: June 23, 2016. 1503), Silver Spring, MD 20993–0002. 9:30 a.m. to 5 p.m., the meeting is open Jill Hartzler Warner, Answers to commonly asked questions to the public. Interested persons may Associate Commissioner for Special Medical including information regarding special present data, information, or views, Programs. accommodations due to a disability, orally or in writing, on issues pending [FR Doc. 2016–15361 Filed 6–28–16; 8:45 am] visitor parking, and transportation may before the committees. Written BILLING CODE 4164–01–P be accessed at: http://www.fda.gov/ submissions may be made to the contact AdvisoryCommittees/ person on or before July 21, 2016. Oral AboutAdvisoryCommittees/ presentations from the public will be DEPARTMENT OF HEALTH AND ucm408555.htm. HUMAN SERVICES scheduled between approximately 1 FOR FURTHER INFORMATION CONTACT: p.m. to 2 p.m. Those individuals Food and Drug Administration Philip A. Bautista, Center for Drug interested in making formal oral Evaluation and Research, Food and presentations should notify the contact [Docket No. FDA–2015–D–4361] Drug Administration, 10903 New person and submit a brief statement of Hampshire Ave., Bldg. 31, Rm. 2417, Gifts to the Food and Drug the general nature of the evidence or Administration: Evaluation and Silver Spring, MD 20993–0002, 301– arguments they wish to present, the 796–9001, FAX: 301–847–8533, Acceptance: Draft Guidance for the names and addresses of proposed Public and Food and Drug AADPAC@fda.hhs.gov, or FDA participants, and an indication of the Administration Staff; Availability Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the approximate time requested to make their presentation on or before July 13, AGENCY: Food and Drug Administration, Washington, DC area). A notice in the HHS. Federal Register about last minute 2016. Time allotted for each presentation may be limited. If the ACTION: Notice of availability. modifications that impact a previously announced advisory committee meeting number of registrants requesting to SUMMARY: The Food and Drug cannot always be published quickly speak is greater than can be reasonably Administration (FDA or we) is enough to provide timely notice. accommodated during the scheduled announcing the availability of a draft Therefore, you should always check the open public hearing session, FDA may guidance for the public and FDA staff Agency’s Web site at http:// conduct a lottery to determine the entitled ‘‘Gifts to FDA: Evaluation and www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public Acceptance.’’ The Secretary of the default.htm and scroll down to the hearing session. The contact person will Department of Health and Human appropriate advisory committee meeting notify interested persons regarding their Services (HHS) has the authority to link, or call the advisory committee request to speak by July 14, 2016. accept conditional or unconditional information line to learn about possible gifts on behalf of the United States. The Closed Committee Deliberations: On modifications before coming to the Secretary has delegated this gift meeting. August 4, 2016, from 8 a.m. to 9:30 a.m., the meeting will be closed to permit authority to the Commissioner of Food SUPPLEMENTARY INFORMATION: Agenda: discussion and review of trade secret and Drugs. This guidance provides the The committees will discuss new drug process and principles we will use in and/or confidential commercial application (NDA) 208630, morphine implementing this authority. information (5 U.S.C. 552b(c)(4)). sulfate extended-release tablets, DATES: Although you can comment on During this session, the committees will submitted by Egalet U.S., Inc., with the any guidance at any time (see 21 CFR discuss the drug development program proposed indication of the management 10.115(g)(5)), to ensure that we consider of pain severe enough to require daily, of an investigational product. your comment on this draft guidance around-the-clock, long-term opioid Persons attending FDA’s advisory before we begin work on the final treatment and for which alternative committee meetings are advised that the version of the guidance, submit either treatment options are inadequate. It has Agency is not responsible for providing electronic or written comments on the been formulated with the intent to access to electrical outlets. draft guidance by September 12, 2016. provide abuse-deterrent properties. The FDA welcomes the attendance of the ADDRESSES: You may submit comments committees will be asked to discuss public at its advisory committee as follows: whether the data submitted by the meetings and will make every effort to applicant are sufficient to support Electronic Submissions accommodate persons with disabilities. labeling of the product with the Submit electronic comments in the If you require accommodations due to a properties expected to deter abuse. following way: FDA intends to make background disability, please Philip Bautista at least • Federal eRulemaking Portal: http:// material available to the public no later 7 days in advance of the meeting. www.regulations.gov. Follow the than 2 business days before the meeting. FDA is committed to the orderly instructions for submitting comments. If FDA is unable to post the background conduct of its advisory committee Comments submitted electronically, material on its Web site prior to the meetings. Please visit our Web site at including attachments, to http:// meeting, the background material will http://www.fda.gov/ www.regulations.gov will be posted to be made publicly available at the AdvisoryCommittees/ the docket unchanged. Because your location of the advisory committee AboutAdvisoryCommittees/ comment will be made public, you are meeting, and the background material solely responsible for ensuring that your mstockstill on DSK3G9T082PROD with NOTICES ucm111462.htm for procedures on will be posted on FDA’s Web site after public conduct during advisory comment does not include any the meeting. Background material is committee meetings. confidential information that you or a available at http://www.fda.gov/ third party may not wish to be posted, AdvisoryCommittees/Calendar/ Notice of this meeting is given under such as medical information, your or default.htm. Scroll down to the the Federal Advisory Committee Act (5 anyone else’s Social Security number, or appropriate advisory committee meeting U.S.C. app. 2). confidential business information, such link. as a manufacturing process. Please note VerDate Sep<11>2014 17:18 Jun 28, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1


Document Created: 2018-02-08 07:42:49
Document Modified: 2018-02-08 07:42:49
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.
DatesThe meeting will be held on August 4, 2016, from 8 a.m. to 5 p.m.
ContactPhilip A. Bautista, 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 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.
FR Citation81 FR 42364 
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