83_FR_48107 83 FR 47923 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

83 FR 47923 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 184 (September 21, 2018)

Page Range47923-47924
FR Document2018-20571

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 83 Issue 184 (Friday, September 21, 2018) 
[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47923-47924]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3160]


Joint Meeting of the Psychopharmacologic Drugs Advisory Committee 
and the Drug Safety and Risk Management Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Psychopharmacologic Drugs 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee. The general function of the committees is to provide advice 
and recommendations to FDA on regulatory issues. The meeting will be 
open to the public. FDA is establishing a docket for public comment on 
this document.

DATES: The meeting will be held on November 1, 2018, from 8 a.m. to 5 
p.m.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 
1503), Silver Spring, MD 20993. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2018-N-3160. The docket will close on October 
31, 2018. Submit either electronic or written comments on this public 
meeting by October 31, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before October 31, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of October 31, 2018. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.
    Comments received on or before October 18, 2018, will be provided 
to the committees. Comments received after that date will be taken into 
consideration by FDA. You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.

[[Page 47924]]

     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3160 for ``Joint Meeting of the Psychopharmacologic Drugs 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper 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.'' FDA 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: kalyani.bhatt@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 FDA's website 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: The committees will discuss the efficacy, safety, and risk-
benefit profile of new drug application (NDA) 210417 for buprenorphine 
and samidorphan sublingual tablets, submitted by Alkermes, Inc., for 
adjunctive treatment of major depressive disorder.
    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 website 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 website 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 October 18, 2018, will be provided to the 
committees. 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 October 10, 2018. 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 October 11, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    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 special accommodations due to a 
disability, please contact Kalyani Bhatt (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20571 Filed 9-20-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices 47923 ACF to fulfill the ongoing legislative specified in the Foster Care leaders, partners and stakeholders, and mandate for program evaluation Independence Act of 1999. front-line staff as well as young adults Respondents: Semi-structured being served by the programs. interviews will be held with program ANNUAL BURDEN ESTIMATES Total Annual Number of Average Annual Instrument number of number of responses per burden hours burden hours respondents respondents respondent per response Outreach email for discussion with program administrators and staff ............................................................................ 16 8 1 8 64 Outreach email for Focus Group Recruiters ....................... 12 6 1 8 48 Discussion Guide for program leaders ................................ 48 24 4 1 96 Discussion Guide for program partners and stakeholders .. 60 30 2 1 60 Discussion Guide for program front-line staff ...................... 104 52 1 1 52 Focus Group Guide for program participants ...................... 160 80 1 2 160 Compilation and Submission of Administrative Data Files .. 48 24 2 12 576 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND 2018. Submit either electronic or Hours: 1,056. HUMAN SERVICES written comments on this public In compliance with the requirements meeting by October 31, 2018. Please Food and Drug Administration note that late, untimely filed comments of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the [Docket No. FDA–2018–N–3160] will not be considered. Electronic comments must be submitted on or Administration for Children and Joint Meeting of the before October 31, 2018. The https:// Families is soliciting public comment Psychopharmacologic Drugs Advisory www.regulations.gov electronic filing on the specific aspects of the system will accept comments until Committee and the Drug Safety and information collection described above. midnight Eastern Time at the end of Risk Management Advisory Copies of the proposed collection of October 31, 2018. Comments received Committee; Notice of Meeting; information can be obtained and by mail/hand delivery/courier (for Establishment of a Public Docket; comments may be forwarded by writing Request for Comments written/paper submissions) will be to the Administration for Children and considered timely if they are Families, Office of Planning, Research AGENCY: Food and Drug Administration, postmarked or the delivery service and Evaluation, 330 C St. SW, HHS. acceptance receipt is on or before that Washington, DC 20201, Attn: OPRE ACTION: Notice; establishment of a date. Reports Clearance Officer. Email public docket; request for comments. Comments received on or before address: OPREinfocollection@ October 18, 2018, will be provided to SUMMARY: The Food and Drug acf.hhs.gov. All requests should be Administration (FDA) announces a the committees. Comments received identified by the title of the information forthcoming public advisory committee after that date will be taken into collection. meeting of the Psychopharmacologic consideration by FDA. You may submit The Department specifically requests Drugs Advisory Committee and the Drug comments as follows: comments on (a) whether the proposed Safety and Risk Management Advisory Electronic Submissions collection of information is necessary Committee. The general function of the for the proper performance of the committees is to provide advice and Submit electronic comments in the functions of the agency, including recommendations to FDA on regulatory following way: whether the information shall have issues. The meeting will be open to the • Federal eRulemaking Portal: practical utility; (b) the accuracy of the public. FDA is establishing a docket for https://www.regulations.gov. Follow the agency’s estimate of the burden of the public comment on this document. instructions for submitting comments. proposed collection of information; (c) DATES: The meeting will be held on Comments submitted electronically, the quality, utility, and clarity of the November 1, 2018, from 8 a.m. to 5 p.m. including attachments, to https:// information to be collected; and (d) ADDRESSES: The meeting will be held at www.regulations.gov will be posted to ways to minimize the burden of the the FDA White Oak Campus, 10903 the docket unchanged. Because your collection of information on New Hampshire Ave., Bldg. 31 comment will be made public, you are respondents, including through the use Conference Center, the Great Room (Rm. solely responsible for ensuring that your of automated collection techniques or 1503), Silver Spring, MD 20993. comment does not include any other forms of information technology. Answers to commonly asked questions confidential information that you or a Consideration will be given to including information regarding special third party may not wish to be posted, accommodations due to a disability, such as medical information, your or comments and suggestions submitted visitor parking, and transportation may anyone else’s Social Security number, or daltland on DSKBBV9HB2PROD with NOTICES within 60 days of this publication. be accessed at: https://www.fda.gov/ confidential business information, such Emily B. Jabbour, AdvisoryCommittees/AboutAdvisory as a manufacturing process. Please note ACF/OPRE Certifying Officer. Committees/ucm408555.htm. that if you include your name, contact [FR Doc. 2018–20594 Filed 9–20–18; 8:45 am] FDA is establishing a docket for information, or other information that public comment on this meeting. The identifies you in the body of your BILLING CODE 4184–01–P docket number is FDA–2018–N–3160. comments, that information will be The docket will close on October 31, posted on https://www.regulations.gov. VerDate Sep<11>2014 17:30 Sep 20, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

47924 Federal Register / Vol. 83, No. 184 / Friday, September 21, 2018 / Notices • If you want to submit a comment and other applicable disclosure law. For Procedure: Interested persons may with confidential information that you more information about FDA’s posting present data, information, or views, do not wish to be made available to the of comments to public dockets, see 80 orally or in writing, on issues pending public, submit the comment as a FR 56469, September 18, 2015, or access before the committees. All electronic written/paper submission and in the the information at: https://www.gpo.gov/ and written submissions submitted to manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- the Docket (see ADDRESSES) on or before Submissions’’ and ‘‘Instructions’’). 23389.pdf. October 18, 2018, will be provided to Written/Paper Submissions Docket: For access to the docket to the committees. Oral presentations from read background documents or the the public will be scheduled between Submit written/paper submissions as electronic and written/paper comments approximately 1 p.m. and 2 p.m. Those follows: received, go to https:// • Mail/Hand delivery/Courier (for individuals interested in making formal www.regulations.gov and insert the oral presentations should notify the written/paper submissions): Dockets docket number, found in brackets in the contact person and submit a brief Management Staff (HFA–305), Food and heading of this document, into the statement of the general nature of the Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts evidence or arguments they wish to Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments and/or go to the Dockets Management present, the names and addresses of submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, proposed participants, and an Staff, FDA will post your comment, as Rockville, MD 20852. indication of the approximate time well as any attachments, except for FOR FURTHER INFORMATION CONTACT: requested to make their presentation on information submitted, marked and Kalyani Bhatt, Center for Drug or before October 10, 2018. Time identified, as confidential, if submitted Evaluation and Research, Food and allotted for each presentation may be as detailed in ‘‘Instructions.’’ Drug Administration, 10903 New limited. If the number of registrants Instructions: All submissions received Hampshire Ave., Bldg. 31, Rm. 2417, requesting to speak is greater than can must include the Docket No. FDA– Silver Spring, MD 20993–0002, 301– be reasonably accommodated during the 2018–N–3160 for ‘‘Joint Meeting of the 796–9001, Fax: 301–847–8533, email: scheduled open public hearing session, Psychopharmacologic Drugs Advisory kalyani.bhatt@fda.hhs.gov, or FDA FDA may conduct a lottery to determine Committee and the Drug Safety and Risk Advisory Committee Information Line, the speakers for the scheduled open Management Advisory Committee; 1–800–741–8138 (301–443–0572 in the public hearing session. The contact Notice of Meeting; Establishment of a Washington, DC area). A notice in the person will notify interested persons Public Docket; Request for Comments.’’ Federal Register about last minute Received comments, those filed in a regarding their request to speak by modifications that impact a previously October 11, 2018. timely manner (see ADDRESSES), will be announced advisory committee meeting placed in the docket and, except for cannot always be published quickly Persons attending FDA’s advisory those submitted as ‘‘Confidential enough to provide timely notice. committee meetings are advised that Submissions,’’ publicly viewable at Therefore, you should always check FDA is not responsible for providing https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ access to electrical outlets. Dockets Management Staff between 9 AdvisoryCommittees/default.htm and For press inquiries, please contact the a.m. and 4 p.m., Monday through scroll down to the appropriate advisory Office of Media Affairs at fdaoma@ Friday. committee meeting link, or call the fda.hhs.gov or 301–796–4540. • Confidential Submissions—To advisory committee information line to submit a comment with confidential FDA welcomes the attendance of the learn about possible modifications information that you do not wish to be public at its advisory committee before coming to the meeting. made publicly available, submit your meetings and will make every effort to comments only as a written/paper SUPPLEMENTARY INFORMATION: accommodate persons with disabilities. submission. You should submit two Agenda: The committees will discuss If you require special accommodations copies total. One copy will include the the efficacy, safety, and risk-benefit due to a disability, please contact information you claim to be confidential profile of new drug application (NDA) Kalyani Bhatt (see FOR FURTHER with a heading or cover note that states 210417 for buprenorphine and INFORMATION CONTACT) at least 7 days in ‘‘THIS DOCUMENT CONTAINS samidorphan sublingual tablets, advance of the meeting. CONFIDENTIAL INFORMATION.’’ FDA submitted by Alkermes, Inc., for FDA is committed to the orderly will review this copy, including the adjunctive treatment of major depressive disorder. conduct of its advisory committee claimed confidential information, in its meetings. Please visit our website at consideration of comments. The second FDA intends to make background https://www.fda.gov/ copy, which will have the claimed material available to the public no later AdvisoryCommittees/ confidential information redacted/ than 2 business days before the meeting. AboutAdvisoryCommittees/ blacked out, will be available for public If FDA is unable to post the background ucm111462.htm for procedures on viewing and posted on https:// material on its website prior to the www.regulations.gov. Submit both meeting, the background material will public conduct during advisory copies to the Dockets Management Staff. be made publicly available at the committee meetings. If you do not wish your name and location of the advisory committee Notice of this meeting is given under contact information to be made publicly meeting, and the background material the Federal Advisory Committee Act (5 daltland on DSKBBV9HB2PROD with NOTICES available, you can provide this will be posted on FDA’s website after U.S.C. app. 2). information on the cover sheet and not the meeting. Background material is Dated: September 18, 2018. in the body of your comments and you available at https://www.fda.gov/ Leslie Kux, must identify this information as AdvisoryCommittees/Calendar/ ‘‘confidential.’’ Any information marked default.htm. Scroll down to the Associate Commissioner for Policy. as ‘‘confidential’’ will not be disclosed appropriate advisory committee meeting [FR Doc. 2018–20571 Filed 9–20–18; 8:45 am] except in accordance with 21 CFR 10.20 link. BILLING CODE 4164–01–P VerDate Sep<11>2014 17:30 Sep 20, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 9990 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2018-09-21 00:23:22
Document Modified: 2018-09-21 00:23:22
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; establishment of a public docket; request for comments.
DatesThe meeting will be held on November 1, 2018, from 8 a.m. to 5 p.m.
ContactKalyani Bhatt, 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 FDA's website 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.
FR Citation83 FR 47923 
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