83_FR_48803 83 FR 48616 - 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 48616 - 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 187 (September 26, 2018)

Page Range48616-48617
FR Document2018-20908

The Food and Drug Administration (FDA or Agency) 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 187 (Wednesday, September 26, 2018) 
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48616-48617]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3306]


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 or Agency) 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 2, 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 20993-0002. 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-3306. 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.
     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-3306 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

[[Page 48617]]

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: [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/Advisory-Committees/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 
benefit-risk profile of new drug application (NDA) 211371, brexanolone 
5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the 
proposed indication of postpartum depression.
    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 the Agency is not responsible for providing access to electrical 
outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] 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 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20908 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P

48616 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices Information Collection will be open to the public. FDA is • If you want to submit a comment 1. Type of Information Collection establishing a docket for public with confidential information that you Request: Extension of a currently comment on this document. do not wish to be made available to the approved collection; Title of DATES: The meeting will be held on public, submit the comment as a Information Collection: Medicaid November 2, 2018, from 8 a.m. to 5 p.m. written/paper submission and in the Program; Eligibility Changes under the ADDRESSES: The meeting will be held at manner detailed (see ‘‘Written/Paper Affordable Care Act of 2010; Use: The the FDA White Oak Campus, 10903 Submissions’’ and ‘‘Instructions’’). eligibility systems are essential to the New Hampshire Ave., Bldg. 31 Written/Paper Submissions goal of increasing coverage in insurance Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as affordability programs while reducing follows: administrative burden on states and Answers to commonly asked questions • Mail/Hand Delivery/Courier (for consumers. The electronic transmission including information regarding special written/paper submissions): Dockets and automation of data transfers are key accommodations due to a disability, Management Staff (HFA–305), Food and elements in managing the expected visitor parking, and transportation may Drug Administration, 5630 Fishers insurance affordability program be accessed at: https://www.fda.gov/ Lane, Rm. 1061, Rockville, MD 20852. caseload that started in 2014. AdvisoryCommittees/AboutAdvisory • For written/paper comments Accomplishing the same work without Committees/ucm408555.htm. submitted to the Dockets Management these information collection FDA is establishing a docket for Staff, FDA will post your comment, as requirements would not be feasible. public comment on this meeting. The well as any attachments, except for Form Number: CMS–10410 (OMB docket number is FDA–2018–N–3306. information submitted, marked and control number 0938–1147); Frequency: The docket will close on October 31, identified, as confidential, if submitted Occasionally; Affected Public: 2018. Submit either electronic or as detailed in ‘‘Instructions.’’ Individuals or Households, and State, written comments on this public Instructions: All submissions received Local, and Tribal Governments; Number meeting by October 31, 2018. Please must include the Docket No. FDA– of Respondents: 25,500,096; Total note that late, untimely filed comments 2018–N–3306 for ‘‘Joint Meeting of the Annual Responses: 25,500,333; Total will not be considered. Electronic Psychopharmacologic Drugs Advisory Annual Hours: 21,276,302. (For policy comments must be submitted on or Committee and the Drug Safety and Risk questions regarding this collection before October 31, 2018. The https:// Management Advisory Committee; www.regulations.gov electronic filing Notice of Meeting; Establishment of a contact Stephanie Bell at 410–786– system will accept comments until Public Docket; Request for Comments.’’ 0617). midnight Eastern Time at the end of Received comments, those filed in a Dated: September 20, 2018. October 31, 2018. Comments received timely manner (see ADDRESSES), will be William N. Parham, III, by mail/hand delivery/courier (for placed in the docket and, except for Director, Paperwork Reduction Staff, Office written/paper submissions) will be those submitted as ‘‘Confidential of Strategic Operations and Regulatory considered timely if they are Affairs. Submissions,’’ publicly viewable at postmarked or the delivery service https://www.regulations.gov or at the [FR Doc. 2018–20868 Filed 9–25–18; 8:45 am] acceptance receipt is on or before that Dockets Management Staff between 9 BILLING CODE 4120–01–P date. a.m. and 4 p.m., Monday through Comments received on or before Friday. October 18, 2018, will be provided to • Confidential Submissions—To DEPARTMENT OF HEALTH AND the committees. Comments received submit a comment with confidential HUMAN SERVICES after that date will be taken into information that you do not wish to be consideration by FDA. You may submit Food and Drug Administration made publicly available, submit your comments as follows: comments only as a written/paper [Docket No. FDA–2018–N–3306] Electronic Submissions submission. You should submit two Submit electronic comments in the copies total. One copy will include the Joint Meeting of the following way: information you claim to be confidential Psychopharmacologic Drugs Advisory Committee and the Drug Safety and • Federal eRulemaking Portal: with a heading or cover note that states https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS Risk Management Advisory instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ FDA Committee; Notice of Meeting; Comments submitted electronically, will review this copy, including the Establishment of a Public Docket; including attachments, to https:// claimed confidential information, in its Request for Comments www.regulations.gov will be posted to consideration of comments. The second AGENCY: Food and Drug Administration, the docket unchanged. Because your copy, which will have the claimed HHS. comment will be made public, you are confidential information redacted/ ACTION: Notice; establishment of a solely responsible for ensuring that your blacked out, will be available for public public docket; request for comments. comment does not include any viewing and posted on https:// confidential information that you or a www.regulations.gov. Submit both SUMMARY: The Food and Drug third party may not wish to be posted, copies to the Dockets Management Staff. Administration (FDA or Agency) such as medical information, your or If you do not wish your name and announces a forthcoming public anyone else’s Social Security number, or contact information to be made publicly daltland on DSKBBV9HB2PROD with NOTICES advisory committee meeting of the confidential business information, such available, you can provide this Psychopharmacologic Drugs Advisory as a manufacturing process. Please note information on the cover sheet and not Committee and the Drug Safety and Risk that if you include your name, contact in the body of your comments and you Management Advisory Committee. The information, or other information that must identify this information as general function of the committees is to identifies you in the body of your ‘‘confidential.’’ Any information marked provide advice and recommendations to comments, that information will be as ‘‘confidential’’ will not be disclosed FDA on regulatory issues. The meeting posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20 VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1

Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices 48617 and other applicable disclosure law. For orally or in writing, on issues pending DEPARTMENT OF HEALTH AND more information about FDA’s posting before the committees. All electronic HUMAN SERVICES of comments to public dockets, see 80 and written submissions submitted to FR 56469, September 18, 2015, or access the Docket (see ADDRESSES) on or before Food and Drug Administration the information at: https://www.gpo.gov/ October 18, 2018, will be provided to [Docket No. FDA–2018–N–0007] fdsys/pkg/FR-2015-09-18/pdf/2015- the committees. Oral presentations from 23389.pdf. the public will be scheduled between Fee for Using a Material Threat Medical Docket: For access to the docket to approximately 1 p.m. and 2 p.m. Those Countermeasure Priority Review read background documents or the individuals interested in making formal Voucher in Fiscal Year 2019 electronic and written/paper comments oral presentations should notify the received, go to https:// AGENCY: Food and Drug Administration, contact person and submit a brief HHS. www.regulations.gov and insert the statement of the general nature of the ACTION: Notice. docket number, found in brackets in the evidence or arguments they wish to heading of this document, into the SUMMARY: The Food and Drug ‘‘Search’’ box and follow the prompts present, the names and addresses of proposed participants, and an Administration (FDA or the Agency) is and/or go to the Dockets Management announcing the fee rate for using a Staff, 5630 Fishers Lane, Rm. 1061, indication of the approximate time requested to make their presentation on material threat medical countermeasure Rockville, MD 20852. (MCM) priority review voucher for fiscal FOR FURTHER INFORMATION CONTACT: or before October 10, 2018. Time allotted for each presentation may be year (FY) 2019. The Federal Food, Drug, Kalyani Bhatt, Center for Drug and Cosmetic Act (the FD&C Act), as Evaluation and Research, Food and limited. If the number of registrants amended by the 21st Century Cures Act Drug Administration, 10903 New requesting to speak is greater than can (Cures Act), authorizes FDA to Hampshire Ave., Bldg. 31, Rm. 2417, be reasonably accommodated during the determine and collect material threat Silver Spring, MD 20993–0002, 301– scheduled open public hearing session, MCM priority review user fees for 796–9001, Fax: 301–847–8533, email: FDA may conduct a lottery to determine certain applications for review of kalyani.bhatt@fda.hhs.gov, or FDA the speakers for the scheduled open human drug products when those Advisory Committee Information Line, public hearing session. The contact applications use a material threat MCM 1–800–741–8138 (301–443–0572 in the person will notify interested persons priority review voucher. These vouchers Washington, DC area). A notice in the regarding their request to speak by are awarded to the applicants of Federal Register about last minute October 11, 2018. material threat MCM applications that modifications that impact a previously Persons attending FDA’s advisory meet all of the requirements of this announced advisory committee meeting committee meetings are advised that the program upon FDA approval of such cannot always be published quickly Agency is not responsible for providing applications. The amount of the fee for enough to provide timely notice. using a material threat MCM priority access to electrical outlets. Therefore, you should always check review voucher is determined each FY FDA’s website at https://-www.fda.gov/ For press inquiries, please contact the based on the difference between the Advisory-Committees/default.htm and Office of Media Affairs at fdaoma@ average cost incurred by FDA to review scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540. of a human drug application designated committee meeting link, or call the FDA welcomes the attendance of the as priority review in the previous FY, advisory committee information line to public at its advisory committee and the average cost incurred in the learn about possible modifications meetings and will make every effort to review of an application that is not before coming to the meeting. accommodate persons with disabilities. subject to priority review in the SUPPLEMENTARY INFORMATION: If you require special accommodations previous FY. This notice establishes the Agenda: The committees will discuss due to a disability, please contact material threat MCM priority review fee the efficacy, safety, and benefit-risk Kalyani Bhatt (see FOR FURTHER rate for FY 2019 and outlines the profile of new drug application (NDA) INFORMATION CONTACT) at least 7 days in payment procedures for such fees. 211371, brexanolone 5 mg/mL advance of the meeting. FOR FURTHER INFORMATION CONTACT: Lola intravenous injection, submitted by Olajide, Office of Financial Sage Therapeutics, for the proposed FDA is committed to the orderly Management, Food and Drug indication of postpartum depression. conduct of its advisory committee Administration, 8455 Colesville Rd., FDA intends to make background meetings. Please visit our website at COLE–14541B, Silver Spring, MD material available to the public no later https://www.fda.gov/Advisory 20993–0002, 240–402–4244. than 2 business days before the meeting. Committees/AboutAdvisoryCommittees/ SUPPLEMENTARY INFORMATION: If FDA is unable to post the background ucm111462.htm for procedures on material on its website prior to the public conduct during advisory I. Background meeting, the background material will committee meetings. Section 3086 of the Cures Act (Pub. L. be made publicly available at the Notice of this meeting is given under 114–255) added section 565A to the location of the advisory committee the Federal Advisory Committee Act (5 FD&C Act (21 U.S.C. 360bbb–4a). In meeting, and the background material U.S.C. app. 2). section 565A of the FD&C Act, Congress will be posted on FDA’s website after encouraged development of material the meeting. Background material is Dated: September 20, 2018. threat MCMs by offering additional daltland on DSKBBV9HB2PROD with NOTICES available at https://www.fda.gov/ Leslie Kux, incentives for obtaining FDA approval AdvisoryCommittees/Calendar/ Associate Commissioner for Policy. of such products. Under section 565A of default.htm. Scroll down to the [FR Doc. 2018–20908 Filed 9–25–18; 8:45 am] the FD&C Act, the applicant of an appropriate advisory committee meeting BILLING CODE 4164–01–P eligible material threat MCM link. application (as defined in section Procedure: Interested persons may 565A(a)(4)) shall receive a priority present data, information, or views, review voucher upon approval of the VerDate Sep<11>2014 19:21 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\26SEN1.SGM 26SEN1


Document Created: 2018-09-26 00:46:35
Document Modified: 2018-09-26 00:46:35
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; establishment of a public docket; request for comments.
DatesThe meeting will be held on November 2, 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/Advisory-Committees/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 48616 
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