81_FR_95395 81 FR 95147 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

81 FR 95147 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range95147-95147
FR Document2016-31144

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016) 
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Page 95147]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31144]



[[Page 95147]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Psychopharmacologic Drugs 
Advisory Committee. The general function of the committee is to provide 
advice and recommendations to the Agency on FDA's regulatory issues. 
The meeting will be open to the public.

DATES: The meeting will be held on February 16, 2017, from 8 a.m. to 5 
p.m.

ADDRESSES: College Park Marriott Hotel and Conference Center, 3501 
University Blvd. East, Hyattsville, MD 20783. The conference center's 
telephone number is 301-985-7300. 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: 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 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 committee will discuss new drug application (NDA) 
209241, Valbenazine 40 milligram (mg) capsules, for the proposed 
treatment of Tardive Dyskinesia, submitted by Neurocrine Biosciences, 
Inc.
    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: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
February 2, 2017. 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 January 25, 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 January 26, 2016.
    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 Kalyani Bhatt 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: December 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31144 Filed 12-23-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices 95147 DEPARTMENT OF HEALTH AND Dyskinesia, submitted by Neurocrine Notice of this meeting is given under HUMAN SERVICES Biosciences, Inc. the Federal Advisory Committee Act (5 FDA intends to make background U.S.C. app. 2). Food and Drug Administration material available to the public no later Dated: December 20, 2016. than 2 business days before the meeting. Leslie Kux, [Docket No. FDA–2016–N–0001] If FDA is unable to post the background Associate Commissioner for Policy. Psychopharmacologic Drugs Advisory material on its Web site prior to the [FR Doc. 2016–31144 Filed 12–23–16; 8:45 am] Committee; Notice of Meeting meeting, the background material will BILLING CODE 4164–01–P be made publicly available at the AGENCY: Food and Drug Administration, location of the advisory committee HHS. meeting, and the background material DEPARTMENT OF HEALTH AND ACTION: Notice. will be posted on FDA’s Web site after HUMAN SERVICES the meeting. Background material is SUMMARY: The Food and Drug available at http://www.fda.gov/ Health Resources and Services Administration (FDA) announces a AdvisoryCommittees/Calendar/ Administration forthcoming public advisory committee default.htm. Scroll down to the meeting of the Psychopharmacologic appropriate advisory committee meeting Agency Information Collection Drugs Advisory Committee. The general link. Activities: Proposed Collection: Public function of the committee is to provide Procedure: Interested persons may Comment Request; Forms for Use With advice and recommendations to the present data, information, or views, Applications to the Maternal and Child Agency on FDA’s regulatory issues. The orally or in writing, on issues pending Health Bureau and Bureau of Health meeting will be open to the public. before the committee. Written Workforce Research and Training DATES: The meeting will be held on submissions may be made to the contact Grants February 16, 2017, from 8 a.m. to 5 p.m. person on or before February 2, 2017. Oral presentations from the public will AGENCY: Health Resources and Services ADDRESSES: College Park Marriott Hotel Administration (HRSA), Department of and Conference Center, 3501 University be scheduled between approximately 1 p.m. and 2 p.m. Those individuals Health and Human Services. Blvd. East, Hyattsville, MD 20783. The ACTION: Notice. conference center’s telephone number is interested in making formal oral 301–985–7300. Answers to commonly presentations should notify the contact SUMMARY: In compliance with the asked questions including information person and submit a brief statement of requirement for opportunity for public regarding special accommodations due the general nature of the evidence or comment on proposed data collection to a disability, visitor parking, and arguments they wish to present, the projects (Section 3506(c)(2)(A) of the transportation may be accessed at: names and addresses of proposed Paperwork Reduction Act of 1995), http://www.fda.gov/ participants, and an indication of the HRSA announces plans to submit an AdvisoryCommittees/ approximate time requested to make Information Collection Request (ICR), AboutAdvisoryCommittees/ their presentation on or before January described below, to the Office of ucm408555.htm. 25, 2016. Time allotted for each Management and Budget (OMB). Prior presentation may be limited. If the to submitting the ICR to OMB, HRSA FOR FURTHER INFORMATION CONTACT: number of registrants requesting to Kalyani Bhatt, Center for Drug seeks comments from the public speak is greater than can be reasonably regarding the burden estimate, below, or Evaluation and Research, Food and accommodated during the scheduled Drug Administration, 10903 New any other aspect of the ICR. open public hearing session, FDA may Hampshire Ave., Bldg. 31, Rm. 2417, DATES: Comments on this ICR must be conduct a lottery to determine the Silver Spring, MD 20993–0002, 301– received no later than February 27, speakers for the scheduled open public 796–9001, Fax: 301–847–8533, email: 2017. hearing session. The contact person will PDAC@fda.hhs.gov, or FDA Advisory notify interested persons regarding their ADDRESSES: Submit your comments to Committee Information Line, 1–800– request to speak by January 26, 2016. paperwork@hrsa.gov or mail the HRSA 741–8138 (301–443–0572 in the Persons attending FDA’s advisory Information Collection Clearance Washington, DC area). A notice in the committee meetings are advised that the Officer, Room 14N–39, 5600 Fishers Federal Register about last minute Agency is not responsible for providing Lane, Rockville, MD 20857. modifications that impact a previously access to electrical outlets. FOR FURTHER INFORMATION CONTACT: To announced advisory committee meeting FDA welcomes the attendance of the request more information on the cannot always be published quickly public at its advisory committee proposed project or to obtain a copy of enough to provide timely notice. meetings and will make every effort to the data collection plans and draft Therefore, you should always check the accommodate persons with disabilities. instruments, email paperwork@hrsa.gov Agency’s Web site at http:// If you require accommodations due to a or call the HRSA Information Collection www.fda.gov/AdvisoryCommittees/ disability, please contact Kalyani Bhatt Clearance Officer at (301) 443–1984. default.htm and scroll down to the at least 7 days in advance of the SUPPLEMENTARY INFORMATION: When appropriate advisory committee meeting meeting. submitting comments or requesting link, or call the advisory committee FDA is committed to the orderly information, please include the asabaliauskas on DSK3SPTVN1PROD with NOTICES information line to learn about possible conduct of its advisory committee information request collection title for modifications before coming to the meetings. Please visit our Web site at reference. meeting. http://www.fda.gov/ Information Collection Request Title: SUPPLEMENTARY INFORMATION: AdvisoryCommittees/ Forms for Use with Applications to the Agenda: The committee will discuss AboutAdvisoryCommittees/ Maternal and Child Health Bureau and new drug application (NDA) 209241, ucm111462.htm for procedures on Bureau of Health Workforce Research Valbenazine 40 milligram (mg) capsules, public conduct during advisory and Training Grants OMB No. 0906– for the proposed treatment of Tardive committee meetings. xxxx—New VerDate Sep<11>2014 20:45 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\27DEN1.SGM 27DEN1


Document Created: 2018-02-14 09:13:52
Document Modified: 2018-02-14 09:13:52
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 February 16, 2017, 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 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 95147 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR