81_FR_5149 81 FR 5129 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

81 FR 5129 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 20 (February 1, 2016)

Page Range5129-5129
FR Document2016-01752

Federal Register, Volume 81 Issue 20 (Monday, February 1, 2016) 
[Federal Register Volume 81, Number 20 (Monday, February 1, 2016)]
[Notices]
[Page 5129]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01752]


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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.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Psychopharmacologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 29, 2016, from 8 
a.m. to 5 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: 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 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 committee will discuss the specific risk-benefit 
profile for new drug application (NDA) 207318, NUPLAZID (pimavanserin) 
17 milligram (mg) immediate-release, film-coated oral tablets, 
submitted by Acadia Pharmaceuticals Inc., for the proposed treatment of 
psychosis associated with Parkinson's disease.
    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 
March 15, 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 March 7, 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 March 8, 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: January 27, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-01752 Filed 1-29-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 5129 Leroy A. Richardson, appropriate advisory committee meeting at least 7 days in advance of the Chief, Information Collection Review Office, link, or call the advisory committee meeting. Office of Scientific Integrity, Office of the information line to learn about possible FDA is committed to the orderly Associate Director for Science, Office of the modifications before coming to the conduct of its advisory committee Director, Centers for Disease Control and meeting. meetings. Please visit our Web site at Prevention. Agenda: The committee will discuss http://www.fda.gov/ [FR Doc. 2016–01722 Filed 1–29–16; 8:45 am] the specific risk-benefit profile for new AdvisoryCommittees/ BILLING CODE 4163–18–P drug application (NDA) 207318, AboutAdvisoryCommittees/ NUPLAZID (pimavanserin) 17 milligram ucm111462.htm for procedures on (mg) immediate-release, film-coated oral public conduct during advisory DEPARTMENT OF HEALTH AND tablets, submitted by Acadia committee meetings. HUMAN SERVICES Pharmaceuticals Inc., for the proposed Notice of this meeting is given under treatment of psychosis associated with the Federal Advisory Committee Act (5 Food and Drug Administration Parkinson’s disease. U.S.C. app. 2). [Docket No. FDA–2016–N–0001] FDA intends to make background Dated: January 27, 2016. material available to the public no later Psychopharmacologic Drugs Advisory than 2 business days before the meeting. Jill Hartzler Warner, Committee; Notice of Meeting If FDA is unable to post the background Associate Commissioner for Special Medical material on its Web site prior to the Programs. AGENCY: Food and Drug Administration, meeting, the background material will [FR Doc. 2016–01752 Filed 1–29–16; 8:45 am] HHS. be made publicly available at the BILLING CODE 4164–01–P ACTION: Notice. location of the advisory committee meeting, and the background material This notice announces a forthcoming will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND meeting of a public advisory committee the meeting. Background material is HUMAN SERVICES of the Food and Drug Administration available at http://www.fda.gov/ (FDA). The meeting will be open to the Office of the Secretary AdvisoryCommittees/Calendar/ public. default.htm. Scroll down to the [Document Identifier: HHS–OS–0990–XXXX– Name of Committee: appropriate advisory committee meeting 60D] Psychopharmacologic Drugs Advisory link. Committee. Procedure: Interested persons may Agency Information Collection General Function of the Committee: present data, information, or views, Activities; Proposed Collection; Public To provide advice and orally or in writing, on issues pending Comment Request recommendations to the Agency on before the committee. Written FDA’s regulatory issues. AGENCY: Office of the Secretary, HHS. submissions may be made to the contact Date and Time: The meeting will be ACTION: Notice. person on or before March 15, 2016. held on March 29, 2016, from 8 a.m. to Oral presentations from the public will SUMMARY: In compliance with section 5 p.m. be scheduled between approximately 1 3506(c)(2)(A) of the Paperwork Location: FDA White Oak Campus, p.m. and 2 p.m. Those individuals Reduction Act of 1995, the Office of the 10903 New Hampshire Ave., Bldg. 31 interested in making formal oral Secretary (OS), Department of Health Conference Center, the Great Room (Rm. presentations should notify the contact and Human Services, announces plans 1503), Silver Spring, MD 20993–0002. person and submit a brief statement of to submit a new Information Collection Answers to commonly asked questions the general nature of the evidence or Request (ICR), described below, to the including information regarding special arguments they wish to present, the Office of Management and Budget accommodations due to a disability, names and addresses of proposed (OMB). Prior to submitting the ICR to visitor parking, and transportation may participants, and an indication of the OMB, OS seeks comments from the be accessed at: http://www.fda.gov/ approximate time requested to make public regarding the burden estimate, AdvisoryCommittees/ their presentation on or before March 7, below, or any other aspect of the ICR. AboutAdvisoryCommittees/ 2016. Time allotted for each DATES: Comments on the ICR must be ucm408555.htm. presentation may be limited. If the Contact Person: Kalyani Bhatt, Center received on or before April 1, 2016. number of registrants requesting to for Drug Evaluation and Research, Food ADDRESSES: Submit your comments to speak is greater than can be reasonably and Drug Administration, 10903 New accommodated during the scheduled Information.CollectionClearance@ Hampshire Ave., Bldg. 31, Rm. 2417, open public hearing session, FDA may hhs.gov or by calling (202) 690–6162. Silver Spring, MD 20993–0002, 301– conduct a lottery to determine the FOR FURTHER INFORMATION CONTACT: 796–9001, FAX: 301–847–8533, PDAC@ speakers for the scheduled open public Information Collection Clearance staff, fda.hhs.gov, or FDA Advisory hearing session. The contact person will Information.CollectionClearance@ Committee Information Line, 1–800– notify interested persons regarding their hhs.gov or (202) 690–6162. 741–8138 (301–443–0572 in the request to speak by March 8, 2016. SUPPLEMENTARY INFORMATION: When Washington, DC area). A notice in the Persons attending FDA’s advisory submitting comments or requesting Federal Register about last minute committee meetings are advised that the information, please include the modifications that impact a previously Agency is not responsible for providing document identifier HHS–OS–0990– rmajette on DSK2TPTVN1PROD with NOTICES announced advisory committee meeting access to electrical outlets. XXXX–60D for reference. cannot always be published quickly FDA welcomes the attendance of the Information Collection Request Title: enough to provide timely notice. public at its advisory committee Surgeon General’s Pledge to Stem the Therefore, you should always check the meetings and will make every effort to Opioid Epidemic Agency’s Web site at http:// accommodate persons with disabilities. Abstract: The Office of the Surgeon www.fda.gov/AdvisoryCommittees/ If you require accommodations due to a General, Office of the Secretary, default.htm and scroll down to the disability, please contact Kalyani Bhatt Department of Health and Human VerDate Sep<11>2014 15:33 Jan 29, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\01FEN1.SGM 01FEN1


Document Created: 2016-01-30 01:17:08
Document Modified: 2016-01-30 01:17:08
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 5129 
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