Psychopharmacologic Drugs Advisory Committee; Notice of Meeting, 74776-74777 [2015-30296]

Download as PDF 74776 Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Notices proposed rule, the comments must be received via email to newtech@ cms.hhs.gov by the date specified in the DATES section of this notice. B. Conference Call, Live Streaming, and Webinar Information For participants who cannot attend the Town Hall Meeting in person, an open toll-free phone line, (877) 267– 1577, has been made available. The Meeting Place meeting ID is 998–698– 471. Also, there will be an option to view and participate in the Town Hall Meeting via live streaming technology or a webinar. Information on the option to participate via live streaming technology or a webinar will be provided through an upcoming listserv notice and posted on the New Technology Web site at https:// www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ AcuteInpatientPPS/newtech.html. Continue to check the Web site for updates. C. Disclaimer We cannot guarantee reliability for live streaming technology or a webinar. jstallworth on DSK7TPTVN1PROD with NOTICES III. Registration Instructions The Division of Acute Care in CMS is coordinating the meeting registration for the Town Hall Meeting on substantial clinical improvement. While there is no registration fee, individuals planning to attend the Town Hall Meeting in person must register to attend. Registration may be completed online at the following Web address: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ AcuteInpatientPPS/newtech.html. Select the link at the bottom of the page ‘‘Register to Attend the New Technology Town Hall Meeting’’. After completing the registration, on-line registrants should print the confirmation page(s) and bring it with them to the meeting(s). If you are unable to register on-line, you may register by sending an email to newtech@cms.hhs.gov. Please include your name, address, telephone number, email address and fax number. If seating capacity has been reached, you will be notified that the meeting has reached capacity. IV. Security, Building, and Parking Guidelines Because this meeting will be located on Federal property, for security reasons, any persons wishing to attend this meeting must register by the date specified in the DATES section of this notice. Please allow sufficient time to go through the security checkpoints. It is VerDate Sep<11>2014 15:23 Nov 27, 2015 Jkt 238001 suggested that you arrive at 7500 Security Boulevard no later than 8:30 a.m. e.s.t. if you are attending the Town Hall Meeting in person so that you will be able to arrive promptly for the meeting. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. The Real ID Act of 2005 (Pub. L. 109–13), establishes minimum standards for the issuance of state-issued driver’s licenses and identification (ID) cards. It prohibits Federal agencies from accepting an official driver’s license or ID card from a state unless the Department of Homeland Security determines that the state is in compliance with the Real ID Act. (For information regarding the states or territories that are not in compliance with the Real ID Act see https://www.dhs.gov/real-idenforcement-brief.) If a state or territory is listed on the https://www.dhs.gov/realid-enforcement-brief Web site as noncompliant, a photographic ID (such as a driver’s license) issued by one of those states or territories will not be accepted as identification to enter Federal buildings. Visitors from these states/ territories will need to provide alternative proof of identification (such as a passport) to gain entrance into Baltimore-based CMS buildings. • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in all areas other than the lower level lobby and cafeteria area and first floor auditorium and conference areas in the Central Building. Seating capacity is limited to the first 250 registrants. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Authority: Section 503 of Pub. L. 108–173. Dated: November 12, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015–30314 Filed 11–27–15; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 February 3, 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: https://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, PDAC@ 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 the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the E:\FR\FM\30NON1.SGM 30NON1 jstallworth on DSK7TPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Notices appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, 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 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 committee. Written submissions may be made to the contact person on or before January 20, 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 January 11, 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 12, 2016. VerDate Sep<11>2014 15:23 Nov 27, 2015 Jkt 238001 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 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: November 23, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015–30296 Filed 11–27–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, NW., Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 74777 Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C–26, Rockville, MD 20857; (301) 443–6593, or visit our Web site at: https://www.hrsa.gov/ vaccinecompensation/. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters, who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa–12(b)(2), requires that ‘‘[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.’’ Set forth below is a list of petitions received by HRSA on October 1, 2015, through October 31, 2015. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction. Section 2112(b)(2) also provides that the special master ‘‘shall afford all interested persons an opportunity to submit relevant, written information’’ relating to the following: E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Notices]
[Pages 74776-74777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    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 February 3, 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: https://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, PDAC@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 the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the

[[Page 74777]]

appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.
    Agenda: During the morning session, the committee will discuss 
cognitive dysfunction in major depressive disorder (MDD). This is an 
evolving concept and experts in the field have not yet reached 
consensus as to whether cognitive dysfunction in MDD is a distinct 
entity. The committee will consider the clinical presentation of 
cognitive dysfunction in MDD, as well as methods for assessing this 
condition.
    During the afternoon session, the committee will discuss new drug 
application 204447/supplemental new drug application 006, for the 
effectiveness of vortioxetine for the treatment of cognitive 
dysfunction in MDD, submitted by Takeda Development Center Americas, 
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 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 committee. 
Written submissions may be made to the contact person on or before 
January 20, 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 January 11, 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 12, 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 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: November 23, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30296 Filed 11-27-15; 8:45 am]
 BILLING CODE 4164-01-P
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