Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 11986 [2019-06135]

Download as PDF 11986 Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that SYMDEKO (tezacaftor/ivacaftor), manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Silver Spring, MD 20993–0002, 301–796–4061, Fax: 301–796–9856, althea.cuff@fda.hhs.gov. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that SYMDEKO (tezacaftor/ivacaftor), manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a priority review voucher. SYMDEKO (tezacaftor/ivacaftor) is indicated for the treatment of patients with cystic fibrosis aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to tezacaftor/ ivacaftor based on in vitro data and/or clinical evidence. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about SYMDEKO (tezacaftor/ivacaftor), go to the ‘‘Drugs@ FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. SUPPLEMENTARY INFORMATION: jbell on DSK30RV082PROD with NOTICES Dated: March 26, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06138 Filed 3–28–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:48 Mar 28, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Advisory Council on Alzheimer’s Research, Care, and Services; Meeting Assistant Secretary for Planning and Evaluation, HHS. ACTION: Notice of meeting. AGENCY: This notice announces the public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer’s Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The April 29, 2019 meeting of the Advisory Council will focus on person-centered planning for older adults including information about implementation of care plans for people living with cognitive symptoms. There will also be discussion about the use of antipsychotic medication for people with dementia and other conditions living in community settings. DATES: The meeting will be held on April 29, 2019 from 9 a.m. to 4:30 p.m. EST. ADDRESSES: The meeting will be held in Room 800 in the Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Comments: Time is allocated on the agenda to hear public comments. The time for oral comments will be limited to two (2) minutes per individual. In lieu of oral comments, formal written comments may be submitted for the record to Helen Lamont, Ph.D., OASPE, 200 Independence Avenue SW, Room 424E, Washington, DC 20201. Comments may also be sent to napa@ hhs.gov. Those submitting written comments should identify themselves and any relevant organizational affiliations. SUMMARY: FOR FURTHER INFORMATION CONTACT: Helen Lamont, 202–260–6075, helen.lamont@hhs.gov. Note: Seating may be limited. Those wishing to attend the meeting must send an email to napa@hhs.gov and put ‘‘April 29 Meeting Attendance’’ in the subject line by Friday, April 19 so that their names may be put on a list of expected attendees and forwarded to the security officers at the Department of Health and Human Services. Any interested member of the public who is a non-U.S. citizen should include this information at the time of registration to ensure that the appropriate security procedure to gain entry to the building is carried out. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Although the meeting is open to the public, procedures governing security and the entrance to Federal buildings may change without notice. If you wish to make a public comment, you must note that within your email. SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). Topics of the Meeting: The April 29, 2019 meeting of the Advisory Council will focus on person-centered planning for older adults including information about implementation of care plans for people living with cognitive symptoms. There will also be discussion about the use of antipsychotic medication for people with dementia and other conditions living in community settings. Procedure and Agenda: This meeting is open to the public. Please allow 30 minutes to go through security and walk to the meeting room. The meeting will also be webcast at www.hhs.gov/live. Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National Alzheimer’s Project Act. The panel is governed by provisions of Public Law 92–463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: March 22, 2019. Brenda Destro, Deputy Assistant Secretary for Planning and Evaluation, Office of Human Services Policy. [FR Doc. 2019–06135 Filed 3–28–19; 8:45 am] BILLING CODE 4150–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Deafness and Other Communication E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Page 11986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Advisory Council on Alzheimer's Research, Care, and Services; 
Meeting

AGENCY: Assistant Secretary for Planning and Evaluation, HHS.

ACTION: Notice of meeting.

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SUMMARY: This notice announces the public meeting of the Advisory 
Council on Alzheimer's Research, Care, and Services (Advisory Council). 
The Advisory Council on Alzheimer's Research, Care, and Services 
provides advice on how to prevent or reduce the burden of Alzheimer's 
disease and related dementias on people with the disease and their 
caregivers. The April 29, 2019 meeting of the Advisory Council will 
focus on person-centered planning for older adults including 
information about implementation of care plans for people living with 
cognitive symptoms. There will also be discussion about the use of 
antipsychotic medication for people with dementia and other conditions 
living in community settings.

DATES: The meeting will be held on April 29, 2019 from 9 a.m. to 4:30 
p.m. EST.

ADDRESSES: The meeting will be held in Room 800 in the Hubert H. 
Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
    Comments: Time is allocated on the agenda to hear public comments. 
The time for oral comments will be limited to two (2) minutes per 
individual. In lieu of oral comments, formal written comments may be 
submitted for the record to Helen Lamont, Ph.D., OASPE, 200 
Independence Avenue SW, Room 424E, Washington, DC 20201. Comments may 
also be sent to [email protected]. Those submitting written comments should 
identify themselves and any relevant organizational affiliations.

FOR FURTHER INFORMATION CONTACT: Helen Lamont, 202-260-6075, 
[email protected]. Note: Seating may be limited. Those wishing to 
attend the meeting must send an email to [email protected] and put ``April 
29 Meeting Attendance'' in the subject line by Friday, April 19 so that 
their names may be put on a list of expected attendees and forwarded to 
the security officers at the Department of Health and Human Services. 
Any interested member of the public who is a non-U.S. citizen should 
include this information at the time of registration to ensure that the 
appropriate security procedure to gain entry to the building is carried 
out. Although the meeting is open to the public, procedures governing 
security and the entrance to Federal buildings may change without 
notice. If you wish to make a public comment, you must note that within 
your email.

SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the 
Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and 
(a)(2)). Topics of the Meeting: The April 29, 2019 meeting of the 
Advisory Council will focus on person-centered planning for older 
adults including information about implementation of care plans for 
people living with cognitive symptoms. There will also be discussion 
about the use of antipsychotic medication for people with dementia and 
other conditions living in community settings.
    Procedure and Agenda: This meeting is open to the public. Please 
allow 30 minutes to go through security and walk to the meeting room. 
The meeting will also be webcast at www.hhs.gov/live.

    Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National 
Alzheimer's Project Act. The panel is governed by provisions of 
Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets 
forth standards for the formation and use of advisory committees.

    Dated: March 22, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and Evaluation, Office of Human 
Services Policy.
[FR Doc. 2019-06135 Filed 3-28-19; 8:45 am]
 BILLING CODE 4150-15-P
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