National Advisory Committee on Rural Health and Human Services, 14017 [2018-06651]
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
14017
Application No.
Drug
Applicant
NDA 020716 ........................
Vicoprofen (hydrocodone bitartrate and ibuprofen) Tablets, 7.5 milligrams (mg)/200 mg.
Ultram ER (tramadol HCl) Extended-Release Tablets,
100 mg, 200 mg, and 300 mg.
Troxyca ER (oxycodone HCl and naltrexone HCl) Extended-Release Capsules, 10 mg/1.2 mg, 20 mg/2.4
mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2 mg,
and 80 mg/9.6 mg.
Vantrela ER (hydrocodone bitartrate) Extended-Release
Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 021692 ........................
NDA 207621 ........................
NDA 207975 ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 2, 2018.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on May 2, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06579 Filed 3–30–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that a meeting is
scheduled for the National Advisory
Committee on Rural Health and Human
Services (NACRHHS). This meeting will
be open to the public. Information about
the NACRHHS and the agenda for this
meeting can be obtained by accessing
the NACRHHS website at https://
www.hrsa.gov/advisorycommittees/
rural/.
DATES: The meeting will be held on
April 16, 2018, from 8:45 a.m.–5:00 p.m.
EDT, April 17, 2018, from 8:30 a.m.–
5:15 p.m. EDT, and April 18, 2018, from
8:30 a.m.–11:00 a.m. EDT.
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SUMMARY:
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19:06 Mar 30, 2018
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Teva Branded Pharmaceutical Products R&D, Inc., 41
Moores Rd., P.O. Box 4011, Frazer, PA 19355.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
Services is hereby giving notice that a
meeting is scheduled to be held of the
National Vaccine Advisory Committee
(NVAC). The meeting will be open to
the public via teleconference; a public
comment session will be held during
the meeting.
DATES: The meeting will be held on May
3, 2018, from 10:30 a.m. to 12:30 p.m.
ET. The confirmed meeting times and
agenda will be posted on the NVAC
website at https://www.hhs.gov/nvpo/
nvac/meetings/ as soon as
they become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
one week prior to the meeting at: https://
www.hhs.gov/nvpo/nvac/meetings/
index.html. Pre-registration is required
for members of the public who wish to
attend the meeting and who wish to
participate in the public comment
session. Individuals who wish to attend
the meeting and/or participate in the
public comment session should register
at https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT:
National Vaccine Program Office, U.S.
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW, Washington, DC 20201.
Phone: (202) 690–5566; email: nvac@
hhs.gov.
[FR Doc. 2018–06651 Filed 3–30–18; 8:45 am]
SUPPLEMENTARY INFORMATION:
This meeting will be held at
The Saratoga Hilton. The address for the
meeting is 534 Broadway Saratoga
Springs, NY 12866–2209, (855) 605–
0316.
FOR FURTHER INFORMATION CONTACT:
Steve Hirsch, MSLS, Administrative
Coordinator, NACRHHS, HRSA,
17W29–C, 5600 Fishers Lane, Rockville,
MD 20857, Telephone (301) 443–0835,
Fax (301) 443–2803.
SUPPLEMENTARY INFORMATION:
NACRHHS provides counsel and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of
health and human services in rural
areas. During the meeting the
Committee will examine the issues of
Assessing and Mitigating the Effect of
Adverse Childhood Experiences and
Health Insurance Markets in Rural
Areas; conduct site visits to the
Adirondack Health Institute in Glens
Falls, New York and St. Vincent de Paul
Catholic Church in Cobleskill, New
York, to visit the Head Start Program;
and summarize key findings and
develop a work plan for the next
quarter. Members of the public will also
have the opportunity to provide
comments.
ADDRESSES:
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The NVAC was
established to provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program. The public meeting
will be dedicated to the deliberation of
the draft recommendations written by
E:\FR\FM\02APN1.SGM
02APN1
Agencies
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Page 14017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, notice
is hereby given that a meeting is scheduled for the National Advisory
Committee on Rural Health and Human Services (NACRHHS). This meeting
will be open to the public. Information about the NACRHHS and the
agenda for this meeting can be obtained by accessing the NACRHHS
website at https://www.hrsa.gov/advisorycommittees/rural/.
DATES: The meeting will be held on April 16, 2018, from 8:45 a.m.-5:00
p.m. EDT, April 17, 2018, from 8:30 a.m.-5:15 p.m. EDT, and April 18,
2018, from 8:30 a.m.-11:00 a.m. EDT.
ADDRESSES: This meeting will be held at The Saratoga Hilton. The
address for the meeting is 534 Broadway Saratoga Springs, NY 12866-
2209, (855) 605-0316.
FOR FURTHER INFORMATION CONTACT: Steve Hirsch, MSLS, Administrative
Coordinator, NACRHHS, HRSA, 17W29-C, 5600 Fishers Lane, Rockville, MD
20857, Telephone (301) 443-0835, Fax (301) 443-2803.
SUPPLEMENTARY INFORMATION: NACRHHS provides counsel and recommendations
to the Secretary with respect to the delivery, research, development,
and administration of health and human services in rural areas. During
the meeting the Committee will examine the issues of Assessing and
Mitigating the Effect of Adverse Childhood Experiences and Health
Insurance Markets in Rural Areas; conduct site visits to the Adirondack
Health Institute in Glens Falls, New York and St. Vincent de Paul
Catholic Church in Cobleskill, New York, to visit the Head Start
Program; and summarize key findings and develop a work plan for the
next quarter. Members of the public will also have the opportunity to
provide comments.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-06651 Filed 3-30-18; 8:45 am]
BILLING CODE 4165-15-P