Advisory Committee on Interdisciplinary, Community-Based Linkages, 10494 [2018-04815]
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10494
Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Goodwin Procter LLP submitted a
citizen petition dated September 26,
2017 (Docket No. FDA–2017–P–5946),
under 21 CFR 10.30, requesting that the
Agency determine whether DORYX
MPC (doxycycline hyclate), delayedrelease tablets, 60 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that this drug
product was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of DORYX
MPC (doxycycline hyclate), delayedrelease tablets, 60 mg, from sale. We
have found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to this drug product
may be approved by the Agency as long
as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for this drug product should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04726 Filed 3–8–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Advisory Committee on
Interdisciplinary, Community-Based
Linkages
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meetings.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that two orientation
meetings are scheduled for the Advisory
Committee on Interdisciplinary,
Community-Based Linkages (ACICBL).
These meetings will be open to the
public. Information about the ACICBL
and the agenda for these meetings can
be obtained by accessing the ACICBL
website at: https://www.hrsa.gov/
advisory-committees/interdisciplinarycommunity-linkages/meetings/
index.html.
SUMMARY:
In order to accommodate the
schedules of the ACICBL members, two
orientation meetings will be held. The
first meeting will be on March 15, 2018
from 11:00 a.m.–4:00 p.m., ET and the
second meeting will be on March 27,
2018 from 12:00 p.m.–5:00 p.m., ET.
ADDRESSES: These meetings will be held
via conference call/webinar.
• The teleconference call-in number
is 1–800–619–2521, passcode: 9271697.
• The webinar link is https://
hrsa.connectsolutions.com/acicbl.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the ACICBL should contact
Joan Weiss, Ph.D., RN, CRNP, FAAN,
HRSA, in one of three ways: (1) Send a
request to the following address: Joan
Weiss, Ph.D., RN, CRNP, FAAN, Senior
Advisor and Designated Federal Officer,
Division of Medicine and Dentistry,
HRSA, 5600 Fishers Lane, Room 15N39,
Rockville, Maryland 20857; (2) call
(301) 443–0430; or (3) send an email to
jweiss@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
ACICBL provides advice and
recommendations on a broad range of
issues relating to grant programs
authorized by sections 750–760, Title
VII, Part D of the Public Health Service
Act. During the March 15, 2018 and
March 27, 2018 meetings. ACICBL
members will be oriented to the work of
the Committee and identify potential
topics to work on for 2018.
The ACICBL’s reports are submitted
to the Secretary of HHS; the Committee
DATES:
PO 00000
Frm 00072
Fmt 4703
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on Health, Education, Labor, and
Pensions of the U.S. Senate; and the
Committee on Energy and Commerce of
the U.S. House of Representatives.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to the ACICBL should be sent by March
13, 2018 for the March 15, 2018 meeting
and by March 25, 2018 for the March 27,
2018 meeting.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–04815 Filed 3–8–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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 Cancer
Institute Special Emphasis Panel; NCI
Pediatric Early Phase Clinical Trials Network
(PEP–CTN).
Date: March 27, 2018.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
7W538, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Shamala K. Srinivas,
Ph.D., Scientific Review Officer, Office of
Referral, Review, and Program Coordination,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W530, Bethesda, MD 20892–
9750, 240–276–6430, ss537t@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; U01 SEP:
Liquid Biopsy & Early Cancer Assessment.
Date: May 1, 2018.
Time: 10:00 a.m. to 5:00 p.m.
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[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Page 10494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04815]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration
Advisory Committee on Interdisciplinary, Community-Based Linkages
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of meetings.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, notice
is hereby given that two orientation meetings are scheduled for the
Advisory Committee on Interdisciplinary, Community-Based Linkages
(ACICBL). These meetings will be open to the public. Information about
the ACICBL and the agenda for these meetings can be obtained by
accessing the ACICBL website at: https://www.hrsa.gov/advisory-committees/interdisciplinary-community-linkages/meetings/.
DATES: In order to accommodate the schedules of the ACICBL members, two
orientation meetings will be held. The first meeting will be on March
15, 2018 from 11:00 a.m.-4:00 p.m., ET and the second meeting will be
on March 27, 2018 from 12:00 p.m.-5:00 p.m., ET.
ADDRESSES: These meetings will be held via conference call/webinar.
The teleconference call-in number is 1-800-619-2521,
passcode: 9271697.
The webinar link is https://hrsa.connectsolutions.com/acicbl.
FOR FURTHER INFORMATION CONTACT: Anyone requesting information
regarding the ACICBL should contact Joan Weiss, Ph.D., RN, CRNP, FAAN,
HRSA, in one of three ways: (1) Send a request to the following
address: Joan Weiss, Ph.D., RN, CRNP, FAAN, Senior Advisor and
Designated Federal Officer, Division of Medicine and Dentistry, HRSA,
5600 Fishers Lane, Room 15N39, Rockville, Maryland 20857; (2) call
(301) 443-0430; or (3) send an email to [email protected].
SUPPLEMENTARY INFORMATION: The ACICBL provides advice and
recommendations on a broad range of issues relating to grant programs
authorized by sections 750-760, Title VII, Part D of the Public Health
Service Act. During the March 15, 2018 and March 27, 2018 meetings.
ACICBL members will be oriented to the work of the Committee and
identify potential topics to work on for 2018.
The ACICBL's reports are submitted to the Secretary of HHS; the
Committee on Health, Education, Labor, and Pensions of the U.S. Senate;
and the Committee on Energy and Commerce of the U.S. House of
Representatives.
Members of the public will have the opportunity to provide
comments. Oral comments will be honored in the order they are requested
and may be limited as time allows. Requests to make oral comments or
provide written comments to the ACICBL should be sent by March 13, 2018
for the March 15, 2018 meeting and by March 25, 2018 for the March 27,
2018 meeting.
Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-04815 Filed 3-8-18; 8:45 am]
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