Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS), 35648 [2018-16103]
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35648
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Jeffery M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–16090 Filed 7–26–18; 8:45 am]
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
BILLING CODE 4163–18–P
Dia Taylor,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–16103 Filed 7–26–18; 8:45 am]
BILLING CODE 4163–19–P
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—Health Disparities
Subcommittee (HDS)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Advisory Committee to the
Director, Centers for Disease Control
and Prevention—Health Disparities
Subcommittee (ACD, CDC–HDS). This
meeting is open to the public, limited
only by the 50 audio phone lines. The
public is also welcome to listen to the
meeting by teleconference. Please dial
(866) 918–8397 and enter code 9346283.
There are 50 lines available. The public
comment period is from 3:15 p.m.–3:20
p.m.
DATES: The meeting will be held on
October 9, 2018, 1:30 p.m. to 3:30 p.m.,
EDT.
ADDRESSES: Teleconference phone
(866) 918–8397 and enter code 9346283.
FOR FURTHER INFORMATION CONTACT:
Leandris Liburd, Ph.D., M.P.H., M.A.,
Designated Federal Officer, Health
Disparities Subcommittee, Advisory
Committee to the Director, CDC, 1600
Clifton Road NE, M/S K–77, Atlanta,
Georgia 30329. Telephone (404) 498–
6482, Email: ACDirector@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Subcommittee will
provide counsel to the CDC Director
through the ACD on strategic and other
health disparities and health equity
issues and provide guidance on
opportunities for CDC.
Matters to be Considered: The agenda
will include discussions on new
member orientation. This meeting will
provide information to new members
regarding their role & duties on this
subcommittee. Agenda items are subject
to change as priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–1283]
Determination That Metaxalone
Tablets, 640 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that metaxalone tablets, 640
milligrams (mg), were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
metaxalone tablets, 640 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT: Glen
Cheng, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 51, Rm. 6217, Silver Spring,
MD 20993–0002, 301–796–1494.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Metaxalone tablets, 640 mg, are the
subject of NDA 22–503, held by Primus
Pharmaceuticals, Inc., and initially
approved on June 1, 2015. Metaxalone
tablets, 640 mg, are indicated as an
adjunct to rest, physical therapy, and
other measures for the relief of
discomfort associated with acute,
painful musculoskeletal conditions.
In a letter dated September 30, 2015,
the previous NDA holder CorePharma,
LLC notified FDA that metaxalone
tablets, 640 mg, were discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Sovereign Pharmaceuticals, LLC
submitted a citizen petition dated
March 26, 2018 (Docket No. FDA–2018–
P–1283), under 21 CFR 10.30,
requesting that the Agency determine
whether metaxalone tablets, 640 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 metaxalone tablets, 640
mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that metaxalone
tablets, 640 mg, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
metaxalone tablets, 640 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
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]]>Agencies
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Committee to the Director (ACD), Centers for Disease
Control and Prevention (CDC)--Health Disparities Subcommittee (HDS)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, the CDC
announces the following meeting for the Advisory Committee to the
Director, Centers for Disease Control and Prevention--Health
Disparities Subcommittee (ACD, CDC-HDS). This meeting is open to the
public, limited only by the 50 audio phone lines. The public is also
welcome to listen to the meeting by teleconference. Please dial (866)
918-8397 and enter code 9346283. There are 50 lines available. The
public comment period is from 3:15 p.m.-3:20 p.m.
DATES: The meeting will be held on October 9, 2018, 1:30 p.m. to 3:30
p.m., EDT.
ADDRESSES: Teleconference phone (866) 918-8397 and enter code 9346283.
FOR FURTHER INFORMATION CONTACT: Leandris Liburd, Ph.D., M.P.H., M.A.,
Designated Federal Officer, Health Disparities Subcommittee, Advisory
Committee to the Director, CDC, 1600 Clifton Road NE, M/S K-77,
Atlanta, Georgia 30329. Telephone (404) 498-6482, Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Purpose: The Subcommittee will provide counsel to the CDC Director
through the ACD on strategic and other health disparities and health
equity issues and provide guidance on opportunities for CDC.
Matters to be Considered: The agenda will include discussions on
new member orientation. This meeting will provide information to new
members regarding their role & duties on this subcommittee. Agenda
items are subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Dia Taylor,
Acting Chief Operating Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2018-16103 Filed 7-26-18; 8:45 am]
BILLING CODE 4163-19-P
