83 FR 35648 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 145 (July 27, 2018)

Page Range		35648-35648
FR Document		2018-16103

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.

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018)

[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35648]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16103]


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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.

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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

35648 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices

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BILLING CODE 4163–19–P was withdrawn from sale for reasons of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Prevention (CDC)—Health Disparities a listed drug was withdrawn from sale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

member orientation. This meeting will do not have to repeat the extensive records concerning the withdrawal of
provide information to new members clinical testing otherwise necessary to metaxalone tablets, 640 mg, from sale.
regarding their role & duties on this gain approval of a new drug application We have also independently evaluated
subcommittee. Agenda items are subject (NDA). relevant literature and data for possible
to change as priorities dictate. The 1984 amendments include what postmarketing adverse events. We have
The Director, Management Analysis is now section 505(j)(7) of the Federal reviewed the available evidence and
and Services Office, has been delegated Food, Drug, and Cosmetic Act (21 U.S.C. determined that this drug product was

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Document Created: 2018-07-27 04:04:42
Document Modified: 2018-07-27 04:04:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of meeting.
Dates		The meeting will be held on October 9, 2018, 1:30 p.m. to 3:30 p.m., EDT.
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]
FR Citation		83 FR 35648

83 FR 35648 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 145 (July 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention