83 FR 19767 - Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)

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

Federal Register Volume 83, Issue 87 (May 4, 2018)

Page Range		19767-19768
FR Document		2018-09473

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, [email protected], or Charles Rothwell, (301) 458- 4500, [email protected] at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.

Federal Register, Volume 83 Issue 87 (Friday, May 4, 2018)

[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19767-19768]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Board of Scientific Counselors, National Center for Health 
Statistics (BSC, NCHS)

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 
Centers for Disease Control and Prevention (CDC), announces the 
following meeting for the Board of Scientific Counselors, National 
Center for Health Statistics (BSC, NCHS). This meeting is open to the 
public; however, visitors must be processed in accordance with 
established federal policies and procedures. For foreign nationals or 
non-U.S. citizens, pre-approval is required (please contact Gwen 
Mustaf, 301-458-4500, [email protected], or Charles Rothwell, (301) 458-
4500, [email protected] at least 10 days in advance for requirements). All 
visitors are required to present a valid form of

[[Page 19768]]

picture identification issued by a state, federal or international 
government. As required by the Federal Property Management Regulations, 
all persons entering in or on Federal controlled property and their 
packages, briefcases, and other containers in their immediate 
possession are subject to being x-rayed and inspected. Federal law 
prohibits the knowing possession or the causing to be present of 
firearms, explosives and other dangerous weapons and illegal 
substances. The meeting room accommodates approximately 78 people.

DATES: The meeting will be held on June 19, 2018, 11:00 a.m.-5:30 p.m., 
EDT, and June 20, 2018, 8:30 a.m.-1:00 p.m., EDT.

ADDRESSES: NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 
20782.

FOR FURTHER INFORMATION CONTACT: Charles J. Rothwell, Director, NCHS/
CDC, 3311 Toledo Road, Room 2627, Hyattsville, Maryland 20782, 
telephone (301) 458-4500, email [email protected].

SUPPLEMENTARY INFORMATION: 
    Purpose: This committee is charged with providing advice and making 
recommendations to the Secretary, Department of Health and Human 
Services; the Director, CDC; and the Director, NCHS, regarding the 
scientific and technical program goals and objectives, strategies, and 
priorities of NCHS.
    Matters to be Considered: Day One meeting agenda includes: Welcome 
remarks by NCHS leadership; update on Selected NCHS OPIOID Related 
Projects; update on Health, United States 2017 and Beyond; Day Two 
meeting agenda includes: Update on Visualizing the National Health 
Interview Survey Early Release Program: A New Online Dynamic Report; 
and an update on National Health and Nutrition Examination Survey 2013: 
The Future is Now. Requests to make oral presentations should be 
submitted in writing to the contact person listed below. All requests 
must contain the name, address, telephone number, and organizational 
affiliation of the presenter. Written comments should not exceed five 
single-spaced typed pages in length and must be received by June 4, 
2018. 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.

Claudette Grant,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2018-09473 Filed 5-3-18; 8:45 am]
 BILLING CODE 4163-19-P

Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 19767

and bringing to market pipeline jeopardize the only generic product on employees of the parties. Under the
products suggests that the divested the market. proposed Consent Agreement, the
products will be placed in the hands of The FDA approved Amneal’s ANDA Commission also will appoint an
a firm with the same ability and for generic methylphenidate Interim Monitor.
incentive to bring the products to hydrochloride ER tablets in February The Commission’s goal in evaluating
market. As explained below, the 2018. Impax also has an approved possible purchasers of divested assets is
Consent Agreement helps make that ANDA. Impax’s product is contract to maintain the competitive
outcome more likely. manufactured, but the contract environment that existed prior to the
For two of the products that both manufacturer needs to resolve Proposed Acquisition. If the
Amneal and Impax currently market, manufacturing issues before it can Commission determines that ANI,
generic desipramine hydrochloride resume manufacturing the product. It Perrigo, and/or G&W are not acceptable
tablets and felbamate tablets, Impax will will be less risky for Impax to assign its acquirers, or that the manner of the
assign its contract manufacturing manufacturing contract to ANI than to divestitures is not acceptable, the
agreements to ANI. For the third affect a technology transfer from proposed Order requires the parties to
currently-marketed product, Amneal Amneal for this complex product, and it unwind the sale of rights to ANI,
will supply ANI with generic ezetimibe will put the product in ANI’s hands, Perrigo, and/or G&W and then divest the
and simvastatin IR tablets for two years which has the same ability and affected products to a Commission-
with the option to extend for two incentive as Impax to bring approved acquirer within six months of
additional years. methylphenidate hydrochloride ER the date the Order becomes final. The
In four overlap markets in which tablets to market. Thus, the proposed proposed Order further allows the
Amneal has an on-market product and Order requires the divestiture of Impax’s Commission to appoint a trustee in the
Impax has a product in development, rights and assets to ANI. event the parties fail to divest the
Impax will divest its rights and assets to For generic diclofenac sodium and products as required.
ANI rather than requiring Amneal to misoprostol DR tablets, Amneal has an The purpose of this analysis is to
divest its on-market, in-house on-market in-house manufactured facilitate public comment on the
manufactured products. Each of these product, and Impax is partnered with proposed Consent Agreement, and it is
product markets has specific facts that Micro Labs to commercialize a not intended to constitute an official
warrant the divestiture of the Impax competing product. Impax holds only interpretation of the proposed Order or
rights and assets rather than the Amneal marketing rights to the product; Micro to modify its terms in any way.
product. Of note, three products— Labs is responsible for development and By direction of the Commission.
generic aspirin and dipyridamole ER manufacturing. Impax will transfer its
Donald S. Clark,
capsules, generic methylphenidate marketing agreement with Micro Labs to
Secretary.
hydrochloride ER tablets, and generic ANI, and Micro Labs will manufacture
diclofenac sodium and misoprostol DR the product for ANI for the current [FR Doc. 2018–09546 Filed 5–3–18; 8:45 am]
tablets—are more complicated to contract term. BILLING CODE 6750–01–P

manufacture because they have For erythromycin tablets, Amneal
extended or delayed release launched its product in March 2018,
characteristics. and only one other competitor, Arbor DEPARTMENT OF HEALTH AND
For generic aspirin and dipyridamole Pharmaceuticals, is currently selling HUMAN SERVICES
ER capsules, Amneal is the only erythromycin tablets. Amneal
manufacturer with a product on the manufactures the erythromycin tablets Centers for Disease Control and
market. Amneal manufactures this in-house. Impax is one of a few Prevention
product in-house. Impax received FDA companies developing the product, and
approval for its ANDA in 2017 and had once approved, it plans to outsource the Board of Scientific Counselors,
expected to use a third-party manufacturing. Here, the easier-to- National Center for Health Statistics
manufacturer to launch its product. divest product is the Impax drug in (BSC, NCHS)
That manufacturer experienced some development. Thus, Commission staff AGENCY: Centers for Disease Control and
manufacturing difficulties and Impax considers it prudent to leave the in- Prevention (CDC), Department of Health
had begun the process of developing the house Amneal-manufactured product and Human Services (HHS).
means to produce the product at its own with the merged firm, an ongoing and ACTION: Notice of meeting.
facilities. With the divestiture, ANI will viable competitor to Arbor. Further,
finalize the manufacturing process and Impax will transfer all of its assets SUMMARY: In accordance with the
expects to have the Impax drug on the related to its development of Federal Advisory Committee Act, the
market soon. Nevertheless, should ANI erythromycin tablets to ANI, which has Centers for Disease Control and
be unable to market its own version of the same ability and incentive to bring Prevention (CDC), announces the
this product by October 1, 2019, ANI a competing third erythromycin tablet to following meeting for the Board of
has the option to source generic aspirin market. Scientific Counselors, National Center
and dipyridamole ER capsules from The proposed Order also requires for Health Statistics (BSC, NCHS). This
Amneal until ANI obtains the necessary Amneal to provide transitional services meeting is open to the public; however,
regulatory approvals or through March to ANI, Perrigo, and G&W to assist them visitors must be processed in
1, 2021, whichever date is earlier. This in establishing their manufacturing accordance with established federal
ensures that ANI will be able to market capabilities and securing all of the policies and procedures. For foreign
amozie on DSK3GDR082PROD with NOTICES

a competing product near the time necessary FDA approvals. These nationals or non-U.S. citizens, pre-
Impax likely would have had the transitional services include technical approval is required (please contact
product on market, and provides the assistance to manufacture the ten Gwen Mustaf, 301–458–4500, glm4@
incentive for ANI to manufacture and products at issue in substantially the cdc.gov, or Charles Rothwell, (301) 458–
market its own product. An alternative same manner and quality employed or 4500, cjr4@cdc.gov at least 10 days in
divestiture of the Amneal product achieved by Impax. It also includes advance for requirements). All visitors
would involve more risk and could advice and training from knowledgeable are required to present a valid form of

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19768 Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices

picture identification issued by a state, Prevention and the Agency for Toxic Dated: April 25, 2018.
federal or international government. As Substances and Disease Registry. Frank J. Hearl,
required by the Federal Property Chief of Staff, National Institute for
Claudette Grant,
Management Regulations, all persons Occupational Safety and Health, Centers for
entering in or on Federal controlled Acting Director, Management Analysis and Disease Control and Prevention.
Services Office, Centers for Disease Control
property and their packages, briefcases, and Prevention. [FR Doc. 2018–09442 Filed 5–3–18; 8:45 am]
and other containers in their immediate BILLING CODE 4163–19–P
[FR Doc. 2018–09473 Filed 5–3–18; 8:45 am]
possession are subject to being x-rayed
BILLING CODE 4163–19–P
and inspected. Federal law prohibits the
knowing possession or the causing to be DEPARTMENT OF HEALTH AND
present of firearms, explosives and other DEPARTMENT OF HEALTH AND HUMAN SERVICES
dangerous weapons and illegal HUMAN SERVICES
substances. The meeting room Centers for Disease Control and
accommodates approximately 78 Centers for Disease Control and Prevention
people. Prevention Notice of Closed Meeting
DATES: The meeting will be held on June
19, 2018, 11:00 a.m.–5:30 p.m., EDT, [CDC–2018–0024; Docket Number NIOSH– Pursuant to section 10(d) of the
and June 20, 2018, 8:30 a.m.–1:00 p.m., 302] Federal Advisory Committee Act, as
EDT. amended, notice is hereby given of the
ADDRESSES: NCHS Headquarters, 3311
Draft—National Occupational Research following meeting.
Toledo Road, Hyattsville, Maryland Agenda for Respiratory Health;
Extension of Comment Period The meeting will be closed to the
20782. public in accordance with the
FOR FURTHER INFORMATION CONTACT: AGENCY: National Institute for provisions set forth in sections
Charles J. Rothwell, Director, NCHS/ Occupational Safety and Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
CDC, 3311 Toledo Road, Room 2627, (NIOSH) of the Centers for Disease as amended, and the Determination of
Hyattsville, Maryland 20782, telephone Control and Prevention (CDC), the Director, Management Analysis and
(301) 458–4500, email cjr4@cdc.gov. Department of Health and Human Services Office, CDC, pursuant to Public
SUPPLEMENTARY INFORMATION: Services (HHS). Law 92–463. The grant applications and
Purpose: This committee is charged the discussions could disclose
Notice and extension of
ACTION: confidential trade secrets or commercial
with providing advice and making comment period.
recommendations to the Secretary, property such as patentable material,
Department of Health and Human and personal information concerning
SUMMARY: On March 15, 2018 the individuals associated with the grant
Services; the Director, CDC; and the National Institute for Occupational
Director, NCHS, regarding the scientific applications, the disclosure of which
Safety and Health (NIOSH) of the would constitute a clearly unwarranted
and technical program goals and Centers for Disease Control and
objectives, strategies, and priorities of invasion of personal privacy.
Prevention (CDC), published a notice in
NCHS. the Federal Register [83 FR 11537] Name of Committee: Disease, Disability,
Matters to be Considered: Day One and Injury Prevention and Control Special
announcing the availability of a draft Emphasis Panel (SEP)—Funding Opportunity
meeting agenda includes: Welcome NORA Agenda entitled National
remarks by NCHS leadership; update on Announcement (FOA), PAR 16–098,
Occupational Research Agenda for Cooperative Research Agreements to the
Selected NCHS OPIOID Related Respiratory Health for public comment. World Trade Center Health Program (U01).
Projects; update on Health, United Written comments were to be received Date: June 25, 2018.
States 2017 and Beyond; Day Two by May 14, 2018. In response to a Times: 1:00 p.m.–4:00 p.m. EDT.
meeting agenda includes: Update on request from an interested party, NIOSH Place: Teleconference.
Visualizing the National Health is extending the public comment period Agenda: To review and evaluate grant
Interview Survey Early Release Program: to July 13, 2018. applications.
A New Online Dynamic Report; and an For Further Information Contact: Nina
update on National Health and FOR FURTHER INFORMATION CONTACT: Turner, Ph.D., Scientific Review Officer,
Nutrition Examination Survey 2013: Emily Novicki NORACoordinator@ CDC/NIOSH, 1095 Willowdale Road,
The Future is Now. Requests to make cdc.gov), National Institute for Mailstop G905, Morgantown, West Virginia
oral presentations should be submitted Occupational Safety and Health, Centers 26505, Telephone: (304) 285–5975.
in writing to the contact person listed for Disease Control and Prevention,
The Director, Management Analysis
below. All requests must contain the Mailstop E–20, 1600 Clifton Road NE,
and Services Office, has been delegated
name, address, telephone number, and Atlanta, GA 30329, phone (404) 498–
the authority to sign Federal Register
organizational affiliation of the 2581 (not a toll free number).
notices pertaining to announcements of
presenter. Written comments should not ADDRESSES: You may submit comments, meetings and other committee
exceed five single-spaced typed pages in identified by CDC–2018–0024 and management activities, for both the
length and must be received by June 4, Docket Number NIOSH–302, by either Centers for Disease Control and
2018. Agenda items are subject to of the following two methods: Prevention and the Agency for Toxic
change as priorities dictate. Substances and Disease Registry.
• Federal eRulemaking Portal: http://
amozie on DSK3GDR082PROD with NOTICES

The Director, Management Analysis
and Services Office, has been delegated www.regulations.gov Follow the Claudette Grant,
the authority to sign Federal Register instructions for submitting comments. Acting Director, Management Analysis and
notices pertaining to announcements of • Mail: National Institute for Services Office, Centers for Disease Control
meetings and other committee Occupational Safety and Health, NIOSH and Prevention.
management activities, for both the Docket Office, 1090 Tusculum Avenue, [FR Doc. 2018–09475 Filed 5–3–18; 8:45 am]
Centers for Disease Control and MS C–34, Cincinnati, Ohio 45226–1998. BILLING CODE 4163–18–P

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Document Created: 2018-11-02 09:53:10
Document Modified: 2018-11-02 09:53:10

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 June 19, 2018, 11:00 a.m.-5:30 p.m., EDT, and June 20, 2018, 8:30 a.m.-1:00 p.m., EDT.
Contact		Charles J. Rothwell, Director, NCHS/ CDC, 3311 Toledo Road, Room 2627, Hyattsville, Maryland 20782, telephone (301) 458-4500, email [email protected]
FR Citation		83 FR 19767

83 FR 19767 - Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 83, Issue 87 (May 4, 2018)

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