Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS), 19767-19768 [2018-09473]
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
and bringing to market pipeline
products suggests that the divested
products will be placed in the hands of
a firm with the same ability and
incentive to bring the products to
market. As explained below, the
Consent Agreement helps make that
outcome more likely.
For two of the products that both
Amneal and Impax currently market,
generic desipramine hydrochloride
tablets and felbamate tablets, Impax will
assign its contract manufacturing
agreements to ANI. For the third
currently-marketed product, Amneal
will supply ANI with generic ezetimibe
and simvastatin IR tablets for two years
with the option to extend for two
additional years.
In four overlap markets in which
Amneal has an on-market product and
Impax has a product in development,
Impax will divest its rights and assets to
ANI rather than requiring Amneal to
divest its on-market, in-house
manufactured products. Each of these
product markets has specific facts that
warrant the divestiture of the Impax
rights and assets rather than the Amneal
product. Of note, three products—
generic aspirin and dipyridamole ER
capsules, generic methylphenidate
hydrochloride ER tablets, and generic
diclofenac sodium and misoprostol DR
tablets—are more complicated to
manufacture because they have
extended or delayed release
characteristics.
For generic aspirin and dipyridamole
ER capsules, Amneal is the only
manufacturer with a product on the
market. Amneal manufactures this
product in-house. Impax received FDA
approval for its ANDA in 2017 and had
expected to use a third-party
manufacturer to launch its product.
That manufacturer experienced some
manufacturing difficulties and Impax
had begun the process of developing the
means to produce the product at its own
facilities. With the divestiture, ANI will
finalize the manufacturing process and
expects to have the Impax drug on the
market soon. Nevertheless, should ANI
be unable to market its own version of
this product by October 1, 2019, ANI
has the option to source generic aspirin
and dipyridamole ER capsules from
Amneal until ANI obtains the necessary
regulatory approvals or through March
1, 2021, whichever date is earlier. This
ensures that ANI will be able to market
a competing product near the time
Impax likely would have had the
product on market, and provides the
incentive for ANI to manufacture and
market its own product. An alternative
divestiture of the Amneal product
would involve more risk and could
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jeopardize the only generic product on
the market.
The FDA approved Amneal’s ANDA
for generic methylphenidate
hydrochloride ER tablets in February
2018. Impax also has an approved
ANDA. Impax’s product is contract
manufactured, but the contract
manufacturer needs to resolve
manufacturing issues before it can
resume manufacturing the product. It
will be less risky for Impax to assign its
manufacturing contract to ANI than to
affect a technology transfer from
Amneal for this complex product, and it
will put the product in ANI’s hands,
which has the same ability and
incentive as Impax to bring
methylphenidate hydrochloride ER
tablets to market. Thus, the proposed
Order requires the divestiture of Impax’s
rights and assets to ANI.
For generic diclofenac sodium and
misoprostol DR tablets, Amneal has an
on-market in-house manufactured
product, and Impax is partnered with
Micro Labs to commercialize a
competing product. Impax holds only
marketing rights to the product; Micro
Labs is responsible for development and
manufacturing. Impax will transfer its
marketing agreement with Micro Labs to
ANI, and Micro Labs will manufacture
the product for ANI for the current
contract term.
For erythromycin tablets, Amneal
launched its product in March 2018,
and only one other competitor, Arbor
Pharmaceuticals, is currently selling
erythromycin tablets. Amneal
manufactures the erythromycin tablets
in-house. Impax is one of a few
companies developing the product, and
once approved, it plans to outsource the
manufacturing. Here, the easier-todivest product is the Impax drug in
development. Thus, Commission staff
considers it prudent to leave the inhouse Amneal-manufactured product
with the merged firm, an ongoing and
viable competitor to Arbor. Further,
Impax will transfer all of its assets
related to its development of
erythromycin tablets to ANI, which has
the same ability and incentive to bring
a competing third erythromycin tablet to
market.
The proposed Order also requires
Amneal to provide transitional services
to ANI, Perrigo, and G&W to assist them
in establishing their manufacturing
capabilities and securing all of the
necessary FDA approvals. These
transitional services include technical
assistance to manufacture the ten
products at issue in substantially the
same manner and quality employed or
achieved by Impax. It also includes
advice and training from knowledgeable
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19767
employees of the parties. Under the
proposed Consent Agreement, the
Commission also will appoint an
Interim Monitor.
The Commission’s goal in evaluating
possible purchasers of divested assets is
to maintain the competitive
environment that existed prior to the
Proposed Acquisition. If the
Commission determines that ANI,
Perrigo, and/or G&W are not acceptable
acquirers, or that the manner of the
divestitures is not acceptable, the
proposed Order requires the parties to
unwind the sale of rights to ANI,
Perrigo, and/or G&W and then divest the
affected products to a Commissionapproved acquirer within six months of
the date the Order becomes final. The
proposed Order further allows the
Commission to appoint a trustee in the
event the parties fail to divest the
products as required.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–09546 Filed 5–3–18; 8:45 am]
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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)
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
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, preapproval is required (please contact
Gwen Mustaf, 301–458–4500, glm4@
cdc.gov, or Charles Rothwell, (301) 458–
4500, cjr4@cdc.gov at least 10 days in
advance for requirements). All visitors
are required to present a valid form of
SUMMARY:
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
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.
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.
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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18:16 May 03, 2018
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[CDC–2018–0024; Docket Number NIOSH–
302]
Draft—National Occupational Research
Agenda for Respiratory Health;
Extension of Comment Period
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
AGENCY:
Charles J. Rothwell, Director, NCHS/
CDC, 3311 Toledo Road, Room 2627,
Hyattsville, Maryland 20782, telephone
(301) 458–4500, email cjr4@cdc.gov.
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
[FR Doc. 2018–09442 Filed 5–3–18; 8:45 am]
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DATES:
FOR FURTHER INFORMATION CONTACT:
Dated: April 25, 2018.
Frank J. Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
Notice and extension of
comment period.
ACTION:
On March 15, 2018 the
National Institute for Occupational
Safety and Health (NIOSH) of the
Centers for Disease Control and
Prevention (CDC), published a notice in
the Federal Register [83 FR 11537]
announcing the availability of a draft
NORA Agenda entitled National
Occupational Research Agenda for
Respiratory Health for public comment.
Written comments were to be received
by May 14, 2018. In response to a
request from an interested party, NIOSH
is extending the public comment period
to July 13, 2018.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Emily Novicki NORACoordinator@
cdc.gov), National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
Mailstop E–20, 1600 Clifton Road NE,
Atlanta, GA 30329, phone (404) 498–
2581 (not a toll free number).
You may submit comments,
identified by CDC–2018–0024 and
Docket Number NIOSH–302, by either
of the following two methods:
• Federal eRulemaking Portal: https://
www.regulations.gov Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
ADDRESSES:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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, and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463. 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: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—Funding Opportunity
Announcement (FOA), PAR 16–098,
Cooperative Research Agreements to the
World Trade Center Health Program (U01).
Date: June 25, 2018.
Times: 1:00 p.m.–4:00 p.m. EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
CDC/NIOSH, 1095 Willowdale Road,
Mailstop G905, Morgantown, West Virginia
26505, Telephone: (304) 285–5975.
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. 2018–09475 Filed 5–3–18; 8:45 am]
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[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19767-19768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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