Delegation of Authority, 25355 [2011-10847]
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Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices
Administration approval, takes at least
two years. In addition to the regulatory
hurdles facing a potential entrant,
manufacturing difficulties in producing
generic injectable products, combined
with the small size of the markets in
question, makes additional entry
unlikely to occur.
jlentini on DSKJ8SOYB1PROD with NOTICES
Effects
The Proposed Acquisition would
cause significant anticompetitive harm
to consumers in the U.S. markets for the
manufacture and sale of generic
injectable phenytoin and generic
injectable promethazine. In generic
injectable pharmaceuticals markets,
price generally decreases as the second,
third, or fourth competitors enter. Thus,
reducing the number of competitors to
two and one in each market,
respectively, would cause
anticompetitive harm to consumers in
these U.S. markets by increasing the
likelihood that consumers would pay
higher prices.
The Consent Agreement
The proposed Consent Agreement
effectively remedies the Proposed
Acquisition’s anticompetitive effects in
the relevant markets by requiring Hikma
to divest certain rights and assets related
to generic injectable phenytoin and
generic injectable promethazine to a
Commission-approved acquirer no later
than ten days after the acquisition. The
acquirer of the divested assets must
receive the prior approval of the
Commission. The Commission’s goal in
evaluating a possible purchaser of
divested assets is to maintain the
competitive environment that existed
prior to the acquisition.
The proposed Consent Agreement
remedies the competitive concerns the
acquisition raises by requiring Hikma to
divest its generic injectable phenytoin
and generic injectable promethazine
products to X-Gen, which will purchase
all rights currently held by Hikma. XGen is a New York-based generic
injectable pharmaceutical company
with 40 active products and an active
product development pipeline. With its
experience in generic injectable markets
and strong ties to manufacturing
partners, X-Gen is expected to replicate
the competition that would otherwise be
lost with the Proposed Acquisition.
If the Commission determines that XGen is not an acceptable acquirer of the
assets to be divested, or that the manner
of the divestitures is not acceptable, the
parties must unwind the sale to X-Gen
and divest the phenytoin and
promethazine product lines, within six
months of the date the Order becomes
final, to a Commission-approved
VerDate Mar<15>2010
17:45 May 03, 2011
Jkt 223001
acquirer. The Commission may appoint
a trustee to divest the products if Hikma
fails to divest the products as required.
The proposed Consent Agreement
contains several provisions to help
ensure that the divestitures are
successful. The Order requires Hikma to
take all action to maintain the economic
viability, marketability, and
competitiveness of the products until
such time as they are transferred to a
Commission-approved acquirer. In
addition, the parties must supply X-Gen
with phenytoin and promethazine
pursuant to a supply agreement while
Hikma transfers the manufacturing
technology to X-Gen or a third-party
manufacturer of X-Gen’s choice.
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.
[FR Doc. 2011–10783 Filed 5–3–11; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have
delegated to HHS’ Operating and Staff
Division heads and the Chair(s) of the
HHS Innovation Council, or their
successors, the authorities vested in the
Secretary under Section 105 of the
America COMPETES Reauthorization
Act of 2010 (Pub. L. 111–358) (which
added Section 24 of the StevensonWydler Technology Innovation Act of
1980, 15 U.S.C. 3701 et seq), as
amended, to administer and fund prize
competitions aimed at stimulating
innovation. This delegation excludes
the authority under Section 24(k)(3) to
develop guidelines for the appointment
of judges, which I hereby delegate to the
Chair(s), HHS Innovation Council.
Additionally, I reserve the authorities
under Section 24(m)(3)(B) to approve an
increase in the amount of a prize after
initial announcement has been made
and to approve the award of more than
$500,000 in cash prizes.
These authorities may be redelegated.
The authorities granted herein shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines. I hereby
affirm and ratify any actions taken by
you or your subordinates, which involve
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
the exercise of this authority prior to the
effective date of this delegation. This
delegation is effective upon date of
signature.
Authority: 44 U.S.C. 3101.
Dated: April 22, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–10847 Filed 5–3–11; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HIT Standards Committee; Schedule
for the Assessment of HIT Policy
Committee Recommendations
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
AGENCY:
Section 3003(b)(3) of the
American Recovery and Reinvestment
Act of 2009 mandates that the HIT
Standards Committee develop a
schedule for the assessment of policy
recommendations developed by the HIT
Policy Committee and publish it in the
Federal Register. This notice fulfills the
requirements of Section 3003(b)(3) and
updates the schedule posted in the
Federal Register on October 8, 2010. In
anticipation of receiving
recommendations originally developed
by the HIT Policy Committee, the HIT
Standards Committee has created four
(4) workgroups or subcommittees to
analyze the areas of clinical quality,
clinical operations, implementation,
and privacy and security.
HIT Standards Committee’s Schedule
for the Assessment of HIT Policy
Committee Recommendations is as
follows: The National Coordinator will
establish priority areas based in part on
recommendations received from the HIT
Policy Committee regarding health
information technology standards,
implementation specifications, and/or
certification criteria. Once the HIT
Standards Committee is informed of
those priority areas, it will:
(A) Direct the appropriate workgroup
or subcommittee to develop a report for
the HIT Standards Committee, to the
extent possible, within 90 days, which
will include, among other items, the
following:
(1) An assessment of what standards,
implementation specifications, and
certification criteria are currently
available to meet the priority area;
(2) An assessment of where gaps exist
(i.e., no standard is available or
harmonization is required because more
than one standard exists) and identify
SUMMARY:
By direction of the Commission.
Donald S. Clark,
Secretary.
25355
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[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Page 25355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10847]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Office of the Secretary
Delegation of Authority
Notice is hereby given that I have delegated to HHS' Operating and
Staff Division heads and the Chair(s) of the HHS Innovation Council, or
their successors, the authorities vested in the Secretary under Section
105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-
358) (which added Section 24 of the Stevenson-Wydler Technology
Innovation Act of 1980, 15 U.S.C. 3701 et seq), as amended, to
administer and fund prize competitions aimed at stimulating innovation.
This delegation excludes the authority under Section 24(k)(3) to
develop guidelines for the appointment of judges, which I hereby
delegate to the Chair(s), HHS Innovation Council. Additionally, I
reserve the authorities under Section 24(m)(3)(B) to approve an
increase in the amount of a prize after initial announcement has been
made and to approve the award of more than $500,000 in cash prizes.
These authorities may be redelegated. The authorities granted
herein shall be exercised in accordance with the Department's
applicable policies, procedures, and guidelines. I hereby affirm and
ratify any actions taken by you or your subordinates, which involve the
exercise of this authority prior to the effective date of this
delegation. This delegation is effective upon date of signature.
Authority: 44 U.S.C. 3101.
Dated: April 22, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011-10847 Filed 5-3-11; 8:45 am]
BILLING CODE 4150-04-P
