Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Health Promotion and Disease Prevention Research Centers, Special Interest Project Competitive Supplements (Panels 5-6), Request for Applications (RFA) DP07-002, 19932-19933 [E7-7500]
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19932
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
and Asia. Abrika is a Sunrise, Florida
based specialty generic pharmaceutical
company engaged in the formulation
and commercialization of both
controlled release and immediate
release products.
Generic Isradipine Capsules
Isradipine belongs to a group of drugs
known as calcium channel blockers.
Calcium is involved in blood vessel
contraction, and by blocking calcium,
isradipine relaxes and widens the blood
vessels, thereby lowering blood
pressure, preventing spasms of the
blood vessels of the heart and reducing
the oxygen needs of the heart muscle.
Isradipine is typically prescribed to
patients as a blood pressure lowering
medication, and is also used to treat
hypertension, ischemia and depression.
Generic isradipine was first introduced
in the United States in 2006. Sales in
that year totaled approximately
$3 million.
Actavis and Abrika are the only two
companies selling generic isradipine
capsules in the United States. The
number of generic suppliers has a direct
and substantial effect on generic pricing,
as each additional generic supplier can
have a competitive impact on the
market. Because there are multiple
generic equivalents for isradipine
capsules, the branded version no longer
significantly constrains the generic’s
pricing.
Entry into the market for the
manufacture and sale of generic
isradipine capsules would not be
timely, likely, or sufficient in its
magnitude, character, and scope to deter
or counteract the anticompetitive effects
of the acquisition. Entry would not take
place in a timely manner because the
combination of generic drug
development times and FDA drug
approval requirements takes at least two
years. Entry would not be likely because
the relevant market is relatively small
and in decline, limiting sales
opportunities for any new entrant.
The proposed acquisition would
cause significant anticompetitive harm
to consumers in the U.S. market for the
manufacture and sale of generic
isradipine capsules. The acquisition
would eliminate Abrika as a competitor
and create a monopoly in the market for
the manufacture and sale of generic
isradipine capsules. The evidence
indicates that the presence of more than
one competitor allows customers to
negotiate lower prices and that the
reduction in the number of competitors
in this market would allow the merged
entity to unilaterally exercise market
power with a resulting increase in
prices.
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The Consent Agreement
The proposed Consent Agreement
effectively remedies the proposed
acquisition’s anticompetitive effects in
the relevant product market. Pursuant to
the Consent Agreement, Actavis and
Abrika are required to divest certain
rights and assets related to the generic
isradipine capsules to a Commissionapproved acquirer no later than ten (10)
days after the acquisition. Specifically,
the proposed Consent Agreement
requires that Abrika divest its rights and
assets relating to generic isradipine
capsules to Cobalt.
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. A proposed
acquirer of divested assets must not
itself present competitive problems.
Cobalt, which specializes in the sale
and marketing of generic
pharmaceuticals, is the United States
arm of the Arrow Group, a private
multinational that employs over 700
individuals. The Arrow Group has
experience in the development,
manufacturing, and sale of
pharmaceuticals and has production
facilities in Canada, Malta, Australia
and Brazil. Cobalt is an acceptable
acquirer of generic isradipine because it
has experience in distributing and
marketing generic pharmaceutical
products in the United States. Currently,
the company has received FDA approval
for the sale of nine generic products.
The acquisition by Cobalt does not
present a competitive problem in the
generic isradipine market because
Cobalt currently does not participate in
the market and has no independent
plans to enter. With its resources, sales
and marketing capabilities, and
experience with generic products,
Cobalt should be successful in restoring
the competition that would be lost if the
proposed Actavis/Abrika transaction
were to proceed unremedied.
If the Commission determines that
Cobalt is not an acceptable acquirer of
the assets to be divested, or that the
manner of the divestitures to Cobalt is
not acceptable, the parties must unwind
the sale and divest the assets within six
(6) months of the date the Order
becomes final to another Commissionapproved acquirer. If the parties fail to
divest within six (6) months, the
Commission may appoint a trustee to
divest the generic isradipine capsule
assets.
The proposed remedy contains
provisions to ensure that the
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divestitures are successful. Abrika’s
isradipine product is manufactured for
Abrika by a third-party manufacturer.
As part of the divestiture, Abrika will
transfer its supply arrangement to
Cobalt. Actavis and Abrika will transfer
all confidential business information
related to Abrika’s isradipine product to
Cobalt. Finally, Actavis and Abrika will
provide technical assistance to Cobalt to
allow it to manufacture isradipine in
substantially the same manner and
quality employed or achieved by
Abrika.
The Commission has appointed
Denise F. Smart of Smart Consulting
Group, LLC as the Interim Monitor to
oversee the asset transfer and to ensure
Actavis and Abrika’s compliance with
all of the provisions of the proposed
Consent Agreement. Ms. Smart has over
twenty years of experience in the
pharmaceutical industry. Her
experience includes providing
consulting services in healthcare
business development and regulatory
compliance to major pharmaceutical
companies, biotechnology companies
and medical device companies. In order
to ensure that the Commission remains
informed about the status of the
proposed divestitures and the transfers
of assets, the proposed Consent
Agreement requires Actavis and Abrika
to file reports with the Commission
periodically until the divestitures and
transfers are accomplished.
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. E7–7478 Filed 4–19–07; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Health
Promotion and Disease Prevention
Research Centers, Special Interest
Project Competitive Supplements
(Panels 5–6), Request for Applications
(RFA) DP07–002
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Notices
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Date: 1 p.m.–4 p.m., June 11,
2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Health Promotion and Disease
Prevention Research Centers, Special Interest
Project Competitive Supplements (Panels 5–
6),’’ RFA DP07–002.
Contact Person for More Information:
Susan Goodman, D.D.S., Scientific Review
Administrator, Office of the Chief Science
Officer, CDC, 1600 Clifton Road NE.,
Mailstop D74, Atlanta, GA 30333, Telephone
404–639–4940.
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 CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 13, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–7500 Filed 4–19–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Health
Promotion and Disease Prevention
Research Centers: Special Interest
Project Competitive Supplements
(Panels 1–4), Request for Applications
(RFA) DP07–002
sroberts on PROD1PC70 with NOTICES
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting of the
aforementioned Special Emphasis
Panel.
Time and Date: 8:30 a.m.–5 p.m., June 19,
2007 (Closed).
Place: Doubletree Buckhead, 3342
Peachtree Road, NE., Atlanta, Georgia 30326.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
VerDate Aug<31>2005
18:52 Apr 19, 2007
Jkt 211001
evaluation of ‘‘Health Promotion and Disease
Prevention Research Centers, Special Interest
Project Competitive Supplements (Panels 1–
4),’’ RFA DP07–002.
Contact Person for More Information:
Juliana Cyril, M.P.H., PhD., Associate
Director for Policy and Peer Review, Office
of the Chief Science Officer, CDC, 1600
Clifton Road NE., Mailstop D74, Atlanta, GA
30333, Telephone 404–639–4939.
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 CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 13, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–7502 Filed 4–19–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): The Sexual
Networks of African American STI
Repeaters, an Elaboration of Risk,
Potential Extramural Project (PEP)
2007–R–01 and Dynamic Mathematical
Modeling of Sexual Transmission of C.
Trachomatis Transmission in the
United States, Evaluating Impact on
Prevention Strategies on Chlamydial
Incidence, Prevalence and Sequelae,
PEP 2007–R–02
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Date: 12 p.m.–2 p.m., May 15,
2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘The Sexual Networks of
African American STI Repeaters, an
Elaboration of Risk,’’ PEP 2007–R–01, and
‘‘Dynamic Mathematical Modeling of Sexual
Transmission of C. Trachomatis
Transmission in the United States,
Evaluating Impact on Prevention Strategies
on Chlamydial Incidence, Prevalence and
Sequelae,’’ PEP 2007–R–02.
Contact Person for More Information:
Susan Goodman, D.D.S., Scientific Review
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19933
Administrator, Office of the Chief Science
Officer, CDC, 1600 Clifton Road NE.,
Mailstop D74, Atlanta, GA 30333, Telephone
404–639–4940.
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 CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: April 13, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–7503 Filed 4–19–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Health
Promotion and Disease Prevention
Research Centers, Special Interest
Project Competitive Supplements
(Panels 9–11), Request for
Applications (RFA) DP07–002
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Date: 8:30 a.m.–5 p.m., June 18,
2007 (Closed).
Place: Doubletree Buckhead, 3342
Peachtree Road NE, Atlanta, GA 30326,
telephone 404–321–1234.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Pub. L. 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Health Promotion and Disease
Prevention Research Centers, Special Interest
Project Competitive Supplements (Panels 9–
11),’’ RFA DP07–002.
Contact Person for More Information:
Juliana Cyril, M.P.H., PhD, Scientific Review
Administrator, Office of the Chief Science
Officer, CDC, 1600 Clifton Road NE.,
Mailstop D74, Atlanta, GA 30333, Telephone
404–639–4639.
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
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Notices]
[Pages 19932-19933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Health Promotion and Disease Prevention Research
Centers, Special Interest Project Competitive Supplements (Panels 5-6),
Request for Applications (RFA) DP07-002
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease
[[Page 19933]]
Control and Prevention (CDC) announces the aforementioned meeting.
Time and Date: 1 p.m.-4 p.m., June 11, 2007 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the public in accordance
with provisions set forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director, Management Analysis
and Services Office, CDC, pursuant to Public Law 92-463.
Matters to be Discussed: The meeting will include the review,
discussion, and evaluation of ``Health Promotion and Disease
Prevention Research Centers, Special Interest Project Competitive
Supplements (Panels 5-6),'' RFA DP07-002.
Contact Person for More Information: Susan Goodman, D.D.S.,
Scientific Review Administrator, Office of the Chief Science
Officer, CDC, 1600 Clifton Road NE., Mailstop D74, Atlanta, GA
30333, Telephone 404-639-4940.
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 CDC and the Agency for Toxic Substances and
Disease Registry.
Dated: April 13, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. E7-7500 Filed 4-19-07; 8:45 am]
BILLING CODE 4163-18-P
