Proposed Data Collections Submitted for Public Comment and Recommendations, 78261-78262 [2011-32202]
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Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices
products are used to treat actinic
keratosis (‘‘AK’’), which is a precancerous lesion that can result from
years of repeated sun exposure. Three
branded topical 5FUs are currently on
the market, including Valeant’s Efudex
and Dermik’s Carac. There are also two
generic versions of Efudex, as well as an
‘‘authorized’’ generic, also sold by
Valeant. The price of the generic drugs
in this market determines the pricing of
branded Carac. Post-acquisition,
Valeant’s market share in the topical
5FU market would be over 50 per cent.
Other treatments for AKs are not viable
substitutes for topical 5FUs because
they are more costly, less efficacious or
impracticable.
III. Entry
Entry into the manufacture and sale of
both BenzaClin and topical 5FU
products is difficult, expensive and time
consuming. Developing and obtaining
U.S. Food and Drug Administration
approval for the manufacture and sale of
topical pharmaceuticals takes over two
years due to substantial regulatory,
technological and intellectual property
barriers. Furthermore, entry would not
be likely because the markets are
relatively small, so the limited sales
opportunities available to a new entrant
would likely be insufficient to justify
the time and investment necessary to
enter.
jlentini on DSK4TPTVN1PROD with NOTICES
IV. Effects of the Acquisition
The proposed acquisition would
cause significant anticompetitive harm
to consumers in the U.S. markets for the
manufacture and sale of both BenzaClin
and topical 5FU products by eliminating
actual, direct and substantial
competition between Valeant and Sanofi
in those markets. With respect to the
BenzaClin market, the transaction
would combine BenzaClin and its only
generic equivalent, eliminating
BenzaClin’s closest competitor and
creating a monopoly. The impact of
eliminating the competition between
BenzaClin and its only currentlymarketed generic equivalent, is highly
likely to result in consumers paying
higher prices.
In the topical 5FU market, the
transaction would give Valeant control
over three linked treatments for AK—
Dermik’s branded Carac and Valeant’s
branded and AG Efudex products. The
combination of these products at
Valeant would eliminate head to head
competition between Carac and the
Efudex AG and is thus likely to result
in higher prices for topical 5FUs.
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V. The Consent Agreement
The proposed Consent Agreement
effectively remedies the acquisition’s
anticompetitive effects in the relevant
markets by requiring Valeant to (1)
divest its ANDA for generic BenzaClin
to Mylan, and (2) supply an authorized
generic of Efudex, pursuant to a license
to Mylan. If approved, Mylan will
acquire all rights and assets currently
held by Valeant, including any existing
inventory. The assets to be transferred
include all manufacturing and research
and development rights in the divested
products.
Mylan is a particularly well-suited
acquirer of generic BenzaClin because it
has been manufacturing and marketing
the product, pursuant to an agreement
with Valeant, since it was introduced in
August 2009. Mylan is the secondlargest generic pharmaceutical
manufacturer in the United States, and
is well-positioned to replicate the
competition that would be lost with the
proposed Valeant/Dermik acquisition.
Headquartered in Pittsburgh,
Pennsylvania, Mylan employs more
than 18,000 employees and generated
approximately $5.45 billion in revenue
in 2010. Mylan sells approximately 270
products and has a manufacturing
facility where BenzaClin is
manufactured. It is in the process of
upgrading that facility to handle
compounds such as 5FU.
Mylan expects to begin manufacturing
generic Efudex at that facility in 2013.
Until that time, the proposed Consent
Agreement contemplates Mylan’s
purchase of topical 5FU from Valeant
pursuant to a supply agreement. In
order to ensure that there is no supply
interruption, the proposed Consent
Agreement would require that Valeant
build up a two-year inventory and
establish its own manufacturing as a
back-up supply until Mylan is able to
manufacture Efudex commercially.
Valeant would also be required to assist
Mylan with developing its
manufacturing capabilities and securing
the necessary FDA approvals. With
these provisions, Mylan will be able to
compete in the 5FU market immediately
following the divestiture and establish
independent manufacturing as soon as
practicable.
The Commission has appointed
Francis J. Civille as the Interim Monitor
to oversee the asset transfer and to
ensure Valeant’s compliance with the
provisions of the proposed Consent
Agreement. Mr. Civille has over 27 years
of experience in the pharmaceutical
industry. He has extensive experience in
areas such as pharmaceutical research
and development, regulatory approval,
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78261
manufacturing and supply, and
marketing. Mr. Civille will oversee the
transfer of Efudex manufacturing
technology to the acquirer and ensure
that Valeant is diligent in building up
the required inventory of the product
and establishing its own back-up supply
capabilities. 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 the parties
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. 2011–32218 Filed 12–15–11; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day 12–12BZ]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call (404) 639–5960 and
send written comments to Daniel
Holcomb, CDC Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an email to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
E:\FR\FM\16DEN1.SGM
16DEN1
78262
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Residential Care Facility and Adult
Day Service Center Components of the
National Study of Long-Term Care
Providers—NEW—National Center for
Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, ‘‘shall collect
statistics on health resources * * *
[and] utilization of health care,
including extended care facilities, and
other institutions.’’
NCHS seeks approval to collect data
for the residential care facility (RCF)
and adult day services center (ADSC)
practices of RCFs and ADSCs, and
aggregate-level distributions of the
demographics, physical functioning,
and cognitive functioning of RCF and
ADSC care recipients.
Expected users of data from this
collection effort include, but are not
limited to CDC; other Department of
Health and Human Services (DHHS)
agencies, such as the Office of the
Assistant Secretary for Planning and
Evaluation and the Agency for
Healthcare Research and Quality;
associations, such as LeadingAge
(formerly the American Association of
Homes and Services for the Aging),
National Center for Assisted Living,
American Seniors Housing Association,
Assisted Living Federation of America,
and National Adult Day Services
Association; universities; foundations;
and other private sector organizations.
Expected burden from data collection
is 45 minutes per respondent for a total
of 5,270 hours. There is no cost to
respondents other than their time to
participate.
components of a planned new survey,
the National Study of Long-Term Care
Providers (NSLTCP). A two year
clearance is requested.
As background here are some details
on the plans for the whole study, of
which this data collection is two
components. The entire NSLTCP is
being designed to: (1) Broaden NCHS’
ongoing coverage of paid, regulated
long-term care (LTC) providers; (2)
merge with existing administrative data
on LTC providers (i.e. Centers for
Medicare and Medicaid Services (CMS)
data on nursing home, home health, and
hospice care); (3) update data more
frequently on LTC providers for which
nationally representative administrative
data do not exist; and (4) enable
comparisons across LTC provider types
and monitor the supply and use of these
providers.
The data will be collected in the 50
states and the District of Columbia from
two types of LTC facilities: 9,450 RCFs
and 4,601 ADSCs. The data to be
collected include the basic
characteristics, services, staffing, and
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Average
burden/
response
(in minutes)
Number of
responses
Response
burden
(in hours)
Type of respondent
Form name
RCF Director ...........................................
ADSC Director .........................................
RCF Questionnaire ....................
ADSC Questionnaire ..................
4,725
2,301
1
1
45/60
45/60
3,544
1,726
Total .................................................
....................................................
........................
........................
........................
5,270
Dated: December 9, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–32202 Filed 12–15–11; 8:45 am]
BILLING CODE 4163–18–P
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Centers for Disease Control and
Prevention
Web-Based HIV Behavioral Survey
among Men who have Sex with Men—
New—National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
[30 Day–12–11HU]
Background and Brief Description
Agency Forms Undergoing Paperwork
Reduction Act Review
The purpose of the proposed
information collection is to monitor
behaviors related to Human
Immunodeficiency Virus (HIV) infection
among men who have sex with men
(MSM), one of the groups at highest risk
for acquiring HIV infection in the
United States. Objectives of the
proposed web-based behavioral survey
of internet-using MSM are to (a)
describe the prevalence of and trends in
risk behaviors; (b) describe the
prevalence of and trends in HIV testing;
jlentini on DSK4TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
email to omb@cdc.gov. Send written
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16:42 Dec 15, 2011
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(c) describe the prevalence of and trends
in use of HIV prevention services; and
(d) identify met and unmet needs for
HIV prevention services. This
information will be used to monitor
progress toward the National HIV/AIDS
Strategy objectives, and will be shared
with health departments, community
based organizations, community
planning groups and other stakeholders
to improve prevention services.
This project also addresses the goals
of CDC’s HIV prevention strategic plan,
specifically the goal of strengthening the
national capacity to monitor the HIV
epidemic to better direct and evaluate
prevention efforts.
The Centers for Disease Control and
Prevention request approval for data
collection for a period of 3 years. Data
will be collected through anonymous
online surveys completed by MSM in 56
U.S. jurisdictions (all 50 U.S. states, the
District of Columbia, Puerto Rico,
American Samoa, Guam, the Northern
Mariana Islands, and the U.S. Virgin
Islands), with oversampling in 21
E:\FR\FM\16DEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Notices]
[Pages 78261-78262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32202]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day 12-12BZ]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call (404) 639-5960
and send written comments to Daniel Holcomb, CDC Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information
[[Page 78262]]
on respondents, including through the use of automated collection
techniques or other forms of information technology. Written comments
should be received within 60 days of this notice.
Proposed Project
Residential Care Facility and Adult Day Service Center Components
of the National Study of Long-Term Care Providers--NEW--National Center
for Health Statistics (NCHS), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, ``shall collect statistics on
health resources * * * [and] utilization of health care, including
extended care facilities, and other institutions.''
NCHS seeks approval to collect data for the residential care
facility (RCF) and adult day services center (ADSC) components of a
planned new survey, the National Study of Long-Term Care Providers
(NSLTCP). A two year clearance is requested.
As background here are some details on the plans for the whole
study, of which this data collection is two components. The entire
NSLTCP is being designed to: (1) Broaden NCHS' ongoing coverage of
paid, regulated long-term care (LTC) providers; (2) merge with existing
administrative data on LTC providers (i.e. Centers for Medicare and
Medicaid Services (CMS) data on nursing home, home health, and hospice
care); (3) update data more frequently on LTC providers for which
nationally representative administrative data do not exist; and (4)
enable comparisons across LTC provider types and monitor the supply and
use of these providers.
The data will be collected in the 50 states and the District of
Columbia from two types of LTC facilities: 9,450 RCFs and 4,601 ADSCs.
The data to be collected include the basic characteristics, services,
staffing, and practices of RCFs and ADSCs, and aggregate-level
distributions of the demographics, physical functioning, and cognitive
functioning of RCF and ADSC care recipients.
Expected users of data from this collection effort include, but are
not limited to CDC; other Department of Health and Human Services
(DHHS) agencies, such as the Office of the Assistant Secretary for
Planning and Evaluation and the Agency for Healthcare Research and
Quality; associations, such as LeadingAge (formerly the American
Association of Homes and Services for the Aging), National Center for
Assisted Living, American Seniors Housing Association, Assisted Living
Federation of America, and National Adult Day Services Association;
universities; foundations; and other private sector organizations.
Expected burden from data collection is 45 minutes per respondent
for a total of 5,270 hours. There is no cost to respondents other than
their time to participate.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average burden/ Response
Type of respondent Form name Number of Number of response (in burden (in
respondents responses minutes) hours)
----------------------------------------------------------------------------------------------------------------
RCF Director.................. RCF 4,725 1 45/60 3,544
Questionnaire.
ADSC Director................. ADSC 2,301 1 45/60 1,726
Questionnaire.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 5,270
----------------------------------------------------------------------------------------------------------------
Dated: December 9, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-32202 Filed 12-15-11; 8:45 am]
BILLING CODE 4163-18-P
