Agency Information Collection Activities; Proposals Submissions, and Approvals, 42550-42551 [05-14564]
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42550
Federal Register / Vol. 70, No. 141 / Monday, July 25, 2005 / Notices
The acquisition of Eon by Novartis
would increase the concentration in the
market significantly.
Entry into manufacture and sale of: (1)
Generic desipramine hydrochloride
tablets, (2) generic orphenadrine citrate
ER tablets, and (3) generic rifampin oral
capsules would not be timely, likely, or
sufficient in its magnitude, character,
and scope to deter or counteract the
anticompetitive effects of the
acquisition. Developing and obtaining
FDA approval for the manufacture and
sale of generic desipramine
hydrochloride tablets, generic
orphenadrine citrate ER tablets, and
generic rifampin oral capsules takes at
least two years due to substantial
regulatory, technological, and
intellectual property barriers.
The proposed acquisition would
cause significant anticompetitive harm
to consumers in the U.S. markets for
generic desipramine hydrochloride
tablets, generic orphenadrine citrate ER
tablets, and generic rifampin oral
capsules by eliminating actual, direct,
and substantial competition between
Novartis and Eon; by increasing the
likelihood that Novartis will be able to
unilaterally exercise market power; by
increasing the likelihood and degree of
coordinated interaction between the few
remaining competitors; and by
increasing the likelihood that
consumers will pay higher prices.
The proposed Consent Agreement
preserves competition in the generic
desipramine hydrochloride tablets,
generic orphenadrine citrate ER tablets,
and generic rifampin oral capsules
markets by requiring that Novartis
divest all of the Sandoz orphenadrine
citrate ER and rifampin assets and all of
Eon’s desipramine hydrochloride assets
to Amide no later than ten days after the
acquisition. Amide, a reputable generic
manufacturer, is particularly wellpositioned to manufacture and market
generic rifampin, because Amide
already currently contract manufactures
generic rifampin capsules for Novartis.
Amide is also well-positioned to obtain
FDA approval to manufacture and
market generic desipramine
hydrochloride and orphenadrine citrate
ER in the near future. If the Commission
determines that Amide is not an
acceptable purchaser, or that the
manner of the divestiture is not
acceptable, Novartis must rescind the
transaction with Amide and divest the
assets to a Commission-approved buyer
not later than six months from the date
the Order becomes final. If Novartis fails
to divest within the six months, the
Commission may appoint a trustee to
divest the desipramine hydrochloride,
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rifampin, and orphenadrine citrate ER
assets.
The proposed remedy contains
several provisions designed to ensure
the successful divestiture of the
desipramine hydrochloride, rifampin,
and orphenadrine citrate ER assets to
Amide. Novartis must provide various
transitional services to enable Amide to
compete against Novartis immediately
following the divestiture. Novartis is
obligated to provide Amide with all
inventory of the three divested products
and to supply Amide the two products
that Amide does not currently
manufacture—desipramine
hydrochloride and orphenadrine citrate
ER—while Amide attempts to obtain
FDA approval to manufacture the
products for itself in its own facility.
Novartis will supply Amide with
desipramine hydrochloride for two
years, and Amide will have options to
extend that supply for two additional
one-year periods if Amide is making
progress toward approval and needs the
additional time to obtain FDA approval.
Novartis will supply Amide with
orphenadrine citrate ER for four years,
and Amide will again have options to
extend the supply up to two additional
one-year periods as it seeks FDA
approval to manufacture orphenadrine
citrate for itself. Novartis is also
required to provide technology transfer
assistance to enable Amide to obtain all
necessary FDA approvals to
manufacture and sell desipramine
hydrochloride, rifampin, and
orphenadrine citrate for itself.
The proposed remedy does not
provide for a technology transfer or
supply obligation for rifampin because
Amide is already in possession of the
manufacturing technology, having
contract manufactured generic rifampin
for Novartis for several years.
The proposed remedy also
incorporates the use of an Interim
Trustee, experienced in obtaining
regulatory approval and the
manufacture of pharmaceuticals, to
oversee the technology transfer and to
assist Amide and the Commission in the
event of difficulties with supply or
delays in obtaining approval. As part of
the proposed remedy, Novartis is
required to execute an agreement
conferring all rights and powers
necessary for the Interim Trustee to
satisfy his responsibilities under the
Order to assure successful divestitures
of the desipramine hydrochloride,
rifampin, and orphenadrine citrate
assets. Novartis has selected Francis J.
Civille to be the Interim Monitor and
Amide has consented to his selection.
The monitor will ensure that the
Commission remains informed about
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the status of the proposed divestitures
and asset transfers.
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 Consent
Agreement or to modify its terms in any
way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–14548 Filed 7–22–05; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–New]
Agency Information Collection
Activities; Proposals Submissions,
and Approvals
Office of the Secretary, Office
of Assistant Secretary for Planning &
Evaluation
Agency Information Collection
Activities: Proposed Collection;
Comment Request.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Type of Information Collection
Request: Regular Clearance;
Title of Information Collection:
Survey of Frontline Supervisors of
Direct Service Workers Participating in
the Better Jobs Better Care
Demonstration;
Form/OMB No.: OS–0990-New;
Use: The President’s New Freedom
Initiative specifies goals for enhancing
the direct service workforce availability
and capability. There is currently a
major shortage of direct care workers—
AGENCY:
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Federal Register / Vol. 70, No. 141 / Monday, July 25, 2005 / Notices
nursing assistants, home health aides,
and personal care attendants—who
provide care and support to elderly
people with chronic diseases and
disabilities. Worker shortages are certain
to grow as the demand for long-term
care increases with the aging
population. Thus, recruitment and
retention of direct care workers has
recently become an issue of interest to
policymakers and providers alike. The
proposed survey will ensure that HHS
and other Federal, state, and local
agencies have timely data available on
the central role of frontline supervisors
in direct care workers job quality and
turnover.
Frequency: Reporting, on occasion;
Affected Public: Individuals or
households, business or other for profit,
not for profit institutions;
Annual Number of Respondents: 906.
Total Annual Responses: 906;
Average Burden Per Response: 30
minutes;
Total Annual Hours: 1,005;
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access the HHS Web
site address at https://www.hhs.gov/
oirm/infocollect/pending/ or e-mail your
request, including your address, phone
number, OMB number, and OS
document identifier, to
naomi.cook@hhs.gov, or call the Reports
Clearance Office on (202) 690–6162.
Written comments and
recommendations for the proposed
information collections must be
received within 60-days, and directed to
the OS Paperwork Clearance Officer at
the following address: Department of
Health and Human Services, Office of
the Secretary, Assistant Secretary for
Budget, Technology, and Finance,
Office of Information and Resource
Management, Attention: Naomi Cook
(0990–New), Room 531–H, 200
Independence Avenue, SW.,
Washington DC 20201.
Dated: July 15, 2005.
Robert E. Polson,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 05–14564 Filed 7–22–05; 8:45 am]
BILLING CODE 4151–05–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Request for Application (RFA) AA068]
Diffusion of Partnership for Health to
Health Care and Medical Agencies
Serving Persons Living With HIV/AIDS;
Notice of Availability of Funds—
Amendment
A notice announcing the availability
of Fiscal Year (FY) 2005 funds to award
a Cooperative Agreement for Diffusion
of Partnership for Health to Health Care
and Medical Agencies Serving Persons
Living with HIV/AIDS was published in
the Federal Register, on July 14, 2005,
Volume 70, Number 134, pages 40704–
40708.
The notice is amended as follows:
On page 40704, First column, please
change the LOI deadline date to: July 27,
2005. Please change the application
deadline date to: August 11, 2005.
On page 40706, Third column, please
change the LOI deadline date to: July 27,
2005. Please change the application
deadline date to: August 11, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–14572 Filed 7–22–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Rapid Expansion of Access to HIV/
AIDS Prevention, Care and Treatment
Interventions Among Rural and Other
Underserved Populations in the
ˆ
Republic of Cote d’Ivoire
Announcement Type: New.
Funding Opportunity Number: CDC–
RFA–AA057.
Catalog of Federal Domestic
Assistance Number: 93.067.
Key Dates:
Application Deadline: August 18,
2005.
I. Funding Opportunity Description
Authority: This program is authorized
under Sections 301(a) and 307 of the
Public Health Service Act [42 U.S.C.
Sections 241 and 242l], as amended,
and under Public Law 108–25 (United
States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003)
[U.S.C. 7601].
Background: President Bush’s
Emergency Plan for AIDS Relief has
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42551
called for immediate, comprehensive
and evidence-based action to turn the
tide of global HIV/AIDS. The initiative
aims to treat more than two million
HIV-infected people with effective
combination anti-retroviral therapy by
2008; care for ten million HIV-infected
and affected persons, including those
orphaned by HIV/AIDS, by 2008; and
prevent seven million infections by
2010, with a focus on 15 priority
countries, including 12 in sub-Saharan
Africa. The five-year strategy for the
Emergency Plan is available at the
following Internet address: https://
www.state.gov/s/gac/rl/or/c11652.htm.
Over the same time period, as part of
a collective national response, the
ˆ
Emergency Plan goals specific to Cote
d’Ivoire are to treat at least 77,000 HIVinfected individuals; care for 385,000
HIV-affected individuals, including
orphans; and prevent 265,000 new HIV
infections.
Purpose: The purpose of this funding
announcement is to progressively build
an indigenous, sustainable response to
the national HIV epidemic through the
rapid expansion of innovative,
culturally appropriate, high-quality
HIV/AIDS prevention and care
interventions, and improved linkages to
HIV counseling and testing and HIV
treatment services targeting rural and
ˆ
other underserved populations in Cote
d’Ivoire.
Under the leadership of the U.S.
Global AIDS Coordinator, as part of the
President’s Emergency Plan, the U.S.
Department of Health and Human
Services (HHS) works with host
countries and other key partners to
assess the needs of each country and
design a customized program of
assistance that fits within the host
nation s strategic plan.
HHS focuses on two or three major
program areas in each country. Goals
and priorities include the following:
• Achieving primary prevention of
HIV infection through activities such as
expanding confidential counseling and
testing programs, building programs to
reduce mother-to-child transmission,
and strengthening programs to reduce
transmission via blood transfusion and
medical injections.
• Improving the care and treatment
of HIV/AIDS, sexually transmitted
diseases (STDs) and related
opportunistic infections by improving
STD management; enhancing care and
treatment of opportunistic infections,
including tuberculosis (TB); and
initiating programs to provide antiretroviral therapy (ART).
• Strengthening the capacity of
countries to collect and use surveillance
data and manage national HIV/AIDS
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]]>Agencies
[Federal Register Volume 70, Number 141 (Monday, July 25, 2005)]
[Notices]
[Pages 42550-42551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14564]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS-0990-New]
Agency Information Collection Activities; Proposals Submissions,
and Approvals
AGENCY: Office of the Secretary, Office of Assistant Secretary for
Planning & Evaluation
Agency Information Collection Activities: Proposed Collection;
Comment Request.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed collection for public comment. Interested persons
are invited to send comments regarding this burden estimate or any
other aspect of this collection of information, including any of the
following subjects: (1) The necessity and utility of the proposed
information collection for the proper performance of the agency's
functions; (2) the accuracy of the estimated burden; (3) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (4) the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
Type of Information Collection Request: Regular Clearance;
Title of Information Collection: Survey of Frontline Supervisors of
Direct Service Workers Participating in the Better Jobs Better Care
Demonstration;
Form/OMB No.: OS-0990-New;
Use: The President's New Freedom Initiative specifies goals for
enhancing the direct service workforce availability and capability.
There is currently a major shortage of direct care workers--
[[Page 42551]]
nursing assistants, home health aides, and personal care attendants--
who provide care and support to elderly people with chronic diseases
and disabilities. Worker shortages are certain to grow as the demand
for long-term care increases with the aging population. Thus,
recruitment and retention of direct care workers has recently become an
issue of interest to policymakers and providers alike. The proposed
survey will ensure that HHS and other Federal, state, and local
agencies have timely data available on the central role of frontline
supervisors in direct care workers job quality and turnover.
Frequency: Reporting, on occasion;
Affected Public: Individuals or households, business or other for
profit, not for profit institutions;
Annual Number of Respondents: 906.
Total Annual Responses: 906;
Average Burden Per Response: 30 minutes;
Total Annual Hours: 1,005;
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access the HHS
Web site address at https://www.hhs.gov/oirm/infocollect/pending/ or e-
mail your request, including your address, phone number, OMB number,
and OS document identifier, to naomi.cook@hhs.gov, or call the Reports
Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
received within 60-days, and directed to the OS Paperwork Clearance
Officer at the following address: Department of Health and Human
Services, Office of the Secretary, Assistant Secretary for Budget,
Technology, and Finance, Office of Information and Resource Management,
Attention: Naomi Cook (0990-New), Room 531-H, 200 Independence Avenue,
SW., Washington DC 20201.
Dated: July 15, 2005.
Robert E. Polson,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 05-14564 Filed 7-22-05; 8:45 am]
BILLING CODE 4151-05-P
