Agency Forms Undergoing Paperwork Reduction Act Review, 57581-57582 [E7-19878]
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Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Notices
rwilkins on PROD1PC63 with NOTICES
number of firms would have on pricing
can also be explained in terms of
unilateral effects, as the likelihood that
the merging parties would be the first
and second choices in a significant
number of bidding situations is
enhanced where the number of firms
participating in the market decreases
substantially.
The Consent Agreement
The proposed Consent Agreement
effectively remedies the proposed
acquisition’s anticompetitive effects in
the relevant product markets. Pursuant
to the Consent Agreement, Mylan and
Merck are required to divest certain
rights and assets related to the Products
to a Commission-approved acquirer no
later than ten (10) days after the
acquisition. Specifically, the proposed
Consent Agreement requires that Merck
divest its assets in the Products to
Amneal.
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.
Amneal, a small but growing generic
manufacturer, is particularly wellpositioned to manufacture and market
its acquired products and compete
effectively in those markets. Amneal
develops, manufacturers, sells, and
distributes generic pharmaceuticals
within the United States. Moreover,
Amneal will not present competitive
problems in any of the markets in which
it will acquire a divested asset because
it currently does not compete in those
markets. With its resources, capabilities,
good reputation, and experience
marketing generic products, Amneal is
well-positioned to replicate the
competition that would be lost with the
proposed acquisition.
If the Commission determines that
Amneal is not an acceptable acquirer of
the assets to be divested, or that the
manner of the divestitures to Amneal 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 Products.
The proposed remedy contains
several provisions to ensure that the
divestitures are successful. The Order
requires Mylan and Merck to provide
transitional services to enable the
Commission-approved acquirer to
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19:46 Oct 09, 2007
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obtain all of the necessary approvals
from the FDA. These transitional
services include technology transfer
assistance to manufacture the Products
in substantially the same manner and
quality employed or achieved by Merck.
The Commission has appointed R.
Owen Richards of Quantic Regulatory
Services, LLC (‘‘Quantic’’) to oversee the
asset transfer and to ensure Mylan and
Merck’s compliance with all of the
provisions of the proposed Consent
Agreement. Mr. Richards is President of
Quantic and has several years of
experience in the pharmaceutical
industry. He is a highly-qualified expert
on FDA regulatory matters and currently
advises Quantic clients on achieving
satisfactory regulatory compliance and
interfacing with the FDA. 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 Mylan and Merck 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. E7–19892 Filed 10–9–07: 8:45 am]
[BILLING CODE 6750–01–S]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30–Day–08–07AY]
Agency Forms Undergoing Paperwork
Reduction Act Review
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
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
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57581
Proposed Project
Long-Term Efficacy of a Program to
Prevent Beryllium Disease—New—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Beryllium is a lightweight metal with
many applications. Exposed workers
may be found in the primary
production, nuclear power and
weapons, aerospace, scrap metal
reclamation, specialty ceramics, and
electronics industries, among others.
The size of the USA workforce at risk
of chronic beryllium disease (CBD),
from either current or past work-related
exposure to the metal, may be as high
as one million. Demand for beryllium is
growing worldwide, which means that
increasing numbers of workers are likely
to be exposed.
Exposure to beryllium can lead to
sensitization and cause an immunologic
granulomatous lung disease.
Sensitization is a cell-mediated allergictype response that may be detected in
the peripheral blood with the beryllium
lymphocyte proliferation test (BeLPT),
which is used by the industry as a
surveillance tool. Workers found to be
sensitized may be clinically evaluated
for CBD with tests including
bronchoalveolar lavage and
transbronchial biopsy. Cross-sectional
studies in various beryllium workplace
populations have identified
sensitization in the range of less than
1% to 14% of workers. The proportion
of sensitized workers who have
beryllium disease at initial clinical
evaluation has varied from 10 to 100%
in different workplaces. Sensitized
workers not initially diagnosed with
CBD are often diagnosed with the
disease upon follow-up, but whether all
sensitized workers will eventually
develop beryllium disease is unknown.
Industry screening programs have
enabled the identification of CBD in
persons without apparent symptoms,
often early in disease progression (often
referred to as ‘‘subclinical disease’’).
Progression from sensitization to
subclinical disease to clinical
impairment, while difficult to predict
for any one individual, is not
uncommon.
Currently, there are no preventive
programs that have been demonstrated
to have long-term effectiveness in
preventing beryllium sensitization and
CBD among beryllium-exposed workers.
In the United States, recent short-term
evidence (i.e., average work tenure 16
months, maximum four years) at one
facility suggests that the comprehensive
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10OCN1
57582
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Notices
preventive program that was
implemented by company management
beginning in 2000 has successfully
reduced the incidence of beryllium
sensitization, as defined by the
occurrence of confirmed abnormal
BeLPTs. However, the follow-up has
thus far been limited to current workers,
the duration has been too short to
document a reduced incidence of CBD,
and it is possible that sensitization has
been delayed, rather than prevented.
Evaluation of this program’s
effectiveness would therefore be more
complete by including individuals who
have left employment and documenting
whether: (1) The program was effective
at two other facilities at which it was
implemented, (2) the program prevented
beryllium sensitization over a longer
period of time (i.e., up to eight years);
and (3) the program prevented CBD,
which generally takes longer to develop.
Study Design
This proposed study is designed to
evaluate the effectiveness of a
comprehensive preventive program at
three beryllium plants. Approximately
579 eligible workers for this survey
include those hired between
implementation of a comprehensive
program (2000) and December 31, 2008,
including any already known to be
sensitized. NIOSH will offer all eligible
current and former workers the BeLPT
to identify sensitization and administer
a work and medical history
questionnaire.
There are no costs to former worker
respondents except their time to
participate in the interview; current
workers will participate during work
hours and thus compensated by their
employer, and former workers will
participate during their own time. The
total estimated annualized burden hours
are 193.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Former workers ............................................................................................................................
Current workers ...........................................................................................................................
Participant Consent and Authorization for Release of Information .............................................
Dated: October 2, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–19878 Filed 10–9–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
evaluation of ‘‘CDC Grants for Public Health
Research Dissertation,’’ PAR07–231, Panel A.
Contact Person for More Information:
Juliana Cyril, PhD, M.P.H., Scientific Review
Administrator, Office of the Chief Science
Officer, CDC, 1600 Clifton Road NE.,
Mailstop D 72, Atlanta, GA 30333. Telephone
(404) 639–4896. 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: October 2, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–19880 Filed 10–9–07; 8:45 am]
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.
rwilkins on PROD1PC63 with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Centers for
Disease Control and Prevention (CDC)
Grants for Public Health Research
Dissertation, Program Announcement
(PA) PAR07–231, Panel A
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Time and Date:
7 a.m.–9 p.m., November 14, 2007 (Closed).
8:30 a.m.–5 p.m., November 15, 2007
(Closed).
Place: Crowne Plaza Buckhead, 3377
Peachtree Road NE., Atlanta, GA 30326.
Telephone (404) 264–1111.
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
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BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Advisory Council for the Elimination of
Tuberculosis (ACET)
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 following meeting of the
aforementioned committee:
Times and Dates:
8:30 a.m.–5 p.m., November 27, 2007.
8:30 a.m.–12:30 p.m., November 28, 2007.
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Number
responses per
respondent
113
80
193
1
1
1
Average
burden/
response
(in hours)
45/60
45/60
15/60
Place: Corporate Square, Building 8, 1st
Floor Conference Room, Atlanta, Georgia
30333. Telephone (404) 639–8317.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 100 people.
Purpose: This council advises and makes
recommendations to the Secretary of Health
and Human Services, the Assistant Secretary
for Health, and the Director, CDC, regarding
the elimination of tuberculosis. Specifically,
the Council makes recommendations
regarding policies, strategies, objectives, and
priorities; addresses the development and
application of new technologies; and reviews
the extent to which progress has been made
toward eliminating tuberculosis.
Matters to be Discussed: Agenda items
include issues pertaining to Foreign-Born
and Immigration Issues; Legal Border Issues;
and National Tuberculosis Training and
Education Centers, and other related
tuberculosis issues.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Margie Scott-Cseh, Coordinating Center for
Infectious Diseases, Small Business Unit,
1600 Clifton Road, NE., M/S E–07, Atlanta,
Georgia 30333. Telephone (404) 639–8317.
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: October 2, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. E7–19885 Filed 10–9–07; 8:45 am]
BILLING CODE 4163–18–P
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]]>Agencies
[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Notices]
[Pages 57581-57582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19878]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-08-07AY]
Agency Forms Undergoing Paperwork Reduction Act Review
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 e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Long-Term Efficacy of a Program to Prevent Beryllium Disease--New--
National Institute for Occupational Safety and Health (NIOSH), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Beryllium is a lightweight metal with many applications. Exposed
workers may be found in the primary production, nuclear power and
weapons, aerospace, scrap metal reclamation, specialty ceramics, and
electronics industries, among others. The size of the USA workforce at
risk of chronic beryllium disease (CBD), from either current or past
work-related exposure to the metal, may be as high as one million.
Demand for beryllium is growing worldwide, which means that increasing
numbers of workers are likely to be exposed.
Exposure to beryllium can lead to sensitization and cause an
immunologic granulomatous lung disease. Sensitization is a cell-
mediated allergic-type response that may be detected in the peripheral
blood with the beryllium lymphocyte proliferation test (BeLPT), which
is used by the industry as a surveillance tool. Workers found to be
sensitized may be clinically evaluated for CBD with tests including
bronchoalveolar lavage and transbronchial biopsy. Cross-sectional
studies in various beryllium workplace populations have identified
sensitization in the range of less than 1% to 14% of workers. The
proportion of sensitized workers who have beryllium disease at initial
clinical evaluation has varied from 10 to 100% in different workplaces.
Sensitized workers not initially diagnosed with CBD are often diagnosed
with the disease upon follow-up, but whether all sensitized workers
will eventually develop beryllium disease is unknown. Industry
screening programs have enabled the identification of CBD in persons
without apparent symptoms, often early in disease progression (often
referred to as ``subclinical disease''). Progression from sensitization
to subclinical disease to clinical impairment, while difficult to
predict for any one individual, is not uncommon.
Currently, there are no preventive programs that have been
demonstrated to have long-term effectiveness in preventing beryllium
sensitization and CBD among beryllium-exposed workers. In the United
States, recent short-term evidence (i.e., average work tenure 16
months, maximum four years) at one facility suggests that the
comprehensive
[[Page 57582]]
preventive program that was implemented by company management beginning
in 2000 has successfully reduced the incidence of beryllium
sensitization, as defined by the occurrence of confirmed abnormal
BeLPTs. However, the follow-up has thus far been limited to current
workers, the duration has been too short to document a reduced
incidence of CBD, and it is possible that sensitization has been
delayed, rather than prevented. Evaluation of this program's
effectiveness would therefore be more complete by including individuals
who have left employment and documenting whether: (1) The program was
effective at two other facilities at which it was implemented, (2) the
program prevented beryllium sensitization over a longer period of time
(i.e., up to eight years); and (3) the program prevented CBD, which
generally takes longer to develop.
Study Design
This proposed study is designed to evaluate the effectiveness of a
comprehensive preventive program at three beryllium plants.
Approximately 579 eligible workers for this survey include those hired
between implementation of a comprehensive program (2000) and December
31, 2008, including any already known to be sensitized. NIOSH will
offer all eligible current and former workers the BeLPT to identify
sensitization and administer a work and medical history questionnaire.
There are no costs to former worker respondents except their time
to participate in the interview; current workers will participate
during work hours and thus compensated by their employer, and former
workers will participate during their own time. The total estimated
annualized burden hours are 193.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number Average burden/
Type of respondents Number of responses per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Former workers.................................................. 113 1 45/60
Current workers................................................. 80 1 45/60
Participant Consent and Authorization for Release of Information 193 1 15/60
----------------------------------------------------------------------------------------------------------------
Dated: October 2, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-19878 Filed 10-9-07; 8:45 am]
BILLING CODE 4163-18-P
