Proposed Data Collections Submitted for Public Comment and Recommendations, 59071-59072 [05-20323]
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Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices
physician services after the transfer of
ownership to Renal Advantage.
Similarly, the Consent Agreement
requires DaVita to obtain the consent of
all lessors necessary to assign the leases
for the real property associated with the
divested clinics to Renal Advantage.
These provisions ensure that Renal
Advantage will have the assets
necessary to operate the divested clinics
in a competitive manner.
The Consent Agreement contains
several additional provisions designed
to ensure that the divestitures are
successful. First, the Consent Agreement
provides Renal Advantage with the
opportunity to interview and hire
employees affiliated with the divested
clinics and prevents DaVita from
offering these employees incentives to
decline Renal Advantage’s offer of
employment. This will ensure that
Renal Advantage has access to patient
care and supervisory staff who are
familiar with the clinics’ patients and
the local physicians. Second, the
Consent Agreement prevents DaVita
from contracting with the medical
directors (or their practice groups)
affiliated with the divested clinics for
three years. This provides Renal
Advantage with sufficient time to build
goodwill and a working relationship
with its medical directors before DaVita
can attempt to capitalize on its prior
relationships in soliciting their services.
Third, to ensure continuity of patient
care and records as Renal Advantage
implements its quality care, billing, and
supply systems, the Consent Agreement
allows DaVita to provide transition
services for a period of 12 months.
Firewalls and confidentiality
agreements have been established to
ensure that competitively sensitive
information is not exchanged. Fourth,
the Consent Agreement requires DaVita
to provide Renal Advantage with a
license to use DaVita’s policies and
procedures, as well as the option to
obtain DaVita’s medical protocols,
which will further enhance Renal
Advantage’s ability to provide
continuity of care to patients. Finally,
the Consent Agreement requires DaVita
to provide prior notice to the
Commission of its planned acquisitions
of dialysis clinics located in the 35
markets addressed by the Consent
Agreement. This provision ensures that
subsequent acquisitions do not
adversely impact competition in the
markets at issue and undermine the
remedial goals of the proposed order.
The Commission is satisfied that
Renal Advantage is a qualified acquirer
of the divested assets. Renal Advantage
is a newly-formed company whose
management has extensive experience
VerDate Aug<31>2005
16:40 Oct 07, 2005
Jkt 208001
operating, acquiring, and developing
outpatient dialysis clinics. The
company has received a substantial
equity investment from Welsh, Carson,
Anderson, and Stowe, which is the
largest healthcare-focused private equity
firm in the United States.
The Commission has appointed Mitch
Nielson and John Strack of FocalPoint
Medical Consulting Group
(‘‘FocalPoint’’) as Monitors to oversee
the transition service agreements, and
the implementation of, and compliance
with, the Consent Agreement. Messrs.
Nielson and Strack are the principles of
FocalPoint, which provides consulting
services to the healthcare industry.
The purpose of this analysis is to
facilitate public comment on the
Consent Agreement, and it is not
intended to constitute an official
interpretation of the proposed Decision
and Order or the Order to Maintain
Assets, or to modify their terms in any
way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 05–20312 Filed 10–7–05; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–06–05CW]
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 404–371–5983 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail 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)
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
59071
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
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
Online Surveys to Measure
Awareness of Chronic Fatigue
Syndrome Public Awareness Campaign
(OMB Control No. 0920–05CW)—New—
National Center for Health Marketing
(NCHM), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Chronic fatigue syndrome (CFS) is a
serious illness that affects many
Americans. With as many as 900,000
cases, many of which are misdiagnosed
or left undiagnosed, the need for a CFS
public education and awareness
campaign is crucial.
With an estimated $9.1 billion lost
annually in U.S. productivity due to
CFS, the economic impact is a
substantial reason for Americans to take
notice. More importantly, the
diminished quality of life for many
patients suffering from CFS is especially
hard to manage. The lack of quality
information regarding CFS makes it all
the more difficult for those affected by
CFS to receive the support and
treatment needed to manage this illness.
Research shows that 80 to 90 percent
of patients have not been clinically
diagnosed and are not receiving proper
medical care. Lack of awareness and
information among health care
providers about CFS as a serious and
treatable illness has created significant
barriers to diagnosing and treating those
who suffer from CFS.
Congress recognized the need to
change this scenario, as reported in the
Committee Reports for the Senate
Appropriations Committee (Senate
Report 108–345—To accompany S. 2810
Sept. 15, 2004) when the committee
stated:
Further, the Committee encourages CDC to
better inform the public about this condition,
its severity and magnitude and to use
heightened awareness to create a registry of
CFS patients to aid research in this field.
During the next two years, CDC, in
partnership with the Chronic Fatigue
and Immune Dysfunction Syndrome
(CFIDS) Association of America, will
build the case that chronic fatigue
syndrome is real, serious and should be
diagnosed quickly to ensure the best
possible health outcomes.
E:\FR\FM\11OCN1.SGM
11OCN1
59072
Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices
To do so, a public education and
awareness campaign will be launched to
bring about changes in beliefs and social
norms among target audiences
(consumers: women aged 40–60,
healthcare practitioners: nurse
practitioners and physician assistants)
that CFS is a diagnosable and treatable
physical illness.
Although considerable research will
be done to ensure that campaign
themes, messages, and materials are
effective, there is no way to test the
impact of the campaign on the target
audience other than to conduct baseline
and follow-up surveys. These surveys
will measure not only the level of
awareness created by the campaign, but
will measure change in key knowledge,
attitudes and beliefs about CFS among
the target audiences. There is no cost to
respondents other than their time.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
responses
per respondent
Response
burden per
respondent
(in hours)
Total annual
burden
(in hours)
1
1
1
1
1
1
10/60
10/60
10/60
10/60
10/60
10/60
67
67
33
33
33
33
....................
....................
266
Number of
respondents
Respondents
Instrument
Consumers (Women, 40–60 years of age)
Consumers (Women, 40–60 years of age)
Physician Assistants ..................................
Physician Assistants ..................................
Nurse Practitioners ....................................
Nurse Practitioners ....................................
Pre-program survey .................................
Post-program survey ...............................
Pre-program survey .................................
Post-program survey ...............................
Pre-program survey .................................
Post-program survey ...............................
400
400
200
200
200
200
Total ...................................................
..................................................................
....................
Dated: October 4, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–20323 Filed 10–7–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0526]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Fast Track Drug
Development Programs—Designation,
Development, and Application Review
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
16:40 Oct 07, 2005
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20305 Filed 10–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry: Fast Track Drug
Development Programs—Designation,
Development, and Application Review’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 7, 2005 (70 FR
33177), the agency announced that the
proposed information collection had
been submitted to OMB for review and
SUMMARY:
VerDate Aug<31>2005
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0389. The
approval expires on August 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Jkt 208001
[Docket No. 2005N–0083]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
General Licensing Provisions:
Biologics License Application,
Changes to an Approved Application,
Labeling, Revocation and Suspension,
and Forms FDA 356h and 2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
to an Approved Application, Labeling,
Revocation and Suspension, and Forms
FDA 356h and 2567’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
In the
Federal Register of July 21, 2005 (70 FR
42068), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0338. The
approval expires on September 30,
2008. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–20306 Filed 10–7–05; 8:45 am]
BILLING CODE 4160–01–S
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘General Licensing Provisions:
Biologics License Application, Changes
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Pages 59071-59072]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20323]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-06-05CW]
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 404-371-5983
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
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 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
Online Surveys to Measure Awareness of Chronic Fatigue Syndrome
Public Awareness Campaign (OMB Control No. 0920-05CW)--New--National
Center for Health Marketing (NCHM), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Chronic fatigue syndrome (CFS) is a serious illness that affects
many Americans. With as many as 900,000 cases, many of which are
misdiagnosed or left undiagnosed, the need for a CFS public education
and awareness campaign is crucial.
With an estimated $9.1 billion lost annually in U.S. productivity
due to CFS, the economic impact is a substantial reason for Americans
to take notice. More importantly, the diminished quality of life for
many patients suffering from CFS is especially hard to manage. The lack
of quality information regarding CFS makes it all the more difficult
for those affected by CFS to receive the support and treatment needed
to manage this illness.
Research shows that 80 to 90 percent of patients have not been
clinically diagnosed and are not receiving proper medical care. Lack of
awareness and information among health care providers about CFS as a
serious and treatable illness has created significant barriers to
diagnosing and treating those who suffer from CFS.
Congress recognized the need to change this scenario, as reported
in the Committee Reports for the Senate Appropriations Committee
(Senate Report 108-345--To accompany S. 2810 Sept. 15, 2004) when the
committee stated:
Further, the Committee encourages CDC to better inform the
public about this condition, its severity and magnitude and to use
heightened awareness to create a registry of CFS patients to aid
research in this field.
During the next two years, CDC, in partnership with the Chronic
Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America,
will build the case that chronic fatigue syndrome is real, serious and
should be diagnosed quickly to ensure the best possible health
outcomes.
[[Page 59072]]
To do so, a public education and awareness campaign will be
launched to bring about changes in beliefs and social norms among
target audiences (consumers: women aged 40-60, healthcare
practitioners: nurse practitioners and physician assistants) that CFS
is a diagnosable and treatable physical illness.
Although considerable research will be done to ensure that campaign
themes, messages, and materials are effective, there is no way to test
the impact of the campaign on the target audience other than to conduct
baseline and follow-up surveys. These surveys will measure not only the
level of awareness created by the campaign, but will measure change in
key knowledge, attitudes and beliefs about CFS among the target
audiences. There is no cost to respondents other than their time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Response Total
Number of responses burden per annual
Respondents Instrument respondents per respondent burden (in
respondent (in hours) hours)
----------------------------------------------------------------------------------------------------------------
Consumers (Women, 40-60 years of Pre-program survey....... 400 1 10/60 67
age).
Consumers (Women, 40-60 years of Post-program survey...... 400 1 10/60 67
age).
Physician Assistants............. Pre-program survey....... 200 1 10/60 33
Physician Assistants............. Post-program survey...... 200 1 10/60 33
Nurse Practitioners.............. Pre-program survey....... 200 1 10/60 33
Nurse Practitioners.............. Post-program survey...... 200 1 10/60 33
--------------
Total........................ ......................... ........... ........... ........... 266
----------------------------------------------------------------------------------------------------------------
Dated: October 4, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-20323 Filed 10-7-05; 8:45 am]
BILLING CODE 4163-18-P
