Proposed Information Collection Activity; Comment Request, 42355-42356 [E8-16616]
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Federal Register / Vol. 73, No. 140 / Monday, July 21, 2008 / Notices
CMS will also evaluate work and
improvement with a small number of
poorly performing nursing homes. CMS
will evaluate the nursing homes’
perception of the effectiveness of QIO
technical assistance and on
improvement in the quality measures.
Prevention (See Sections C.5 and C.6.3.
of the 9th SOW)
CMS will evaluate achievement of
minimum performance thresholds on
specific clinical measures at the 18th
and 28th month evaluation periods.
CMS will evaluate the work with a
selected group of participating practices
(PPs) in its state/jurisdiction with
already implemented electronic health
records (EHRs) to assess improvements
in breast cancer and CRC screening rates
and to improvements in immunization
rates for influenza and pneumococcal
pneumonia among Medicare
beneficiaries.
Sub-National Theme Requirements
Prevention: Disparities (Directed SubNational Task, See Sections C.5 and
C.7.1. of the 9th SOW
CMS will evaluate achievement of
minimum performance thresholds on
specific measures on a quarterly basis
and at the 18th and 28th month
evaluation periods. CMS will evaluate
recruitment of targeted providers and
enrollment of targeted patients. CMS
will also evaluate improvements in the
rates for hemoglobin A1c testing, eye
exams, lipid testing and blood pressure
control for diabetic patients.
Care Transitions, (Optional SubNational Theme, See Sections C.5 and
C.7.2. of the 9th SOW)
CMS will evaluate achievement of
minimum performance thresholds on
specific clinical measures at the 18th
and 28th month evaluation periods.
CMS will evaluate patient care
transitions that are: attributable to
participating providers; related to
implementation of interventions that
address hospital/community system-
wide processes; the potential subject of
an implemented intervention that
addresses acute myocardial infarction,
congestive heart failure, and
pneumonia; the potential subject of an
implemented intervention that
addresses specific reasons for
readmission. CMS will also evaluate the
percentage of implemented
interventions that are measured and the
percentage of patient care transitions to
which implemented and measured
interventions apply and show
improvement. CMS will also evaluate
patient satisfaction and patient
readmission rates.
Prevention: Chronic Kidney Disease
(Optional Sub-National Task, See
Sections C.5 and C.7.3 of the 9th SOW)
CMS will evaluate achievement of
minimum performance thresholds on all
clinical outcome measures at the 18th
and 28th month evaluation periods.
CMS will evaluate timely testing to
reduce the rate of kidney failure due to
diabetes, improvement in the use of
ACE inhibitor and/or ARB agent, and
improvement in the rate of AV fistula
placement.
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program.
Dated: April 25, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–16757 Filed 7–18–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Child Care Quarterly Case
Record Report—ACF–801.
OMB No.: 0970–0167.
Description: Section 658K of the Child
Care and Development Block Grant Act
of 1990 (Pub. L. 101–508, 42 U.S.C.
9858) requires that States and
Territories submit monthly case-level
data on the children and families
receiving direct services under the Child
Care and Development Fund. The
implementing regulations for the
statutorily required reporting are at 45
CFR 98.70. Case-level reports, submitted
quarterly or monthly (at grantee option),
include monthly sample or full
population case-level data. The data
elements to be included in these reports
are represented in the ACF–801. ACF
uses disaggregate data to determine
program and participant characteristics
as well as costs and levels of child care
services provided. This provides ACF
with the information necessary to make
reports to Congress, address national
child care needs, offer technical
assistance to grantees, meet performance
measures, and conduct research.
Consistent with the statute and
regulations, ACF requests extension of
the ACF–801. With this extension, ACF
is proposing several changes and
clarifications to the reporting
requirements and instructions.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Instrument
PWALKER on PROD1PC71 with NOTICES
ACF–801 ..........................................................................................
Estimated Total Annual Burden
Hours: 4,480.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
VerDate Aug<31>2005
19:22 Jul 18, 2008
Jkt 214001
56
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
PO 00000
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Fmt 4703
Sfmt 4703
Average
burden
hours
per
response
No. of
responses
per
respondent
No. of
respondents
4
Total
burden
hours
20
4,480
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
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42356
Federal Register / Vol. 73, No. 140 / Monday, July 21, 2008 / Notices
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: July 16, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–16616 Filed 7–18–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Food and Drug Administration Critical
Path Workshop on Clinical Trials for
Local Treatment of Breast Cancer by
Thermal Ablation
AGENCY:
Food and Drug Administration,
HHS.
PWALKER on PROD1PC71 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop to discuss the issues
associated with the development and
implementation of feasibility trials for
local treatment of breast cancer by
thermal ablation (i.e., cryoablation,
focused ultrasound, interstitial laser,
microwave, radiofrequency ablation).
We are inviting individuals, companies,
organizations, and other stakeholders to
attend this public workshop to discuss
how standardized protocols for
evaluation of tissue biopsy pathology,
selection of tumors amenable to
ablation, image guidance for ablation,
post-ablation imaging and assessment,
and tissue pathology of ablated
specimens can be developed and used
in breast cancer thermal ablation
clinical trials. The public workshop will
VerDate Aug<31>2005
19:22 Jul 18, 2008
Jkt 214001
also serve as a forum for discussing
where within the multispecialty care
path involving operative therapy,
chemotherapy, and radiation therapy,
thermal ablation may play a role.
Date and Time: The public workshop
will be held on September 15, 2008,
from 9 a.m. to 6 p.m. Online registration
is available at https://
www.blsmeetings.net/
2008ThermalAblationWorkshop until 5
p.m. on August 30, 2008 (see section III
of this document for details).
Location: The public workshop will
be held at the FDA White Oak Campus,
conference rooms 2047 F and G (https://
grouper.ieee.org/groups/scc34/sc2/
meeting_info/Meeting_WhiteOak_1518OCT2007/
White_Oak_Campus_Info_2007.pdf)
located at 10903 New Hampshire Ave.,
Silver Spring, MD 20993.
Contact: Binita Ashar, Center for
Devices and Radiological Health (HFZ–
410), Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD
20850, 240–276–3600, e-mail:
Binita.Ashar@FDA.HHS.gov.
If you need special accommodations
due to a disability, please contact Paula
Gumbs at 301–594–4453 at least 7 days
in advance.
SUPPLEMENTARY INFORMATION:
I. Background
On July 24, 2003, the FDA’s General
and Plastic Surgery Devices Advisory
Panel discussed issues pertaining to the
use of thermal ablation devices to
percutaneously or non-invasively treat
breast cancer by causing coagulation
necrosis of the tumor. The panel
discussed clinical trial issues pertaining
to the local treatment of breast cancer
using thermal ablation versus operative
resection.
The panel addressed the following
issues: (1) The level of evidence that
would be required, in initial studies of
treatment of primary breast cancer by
minimally invasive ablation followed by
immediate lumpectomy for pathologic
examination of margins (i.e., feasibility
ablate and resect studies), to permit
initiation of studies that use minimally
invasive ablation to definitively treat the
cancer without followup resection (i.e.,
ablate and follow studies); (2) the type
of pivotal study that could demonstrate
the efficacy of a thermal ablation device
to provide local breast cancer treatment
in lieu of lumpectomy; (3) how to
mitigate concerns regarding the effect of
thermal ablation on surrounding breast
tissue and radio/chemosensitivity; and
(4) the limitations of breast imaging and
its effect on patient selection and
treatment followup. This panel’s
discussion of these issues has
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significantly contributed to FDA’s
evaluation of these technologies.
Investigators studying the feasibility
of thermal ablation devices for the
treatment of breast cancers have refined
their techniques. In fact, there have been
small studies demonstrating nearly 100
percent ablation accuracy.
Unfortunately, the lack of uniformity
among different feasibility study
protocols has resulted in various study
results that cannot be easily compared.
Uniformity with respect to standardized
evaluation of tissue biopsy pathology,
selection of tumors amenable to
ablation, image guidance for ablation,
timing of ablation (with respect to
lymph node biopsy, radiation therapy
and chemotherapy), post-ablation
imaging and assessment, and tissue
pathology of ablated specimens would
facilitate the assembly of results across
both studies and ablation modalities
and better allow the formulation of
science-based hypotheses regarding best
practices for breast cancer ablation
therapy. The purpose of this critical
path effort is to motivate the breast
cancer ablation industry to standardize
its feasibility study protocols so that
data emerging are comparable in all
respects except for the specific ablation
modality. Such data could be used to
create a validated imaging tool that
correlates pathological results with
imaging findings of an ablated breast
cancer and hypothesize best practices
that could potentially serve as the basis
for longitudinal prospective clinical
trials.
We believe that there may be a variety
of opinions and experiences regarding
the information required to obtain
uniformity with respect to standardized
evaluation of tissue biopsy pathology,
selection of tumors amenable to
ablation, image guidance for ablation,
timing of ablation (with respect to
lymph node biopsy, radiation therapy
and chemotherapy), post-ablation
imaging and assessment, and tissue
pathology of ablated specimens to
facilitate the assembly of results across
both studies and ablation modalities
and better allow the formulation of
science-based hypotheses regarding best
practices for breast cancer ablation
therapy. We therefore published a
notice in the Federal Register of May
28, 2008 (73 FR 30619) (https://
www.access.gpo.gov) requesting
comments by November 24, 2008, to
help the agency understand how a
potential registry of breast cancer
treatment using thermal ablation
devices may motivate this effort.
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 73, Number 140 (Monday, July 21, 2008)]
[Notices]
[Pages 42355-42356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16616]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Child Care Quarterly Case Record Report--ACF-801.
OMB No.: 0970-0167.
Description: Section 658K of the Child Care and Development Block
Grant Act of 1990 (Pub. L. 101-508, 42 U.S.C. 9858) requires that
States and Territories submit monthly case-level data on the children
and families receiving direct services under the Child Care and
Development Fund. The implementing regulations for the statutorily
required reporting are at 45 CFR 98.70. Case-level reports, submitted
quarterly or monthly (at grantee option), include monthly sample or
full population case-level data. The data elements to be included in
these reports are represented in the ACF-801. ACF uses disaggregate
data to determine program and participant characteristics as well as
costs and levels of child care services provided. This provides ACF
with the information necessary to make reports to Congress, address
national child care needs, offer technical assistance to grantees, meet
performance measures, and conduct research. Consistent with the statute
and regulations, ACF requests extension of the ACF-801. With this
extension, ACF is proposing several changes and clarifications to the
reporting requirements and instructions.
Respondents: States, the District of Columbia, and Territories
including Puerto Rico, Guam, the Virgin Islands, American Samoa, and
the Northern Marianna Islands.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average burden
Instrument No. of No. of responses hours per Total burden
respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-801................................. 56 4 20 4,480
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 4,480.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370
[[Page 42356]]
L'Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports
Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All
requests should be identified by the title of the information
collection.
The Department specifically requests comments 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) 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: July 16, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8-16616 Filed 7-18-08; 8:45 am]
BILLING CODE 4184-01-P
