Agency Information Collection Activities: Submission for OMB Review; Comment Request, 25319-25320 [E7-8424]
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Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices
following summary of proposed
collections 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.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: The Medicare
and Medicaid Programs: Programs of
All-inclusive Care for the Elderly
(PACE); Form Number: CMS–R–244
(OMB#: 0938–0790); Use: PACE
organizations must demonstrate their
ability to provide quality communitybased care for the frail elderly who meet
their State’s nursing home eligibility
standards using capitated payments
from Medicare and the State. PACE
programs must provide all Medicare and
Medicaid covered services including
hospital, nursing home, home health,
and other specialized services. This
collection is necessary to ensure that
only appropriate organizations are
selected to become PACE organizations
and that CMS has the information
necessary to monitor the care they
provide; Frequency: Reporting—Once
and On occasion; Affected Public: Notfor-profit institutions and State, Local,
or Tribal Governments; Number of
Respondents: 54; Total Annual
Responses: 108; Total Annual Hours:
44131.50.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Application for
Hospital Insurance Benefits; Form
Number: CMS–18F5 (OMB#: 0938–
0251); Use: The CMS–18F5 form is used
to establish entitlement to and
enrollment in Part A of Medicare for
beneficiaries who are not automatically
entitled to Medicare Part A under Title
XVIII of the Social Security Act and
must file an application. Sections
226(a), 227 and 1818A of the Social
Security Act and sections 42 CFR
406.10, 406.11 and 406.20 outline the
requirements for entitlement to
Medicare hospital insurance (Part A).
Section 42 CFR 406.6 provides
information about who needs to file an
application for Part A and who does not.
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Section 42 CFR 406.7 lists the CMS–
18F5 form as the application to be used
by individuals applying for Part A of
Medicare. The CMS–18F5 form was
designed to capture all the information
needed to make a determination of an
individual’s entitlement to hospital
insurance (Part A); Frequency:
Reporting—Once; Affected Public:
Individuals or households; Number of
Respondents: 50,000; Total Annual
Responses: 50,000; Total Annual Hours:
12,495.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Hospice Request
for Certification in the Medicare
Program; Form Number: CMS–417
(OMB#: 0938–0313); Use: The Hospice
Request for Certification Form is the
identification and screening form used
to initiate the certification process and
to determine if the provider has
sufficient personnel to participate in the
Medicare program; Frequency:
Reporting—Yearly; Affected Public:
Private Sector: Business or other forprofits; Number of Respondents: 2,286;
Total Annual Responses: 2,286; Total
Annual Hours: 572.
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Psychiatric
Hospital Survey Data and Supporting
Regulations at 42 CFR 482.60, 482.61,
and 482.62; Form Number: CMS–724
(OMB#: 0938–0378); Use: The
Medicare/Medicaid Psychiatric Hospital
Survey is used to collect data that is not
collected elsewhere and assists CMS in
program planning and evaluation of
survey needs. In addition, the survey
assists CMS in maintaining an accurate
data base on providers participating in
the Medicare psychiatric hospital
program; Frequency: Reporting—Yearly;
Affected Public: Private Sector: Business
or other for-profits; Number of
Respondents: 420; Total Annual
Responses: 200; Total Annual Hours:
100.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
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25319
be received at the address below, no
later than 5 p.m. on July 3, 2007.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—C, Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 27, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–8423 Filed 5–3–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS-R–245]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections 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 function;
(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.
1. Type of Information Collection
Request: Revision of the currently
approved collection; Title of
Information Collection: Medicare and
Medicaid Programs OASIS Collection
Requirements as Part of the Conditions
of Participation for Home Health
Agencies and Supporting Regulations in
42 CFR 484.55, 484.205, 484.245,
484.250; Form No.: CMS–R–245 (OMB#
0938–0760) Use: The Outcome and
Assessment Information Set (OASIS) is
a requirement for one of the Conditions
of Participation (CoPs) that Home
Health Agencies (HHAs) must meet in
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25320
Federal Register / Vol. 72, No. 86 / Friday, May 4, 2007 / Notices
order to participate in the Medicare
program. Specifically, the CoP at
§ 484.55 requires that each patient
receive from an HHA a patient-specific,
comprehensive assessment that
identifies a patient’s continuing need for
home care and meets the patient’s
medical, nursing, rehabilitative, social
and discharge planning needs. In
addition, the regulation requires that as
part of the comprehensive assessment,
HHAs use a standard core assessment
data set, the OASIS, to evaluate, nonmaternity patients. The data collected
using OASIS is used for three main
purposes: assessing and improving the
quality of care provided by an HHA,
submitting and paying claims for
Medicare home health services, and
surveying the HHAs in accordance with
Section 1891 of the Social Security Act
(the Act).
We have made several modifications
to this information collection without
increasing the burden. The
modifications include but are not
limited to the following items. In order
for the OASIS to have the information
necessary to allow the grouper to priceout the claim, we propose to make the
following changes to the OASIS to
capture whether an episode is an early
or later episode. In addition, for the
purposes of payment, we propose to
make changes to the OASIS in order to
enable agencies to report secondary case
mix diagnosis codes. The proposed
changes clarify how to appropriately fill
out OASIS items M0230 and M0240,
using ICD–9–CM sequencing
requirements if multiple coding is
indicated for any diagnosis. The
proposed OASIS revisions also include
incorporating previously revised
instructions regarding diagnosis coding
in items M0190, M0210, and M0230/
M0240/M0246 (previously M0245). The
burden associated with these proposed
changes includes possible training of
staff, the time and effort associated with
downloading a new form and replacing
previously pre-printed versions of the
OASIS, and utilizing updated vendor
software. However, CMS will be
removing or modifying existing
questions in the OASIS data set to
accommodate the requirements
referenced above. Therefore, CMS
believes the burden increase associated
with these changes is negated by the
removal or modification of several
current data items. Frequency:
Recordkeeping and Reporting—upon
patient assessment; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 8,277; Total Annual
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Responses: 10,105,827; Total Annual
Hours: 11,977,601.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: April 27, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–8424 Filed 5–3–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
PO 00000
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Method for Predicting and Detecting
Tumor Metastasis
Description of Technology: Detecting
cancer prior to metastasis greatly
increases the efficacy of treatment and
the chances of patient survival.
Although numerous biomarkers have
been reported to identify aggressive
tumor types and predict prognosis, each
biomarker is specific for a particular
type of cancer, and no universal marker
that can predict metastasis in a number
of cancers have been identified. In
addition, due to a lack of reliability,
several markers are typically required to
determine the prognosis and course of
therapy.
Available for licensing are
carboxypeptidase E (CPE) inhibitor
compositions and methods to progonose
and treat cancer as well as methods to
determine the stage of cancer. The
inventors discovered that CPE
expression levels increase according to
the presence of cancer and metastasis
wherein CPE is upregulated in tumors
and CPE levels are further increased in
metastatic cancer. This data has been
demonstrated both in vitro and in vivo
experiments and in liver, breast,
prostate, colon, and head and neck
cancers. Metastatic liver cells treated
with CPE siRNA reversed the cells from
being metastatic and arrested cells from
further metastasis. Thus, CPE as a
biomarker for predicting metastasis and
its inhibitors have an enormous
potential to increase patient survival.
Applications:
1. Method to prognose multiple types
of cancer and determine likelihood of
metastasis.
2. Compositions that inhibit CPE such
as siRNA.
3. Method to prevent and treat cancer
with CPE inhibitors.
Market:
1. 600,000 cancer related deaths in
2006;
2. Global cancer market is worth more
than eight percent of total global
pharmaceutical sales;
3. Cancer industry is predicted to
expand to $85.3 billion by 2010.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Inventors: Y. Peng Loh (NICHD) et al.
Publication: Manuscript in
preparation.
Patent Status:
1. U.S. Provisional Application No.
60/885,809 filed 19 Jan 2007 (HHS
Reference No. E–096–2007/0–US–01)
2. U.S. Provisional Application No.
60/887,061 filed 29 Jan 2007 (HHS
Reference No. E–096–2007/1–US–01)
E:\FR\FM\04MYN1.SGM
04MYN1
]]>Agencies
[Federal Register Volume 72, Number 86 (Friday, May 4, 2007)]
[Notices]
[Pages 25319-25320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8424]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-245]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections 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 function; (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.
1. Type of Information Collection Request: Revision of the
currently approved collection; Title of Information Collection:
Medicare and Medicaid Programs OASIS Collection Requirements as Part of
the Conditions of Participation for Home Health Agencies and Supporting
Regulations in 42 CFR 484.55, 484.205, 484.245, 484.250; Form No.: CMS-
R-245 (OMB 0938-0760) Use: The Outcome and Assessment
Information Set (OASIS) is a requirement for one of the Conditions of
Participation (CoPs) that Home Health Agencies (HHAs) must meet in
[[Page 25320]]
order to participate in the Medicare program. Specifically, the CoP at
Sec. 484.55 requires that each patient receive from an HHA a patient-
specific, comprehensive assessment that identifies a patient's
continuing need for home care and meets the patient's medical, nursing,
rehabilitative, social and discharge planning needs. In addition, the
regulation requires that as part of the comprehensive assessment, HHAs
use a standard core assessment data set, the OASIS, to evaluate, non-
maternity patients. The data collected using OASIS is used for three
main purposes: assessing and improving the quality of care provided by
an HHA, submitting and paying claims for Medicare home health services,
and surveying the HHAs in accordance with Section 1891 of the Social
Security Act (the Act).
We have made several modifications to this information collection
without increasing the burden. The modifications include but are not
limited to the following items. In order for the OASIS to have the
information necessary to allow the grouper to price-out the claim, we
propose to make the following changes to the OASIS to capture whether
an episode is an early or later episode. In addition, for the purposes
of payment, we propose to make changes to the OASIS in order to enable
agencies to report secondary case mix diagnosis codes. The proposed
changes clarify how to appropriately fill out OASIS items M0230 and
M0240, using ICD-9-CM sequencing requirements if multiple coding is
indicated for any diagnosis. The proposed OASIS revisions also include
incorporating previously revised instructions regarding diagnosis
coding in items M0190, M0210, and M0230/M0240/M0246 (previously M0245).
The burden associated with these proposed changes includes possible
training of staff, the time and effort associated with downloading a
new form and replacing previously pre-printed versions of the OASIS,
and utilizing updated vendor software. However, CMS will be removing or
modifying existing questions in the OASIS data set to accommodate the
requirements referenced above. Therefore, CMS believes the burden
increase associated with these changes is negated by the removal or
modification of several current data items. Frequency: Recordkeeping
and Reporting--upon patient assessment; Affected Public: Business or
other for-profit and Not-for-profit institutions; Number of
Respondents: 8,277; Total Annual Responses: 10,105,827; Total Annual
Hours: 11,977,601.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS Web
Site address at https://www.cms.hhs.gov/PaperworkReductionActof1995, or
E-mail your request, including your address, phone number, OMB number,
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786-1326.
Written comments and recommendations for the proposed information
collections must be mailed or faxed within 30 days of this notice
directly to the OMB desk officer: OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett, New Executive Office Building, Room
10235, Washington, DC 20503, Fax Number: (202) 395-6974.
Dated: April 27, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-8424 Filed 5-3-07; 8:45 am]
BILLING CODE 4120-01-P
