Agency Information Collection Activities: Proposed Collection; Comment Request, 63613-63614 [E7-21990]
Download as PDF
<![CDATA[
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices
functional status and other factors
related to outcomes and resource
utilization at admission, discharge, and
interim times during post acute
treatment, and (3) understand the
relationship between severity of illness,
functional status, social support factors,
and resource utilization. The CARE
instrument will be used in the PostAcute Care (PAC) Payment Reform
Demonstration program mandated by
Section 5008 of the Deficit Reduction
Act of 2005 to develop payment groups
that reflect patient severity and related
cost and resource use across post acute
settings. Specifically, the data collected
using the CARE instrument during the
Post-Acute Care Payment Demonstration
will be used by CMS to develop a
setting neutral post-acute care payment
model as mandated by the Congress.
The data will be used to characterize
patient severity of illness and level of
function in order to predict resource
use, post-acute care discharge
placement, and beneficiary outcomes.
CMS will use the data from the CARE
instrument to examine the degree to
which the items on the instrument can
be used to predict beneficiary resource
use and outcomes.
CMS made over 150 changes and
improvements to the CARE instrument
following the 60 day public comment
period. Many revisions were minor
word changes or clarifications to itemcoding instructions. A significant
number of changes were made to delete
unnecessary items and to add skip
patterns to allow respondents to skip
over items/sections that do not apply to
a particular condition. The revised
version of CARE retains its clinical
integrity while allowing for greater
response specificity. Form Number:
CMS–10243 (OMB#: 0938–NEW);
Frequency: Reporting—Daily; Affected
Public: Private Sector—Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
388; Total Annual Responses: 244,292;
Total Annual Hours: 179,341.
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
be received by the OMB desk officer at
the address below, no later than 5 p.m.
VerDate Aug<31>2005
23:48 Nov 08, 2007
Jkt 214001
on December 10, 2007. OMB Human
Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: November 2, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–21989 Filed 11–8–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10239 and CMS–
R–48]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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) 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 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: New collection; Title of
Information Collection: Conditions of
Participation for Critical Access
Hospitals; Use: With this submission,
we are creating a new information
collection request for critical access
hospitals (CAH). Currently, the
information collection requirements
associated with the critical access
hospital (CAH) conditions of
participation (CoPs) are included with
the hospital CoPs reported under CMS–
R–48 (0938–0328). Because the CAH
program has grown in scope of services
and the number of providers, we have
removed the CAH burden from the
AGENCY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
63613
CMS–R–48 with the exception of the
burden associated with the 101 CAHs
that have distinct part units (DPUs), and
created a separate information
collection request for OMB review and
approval. Section 1820(c)(2)(E)(i) of the
Social Security Act states that if a CAH
operates a distinct part psychiatric or
rehabilitation unit it must have 10 beds
or less in the DPU and it must comply
with the hospital requirements specified
in 42 CFR Subpart A, B, C, and D of part
482. Based on 2007 data from HRSA, 81
CAHs have psychiatric distinct part
units (DPUs) and 20 CAHs have
rehabilitation DPUs. The burden
associated with the 101 CAHs with
DPUs is reported in CMS–R–48. Form
Number: CMS–10239 (OMB#: 0938–
New); Frequency: Yearly; Affected
Public: Private sector—Business or other
for-profit; Number of Respondents:
1,189; Total Annual Responses:
137,990; Total Annual Hours: 23,291.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Hospital
Conditions of Participation and
Supporting Regulations in 42 CFR
482.12, 482.13, 482.21, 482.22, 482.23,
482.24, 482.27, 482.30, 482.41, 482.43,
482.45, 482.53, 482.56, 482.57, 482.60,
482.61, 482.62, and 485.616 and
485.631; Use: The information
collection requirements described in
this information collection request are
needed to implement the Medicare and
Medicaid conditions of participation
(CoP) for 4,890 accredited and nonaccredited hospitals and an additional
101 critical access hospitals (CAHs) that
have distinct part psychiatric or
rehabilitation units (DPUs). CAHs that
have DPUs must comply with all of the
hospital CoPs on these units. Thus, this
package reflects the paperwork burden
for a total of 4,991 (that is, 4,890
hospitals and 101 CAHs which include
81 CAHs that have psychiatric DPUs
and 20 CAHs that have rehabilitation
DPUs). The information collection
requirements for the remaining 1,183
CAHs have been reported in a separate
package under CMS–10239.
The CoPs and accompanying
requirements specified in the
regulations are used by our surveyors as
a basis for determining whether a
hospital qualifies for a provider
agreement under Medicare and
Medicaid. CMS and the health care
industry believe that the availability to
the facility of the type of records and
general content of records, which this
regulation specifies, is standard medical
practice and is necessary in order to
ensure the well-being and safety of
patients and professional treatment
E:\FR\FM\09NON1.SGM
09NON1
63614
Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices
accountability. Form Number: CMS–R–
48 (OMB#: 0938–328); Frequency:
Yearly; Affected Public: Private sector—
Business or other for-profit; Number of
Respondents: 4,991; Total Annual
Responses: 1,120,817; Total Annual
Hours: 9,151,200.57.
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
be received at the address below, no
later than 5 p.m. on January 8, 2008.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—B, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: November 2, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–21990 Filed 11–8–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0422]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Participation in the Medical Device
Fellowship Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the application for participation in the
Medical Device Fellowship Program
(MDFP).
DATES: Submit written or electronic
comments on the collection of
information by January 8, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments or https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Application for Participation in the
Medical Device Fellowship Program; 5
U.S.C. 1104, 1302, 3301, 3304, 3320,
3361, 3393, and 3394 (OMB Control
Number 0910–0551)—Extension
Sections 1104, 1302, 3301, 3304,
3320, 3361, 3393, and 3394 of Title 5 of
the United States Code, authorize
Federal agencies to rate applicants for
Federal jobs. Collecting applications for
the MDFP will allow FDA’s Center for
Devices and Radiological Health (CDRH)
to easily and efficiently elicit and
review information from students and
health care professionals who are
interested in becoming involved in
CDRH activities. The process will
reduce the time and cost of submitting
written documentation to the agency
and lessen the likelihood of applications
being misrouted within the agency mail
system. It will assist the agency in
promoting and protecting the public
health by encouraging outside persons
to share their expertise with CDRH.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
mstockstill on PROD1PC66 with NOTICES
5 U.S.C. Section/
FDA Form No.
No. of
Respondents
1104, 1302, 3301, 3304, 3320, 3361,
3393, 3394/
Form No. 3608
1 There
Annual Frequency
per Response
250
1
Total Annual
Responses
Hours per
Response
250
1
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
23:48 Nov 08, 2007
Jkt 214001
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\09NON1.SGM
Total Hours
09NON1
250
]]>Agencies
[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Pages 63613-63614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21990]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10239 and CMS-R-48]
Agency Information Collection Activities: Proposed Collection;
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) 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 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: New collection; Title of
Information Collection: Conditions of Participation for Critical Access
Hospitals; Use: With this submission, we are creating a new information
collection request for critical access hospitals (CAH). Currently, the
information collection requirements associated with the critical access
hospital (CAH) conditions of participation (CoPs) are included with the
hospital CoPs reported under CMS-R-48 (0938-0328). Because the CAH
program has grown in scope of services and the number of providers, we
have removed the CAH burden from the CMS-R-48 with the exception of the
burden associated with the 101 CAHs that have distinct part units
(DPUs), and created a separate information collection request for OMB
review and approval. Section 1820(c)(2)(E)(i) of the Social Security
Act states that if a CAH operates a distinct part psychiatric or
rehabilitation unit it must have 10 beds or less in the DPU and it must
comply with the hospital requirements specified in 42 CFR Subpart A, B,
C, and D of part 482. Based on 2007 data from HRSA, 81 CAHs have
psychiatric distinct part units (DPUs) and 20 CAHs have rehabilitation
DPUs. The burden associated with the 101 CAHs with DPUs is reported in
CMS-R-48. Form Number: CMS-10239 (OMB: 0938-New); Frequency:
Yearly; Affected Public: Private sector--Business or other for-profit;
Number of Respondents: 1,189; Total Annual Responses: 137,990; Total
Annual Hours: 23,291.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Hospital
Conditions of Participation and Supporting Regulations in 42 CFR
482.12, 482.13, 482.21, 482.22, 482.23, 482.24, 482.27, 482.30, 482.41,
482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, and
485.616 and 485.631; Use: The information collection requirements
described in this information collection request are needed to
implement the Medicare and Medicaid conditions of participation (CoP)
for 4,890 accredited and non-accredited hospitals and an additional 101
critical access hospitals (CAHs) that have distinct part psychiatric or
rehabilitation units (DPUs). CAHs that have DPUs must comply with all
of the hospital CoPs on these units. Thus, this package reflects the
paperwork burden for a total of 4,991 (that is, 4,890 hospitals and 101
CAHs which include 81 CAHs that have psychiatric DPUs and 20 CAHs that
have rehabilitation DPUs). The information collection requirements for
the remaining 1,183 CAHs have been reported in a separate package under
CMS-10239.
The CoPs and accompanying requirements specified in the regulations
are used by our surveyors as a basis for determining whether a hospital
qualifies for a provider agreement under Medicare and Medicaid. CMS and
the health care industry believe that the availability to the facility
of the type of records and general content of records, which this
regulation specifies, is standard medical practice and is necessary in
order to ensure the well-being and safety of patients and professional
treatment
[[Page 63614]]
accountability. Form Number: CMS-R-48 (OMB: 0938-328);
Frequency: Yearly; Affected Public: Private sector--Business or other
for-profit; Number of Respondents: 4,991; Total Annual Responses:
1,120,817; Total Annual Hours: 9,151,200.57.
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.
To be assured consideration, comments and recommendations for the
proposed information collections must be received at the address below,
no later than 5 p.m. on January 8, 2008. CMS, Office of Strategic
Operations and Regulatory Affairs, Division of Regulations
Development--B, Attention: William N. Parham, III, Room C4-26-05, 7500
Security Boulevard, Baltimore, Maryland 21244-1850.
Dated: November 2, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-21990 Filed 11-8-07; 8:45 am]
BILLING CODE 4120-01-P
