Agency Information Collection Activities: Proposed Collection; Comment Request, 19522-19523 [E6-5408]
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Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices
484.11 and 484.20; Use: This request is
for OMB approval to continue to require
home health agencies (HHAs) to
electronically report the Outcome and
Assessment Information Set (OASIS)
data to CMS. OASIS is a requirement of
one of the Conditions of Participation
(CoP) that HHAs must meet in order to
participate in the Medicare program.
Specifically, the aforementioned
regulation sections provide guidelines
for HHAs for the electronic transmission
of the OASIS data as well as
responsibilities of the State agency or
OASIS contractor in collecting and
transmitting this information to CMS.
These requirements are necessary to
achieve broad-based, measurable
improvement, in the quality of care
furnished through Federal programs,
and to establish a prospective payment
system for HHAs; Form Number: CMS–
R–209 (OMB#: 0938–761); Frequency:
Reporting—Monthly; Affected Public:
Business or other for-profit, Not-forprofit institutions, Federal government,
State, Local, or Tribal governments;
Number of Respondents: 8,277; Total
Annual Responses: 102,203; Total
Annual Hours: 1,374,051.
4. Type of Information Collection
Request: Extension of a 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; Use: The Medicare and
Medicaid Programs OASIS Collection
Requirements as Part of the Conditions
of Participation for Home Health
Agencies (HHAs) information collection
requires HHAs to use a standard core
assessment data set, the Outcome and
Assessment Information Set (OASIS), to
collect information and to evaluate
adult non-maternity patients. In
addition, data from the OASIS will be
used for purposes of case mix adjusting
patients under the home health
prospective payment system and will
facilitate the production of necessary
case mix information at relevant time
points in the patient’s home health stay;
Form Number: CMS–R–245 (OMB#:
0938–760); Frequency: Recordkeeping
and Reporting—Other, upon patient
assessment; Affected Public: Business or
other for-profit, Not-for-profit
institutions, Federal government, State,
Local, or Tribal governments; Number of
Respondents: 8,277; Total Annual
Responses: 11,087,565; Total Annual
Hours: 9,339,184.
5. Type of Information Collection
Request: New collection; Title of
Information Collection: Collection of
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Medicaid and State Children’s Health
Insurance (SCHIP) Managed Care Claims
and Related Information; Use: The
Improper Payments Information Act
(IPIA) of 2002 (Pub. L. 107–300)
requires CMS to produce national error
rates in the Medicaid program and the
State Children’s Health Insurance
Program (SCHIP). To comply with the
IPIA, CMS will engage a Federal
contractor to produce error rates in
Medicaid managed care and SCHIP
managed care. Beginning in 2007, CMS
will use a rotational approach to review
up to 18 States for each program, for a
total 36 States each year. CMS has
completed the State selection process
for the Medicaid improper payments
measurement. States have not yet been
selected for the measurement of
improper payments in SCHIP. CMS
expects to select the SCHIP States in the
fall of 2006; Form Number: CMS–10178
(OMB#: 0938–NEW); Frequency:
Reporting—On occasion, Quarterly;
Affected Public: State, Local, or Tribal
governments; Number of Respondents:
36; Total Annual Responses: 23,400;
Total Annual Hours: 23,400.
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 4, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–5406 Filed 4–13–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–05, CMS–R–
72, CMS–10175, CMS 10050, CMS–1957,
CMS–1515 & 1572]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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: Extension of a currently
approved collection; Title of
Information Collection: Physician
Certifications/Recertifications in Skilled
Nursing Facilities (SNFs) Manual
Instructions and Supporting Regulations
in 42 CFR 424.20; Use: Regulations at 42
CFR 424.20 require SNFs to keep record
of physician certifications and
recertifications of information such as
the need for care and services, estimated
duration of the SNF stay, and plan for
home care. As a condition for Medicare
Part A payment for post-hospital skilled
nursing facility (SNF) services, the
Medicare program requires that a
physician certify and periodically
recertify that a beneficiary requires an
SNF level of care. The physician
certification and recertification is
intended to ensure that the beneficiary’s
need for services has been established
and then reviewed and updated at
appropriate intervals; Form Number:
CMS–R–05 (OMB#: 0938–0454);
Frequency: Recordkeeping and
Reporting—On occasion; Affected
Public: State, Local or Tribal
governments, Individuals or
Households, Business or other for-profit
AGENCY:
E:\FR\FM\14APN1.SGM
14APN1
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Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices
and Not-for-profit institutions; Number
of Respondents: 2,458,549; Total
Annual Responses: 981,642; Total
Annual Hours: 547,578.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements in 42 CFR
478.18, 478.34, 478.36, 478.42, QIO
Reconsiderations and Appeals; Use: In
the event that a beneficiary, provider,
physician, or other practitioner does not
agree with the initial determination of a
Quality Improvement Organization
(QIO) or a QIO subcontractor, it is
within that party’s rights to request
reconsideration. The information
collection requirements 42 CFR 478.18,
478.34, 478.36, and 478.42, contain
procedures for QIOs to use in
reconsideration of initial
determinations. The information
requirements contained in these
regulations are on QIOs to provide
information to parties requesting the
reconsideration. These parties will use
the information as guidelines for appeal
rights in instances where issues are
actively being disputed.; Form Number:
CMS–R–72 (OMB#: 0938–0443);
Frequency: Reporting—On occasion;
Affected Public: Individuals or
Households and Business or other forprofit institutions; Number of
Respondents: 2,590; Total Annual
Responses: 5,228; Total Annual Hours:
2,822.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Certification
Statement for Electronic File
Interchange Organizations (EFIOS) that
Submit National Provider Identifier
(NPI) Data to the National Plan and
Enumeration System; Use: The EFI
process is designed to allow
organizations to submit NPI application
information for large numbers of
providers in a single file. Once it has
obtained and formatted the necessary
provider data, the EFIO will
electronically submit the file to NPPES
for processing. As each file can contain
up to approximately 100,000 records, or
provider applications, the EFI process
greatly reduces the paperwork and
overall administrative burden associated
with enumerating providers; Form
Number: CMS–10175 (OMB#: 0938–
0984); Frequency: Reporting—Other,
One-time; Affected Public: Business or
other for-profit, and Not-for-profit
institutions; Number of Respondents:
1000; Total Annual Responses: 1000;
Total Annual Hours: 3000.
4. Type of Information Collection
Request: Extension of a currently
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approved collection; Title of
Information Collection: Survey of Newly
Eligible Medicare Beneficiaries; Use:
CMS is responsible for providing
beneficiaries with the Medicare program
information they need to effectively
choose the health care plan best suited
to their needs. In order to provide such
information, CMS needs to know (1)
Whether or not new enrollees are aware
of the choices they have, (2) what
beneficiaries understand about the basic
elements of the Medicare program, (3)
what other sources currently provide
Medicare-related information, and (4)
how all of these items vary across
beneficiary subpopulations. To this end,
CMS must have the ability to measure
over time what beneficiaries know and
understand about the Medicare
program. Measuring beneficiaries’
information needs and knowledge over
time will help CMS evaluate its impact
on information/education, population
changes and other initiatives; Form
Number: CMS–10050 (OMB#: 0938–
0869); Frequency: Reporting—Quarterly;
Affected Public: Individuals or
Households; Number of Respondents:
2400; Total Annual Responses: 2400;
Total Annual Hours: 800.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: SSO Report of
State Buy-in Problem and Supporting
Regulations in 42 CFR 407.40; Use:
Under the State Buy-In program, States
enroll certain groups of needy people
under the Part B Supplementary
Medical Insurance (SMI) Program and
pay their premiums. The purpose of the
‘‘buy-in’’ is to allow the States to
provide SMI protection to certain
groups of needy individuals as part of
its total assistance plan. Generally,
States ‘‘buy-in’’ for individuals who are
categorically needy under Medicaid and
meet the eligibility requirements for
Medicare Part B. States can also include
in their buy-in agreement those eligible
for medical assistance only. The CMS–
1957 is used in the resolution of
beneficiary complaints regarding State
buy-in. This form facilitates the
coordination of efforts between the SSO,
State Medicaid Agencies, and CMS in
the resolution of a beneficiary’s State
buy-in problem; Form Number: CMS–
1957 (OMB#: 0938–0035); Frequency:
Reporting—On occasion; Affected
Public: Federal government, Individuals
or Households, and State, Local, and
Tribal governments; Number of
Respondents: 6,600; Total Annual
Responses: 6,600; Total Annual Hours:
2,366.
6. Type of Information Collection
Request: Extension of a currently
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19523
approved collection; Title of
Information Collection: Home Health
Agency Survey and Deficiencies Report,
Home Health Functional Assessment
Instrument and Supporting Regulations
in 42 CFR 488.26 and 442.30; Use: In
order to participate in the Medicare
program as a Home Health Agency
(HHA) provider, the HHA must meet
Federal Standards. These forms used to
record information about patients’
health and provider compliance with
requirement and report information to
the Federal Government; Form Number:
CMS–1515 & 1572 (OMB#: 0938–0355);
Frequency: Reporting—Annually;
Affected Public: Business or other forprofit, Individuals or Households, and
Not-for-profit institutions; Number of
Respondents: 24,150; Total Annual
Responses: 24,150; Total Annual Hours:
3,864.
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 June 13, 2006.
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: April 4, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–5408 Filed 4–13–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0107]
Food and Drug AdministrationRegulated Products Containing
Nanotechnology Materials; Planning of
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\14APN1.SGM
Request for comments.
14APN1
Agencies
[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19522-19523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5408]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-05, CMS-R-72, CMS-10175, CMS 10050, CMS-
1957, CMS-1515 & 1572]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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: Extension of a currently
approved collection; Title of Information Collection: Physician
Certifications/Recertifications in Skilled Nursing Facilities (SNFs)
Manual Instructions and Supporting Regulations in 42 CFR 424.20; Use:
Regulations at 42 CFR 424.20 require SNFs to keep record of physician
certifications and recertifications of information such as the need for
care and services, estimated duration of the SNF stay, and plan for
home care. As a condition for Medicare Part A payment for post-hospital
skilled nursing facility (SNF) services, the Medicare program requires
that a physician certify and periodically recertify that a beneficiary
requires an SNF level of care. The physician certification and
recertification is intended to ensure that the beneficiary's need for
services has been established and then reviewed and updated at
appropriate intervals; Form Number: CMS-R-05 (OMB: 0938-0454);
Frequency: Recordkeeping and Reporting--On occasion; Affected Public:
State, Local or Tribal governments, Individuals or Households, Business
or other for-profit
[[Page 19523]]
and Not-for-profit institutions; Number of Respondents: 2,458,549;
Total Annual Responses: 981,642; Total Annual Hours: 547,578.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Information
Collection Requirements in 42 CFR 478.18, 478.34, 478.36, 478.42, QIO
Reconsiderations and Appeals; Use: In the event that a beneficiary,
provider, physician, or other practitioner does not agree with the
initial determination of a Quality Improvement Organization (QIO) or a
QIO subcontractor, it is within that party's rights to request
reconsideration. The information collection requirements 42 CFR 478.18,
478.34, 478.36, and 478.42, contain procedures for QIOs to use in
reconsideration of initial determinations. The information requirements
contained in these regulations are on QIOs to provide information to
parties requesting the reconsideration. These parties will use the
information as guidelines for appeal rights in instances where issues
are actively being disputed.; Form Number: CMS-R-72 (OMB:
0938-0443); Frequency: Reporting--On occasion; Affected Public:
Individuals or Households and Business or other for-profit
institutions; Number of Respondents: 2,590; Total Annual Responses:
5,228; Total Annual Hours: 2,822.
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Certification
Statement for Electronic File Interchange Organizations (EFIOS) that
Submit National Provider Identifier (NPI) Data to the National Plan and
Enumeration System; Use: The EFI process is designed to allow
organizations to submit NPI application information for large numbers
of providers in a single file. Once it has obtained and formatted the
necessary provider data, the EFIO will electronically submit the file
to NPPES for processing. As each file can contain up to approximately
100,000 records, or provider applications, the EFI process greatly
reduces the paperwork and overall administrative burden associated with
enumerating providers; Form Number: CMS-10175 (OMB: 0938-
0984); Frequency: Reporting--Other, One-time; Affected Public: Business
or other for-profit, and Not-for-profit institutions; Number of
Respondents: 1000; Total Annual Responses: 1000; Total Annual Hours:
3000.
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Survey of Newly
Eligible Medicare Beneficiaries; Use: CMS is responsible for providing
beneficiaries with the Medicare program information they need to
effectively choose the health care plan best suited to their needs. In
order to provide such information, CMS needs to know (1) Whether or not
new enrollees are aware of the choices they have, (2) what
beneficiaries understand about the basic elements of the Medicare
program, (3) what other sources currently provide Medicare-related
information, and (4) how all of these items vary across beneficiary
subpopulations. To this end, CMS must have the ability to measure over
time what beneficiaries know and understand about the Medicare program.
Measuring beneficiaries' information needs and knowledge over time will
help CMS evaluate its impact on information/education, population
changes and other initiatives; Form Number: CMS-10050 (OMB:
0938-0869); Frequency: Reporting--Quarterly; Affected Public:
Individuals or Households; Number of Respondents: 2400; Total Annual
Responses: 2400; Total Annual Hours: 800.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: SSO Report of
State Buy-in Problem and Supporting Regulations in 42 CFR 407.40; Use:
Under the State Buy-In program, States enroll certain groups of needy
people under the Part B Supplementary Medical Insurance (SMI) Program
and pay their premiums. The purpose of the ``buy-in'' is to allow the
States to provide SMI protection to certain groups of needy individuals
as part of its total assistance plan. Generally, States ``buy-in'' for
individuals who are categorically needy under Medicaid and meet the
eligibility requirements for Medicare Part B. States can also include
in their buy-in agreement those eligible for medical assistance only.
The CMS-1957 is used in the resolution of beneficiary complaints
regarding State buy-in. This form facilitates the coordination of
efforts between the SSO, State Medicaid Agencies, and CMS in the
resolution of a beneficiary's State buy-in problem; Form Number: CMS-
1957 (OMB: 0938-0035); Frequency: Reporting--On occasion;
Affected Public: Federal government, Individuals or Households, and
State, Local, and Tribal governments; Number of Respondents: 6,600;
Total Annual Responses: 6,600; Total Annual Hours: 2,366.
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Home Health
Agency Survey and Deficiencies Report, Home Health Functional
Assessment Instrument and Supporting Regulations in 42 CFR 488.26 and
442.30; Use: In order to participate in the Medicare program as a Home
Health Agency (HHA) provider, the HHA must meet Federal Standards.
These forms used to record information about patients' health and
provider compliance with requirement and report information to the
Federal Government; Form Number: CMS-1515 & 1572 (OMB: 0938-
0355); Frequency: Reporting--Annually; Affected Public: Business or
other for-profit, Individuals or Households, and Not-for-profit
institutions; Number of Respondents: 24,150; Total Annual Responses:
24,150; Total Annual Hours: 3,864.
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 June 13, 2006.
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: April 4, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E6-5408 Filed 4-13-06; 8:45 am]
BILLING CODE 4120-01-P