Agency Information Collection Activities: Proposed Collection; Comment Request, 79000-79001 [2010-31541]
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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices
entitlement to Part A and
Supplementary Medical Insurance (Part
B). Form Number: CMS–18F5 (OMB#:
0938–0251); Frequency: Once; Affected
Public: Individuals or households;
Number of Respondents: 50,000; Total
Annual Responses: 50,000; Total
Annual Hours: 12,495. (For policy
questions regarding this collection
contact Naomi Rappaport at 410–786–
2175. For all other issues call 410–786–
1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Clinical
Laboratory Improvement Amendment
(CLIA) of 1988 and Supporting
Regulations in 42 CFR 493.1–.2001; Use:
The information collection requirements
in 42 CFR part 493 outline the
requirements necessary to determine an
entity’s compliance with CLIA. CLIA
requires laboratories that perform
testing on human beings to meet
performance requirements (quality
standards) in order to be certified by the
Department of Health and Human
Services (DHHS). DHHS conducts
inspections to determine a laboratory’s
compliance with CLIA requirements.
CLIA implements the certificate,
laboratory standards and inspection
requirements; Form Number:
CMS–R–26 (OMB#: 0938–0612);
Frequency: Occasionally; Affected
Public: Federal Government; State,
Local, or Tribal Governments; Private
Sector: Business or other for-profits and
not-for-profit institutions; Number of
Respondents: 168,688; Total Annual
Responses: 756,240; Total Annual
Hours: 11,363,280. (For policy questions
regarding this collection contact Raelene
Perfetto at 410–786–6876. For all other
issues call 410–786–1326.)
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.
on January 18, 2011.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974.
E-mail: OIRA_submission@omb.eop.gov.
VerDate Mar<15>2010
16:45 Dec 16, 2010
Jkt 223001
Dated: December 10, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–31599 Filed 12–16–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–102 and CMS–
105, CMS–10241, CMS–10261, CMS–10185,
and CMS–10340]
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: Extension without change of a
currently approved collection; Title of
Information Collection: Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Budget Workload
Reports and Supporting Regulations in
42 CFR 493.1-.2001; Use: The collected
information will be used by CMS to
determine the amount of Federal
reimbursement for surveys conducted.
Use of the information includes program
evaluation, audit, budget formulation
and budget approval. Form CMS–102 is
a multi-purpose form designed to
capture and record all budget and
expenditure data. Form CMS–105
captures the annual projected CLIA
workload that the State survey agency
will accomplish. It is also used by the
CMS regional office to approve the
annual projected CLIA workload. The
AGENCY:
PO 00000
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Sfmt 4703
information is required as part of the
section 1864 agreement with the State;
Form Numbers: CMS–102 and CMS–105
(OMB#: 0938–0599); Frequency:
Quarterly; Affected Public: State, Local,
or Tribal Governments; Number of
Respondents: 50; Total Annual
Responses: 50; Total Annual Hours:
4,500. (For policy questions regarding
this collection contact Carla Ausby at
410–786–2153. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Annual State
Report and Annual State Performance
Rankings; Use: Section 6001(f) of the
Deficit Reduction Act (DRA) requires
CMS to contract with a vendor to
conduct a monthly national survey of
retail prescription drug prices and to
report the prices to the States. These
national average prices may be used as
a benchmark by the States for the
management of their prescription drug
programs. The DRA also requires that
the States submit pricing information
for the 50 most widely prescribed drugs
so that the States’ prices can be
compared to the national average prices
obtained from the survey. The States
pricing information will be compared
and the States will be ranked. The Act
also requires that States report their
drug utilization rates for noninnovator
multiple source (generic) drugs, their
payment rates under their State plan,
and their dispensing fees. The template
has been developed to facilitate data
collection; Form Number: CMS–10241
(OMB#: 0938–1041); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 51; Total
Annual Hours: 765. (For policy
questions regarding this collection
contact Joseph Fine at 410–786–2128.
For all other issues call 410–786–1326.)
3. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Part C Medicare Advantage
(MA) Reporting Requirements and
Supporting Regulations; Use: CMS has
authority to establish reporting
requirements for Medicare Advantage
Organizations (MAO’s) as described in
42 CFR § 422.516 (a). Each MAO must
have an effective procedure to develop,
compile, evaluate, and report to CMS, to
its enrollees, and to the general public,
at the times and in the manner that CMS
requires, and while safeguarding the
confidentiality of the doctor-patient
relationship, statistics and other
information with respect to the cost of
its operations, patterns of service
utilization, availability, accessibility,
E:\FR\FM\17DEN1.SGM
17DEN1
emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices
and acceptability of its services,
developments in the health status of its
enrollees, and other matters that CMS
may require. Data collected via
Medicare Part C Reporting
Requirements will be an integral
resource for oversight, monitoring,
compliance and auditing activities
necessary to ensure quality provision of
the benefits provided by MA plans to
enrollees. Form Number: CMS–10261
(OMB# 0938–1054); Frequency: Yearly,
Quarterly; Affected Public: Business or
other for-profits; Number of
Respondents: 588; Total Annual
Responses: 1158; Total Annual Hours:
245,528. (For policy questions regarding
this collection contact Terry Leid at
410–786–8973. For all other issues call
410–786–1326.)
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Part D
Reporting Requirements and Supporting
Regulations; Use: 42 CFR part 423,
§ 423.514, requires each Part D Sponsor
to have an effective procedure to
provide statistics indicating: the cost of
its operations, the patterns of utilization
of its services, the availability,
accessibility, and acceptability of its
services, information demonstrating it
has a fiscally sound operation and other
matters as required by CMS. In addition,
subsection 423.505 of the Medicare
Prescription Drug, Improvement, and
Modernization Act (MMA), establishes
as a contract provision that Part D
Sponsors must comply with the
reporting requirements for submitting
drug claims and related information to
CMS. Data collected via Medicare Part
D Reporting Requirements will be an
integral resource for oversight,
monitoring, compliance and auditing
activities necessary to ensure quality
provision of the Medicare Prescription
Drug Benefit to beneficiaries. Data will
be validated, analyzed, and utilized for
trend reporting by the Division of
Clinical and Operational Performance
(DCOP) within the Medicare Drug
Benefit Group. Form Number: CMS–
10185 (OMB#: 0938–0992); Frequency:
Yearly, Quarterly, Semi-Annually;
Affected Public: Private sector, business
or other for-profit; Number of
Respondents: 2993; Total Annual
Responses: 48,490; Total Annual Hours:
128,754. (For policy questions regarding
this collection contact LaToyia Grant at
410–786–5434. For all other issues call
410–786–1326.)
5. Type of Information Collection
Request: New collection; Title of
Information Collection: Collection of
Encounter Data from Medicare
Advantage Organizations; Use: The
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16:45 Dec 16, 2010
Jkt 223001
Centers for Medicare and Medicaid
Services (CMS) intends to collect
encounter data, or data on each item or
service delivered to an enrollee, from
Medicare Advantage Organizations.
Medicare Advantage organizations will
obtain this data from providers. CMS
would collect the data electronically
from Medicare Advantage Organizations
via the Health Insurance Portability and
Accountability Act (HIPAA) compliant
standard Health Care Claims
transactions for professional data and
institutional data. The information is
used to submit health care claims or
equivalent health encounter
information, carry out health plan
enrollments and disenrollments,
determine health plan eligibility, send
and receive health care payment and
remittance advices, transmit health plan
premium payments, determine health
care claim status, provide referral
certifications and authorizations, and
coordinate the benefits for individuals
who have more than one health plan.
Form Number: CMS–10340 (OMB#:
0938–New); Frequency: Weekly;
Affected Public: Private sector;
businesses or other for-profits; Number
of Respondents: 678; Total Annual
Responses: 384,041,063; Total Annual
Hours: 768. (For policy questions
regarding this collection contact Sean
Creighton at 410–786–9302 or Deondra
Moseley at 410–786–4577. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
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.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by February 15, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
79001
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: December 10, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–31541 Filed 12–16–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0627]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Food and Drug Administration
Approval to Market a New Drug
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
requirements governing applications for
FDA approval to market a new drug.
DATES: Submit either electronic or
written comments on the collection of
information by February 15, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to: 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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
SUMMARY:
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79000-79001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-102 and CMS-105, CMS-10241, CMS-10261, CMS-
10185, and CMS-10340]
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: Extension without change
of a currently approved collection; Title of Information Collection:
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Budget
Workload Reports and Supporting Regulations in 42 CFR 493.1-.2001; Use:
The collected information will be used by CMS to determine the amount
of Federal reimbursement for surveys conducted. Use of the information
includes program evaluation, audit, budget formulation and budget
approval. Form CMS-102 is a multi-purpose form designed to capture and
record all budget and expenditure data. Form CMS-105 captures the
annual projected CLIA workload that the State survey agency will
accomplish. It is also used by the CMS regional office to approve the
annual projected CLIA workload. The information is required as part of
the section 1864 agreement with the State; Form Numbers: CMS-102 and
CMS-105 (OMB: 0938-0599); Frequency: Quarterly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 50;
Total Annual Responses: 50; Total Annual Hours: 4,500. (For policy
questions regarding this collection contact Carla Ausby at 410-786-
2153. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Annual State Report and Annual State Performance Rankings; Use: Section
6001(f) of the Deficit Reduction Act (DRA) requires CMS to contract
with a vendor to conduct a monthly national survey of retail
prescription drug prices and to report the prices to the States. These
national average prices may be used as a benchmark by the States for
the management of their prescription drug programs. The DRA also
requires that the States submit pricing information for the 50 most
widely prescribed drugs so that the States' prices can be compared to
the national average prices obtained from the survey. The States
pricing information will be compared and the States will be ranked. The
Act also requires that States report their drug utilization rates for
noninnovator multiple source (generic) drugs, their payment rates under
their State plan, and their dispensing fees. The template has been
developed to facilitate data collection; Form Number: CMS-10241
(OMB: 0938-1041); Frequency: Yearly; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 51; Total Annual
Responses: 51; Total Annual Hours: 765. (For policy questions regarding
this collection contact Joseph Fine at 410-786-2128. For all other
issues call 410-786-1326.)
3. Type of Information Collection Request: Revision of currently
approved collection; Title of Information Collection: Part C Medicare
Advantage (MA) Reporting Requirements and Supporting Regulations; Use:
CMS has authority to establish reporting requirements for Medicare
Advantage Organizations (MAO's) as described in 42 CFR Sec. 422.516
(a). Each MAO must have an effective procedure to develop, compile,
evaluate, and report to CMS, to its enrollees, and to the general
public, at the times and in the manner that CMS requires, and while
safeguarding the confidentiality of the doctor-patient relationship,
statistics and other information with respect to the cost of its
operations, patterns of service utilization, availability,
accessibility,
[[Page 79001]]
and acceptability of its services, developments in the health status of
its enrollees, and other matters that CMS may require. Data collected
via Medicare Part C Reporting Requirements will be an integral resource
for oversight, monitoring, compliance and auditing activities necessary
to ensure quality provision of the benefits provided by MA plans to
enrollees. Form Number: CMS-10261 (OMB 0938-1054); Frequency:
Yearly, Quarterly; Affected Public: Business or other for-profits;
Number of Respondents: 588; Total Annual Responses: 1158; Total Annual
Hours: 245,528. (For policy questions regarding this collection contact
Terry Leid at 410-786-8973. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Part D
Reporting Requirements and Supporting Regulations; Use: 42 CFR part
423, Sec. 423.514, requires each Part D Sponsor to have an effective
procedure to provide statistics indicating: the cost of its operations,
the patterns of utilization of its services, the availability,
accessibility, and acceptability of its services, information
demonstrating it has a fiscally sound operation and other matters as
required by CMS. In addition, subsection 423.505 of the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA),
establishes as a contract provision that Part D Sponsors must comply
with the reporting requirements for submitting drug claims and related
information to CMS. Data collected via Medicare Part D Reporting
Requirements will be an integral resource for oversight, monitoring,
compliance and auditing activities necessary to ensure quality
provision of the Medicare Prescription Drug Benefit to beneficiaries.
Data will be validated, analyzed, and utilized for trend reporting by
the Division of Clinical and Operational Performance (DCOP) within the
Medicare Drug Benefit Group. Form Number: CMS-10185 (OMB:
0938-0992); Frequency: Yearly, Quarterly, Semi-Annually; Affected
Public: Private sector, business or other for-profit; Number of
Respondents: 2993; Total Annual Responses: 48,490; Total Annual Hours:
128,754. (For policy questions regarding this collection contact
LaToyia Grant at 410-786-5434. For all other issues call 410-786-1326.)
5. Type of Information Collection Request: New collection; Title of
Information Collection: Collection of Encounter Data from Medicare
Advantage Organizations; Use: The Centers for Medicare and Medicaid
Services (CMS) intends to collect encounter data, or data on each item
or service delivered to an enrollee, from Medicare Advantage
Organizations. Medicare Advantage organizations will obtain this data
from providers. CMS would collect the data electronically from Medicare
Advantage Organizations via the Health Insurance Portability and
Accountability Act (HIPAA) compliant standard Health Care Claims
transactions for professional data and institutional data. The
information is used to submit health care claims or equivalent health
encounter information, carry out health plan enrollments and
disenrollments, determine health plan eligibility, send and receive
health care payment and remittance advices, transmit health plan
premium payments, determine health care claim status, provide referral
certifications and authorizations, and coordinate the benefits for
individuals who have more than one health plan. Form Number: CMS-10340
(OMB: 0938-New); Frequency: Weekly; Affected Public: Private
sector; businesses or other for-profits; Number of Respondents: 678;
Total Annual Responses: 384,041,063; Total Annual Hours: 768. (For
policy questions regarding this collection contact Sean Creighton at
410-786-9302 or Deondra Moseley at 410-786-4577. For all other issues
call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web Site 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.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by February 15, 2011:
1. Electronically. You may submit your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
Dated: December 10, 2010.
Martique Jones,
Director, Regulations Development Division-B, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2010-31541 Filed 12-16-10; 8:45 am]
BILLING CODE 4120-01-P
