Agency Information Collection Activities: Proposed Collection; Comment Request, 1872-1873 [2014-00195]
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Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the 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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by February 10, 2014:
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. The term ‘‘collection of
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:40 Jan 09, 2014
Jkt 232001
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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Healthcare
Fraud Prevention Partnership (HFPP):
Data Sharing and Information Exchange;
Use: Section 1128C(a)(2) of the Social
Security Act (42 U.S.C. 1320a–7c(a)(2))
authorizes the Secretary and the
Attorney General to consult with, and
arrange for the sharing of data with
representatives of health plans to
establish a Fraud and Abuse Control
Program as specified in Section
1128(C)(a)(1) of the Social Security Act.
This is known as the Healthcare Fraud
Prevention Partnership (HFPP). It was
officially established by a Charter in fall
2012 and signed by HHS Secretary
Sibelius and US Attorney General
Holder. The HFPP is a joint initiative
established by the Department of Health
and Human Services (HHS) and
Department of Justice (DOJ) to detect
and prevent the prevalence of
healthcare fraud through data and
information-sharing and applying
analytic capabilities by the public and
private sectors. The HFPP collaboration
provides a unique opportunity to
transition from traditional ‘‘pay and
chase’’ approaches for fraud detection
and recovery towards a data-driven
model for identifying and predicting
aberrant activity. A central goal of the
HFPP is to identify the optimal way to
coordinate nationwide sharing of health
care claims information, including
aggregating claims and payment
information from large public healthcare
programs and private insurance payers.
In addition to sharing data and
information, the HFPP is focused on
advancing analytics, training, outreach,
education to support anti-fraud efforts
and achieving its objectives, primarily
through goal-oriented, well-designed
fraud studies. Form Number: CMS–
10501 (OCN: 0938–New); Frequency:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Occasionally; Affected Public: Private
sector (Business or other for-profits);
Number of Respondents: 75; Total
Annual Responses: 75; Total Annual
Hours: 180,000. (For policy questions
regarding this collection contact
Johnalyn Lyles at 410–786–8410.)
Dated: January 6, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–00188 Filed 1–9–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–102 and 105,
and CMS–10209]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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.
SUMMARY:
Comments must be received by
March 11, 2014.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). To be
assured consideration, comments and
DATES:
E:\FR\FM\10JAN1.SGM
10JAN1
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send 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) that are 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 ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
mstockstill on DSK4VPTVN1PROD with NOTICES
CMS–102 and 105 Clinical Laboratory
Improvement Amendments of 1988
(CLIA) Budget Workload Reports and
Supporting Regulations
CMS–10209 Medicare Advantage
Chronic Care Improvement Program
(CCIP) and Quality Improvement (QI)
Project Reporting Tools
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.
The term ‘‘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
requires federal agencies to publish a
VerDate Mar<15>2010
16:40 Jan 09, 2014
Jkt 232001
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collections
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;
Use: We will use the collected
information 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 multipurpose 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. Our
regional offices also use the information
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 (OCN: 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 Angela
Stancel at 410–786–4876.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Advantage Chronic Care Improvement
Program (CCIP) and Quality
Improvement (QI) Project Reporting
Tools; Use: Medicare Advantage
Organizations (MAOs) are required to
have an ongoing quality improvement
(QI) program that meets our
requirements and includes at least one
chronic care improvement program
(CCIP) and one QI Project. Every MAO
must have a QI program that monitors
and identifies areas where
implementing appropriate interventions
would improve patient outcomes and
patient safety. Information collected
using the CCIP and QIP reporting tools
is an integral resource for oversight,
monitoring, compliance, and auditing
activities necessary to ensure high
quality value-based health care for
Medicare beneficiaries. Form Number:
CMS–10209 (OCN: 0938–1023);
PO 00000
Frm 00055
Fmt 4703
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1873
Frequency: Yearly; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 1,904; Total
Annual Responses: 1,904; Total Annual
Hours: 28,560. (For policy questions
regarding this collection contact Ellen
Dieujuste at 410–786–2191).
Dated: January 6, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–00195 Filed 1–9–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1630]
Draft Guidance for Industry on
Qualification of Exacerbations of
Chronic Pulmonary Disease Tool for
Measurement of Symptoms of Acute
Bacterial Exacerbation of Chronic
Bronchitis in Patients With Chronic
Obstructive Pulmonary Disease;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Qualification of
Exacerbations of Chronic Pulmonary
Disease Tool for Measurement of
Symptoms of Acute Bacterial
Exacerbation of Chronic Bronchitis in
Patients with Chronic Obstructive
Pulmonary Disease.’’ This draft
guidance provides a statement of
qualification for the Exacerbations of
Chronic Pulmonary Disease Tool
(EXACT) patient-reported outcome
instrument and summarizes the concept
of interest and context of use (COU) for
which the tool is qualified through the
Center for Drug Evaluation and
Research’s (CDER’s) drug development
tool (DDT) qualification program.
Qualification of the EXACT represents a
conclusion that, within the stated COU,
the instrument can be relied on to have
a specific interpretation and application
in drug development and regulatory
review. This draft guidance is an
attachment to the guidance for industry
entitled ‘‘Qualification Process for Drug
Development Tools.’’
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
SUMMARY:
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1872-1873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00195]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-102 and 105, and CMS-10209]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. 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 or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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.
DATES: Comments must be received by March 11, 2014.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
[[Page 1873]]
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send 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) that are 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.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-102 and 105 Clinical Laboratory Improvement Amendments of 1988
(CLIA) Budget Workload Reports and Supporting Regulations
CMS-10209 Medicare Advantage Chronic Care Improvement Program (CCIP)
and Quality Improvement (QI) Project Reporting Tools
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. The term
``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 requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collections
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; Use: We will use the
collected information 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. Our regional
offices also use the information 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 (OCN: 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 Angela Stancel at 410-786-4876.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Advantage Chronic Care Improvement Program (CCIP) and Quality
Improvement (QI) Project Reporting Tools; Use: Medicare Advantage
Organizations (MAOs) are required to have an ongoing quality
improvement (QI) program that meets our requirements and includes at
least one chronic care improvement program (CCIP) and one QI Project.
Every MAO must have a QI program that monitors and identifies areas
where implementing appropriate interventions would improve patient
outcomes and patient safety. Information collected using the CCIP and
QIP reporting tools is an integral resource for oversight, monitoring,
compliance, and auditing activities necessary to ensure high quality
value-based health care for Medicare beneficiaries. Form Number: CMS-
10209 (OCN: 0938-1023); Frequency: Yearly; Affected Public: Private
sector (Business or other for-profits and Not-for-profit institutions);
Number of Respondents: 1,904; Total Annual Responses: 1,904; Total
Annual Hours: 28,560. (For policy questions regarding this collection
contact Ellen Dieujuste at 410-786-2191).
Dated: January 6, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-00195 Filed 1-9-14; 8:45 am]
BILLING CODE 4120-01-P
