Agency Information Collection Activities: Submission for OMB Review; Comment Request, 60704-60705 [2016-21201]
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60704
Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–21103 Filed 9–1–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10476]
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: The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
the accuracy of the estimated burden;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
November 1, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
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.
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SUMMARY:
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18:25 Sep 01, 2016
Jkt 238001
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).
CMS–10476 Medical Loss Ratio (MLR)
Report for Medicare Advantage (MA)
Plans and Prescription Drug Plans
(PDP)
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 Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
PO 00000
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Sfmt 4703
Information Collection: Medical Loss
Ratio (MLR) Report for Medicare
Advantage (MA) Plans and Prescription
Drug Plans (PDP); Use: We will use the
data collection of annual reports
provided by plan sponsors for each
contract to ensure that beneficiaries are
receiving value for their premium dollar
by calculating each contract’s medical
loss ratio (MLR) and any remittances
due for the respective MLR reporting
year. The recordkeeping requirements
will be used to determine plan sponsors’
compliance with the MLR requirements,
including compliance with how plan
sponsors’ experience is to be reported,
and how their MLR and any remittances
are calculated. Form Number: CMS–
10476 (OMB control number: 0938–
1232); Frequency: Yearly; Affected
Public: Private sector (Business or other
for-profits and Not-for-profit
institutions); Number of Respondents:
616; Total Annual Responses: 616; Total
Annual Hours: 130,004. (For policy
questions regarding this collection
contact Diane Spitalnic at 410–786–
5745.)
Dated: August 30, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–21199 Filed 9–1–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–142 and
CMS–10148]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services.
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
(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
SUMMARY:
E:\FR\FM\02SEN1.SGM
02SEN1
Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
other aspect of this collection of
information, including any of the
following subjects: The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; the accuracy of
the estimated burden; ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by October 3, 2016.
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.
DATES:
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
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
mstockstill on DSK3G9T082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:25 Sep 01, 2016
Jkt 238001
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: Extension of a currently
approved collection; Title of
Information Collection: Examination
and Treatment for Emergency Medical
Conditions and Women in Labor; Use:
Pursuant to regulation sections 488.18,
489.20 and 489.24, during Medicare
surveys of hospitals and State agencies
CMS will review hospital records for
lists of on-call physicians, and will
review and obtain the information
which must be recorded on hospital
medical records for individuals with
emergency medical conditions and
women in labor, and the emergency
department reporting information
Medicare participating hospitals and
Medicare State survey agencies must
pass on to CMS. Additionally, CMS will
use the QIO Report assessing whether
an individual had an emergency
condition and whether the individual
was stabilized to determine whether to
impose a CMP or physician exclusion
sanctions. Without such information,
CMS will be unable to make the hospital
emergency services compliance
determinations that Congress expects
CMS to make under sections 1154, 1866
and 1867 of the Act. Form Number:
CMS–R–142 (OMB control number:
0938–0667); Frequency: Occasionally;
Affected Public: Private Sector; Number
of Respondents: 6,149; Total Annual
Responses: 6,149; Total Annual Hours:
1. (For policy questions regarding this
collection contact Renate Dombrowski
at 410–786–4645.)
2. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: HIPAA
Administrative Simplification
Complaint Form; Use: The Health
Insurance Portability and
Accountability Act (HIPAA) became law
in 1996 (Pub. L. 104–191). Subtitle F of
Title II of HIPAA, titled ‘‘Administrative
Simplification,’’ (A.S.) requires the
Secretary of HHS to adopt national
standards for certain information-related
activities of the health care industry.
The HIPAA provisions, by statute, apply
only to ‘‘covered entities’’ referred to in
section 1320d–2(a)(1) of this title.
Responsibility for administering and
enforcing the HIPAA A.S. Transactions,
Code Sets, Identifiers has been
delegated to the Centers for Medicare &
Medicaid Services (CMS). This updated
information collection will be used to
initiate enforcement actions.
This reinstatement request clarifies
the removal of the HIPAA Security
PO 00000
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Fmt 4703
Sfmt 4703
60705
complaint category. Specifically, the
information collection revisions clarify
the ‘‘Identify the HIPAA Non-Privacy/
Security complaint category’’ section of
the complaint form. In this section,
complainants are given an opportunity
to check the ‘‘Unique Identifiers’’ and
‘‘Operating Rules’’ option to
additionally categorize the type of
HIPAA complaint being filed. The
revised form now includes an option for
identifying Unique Identifier and
Operating Rules complaints. It also
requests email information about filed
against entities, if available. Form
Number: CMS–10148 (OMB control
number: 0938–0948); Frequency:
Occasionally; Affected Public:
Individuals; Number of Respondents:
500; Total Annual Responses: 500; Total
Annual Hours: 500. (For policy
questions regarding this collection
contact Cecily Austin at 410–786–0895.)
Dated: August 30, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–21201 Filed 9–1–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0450]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Abbreviated New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 3,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0669. Also
SUMMARY:
E:\FR\FM\02SEN1.SGM
02SEN1
]]>Agencies
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60704-60705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21201]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-142 and CMS-10148]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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 (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
[[Page 60705]]
other aspect of this collection of information, including any of the
following subjects: The necessity and utility of the proposed
information collection for the proper performance of the agency's
functions; the accuracy of the estimated burden; ways to enhance the
quality, utility, and clarity of the information to be collected; and
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 October 3, 2016.
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
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: Extension of a currently
approved collection; Title of Information Collection: Examination and
Treatment for Emergency Medical Conditions and Women in Labor; Use:
Pursuant to regulation sections 488.18, 489.20 and 489.24, during
Medicare surveys of hospitals and State agencies CMS will review
hospital records for lists of on-call physicians, and will review and
obtain the information which must be recorded on hospital medical
records for individuals with emergency medical conditions and women in
labor, and the emergency department reporting information Medicare
participating hospitals and Medicare State survey agencies must pass on
to CMS. Additionally, CMS will use the QIO Report assessing whether an
individual had an emergency condition and whether the individual was
stabilized to determine whether to impose a CMP or physician exclusion
sanctions. Without such information, CMS will be unable to make the
hospital emergency services compliance determinations that Congress
expects CMS to make under sections 1154, 1866 and 1867 of the Act. Form
Number: CMS-R-142 (OMB control number: 0938-0667); Frequency:
Occasionally; Affected Public: Private Sector; Number of Respondents:
6,149; Total Annual Responses: 6,149; Total Annual Hours: 1. (For
policy questions regarding this collection contact Renate Dombrowski at
410-786-4645.)
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: HIPAA Administrative Simplification Complaint Form; Use:
The Health Insurance Portability and Accountability Act (HIPAA) became
law in 1996 (Pub. L. 104-191). Subtitle F of Title II of HIPAA, titled
``Administrative Simplification,'' (A.S.) requires the Secretary of HHS
to adopt national standards for certain information-related activities
of the health care industry. The HIPAA provisions, by statute, apply
only to ``covered entities'' referred to in section 1320d-2(a)(1) of
this title. Responsibility for administering and enforcing the HIPAA
A.S. Transactions, Code Sets, Identifiers has been delegated to the
Centers for Medicare & Medicaid Services (CMS). This updated
information collection will be used to initiate enforcement actions.
This reinstatement request clarifies the removal of the HIPAA
Security complaint category. Specifically, the information collection
revisions clarify the ``Identify the HIPAA Non-Privacy/Security
complaint category'' section of the complaint form. In this section,
complainants are given an opportunity to check the ``Unique
Identifiers'' and ``Operating Rules'' option to additionally categorize
the type of HIPAA complaint being filed. The revised form now includes
an option for identifying Unique Identifier and Operating Rules
complaints. It also requests email information about filed against
entities, if available. Form Number: CMS-10148 (OMB control number:
0938-0948); Frequency: Occasionally; Affected Public: Individuals;
Number of Respondents: 500; Total Annual Responses: 500; Total Annual
Hours: 500. (For policy questions regarding this collection contact
Cecily Austin at 410-786-0895.)
Dated: August 30, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-21201 Filed 9-1-16; 8:45 am]
BILLING CODE 4120-01-P
