81 FR 60704 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 171 (September 2, 2016)

Page Range		60704-60705
FR Document		2016-21201

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: 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.

Federal Register, Volume 81 Issue 171 (Friday, September 2, 2016)

[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60704-60705]
From the Federal Register Online  [www.thefederalregister.org]
[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: 
[email protected].
    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 http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    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

Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices 60705

other aspect of this collection of comply with this requirement, CMS is complaint category. Specifically, the
information, including any of the publishing this notice that summarizes information collection revisions clarify
following subjects: The necessity and the following proposed collection(s) of the ‘‘Identify the HIPAA Non-Privacy/
utility of the proposed information information for public comment: Security complaint category’’ section of
collection for the proper performance of 1. Type of Information Collection the complaint form. In this section,
the agency’s functions; the accuracy of Request: Extension of a currently complainants are given an opportunity
the estimated burden; ways to enhance approved collection; Title of to check the ‘‘Unique Identifiers’’ and
the quality, utility, and clarity of the Information Collection: Examination ‘‘Operating Rules’’ option to
information to be collected; and the use and Treatment for Emergency Medical additionally categorize the type of
of automated collection techniques or Conditions and Women in Labor; Use: HIPAA complaint being filed. The
other forms of information technology to Pursuant to regulation sections 488.18, revised form now includes an option for
minimize the information collection 489.20 and 489.24, during Medicare identifying Unique Identifier and
burden. surveys of hospitals and State agencies Operating Rules complaints. It also
CMS will review hospital records for requests email information about filed
DATES: Comments on the collection(s) of lists of on-call physicians, and will
information must be received by the against entities, if available. Form
review and obtain the information Number: CMS–10148 (OMB control
OMB desk officer by October 3, 2016. which must be recorded on hospital number: 0938–0948); Frequency:
ADDRESSES: When commenting on the medical records for individuals with Occasionally; Affected Public:
proposed information collections, emergency medical conditions and Individuals; Number of Respondents:
please reference the document identifier women in labor, and the emergency 500; Total Annual Responses: 500; Total
or OMB control number. To be assured department reporting information Annual Hours: 500. (For policy
consideration, comments and Medicare participating hospitals and questions regarding this collection
recommendations must be received by Medicare State survey agencies must contact Cecily Austin at 410–786–0895.)
the OMB desk officer via one of the pass on to CMS. Additionally, CMS will
following transmissions: OMB, Office of use the QIO Report assessing whether Dated: August 30, 2016.
Information and Regulatory Affairs, an individual had an emergency William N. Parham, III,
Attention: CMS Desk Officer, Fax condition and whether the individual Director, Paperwork Reduction Staff, Office
Number: (202) 395–5806 OR, Email: was stabilized to determine whether to of Strategic Operations and Regulatory
OIRA_submission@omb.eop.gov. impose a CMP or physician exclusion Affairs.
To obtain copies of a supporting sanctions. Without such information, [FR Doc. 2016–21201 Filed 9–1–16; 8:45 am]
statement and any related forms for the CMS will be unable to make the hospital BILLING CODE 4120–01–P
proposed collection(s) summarized in emergency services compliance
this notice, you may make your request determinations that Congress expects
using one of following: CMS to make under sections 1154, 1866 DEPARTMENT OF HEALTH AND
1. Access CMS’ Web site address at and 1867 of the Act. Form Number: HUMAN SERVICES
http://www.cms.hhs.gov/ CMS–R–142 (OMB control number:
0938–0667); Frequency: Occasionally; Food and Drug Administration
PaperworkReductionActof1995.
2. Email your request, including your Affected Public: Private Sector; Number [Docket No. FDA–2013–N–0450]
address, phone number, OMB number, of Respondents: 6,149; Total Annual
and CMS document identifier, to Responses: 6,149; Total Annual Hours: Agency Information Collection
Paperwork@cms.hhs.gov. 1. (For policy questions regarding this Activities; Submission for Office of
3. Call the Reports Clearance Office at collection contact Renate Dombrowski Management and Budget Review;
(410) 786–1326. at 410–786–4645.) Comment Request; Abbreviated New
FOR FURTHER INFORMATION CONTACT:
2. Type of Information Collection Animal Drug Applications
Reports Clearance Office at (410) 786– Request: Reinstatement with change of a
AGENCY: Food and Drug Administration,
1326. previously approved collection; Title of
Information Collection: HIPAA HHS.
SUPPLEMENTARY INFORMATION: Under the Administrative Simplification ACTION: Notice.
Paperwork Reduction Act of 1995 (PRA) Complaint Form; Use: The Health
(44 U.S.C. 3501–3520), federal agencies SUMMARY: The Food and Drug
Insurance Portability and
must obtain approval from the Office of Administration (FDA) is announcing
Accountability Act (HIPAA) became law
Management and Budget (OMB) for each that a proposed collection of
in 1996 (Pub. L. 104–191). Subtitle F of
collection of information they conduct information has been submitted to the
Title II of HIPAA, titled ‘‘Administrative
or sponsor. The term ‘‘collection of Office of Management and Budget
Simplification,’’ (A.S.) requires the
information’’ is defined in 44 U.S.C. (OMB) for review and clearance under
Secretary of HHS to adopt national
3502(3) and 5 CFR 1320.3(c) and the Paperwork Reduction Act of 1995.
standards for certain information-related
includes agency requests or activities of the health care industry. DATES: Fax written comments on the
requirements that members of the public The HIPAA provisions, by statute, apply collection of information by October 3,
submit reports, keep records, or provide only to ‘‘covered entities’’ referred to in 2016.
information to a third party. Section section 1320d–2(a)(1) of this title. ADDRESSES: To ensure that comments on
3506(c)(2)(A) of the PRA (44 U.S.C. Responsibility for administering and the information collection are received,
3506(c)(2)(A)) requires federal agencies enforcing the HIPAA A.S. Transactions, OMB recommends that written
mstockstill on DSK3G9T082PROD with NOTICES

to publish a 30-day notice in the Code Sets, Identifiers has been comments be faxed to the Office of
Federal Register concerning each delegated to the Centers for Medicare & Information and Regulatory Affairs,
proposed collection of information, Medicaid Services (CMS). This updated OMB, Attn: FDA Desk Officer, FAX:
including each proposed extension or information collection will be used to 202–395–7285, or emailed to oira_
reinstatement of an existing collection initiate enforcement actions. submission@omb.eop.gov. All
of information, before submitting the This reinstatement request clarifies comments should be identified with the
collection to OMB for approval. To the removal of the HIPAA Security OMB control number 0910–0669. Also

VerDate Sep<11>2014 18:25 Sep 01, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1

Document Created: 2018-02-09 11:55:18
Document Modified: 2018-02-09 11:55:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the collection(s) of information must be received by the OMB desk officer by October 3, 2016.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 60704

81 FR 60704 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 171 (September 2, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services