83 FR 40055 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 83, Issue 156 (August 13, 2018)

Page Range		40055-40055
FR Document		2018-17302

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 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 83 Issue 156 (Monday, August 13, 2018)

[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Page 40055]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17302]



[[Page 40055]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10545]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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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 other aspect of this 
collection of information, including 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 September 12, 2018.

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' website 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:

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Outcome and 
Assessment Information Set (OASIS) OASIS-C2/ICD-10; Use: This request 
is for OMB approval to modify the Outcome and Assessment Information 
Set (OASIS) that home health agencies (HHAs) are required to collect in 
order to participate in the Medicare program. CMS is seeking OMB 
approval for the proposed revised OASIS item set, referred to hereafter 
as OASIS-D, scheduled for implementation on January 1, 2019. The OASIS 
D is being modified to: include changes pursuant to the Improving 
Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act); 
accommodate data element removals to reduce burden; and improve 
formatting throughout the document. Form Number: CMS-10545 (OMB control 
number: 0938-1279); Frequency: Occasionally; Affected Public: Private 
Sector (Business or other for-profit and Not-for-profit institutions); 
Number of Respondents: 12,149; Total Annual Responses: 18,161,942; 
Total Annual Hours: 9,943,140. (For policy questions regarding this 
collection contact Joan Proctor at 410-786-0949).

    Dated: August 8, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-17302 Filed 8-10-18; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40055

DEPARTMENT OF HEALTH AND 2. Email your request, including your regarding this collection contact Joan
HUMAN SERVICES address, phone number, OMB number, Proctor at 410–786–0949).
and CMS document identifier, to Dated: August 8, 2018.
Centers for Medicare & Medicaid Paperwork@cms.hhs.gov. William N. Parham, III,
Services 3. Call the Reports Clearance Office at
Director, Paperwork Reduction Staff Office
(410) 786–1326.
of Strategic Operations and Regulatory
[Document Identifier: CMS–10545] FOR FURTHER INFORMATION CONTACT: Affairs.
Reports Clearance Office at (410) 786– [FR Doc. 2018–17302 Filed 8–10–18; 8:45 am]
Agency Information Collection 1326.
BILLING CODE 4120–01–P
Activities: Submission for OMB
SUPPLEMENTARY INFORMATION: Under the
Review; Comment Request
Paperwork Reduction Act of 1995 (PRA)
AGENCY: Centers for Medicare & (44 U.S.C. 3501–3520), federal agencies DEPARTMENT OF HEALTH AND
Medicaid Services, HHS. must obtain approval from the Office of HUMAN SERVICES
ACTION: Notice. Management and Budget (OMB) for each
collection of information they conduct Food and Drug Administration
SUMMARY: The Centers for Medicare & or sponsor. The term ‘‘collection of [Docket No. FDA–2018–D–2777]
Medicaid Services (CMS) is announcing information’’ is defined in 44 U.S.C.
an opportunity for the public to 3502(3) and 5 CFR 1320.3(c) and Expansion Cohorts: Use in First-In-
comment on CMS’ intention to collect includes agency requests or Human Clinical Trials To Expedite
information from the public. Under the requirements that members of the public Development of Oncology Drugs and
Paperwork Reduction Act of 1995 submit reports, keep records, or provide Biologics; Draft Guidance for Industry;
(PRA), federal agencies are required to information to a third party. Section Availability
publish notice in the Federal Register 3506(c)(2)(A) of the PRA (44 U.S.C.
concerning each proposed collection of 3506(c)(2)(A)) requires federal agencies AGENCY: Food and Drug Administration,
information, including each proposed to publish a 30-day notice in the HHS.
extension or reinstatement of an existing Federal Register concerning each ACTION: Notice of availability.
collection of information, and to allow proposed collection of information,
SUMMARY: The Food and Drug
a second opportunity for public including each proposed extension or
Administration (FDA or Agency) is
comment on the notice. Interested reinstatement of an existing collection
announcing the availability of a draft
persons are invited to send comments of information, before submitting the
guidance for industry entitled
regarding the burden estimate or any collection to OMB for approval. To
‘‘Expansion Cohorts: Use in First-In-
other aspect of this collection of comply with this requirement, CMS is
Human Clinical Trials to Expedite
information, including the necessity and publishing this notice that summarizes
Development of Oncology Drugs and
utility of the proposed information the following proposed collection(s) of
Biologics.’’ The purpose of this draft
collection for the proper performance of information for public comment:
guidance is to provide advice to
the agency’s functions, the accuracy of
Information Collection sponsors regarding the design and
the estimated burden, ways to enhance
1. Type of Information Collection conduct of first-in-human (FIH) clinical
the quality, utility, and clarity of the
Request: Revision of a currently trials intended to efficiently expedite
information to be collected and the use
approved collection; Title of the clinical development of cancer
of automated collection techniques or
Information Collection: Outcome and drugs, including biological products,
other forms of information technology to
Assessment Information Set (OASIS) through multiple expansion cohort
minimize the information collection
OASIS–C2/ICD–10; Use: This request is study designs.
burden.
for OMB approval to modify the DATES: Submit either electronic or
DATES:Comments on the collection(s) of Outcome and Assessment Information written comments on the draft guidance
information must be received by the Set (OASIS) that home health agencies by October 12, 2018 to ensure that the
OMB desk officer by September 12, (HHAs) are required to collect in order Agency considers your comment on this
2018. to participate in the Medicare program. draft guidance before it begins work on
ADDRESSES: When commenting on the CMS is seeking OMB approval for the the final version of the guidance.
proposed information collections, proposed revised OASIS item set, ADDRESSES: You may submit comments
please reference the document identifier referred to hereafter as OASIS–D, on any guidance at any time as follows:
or OMB control number. To be assured scheduled for implementation on
consideration, comments and January 1, 2019. The OASIS D is being Electronic Submissions
recommendations must be received by modified to: include changes pursuant Submit electronic comments in the
the OMB desk officer via one of the to the Improving Medicare Post-Acute following way:
following transmissions: OMB, Office of Care Transformation Act of 2014 (the • Federal eRulemaking Portal:
Information and Regulatory Affairs, IMPACT Act); accommodate data https://www.regulations.gov. Follow the
Attention: CMS Desk Officer, Fax element removals to reduce burden; and instructions for submitting comments.
Number: (202) 395–5806 OR, Email: improve formatting throughout the Comments submitted electronically,
OIRA_submission@omb.eop.gov. document. Form Number: CMS–10545 including attachments, to https://
To obtain copies of a supporting (OMB control number: 0938–1279); www.regulations.gov will be posted to
sradovich on DSK3GMQ082PROD with NOTICES

statement and any related forms for the Frequency: Occasionally; Affected the docket unchanged. Because your
proposed collection(s) summarized in Public: Private Sector (Business or other comment will be made public, you are
this notice, you may make your request for-profit and Not-for-profit solely responsible for ensuring that your
using one of following: institutions); Number of Respondents: comment does not include any
1. Access CMS’ website address at 12,149; Total Annual Responses: confidential information that you or a
http://www.cms.hhs.gov/Paperwork 18,161,942; Total Annual Hours: third party may not wish to be posted,
ReductionActof1995. 9,943,140. (For policy questions such as medical information, your or

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Document Created: 2018-08-11 00:27:38
Document Modified: 2018-08-11 00:27:38

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 September 12, 2018.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		83 FR 40055

83 FR 40055 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 156 (August 13, 2018)

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