Agency Information Collection Activities: Submission for OMB Review; Comment Request, 40055 [2018-17302]
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Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
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
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
(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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by September 12,
2018.
DATES:
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’ website address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
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ADDRESSES:
VerDate Sep<11>2014
20:42 Aug 10, 2018
Jkt 244001
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:
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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
40055
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2777]
Expansion Cohorts: Use in First-InHuman Clinical Trials To Expedite
Development of Oncology Drugs and
Biologics; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Expansion Cohorts: Use in First-InHuman Clinical Trials to Expedite
Development of Oncology Drugs and
Biologics.’’ The purpose of this draft
guidance is to provide advice to
sponsors regarding the design and
conduct of first-in-human (FIH) clinical
trials intended to efficiently expedite
the clinical development of cancer
drugs, including biological products,
through multiple expansion cohort
study designs.
DATES: Submit either electronic or
written comments on the draft guidance
by October 12, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Page 40055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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 https://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
