Submission for OMB Review; Comment Request, 8484-8485 [2018-03976]
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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices
for the entire information collection, we
are also seeking approval for the
provisions that were set out in the
proposed rule. Form Number: CMS–R–
267 (OMB control number: 0938–0753);
Frequency: Yearly; Affected Public:
Individuals or households and Business
or other for-profits; Number of
Respondents: 13,958,526; Total Annual
Responses: 35,596,762; Total Annual
Hours: 8,529,541. (For policy questions
regarding this collection contact Russell
Hendel at 410–786–0329.)
Dated: February 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–03972 Filed 2–26–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10536]
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
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SUMMARY:
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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 March 29, 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:
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.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
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:
William Parham at (410) 786–4669.
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:
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1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid
Eligibility and Enrollment (EE)
Implementation Advanced Planning
Document (IAPD) Template; Use: To
assess the appropriateness of states’
requests for enhanced federal financial
participation for expenditures related to
Medicaid eligibility determination
systems, we will review the submitted
information and documentation to make
an approval determination for the
advanced planning document. Form
Number: CMS–10536 (OMB control
number: 0938–1268); Frequency: Yearly,
once, and occasionally; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 168; Total Annual
Hours: 2,688. (For policy questions
regarding this collection contact Martin
Rice at 410–786–2417.)
Dated: February 22, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–03966 Filed 2–26–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Generic Clearance for Financial
Reports used in the Administration of
Mandatory Grants.
OMB No.: 0970–New.
Description: OMB has granted
permission for ACF to submit a request
for a generic clearance to be used for the
financial reports used in the
administration of mandatory grants.
This clearance supports the
Departments initiative of Generating
Efficiencies through Streamlined
Processes by employing an abbreviated
process.
If approved program offices will be at
liberty to tailor a financial report to their
specific needs rather than adhering to a
standard form.
Respondents: States and Territories.
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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Mandatory Grant Financial Report ..................................................................
900
4
5
18,000
Estimated Total Annual Burden
Hours:
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV. Attn:
Desk Officer for the Administration for
Children and Families.
abbreviated new drug applications from
multiple applicants, withdrawn as of
July 21, 2017. The document indicated
that FDA was withdrawing approval of
NDA 204508, Clinolipid 20% (olive oil
and soybean oil) USP, 16%/4%, after
receiving a request from the NDA
holder, Baxter Healthcare Corp. (Baxter),
32650 N Wilson Rd., Round Lake, IL
60073. Before the approval of NDA
204508 was withdrawn, Baxter
informed FDA that it did not want the
approval of this NDA withdrawn.
Because Baxter timely requested that
approval of this NDA not be withdrawn,
the approval of NDA 204508 is still in
effect.
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, June 21,
2017, appearing on page 28322 in FR
Doc. 2017–12908, the following
correction is made:
On page 28329, in table 1, the entry
for NDA 204508 is removed.
Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–03976 Filed 2–26–18; 8:45 am]
[FR Doc. 2018–03925 Filed 2–26–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2017–N–3203]
[Docket No. FDA–2018–N–0663]
Wyeth Pharmaceuticals Inc. et al.;
Withdrawal of Approval of 121 New
Drug Applications and 161 Abbreviated
New Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 21, 2017 (82 FR 28322).
The document announced the
withdrawal of approval of 121 new drug
applications (NDAs) and 161
SUMMARY:
19:49 Feb 26, 2018
AGENCY:
Food and Drug Administration,
HHS.
Notice; correction.
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Tissue Agnostic Therapies in
Oncology: Regulatory Considerations
for Orphan Drug Designation; Public
Workshop; Request for Comments
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Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the following public
workshop entitled ‘‘Tissue Agnostic
Therapies in Oncology: Regulatory
SUMMARY:
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Considerations for Orphan Drug
Designation.’’ The purpose of the public
workshop is to discuss factors FDA
should consider when evaluating drugs
for orphan designation that treat a tissue
agnostic disease or condition in
oncology, and additional factors related
to orphan exclusivity FDA should
consider when approving a product
with a tissue agnostic indication.
DATES: The public workshop will be
held on May 9, 2018, from 9 a.m. to 5
p.m. The public workshop may be
extended or may end early depending
on the level of public participation.
Submit either electronic or written
comments on this public workshop by
June 8, 2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring,
MD 20993–0002. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before June 8, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
June 8, 2018. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
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
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]]>Agencies
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8484-8485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03976]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Generic Clearance for Financial Reports used in the
Administration of Mandatory Grants.
OMB No.: 0970-New.
Description: OMB has granted permission for ACF to submit a request
for a generic clearance to be used for the financial reports used in
the administration of mandatory grants. This clearance supports the
Departments initiative of Generating Efficiencies through Streamlined
Processes by employing an abbreviated process.
If approved program offices will be at liberty to tailor a
financial report to their specific needs rather than adhering to a
standard form.
Respondents: States and Territories.
[[Page 8485]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Mandatory Grant Financial Report............ 900 4 5 18,000
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours:
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 330 C Street SW, Washington, DC 20201. Attention
Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
[email protected].
OMB Comment
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Email:
[email protected]. Attn: Desk Officer for the Administration
for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018-03976 Filed 2-26-18; 8:45 am]
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