83 FR 8484 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 83, Issue 39 (February 27, 2018)

Page Range		8484-8485
FR Document		2018-03976

Federal Register, Volume 83 Issue 39 (Tuesday, February 27, 2018)

[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8484-8485]
From the Federal Register Online  [www.thefederalregister.org]
[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]
 BILLING CODE P

8484 Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices

for the entire information collection, we other forms of information technology to 1. Type of Information Collection
are also seeking approval for the minimize the information collection Request: Extension of a currently
provisions that were set out in the burden. approved collection; Title of
proposed rule. Form Number: CMS–R– DATES: Comments on the collection(s) of Information Collection: Medicaid
267 (OMB control number: 0938–0753); information must be received by the Eligibility and Enrollment (EE)
Frequency: Yearly; Affected Public: OMB desk officer by March 29, 2018. Implementation Advanced Planning
Individuals or households and Business ADDRESSES: When commenting on the
Document (IAPD) Template; Use: To
or other for-profits; Number of proposed information collections, assess the appropriateness of states’
Respondents: 13,958,526; Total Annual please reference the document identifier requests for enhanced federal financial
Responses: 35,596,762; Total Annual or OMB control number. To be assured participation for expenditures related to
Hours: 8,529,541. (For policy questions consideration, comments and Medicaid eligibility determination
regarding this collection contact Russell recommendations must be received by systems, we will review the submitted
Hendel at 410–786–0329.) the OMB desk officer via one of the information and documentation to make
Dated: February 22, 2018. following transmissions: OMB, Office of an approval determination for the
William N. Parham, III, Information and Regulatory Affairs, advanced planning document. Form
Attention: CMS Desk Officer, Fax Number: CMS–10536 (OMB control
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory Number: (202) 395–5806 OR Email: number: 0938–1268); Frequency: Yearly,
Affairs. OIRA_submission@omb.eop.gov. once, and occasionally; Affected Public:
[FR Doc. 2018–03972 Filed 2–26–18; 8:45 am] To obtain copies of a supporting State, Local, or Tribal Governments;
statement and any related forms for the Number of Respondents: 56; Total
BILLING CODE 4120–01–P
proposed collection(s) summarized in Annual Responses: 168; Total Annual
this notice, you may make your request Hours: 2,688. (For policy questions
DEPARTMENT OF HEALTH AND using one of following: regarding this collection contact Martin
HUMAN SERVICES 1. Access CMS’ website address at Rice at 410–786–2417.)
https://www.cms.gov/Regulations-and- Dated: February 22, 2018.
Centers for Medicare & Medicaid Guidance/Legislation/ William N. Parham, III,
Services PaperworkReductionActof1995/PRA- Director, Paperwork Reduction Staff, Office
Listing.html. of Strategic Operations and Regulatory
[Document Identifier CMS–10536] 2. Email your request, including your Affairs.
Agency Information Collection address, phone number, OMB number, [FR Doc. 2018–03966 Filed 2–26–18; 8:45 am]
Activities: Submission for OMB and CMS document identifier, to
BILLING CODE 4120–01–P
Review; Comment Request Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
AGENCY: Centers for Medicare & (410) 786–1326.
DEPARTMENT OF HEALTH AND
Medicaid Services, HHS. FOR FURTHER INFORMATION CONTACT: HUMAN SERVICES
ACTION: Notice. William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the Administration for Children and
SUMMARY: The Centers for Medicare & Paperwork Reduction Act of 1995 (PRA) Families
Medicaid Services (CMS) is announcing (44 U.S.C. 3501–3520), federal agencies
an opportunity for the public to must obtain approval from the Office of Submission for OMB Review;
comment on CMS’ intention to collect Management and Budget (OMB) for each Comment Request
information from the public. Under the collection of information they conduct
Paperwork Reduction Act of 1995 or sponsor. The term ‘‘collection of Title: Generic Clearance for Financial
(PRA), federal agencies are required to information’’ is defined in 44 U.S.C. Reports used in the Administration of
publish notice in the Federal Register 3502(3) and 5 CFR 1320.3(c) and Mandatory Grants.
concerning each proposed collection of includes agency requests or OMB No.: 0970–New.
information, including each proposed requirements that members of the public Description: OMB has granted
extension or reinstatement of an existing submit reports, keep records, or provide permission for ACF to submit a request
collection of information, and to allow information to a third party. Section for a generic clearance to be used for the
a second opportunity for public 3506(c)(2)(A) of the PRA (44 U.S.C. financial reports used in the
comment on the notice. Interested 3506(c)(2)(A)) requires federal agencies administration of mandatory grants.
persons are invited to send comments to publish a 30-day notice in the This clearance supports the
regarding the burden estimate or any Federal Register concerning each Departments initiative of Generating
other aspect of this collection of proposed collection of information, Efficiencies through Streamlined
information, including the necessity and including each proposed extension or Processes by employing an abbreviated
utility of the proposed information reinstatement of an existing collection
process.
collection for the proper performance of of information, before submitting the
the agency’s functions; the accuracy of collection to OMB for approval. To If approved program offices will be at
the estimated burden; ways to enhance comply with this requirement, CMS is liberty to tailor a financial report to their
the quality, utility, and clarity of the publishing this notice that summarizes specific needs rather than adhering to a
information to be collected; and the use the following proposed collection(s) of standard form.
daltland on DSKBBV9HB2PROD with NOTICES

of automated collection techniques or information for public comment: Respondents: States and Territories.

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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices 8485

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Mandatory Grant Financial Report .................................................................. 900 4 5 18,000

Estimated Total Annual Burden abbreviated new drug applications from Considerations for Orphan Drug
Hours: multiple applicants, withdrawn as of Designation.’’ The purpose of the public
July 21, 2017. The document indicated workshop is to discuss factors FDA
Additional Information
that FDA was withdrawing approval of should consider when evaluating drugs
Copies of the proposed collection may NDA 204508, Clinolipid 20% (olive oil for orphan designation that treat a tissue
be obtained by writing to the and soybean oil) USP, 16%/4%, after agnostic disease or condition in
Administration for Children and receiving a request from the NDA oncology, and additional factors related
Families, Office of Planning, Research holder, Baxter Healthcare Corp. (Baxter), to orphan exclusivity FDA should
and Evaluation, 330 C Street SW, 32650 N Wilson Rd., Round Lake, IL consider when approving a product
Washington, DC 20201. Attention 60073. Before the approval of NDA with a tissue agnostic indication.
Reports Clearance Officer. All requests 204508 was withdrawn, Baxter DATES: The public workshop will be
should be identified by the title of the informed FDA that it did not want the held on May 9, 2018, from 9 a.m. to 5
information collection. Email address: approval of this NDA withdrawn. p.m. The public workshop may be
infocollection@acf.hhs.gov. Because Baxter timely requested that extended or may end early depending
OMB Comment approval of this NDA not be withdrawn, on the level of public participation.
the approval of NDA 204508 is still in Submit either electronic or written
OMB is required to make a decision effect. comments on this public workshop by
concerning the collection of information June 8, 2018. See the SUPPLEMENTARY
FOR FURTHER INFORMATION CONTACT:
between 30 and 60 days after INFORMATION section for registration date
publication of this document in the Florine Purdie, Center for Drug
Evaluation and Research, Food and and information.
Federal Register. Therefore, a comment ADDRESSES: The public workshop will
is best assured of having its full effect Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, be held at the FDA White Oak Campus,
if OMB receives it within 30 days of 10903 New Hampshire Ave., Building
publication. Written comments and Silver Spring, MD 20993–0002, 301–
796–3601. 31 Conference Center, the Great Room
recommendations for the proposed (Rm. 1503, Section A), Silver Spring,
information collection should be sent SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, June 21, MD 20993–0002. Entrance for the public
directly to the following: Office of workshop participants (non-FDA
Management and Budget, Paperwork 2017, appearing on page 28322 in FR
Doc. 2017–12908, the following employees) is through Building 1, where
Reduction Project, Email: OIRA_ routine security check procedures will
SUBMISSION@OMB.EOP.GOV. Attn: correction is made:
On page 28329, in table 1, the entry be performed. For parking and security
Desk Officer for the Administration for information, please refer to https://www.
Children and Families. for NDA 204508 is removed.
fda.gov/AboutFDA/WorkingatFDA/
Dated: February 21, 2018. BuildingsandFacilities/WhiteOak
Robert Sargis,
Leslie Kux, CampusInformation/ucm241740.htm.
Reports Clearance Officer.
Associate Commissioner for Policy. You may submit comments as
[FR Doc. 2018–03976 Filed 2–26–18; 8:45 am]
[FR Doc. 2018–03925 Filed 2–26–18; 8:45 am] follows. Please note that late, untimely
BILLING CODE P
BILLING CODE 4164–01–P filed comments will not be considered.
Electronic comments must be submitted
DEPARTMENT OF HEALTH AND on or before June 8, 2018. The https://
HUMAN SERVICES DEPARTMENT OF HEALTH AND www.regulations.gov electronic filing
HUMAN SERVICES system will accept comments until
Food and Drug Administration midnight Eastern Time at the end of
Food and Drug Administration June 8, 2018. Comments received by
[Docket No. FDA–2017–N–3203] mail/hand delivery/courier (for written/
[Docket No. FDA–2018–N–0663]
Wyeth Pharmaceuticals Inc. et al.; paper submissions) will be considered
Withdrawal of Approval of 121 New Tissue Agnostic Therapies in timely if they are postmarked or the
Drug Applications and 161 Abbreviated Oncology: Regulatory Considerations delivery service acceptance receipt is on
New Drug Applications; Correction for Orphan Drug Designation; Public or before that date.
Workshop; Request for Comments Electronic Submissions
AGENCY: Food and Drug Administration,
HHS. AGENCY: Food and Drug Administration, Submit electronic comments in the
ACTION: Notice; correction. HHS. following way:
ACTION: Notice of public workshop; • Federal eRulemaking Portal:
daltland on DSKBBV9HB2PROD with NOTICES

SUMMARY: The Food and Drug request for comments. https://www.regulations.gov. Follow the
Administration (FDA) is correcting a instructions for submitting comments.
notice that appeared in the Federal SUMMARY: The Food and Drug Comments submitted electronically,
Register of June 21, 2017 (82 FR 28322). Administration (FDA or the Agency) is including attachments, to https://
The document announced the announcing the following public www.regulations.gov will be posted to
withdrawal of approval of 121 new drug workshop entitled ‘‘Tissue Agnostic the docket unchanged. Because your
applications (NDAs) and 161 Therapies in Oncology: Regulatory comment will be made public, you are

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Document Created: 2018-02-27 01:14:31
Document Modified: 2018-02-27 01:14:31

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
FR Citation		83 FR 8484

83 FR 8484 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 83, Issue 39 (February 27, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families