80 FR 57620 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 185 (September 24, 2015)

Page Range		57620-57621
FR Document		2015-24270

Federal Register, Volume 80 Issue 185 (Thursday, September 24, 2015)

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57620-57621]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24270]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Child Care and Development Fund Plan for States and 
Territories FY 2016-2018 (ACF-118).
    OMB No.: 0970-0114.
    Description: The Child Care and Development Fund (CCDF) Plan (the 
Plan) for States and Territories is required from each CCDF Lead Agency 
in accordance with Section 658E of the Child Care and Development Block 
Grant (CCDBG Act), 42 U.S.C.9858 as amended by the CCDBG Act of 2014, 
Public Law113-186. The Plan, submitted on the ACF-118, is now required 
triennially, and will remain in effect for three years. The Plan 
provides ACF and the public with a description of, and assurance about, 
the States' and Territories' child care programs. ACF extended the 
deadline for the submission of the State and Territory FY 2016-2018 
CCDF Plan from July 1, 2015 to March 1, 2016. The extension provides 
States and Territories more time to engage partner agencies and 
stakeholders, brief legislators on needed statutory changes, and 
develop meaningful implementation plans. The extension does not extend 
the FY 2016-2018 3-year plan period; Plans will be effective June 1, 
2016 through September 30, 2018.
    The Office of Child Care (OCC) has given thoughtful consideration 
to the comments received during the 60-day Public Comment Period. The 
Plan has been revised to incorporate public comments, better align the 
Plan with the new program requirements of the CCDBG Act of 2014 and 
includes additional guidance and clarification where appropriate in 
order to improve the quality of information that is being collected. 
This 30-day second Public Comment Period provides an opportunity for 
the public to submit comments to the Office of Management and Budget 
(OMB). The Tribal Plan (ACF-118a) will be addressed under a separate 
notice.
    Respondents: State and Territory CCDF Lead Agencies (56).

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ACF-118.....................................              56             0.50           162.50            4,550
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 4,550.
    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, 370 L'Enfant Promenade 
SW., Washington,

[[Page 57621]]

DC 20447, Attn: ACF 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. 2015-24270 Filed 9-23-15; 8:45 am]
BILLING CODE 4184-01-P

57620 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices

approval from the Office of Management 2. Type of Information Collection OMB No.: 0970–0114.
and Budget (OMB) for each collection of Request: Revision of a currently Description: The Child Care and
information they conduct or sponsor. approved collection; Title of Development Fund (CCDF) Plan (the
The term ‘‘collection of information’’ is Information Collection: Bid Pricing Tool Plan) for States and Territories is
defined in 44 U.S.C. 3502(3) and 5 CFR (BPT) for Medicare Advantage (MA) required from each CCDF Lead Agency
1320.3(c) and includes agency requests Plans and Prescription Drug Plans
in accordance with Section 658E of the
or requirements that members of the (PDP); Use: We require that Medicare
public submit reports, keep records, or Child Care and Development Block
Advantage organizations and
provide information to a third party. Prescription Drug Plans complete the Grant (CCDBG Act), 42 U.S.C.9858 as
Section 3506(c)(2)(A) of the PRA Bid Pricing Tool (BPT) as part of the amended by the CCDBG Act of 2014,
requires federal agencies to publish a annual bidding process. During this Public Law113–186. The Plan,
60-day notice in the Federal Register process, organizations prepare their submitted on the ACF–118, is now
concerning each proposed collection of proposed actuarial bid pricing for the required triennially, and will remain in
information, including each proposed upcoming contract year and submit effect for three years. The Plan provides
extension or reinstatement of an existing them to us for review and approval. The ACF and the public with a description
collection of information, before purpose of the BPT is to collect the of, and assurance about, the States’ and
submitting the collection to OMB for actuarial pricing information for each Territories’ child care programs. ACF
approval. To comply with this plan. The BPT calculates the plan’s bid, extended the deadline for the
requirement, CMS is publishing this enrollee premiums, and payment rates. submission of the State and Territory FY
notice. We publish beneficiary premium 2016–2018 CCDF Plan from July 1, 2015
Information Collection information using a variety of formats to March 1, 2016. The extension
(www.medicare.gov, the Medicare & You provides States and Territories more
1. Type of Information Collection handbook, Summary of Benefits time to engage partner agencies and
Request: Revision of a currently marketing information) for the purpose
approved collection; Title of stakeholders, brief legislators on needed
of beneficiary education and statutory changes, and develop
Information Collection: Contract Year enrollment. Form Number: CMS–10142
2017 Plan Benefit Package (PBP) meaningful implementation plans. The
(OMB control number 0938–0944); extension does not extend the FY 2016–
Software and Formulary Submission; Frequency: Yearly; Affected Public:
Use: We require that Medicare 2018 3-year plan period; Plans will be
Private sector (Business or other for- effective June 1, 2016 through
Advantage and Prescription Drug Plan
profits and Not-for-profit institutions); September 30, 2018.
organizations submit a completed PBP
Number of Respondents: 555; Total
and formulary as part of the annual The Office of Child Care (OCC) has
Annual Responses: 4,995; Total Annual
bidding process. During this process, given thoughtful consideration to the
Hours: 149,850. (For policy questions
organizations prepare their proposed comments received during the 60-day
regarding this collection contact Rachel
plan benefit packages for the upcoming Public Comment Period. The Plan has
Shevland at 410–786–3026).
contract year and submit them to us for been revised to incorporate public
review and approval. We publish Dated: September 21, 2015.
William N. Parham, III,
comments, better align the Plan with the
beneficiary education information using
new program requirements of the
a variety of formats. The specific Director, Paperwork Reduction Staff, Office
education initiatives that utilize PBP of Strategic Operations and Regulatory CCDBG Act of 2014 and includes
and formulary data include web Affairs. additional guidance and clarification
application tools on www.medicare.gov [FR Doc. 2015–24263 Filed 9–23–15; 8:45 am] where appropriate in order to improve
and the plan benefit insert in the BILLING CODE 4120–01–P
the quality of information that is being
Medicare & You handbook. In addition, collected. This 30-day second Public
organizations utilize the PBP data to Comment Period provides an
generate their Summary of Benefits DEPARTMENT OF HEALTH AND opportunity for the public to submit
marketing information. Form Number: HUMAN SERVICES comments to the Office of Management
CMS–R–262 (OMB control number and Budget (OMB). The Tribal Plan
0938–0763); Frequency: Yearly; Affected Administration for Children and (ACF–118a) will be addressed under a
Public: Private sector (business or other Families separate notice.
for-profits and not-for-profit Respondents: State and Territory
Submission for OMB Review;
institutions); Number of Respondents: CCDF Lead Agencies (56).
Comment Request
552; Total Annual Responses: 5,448;
Total Annual Hours: 52,902. (For policy Title: Child Care and Development
questions regarding this collection Fund Plan for States and Territories FY
contact Kristy Holtje at 410–786–2209). 2016–2018 (ACF–118).

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
tkelley on DSK3SPTVN1PROD with NOTICES

ACF–118 .......................................................................................................... 56 0.50 162.50 4,550

Estimated Total Annual Burden Additional Information: Copies of the Children and Families, Office of
Hours: 4,550. proposed collection may be obtained by Planning, Research and Evaluation, 370
writing to the Administration for L’Enfant Promenade SW., Washington,

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Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57621

DC 20447, Attn: ACF Reports Clearance ADDRESSES: Submit electronic www.regulations.gov or written
Officer. All requests should be comments on the interim report to comments to the Division of Dockets
identified by the title of the information http://www.regulations.gov. Submit Management (see ADDRESSES). It is only
collection. Email address: written comments to the Division of necessary to send one set of comments.
infocollection@acf.hhs.gov. Dockets Management (HFA–305), Food Identify comments with the docket
OMB Comment: and Drug Administration, 5630 Fishers number found in brackets in the
OMB is required to make a decision Lane, Rm. 1061, Rockville, MD 20852. heading of this document. Received
concerning the collection of information FOR FURTHER INFORMATION CONTACT: comments may be seen in the Division
between 30 and 60 days after Mark Ascione, Center for Drug of Dockets Management between 9 a.m.
publication of this document in the Evaluation and Research, Food and and 4 p.m., Monday through Friday, and
Federal Register. Therefore, a comment Drug Administration, 10903 New will be posted to the docket at http://
is best assured of having its full effect Hampshire Ave., Bldg. 51, Rm. 1150, www.regulations.gov.
if OMB receives it within 30 days of Silver Spring, MD 20993–0002, 301–
publication. Written comments and III. Electronic Access
796–7652, FAX: 301–847–8443.
recommendations for the proposed The interim report can be accessed at
SUPPLEMENTARY INFORMATION:
information collection should be sent http://www.fda.gov/downloads/
directly to the following: Office of I. Background ForIndustry/UserFees/
Management and Budget, Paperwork BiosimilarUserFeeActBsUFA/
The Patient Protection and Affordable
Reduction Project, Email: OIRA_ UCM459686.pdf.
Care Act of 2010 (Pub. L. 111–148)
SUBMISSION@OMB.EOP.GOV, Attn: amended the Public Health Service Act Dated: September 18, 2015.
Desk Officer for the Administration for to create an abbreviated licensure Leslie Kux,
Children and Families. pathway for biological products that are Associate Commissioner for Policy.
Robert Sargis, demonstrated to be ‘‘biosimilar’’ to or [FR Doc. 2015–24227 Filed 9–23–15; 8:45 am]
Reports Clearance Officer. ‘‘interchangeable’’ with an FDA- BILLING CODE 4164–01–P
[FR Doc. 2015–24270 Filed 9–23–15; 8:45 am] licensed biological product. The Federal
BILLING CODE 4184–01–P
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by BsUFA (Title DEPARTMENT OF HEALTH AND
IV of the Food and Drug Administration HUMAN SERVICES
DEPARTMENT OF HEALTH AND Safety and Innovation Act, Pub. L. 112–
HUMAN SERVICES 144), authorizes FDA to assess and Food and Drug Administration
collect fees for biosimilar biological [Docket No. FDA–2015–N–1837]
Food and Drug Administration products from October 2012 through
September 2017. FDA uses these fees to Agency Information Collection
[Docket No. FDA–2015–N–3155]
expedite the review process for Activities; Submission for Office of
Interim Results of Study of Workload biosimilar biological products. Management and Budget Review;
Volume and Full Costs Associated Biosimilar biological products represent Comment Request; Electronic User
With Review of Biosimilar Biological an important public health benefit, with Fee Payment Request Forms
Product Applications the potential to offer life-saving or life-
altering benefits at reduced cost to the AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, patient. BsUFA facilitates the HHS.
HHS. development of safe and effective ACTION: Notice.
ACTION: Notice; request for comments. biosimilar products for the American
SUMMARY: The Food and Drug
public.
SUMMARY: The Food and Drug Administration (FDA) is announcing
As part of BsUFA, FDA is required to
Administration (FDA or Agency) is that a proposed collection of
contract with an independent
announcing an opportunity for public information has been submitted to the
accounting or consulting firm to study
comment on the interim results of a Office of Management and Budget
the workload volume and full costs
study of the workload volume and full (OMB) for review and clearance under
associated with the process for the
costs associated with the process for the the Paperwork Reduction Act of 1995.
review of biosimilar biological product
review of biosimilar biological product DATES: Fax written comments on the
applications. This notice solicits
applications (interim report). This study comments on the interim report, and the collection of information by October 26,
was conducted by an independent final report is due no later than 2015.
consulting firm, and it fulfills FDA’s September 30, 2016. The interim report ADDRESSES: To ensure that comments on
statutory requirement under the first is described in section 744I(d) of the the information collection are received,
authorization of the Biosimilar User Fee FD&C Act (21 U.S.C. 379j–53(d)) (http:// OMB recommends that written
Act of 2012 (BsUFA), which enables uscode.house.gov/ comments be faxed to the Office of
FDA to collect user fees for the review view.xhtml?req=granuleid:U.S.C.- Information and Regulatory Affairs,
of biosimilar biological applications for prelim-title21-section379j- OMB, Attn: FDA Desk Officer, FAX:
fiscal years 2013 to 2017. This notice 53&num=0&edition=prelim), as 202–395–7285, or emailed to oira_
solicits comments on the interim report. amended by the Food and Drug submission@omb.eop.gov. All
DATES: The interim report will be Administration Safety and Innovation comments should be identified with the
tkelley on DSK3SPTVN1PROD with NOTICES

released on September 24, 2015, and Act enacted in 2012. title Electronic User Fee Payment
will be available at http://www.fda.gov/ Request Forms. Also include the FDA
downloads/ForIndustry/UserFees/ II. Comments docket number found in brackets in the
BiosimilarUserFeeActBsUFA/ FDA is issuing this notice to request heading of this document.
UCM459686.pdf. Submit either public comment on the interim report. FOR FURTHER INFORMATION CONTACT: FDA
electronic or written comments on the Interested persons may submit either PRA Staff, Office of Operations, Food
interim report by October 26, 2015. electronic comments to http:// and Drug Administration, 8455

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Document Created: 2018-02-26 10:18:19
Document Modified: 2018-02-26 10:18:19

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		80 FR 57620

80 FR 57620 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 185 (September 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families