Submission for OMB Review; Comment Request, 57620-57621 [2015-24270]

Download as PDF 57620 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 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 requires federal agencies to publish a 60-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. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Contract Year 2017 Plan Benefit Package (PBP) Software and Formulary Submission; Use: We require that Medicare Advantage and Prescription Drug Plan organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to us for review and approval. We publish beneficiary education information using a variety of formats. The specific education initiatives that utilize PBP and formulary data include web application tools on www.medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information. Form Number: CMS–R–262 (OMB control number 0938–0763); Frequency: Yearly; Affected Public: Private sector (business or other for-profits and not-for-profit institutions); Number of Respondents: 552; Total Annual Responses: 5,448; Total Annual Hours: 52,902. (For policy questions regarding this collection contact Kristy Holtje at 410–786–2209). 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP); Use: We require that Medicare Advantage organizations and Prescription Drug Plans complete the Bid Pricing Tool (BPT) as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to us for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan’s bid, enrollee premiums, and payment rates. We publish beneficiary premium information using a variety of formats (www.medicare.gov, the Medicare & You handbook, Summary of Benefits marketing information) for the purpose of beneficiary education and enrollment. Form Number: CMS–10142 (OMB control number 0938–0944); Frequency: Yearly; Affected Public: Private sector (Business or other forprofits and Not-for-profit institutions); Number of Respondents: 555; Total Annual Responses: 4,995; Total Annual Hours: 149,850. (For policy questions regarding this collection contact Rachel Shevland at 410–786–3026). Dated: September 21, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015–24263 Filed 9–23–15; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request 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). Title: Child Care and Development Fund Plan for States and Territories FY 2016–2018 (ACF–118). ANNUAL BURDEN ESTIMATES tkelley on DSK3SPTVN1PROD with NOTICES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours ACF–118 .......................................................................................................... 56 0.50 162.50 4,550 Estimated Total Annual Burden Hours: 4,550. VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices DC 20447, Attn: ACF 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. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–24270 Filed 9–23–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3155] Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA’s statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report. DATES: The interim report will be released on September 24, 2015, and will be available at http://www.fda.gov/ downloads/ForIndustry/UserFees/ BiosimilarUserFeeActBsUFA/ UCM459686.pdf. Submit either electronic or written comments on the interim report by October 26, 2015. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 Submit electronic comments on the interim report to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mark Ascione, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1150, Silver Spring, MD 20993–0002, 301– 796–7652, FAX: 301–847–8443. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111–148) amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be ‘‘biosimilar’’ to or ‘‘interchangeable’’ with an FDAlicensed biological product. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by BsUFA (Title IV of the Food and Drug Administration Safety and Innovation Act, Pub. L. 112– 144), authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017. FDA uses these fees to expedite the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or lifealtering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public. As part of BsUFA, FDA is required to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. This notice solicits comments on the interim report, and the final report is due no later than September 30, 2016. The interim report is described in section 744I(d) of the FD&C Act (21 U.S.C. 379j–53(d)) (http:// uscode.house.gov/ view.xhtml?req=granuleid:U.S.C.prelim-title21-section379j53&num=0&edition=prelim), as amended by the Food and Drug Administration Safety and Innovation Act enacted in 2012. II. Comments FDA is issuing this notice to request public comment on the interim report. Interested persons may submit either electronic comments to http:// PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 57621 www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. III. Electronic Access The interim report can be accessed at http://www.fda.gov/downloads/ ForIndustry/UserFees/ BiosimilarUserFeeActBsUFA/ UCM459686.pdf. Dated: September 18, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24227 Filed 9–23–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1837] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 26, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the title Electronic User Fee Payment Request Forms. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 SUMMARY: E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57620-57621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24270]


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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: 
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.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-24270 Filed 9-23-15; 8:45 am]
BILLING CODE 4184-01-P