Submission for OMB Review; Comment Request; Child Care and Development Fund Quality Progress Report, 45290-45291 [2017-20765]

Download as PDF 45290 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices Commission considers your online comment, you must file it at https:// ftcpublic.commentworks.com/ftc/ BusinessOpportunityRulePRA_by following the instructions on the webbased form. When this Notice appears at https://www.regulations.gov/#!home, you also may file a comment through that Web site. If you file your comment on paper, write ‘‘Business Opportunity Rule Paperwork Comment, FTC File No. P114408’’ on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC– 5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610, Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. 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[FR Doc. 2017–20846 Filed 9–27–17; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB No.: 0970—NEW] Submission for OMB Review; Comment Request; Child Care and Development Fund Quality Progress Report Description: Lead Agencies are required to spend a certain percent of their Child Care and Development Fund (CCDF) awards on activities to improve the quality of child care. Lead Agencies are also required to invest in at least one of 10 allowable quality activities included in the Child Care and Development Block Grant (CCDBG) Act of 2014. In order to ensure that States and Territories are meeting these requirements, the CCDBG Act and the CCDF final rule require Lead Agencies to submit an annual report, identified as the Quality Progress Report in the CCDF final rule. The report must describe how quality funds were expended, including what types of activities were funded and PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 measures used to evaluate progress in improving the quality of child care programs and services. The QPR replaces the Quality Performance Report that was previously an appendix to the CCDF Plan. The QPR increased transparency on quality spending and will continue to gather detailed information on how States and Territories are spending their quality funds, as well as more specific data points to reflect the requirements in the CCDBG Act and the CCDF final rule. In the QPR, Lead Agencies are asked about the State’s or Territory’s progress in meeting its goals as reported in the CCDF Plan, and provide available data on the results of those activities. Specifically, this report will: (1) Ensure accountability for the use of CCDF quality funds, including a set-aside for quality infant and toddler care that begins in FY 2017; (2) track progress toward meeting State- and Territory-set indicators and benchmarks for improvement of child care quality per what they described in their CCDF Plans; (3) summarize how the Lead Agency is building a progression of professional development for child care providers as envisioned in the CCDBG Act of 2014 and CCDF final rule; and (4) inform federal technical assistance efforts and decisions regarding strategic use of quality funds. The Office of Child Care (OCC) has given thoughtful consideration to the comments received during the 60-day Public Comment Period and has revised the QPR to better align with the new program requirements made under the CCDBG Act of 2014 and the final rule. The revised document also contains additional guidance and clarification where appropriate in order to improve the quality of information that is being collected. Note: A correction was also made to the burden hours. This 30-day Public Comment Period provides an opportunity for the public to submit comments to the Office of Management and Budget (OMB). Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade SW., Washington, 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. Respondents: State and Territory CCDF Lead Agencies (56). E:\FR\FM\28SEN1.SGM 28SEN1 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45291 ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours CCDF QPR ...................................................................................................... 56 1 60.0 3,360 Estimated Total Annual Burden Hours: 3,360 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. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–20765 Filed 9–27–17; 8:45 am] BILLING CODE 4184–43–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0007] Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2018 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user SUMMARY: VerDate Sep<11>2014 18:44 Sep 27, 2017 Jkt 241001 fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of rare pediatric disease product applications that meet all of the requirements of this program and that are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2018 and outlines the payment procedures for such fees. FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14202F, Silver Spring, MD 20993–0002, 301–796–7223. SUPPLEMENTARY INFORMATION: I. Background Section 908 of FDASIA (Pub. L. 112– 144) added section 529 to the FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress encouraged development of new human drugs and biological products for prevention and treatment of certain rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products. Under section 529 of the FD&C Act, the sponsor of an eligible human drug application submitted 90 days or more after July 9, 2012, for a rare pediatric disease (as defined in section 529(a)(3)) shall receive a priority review voucher upon approval of the rare pediatric disease product application. The recipient of a rare pediatric disease priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party. The PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 voucher may be transferred (including by sale) repeatedly until it ultimately is used for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the Public Health Service Act. A priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding PDUFA goals is available at https://www.fda.gov/downloads/ forindustry/userfees/prescriptiondrug userfee/ucm511438.pdf. The applicant that uses a rare pediatric disease priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a rare pediatric disease priority review user fee in addition to any user fee required by PDUFA for the application. Information regarding the rare pediatric disease priority review voucher program is available at: https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ DevelopmentResources/ ucm375479.htm. This notice establishes the rare pediatric disease priority review fee rate for FY 2018 at $2,830,579 and outlines FDA’s procedures for payment of rare pediatric disease priority review user fees. This rate is effective on October 1, 2017, and will remain in effect through September 30, 2018. II. Rare Pediatric Priority Review User Fee for FY 2018 Under section 529(c)(2) of the FD&C Act, the amount of the rare pediatric disease priority review user fee is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year. A priority review is a review conducted with a PDUFA goal date of 6 months after the receipt or filing date, depending on the type of application. Under the PDUFA goals letter, FDA has committed to reviewing and acting on 90 percent of the applications granted E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45290-45291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20765]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families

[OMB No.: 0970--NEW]


Submission for OMB Review; Comment Request; Child Care and 
Development Fund Quality Progress Report

    Description: Lead Agencies are required to spend a certain percent 
of their Child Care and Development Fund (CCDF) awards on activities to 
improve the quality of child care. Lead Agencies are also required to 
invest in at least one of 10 allowable quality activities included in 
the Child Care and Development Block Grant (CCDBG) Act of 2014. In 
order to ensure that States and Territories are meeting these 
requirements, the CCDBG Act and the CCDF final rule require Lead 
Agencies to submit an annual report, identified as the Quality Progress 
Report in the CCDF final rule. The report must describe how quality 
funds were expended, including what types of activities were funded and 
measures used to evaluate progress in improving the quality of child 
care programs and services. The QPR replaces the Quality Performance 
Report that was previously an appendix to the CCDF Plan. The QPR 
increased transparency on quality spending and will continue to gather 
detailed information on how States and Territories are spending their 
quality funds, as well as more specific data points to reflect the 
requirements in the CCDBG Act and the CCDF final rule.
    In the QPR, Lead Agencies are asked about the State's or 
Territory's progress in meeting its goals as reported in the CCDF Plan, 
and provide available data on the results of those activities. 
Specifically, this report will: (1) Ensure accountability for the use 
of CCDF quality funds, including a set-aside for quality infant and 
toddler care that begins in FY 2017; (2) track progress toward meeting 
State- and Territory-set indicators and benchmarks for improvement of 
child care quality per what they described in their CCDF Plans; (3) 
summarize how the Lead Agency is building a progression of professional 
development for child care providers as envisioned in the CCDBG Act of 
2014 and CCDF final rule; and (4) inform federal technical assistance 
efforts and decisions regarding strategic use of quality funds.
    The Office of Child Care (OCC) has given thoughtful consideration 
to the comments received during the 60-day Public Comment Period and 
has revised the QPR to better align with the new program requirements 
made under the CCDBG Act of 2014 and the final rule. The revised 
document also contains additional guidance and clarification where 
appropriate in order to improve the quality of information that is 
being collected. Note: A correction was also made to the burden hours. 
This 30-day Public Comment Period provides an opportunity for the 
public to submit comments to the Office of Management and Budget (OMB).
    Copies of the proposed collection may be obtained by writing to the 
Administration for Children and Families, Office of Administration, 
Office of Information Services, 370 L'Enfant Promenade SW., Washington, 
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.
    Respondents: State and Territory CCDF Lead Agencies (56).

[[Page 45291]]



                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
                 Instrument                      Number of      responses  per      hours per      Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
CCDF QPR....................................              56                1             60.0            3,360
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 3,360 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.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017-20765 Filed 9-27-17; 8:45 am]
 BILLING CODE 4184-43-P

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