82_FR_43417 82 FR 43240 - Submission for OMB Review; Comment Request

82 FR 43240 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 82, Issue 177 (September 14, 2017)

Page Range43240-43241
FR Document2017-19467

Federal Register, Volume 82 Issue 177 (Thursday, September 14, 2017) 
[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43240-43241]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19467]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Refugee Data Submission System for Formula Funds 
Allocation--ORR-5.
    OMB No.: 0970-0043.
    Description: The information collection, Refugee Data Submission 
System for Formula Funds Allocations, (ORR-5) satisfies the statutory 
requirements of the Immigration and Nationality Act (INA). Section 
412(a)(3) of the Act requires the Director of the Office of Refugee 
Resettlement (ORR) to make a periodic assessment, based on refugee 
population and other relevant factors, of the relative needs of 
refugees for assistance and services and the resources available to 
meet those needs. This includes compiling and maintaining data on the 
secondary migration of refugees within the United States after arrival. 
Further, INA 412(c)(1)(B) states that formula funds shall be allocated 
based on the total number of refugees, taking into account secondary 
migration.
    Respondents: States or replacement designees.

[[Page 43241]]



                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ORR-5 Form..................................              50                1               22            1,100
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 1,100.
    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. 2017-19467 Filed 9-13-17; 8:45 am]
 BILLING CODE 4184-01-P

43240 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices recommendations to the Secretary of In addition, meeting registration is Laboratory Tests is available on the HHS and the Administrator of CMS required to access the meeting. CMS Web site at http://cms.gov/ regarding the following questions as it Regulations-and-Guidance/Guidance/ V. Panel Recommendations and relates to these codes: FACA/AdvisoryPanelon Discussions • Should the code be included on the ClinicalDiagnosticLaboratoryTests.html CLFS? The Panel’s recommendations will be or you may obtain a copy of the charter • If the code should be included on posted after the meeting on the CMS by submitting a request to the contact the CLFS, what method of payment Web site at https://www.cms.gov/ listed in the FOR FURTHER INFORMATION should be used to price the test codes Regulations-and-Guidance/Guidance/ CONTACT section of this notice. (crosswalking or gapfilling, as required FACA/AdvisoryPanelon ClinicalDiagnosticLaboratoryTests.html. VII. Collection of Information by 42 CFR 414.507(g))? • If crosswalking, specify the Requirements VI. Additional Information crosswalk code(s). This document does not impose The Panel will also provide input on A. Webinar, Webcast, and information collection requirements, other CY 2018 CLFS issues that are Teleconference Meeting Information that is, reporting, recordkeeping or designated in the Panel’s charter and The Panel meeting will be conducted third-party disclosure requirements. specified on the meeting agenda. only via webinar, webcast or by Consequently, there is no need for teleconference. The meeting registration review by the Office of Management and II. Agenda information, teleconference dial-in Budget under the authority of the The Agenda for the September 25, instructions, and related webcast and Paperwork Reduction Act of 1995 (44 2017, Panel Meeting will provide for webinar details will be posted on the U.S.C. 3501 et seq.). discussion and comment on the meeting agenda, which will be available Dated: September 8, 2017. following topics as designated in the on the CMS Web site approximately 1 Seema Verma, Panel’s charter: week prior to the meeting at https:// Administrator, Centers for Medicare & • CY 2018 CLFS laboratory test codes www.cms.gov/Regulations-and- Medicaid Services. for which CMS received no applicable Guidance/Guidance/FACA/ [FR Doc. 2017–19539 Filed 9–11–17; 4:15 pm] information to calculate a Medicare AdvisoryPanelonClinicalDiagnostic BILLING CODE 4120–01–P payment rate and was posted on August LaboratoryTests.html. 4, 2017, on the CMS Web site at https:// www.cms.gov/Medicare/Medicare-Fee- B. Meeting Registration DEPARTMENT OF HEALTH AND for-Service-Payment/ Registration is required to participate HUMAN SERVICES ClinicalLabFeeSched/Laboratory_ in this teleconference public meeting. Public_Meetings.html. Interested participants will be able to Administration for Children and • Other CY 2018 CLFS issues access the registration, teleconference, Families designated in the Panel’s charter and webcast, and webinar instructions, by further described on our Agenda. following the instructions on the Submission for OMB Review; • CDLTs that will be discussed meeting agenda. There is no deadline Comment Request during this meeting is available on the for meeting registration. CMS Web site, in the document entitled Title: Refugee Data Submission ‘‘2017 Clinical Laboratory Test Codes C. Deadline for Submission of System for Formula Funds Allocation— with No Data,’’ at https://www.cms.gov/ Presentations ORR–5. Medicare/Medicare-Fee-for-Service- There will be an opportunity during OMB No.: 0970–0043. Payment/ClinicalLabFeeSched/ the meeting for public presentations and Description: The information Laboratory_Public_Meetings.html. oral comments. During the meeting, an collection, Refugee Data Submission A detailed Agenda will be posted individual will be limited to 1 minute System for Formula Funds Allocations, approximately 1 week before the of comments for each laboratory test (ORR–5) satisfies the statutory meeting, on the CMS Web site at https:// code. All presenters for the meeting requirements of the Immigration and www.cms.gov/Regulations-and- must register and submit their Nationality Act (INA). Section 412(a)(3) Guidance/Guidance/FACA/ presentations and comments of the Act requires the Director of the AdvisoryPanelonClinicalDiagnostic electronically to our CLFS dedicated Office of Refugee Resettlement (ORR) to LaboratoryTests.html. email mailbox, CDLTPanel@ make a periodic assessment, based on cms.hhs.gov, by the date listed in the refugee population and other relevant III. Special Accommodations factors, of the relative needs of refugees DATES section of this notice. Presenters Individuals requiring special should submit all presentations and for assistance and services and the accommodations must include the comments using a standard PowerPoint resources available to meet those needs. request for these services during template that is available on the CMS This includes compiling and registration. Web site at https://www.cms.gov/ maintaining data on the secondary Regulations-and-Guidance/Guidance/ migration of refugees within the United IV. Meeting Participation States after arrival. Further, INA FACA/AdvisoryPanelon This meeting is open to the public. As ClinicalDiagnosticLaboratoryTests.html, 412(c)(1)(B) states that formula funds asabaliauskas on DSKBBXCHB2PROD with NOTICES noted previously, the public may under the ‘‘Panel Meetings’’ heading. shall be allocated based on the total participate in the meeting via number of refugees, taking into account teleconference, webcast, and webinar. VI. Copies of the Charter secondary migration. There will not be an in-person meeting The Secretary’s Charter for the Respondents: States or replacement location for this public Panel meeting. Advisory Panel on Clinical Diagnostic designees. VerDate Sep<11>2014 16:41 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1

Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43241 ANNUAL BURDEN ESTIMATES Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response ORR–5 Form ................................................................................................... 50 1 22 1,100 Estimated Total Annual Burden biological product approved in a grants the sponsor’s request for a BPD Hours: 1,100. biosimilar biological product meeting for that product, or upon the Additional Information: Copies of the application. date of submission by the sponsor of an proposed collection may be obtained by BsUFA II directs FDA to establish, IND describing an investigation that writing to the Administration for before the beginning of each fiscal year, FDA determines is intended to support Children and Families, Office of the amount of initial and annual a biosimilar biological product Planning, Research and Evaluation, 330 biosimilar biological product application. The sponsor will be C Street SW., Washington, DC 20201. development (BPD) fees, the assessed an annual BPD fee beginning Attention Reports Clearance Officer. All reactivation fee, and the biosimilar with the first fiscal year after payment requests should be identified by the title biological product application and of the reactivation fee. of the information collection. Email program fees for such year. These fees BsUFA II also authorizes fees for address: infocollection@acf.hhs.gov. apply to the period from October 1, certain biosimilar biological product OMB Comment: OMB is required to 2017, through September 30, 2018. applications and for each biosimilar make a decision concerning the FOR FURTHER INFORMATION CONTACT: biological product identified in an collection of information between 30 David Haas, Office of Financial approved biosimilar biological product and 60 days after publication of this Management, Food and Drug application (sections 744H(a)(2) and document in the Federal Register. Administration, 8455 Colesville Rd., 744H(a)(3) of the FD&C Act). Under Therefore, a comment is best assured of COLE–14202I, Silver Spring, MD certain conditions, FDA may grant a having its full effect if OMB receives it 20993–0002, 240–402–9845. small business a waiver from its first within 30 days of publication. Written SUPPLEMENTARY INFORMATION: biosimilar biological product comments and recommendations for the application fee (section 744H(d)(1) of proposed information collection should I. Background the FD&C Act). be sent directly to the following: Office Sections 744G, 744H, and 744I of the For FY 2018, the fee revenue amount of Management and Budget, Paperwork FD&C Act (21 U.S.C. 379j–51, 379j–52, is $45,000,000, adjusted as needed to Reduction Project, Email: OIRA_ and 379j–53), as amended by BsUFA II reflect an updated assessment of the SUBMISSION@OMB.EOP.GOV. Attn: (title IV of the FDA Reauthorization Act workload for the process for the review Desk Officer for the Administration for of 2017, Pub. L. 115–52), authorizes the of biosimilar biological product Children and Families program of fees for biosimilar biological applications. FDA is adjusting the FY products. Under section 744H(a)(1)(A) 2018 revenue amount to $40,214,000 Robert Sargis, of the FD&C Act, the initial BPD fee for (rounded to the nearest thousand Reports Clearance Officer. a product is due when the sponsor dollars) reflecting its updated [FR Doc. 2017–19467 Filed 9–13–17; 8:45 am] submits an investigational new drug assessment of the likely workload for BILLING CODE 4184–01–P (IND) application that FDA determines the BsUFA program in FY 2018. is intended to support a biosimilar This document provides fee rates for biological product application or within FY 2018 for the initial and annual BPD DEPARTMENT OF HEALTH AND 5 calendar days after FDA grants the fee ($227,213), for the reactivation fee HUMAN SERVICES first BPD meeting, whichever occurs ($454,426), for an application requiring Food and Drug Administration first. A sponsor who has paid the initial clinical data ($1,746,745), for an BPD fee is considered to be participating application not requiring clinical data [Docket No. FDA–2017–N–0007] in FDA’s BPD program for that product. ($873,373), and for the program fee Under section 744H(a)(1)(B) of the ($304,162). These fees apply to the Biosimilar User Fee Rates for Fiscal FD&C Act, once a sponsor has paid the period from October 1, 2017, through Year 2018 initial BPD fee for a product, the annual September 30, 2018. For applications AGENCY: Food and Drug Administration, BPD fee is assessed beginning with the that are submitted for this period, this HHS. next fiscal year. The annual BPD fee is FY 2018 fee schedule must be used. ACTION: Notice. assessed for the product each fiscal year until the sponsor submits a marketing II. Fee Revenue Amount for FY 2018 SUMMARY: The Food and Drug application for the product that is The fee revenue amount for FY 2018 Administration (FDA) is announcing the accepted for filing, or discontinues is $45,000,000 adjusted for updated rates for biosimilar user fees for fiscal participation in FDA’s BPD program. workload estimates (see sections year (FY) 2018. The Federal Food, Drug, Under section 744H(a)(1)(D) of the 744H(b)(1) and 744H(c)(4) of the FD&C asabaliauskas on DSKBBXCHB2PROD with NOTICES and Cosmetic Act (the FD&C Act), as FD&C Act, if a sponsor has discontinued Act). amended by the Biosimilar User Fee participation in FDA’s BPD program and Amendments of 2017 (BsUFA II), wants to re-engage with FDA on A. Statutory Fee Revenue Adjustments authorizes FDA to assess and collect development of the product, the sponsor for Inflation user fees for certain activities in must pay a reactivation fee to resume BsUFA II specifies that the annual fee connection with biosimilar biological participation in the program. The revenue amount is to be further adjusted product development; review of certain sponsor must pay the reactivation fee by for inflation increases for FY 2019 applications for approval of biosimilar the earlier of the following dates: No through FY 2022 using two separate biological products; and each biosimilar later than 5 calendar days after FDA adjustments—one for personnel VerDate Sep<11>2014 16:41 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1


Document Created: 2017-09-13 23:49:43
Document Modified: 2017-09-13 23:49:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation82 FR 43240 
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