43240 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

recommendations to the Secretary of 

HHS and the Administrator of CMS 

regarding the following questions as it 

relates to these codes: 

• Should the code be included on the 

CLFS? 

• If the code should be included on 

the CLFS, what method of payment 

should be used to price the test codes 

(crosswalking or gapfilling, as required 

by 42 CFR 414.507(g))? 

• If crosswalking, specify the 

crosswalk code(s). 

The Panel will also provide input on 

other CY 2018 CLFS issues that are 

designated in the Panel’s charter and 

specified on the meeting agenda. 

II. Agenda 

The Agenda for the September 25, 

2017, Panel Meeting will provide for 

discussion and comment on the 

following topics as designated in the 

Panel’s charter: 

• CY 2018 CLFS laboratory test codes 

for which CMS received no applicable 

information to calculate a Medicare 

payment rate and was posted on August 

4, 2017, on the CMS Web site at https:// 

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/

ClinicalLabFeeSched/Laboratory_

Public_Meetings.html. 

• Other CY 2018 CLFS issues 

designated in the Panel’s charter and 

further described on our Agenda. 

• CDLTs that will be discussed 

during this meeting is available on the 

CMS Web site, in the document entitled 

‘‘2017 Clinical Laboratory Test Codes 

with No Data,’’ at https://www.cms.gov/ 

Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/

Laboratory_Public_Meetings.html. 

A detailed Agenda will be posted 

approximately 1 week before the 

meeting, on the CMS Web site at https:// 

www.cms.gov/Regulations-andGuidance/Guidance/FACA/

AdvisoryPanelonClinicalDiagnostic

LaboratoryTests.html. 

III. Special Accommodations 

Individuals requiring special 

accommodations must include the 

request for these services during 

registration. 

IV. Meeting Participation 

This meeting is open to the public. As 

noted previously, the public may 

participate in the meeting via 

teleconference, webcast, and webinar. 

There will not be an in-person meeting 

location for this public Panel meeting. 

In addition, meeting registration is 

required to access the meeting. 

V. Panel Recommendations and 

Discussions 

The Panel’s recommendations will be 

posted after the meeting on the CMS 

Web site at https://www.cms.gov/

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.html. 

VI. Additional Information 

A. Webinar, Webcast, and 

Teleconference Meeting Information 

The Panel meeting will be conducted 

only via webinar, webcast or by 

teleconference. The meeting registration 

information, teleconference dial-in 

instructions, and related webcast and 

webinar details will be posted on the 

meeting agenda, which will be available 

on the CMS Web site approximately 1 

week prior to the meeting at https://

www.cms.gov/Regulations-andGuidance/Guidance/FACA/

AdvisoryPanelonClinicalDiagnostic

LaboratoryTests.html. 

B. Meeting Registration 

Registration is required to participate 

in this teleconference public meeting. 

Interested participants will be able to 

access the registration, teleconference, 

webcast, and webinar instructions, by 

following the instructions on the 

meeting agenda. There is no deadline 

for meeting registration. 

C. Deadline for Submission of 

Presentations 

There will be an opportunity during 

the meeting for public presentations and 

oral comments. During the meeting, an 

individual will be limited to 1 minute 

of comments for each laboratory test 

code. All presenters for the meeting 

must register and submit their 

presentations and comments 

electronically to our CLFS dedicated 

email mailbox, CDLTPanel@

cms.hhs.gov, by the date listed in the 

DATES section of this notice. Presenters 

should submit all presentations and 

comments using a standard PowerPoint 

template that is available on the CMS 

Web site at https://www.cms.gov/

Regulations-and-Guidance/Guidance/

FACA/AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.html, 

under the ‘‘Panel Meetings’’ heading. 

VI. Copies of the Charter 

The Secretary’s Charter for the 

Advisory Panel on Clinical Diagnostic 

Laboratory Tests is available on the 

CMS Web site at http://cms.gov/

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.html 

or you may obtain a copy of the charter 

by submitting a request to the contact 

listed in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

VII. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Dated: September 8, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–19539 Filed 9–11–17; 4:15 pm] 

BILLING CODE 4120–01–P 

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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43241 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

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: 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. 2017–19467 Filed 9–13–17; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Biosimilar User Fee Rates for Fiscal 

Year 2018 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates for biosimilar user fees for fiscal 

year (FY) 2018. The Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), as 

amended by the Biosimilar User Fee 

Amendments of 2017 (BsUFA II), 

authorizes FDA to assess and collect 

user fees for certain activities in 

connection with biosimilar biological 

product development; review of certain 

applications for approval of biosimilar 

biological products; and each biosimilar 

biological product approved in a 

biosimilar biological product 

application. 

BsUFA II directs FDA to establish, 

before the beginning of each fiscal year, 

the amount of initial and annual 

biosimilar biological product 

development (BPD) fees, the 

reactivation fee, and the biosimilar 

biological product application and 

program fees for such year. These fees 

apply to the period from October 1, 

2017, through September 30, 2018. 

FOR FURTHER INFORMATION CONTACT: 

David Haas, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202I, Silver Spring, MD 

20993–0002, 240–402–9845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 744G, 744H, and 744I of the 

FD&C Act (21 U.S.C. 379j–51, 379j–52, 

and 379j–53), as amended by BsUFA II 

(title IV of the FDA Reauthorization Act 

of 2017, Pub. L. 115–52), authorizes the 

program of fees for biosimilar biological 

products. Under section 744H(a)(1)(A) 

of the FD&C Act, the initial BPD fee for 

a product is due when the sponsor 

submits an investigational new drug 

(IND) application that FDA determines 

is intended to support a biosimilar 

biological product application or within 

5 calendar days after FDA grants the 

first BPD meeting, whichever occurs 

first. A sponsor who has paid the initial 

BPD fee is considered to be participating 

in FDA’s BPD program for that product. 

Under section 744H(a)(1)(B) of the 

FD&C Act, once a sponsor has paid the 

initial BPD fee for a product, the annual 

BPD fee is assessed beginning with the 

next fiscal year. The annual BPD fee is 

assessed for the product each fiscal year 

until the sponsor submits a marketing 

application for the product that is 

accepted for filing, or discontinues 

participation in FDA’s BPD program. 

Under section 744H(a)(1)(D) of the 

FD&C Act, if a sponsor has discontinued 

participation in FDA’s BPD program and 

wants to re-engage with FDA on 

development of the product, the sponsor 

must pay a reactivation fee to resume 

participation in the program. The 

sponsor must pay the reactivation fee by 

the earlier of the following dates: No 

later than 5 calendar days after FDA 

grants the sponsor’s request for a BPD 

meeting for that product, or upon the 

date of submission by the sponsor of an 

IND describing an investigation that 

FDA determines is intended to support 

a biosimilar biological product 

application. The sponsor will be 

assessed an annual BPD fee beginning 

with the first fiscal year after payment 

of the reactivation fee. 

BsUFA II also authorizes fees for 

certain biosimilar biological product 

applications and for each biosimilar 

biological product identified in an 

approved biosimilar biological product 

application (sections 744H(a)(2) and 

744H(a)(3) of the FD&C Act). Under 

certain conditions, FDA may grant a 

small business a waiver from its first 

biosimilar biological product 

application fee (section 744H(d)(1) of 

the FD&C Act). 

For FY 2018, the fee revenue amount 

is $45,000,000, adjusted as needed to 

reflect an updated assessment of the 

workload for the process for the review 

of biosimilar biological product 

applications. FDA is adjusting the FY 

2018 revenue amount to $40,214,000 

(rounded to the nearest thousand 

dollars) reflecting its updated 

assessment of the likely workload for 

the BsUFA program in FY 2018. 

This document provides fee rates for 

FY 2018 for the initial and annual BPD 

fee ($227,213), for the reactivation fee 

($454,426), for an application requiring 

clinical data ($1,746,745), for an 

application not requiring clinical data 

($873,373), and for the program fee 

($304,162). These fees apply to the 

period from October 1, 2017, through 

September 30, 2018. For applications 

that are submitted for this period, this 

FY 2018 fee schedule must be used. 

II. Fee Revenue Amount for FY 2018 

The fee revenue amount for FY 2018 

is $45,000,000 adjusted for updated 

workload estimates (see sections 

744H(b)(1) and 744H(c)(4) of the FD&C 

Act). 

A. Statutory Fee Revenue Adjustments 

for Inflation 

BsUFA II specifies that the annual fee 

revenue amount is to be further adjusted 

for inflation increases for FY 2019 

through FY 2022 using two separate 

adjustments—one for personnel 


asabaliauskas on DSKBBXCHB2PROD with NOTICES