31150 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 

requirements of CFPB’s Regulation B is 

mandatory. Because the recordkeeping 

and disclosure requirements of the 

CFPB’s Regulation B require creditors to 

retain their own records and to make 

certain disclosures to customers, the 

Freedom of Information Act (FOIA) 

would only be implicated if the Board’s 

examiners retained a copy of this 

information as part of an examination of 

a bank. Records obtained as a part of an 

examination or supervision of a bank 

are exempt from disclosure under FOIA 

exemption (b)(8), for examination 

material (5 U.S.C. 552(b)(8)). In 

addition, the records may also be 

exempt under FOIA exemption (b)(4) or 

(b)(6). Records would be exempt under 

(b)(4) if the records contained ‘‘trade 

secrets and commercial or financial 

information obtained from a person 

[that is] privileged or confidential’’ and 

the disclosure of the information is 

likely to cause substantial harm to the 

competitive position of the respondents 

(5 U.S.C. 552(b)(4)). Records would be 

exempt under (b)(6) if the records 

contained personal information, the 

disclosure of which would ‘‘constitute a 

clearly unwarranted invasion of 

personal privacy’’ (5 U.S.C. 552(b)(6)). 

Current actions: On April 13, 2018, 

the Board published a notice in the 

Federal Register (83 FR 16098) 

requesting public comment for 60 days 

on the extension, without revision, of 

the FR B. The comment period for this 

notice expired on June 12, 2018. The 

Board received one comment letter that 

addressed matter outside the scope of 

this proposal. 

Board of Governors of the Federal Reserve 

System, June 28, 2018. 

Michele Taylor Fennell, 

Assistant Secretary of the Board. 

[FR Doc. 2018–14305 Filed 7–2–18; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[CDC–2018–0006; Docket Number NIOSH– 

306] 

Final National Occupational Research 

Agenda for Services 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: NIOSH announces the 

availability of the final National 

Occupational Research Agenda for 

Services. 

DATES: The final document was 

published on June 26, 2018. 

ADDRESSES: The document may be 

obtained at the following link: https://

www.cdc.gov/niosh/nora/sectors/serv/ 

agenda.html. 

FOR FURTHER INFORMATION CONTACT: 

Emily Novicki, M.A., M.P.H, 

(NORACoordinator@cdc.gov), National 

Institute for Occupational Safety and 

Health, Centers for Disease Control and 

Prevention, Mailstop E–20, 1600 Clifton 

Road NE, Atlanta, GA 30329, phone 

(404) 498–2581 (not a toll free number). 

SUPPLEMENTARY INFORMATION: On 

January 29, 2018, NIOSH published a 

request for public review in the Federal 

Register [83 FR 4058] of the draft 

version of the National Occupational 

Research Agenda for Services. All 

comments received were reviewed and 

addressed where appropriate. 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–14227 Filed 7–2–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10673] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

September 4, 2018. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number ___, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10673 Medicare Advantage 

Qualifying Payment Arrangement 

Incentive (MAQI) Demonstration 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 31151 

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: New Collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicare 

Advantage Qualifying Payment 

Arrangement Incentive (MAQI) 

Demonstration; Use: The Centers for 

Medicare & Medicaid Services (CMS) 

may test a demonstration, under Section 

402 of the Social Security Amendments 

of 1968 (as amended), entitled the 

Medicare Advantage Qualifying 

Payment Arrangement Incentive (MAQI) 

Demonstration (‘‘the Demonstration’’). If 

it goes forward, the MAQI 

demonstration could test whether 

exempting, through the use of waiver 

authority, clinicians who participate to 

a sufficient degree in certain payment 

arrangements with Medicare Advantage 

Organizations (MAOs) (combined with 

participation, if any, in Advanced 

Alternative Payment Models (APMs) 

with Medicare Fee-for-Service (FFS)) 

from the Merit-based Incentive Payment 

System (MIPS) reporting requirements 

and payment adjustment will increase 

or maintain participation in payment 

arrangements with MAOs similar to 

Advanced APMs and change the 

manner in which clinicians deliver care. 

Clinicians may currently participate 

in one of two paths of the Quality 

Payment Program (QPP): (1) MIPS, 

which adjusts Medicare payments based 

on combined performance on measures 

of quality, cost, improvement activities, 

and advancing care information, or (2) 

Advanced Alternative Payment Models 

with Medicare (Advanced APMs), under 

which eligible clinicians may earn an 

incentive payment for sufficient 

participation in certain payment 

arrangements with Medicare fee-forservice (FFS) and other payers, and 

starting in the 2019 performance period, 

with other payers such as Medicare 

Advantage, commercial payers, and 

Medicaid managed care. To participate 

in the Advanced APM path of QPP for 

a given year, eligible clinicians must 

meet the criteria of Qualifying APM 

Participants (QPs); in addition to 

earning an APM incentive payment, QPs 

are excluded from the MIPS reporting 

requirements and payment adjustment. 

An eligible clinician that does not 

meet the criteria to be a QP for a given 

year will be subject to MIPS for that year 

unless the clinician meets certain other 

MIPS exclusion criteria, such as being 

newly enrolled in Medicare or meeting 

the low volume threshold for Medicare 

FFS patients. The MAQI Demonstration 

could allow participating clinicians to 

have the opportunity to be exempt from 

MIPS reporting and payment 

consequences for a given year if they 

participate to a sufficient degree in 

certain Qualifying Payment 

Arrangements with MAOs (and 

Advanced APMs with Medicare FFS) 

during the performance period for that 

year, without requiring them to be QPs 

or otherwise meet the MIPS exclusion 

criteria of QPP. Under a possible 

Demonstration, clinicians might not be 

required to have a minimum amount of 

participation in an Advanced APM with 

Medicare FFS in order to be exempt 

from MIPS reporting requirements and 

payment adjustments for a year, but if 

they did have participation in Advanced 

APMs with Medicare FFS, that 

participation could also be counted 

towards the thresholds that trigger the 

waiver from MIPS reporting and 

payment consequences. In addition, the 

Demonstration could permit 

consideration of participation in 

‘‘Qualifying Payment Arrangements’’ 

with Medicare Advantage plans that 

meet the criteria to be Other Payer 

Advanced APMs a year before the AllPayer Combination Option is available. 

In the Calendar Year 2018 Quality 

Payment Program Final Rule, CMS 

noted its intention ‘‘to develop a 

demonstration project to test the effects 

of expanding incentives for eligible 

clinicians to participate in innovative 

alternative payment arrangements under 

Medicare Advantage that qualify as 

Advanced APMs, by allowing credit for 

participation in such Medicare 

Advantage arrangements prior to 2019 

and incentivizing participation in such 

arrangements in 2018 through 2024.’’ 

(92 FR 53865). 

The first performance period for the 

Demonstration is tentatively planned for 

2018 and the Demonstration would last 

up to five years. Clinicians who meet 

the definition of MIPS eligible clinician 

under QPP as defined under 42 CFR 

414.1305 would be eligible to 

participate in the MAQI Demonstration. 

Currently, MIPS eligible clinicians 

include physicians (including doctors of 

medicine, doctors of osteopathy, 

osteopathic practitioners, doctors of 

dental surgery, doctors of dental 

medicine, doctors of podiatric medicine, 

doctors of optometry, and 

chiropractors), physician assistants, 

nurse practitioners, clinical nurse 

specialists, and certified registered 

nurse anesthetists. If the definition of 

MIPS eligible clinician changes under 

future rulemaking, the Demonstration 

would use the updated definition to 

define Demonstration eligibility. 

Participation could last the duration 

of the Demonstration, unless 

participation is voluntarily or 

involuntarily terminated under the 

terms and conditions of the 

Demonstration. Participants would have 

the opportunity to submit the required 

documentation and be evaluated for 

MIPS waivers through the 

Demonstration each year. 

Should this demonstration move 

forward, and in order to conduct an 

evaluation and effectively implement 

the MAQI Demonstration, CMS would 

need to collect information from 

Demonstration participants on (a) 

payment arrangements with MAOs and 

(b) Medicare Advantage (MA) payments 

and patient counts. CMS would require 

a new collection of this information as 

this information is not already available 

through other sources and/or has not 

been previously approved for use under 

the MAQI Demonstration. The 

information collected in these forms 

would allow CMS to evaluate whether 

the payment arrangement that clinicians 

have with MAOs meet the Qualifying 

Payment Arrangement criteria, and 

determine whether a clinician’s MAO 

and FFS APM patient population or 

payments meet demonstration 

thresholds. Both of these areas are also 

requirements for review and data 

collection under QPP (i.e. the Eligible 

Clinician-Initiated Other Payer 

Advanced APM Determination form and 

All-Payer QP Submission form), and 

therefore similar to forms have been 

prepared and reviewed under the QPP. 

Given these similarities in forms, 

burden estimates for the MAQI 

Demonstration PRA package were 

derived from burden analyses and 

formulation done in conjunction with 

the QPP forms; more specifically the 

estimated burden associated with the 

submission of payment arrangement 

information for Other Payer Advanced 

APM Determinations: Eligible ClinicianInitiated Process, and the estimated 

burden associated with the submission 

of data for All-Payer QP determinations. 

CMS estimates the total hour burden per 


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31152 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 

respondent for the MAQI demonstration 

to be 15 hours, to match the hours listed 

in the equivalent QPP forms. Full detail 

of how these estimates were derived can 

be found in the forthcoming Calendar 

Year 2019 Proposed QPP rule. 

If Demonstration participants 

submitted information, but did not meet 

these conditions of the Demonstration, 

their participation in the Demonstration 

would not be terminated, but they 

would not receive the waivers from 

MIPS reporting requirements and 

payment adjustments. Therefore, unless 

they become QPs or are excluded from 

MIPS for other reasons, the participating 

clinicians would be subject to MIPS and 

would face the MIPS payment 

adjustments for the applicable year. We 

are requesting approval of 2 information 

collections associated with the MAQI 

Demonstration: (a) A Qualifying 

Payment Arrangement Submission Form 

and (b) a Threshold Data Submission 

Form. Form Number: CMS–10673 (OMB 

control number: 0938–NEW); 

Frequency: Annually; Affected Public: 

Private sector—Business or other forprofit and Not-for-profit institutions; 

Number of Respondents: 100,000; Total 

Annual Responses: 100,000; Total 

Annual Hours: 1,500,000. (For policy 

questions regarding this collection 

contact John Amoh at john.amoh@

cms.hhs.gov.) 

Dated: June 28, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–14336 Filed 6–29–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2012–N–0129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; General Licensing 

Provisions; Section 351(k) Biosimilar 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection in an application for a 

proposed biosimilar product and an 

application for a supplement for a 

proposed interchangeable product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 4, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 4, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 4, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA 2012– 

N–0129 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; General 

Licensing Provisions; Section 351(k) 

Biosimilar Applications.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 


sradovich on DSK3GMQ082PROD with NOTICES