Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26693 

of the drug under Medicare Part D. Per 

statute, drugs that are necessary for the 

palliation and management of the 

terminal illness and related conditions 

are not eligible for payment under Part 

D. The standard form provides a vehicle 

for the hospice provider, prescriber or 

sponsor to document that the drug 

prescribed is ‘‘unrelated’’ to the 

terminal illness and related conditions. 

It also gives a hospice organization the 

option to communicate a beneficiary’s 

change in hospice status and care plan 

to Part D sponsors. Form Number: CMS– 

10538 (OMB control number: 0938– 

1269); Frequency: Occasionally; 

Affected Public: Private sector (business 

or other for-profits); Number of 

Respondents: 424; Total Annual 

Responses: 376,487; Total Annual 

Hours: 31,374. (For policy questions 

regarding this collection contact Shelly 

Winston at 410–786–3694.) 

6. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Good 

Cause Processes; Use: Section 

1851(g)(3)(B)(i) of the Act provides that 

MA organizations may terminate the 

enrollment of individuals who fail to 

pay basic and supplemental premiums 

after a grace period established by the 

plan. Section 1860D–1(b)(1)(B)(v) of the 

Act generally directs us to establish 

rules related to enrollment, disenrollment, and termination for Part D 

plan sponsors that are similar to those 

established for MA organizations under 

section 1851 of the Act. Consistent with 

these sections of the Act, subpart B in 

each of the Parts C and D regulations 

sets forth requirements with respect to 

involuntary dis-enrollment procedures 

at 42 CFR 422.74 and 423.44, 

respectively. In addition, section 

1876(c)(3)(B) establishes that 

individuals may be dis-enrolled from 

coverage as specified in regulations. 

Thus, current regulations at 42 CFR 

417.460 specify that a cost plan, 

specifically a Health Maintenance 

Organization (HMO) or competitive 

medical plan (CMP), may dis-enroll a 

member who fails to pay premiums or 

other charges imposed by the plan for 

deductible and coinsurance amounts. 

Within these regulatory provisions, 

individuals dis-enrolled for 

nonpayment of premiums are afforded a 

grace period in which to request 

reinstatement. As part of the 

reinstatement request process, they 

must demonstrate good cause for failure 

to pay within the initial grace period 

that led to their involuntary disenrollment and pay all overdue 

premiums within three calendar months 

after the dis-enrollment date. Form 

Number: CMS–10544 (OMB control 

number: 0938–1271); Frequency: 

Reporting—Monthly; Affected Public: 

Private Sector (Business or other forprofit institutions); Number of 

Respondents: 10,008; Total Annual 

Responses: 10,008; Total Annual Hours: 

6,665. (For policy questions regarding 

this collection contact Carla Patterson at 

410–786–1000.) 

Dated: June 5, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–12393 Filed 6–7–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10418] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

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 

August 7, 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 ll, 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/PaperworkReducti

onActof1995/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–10418 Annual MLR and Rebate 

Calculation Report and MLR Rebate 

Notices 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

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 


amozie on DSK3GDR082PROD with NOTICES1
26694 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

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: Annual MLR 

and Rebate Calculation Report and MLR 

Rebate Notices; Use: Under Section 

2718 of the Affordable Care Act and 

implementing regulation at 45 CFR part 

158, a health insurance issuer (issuer) 

offering group or individual health 

insurance coverage must submit a report 

to the Secretary concerning the amount 

the issuer spends each year on claims, 

quality improvement expenses, nonclaims costs, Federal and State taxes 

and licensing and regulatory fees, the 

amount of earned premium, and 

beginning with the 2014 reporting year, 

the amounts related to the transitional 

reinsurance, risk corridors, and risk 

adjustment programs established under 

sections 1341, 1342, and 1343, 

respectively, of the Affordable Care Act. 

An issuer must provide an annual rebate 

if the amount it spends on certain costs 

compared to its premium revenue 

(excluding Federal and States taxes and 

licensing and regulatory fees) does not 

meet a certain ratio, referred to as the 

medical loss ratio (MLR). Each issuer is 

required to submit annually MLR data, 

including information about any rebates 

it must provide, on a form prescribed by 

CMS, for each State in which the issuer 

conducts business. Each issuer is also 

required to provide a rebate notice to 

each policyholder that is owed a rebate 

and each subscriber of policyholders 

that are owed a rebate for any given 

MLR reporting year. Additionally, each 

issuer is required to maintain for a 

period of seven years all documents, 

records and other evidence that support 

the data included in each issuer’s 

annual report to the Secretary. Based 

upon CMS’ experience in the MLR data 

collection and evaluation process, CMS 

is updating its annual burden hour 

estimates to reflect the actual numbers 

of submissions, rebates and rebate 

notices. 

The 2017 MLR Reporting Form and 

Instructions reflect changes for the 2017 

reporting year and beyond. The 2017 

MLR Reporting Form and instructions 

are also modified to eliminate the 

reporting elements that were required 

under the risk corridors data submission 

requirements in 45 CFR 153.530 for the 

2014 through 2016 benefit years. For 

2017, it is expected that issuers will 

submit fewer reports and on average, 

send fewer notices and rebate checks in 

the mail to policyholders and 

subscribers, which will reduce burden 

on issuers. In addition, issuers of 

qualified health plans will no longer 

have to submit on the annual report the 

data for the risk corridors program 

established under section 1342 of the 

Patient Protection and Affordable Care 

Act. Form Number: CMS–10418 (OMB 

control number: 0938–1164); Frequency: 

Annually; Affected Public: Private 

Sector, Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 522; Number of 

Responses: 2,138; Total Annual Hours: 

170,589. (For policy questions regarding 

this collection contact Christina 

Whitefield at 301–492–4172.) 

Dated: June 5, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–12394 Filed 6–7–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6730] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary 

Malfunction Summary Reporting 

Program for Manufacturers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 July 9, 

2018. 

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 

OMB control number 0910–0437. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Reporting: Electronic 

Submission Requirements 

OMB Control Number 0910–0437— 

Extension 

The information collection associated 

with 21 CFR part 803 is approved under 

OMB control number 0910–0437. We 

request revision of the information 

collection approval as described in this 

document. 

In the Federal Register of December 

26, 2017 (82 FR 60922), FDA published 

a notification and request for comments 

entitled ‘‘Center for Devices and 

Radiological Health; Medical Devices 

and Combination Products; Voluntary 

Malfunction Summary Reporting 

Program for Manufacturers’’ (the 

notification) which, among other things, 

proposed a program for manufacturer 

reporting of certain device malfunction 

medical device reports (MDRs) in 

summary form—the Voluntary 

Malfunction Summary Reporting 

Program. The proposed program would 

permit manufacturers of devices in 

certain product codes to report 

malfunctions for those devices on a 

quarterly basis and in a summary format 

(instead of reporting them as individual, 

30-day reports), subject to certain 

conditions. Therefore, we have added a 

line item to the reporting burden table 

in OMB control number 0910–0437, 

‘‘Medical Device Reporting: Electronic 

Submission Requirements,’’ for the 

proposed Voluntary Malfunction 

Summary Reporting Program. 

FDA believes that submission of 

voluntary summary reports in the 

format described in this document 

would provide the most compact and 

efficient reporting mechanism for 

streamlining malfunction reporting that 

still provides sufficient detail for FDA to 

monitor devices effectively. The 

proposed Voluntary Malfunction 

Summary Reporting Program is meant to 

streamline the process of reporting 

malfunctions. It does not change 

regulatory requirements for MDR-related 

investigations or recordkeeping by 

manufacturers. The proposed program 

would neither apply to importers or 

device user facilities, nor affect 


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