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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26695 

requirements under part 803 for 

importers or device user facilities. The 

proposed program would not apply to 

reportable death or serious injury 

events, as described in section III.A of 

the notification (82 FR 60922 at 60924). 

In addition, the reporting requirements 

at § 803.53, which require a 5-day report 

to be filed at the written request of FDA 

or if a manufacturer becomes aware of 

an MDR reportable event that 

necessitates remedial action to prevent 

an unreasonable risk of substantial harm 

to the public health, would continue to 

apply to manufacturers participating in 

the proposed program. The conditions 

of the proposed Voluntary Summary 

Malfunction Reporting Program would 

also require manufacturers to submit 

individual malfunction reports in 

certain circumstances (see section III.A 

of the notification). These factors were 

considered in determining the revised 

burden estimates described in table 1. 

In the Federal Register of December 

26, 2017 (82 FR 60922), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment related to the information 

collection, that stated that the average 

burden on manufacturers per response 

of 6 minutes appears to be a very low 

estimate. 

FDA disagrees with this comment. 

The estimation of time is the amount of 

time needed to submit a summary 

malfunction report. It is essentially the 

same amount of time needed to submit 

an individual report because the event 

narrative should be the same, with the 

exception of one additional line that is 

entered that indicates the number of 

adverse events represented by the 

report. It does not include the time 

needed to investigate the issue. 

Manufacturers have 120 calendar days 

from the date they become aware of a 

reportable malfunction to submit a 

summary malfunction report that is 

allowed as part of this voluntary 

reporting program. 

For the convenience of the reader, we 

have noted below the information 

collection line-items (ICs) that we 

anticipate would be affected by the 

Voluntary Malfunction Summary 

Reporting Program. While the other ICs 

from OMB control number 0910–0437 

are not affected by the Voluntary 

Malfunction Summary Reporting 

Program, for consistency and accuracy, 

we have adjusted the respondent 

estimates for the ICs using more recent 

data. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/CFR section FDA 

Form No. 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Exemptions—803.19 2 .............................. ........................ 85 4 340 1 340 

User Facility Reporting—803.30 and 

803.32 2 ................................................ ........................ 520 10.06 5,232 0.35 1,831 

User Facility Annual Reporting—803.33 2 3419 159 1 159 1 159 

Importer Reporting, Death and Serious 

Injury—803.40 and 803.42 2 ................. ........................ 578 1 578 1 578 

Manufacturer Reporting—803.50 through 

803.53 3 ................................................ ........................ 1,240 272.50 337,900 0.10 33,790 

Voluntary Malfunction Summary Reporting Program 3 ........................................ ........................ 1,240 54.47 67,546 0.10 6,755 

Supplemental Reports—803.56 3 ............. ........................ 1,050 128.71 135,148 0.10 13,515 

Total .................................................. ........................ ........................ ........................ ........................ ........................ 56,968 

1There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information. 2This IC has been adjusted based on calendar year (CY) 2016 data; however, there is no program change to this IC. 

3This IC revises OMB control number 0910–0437 to reflect the Voluntary Malfunction Summary Reporting Program. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

MDR Procedures—803.17 2 ................................................. 1,240 1 1,240 3.3 4,092 

MDR Files—803.18 2 ........................................................... 1,240 1 1,240 1.5 1,860 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,952 

1There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information. 2This IC has been adjusted based on CY 2016 data; however, there is no program change to this IC. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 3

Importer Reporting, Death and Serious Injury—803.40 and 

803.42 2 ............................................................................ 578 25 14,450 0.35 5,058 

1There is no change to the capital costs or operating and maintenance costs associated with the revision of the collection of information. 2This IC has been adjusted based on CY 2016 data; however, there is no program change to this IC. 

3 Number has been rounded. 


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26696 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

For consistency and accuracy, we 

have adjusted the respondent estimates 

for all the ICs from OMB control number 

0910–0437, including those that are not 

affected by the Voluntary Malfunction 

Summary Reporting Program, to reflect 

more recent data from calendar year 

(CY) 2016 (the currently approved 

estimates are based on CY 2006–2009 

data). This adjustment, along with the 

revisions for the Voluntary Malfunction 

Summary Reporting Program increases 

the estimated total burden of OMB 

control number 0910–0437 by 21,532 

hours (currently approved for 46,446 

hours; requesting 67,978 hours). 

We have added the new burden 

estimate for the Voluntary Malfunction 

Summary Reporting Program. This 

increases the reporting burden estimate 

by 6,755 hours. 

We have revised the burden estimates 

for ‘‘Manufacturer Reporting’’ and 

‘‘Supplemental Reports’’ to update the 

respondent estimates using more recent 

data, as described above, and to reflect 

the revisions resulting from the 

availability of the Voluntary 

Malfunction Summary Reporting 

Program. We believe the availability of 

the summary reporting option for 

manufacturers of certain devices would 

cause a decrease in the number of 

individual manufacturer reports for 

malfunctions submitted under 

§§ 803.50 and 803.52. However, because 

we also adjusted the respondent 

estimates for the ICs using more recent 

data from CY 2016, the estimated 

burden for these ICs is an increase of 

12,139 hours from the currently 

approved burden estimates (the 

previous estimate based on CY 2006– 

2008 data was 35,166 hours for these ICs 

only). We attribute the increase to the 

increase in the number of submissions 

we received in recent years, rather than 

the revisions related to the Voluntary 

Malfunction Summary Reporting 

Program. 

Dated: June 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12336 Filed 6–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1881] 

Development of Inhaled Antibacterial 

Drugs for Cystic Fibrosis and NonCystic Fibrosis Bronchiectasis; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Development of 

Inhaled Antibacterial Drugs for Cystic 

Fibrosis and Non-Cystic Fibrosis 

Bronchiectasis.’’ The purpose of the 

public workshop is to discuss the 

clinical trial design challenges and 

future considerations for inhaled 

antibacterial products to treat cystic 

fibrosis (CF) and non-CF bronchiectasis. 

DATES: The public workshop will be 

held on June 27, 2018, from 8:30 a.m. 

to 4:30 p.m. Submit either electronic or 

written comments on this public 

workshop by July 16, 2018. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

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 July 16, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time on July 16, 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– 

2018–N–1881 for ‘‘Development of 

Inhaled Antibacterial Drugs for Cystic 

Fibrosis and Non-Cystic Fibrosis 

Bronchiectasis.’’ 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 


amozie on DSK3GDR082PROD with NOTICES1