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
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26697 

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 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Lori 

Benner and/or Jessica Barnes, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6221, 

Silver Spring, MD 20993–0002, 301– 

796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing a public 

workshop regarding the development of 

inhaled antibacterial drugs for CF and 

non-CF bronchiectasis. As such, 

discussions will focus on challenges 

and potential paths forward for inhaled 

antibacterial drugs pertaining to CF and 

non-CF bronchiectasis. 

II. Topics for Discussion at the Public 

Workshop 

FDA is particularly interested in 

discussing challenges and 

considerations regarding CF and non-CF 

bronchiectasis. Discussions are planned 

around the following topics for each of 

the disease areas: 

• Trial design challenges 

• Trial endpoints 

• Trial populations, duration of 

therapy, duration of microbiologic 

testing and followup 

• Device considerations 

The Agency encourages health care 

providers, other U.S. Government 

Agencies, academic experts, industry, 

and other stakeholders to attend this 

public workshop. 

III. Participating in the Public 

Workshop 

Registration: Registration is free and 

based on space availability, with 

priority given to early registrants. 

Persons interested in attending this 

public workshop must register online by 

June 11, 2018, midnight Eastern Time. 

To register, please email complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone to 

InhaledAntibacterialsWorkshop2018@

fda.hhs.gov. 

Early registration is recommended 

because seating is limited; therefore, 

FDA may limit the number of 

participants from each organization. 

Registrants will receive confirmation 

when they have been accepted. If time 

and space permit, onsite registration on 

the day of the public workshop will be 

provided beginning at 7:30 a.m. We will 

let registrants know if registration closes 

before the day of the public workshop. 

If you need special accommodations 

due to a disability, please contact Jessica 

Barnes or Lori Benner (see FOR FURTHER

INFORMATION CONTACT) no later than June 

19, 2018. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session or participate 

in a specific session, and which topic(s) 

you wish to address. We will do our 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

June 19, 2018. All requests to make oral 

presentations must be received by the 

close of registration on June 15, 2018. If 

selected for presentation, any 

presentation materials must 

be emailed to 

InhaledAntibacterialsWorkshop2018@

fda.hhs.gov no later than June 21, 2018. 

No commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Streaming Webcast of the public 

workshop: This public workshop will 

also be webcast at the following site: 

https://collaboration.fda.gov/inhaleda

ntibacterials/. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the website addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/FDAgov/Drugs/ 

NewsEvents/ucm602331.htm. 

Dated: June 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12341 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–0529] 

Draft Concept Paper: Illicit Trade in 

Tobacco Products After 

Implementation of a Food and Drug 

Administration Product Standard; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability (NOA) that 

appeared in the Federal Register of 

March 16, 2018. In the NOA, FDA 

requested public comment on the draft 

concept paper regarding the potential 

for illicit trade markets to develop in 

response to a tobacco product standard. 

The Agency is taking this action in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the NOA published March 16, 

2018 (83 FR 11754). Submit either 

electronic or written comments by July 

16, 2018. 


amozie on DSK3GDR082PROD with NOTICES1