33940 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 

regulatory science; and input into the 

Agency’s research agenda; and on 

upgrading its scientific and research 

facilities and training opportunities. It 

will also provide, where requested, 

expert review of Agency-sponsored 

intramural and extramural scientific 

research programs. 

The Committee shall consist of a core 

of 21 voting members including a Chair 

and Co-Chair. The members, Chair, and 

Co-Chair are selected by the 

Commissioner or designee from among 

authorities knowledgeable in the fields 

of food science, safety, and nutrition; 

chemistry; pharmacology; translational 

and clinical medicine and research; 

toxicology; biostatistics; medical 

devices; imaging; robotics; cell and 

tissue based-products; regenerative 

medicine; public health and 

epidemiology; international health and 

regulation; product safety; product 

manufacturing sciences and quality; and 

other scientific areas relevant to FDA 

regulated products such as systems 

biology, informatics, nanotechnology, 

and combination products. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Almost all nonFederal members of this committee 

serve as Special Government 

Employees. The core of voting members 

may include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. The Committee may 

also include technically qualified 

Federal members. The Commissioner or 

designee shall have the authority to 

select members of other scientific and 

technical FDA advisory committees 

(normally not to exceed 10 members) to 

serve temporarily as voting members 

and to designate consultants to serve 

temporarily as voting members when: 

(1) Expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members), or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 

a committee charter to specify quorum 

requirements. If functioning as a 

medical device panel, a non-voting 

representative of consumer interests and 

a non-voting representative of industry 

interests will be included in addition to 

the voting members. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Science

BoardtotheFoodandDrug

Administration/ucm115356.htm or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: July 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15297 Filed 7–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1771] 

Metal Expandable Biliary Stents— 

Premarket Notification (510(k)) 

Submissions; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Metal Expandable 

Biliary Stents—Premarket Notification 

(510(k)) Submissions.’’ This draft 

guidance provides recommendations for 

information and testing that should be 

included in 510(k) submissions for 

metal expandable biliary stents and 

their associated delivery systems 

intended to provide luminal patency of 

malignant strictures in the biliary tree. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 17, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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–D–1771 for ‘‘Metal Expandable 

Biliary Stents—Premarket Notification 

(510(k)) Submissions.’’ Received 

comments 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33941 

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 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Metal Expandable 

Biliary Stents—Premarket Notification 

(510(k)) Submissions’’ to the Office of 

the Center Director, Guidance and 

Policy Development, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

April Marrone, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G218, Silver Spring, 

MD 20993–0002, 240–402–6510. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance provides draft 

recommendations for 510(k) 

submissions for metal expandable 

biliary stents and their associated 

delivery systems. These devices are 

intended to provide luminal patency of 

malignant strictures in the biliary tree. 

FDA is updating this guidance to reflect 

current review practices. The scope of 

this guidance is limited to metal 

expandable biliary stents regulated 

under 21 CFR 876.5010 (Biliary catheter 

and accessories) and with product code 

FGE (Catheter, Biliary, Diagnostic). This 

draft guidance applies only to biliary 

stents indicated for palliation of 

malignant strictures in the biliary tree. 

It does not apply to biliary stents 

indicated to treat benign strictures or 

stents intended to be used in the 

vasculature, tracheal/bronchial tubes, or 

other gastrointestinal anatomy. This 

draft guidance, when final, will 

supersede the guidance ‘‘Guidance for 

the Content of Premarket Notifications 

for Metal Expandable Biliary Stents,’’ 

issued on February 5, 1998. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Metal Expandable Biliary Stents— 

Premarket Notification (510(k)) 

Submissions.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

draft guidance is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Metal Expandable Biliary Stents— 

Premarket Notification (510(k)) 

Submissions’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1500070 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807, 

subpart E, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

parts 50 and 56 have been approved 

under OMB control number 0910–0755; 

the collections of information in 21 CFR 

56.115 have been approved under OMB 

control number 0910–0130; the 

collections of information in 21 CFR 

50.23 have been approved under OMB 

control number 0910–0586; and the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. 

Dated: July 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15294 Filed 7–17–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Office of the Assistant Secretary for 

Preparedness and Response; 

Statement of Organization, Functions 

and Delegations of Authority 

Part A, Office of the Secretary, 

Statement of Organization, Functions, 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS) is being amended at 

Chapter AN, Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), as last amended at 79 

FR 70.535 (Nov. 26, 2014), 78 FR 25277 

(April 30, 2013), 78 FR 7784 (Feb. 4, 

2013), 75 FR 35.035 (June 21, 2010) to 

realign the functions of ASPR to reflect 

the changes mandated by the 21st 

Century Cures Act and to address everincreasing manmade and naturally 

occurring threats which degrade public 

health, access to healthcare, access to 

emergency medical services and 


amozie on DSK3GDR082PROD with NOTICES1