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single hard copy of the draft guidance 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
33942 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 

national security. The changes are as 

follows. 

I. Under AN.10 Organization, delete 

all of the components and replace with 

the following: 

A. Immediate Office of the Assistant 

Secretary for Preparedness and 

Response (ANA) 

B. Office of Biomedical Advanced 

Research and Development Authority 

(ANB) 

C. Office of the Principal Deputy 

Assistant Secretary (ANC) 

D. Office of the Deputy Assistant 

Secretary Incident Command and 

Control (ANG) 

II. Delete AN.20 Functions, in its 

entirety and replace with the following: 

Section AR.20 Functions. 

A. Immediate Office of the Assistant 

Secretary for Preparedness and 

Response: The Immediate Office of the 

Assistant Secretary for Preparedness 

and Response (IO/ASPR) is headed by 

the Assistant Secretary, who provides 

leadership and executive and strategic 

direction for the ASPR organization. 

The Assistant Secretary is the principal 

advisor to the Secretary on all matters 

related to Federal public health and 

medical preparedness and response for 

public health emergencies. The 

Assistant Secretary is responsible for 

carrying out ASPR’s mission and 

implementing the functions of ASPR. 

The IO/ASPR (1) ensures development 

and maintenance of liaison 

relationships with HHS operating and 

staff divisions and represents HHS at 

interagency meetings, as required; (2) 

establishes and maintains effective 

communications and outreach guidance 

and support for all external 

communications, including legislative 

and executive branch questions and 

inquiries, and serves as the principal 

advisor to the ASPR on all legislative 

strategies to fulfill the Office of the 

ASPR and the HHS mission under 

section 2811 and other relevant sections 

of the Public Health Service Act, as 

amended; (3) oversees advanced 

research, development and procurement 

of qualified countermeasures, security 

countermeasures and qualified 

pandemic or epidemic products; (4) 

coordinate with relevant federal officials 

to ensure integration of federal 

preparedness and response activities for 

public health emergencies; (5) manages 

correspondence control for the Assistant 

Secretary; and (6) coordinates the 

strategic and operational activities for 

public health preparedness response 

and recovery. 

B. Office of Biomedical Advance 

Research and Development Authority 

(ANB). The Office of Biomedical 

Advanced Research and Development 

Authority (BARDA), established in 

April 2007 in response to the Pandemic 

and All-Hazards Preparedness Act of 

2006, serves preparedness and response 

roles to provide medical 

countermeasures (MCM) in order to 

mitigate the medical consequences of 

chemical, biological, radiological, and 

nuclear (CBRN) threats and agents and 

emerging infectious diseases, including 

pandemic influenza. BARDA executes 

this mission by facilitating research, 

development, innovation, and 

acquisition of MCM and expanding 

domestic manufacturing infrastructure 

and surge capacity of these MCM. 

BARDA is headed by a Deputy 

Assistant Secretary, and includes the 

following components: 

• Division of Influenza (ANB1) 

• Division of Emerging Infectious 

Diseases (ANB2) 

• Division of Chemical, Biological, 

Radiological and Nuclear Threats 

(ANB3) 

• Division of Strategic Science and 

Technology (ANB4) 

• Division of Regulatory and Quality 

Affairs (ANB5) 

• Division of Research, Innovation and 

Ventures (ANB6) 

C. Office of the Principal Deputy 

Assistant Secretary (ANC). The Office of 

the Principal Deputy Assistant Secretary 

(OPDAS) is responsible for providing a 

well-integrated infrastructure that 

supports the Department’s capabilities 

to prevent, prepare for, respond to and 

recover from natural public health and 

medical threats and emergencies. 

OPDAS leads the preparedness and 

response activities required to 

coordinate public health and healthcare 

response systems and activities with 

relevant federal, state, tribal, territorial, 

local, and international communities 

under the National Response 

Framework and Emergency Support 

Annexes #8, #6 and #14. OPDAS is 

responsible for the execution of 

business management operations and 

managing coordination. OPDAS 

provides for the facility, logistics, 

information technology and 

infrastructure support services 

necessary to maintain day-to-day 

operations of ASPR, including functions 

of Human Resources, Organization and 

Employee Development, Ethics, United 

States Public Health Service (USPHS) 

liaison, acquisitions management, 

contracts, grants, and all financial 

planning and analysis. 

The Office of the Principal Deputy 

Assistant Secretary is headed by the 

Principal Deputy Assistant Secretary, 

and includes the following components: 

• Division of Management Finance and 

Human Capital (ANC1) 

• Division of Emergency Management 

and Medical Operations (ANC2) 

• Division of Resource Management 

(ANC3) 

D. Deputy Assistant Secretary 

Incident Command and Control (ANG): 

The Deputy Assistant Secretary (DAS/ 

ICC) is responsible for the policy 

development, planning analysis, 

requirements and strategic planning. 

DAS/ICC manages and operates the HHS 

Secretary’s Operation Center (SOC), 

intelligence, security, information 

management and is also responsible for 

the HHS Continuity of Operations 

(COOP) and the development of the 

ASPR COOP Plan. The Office of the 

Assistant Secretary Incident Command 

and Control (DAS/ICC) is headed by the 

Deputy Assistant Secretary Incident 

Command and Control, and includes the 

following components: 

• Division of Security Intelligence and 

Information Management 

• Division of Strategy, Policy, Planning 

and Requirements 

III. Delegations of Authority. All 

delegations and redelegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegation, provided they are 

consistent with this reorganization. 

Alex M. Azar II, 

Secretary. 

[FR Doc. 2018–15310 Filed 7–17–18; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 


amozie on DSK3GDR082PROD with NOTICES1