Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2165 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Total .............................................................................. ........................ ........................ ........................ ........................ 23,100 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimate for this 

information collection has not changed 

since the last OMB approval. 

This document also refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by OMB under the 

PRA (44 U.S.C. 3501–3520). The 

collections of information found in 

§§ 821.2(b), 821.25(e), and 821.30(e) 

have been approved under OMB control 

number 0910–0191. 

Dated: January 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00568 Filed 1–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6877] 

Accreditation Scheme for Conformity 

Assessment of Medical Devices to 

Food and Drug AdministrationRecognized Standards; 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 ‘‘Accreditation 

Scheme for Conformity Assessment of 

Medical Devices to FDA-Recognized 

Standards.’’ The purpose of the 

workshop is to present a draft design of 

the Accreditation Scheme for 

Conformity Assessment (ASCA) pilot 

program. The workshop is intended to 

discuss and obtain input and 

recommendations from stakeholders on 

the draft accreditation scheme, 

including its goals and scope, a suitable 

framework and procedures, and 

requirements to facilitate 

implementation of an eventual pilot 

program. The overarching objectives of 

the ASCA pilot program are to 

streamline the standards conformity 

assessment of medical devices and to 

improve consistency and predictability 

in the premarket review process where 

certain FDA recognized standards are 

used. 

DATES: The public workshop will be 

held on May 22 and 23, 2018, from 9 

a.m. to 5 p.m. Submit either electronic 

or written comments on this public 

workshop by June 29, 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., Bldg. 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 June 29, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

June 29, 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– 

2017–N–6877 for ‘‘Accreditation 

Scheme for Conformity Assessment of 

Medical Devices to FDA-Recognized 

Standards; Public Workshop; Request 

for Comments.’’ 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 

Agency will review this copy, including 


daltland on DSKBBV9HB2PROD with NOTICES
2166 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 

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: 

Scott Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5514, Silver Spring, 

MD 20993–0002, 301–796–6287, 

CDRHStandardsStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part of the Medical Device User 

Fee Amendments of 2017 (MDUFA IV), 

FDA and industry agreed to establish a 

Pilot Accreditation Scheme for 

Conformity Assessment (ASCA) 

Program for recognizing accredited 

testing laboratories that evaluate 

medical devices per certain FDArecognized standards. Section 514 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360d) was 

amended by adding a new subsection 

(d) with the title ‘‘Pilot Accreditation 

Scheme for Conformity Assessment,’’ 

under the FDA Reauthorization Act of 

2017 (FDARA). The new section 514(d) 

authorizes FDA to establish a pilot 

program under which FDA may select 

accreditation bodies that can accredit 

testing laboratories meeting FDAspecified criteria to assess conformance 

of medical devices to certain FDArecognized consensus standards under 

the ASCA pilot program. The goal of 

this pilot program is to streamline the 

standards conformity assessment of 

medical devices during the premarket 

review process. The objectives of the 

ASCA pilot include improved 

consistency and predictability in the 

premarket review process where certain 

FDA recognized standards are used. 

Traditionally, under section 514(c) of 

the FD&C Act, FDA has been accepting 

a manufacturer’s self-declaration of 

conformity to an FDA-recognized 

consensus standard as part of its 

premarket submission. Since medical 

devices are increasingly complex and 

involve high risks to the patients, such 

self-declaration of conformity is not 

always sufficient to guarantee safety and 

performance, especially when 

deviations from the standard have been 

introduced. In addition, testing 

performed by the independent 

laboratories or the manufacturers 

themselves to support the selfdeclaration of conformity varies 

depending on the standard being used. 

As a result, reviewers sometimes need 

to request and review test reports to 

ensure requirements of the standard 

have been met. The ASCA pilot program 

is designed to address such issues 

through improved quality and increased 

confidence in the testing labs to achieve 

a least burdensome and streamlined 

regulatory process. 

The purpose of this public workshop 

is to present a draft design of the ASCA 

scheme. FDA intends to discuss and 

obtain input and recommendations from 

stakeholders on the draft scheme, 

including its goals and scope, its 

framework and procedures, and 

requirements as required per FDARA. 

Public input and feedback gained 

through this workshop are also intended 

to aid in the development of a draft 

ASCA guidance, which is another 

MDUFA IV commitment. 

II. Topics for Discussion at the Public 

Workshop 

This public workshop will consist of 

both plenary presentations and breakout 

sessions. A keynote presentation is 

planned to provide high-level 

background information about standards 

use and standards conformity 

assessment (CA) in medical device 

regulatory processes, major existing CA 

programs, and significance of and 

challenges to national and international 

harmonization in CA. FDA will present 

background information about the 

proposed ASCA pilot program, its 

objectives and plans, what issues it aims 

to resolve and how. Following the 

plenary presentations, multiple 

breakout sessions will be convened. 

Each breakout session is designed to 

focus on a major ASCA-related topic. 

The topics to be discussed include: 

• Performance metrics to measure the 

success and impact of the ASCA 

• Additional requirements for 

accrediting bodies beyond the 

standard (ISO/IEC 17011:2017 

Conformity assessment— 

Requirements for accreditation bodies 

accrediting conformity assessment 

bodies, available at https://

www.iso.org/standard/67198.html) 

and for testing organizations beyond 

the standard (ISO/IEC 17025:2017 

General requirements for the 

competence of testing and calibration 

laboratories, available at https://

www.iso.org/standard/66912.html) 

• Criteria for selection of pilot 

standards for ASCA 

• Roles that testing organizations can 

play for ASCA 

A detailed agenda will be posted on 

the following website in advance of the 

workshop: https://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm; 

select this event from the list of items 

provided. The overarching objectives of 

the ASCA pilot program are to 

streamline the standards conformity 

assessment of medical devices, and 

improve consistency and predictability 

in the premarket review process where 

certain FDA recognized standards are 

used. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit FDA’s Medical 

Devices News & Events—Workshops & 

Conferences calendar (https://

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm) and select this event from 

the list of items provided. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by May 14, 2018, 4 p.m. Eastern 

Time. 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 8 a.m. We will let 

registrants know if registration closes 

before the day of the public workshop. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2167 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5231, Silver Spring, 

MD 20993–0002, 301–796–5661, or 

email: Susan.Monahan@fda.hhs.gov, no 

later than May 8, 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 

May 16, 2018, midnight Eastern Time. 

All requests to make oral presentations 

must be received by the close of 

registration on May 14, 2018, 4 p.m. 

Eastern Time. If selected for 

presentation, any presentation materials 

must be emailed to Scott Colburn (see 

FOR FURTHER INFORMATION CONTACT) no 

later than May 18, 2018, midnight 

Eastern Time. 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. The webcast link will 

be available on the registration web page 

after May 14, 2018. Please visit FDA’s 

Medical Devices News & Events— 

Workshops & Conferences calendar 

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

NewsEvents/WorkshopsConferences/ 

default.htm) and select this event from 

the list of items provided. Organizations 

are requested to register all participants, 

but to view using one connection per 

location. 

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/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm. 

Dated: January 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00551 Filed 1–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Advisory Council on Alzheimer’s 

Research, Care, and Services; Meeting 

AGENCY: Assistant Secretary for 

Planning and Evaluation, HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

public meeting of the Advisory Council 

on Alzheimer’s Research, Care, and 

Services (Advisory Council). The 

Advisory Council on Alzheimer’s 

Research, Care, and Services provides 

advice on how to prevent or reduce the 

burden of Alzheimer’s disease and 

related dementias on people with the 

disease and their caregivers. During the 

January meeting, the Research 

Subcommittee will be taking charge of 

the theme, focusing on the process from 

targets to treatments. The Council will 

hear speakers on the preclinical 

pipeline, the clinical trial pipeline, and 

the industry perspective. The meeting 

will also include discussion of a driver 

diagram to guide the Council’s future 

work, updates and a report from the 

October Care Summit, and federal 

workgroup updates. 

DATES: The meeting will be held on 

January 26, 2018 from 9:00 a.m. to 5:00 

p.m. EDT. 

ADDRESSES: The meeting will be held in 

Room 800 in the Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW, Washington, DC 20201. 

Comments: Time is allocated in the 

afternoon on the agenda to hear public 

comments. The time for oral comments 

will be limited to two (2) minutes per 

individual. In lieu of oral comments, 

formal written comments may be 

submitted for the record to Rohini 

Khillan, OASPE, 200 Independence 

Avenue SW, Room 424E, Washington, 

DC 20201. Comments may also be sent 

to napa@hhs.gov. Those submitting 

written comments should identify 

themselves and any relevant 

organizational affiliations. 

FOR FURTHER INFORMATION CONTACT: 

Rohini Khillan (202) 690–5932, 

rohini.khillan@hhs.gov. Note: Seating 

may be limited. Those wishing to attend 

the meeting must send an email to 

napa@hhs.gov and put ‘‘January 26 

Meeting Attendance’’ in the Subject line 

by Tuesday, January 16, so that their 

names may be put on a list of expected 

attendees and forwarded to the security 

officers at the Department of Health and 

Human Services. Any interested 

member of the public who is a non-U.S. 

citizen should include this information 

at the time of registration to ensure that 

the appropriate security procedure to 

gain entry to the building is carried out. 

Although the meeting is open to the 

public, procedures governing security 

and the entrance to Federal buildings 

may change without notice. If you wish 

to make a public comment, you must 

note that within your email. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act (5 

U.S.C. App. 2, section 10(a)(1) and 

(a)(2)). Topics of the Meeting: During 

the January meeting, the Research 

Subcommittee will be taking charge of 

the theme, focusing on the process from 

targets to treatments. The Council will 

hear speakers on the preclinical 

pipeline, the clinical trial pipeline, and 

the industry perspective. The meeting 

will also include discussion of a driver 

diagram to guide the Council’s future 

work, updates and a report from the 

October Care Summit, and federal 

workgroup updates. 

Procedure and Agenda: This meeting 

is open to the public. Please allow 30 

minutes to go through security and walk 

to the meeting room. The meeting will 

also be webcast at www.hhs.gov/live. 

Authority: 42 U.S.C. 11225; Section 2(e)(3) 

of the National Alzheimer’s Project Act. The 

panel is governed by provisions of Public 

Law 92–463, as amended (5 U.S.C. Appendix 

2), which sets forth standards for the 

formation and use of advisory committees. 

Dated: January 9, 2018. 

John R. Graham, 

Acting Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2018–00480 Filed 1–12–18; 8:45 am] 

BILLING CODE 4150–05–P 


daltland on DSKBBV9HB2PROD with NOTICES