Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2163 

Instrument 

Total/annual 

number 

of respondents 

Number of responses 

per respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Extension of Previously Approved Information Collection 

6-Month Follow-Up Survey .............................................................................. 766 1 .333 255 

Estimated Total Annual Burden 

Hours: 255. 

In compliance with the requirements 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. Email 

address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on (a) whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Mary Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–00612 Filed 1–12–18; 8:45 am] 

BILLING CODE 4184–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5569] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Device Tracking 

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 February 

15, 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 0910–0442. 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 Devices; Device Tracking—21 

CFR Part 821 

OMB Control Number 0910–0442— 

Extension 

Section 211 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

became effective on February 19, 1998. 

FDAMA amended the previous medical 

device tracking provisions under section 

519(e)(1) and (2) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i(e)(1) and (2)) that were 

added by the Safe Medical Devices Act 

of 1990 (SMDA) (Pub. L. 101–629). 

Unlike the tracking provisions under 

SMDA, which required tracking of any 

medical device meeting certain criteria, 

FDAMA allows FDA discretion in 

applying tracking provisions to medical 

devices meeting certain criteria and 

provides that tracking requirements for 

medical devices can be imposed only 

after FDA issues an order. In the Federal 

Register of February 8, 2002 (67 FR 

5943), FDA issued a final rule that 

conformed existing tracking regulations 

to changes in tracking provisions 

effected by FDAMA under part 821 (21 

CFR part 821). 

Section 519(e)(1) of the FD&C Act, as 

amended by FDAMA, provides that 

FDA may require by order that a 

manufacturer adopt a method for 

tracking a class II or III medical device, 

if the device meets one of the three 

following criteria: (1) The failure of the 

device would be reasonably likely to 

have serious adverse health 

consequences, (2) the device is intended 

to be implanted in the human body for 

more than 1 year (referred to as a 

‘‘tracked implant’’), or (3) the device is 

life-sustaining or life-supporting 

(referred to as a ‘‘tracked l/s-l/s device’’) 

and is used outside a device user 

facility. 

Tracked device information is 

collected to facilitate identifying the 

current location of medical devices and 

patients possessing those devices, to the 

extent that patients permit the 

collection of identifying information. 

Manufacturers and FDA (where 

necessary) use the data to: (1) Expedite 

the recall of distributed medical devices 

that are dangerous or defective and (2) 

facilitate the timely notification of 

patients or licensed practitioners of the 

risks associated with the medical 

device. 

In addition, the regulations include 

provisions for: (1) Exemptions and 

variances; (2) system and content 

requirements for tracking; (3) 


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2164 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 

obligations of persons other than device 

manufacturers, e.g., distributors; (4) 

records and inspection requirements; (5) 

confidentiality; and (6) record retention 

requirements. 

Respondents for this collection of 

information are medical device 

manufacturers, importers, and 

distributors of tracked implants or 

tracked l/s-l/s devices used outside a 

device user facility. Distributors include 

multiple and final distributors, 

including hospitals. 

The annual hourly burden for 

respondents involved with medical 

device tracking is estimated to be 

615,380 hours per year. The burden 

estimates cited in tables 1 through 3 are 

based on the number of device tracking 

orders issued in the last 3 years, an 

average of 12 tracking orders annually. 

FDA estimates that approximately 

22,000 respondents may be subject to 

tracking reporting requirements. 

Under § 821.25(a), device 

manufacturers subject to FDA tracking 

orders must adopt a tracking method 

that can provide certain device, patient, 

and distributor information to FDA 

within 3 to 10 working days. Assuming 

one occurrence per year, FDA estimates 

it would take a firm 20 hours to provide 

FDA with location data for all tracked 

devices and 56 hours to identify all 

patients and/or multiple distributors 

possessing tracked devices. 

Under § 821.25(d) manufacturers must 

notify FDA of distributor 

noncompliance with reporting 

requirements. Based on the number of 

audits manufacturers conduct annually, 

FDA estimates it would receive no more 

than one notice in any year, and that it 

would take 1 hour per incident. 

Under § 821.30(c)(2), multiple 

distributors must provide data on 

current users of tracked devices, current 

device locations, and other information, 

upon request from a manufacturer or 

FDA. FDA has not made such a request 

and is not aware of any manufacturer 

making a request. Assuming one 

multiple distributor receives one request 

in a year from either a manufacturer or 

FDA, and that lists may be generated 

electronically, the Agency estimates a 

burden of 1 hour to comply. 

Under § 821.30(d) distributors must 

verify data or make required records 

available for auditing, if a manufacturer 

provides a written request. FDA’s 

estimate of the burden for distributor 

audit responses assumes that 

manufacturers audit database entries for 

5 percent of tracked devices distributed. 

Each audited database entry prompts 

one distributor audit response. Because 

lists may be generated electronically, 

FDA estimates a burden of 1 hour to 

comply. 

In the Federal Register of October 18, 

2017 (82 FR 48516), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Discontinuation of business—821.1(d) ................................ 1 1 1 1 1 

Exemption or variance—821.2 and 821.30(e) ..................... 1 1 1 1 1 

Notification of failure to comply—821.25(d) ........................ 1 1 1 1 1 

Multiple distributor data—821.30(c)(2) ................................ 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 4 

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

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 

Tracking information—821.25(a) ......................................... 12 1 12 76 912 

Record of tracking data—821.25(b) .................................... 12 46,260 555,120 1 555,120 

Standard operating procedures—821.25(c) 2 ...................... 12 1 12 63 756 

Manufacturer data audit—821.25(c)(3) ................................ 12 1,124 13,488 1 13,488 

Multiple distributor data and distributor tracking records— 

821.30(c)(2) and (d) ......................................................... 22,000 1 22,000 1 22,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 592,276 

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

2One-time burden. 

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 

Acquisition of tracked devices and final distributor data— 

821.30(a) and (b) ............................................................. 22,000 1 22,000 1 22,000 

Multiple distributor data and distributor tracking records— 

821.30(c)(2) and (d) ......................................................... 1,100 1 1,100 1 1,100 


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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 


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