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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices by using the search function. The OMB
control number for this information collection is 09100432. Also include the FDA docket number found in brackets in the heading of this document.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2018N0405

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Medical Device Recall Authority AGENCY:

FOR FURTHER INFORMATION CONTACT:

Food and Drug Administration,
HHS.
ACTION:

device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious, adverse health consequences or death, to: 1 Immediately cease distribution of such device and 2
immediately notify health professionals and device-user facilities of the order and to instruct such professionals and facilities to cease use of such device.
FDA will then provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be amended to require a mandatory recall of the device. If, after providing the opportunity for an informal hearing, FDA determines that such an order is necessary, the Agency may amend the order to require a mandatory recall.
FDA issued part 810 to implement the provisions of section 518 of the FD&C
Act. The information collected under the mandatory recall authority provisions will be used by FDA to implement mandatory recalls.
In the Federal Register of April 5, 2021 86 FR 17610, FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:

Notice.

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017968867, PRAStaff@
fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.

SUPPLEMENTARY INFORMATION:

The Food and Drug Administration FDA, the Agency, or we 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: Submit written comments including recommendations on the collection of information by September 3, 2021.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting Currently under Review-Open for Public Comments or SUMMARY:

Medical Device Recall Authority21
CFR Part 810
OMB Control Number 09100432
Extension This collection of information implements section 518e of the Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C. 360he and part 810 21 CFR part 810, mandatory medical device recall authority provisions. Section 518e of the FD&C
Act provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a
TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of responses per respondent
Number of respondents
Activity; 21 CFR section
Total annual responses
Average burden per response
Total hours
Collections Specified in the Order810.10d
Request for Regulatory Hearing810.11a
Written Request for Review810.12a and b
Mandatory Recall Strategy810.14
Periodic Status Reports810.16a and b
Termination Request810.17a

2
1 1
2 2
2

1
1 1
1 12
1

2
1 1
2 24
2

8
8 8
16
40
8

16
8 8
32
960
16

Total Hours

1,040

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

TABLE 2ESTIMATED 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
Documentation of Notifications to Recipients810.15b

2

1

2

8

16

Average burden per disclosure
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

lotter on DSK11XQN23PROD with NOTICES1

Number of disclosures per respondent
Number of respondents
Activity; 21 CFR section
Total annual disclosures
Notification to Recipients810.15a through c
Notification to Recipients; Follow-up810.15d
Notification of Consignees by Recipients810.15e

2
2 10

1
1 1

2
2 10

12
4 1

24
8 10

Total

42

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

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