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

Federal RegisterSep 25, 2024

89 Fed. Reg. 78313 (Sep. 25, 2024)

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Department of Health and Human Services Food and Drug Administration

[Docket No. FDA-2024-N-2381]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, 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 October 25, 2024.

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 by using the search function. The OMB control number for this information collection is 0910-0432. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 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 Device Recall Authority

OMB Control Number 0910-0432—Extension

This collection of information helps to implement section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and regulations in part 810 (21 CFR part 810) which set forth mandatory medical device recall authority provisions. Section 518(e) 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 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.

The person named in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that the order be modified, vacated, or amended. FDA may later amend the order to require a mandatory recall of the device. FDA currently allows for these requests, along with other reports and records concerning mandatory recalls, to be submitted to the Agency using electronic methods including email and FDA's eSubmitter program ( https://www.fda.gov/industry/fda-esubmitter ).

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 is used by FDA to implement mandatory recalls.

Description of Respondents: Respondents for this collection of information are firms, including medical device manufacturers, importers, distributors, and retailers, that have been issued a cease distribution and notification order or mandatory recall order in accordance with the provisions under part 810, during the timeframe(s) specified in the order.

In the Federal Register of June 5, 2024 (89 FR 48174), 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:

Table 1—Estimated Annual Reporting Burden

Collection activity—21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Submission of information to FDA about device distribution and remedial actions to be taken, as specified in the order—810.10(d)	2	1	2	8	16
Submission of a written request for regulatory hearing—810.11(a)	1	1	1	8	8
Submission of a written request to FDA asking that the order be modified or vacated—810.12(a-b)	1	1	1	8	8
Submission of a strategy for compliance with cease distribution and notification or mandatory recall order—810.14	2	1	2	16	32
Submission of periodic status reports to FDA to enable the Agency to assess progress in compliance with the order—810.16(a-b)	2	12	24	40	960
Submission of a written request to FDA to certify compliance with and terminate the order—810.17(a)	2	1	2	8	16
Total Hours					1,040
There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden

Collection activity—21 CFR section	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Documentation of communications to appropriate person(s)—810.15(b)	2	1	2	8	16
There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3—Estimated Annual Third-Party Disclosure Burden

Collection activity—21 CFR section	Number of respondents	Number of disclosures per respondent	Total annual responses	Average burden per disclosure	Total hours
Communications to appropriate person(s) concerning a cease distribution and notification or mandatory recall order—810.15(a)-(c)	2	1	2	12	24
Follow up communications to appropriate person(s) who fail to respond to the initial communication—810.15(d)	2	1	2	4	8

Notifications provided by recipients of communications to appropriate consignees—810.15(e)	10	1	10	1	10
Total					42
There are no capital costs or operating and maintenance costs associated with this collection of information.