2024-21904. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority

Table 1—Estimated Annual Reporting Burden ¹

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

Table 2—Estimated Annual Recordkeeping Burden ¹

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

Table 3—Estimated Annual Third-Party Disclosure Burden ¹

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
( print page 78315)
Notifications provided by recipients of communications to appropriate consignees—810.15(e)	10	1	10	1	10
Total					42
1  There are no capital costs or operating and maintenance costs associated with this collection of information.