2024-28044. Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Administrative detention reporting requirements—800.55(g) & (h)	1	1	1	25	25
Banned devices reporting requirements—895.21(d)(8) and 895.22(a)	26	1	26	16	416
Total					441
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden1

21 CFR section	Number of recordkeepers	Number of records per recordkeepers	Total annual records	Average burden per recordkeeping	Total hours
Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k)	1	1	1	20	20
1  There are no capital costs or operating and maintenance costs associated with this collection of information.