2024-21436. Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs

Table 1—Estimated Annual Recordkeeping Burden ¹

Activity/21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Labeling requirements for prescription drugs; §§ 201.56 and 201.57	414	1.326	549	3,349	1,838,601
Labeling applicable to medical gas containers; §§ 201.161(b) and 201.328	260	1,663	432,380	0.17 (10 minutes)	73,505
Exemption from barcode requirements § 201.25(d)	2	1	2	24	48
Safety labeling required under section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and rebuttal statement	36	1	36	6	216
Safety labeling changes; posting approved letter on application holder's website	351	1	351	4	1,404
Exceptions or alternatives to labeling requirements for human drug product held by SNS; § 201.26	1	1	1	32	32
Hypertension claims; recommended labeling considerations	5	1	5	18	90
Total			433,324		1,913,896
1  There are no capital costs or operating and maintenance costs associated with this collection of information.