Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Adequate directions for use--801.5 New 39942 892704 0
Advertising and promotional materials for ASRs--809.30(d) New 7500 7500 0
Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c) New 136 136 0
Declaration of net quantity of contents--801.62 New 39942 39942 0
Dentures; information regarding temporary and emergency use--801.405(c) New 31 124 0
Hearing aid records--801.421(d) New 1600000 400000 0
Hearing aids, availability of User Instructional Brochure--801.421(c) New 110 8500 0
Hearing aids, opportunity to review User Instructional Brochure--801.421(b) New 1600000 480000 0
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f) New 33758088 39208 0
Labeling for IVDs--809.10(a) and (b) New 10200 816000 0
Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f) New 20 2000 0
Labeling for analyte specific reagents--809.10(e) New 7500 7500 0
Labeling for general purpose laboratory reagents--809.10(d)(1) New 600 24000 0
Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1) New 31 124 0
Labeling of sunlamp products--1040.20(d) New 30 300 0
Labeling requirements for hearing aids--801.420(c)(1) New 1032 41280 0
Latex condoms; justification for the application of testing data to the variation of the tested product--801.435(g) New 378 378 0
Liquid ophthalmic preparation labeling--800.10(b)(2) New 136 136 0
Manufacturer, packer, or distributor information--801.1 New 96460 96460 0
Menstrual tampons, ranges of absorbency--801.430(e)(2) New 176 352 0
Menstrual tampons, sampling plan for measuring absorbency--801.430(f) New 176 14080 0
Prescription device labeling--801.109 New 45348 805834 0
Processing, labeling, or repacking agreement--801.150(a)(2) Modified 3598930 1799465 0
Processing, labeling, or repacking; non-sterile devices--801.150(e) New 12818 51272 0
Retail exemption for prescription devices--801.110 New 20010000 5002500 0
Statement of identify--801.61 New 39942 39942 0
Technical Data for hearing aids--801.420(c)(4) New 1032 82560 0
User labeling for latex condoms--801.435(b), (c), and (h) New 378 37800 0
User labeling for menstrual tampons--801.430(d) New 176 352 0
Total burden requested under this ICR: 60871112 10690449 0  
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