Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Adequate directions for use--801.5 Removed 0 0 0
Advertising and promotional materials for ASRs--809.30(d) Removed 0 0 0
Contact lens cleaning solution labeling--800.10(a)(3) and 800.12(c) Removed 0 0 0
Declaration of net quantity of contents--801.62 Removed 0 0 0
Dentures; information regarding temporary and emergency use--801.405(c) Removed 0 0 0
Hearing aid records--801.421(d) Removed 0 0 0
Hearing aids, availability of User Instructional Brochure--801.421(c) Removed 0 0 0
Hearing aids, opportunity to review User Instructional Brochure--801.421(b) Removed 0 0 0
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution--801.410(e) and (f) Removed 0 0 0
Labeling for IVDs--809.10(a) and (b) Removed 0 0 0
Labeling for OTC test sample collection systems for drugs of abuse testing--809.10(f) Removed 0 0 0
Labeling for analyte specific reagents--809.10(e) Removed 0 0 0
Labeling for general purpose laboratory reagents--809.10(d)(1) Removed 0 0 0
Labeling of articles intended for lay use in the repairing and/or refitting of dentures--801.405(b)(1) Removed 0 0 0
Labeling of sunlamp products--1040.20(d) Removed 0 0 0
Labeling requirements for hearing aids--801.420(c)(1) Removed 0 0 0
Latex condoms; justification for the application of testing data to the variation of the tested product--801.435(g) Removed 0 0 0
Liquid ophthalmic preparation labeling--800.10(b)(2) Removed 0 0 0
Manufacturer, packer, or distributor information--801.1 Removed 0 0 0
Medical Device Labeling Regulations; Recordkeeping New 59864909 3264184 0
Medical Device Labeling Regulations; Third-Party Disclosure New 22043773 9025056 0
Menstrual tampons, ranges of absorbency--801.430(e)(2) Removed 0 0 0
Menstrual tampons, sampling plan for measuring absorbency--801.430(f) Removed 0 0 0
Prescription device labeling--801.109 Removed 0 0 0
Processing, labeling, or repacking agreement--801.150(a)(2) Removed 0 0 0
Processing, labeling, or repacking; non-sterile devices--801.150(e) Removed 0 0 0
Retail exemption for prescription devices--801.110 Removed 0 0 0
Statement of identify--801.61 Removed 0 0 0
Technical Data for hearing aids--801.420(c)(4) Removed 0 0 0
User labeling for latex condoms--801.435(b), (c), and (h) Removed 0 0 0
User labeling for menstrual tampons--801.430(d) Removed 0 0 0
Total burden requested under this ICR: 81908682 12289240 0  
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