Latex Condoms; User Labeling - Expiration Dating (21 CFR 801.435)

ICR 200009-0910-007

OMB: 0910-0352

Federal Form Document

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ICR Details
0910-0352 200009-0910-007
Historical Active 199809-0910-016
Latex Condoms; User Labeling - Expiration Dating (21 CFR 801.435)
Extension without change of a currently approved collection   No
Approved without change 11/20/2000
Retrieve Notice of Action (NOA) 09/20/2000
  Inventory as of this Action Requested Previously Approved
11/30/2003 11/30/2003 11/30/2000
45 0 58
4,320 0 5,568
0 0 2,000

The FDA has amended device labeling requirements under 21 CFR 801 to include 21 CFR 801.435. This section requires that expiration labeling for latex condoms be displayed with an expiration date based on physical and mechanical testing, performed after exposing the product to varying conditions that age latex. The effectiveness of latex condoms as a barrier to the transmission of infectious agents is dependent upon the integrity of the latex material. The information and records generated under this regulation will be used to establish an expiration date that will inform consumers when the product should no longer be used.



IC Title Form No. Form Name
Latex Condoms; User Labeling - Expiration Dating (21 CFR 801.435)

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 45 58 0 0 -13 0
Annual Time Burden (Hours) 4,320 5,568 0 0 -1,248 0
Annual Cost Burden (Dollars) 0 2,000 0 0 -2,000 0



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