Latex Condoms: User Labeling, Expiration Dating

ICR 199809-0910-016

OMB: 0910-0352

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
37640
Migrated
ICR Details
0910-0352 199809-0910-016
Historical Active 199710-0910-001
HHS/FDA
Latex Condoms: User Labeling, Expiration Dating
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/13/1998
Retrieve Notice of Action (NOA) 09/13/1998
  Inventory as of this Action Requested Previously Approved
11/30/2000 11/30/2000 11/30/2000
58 0 58
5,568 0 5,568
2,000 0 96,511,000

This final regulation requires that labeling of latex condoms contain an expiration date based upon physical and mechanical testing.

None
None


No

1
IC Title Form No. Form Name
Latex Condoms: User Labeling, Expiration Dating

  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 58 58 0 0 0 0
Annual Time Burden (Hours) 5,568 5,568 0 0 0 0
Annual Cost Burden (Dollars) 2,000 96,511,000 0 -96,509,000 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
09/13/1998


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