Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

ICR 200811-0910-002

OMB: 0910-0633

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2008-11-05
Supporting Statement A
2008-11-05
ICR Details
0910-0633 200811-0910-002
Historical Active
HHS/FDA
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/15/2008
Retrieve Notice of Action (NOA) 11/11/2008
  Inventory as of this Action Requested Previously Approved
12/31/2011 36 Months From Approved
1,190 0 0
15,504 0 0
0 0 0

In re-examining condom labeling as directed by Public Law 106-554, FDA identified developments in the scientific research that would justify updating the labeling for latex condoms to ensure the labeling provided the most accurate information possible. This guidance document lists the issues requiring special controls identified by FDA and describe labeling measures that, if followed by manufacturers, will generally address the issues requiring special controls associated with latex condoms.

Statute at Large: 21 Stat. 360 Name of Statute: null
  
US Code: 21 USC 360c Name of Law: null

0910-AF21 Final or interim final rulemaking 73 FR 66522 11/10/2008

  73 FR 66522 11/10/2008
73 FR 66645 11/10/2008
No

1
IC Title Form No. Form Name
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300

  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 1,190 0 1,190 0 0 0
Annual Time Burden (Hours) 15,504 0 15,504 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new collection.

$21,879
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Denver Presley 3018271462

  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.
11/11/2008


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