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

ICR 201111-0910-007

OMB: 0910-0633

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-11-18
ICR Details
0910-0633 201111-0910-007
Historical Active 200811-0910-002
HHS/FDA
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
Extension without change of a currently approved collection   No
Regular
Approved without change 03/19/2012
Retrieve Notice of Action (NOA) 11/22/2011
  Inventory as of this Action Requested Previously Approved
03/31/2015 36 Months From Approved 03/31/2012
102 0 1,190
1,224 0 15,504
0 0 0

This request includes the third-party disclosures (i.e., labeling) associated with the guidance document Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.

US Code: 21 USC 360c Name of Law: null
  
None

Not associated with rulemaking

  76 FR 40377 07/08/2011
76 FR 71575 11/18/2011
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 102 1,190 0 0 -1,088 0
Annual Time Burden (Hours) 1,224 15,504 0 0 -14,280 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$21,879
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
11/22/2011


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