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

ICR 201803-0910-009

OMB: 0910-0633

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-04-11
ICR Details
0910-0633 201803-0910-009
Active 201501-0910-004
HHS/FDA CDRH
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 05/17/2018
Retrieve Notice of Action (NOA) 04/12/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved 05/31/2018
5 0 5
60 0 60
0 0 0

This ICR pertains to information that manufactures and repackagers of natural rubber latex condoms disclose to the health professionals who use or prescribe the device or the lay consumers who use the device. Natural rubber latex condoms without spermicidal lubricant are class II devices; devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance. The Food and Drug Administration (FDA) describes in a special controls guidance document its labeling recommendations for condoms without spermicidal lubricant. Respondents are expected to comply with the requirement of special controls and address the issues of safety and effectiveness identified in the special controls guidance, either by following the recommendations in the guidance or by some other means that provides equivalent assurance of safety and effectiveness.7

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

Not associated with rulemaking

  82 FR 52056 11/09/2017
83 FR 15158 04/09/2018
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 5 5 0 0 0 0
Annual Time Burden (Hours) 60 60 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
04/12/2018


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