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

ICR 201501-0910-004

OMB: 0910-0633

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0633 201501-0910-004
Historical Active 201111-0910-007
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
Revision of a currently approved collection   No
Approved with change 05/18/2015
Retrieve Notice of Action (NOA) 01/30/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved 05/31/2015
5 0 102
60 0 1,224
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

Not associated with rulemaking

  79 FR 61874 10/15/2014
80 FR 4273 01/27/2015

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 5 102 0 0 -97 0
Annual Time Burden (Hours) 60 1,224 0 0 -1,164 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
We updated the No. of Respondents (previously estimated at 3; now 5, due to an increase in the number of manufacturers of natural rubber latex condoms) and No. of Disclosures per Respondent (previously estimated at 34; now 1) using current data. The number of disclosures per respondent represents the number of new natural rubber latex condom products for which manufacturers would follow the labeling recommendations in the guidance document. The disclosure burden is a one-time burden, i.e., products already on the market will have already adjusted their labeling to meet the recommendations in the guidance and only new products would incur this information collection burden. These adjustments resulted in a decrease of 1,164 hours in the burden estimate.

Amber Sanford 301 796-8867 [email protected]


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.

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