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

Forms and Documents

Document Name	Status
0633--Condom Labeling--SS--01-27-15 (2).doc Supporting Statement A	2015-01-30

IC Document Collections

IC ID	Document Title	Status
187166	Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 Instruction	Modified

ICR Details

OMB Control No: 0910-0633	ICR Reference No: 201501-0910-004
Status: Historical Active	Previous ICR Reference No: 201111-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 01/30/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	5	0	102
Time Burden (Hours)	60	0	1,224
Cost Burden (Dollars)	0	0	0

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Abstract: 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

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Authorizing Statute(s): US Code: 21 USC 360c Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 61874	10/15/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 4273	01/27/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: 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.

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Annual Cost to Federal Government: $21,879

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/30/2015

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