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View ICR - OIRA Conclusion

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	5	102	-97
Annual Time Burden (Hours)	60	1,224	-1,164
Annual Cost Burden (Dollars)	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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