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View ICR - OIRA Conclusion

OMB Control No: 0910-0027	ICR Reference No: 201707-0910-006
Status: Historical Active	Previous ICR Reference No: 201407-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Voluntary Cosmetic Registration Program
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/22/2017
	Date Received in OIRA: 08/22/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	12,187	0	7,827
Time Burden (Hours)	3,233	0	1,987
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	12,187	7,827	4,360
Annual Time Burden (Hours)	3,233	1,987	1,246
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: No

Burden Reduction Due to:

Short Statement: This information collection reflects agency adjustments. The total annual number of responses reflects an overall increase from 7,827 to 12,187 responses (an increase of 4,360 responses) and a total annual hour burden increase from 1,987 to 3,233 hours (an increase of 1,246 hours). We attribute the increase to industry growth, specifically an increase in the number of respondents. Specific fluctuations to the individual information collections are summarized in Q15.

Annual Cost to Federal Government: $452,593

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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