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OMB Control No: 0910-0717	ICR Reference No: 201205-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: SPF Labeling and Testing Requirements for OTC Sunscreen Products
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/15/2012
	Date Received in OIRA: 05/17/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved
Responses	6,734	0	0
Time Burden (Hours)	73,986	0	0
Cost Burden (Dollars)	0	0	0

Abstract: Under the 2011 final rule, OTC sunscreen products are required to be tested according to the SPF test procedure in 21 CFR 201.327(i). The SPF test demonstrates a product's effectiveness in protecting against sunburn. A product's numerical SPF value, as determined by the SPF test, reflects the level of sun protection provided by the product. The 2011 final rule requires that an OTC sunscreen product be labeled with its SPF value on its principal display panel according to labeling requirements in 21 CFR 201.327(a)(1). Requiring labeling with SPF values allows consumers to compare the levels of sunburn protection between sunscreen products. The requirement to label OTC sunscreen products with an SPF value determined by the SPF test results in an information collection with a third-party disclosure burden for manufacturers of OTC sunscreen products covered by the final rule. The 2011 final rule also lifts the delay of implementation date of the Drug Facts regulation (21 CFR 201.66) for all OTC sunscreens effective June 18, 2012. Compliance with the Drug Facts regulation results in an additional third-party disclosure burden for manufacturers of OTC sunscreen products covered by the final rule.

Authorizing Statute(s): US Code: 21 USC 201 Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)
   US Code: 21 USC 502 Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)
   US Code: 21 USC 503 Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)
   US Code: 21 USC 505 & 701 Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF43	Final or interim final rulemaking	77 FR 35620	06/17/2011

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 35678	06/17/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 27230	05/09/2012
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	6,734	6,734
Annual Time Burden (Hours)	73,986	73,986
Annual Cost Burden (Dollars)	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:

Annual Cost to Federal Government: $0

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

Agency Contact: Johnny Vilela 301 796-3792 juanmanuel.vilela@fda.hhs.gov

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