SPF Labeling and Testing Requirements for OTC Sunscreen Products

Forms and Documents

Document Name	Status
Labeling Effectiveness - Final Rule - 2011-14766.pdf Supplementary Document	2012-05-09
Supporting_Statement_A_(2011 Sunscreen final rule) - OMB 8-14-12.doc Supporting Statement A	2012-08-15

IC Document Collections

IC ID	Document Title	Status
202348	Format labeling in accordance with 201.66(c) and (d) for new sunscreen SKUs	New
202347	Format labeling in accordance with 201.66(c) and (d) for existing sunscreen SKUs	New
202346	Create PDP labeling in accordance with 201.327(a)(1) for new sunscreen SKUs	New
202345	Create PDP labeling in accordance with 201.327(a)(1) for existing sunscreen SKUs	New
202344	Conduct SPF testing in accordance with 201.327(i) for new sunscreen formulations	New
202343	Conduct SPF testing in accordance with 201.327(i) for existing sunscreen formulations	New

ICR Details

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

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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.

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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

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

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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

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Conduct SPF testing in accordance with 201.327(i) for existing sunscreen formulations
Conduct SPF testing in accordance with 201.327(i) for new sunscreen formulations
Create PDP labeling in accordance with 201.327(a)(1) for existing sunscreen SKUs
Create PDP labeling in accordance with 201.327(a)(1) for new sunscreen SKUs
Format labeling in accordance with 201.66(c) and (d) for existing sunscreen SKUs
Format labeling in accordance with 201.66(c) and (d) for new sunscreen SKUs

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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	6,734	0	0	0	6,734	0
Annual Time Burden (Hours)	73,986	0	0	0	73,986	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: No

Burden Reduction Due to:

Short Statement:

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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

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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: 05/17/2012

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