SPF Labeling and Testing Requirements for OTC Sunscreen Products

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0717 7-27-2015.doc Supporting Statement A	2015-07-27

IC Document Collections

IC ID	Document Title	Status
202348	Format labeling in accordance with 201.66(c) and (d) for new sunscreen SKUs	Removed
202347	Format labeling in accordance with 201.66(c) and (d) for existing sunscreen SKUs	Removed
202346	Request for Drug Facts Exemption or Deferral	Modified
202345	Format Labeling for New Sunscreen Stock Keeping Units	Modified
202344	Create Principal Display Panel Labeling for New Sunscreen Stock Keeping Units	Modified
202343	Conduct Sun Protection Factor Testing for New Sunscreen Formulations	Modified

ICR Details

OMB Control No: 0910-0717	ICR Reference No: 201507-0910-010
Status: Historical Active	Previous ICR Reference No: 201205-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: SPF Labeling and Testing Requirements for OTC Sunscreen Products
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: 02/23/2016
	Date Received in OIRA: 07/28/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved	02/29/2016
Responses	183	0	6,734
Time Burden (Hours)	1,689	0	73,986
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR pertains to testing and labeling requirements for OTC sunscreen products marketed containing specified active ingredients and marketed without an approved new drug application or abbreviated new drug application. OTC sunscreen products are required to be tested according to the SPF test procedure in 21 CFR 201.327(i). OTC sunscreen product must be labeled with its SPF value on its principal display panel according to labeling requirements in 21 CFR 201.327(a)(1). 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. Compliance with the drug facts label requirement at 21 CFR 201.66 results in an additional third-party disclosure burden for these manufacturers.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 20499	04/16/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 43782	07/23/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
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
Conduct Sun Protection Factor Testing for New Sunscreen Formulations
Create Principal Display Panel Labeling for New Sunscreen Stock Keeping Units
Format Labeling for New Sunscreen Stock Keeping Units
Request for Drug Facts Exemption or Deferral

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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	183	6,734	0	0	-6,551	0
Annual Time Burden (Hours)	1,689	73,986	0	0	-72,297	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: 07/28/2015

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