SPF Labeling and Testing Requirements for OTC Sunscreen Products

Forms and Documents

Document Name	Status
0717 OTC Sunscreen SSA 2019 Ext.pdf Supporting Statement A	2019-02-27

IC Document Collections

IC ID	Document Title	Status
202346	Request for Drug Facts Exemption or Deferral	Unchanged
202345	Format Labeling for New Sunscreen Stock Keeping Units	Unchanged
202344	Create Principal Display Panel Labeling for New Sunscreen Stock Keeping Units	Unchanged
202343	Conduct Sun Protection Factor Testing for New Sunscreen Formulations	Unchanged

ICR Details

OMB Control No: 0910-0717	ICR Reference No: 201902-0910-001
Status: Active	Previous ICR Reference No: 201507-0910-010
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: 03/21/2019
	Date Received in OIRA: 02/28/2019
Terms of Clearance: If related regulatory changes are finalized, this ICR will need to be revised accordingly (in time for a final rule's effective date).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved	03/31/2019
Responses	183	0	183
Time Burden (Hours)	1,689	0	1,689
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 301 et seq. 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:
	83 FR 42509	08/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 2878	02/08/2019
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
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	183	0	0	0	0
Annual Time Burden (Hours)	1,689	1,689	0	0	0	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

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

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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: 02/28/2019

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