SPF Labeling and Testing Requirements for OTC Sunscreen Products with SPF Values Greater Than 50

Forms and Documents

Document Name	Status
Sunscreen Proposed Rule_SPF 50 6 2011.doc Supplementary Document	2011-06-16
SPF Labeling and Testing - Supporting Statement - 06_16_2011.doc Supporting Statement A	2011-06-23

IC Document Collections

IC ID	Document Title	Status
198346	Reexamining/relabeling of effectivenes statement	New
198345	labeling new sunscreen products	New

ICR Details

OMB Control No: 0910-0694	ICR Reference No: 201106-0910-011
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: SPF Labeling and Testing Requirements for OTC Sunscreen Products with SPF Values Greater Than 50
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: Comment filed on proposed rule	Conclusion Date: 09/05/2011
	Date Received in OIRA: 06/30/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA's legal authority to modify and simplify the manner in which certain information is presented in over-the-counter (OTC) drug product labeling derives from sections 201, 502, 503, 505, and 701 of the Federal Food, Drug, and Cosmetics Act (the act). Regulating the order, appearance, and format of OTC drug product labeling is consistent with FDA's authority to ensure that drug labeling conveys all material information to the consumer (sections 201(n) and 502(a) of the act), and that labeling communicates this information in a manner that is ''likely to be read and understood by the ordinary individual under customary conditions of purchase and use'' (section 502(c) of the act).

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Authorizing Statute(s): US Code: 21 USC 502 Name of Law: FFDCA
   US Code: 21 USC 503 Name of Law: FFDCA
   US Code: 21 USC 505 Name of Law: FFDCA
   US Code: 21 USC 701 Name of Law: FFDCA
   US Code: 21 USC 201 Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 201.327(a)(1) Name of Law: FFDCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF43	Proposed rulemaking	76 FR 35672	06/14/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
labeling new sunscreen products
Reexamining/relabeling of effectivenes statement

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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 is a new proposed rule, the burden for the broad spectrum average burden per disclosure is .5 in the supporting statement but will round to 1 in the ICRAS/ROCIS system.

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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: 06/30/2011

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