SPF Labeling and Testing Requirements for OTC Sunscreen Products

ICR 201205-0910-007

OMB: 0910-0717

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-05-09
Supporting Statement A
2012-08-15
ICR Details
0910-0717 201205-0910-007
Historical Active
HHS/FDA
SPF Labeling and Testing Requirements for OTC Sunscreen Products
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 08/15/2012
Retrieve Notice of Action (NOA) 05/17/2012
  Inventory as of this Action Requested Previously Approved
08/31/2015 36 Months From Approved
6,734 0 0
73,986 0 0
0 0 0

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.

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)
  
None

0910-AF43 Final or interim final rulemaking 77 FR 35620 06/17/2011

  76 FR 35678 06/17/2011
77 FR 27230 05/09/2012
Yes

  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
No
No

$0
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/17/2012


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