Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard)

ICR 201910-0910-001

OMB: 0910-0878

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-10-01
IC Document Collections
IC ID
Document
Title
Status
237954
New
ICR Details
0910-0878 201910-0910-001
Historical Inactive
HHS/FDA CDRH
Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard)
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 10/04/2019
Retrieve Notice of Action (NOA) 10/01/2019
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
36 Months From Approved
0 0 0
0 0 0
0 0 0

This ICR collects information from sunlamp product manufacturers. The information collected includes reporting, recordkeeping, and third-party disclosures related to amendments of the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products. This standard was last amended in 1985. The current amendments seek to improve consumer safety by requiring more effective communication regarding the risks posed by these products. They also would reduce risks to consumers by updating technical requirements to reflect current science, and by adopting and incorporating by reference certain elements from the International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12.

US Code: 21 USC 360hh Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)
  
None

0910-AG30 Proposed rulemaking 80 FR 79505 12/22/2015

No

1
IC Title Form No. Form Name
Reporting

No
No
NEW

$2,200
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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.
10/01/2019


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