Restricted Sale, Distribution, and Use of Sunlamp Products

ICR 201609-0910-001

OMB: 0910-0825

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0825 201609-0910-001
Historical Inactive
Restricted Sale, Distribution, and Use of Sunlamp Products
New collection (Request for a new OMB Control Number)   No
Comment filed on proposed rule 12/06/2016
Retrieve Notice of Action (NOA) 09/13/2016
These information collections are not approved at this time. FDA will submit them along with the final rule when appropriate.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

FDA is establishing device restrictions for sunlamp products to address the risks to health that these devices pose to users. The proposed requirements establish device restrictions for sunlamp products that: (1) Restrict use to individuals age 18 years and older; (2) require the provision of requested user manuals by facilities to users; (3) require sunlamp product 510(k) holders to provide, upon request, a copy of the sunlamp product user manual to any tanning facility operator, sunlamp product user, or prospective user with respect to any sunlamp product they manufactures/manufactured or distributes/distributed; and (4) require prospective users to sign a risk acknowledgement certification before use (unless the prospective user has previously signed the certification within the preceding 6 months). This ICR relates to information collection, including recordkeeping and third-party disclosure, by tanning facility operators at facilities where sunlamp products are offered for sale as the primary business (tanning salons) or nonprimary business (for example, a gym) and by manufacturers/distributors of sunlamp products.

US Code: 21 USC 374(a) Name of Law: null
   US Code: 21 USC 360j(e) Name of Law: null

0910-AH14 Proposed rulemaking 80 FR 79493 12/22/2015


Miscellaneous Actions

Amber Sanford 301 796-8867 [email protected]


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.

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