Restricted Sale, Distribution, and Use of Sunlamp Products

Forms and Documents

Document Name	Status
Sunlamps_Supporting Statement.doc Supporting Statement A	2016-09-12

IC Document Collections

IC ID	Document Title	Status
223482	Manufacturer/Distributor provides user manual with device; provides copy of manual upon request (one-time burden)	New
223481	Facility explains certification on user's first visit (one-time burden)	New
223480	Facility provides user manual upon request	New
223479	Facility maintains signed certification	New

ICR Details

OMB Control No: 0910-0825	ICR Reference No: 201609-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Restricted Sale, Distribution, and Use of Sunlamp Products
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: 12/06/2016
	Date Received in OIRA: 09/13/2016
Terms of Clearance: 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
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 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.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH14	Proposed rulemaking	80 FR 79493	12/22/2015

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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: 4

IC Title	Form No.	Form Name
Facility maintains signed certification
Facility provides user manual upon request
Facility explains certification on user's first visit (one-time burden)
Manufacturer/Distributor provides user manual with device; provides copy of manual upon request (one-time burden)

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: New

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Annual Cost to Federal Government: $566,974

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: 09/13/2016

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