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

Forms and Documents

Document Name	Status
NEW--Sunlamp PS prorule--SS.doc Supporting Statement A	2019-10-01

IC Document Collections

IC ID	Document Title	Status
237954	Reporting	New

ICR Details

OMB Control No: 0910-0878	ICR Reference No: 201910-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard)
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: 10/04/2019
	Date Received in OIRA: 10/01/2019
Terms of Clearance: 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: 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.

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Authorizing Statute(s): US Code: 21 USC 360hh Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG30	Proposed rulemaking	80 FR 79505	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: 1

IC Title	Form No.	Form Name
Reporting

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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: NEW

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Annual Cost to Federal Government: $2,200

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 10/01/2019

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