Proposed Amendment to Laser Product Performance Standard

Forms and Documents

Document Name	Status
Laser Perf Stand SS Final.doc Supporting Statement A	2013-06-25

IC Document Collections

IC ID	Document Title	Status
207537	Recordkeeping 1040.10(a)(3)(iii)	New
207536	Reporting and Recordkeeping Part 1040.11(e)	New

ICR Details

OMB Control No: 0910-0742	ICR Reference No: 201306-0910-010
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 19865
Title: Proposed Amendment to Laser Product 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: 07/26/2013
	Date Received in OIRA: 06/25/2013
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. 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 proposed rule proposes to amend FDA's performance standard for laser products to better harmonize with international standards. This ICR collects information from laser manufactures who wish to market their electronic product. Respondents submit information as provided in Agency regulations regarding exemptions and registration. New ? 1040.11(e), would allow FDA or a DOD procuring agency to verify that a manufacturer went through the process of obtaining a DOD exemption from the laser product performance standard. For ? 1040.11(a)(3)(iii), the manufacturer would collect documentation sufficient to support the validity of a claim by the manufacturer that the purchaser is a manufacturer or supplier (dealer / distributor) and a bona fide business entity engaged in laser product commerce.

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Authorizing Statute(s): US Code: 21 USC 351 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 201 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF87	Proposed rulemaking	78 FR 37723	06/24/2013

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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: 2

IC Title	Form No.	Form Name
Reporting and Recordkeeping Part 1040.11(e)
Recordkeeping 1040.10(a)(3)(iii)

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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: This proposed rule proposes to amend FDA's performance standard for laser products to better harmonize with international standards.

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Annual Cost to Federal Government: $46,000

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: 06/25/2013

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