Proposed Amendment to Laser Product Performance Standard

ICR 201306-0910-010

OMB: 0910-0742

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-06-25
IC Document Collections
ICR Details
0910-0742 201306-0910-010
Historical Inactive
HHS/FDA 19865
Proposed Amendment to Laser Product Performance Standard
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 07/26/2013
Retrieve Notice of Action (NOA) 06/25/2013
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
36 Months From Approved
0 0 0
0 0 0
0 0 0

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.

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
  
None

0910-AF87 Proposed rulemaking 78 FR 37723 06/24/2013

No

2
IC Title Form No. Form Name
Reporting and Recordkeeping Part 1040.11(e)
Recordkeeping 1040.10(a)(3)(iii)

Yes
Miscellaneous Actions
No
This proposed rule proposes to amend FDA's performance standard for laser products to better harmonize with international standards.

$46,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [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.
06/25/2013


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