APPLICATION FOR EXEMPTION FROM PREEMPTION FOR MEDICAL DEVICE REQUIREMENTS

ICR 198307-0910-007

OMB: 0910-0129

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0129 198307-0910-007
Historical Active 198106-0910-001
HHS/FDA
APPLICATION FOR EXEMPTION FROM PREEMPTION FOR MEDICAL DEVICE REQUIREMENTS
Revision of a currently approved collection   No
Regular
Approved without change 09/22/1983
Retrieve Notice of Action (NOA) 07/26/1983
  Inventory as of this Action Requested Previously Approved
07/31/1986 07/31/1986 07/31/1983
4 0 5
400 0 500
0 0 0

A STATE OR LOCAL GOVERNMENT MUST APPLY FOR EXEMPTION FROM PREEMPTION IF IT WHISHES TO ENFORCE ANY MEDICAL DEVISE REQUIREMENTS THAT ARE DIFFERENT FROM OR IN ADDITION TO A FEDERAL REQUIREMENT. THE INFORMATION IN THE APPLICATION WILL BE USED TO DETERMINE WHETHER THE REQUIREMENT MEETS THE CRITERIA FOR EXEMPTION.

None
None


No

1
IC Title Form No. Form Name
APPLICATION FOR EXEMPTION FROM PREEMPTION FOR MEDICAL DEVICE REQUIREMENTS

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 4 5 0 0 -1 0
Annual Time Burden (Hours) 400 500 0 0 -100 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
07/26/1983


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