APPLICATION FOR EXEMPTION FROM PRE-EMPTION FOR MEDICAL DEVICES

ICR 198910-0910-001

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 198910-0910-001
Historical Active 198702-0910-002
HHS/FDA
APPLICATION FOR EXEMPTION FROM PRE-EMPTION FOR MEDICAL DEVICES
Revision of a currently approved collection   No
Regular
Approved without change 12/11/1989
Retrieve Notice of Action (NOA) 10/06/1989
  Inventory as of this Action Requested Previously Approved
12/31/1992 12/31/1992 10/31/1989
3 0 3
300 0 300
0 0 0

A STATE OR LOCAL GOVERNMENT MUST APPLY FOR EXEMPTION FROM PRE-EMPTION IF IT WISHES TO ENFORCE ANY MEDICAL DEVICE REQUIREMENT THAT IS DIFFERE FROM, OR IN ADDITION TO, A FEDERAL REQUIREMENT. THE INFORMATION IN TH APPLICATION WILL BE USED TO DETERMINE WHETHER THE REQUIREMENT MEETS TH CRITERIA FOR EXEMPTION.

None
None


No

1
IC Title Form No. Form Name
APPLICATION FOR EXEMPTION FROM PRE-EMPTION FOR MEDICAL DEVICES

  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 3 3 0 0 0 0
Annual Time Burden (Hours) 300 300 0 0 0 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.
10/06/1989


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