Performance Standard for Electrode Lead Wires and Patient Cables: Petitions for Exemptions and Variances

ICR 199801-0910-005

OMB: 0910-0367

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0367 199801-0910-005
Historical Active
HHS/FDA
Performance Standard for Electrode Lead Wires and Patient Cables: Petitions for Exemptions and Variances
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/02/1998
Retrieve Notice of Action (NOA) 01/28/1998
  Inventory as of this Action Requested Previously Approved
04/30/2001 04/30/2001
50 0 0
500 0 0
0 0 0

FDA established a performance standard for electrode lead wires and patient cables for medical devices for which there was a risk of connecting the patient to hazardous voltages. Affected persons may request an exemption or variance from this performance standard by submitting a petition demonstrating that compliance with the standard is unnecessary or impractical for their device and that adequate precautions are in place to assure the safety of the patient.

None
None


No

1
IC Title Form No. Form Name
Performance Standard for Electrode Lead Wires and Patient Cables: Petitions for Exemptions and Variances

  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 50 0 0 50 0 0
Annual Time Burden (Hours) 500 0 0 500 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
01/28/1998


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