Medical Devices; Exception from General Requirements for Informed Consent

ICR 200603-0910-005

OMB: 0910-0586

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0586 200603-0910-005
Historical Active
HHS/FDA
Medical Devices; Exception from General Requirements for Informed Consent
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 05/25/2006
Retrieve Notice of Action (NOA) 03/16/2006
This paperwork is approved on an emergency basis for 6 months. No emergency extensions will be granted for this collection. Prior to the expiration date (11/30/2006), FDA must submit to OMB a request for an extension including a summary of the public comments received and how the agency will address substantive issues raised by commenters. We will also expect an update on the progress of the final rule when we review the PRA extension request.
  Inventory as of this Action Requested Previously Approved
11/30/2006 11/30/2006
450 0 0
900 0 0
0 0 0

The interim final rule would amend FDA#s informed consent regulation to provide an exception to the general requirement to obtain informed consent from the subject of an investigation involving and unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent.

None
None


No

1
IC Title Form No. Form Name
Medical Devices; Exception from General Requirements for Informed Consent

  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 450 0 0 450 0 0
Annual Time Burden (Hours) 900 0 0 900 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.
03/16/2006


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