INVESTIGATIONAL DEVICE EXEMPTIONS, DISQUALIFICATION OF CLINICAL INVESTIGATORS (PROPOSED RULE)

ICR 199310-0910-004

OMB: 0910-0299

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
0910-0299 199310-0910-004
Historical Active
HHS/FDA
INVESTIGATIONAL DEVICE EXEMPTIONS, DISQUALIFICATION OF CLINICAL INVESTIGATORS (PROPOSED RULE)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/30/1993
Retrieve Notice of Action (NOA) 10/22/1993
  Inventory as of this Action Requested Previously Approved
12/31/1996 12/31/1996
1 0 0
1 0 0
0 0 0

THESE MEDICAL DEVICE REGULATIONS WILL INCLUDE PROVISIONS FOR THE DISQUALIFICATION OF CLINICAL INVESTIGATORS. THEY WILL FURTHER IMPLEME AGENCY PLANS FOR CONSISTENT BIORESEARCH MONITORING AND TO IMPROVE THE REMEDIES AVAILABLE TO DEAL WITH CLINICAL INVESTIGATOR MISCONDUCT.

None
None


No

1
IC Title Form No. Form Name
INVESTIGATIONAL DEVICE EXEMPTIONS, DISQUALIFICATION OF CLINICAL INVESTIGATORS (PROPOSED RULE)

  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 1 0 0 1 0 0
Annual Time Burden (Hours) 1 0 0 1 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.
10/22/1993


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