Investigational Device Exemptions Reports and Records -- 21 CFR 812

ICR 199707-0910-001

OMB: 0910-0078

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
0910-0078 199707-0910-001
Historical Active 199303-0910-002
HHS/FDA
Investigational Device Exemptions Reports and Records -- 21 CFR 812
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 09/18/1997
Retrieve Notice of Action (NOA) 07/18/1997
This collection expired 5/31/96 and is therefore a violation of the Paperwork Reduction Act. FDA should take careful steps to ensure that such lapses in approval do not occur in the future.
  Inventory as of this Action Requested Previously Approved
09/30/2000 09/30/2000
3,645 0 0
46,271 0 0
0 0 0

The Food and Drug Administration (FDA) is requesting approval from the Office of Management and Budget (OMB) for information collection requirements contained in 21 CFR part 812. The IDE regulation permits a device to be shipped in interstate commerce for clinical investigation to determine its medical safety and effectiveness. Although the IDE regulation exempts the device from certain requirements of the Act, it requires safeguards for humans who are subjects of investigations, maintenance of sound ethical standards, and procedures to asssure development of reliable scientific data.

None
None


No

1
IC Title Form No. Form Name
Investigational Device Exemptions Reports and Records -- 21 CFR 812

  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 3,645 0 0 3,645 0 0
Annual Time Burden (Hours) 46,271 0 0 46,271 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.
07/18/1997


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