Investigational Device Exemptions Reports and Records - 21 CFR 812

ICR 201212-0910-011

OMB: 0910-0078

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-12-12
Justification for No Material/Nonsubstantive Change
2012-12-12
IC Document Collections
ICR Details
0910-0078 201212-0910-011
Historical Active 201001-0910-010
HHS/FDA
Investigational Device Exemptions Reports and Records - 21 CFR 812
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/19/2012
Retrieve Notice of Action (NOA) 12/17/2012
  Inventory as of this Action Requested Previously Approved
02/28/2013 02/28/2013 02/28/2013
7,825 0 7,825
48,986 0 48,986
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 regulations 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 assure development of reliable scientific data.

US Code: 21 USC 360j(g)) Name of Law: FFDCA
  
None

Not associated with rulemaking

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 7,825 7,825 0 0 0 0
Annual Time Burden (Hours) 48,986 48,986 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$4,842,864
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
12/13/2012


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