Investigational Device Exemptions Reports and Records - 21 CFR 812

ICR 201603-0910-005

OMB: 0910-0078

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-03-15
IC Document Collections
IC ID
Document
Title
Status
5718
Modified
205261
Modified
205260
Modified
ICR Details
0910-0078 201603-0910-005
Historical Active 201301-0910-001
HHS/FDA CDRH
Investigational Device Exemptions Reports and Records - 21 CFR 812
Extension without change of a currently approved collection   No
Regular
Approved without change 11/22/2016
Retrieve Notice of Action (NOA) 03/22/2016
  Inventory as of this Action Requested Previously Approved
11/30/2019 36 Months From Approved 11/30/2016
17,243 0 9,493
46,311 0 64,227
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

  80 FR 66009 10/28/2015
81 FR 12735 03/10/2016
No

3
IC Title Form No. Form Name
Reporting
Recordkeeping
Third Party Disclosures

  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 17,243 9,493 0 0 7,750 0
Annual Time Burden (Hours) 46,311 64,227 0 0 -17,916 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The estimated annual reporting burden for this extension has decreased to 38,505 hours (previously 54,253 hours) as the result of a decrease in the average number of applications and supplements submitted. For the same reason, the recordkeeping burden has decreased to 7,800 hours (previously 9,968). The previous approved total burden hours of 64,227, have therefore decreased by 17,916 to 46,311.

$24,663,369
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
03/22/2016


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