Investigational Device Exemptions Reports and Records - 21 CFR 812

ICR 202104-0910-011

OMB: 0910-0078

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-05-14
Supporting Statement A
2019-10-04
IC Document Collections
IC ID
Document
Title
Status
5718
Unchanged
205261
Unchanged
205260
Unchanged
ICR Details
0910-0078 202104-0910-011
Received in OIRA 201912-0910-007
HHS/FDA CDRH
Investigational Device Exemptions Reports and Records - 21 CFR 812
No material or nonsubstantive change to a currently approved collection   No
Regular 05/19/2021
  Requested Previously Approved
11/30/2022 11/30/2022
16,648 16,648
45,782 45,782
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

  84 FR 27139 06/11/2019
84 FR 53448 10/07/2019
No

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

  Total Request 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 16,648 16,648 0 0 0 0
Annual Time Burden (Hours) 45,782 45,782 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The estimated annual reporting burden for this extension has decreased to 38,080 hours (previously 38,505 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 7,696 hours (previously 7,800). The previous approved total burden hours of 46,311, have therefore decreased by 529 to 45,782 total burden hours.

$23,516,535
No
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

  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.
05/19/2021


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