Investigational Device Exemptions Reports and Records - 21 CFR 812

Forms and Documents

Document Name	Status
0078--change request--moving OUS to 0078--05-06-21.pdf Justification for No Material/Nonsubstantive Change	2021-05-14
0078_Supporting Statement_2019.doc Supporting Statement A	2019-10-04

IC Document Collections

IC ID	Document Title	Status
5718	Reporting	Unchanged
205261	Third Party Disclosures	Unchanged
205260	Recordkeeping	Unchanged

ICR Details

OMB Control No: 0910-0078	ICR Reference No: 202104-0910-011
Status: Received in OIRA	Previous ICR Reference No: 201912-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Investigational Device Exemptions Reports and Records - 21 CFR 812
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/19/2021

	Requested	Previously Approved
Expiration Date	11/30/2022	11/30/2022
Responses	16,648	16,648
Time Burden (Hours)	45,782	45,782
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 360j(g)) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 27139	06/11/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 53448	10/07/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $23,516,535

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 05/19/2021

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