Medical Devices; Humanitarian Use Devices

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3674 Certification of Compliance with 42 USC 282(j)(5)(B)	Form	New	Available
Form FDA 3674 Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)	Form	New	Repair queued
83-C for 0332 to add certification element under 0616 MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-12	Available
83-C for 0332 to add certification element under 0616 MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-12	Repair queued
0332_Supporting Statement_2022.docx	Supporting Statement A	Uploaded 2022-09-09	Available
0332_Supporting Statement_2022.docx	Supporting Statement A	Uploaded 2022-09-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5922	Medical Devices; Humanitarian Use Devices		Unchanged
258995	Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)	Form	New	Certification of Compliance with 42 USC 282(j)(5)(B)
258995	Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)	Form	New
255790	Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements	Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0332	ICR Reference No: 202303-0910-005
Status: Historical Active	Previous ICR Reference No: 202202-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Humanitarian Use Devices
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/24/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/13/2023
Terms of Clearance: Approved with the understanding that FDA will now discontinue 0910-0616, given that the associated burden is now reflected in this package.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2025	10/31/2025	10/31/2025
Responses	386	0	382
Time Burden (Hours)	22,905	0	22,902
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports implementation of statutory and regulatory requirements governing humanitarian use devices (HUDs) required by the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are manufacturers and/or sponsors of these devices.

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Authorizing Statute(s): US Code: 21 USC 360(d)
   US Code: 21 USC 360(e)
  

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:
	87 FR 20429	04/07/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 51993	08/24/2022
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Certification of Compliance with 42 U.S.C. § 282(j)(5)(B)	FDA 3674	Certification of Compliance with 42 USC 282(j)(5)(B)
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Medical Devices; Humanitarian Use Devices

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ICR Summary of Burden

table that charts list of burden

	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	386	382	0	0	4	0
Annual Time Burden (Hours)	22,905	22,902	0	0	3	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:

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Annual Cost to Federal Government: $7,109,802

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: 03/13/2023

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