Medical Devices; Humanitarian Use Devices

Forms and Documents

Document Name	Status
0332_Supporting Statement_2021.pdf Supporting Statement A	2021-02-24

IC Document Collections

IC ID	Document Title	Status
5922	Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0332	ICR Reference No: 202101-0910-008
Status: Received in OIRA	Previous ICR Reference No: 201912-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Humanitarian Use Devices
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/24/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2021
Responses	213	175
Time Burden (Hours)	22,542	16,739
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information from manufactures who wish to obtain "Humanitarian Use Device" (HUD) designation for a medical device and marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required. To the extent consistent with the protection of the public health and safety and with ethical standards, this program encourages the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. Obtaining marketing approval for a HUD involves two steps: (1) Obtaining designation of the device as a HUD from FDA's Office of Orphan Products Development and (2) submitting a Humanitarian Device Exemption (HDE) application to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), or the Center for Drug Evaluation and Research (CDER), as applicable. A person granted an exemption must submit periodic reports.

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Authorizing Statute(s): US Code: 21 USC 360(d) Name of Law: null
   US Code: 21 USC 360(e) Name of Law: null
  

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:
	85 FR 49379	08/13/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 11303	02/24/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

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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	213	175	0	0	38	0
Annual Time Burden (Hours)	22,542	16,739	0	0	5,803	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: We have also updated the burden estimate consistent with new provisions in §814.104(b)(4)(i)) regarding “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” (83 FR 7366; February 21, 2018) (approved under OMB control number 0910-0741). Section 814.104 is being amended to address submission of data from clinical investigations in a Humanitarian Device Exemption (HDE). To the extent the applicant includes data from clinical investigations, the applicant will be required to include the information and statements as described in § 814.104(b)(4)(i). Consistent with our estimate in OMB control number 0910-0741, this revision increases our burden estimate for a Humanitarian Device Exemption (HDE) by 8 hours per submission. These adjustments have resulted in an overall increase of 5,803 hours to the total estimated burden.

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Annual Cost to Federal Government: $5,924,835

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: 02/24/2021

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