Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

Forms and Documents

Document Name	Status
0661_Supporting Statement_2019.doc Supporting Statement A	2019-07-11

IC Document Collections

IC ID	Document Title	Status
206353	Request for Determination of Eligibility Criteria Other-Guidance; Humanitarian Device Exemption (HDE) Regulation:	Modified
192261	ADN Modification Other-Guidance; Humanitarian Device Exemption (HDE) Regulation:	Modified
192260	ADN Notification Other-Guidance; Humanitarian Device Exemption (HDE) Regulation:	Modified
192259	Exemption from Profit Prohibition Information Other-Guidance; Humanitarian Device Exemption (HDE) Regulation:	Modified
192258	Pediatric Subpopulation and Patient Information Other-Guidance; Humanitarian Device Exemption (HDE) Regulation:	Modified

ICR Details

OMB Control No: 0910-0661	ICR Reference No: 201907-0910-008
Status: Active	Previous ICR Reference No: 201604-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/05/2019
	Date Received in OIRA: 08/08/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved	09/30/2019
Responses	5	0	17
Time Burden (Hours)	360	0	1,370
Cost Burden (Dollars)	0	0	0

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Abstract: Under section 520(m) (21 U.S.C. 360j(m)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the FDA is authorized to exempt a humanitarian use device (HUD) from the effectiveness requirements in sections 514 and 515 of the FD&C Act. HUDs are subject to the general restriction that no profit may be made on their use. For HUDs labeled for use in certain populations, FDA exempts a certain number of these devices each year from the prohibition on profit. This number is known as the ADN. The information gathered by this collection enables FDA to set this number. Failure to collect this information would prevent FDA from assigning an ADN. Section 520(m)(6)(A)(ii), as amended by FDASIA, provides that the Secretary of Health and Human Services (the Secretary) will assign an annual distribution number (ADN) for devices that meet the eligibility criteria to be permitted to be sold for profit.. The ADN is defined as the number of devices "reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States," and therefore shall be based on the following information in a humanitarian device exemption (HDE) application: the number of devices reasonably necessary to treat such individuals. FDA is requesting OMB approval for the collection of information required under the statutory mandate of sections 515A and 520(m) of the FD&C Act as amended. Reporting Requirements: Pediatric Subpopulation and Patient Information--Section 515A(a)(2) Requires that an HDE application include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure and the number of affected pediatric patients.

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Authorizing Statute(s): US Code: 21 USC 360j(m) 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:
	84 FR 8874	03/12/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 37314	07/31/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Request for Determination of Eligibility Criteria
Pediatric Subpopulation and Patient Information
Exemption from Profit Prohibition Information
ADN Notification
ADN Modification

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ICR Summary 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	5	17	0	0	-12	0
Annual Time Burden (Hours)	360	1,370	0	0	-1,010	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 reduced the estimated number of respondents based on recent data on the number of original HDE applications. This adjustment results in an overall reduction of 1,010 burden hours.

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Annual Cost to Federal Government: $1,081,220

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? Uncollected

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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: 08/08/2019

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