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

ICR 201907-0910-008

OMB: 0910-0661

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0661 201907-0910-008
Active 201604-0910-009
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Extension without change of a currently approved collection   No
Approved without change 09/05/2019
Retrieve Notice of Action (NOA) 08/08/2019
  Inventory as of this Action Requested Previously Approved
09/30/2022 36 Months From Approved 09/30/2019
5 0 17
360 0 1,370
0 0 0

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.

US Code: 21 USC 360j(m) Name of Law: null

Not associated with rulemaking

  84 FR 8874 03/12/2019
84 FR 37314 07/31/2019

  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
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.

Amber Sanford 301 796-8867 [email protected]


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.

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