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

ICR 201304-0910-001

OMB: 0910-0661

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-04-03
ICR Details
0910-0661 201304-0910-001
Historical Active 201212-0910-009
HHS/FDA 19171
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Revision of a currently approved collection   No
Regular
Approved without change 05/13/2013
Retrieve Notice of Action (NOA) 04/04/2013
  Inventory as of this Action Requested Previously Approved
05/31/2016 36 Months From Approved 05/31/2013
17 0 14
1,370 0 1,250
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
  
None

Not associated with rulemaking

  77 FR 74667 12/17/2012
78 FR 20115 04/03/2013
No

  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 17 14 0 3 0 0
Annual Time Burden (Hours) 1,370 1,250 0 120 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
FDA revised the title of the information collection to more accurately reflect its content subsequent to the FDASIA amendment. FDA has increased the reporting burden estimate slightly to reflect the expected number of respondents for pediatric subpopulation and patient information based on updated data from the last three years and our expectation of an increase due to the FDASIA legislation. The total burden hours will, therefore, increase by 120 to 1,370. The annualized cost burden estimate has increased by $53,640 to $57,540 due to updated wage rates and to correct a miscalculation in the previously approved cost burden estimate, which only accounted for the cost burden for a single response to a 100-hour burden. Under section 1136 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), FDA now requires an eCopy of submissions. We have added text describing the eCopy requirement in section 3 of this supporting statement, "Use of Improved Information Technology and Burden Reduction." As described in section 3, the new eCopy requirement does not change any cost or hourly burden. OMB approved this non-material/nonsubstantive change on December 17, 2012.

$4,716,720
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  No

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.
04/04/2013


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