Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

ICR 201212-0910-009

OMB: 0910-0661

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-12-12
Justification for No Material/Nonsubstantive Change
2012-12-12
ICR Details
0910-0661 201212-0910-009
Historical Active 201003-0910-002
HHS/FDA
Guidance: Humanitarian Device Exemption Regulation: Questions and Answers
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/17/2012
Retrieve Notice of Action (NOA) 12/13/2012
  Inventory as of this Action Requested Previously Approved
05/31/2013 05/31/2013 05/31/2013
14 0 14
1,250 0 1,250
0 0 0

Title III of the Food and Drug Administration Amemdments Act of 2007 (FDAAA) (Public Law 110-85) amended chapter V of the Federal Food and Drug Cosmetic Act(the act)(21 U.S.C.351 et seq.) by inserting section 515A, Pediatric Uses of Devices ( 21 U.S.C. 360e-1) The new privision requires that new applications under section 520(m) of the act (21U.S.C. 360j(m) include both a desciption of any pediatic subpopulation that suffers from: (1) A disease or condition that the device is intended to treat, diagnose, or cure and (2) the number of affected pediatic patients.

US Code: 21 USC 360j(m) Name of Law: null
  
None

Not associated with rulemaking

Yes

  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 14 14 0 0 0 0
Annual Time Burden (Hours) 1,250 1,250 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,704,080
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
12/13/2012


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