Companion Proposed Rule: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

ICR 201005-0910-001

OMB: 0910-0748

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2010-04-26
Supporting Statement A
2010-04-23
ICR Details
0910-0748 201005-0910-001
Historical Inactive
HHS/FDA
Companion Proposed Rule: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 10/01/2010
Retrieve Notice of Action (NOA) 05/03/2010
OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the agency should resubmit this ICR at the final rule stage.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007(FDAAA)(Public Law 110-85,)amended the Federal Food Drug and Cosmetic Act(the act) by adding among other things, a new section 515A (a) of the act (21 U.S.C. 360e-1). Section 515A(a) of the act requires persons who submit certain medical device applications to include readily available information providing 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 360-e-1 Name of Law: null
  
US Code: 21 USC 360-e-1 Name of Law: null

0910-AG29 Proposed rulemaking 75 FR 16365 04/01/2010

No

No
No
This is a new collection of information.

$36,300
No
No
No
Uncollected
No
Uncollected
Denver Presley 3018271462

  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.
05/03/2010


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