Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act

ICR 201401-0910-001

OMB: 0910-0762

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0762 201401-0910-001
Historical Active
HHS/FDA 21118
Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act
New collection (Request for a new OMB Control Number)   No
Approved without change 03/12/2014
Retrieve Notice of Action (NOA) 01/09/2014
  Inventory as of this Action Requested Previously Approved
03/31/2017 36 Months From Approved
148 0 0
74 0 0
0 0 0

This ICR collects information from medical device manufacturers specifically when submitting a premarket approval application or supplement thereto, premarket notification, or humanitarian device exemption. The guidance document suggests that applicants include, if readily available, pediatric use information for diseases or conditions that the device is being used to treat, diagnose, or cure that are outside the device's approved or proposed indications for use, as well as an estimate of the number of pediatric patients with such diseases or conditions.

US Code: 21 USC 351 Name of Law: FFDCA

Not associated with rulemaking

  78 FR 11654 02/19/2013
78 FR 76150 12/16/2013

IC Title Form No. Form Name
Uses outside approved indication

  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 148 0 0 148 0 0
Annual Time Burden (Hours) 74 0 0 74 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new information collection.

JonnaLynn Capezzuto 301 827-4659 [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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