Survey of Health Care Practitioners for Device Labeling Format and Content

ICR 201503-0910-008

OMB: 0910-0790

Federal Form Document

ICR Details
0910-0790 201503-0910-008
Historical Active
Survey of Health Care Practitioners for Device Labeling Format and Content
New collection (Request for a new OMB Control Number)   No
Approved without change 05/27/2015
Retrieve Notice of Action (NOA) 04/14/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved
96 0 0
83 0 0
0 0 0

This ICR collects information from health care providers (HCPs). The study will compare existing device labeling with a standard content and format of the same labeling that FDA researchers will develop. The study will quantify the usability and usefulness of standardized labeling for the HCP community. The anticipated final outcome will be standardized medical device labeling that will lead to an increase in the safe and effective use of medical devices and a reduction in adverse events and recalls.

US Code: 21 USC 301 Name of Law: Federal Food, Drug, and Cosmetic Act

Not associated with rulemaking

  79 FR 54727 09/12/2014
80 FR 18410 04/06/2015

IC Title Form No. Form Name
Health Care Professionals Participating at a Hospital
Health Care Professionals Participating at FDA

  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 96 0 0 96 0 0
Annual Time Burden (Hours) 83 0 0 83 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new collection

Yes Part B of Supporting Statement
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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