FDA Safety Communication Readership Survey

ICR 201404-0910-020

OMB: 0910-0341

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-05-19
Supporting Statement B
2014-05-14
IC Document Collections
IC ID
Document
Title
Status
43600 Modified
ICR Details
0910-0341 201404-0910-020
Historical Active 201103-0910-008
HHS/FDA CDRH
FDA Safety Communication Readership Survey
Extension without change of a currently approved collection   No
Regular
Approved without change 07/03/2014
Retrieve Notice of Action (NOA) 05/21/2014
  Inventory as of this Action Requested Previously Approved
07/31/2017 36 Months From Approved 07/31/2014
900 0 924
153 0 157
0 0 0

This ICR collects information from health care practitioners and patients. FDA seeks to evaluate the clarity, timeliness, and impact of Safety Communications by surveying a sample of recipients. The information to be collected will address how clearly Safety Communications for reducing risks are explained, the timeliness of the information, and whether the reader has taken any action to eliminate or reduce risk as a result of the information in the Safety Communication. The information will be used to shape FDA's editorial policy for such communications. Understanding how audiences view these publications will aid the Agency in deciding what changes should be considered in their content and format, and method of dissemination.

US Code: 21 USC 375 (b) Name of Law: null
  
None

Not associated with rulemaking

  79 FR 7677 02/10/2014
79 FR 28526 05/16/2014
No

1
IC Title Form No. Form Name
FDA Safety Communication Readership Survey

  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 900 924 0 0 -24 0
Annual Time Burden (Hours) 153 157 0 0 -4 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
Updated the title of the survey from "FDA PUBLIC HEALTH NOTIFICATION READERSHIP SURVEY" to "FDA Safety Communication Readership Survey". Updated the estimated number of respondents. This adjustment has caused a reduction of four hours to the total estimated hour burden.

$19,200
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@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.
05/21/2014


© 2024 OMB.report | Privacy Policy