Generic FDA Rapid Response Surveys

ICR 201404-0910-010

OMB: 0910-0500

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2014-04-18
Supporting Statement B
2014-04-18
Supporting Statement A
2014-04-18
ICR Details
0910-0500 201404-0910-010
Historical Active 201012-0910-003
HHS/FDA Generic
Generic FDA Rapid Response Surveys
Extension without change of a currently approved collection   No
Regular
Approved without change 07/03/2014
Retrieve Notice of Action (NOA) 04/23/2014
  Inventory as of this Action Requested Previously Approved
07/31/2017 36 Months From Approved 07/31/2014
60,000 0 60,000
30,000 0 30,000
0 0 0

This program will obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions. This information will be collected from health professionals, hospitals, and other user facilities (e.g., nursing homes, ambulatory surgical facilities and outpatient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical products, distributors, and importers when FDA must quickly determine whether or not a problem with a medical product impacts the public health.

US Code: 21 USC 355 Name of Law: FD&C Act
   US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  78 FR 77686 12/24/2013
79 FR 19618 04/09/2014
No

  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 60,000 60,000 0 0 0 0
Annual Time Burden (Hours) 30,000 30,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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.
04/23/2014


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