Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

ICR 201412-0910-017

OMB: 0910-0701

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-12-24
ICR Details
0910-0701 201412-0910-017
Historical Active 201107-0910-010
HHS/FDA CDER
Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
Extension without change of a currently approved collection   No
Regular
Approved without change 04/06/2015
Retrieve Notice of Action (NOA) 01/08/2015
  Inventory as of this Action Requested Previously Approved
04/30/2018 36 Months From Approved 04/30/2015
6,500 0 6,500
262,000 0 262,000
0 0 0

The guidance explains that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic should: (1) Maintain documentation of the conditions that prevent them from meeting normal reporting requirements; (2) notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist and when the reporting process is restored; and (3) maintain records to identify what reports have been stored.

US Code: 21 USC 321, 331, 351-353, 355, 356 Name of Law: FD&C Act
   US Code: 21 USC 356a, 356b, 356c, 371,374,379e Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 46839 08/11/2014
79 FR 508 01/06/2015
Yes

  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 6,500 6,500 0 0 0 0
Annual Time Burden (Hours) 262,000 262,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$12,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
01/08/2015


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