Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

ICR 201411-0910-001

OMB: 0910-0638

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-11-03
IC Document Collections
ICR Details
0910-0638 201411-0910-001
Historical Active 201106-0910-009
HHS/FDA CDER
Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 02/04/2015
Retrieve Notice of Action (NOA) 11/10/2014
  Inventory as of this Action Requested Previously Approved
02/28/2018 36 Months From Approved 02/28/2015
2 0 2
32 0 32
0 0 0

Section 1111 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. The guidance informs industry of how FDA will comply with the FDAAA requirement.

US Code: 21 USC 301 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 19099 04/07/2014
79 FR 65403 11/04/2014
Yes

1
IC Title Form No. Form Name
Justification Submitted as General Correspondent and in the Annual Report

  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 2 2 0 0 0 0
Annual Time Burden (Hours) 32 32 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
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.
11/10/2014


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