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

ICR 201105-0910-003

OMB: 0910-0638

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0638 201105-0910-003
Historical Inactive 200902-0910-001
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
Improperly submitted and continue 06/27/2011
Retrieve Notice of Action (NOA) 05/17/2011
In accordance with 5 CFR 1320, OMB considers this ICR to be improperly submitted. FDA has not responded to terms of clearance set at the most recent approval. Please provide a detailed response describing how FDA has addressed the terms. Previous terms of clearance remain in effect: This ICR is approved for 2 years or until FDA issues the "separate guidance document with recommendations on the scientific issues associated with updating susceptibility test interpretive criteria" (referenced on FDA's memo of June 25, 2009). Prior to submission of this ICR for renewal, FDA shall consult with the commenters identified in OMB memos of May 27, 2009 and June 22, 2009 (which have been made part of the public docket). Should FDA publish the separate guidance within the 2 year approval period, FDA shall revise this collection, soliciting public comment related to this ICR in a manner that ensures the public is not confused about how to comment on the burden and practical utility of the collection. Once the "separate guidance" has been issued, the public will be in a better position to comment on the burden required to comply with this ICR. Should the consultations or public comments reveal that the burden estimates for this ICR are not accurate, FDA agrees to revise them accordingly, understanding that "burden" includes not only the time required to complete and send the actual reports, but also the "time, effort, or financial resources" spent on "reviewing instructions," "adjusting the existing ways to comply with any previously applicable instructions and requirements," and "searching data sources," among other things (5 CFR 1320.3). OMB appreciates FDA’s submission of "a summary of the public comments received... including actions taken by the agency in response to the comments..." consistent with the PRA. When an ICR associated with rulemaking or guidance documents containing labeling or reporting requirements, comments pertaining to the rule/guidance document usually also pertain to the ICRs. In such cases, the guidance documents function as instructions for the information collection and should be submitted as part of the ICR package for the package to be considered complete. To the extent that FDA believes that some of the public comments refer to other ICRs, FDA agrees to address these comments in the context of those ICRs.
  Inventory as of this Action Requested Previously Approved
06/30/2011 36 Months From Approved 11/30/2011
2 0 2
32 0 32
0 0 0

This guidance describes procedures for FDA, drug application holders, and AST device manufacturers to ensure that updated susceptibility test information is available to health care providers.

US Code: 21 USC 301 Name of Law: FFDCA

Not associated with rulemaking

  75 FR 80823 12/23/2010
76 FR 27061 05/10/2011


Eliazabeth Berbakos 3018271482


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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