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
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0638 can be found here:
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
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 FDAs 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.
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.