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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0638 FINAL 5-12-11.doc Supporting Statement A	2011-05-16

IC Document Collections

IC ID	Document Title	Status
188042	Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices	Modified

ICR Details

OMB Control No: 0910-0638	ICR Reference No: 201105-0910-003
Status: Historical Inactive	Previous ICR Reference No: 200902-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 06/27/2011
	Date Received in OIRA: 05/17/2011
Terms of Clearance: 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
Expiration Date	06/30/2011	36 Months From Approved	11/30/2011
Responses	2	0	2
Time Burden (Hours)	32	0	32
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 80823	12/23/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 27061	05/10/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

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Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 05/17/2011

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