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
FDA Response June 25 2009.pdf Supplementary Document	2009-06-25
OMB memo June 22 2009.pdf Supplementary Document	2009-06-25
FDA response June 3 2009.pdf Supplementary Document	2009-06-25
OMB memo May 27 2009.pdf Supplementary Document	2009-06-25
OMB memo March 13 and 16 2009.pdf Supplementary Document	2009-06-25
BreakpointsAntibacterialFGuidance SS (2).doc Supporting Statement A	2009-01-13

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	New

ICR Details

OMB Control No: 0910-0638	ICR Reference No: 200902-0910-001
Status: Historical Active	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/26/2009
	Date Received in OIRA: 02/12/2009
Terms of Clearance: 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
Responses	2	0	0
Time Burden (Hours)	32	0	0
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: PL: Pub.L. 110 - 85 1111 Name of Law: FDAAA

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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:
	73 FR 33438	06/12/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 6634	02/10/2009
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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ICR Summary of Burden

	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	0	2	0	0	0
Annual Time Burden (Hours)	32	0	32	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: This is a new collection. Section 1111 of the Food and Drug Administration Amendments Act of 2007 includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This guidance informs industry on how FDA will comply with this requirement.

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 02/12/2009

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