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

Forms and Documents

Document	Type	Status	Availability
SUPPORTING_STATEMENT_0638_FINAL_5-12-11[2].doc	Supporting Statement A	Uploaded 2011-06-28	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
188042	Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices	Instruction	Modified

ICR Details

OMB Control No: 0910-0638	ICR Reference No: 201106-0910-009
Status: Historical Active	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: Approved without change	Conclusion Date: 11/08/2011
	Date Received in OIRA: 06/28/2011
Terms of Clearance: By the time of the next submission, FDA will consult with respondents (i.e., beyond the 60-day and 30-day Federal Register notices) to verify the burden estimates for this collection. Any revised estimates should acknowledge 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).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2014	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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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	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

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: 06/28/2011

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