Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

Forms and Documents

Document Name	Status
0675 SUPPORTING STATEMENT FINAL 12-18-13.doc Supporting Statement A	2013-12-18

IC Document Collections

IC ID	Document Title	Status
195094	RecordKeeping - Develop Initial Plan Other-Guidance	Modified
195093	Reporting - Notify FDA of Plan Activation and Deactivation Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0675	ICR Reference No: 201401-0910-002
Status: Historical Active	Previous ICR Reference No: 201011-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: 21176
Title: Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
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: 03/18/2014
	Date Received in OIRA: 01/10/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2017	36 Months From Approved	03/31/2014
Responses	72	0	72
Time Burden (Hours)	35,032	0	35,032
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance recommends that manufacturers develop, maintain, and update a Plan as specified in the guidance (i.e., 1 Plan per manufacturer to include all manufacturing facilities, sites, and drug products). In addition, manufacturers are encouraged to include a procedure in their Plan for notifying the Center for Drug Evaluation and Research when the Plan is activated and when returning to normal operations. The guidance recommends that these notifications occur within one day of a Plan's activation and within one day of a Plan's deactivation.

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Authorizing Statute(s): US Code: 21 USC 314.2 Name of Law: FD&C Act
  

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:
	78 FR 37548	06/21/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 72091	12/02/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Reporting - Notify FDA of Plan Activation and Deactivation
RecordKeeping - Develop Initial Plan

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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	72	72	0	0	0	0
Annual Time Burden (Hours)	35,032	35,032	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: 01/10/2014

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