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

ICR 201401-0910-002

OMB: 0910-0675

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-12-18
ICR Details
0910-0675 201401-0910-002
Historical Active 201011-0910-001
HHS/FDA 21176
Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
Extension without change of a currently approved collection   No
Regular
Approved without change 03/18/2014
Retrieve Notice of Action (NOA) 01/10/2014
  Inventory as of this Action Requested Previously Approved
03/31/2017 36 Months From Approved 03/31/2014
72 0 72
35,032 0 35,032
0 0 0

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.

US Code: 21 USC 314.2 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  78 FR 37548 06/21/2013
78 FR 72091 12/02/2013
No

2
IC Title Form No. Form Name
Reporting - Notify FDA of Plan Activation and Deactivation
RecordKeeping - Develop Initial Plan

  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
No
No

$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

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.
01/10/2014


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