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

ICR 201011-0910-001

OMB: 0910-0675

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-10-21
ICR Details
0910-0675 201011-0910-001
Historical Active
HHS/FDA
Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/06/2011
Retrieve Notice of Action (NOA) 11/02/2010
  Inventory as of this Action Requested Previously Approved
01/31/2014 36 Months From Approved
72 0 0
35,032 0 0
0 0 0

The guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities. The guidance provides recommendations regarding considerations for the development and implementation of a contingency production plan, including specific elements to include in such a plan. The guidance also discusses the Center for Drug Evaluation and Research's (CDER's) intended approach to helping to avoid drug product shortages that could have a negative impact on the national public health during such emergencies. The guidance is intended for manufacturers of finished drug products as well as manufacturers of the raw materials necessary for manufacturing an MNP.

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

Not associated with rulemaking

  75 FR 1060 01/08/2010
75 FR 63832 10/18/2010
Yes

2
IC Title Form No. Form Name
Reporting - Notify FDA of Plan Activation and Deactivation
Record Keeping - 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 0 0 72 0 0
Annual Time Burden (Hours) 35,032 0 0 35,032 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new collection.

$0
No
No
No
No
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
11/02/2010


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