Guidance for Industry (GFI): Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

ICR 201703-0910-008

OMB: 0910-0675

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-03-15
ICR Details
0910-0675 201703-0910-008
Historical Active 201401-0910-002
HHS/FDA CDER
Guidance for Industry (GFI): 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 05/18/2017
Retrieve Notice of Action (NOA) 03/15/2017
  Inventory as of this Action Requested Previously Approved
05/31/2020 36 Months From Approved 05/31/2017
72 0 72
35,032 0 35,032
0 0 0

The information collection supports agency guidance for industry (GFI). The guidance provides recommendations for manufacturers regarding the development and maintenance of a plan for ensuring the availability of medically necessary drug products. In addition, the guidance recommends manufacturers include a procedure in their plan 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

  81 FR 76618 11/03/2016
82 FR 13822 03/15/2017
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
Domini Bean 301 796-5733 domini.bean@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.
03/15/2017


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