Survey of Drug Product Manufacturing, Processing, and Packing Facilities

ICR 202104-0910-002

OMB: 0910-0899

Federal Form Document

Forms and Documents
ICR Details
202104-0910-002
Received in OIRA
HHS/FDA CDER
Survey of Drug Product Manufacturing, Processing, and Packing Facilities
New collection (Request for a new OMB Control Number)   No
Regular 04/07/2021
  Requested Previously Approved
36 Months From Approved
1,395 0
1,970 0
0 0

This ICR collects information on current supply chain risk management practices and manufacturing practices of components in finished pharmaceutical products. The purpose of this survey is to help FDA understand how manufacturers of pharmaceutical products for human and animal use deal with safety and quality issues in their supply chains. This survey will also help FDA understand how practices among manufacturers of drug products may differ due to the different characteristics of the manufactured product(s). The information from this survey will help inform FDA as it develops requirements for good manufacturing practices.

None
None

Not associated with rulemaking

  85 FR 58370 09/18/2020
86 FR 4098 01/15/2021
No

  Total Request 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 1,395 0 0 1,395 0 0
Annual Time Burden (Hours) 1,970 0 0 1,970 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection.

$243,889
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 [email protected]

  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.
04/07/2021


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