Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

ICR 201612-0910-005

OMB: 0910-0045

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-12-13
Supplementary Document
2016-12-09
ICR Details
0910-0045 201612-0910-005
Historical Active 201507-0910-002
HHS/FDA CDER
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Revision of a currently approved collection   No
Regular
Approved without change 12/29/2016
Retrieve Notice of Action (NOA) 12/16/2016
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2018
135,826 0 135,534
149,561 0 633,868
0 0 0

Manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishments. In addition, manufacturers, repackers, and relabelers are required to submit a listing of every drug or biological product in commercial distribution. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States. This information collection supports agency regulations regarding these requirements.

US Code: 21 USC 360 Name of Law: Federal Food, Drug, & Cosmetic Act; Registration of producers of drugs or devices
  
PL: Pub.L. 110 - 85 224 Name of Law: FDA Amendments Act; Electronic Registration and Listing

0910-AA49 Final or interim final rulemaking 81 FR 60170 08/31/2016

  71 FR 51276 08/29/2006
81 FR 60170 08/31/2016
No

  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 135,826 135,534 292 0 0 0
Annual Time Burden (Hours) 149,561 633,868 -484,307 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,250,000
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.
12/16/2016


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