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

ICR 201507-0910-002

OMB: 0910-0045

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-07-06
ICR Details
0910-0045 201507-0910-002
Historical Active 201406-0910-009
HHS/FDA CDER
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Extension without change of a currently approved collection   No
Regular
Approved without change 12/09/2015
Retrieve Notice of Action (NOA) 07/08/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 08/31/2017
135,534 0 45,168
633,868 0 227,222
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 establishment. 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.

None
None

Not associated with rulemaking

  80 FR 15214 03/23/2015
80 FR 37622 07/01/2015
Yes

  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 135,534 45,168 0 0 90,366 0
Annual Time Burden (Hours) 633,868 227,222 0 0 406,646 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,250,000
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.
07/08/2015


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