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

ICR 202110-0910-002

OMB: 0910-0045

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0045 202110-0910-002
Received in OIRA 202010-0910-006
HHS/FDA CDER
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Revision of a currently approved collection   No
Regular 11/03/2021
  Requested Previously Approved
36 Months From Approved 12/31/2021
380,481 132,531
208,254 146,266
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 301 et seq. 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

Not associated with rulemaking
Other Documents for OIRA Review

  86 FR 24871 05/10/2021
86 FR 59402 10/27/2021
Yes

  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 380,481 132,531 247,950 0 0 0
Annual Time Burden (Hours) 208,254 146,266 61,988 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects both changes and adjustments. We have revised the scope of the collection to include new reporting elements and exemptions mandated by section 3112 of the CARES Act, which results in an increase of 247,950 responses and 61,988 burden hours annually.

$3,250,000
No
    No
    No
No
No
No
No
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.
11/03/2021


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