Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

ICR 201911-0910-001

OMB: 0910-0827

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
224062
Modified
224059
Modified
ICR Details
0910-0827 201911-0910-001
Active 201610-0910-005
HHS/FDA CDER
Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Regular
Approved without change 11/26/2019
Retrieve Notice of Action (NOA) 11/04/2019
  Inventory as of this Action Requested Previously Approved
11/30/2022 36 Months From Approved 12/31/2019
230 0 36,302
230 0 36,302
4,638,542 0 0

After an entity has elected to register as an outsourcing facility, it must report information identifying the drugs compounded at the facility as prescribed by the Drug Quality and Security Act. FDA has issued agency guidance to assist respondents in this regard. This information collection supports implementation of these reporting requirements.

US Code: 21 USC 353b Name of Law: Federal Food, Drug, and Cosmetic Act; Outsourcing Facilities
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  84 FR 34184 07/17/2019
84 FR 54612 10/10/2019
No

2
IC Title Form No. Form Name
503B continued product reports
503B Initial drug product reports

  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 230 36,302 0 0 -36,072 0
Annual Time Burden (Hours) 230 36,302 0 0 -36,072 0
Annual Cost Burden (Dollars) 4,638,542 0 0 0 4,638,542 0
No
No
We have reduced our estimate by 36,150 hours and 36,072 responses. Upon evaluation we find that our original projections were higher than what we have realized in reports over the past three years.

$142,500
No
    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.
11/04/2019


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