Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

ICR 201808-0910-004

OMB: 0910-0800

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0800 201808-0910-004
Historical Active 201507-0910-008
HHS/FDA CDER
Adverse Event Reporting for 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 10/30/2018
Retrieve Notice of Action (NOA) 09/27/2018
  Inventory as of this Action Requested Previously Approved
10/31/2021 36 Months From Approved 10/31/2018
110 0 110
941 0 941
0 0 0

This information collection supports implementation of the Drug Quality and Security Act (DQSA) and FDA regulations. We have issued this guidance on adverse event reporting for respondents categorized as "outsourcing facilities" under section 503B of the Federal Food, Drug, and Cosmetic Act. The guidance explains that section 503B of the act requires outsourcing facilities to report adverse events to FDA. The guidance also provides instruction on reporting and associated recordkeeping, and identifies data elements that must be included in submissions, as required under the statute.

US Code: 21 USC 353b Name of Law: FFDCA
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  83 FR 28854 06/21/2018
83 FR 48619 09/26/2018
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 110 110 0 0 0 0
Annual Time Burden (Hours) 941 941 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$275,000
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
09/27/2018


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