View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0230
ICR Reference No:
202405-0910-001
Status:
Active
Previous ICR Reference No:
202303-0910-017
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Postmarketing Adverse Drug Experience Reporting
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/31/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/23/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2028
36 Months From Approved
07/31/2025
Responses
3,682,539
0
1,136,427
Time Burden (Hours)
76,318,599
0
14,703,678
Cost Burden (Dollars)
25,000
0
0
Abstract:
FDA regulations require the reporting to FDA of important adverse drug experience information associated with the use of unapproved-marketed prescription drug product. This information is used by FDA to determine at the earliest possible time whether to request a manufacturer, packer, or distributor to recall a product from the market or to recommend a seizure or injunction action to halt the marketing of the product and to remove it from the market. Such action, initiated promptly, may avert further adverse effects that may be associated with the use of the product.
Authorizing Statute(s):
PL:
Pub.L. 109 - 462 2(e)(3)
Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
US Code:
21 USC 321, 352, 355, 371, 379aa
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 77515
09/23/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 5898
01/17/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
13
IC Title
Form No.
Form Name
Disclosure - Postmarketing safety reporting for combination products
Recordkeeping - AER and Records During Pandemic (COOP planning; documenting conditions and high absenteeism; documenting AER process)
Recordkeeping - AER records for Rx products not subject of marketing application
Recordkeeping - AER records under 314.80 (marketing applications)
Recordkeeping - AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))
Recordkeeping - Postmarketing Safety Reporting for Combination Products
Reporting - AER Rx products not subject of marketing application
Reporting - AER for non-prescription drug products (21 CFR 329.100)
Reporting - AER under 314.80 (marketing applications) - 15 day alerts
Reporting - AER under 314.80 (marketing applications) - quarterly reports
Reporting - ICH E2C(R2) Guidance: Providing periodic safety updates (applicants with and without waiver for an approved application)
Reporting - Pandemic Guidance; notifying FDA when normal reporting is not feasible
Reporting - Waiver requests from electronic reporting
ICR Summary of Burden
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
3,682,539
1,136,427
0
0
2,546,112
0
Annual Time Burden (Hours)
76,318,599
14,703,678
0
0
61,614,921
0
Annual Cost Burden (Dollars)
25,000
0
0
0
25,000
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This information collection incorporates a revision to include the guidance for industry regarding electronic submission of adverse event reports and adjustments. The information collection also includes the consolidation of burden from OMB control number 0910-0834 (previously added to this collection in March 2023). The total burden hours of the information collection have increased by 61,614,921 hours and 2,546,112 responses as compared to the previous renewal.
Annual Cost to Federal Government:
$9,358,440
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
01/23/2025
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