Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting
Published Date: 1/17/2025
Notice
Summary
The FDA is updating how drug companies report problems people have after using their medicines. This helps keep medicines safe by making sure the FDA gets clear, timely info. Drug makers need to follow new rules and send comments by February 18, 2025, but there’s no big cost change expected.
Analyzed Economic Effects
6 provisions identified: 0 benefits, 6 costs, 0 mixed.
Mandatory Electronic Adverse Event Reports
If you manufacture, pack, distribute, or sponsor drugs or biologics, all adverse experience reports and followup reports must be submitted to FDA in electronic format (via the Electronic Submissions Gateway or the Safety Reporting Portal). Waivers of the electronic requirement may be granted for good cause.
Large Estimated Increase in Paperwork Burden
FDA reports the total burden hours for this information collection have increased by 61,614,921 hours and 2,546,112 responses compared to the previous renewal; current total estimated annual reporting hours are 51,690,702 and recordkeeping hours are 24,627,827.8. FDA also estimates operating and maintenance costs of approximately $25,000 (reporting) and $22,000 (recordkeeping) annually.
Long Recordkeeping Timeframes Required
Manufacturers, applicants, packers, and distributors must keep records of adverse drug experience reports for long periods: 10 years for prescription drug applicants and manufacturers (21 CFR 314.80(j) and 310.305(g)) and 6 years for nonprescription (OTC) drug adverse event records under section 760(e).
15-Day Alerts and Periodic Reporting Deadlines
Applicants must send 15-day 'Alert' reports for serious, unexpected adverse drug experiences (Sec. 314.80(c)(1)(i)) and must submit periodic safety reports quarterly for the first 3 years after U.S. approval and annually thereafter (Sec. 314.80(c)(2) and 600.80(c)(2)).
OTC Products Included in Reporting Rules
Over-the-counter (OTC) drug products marketed without an approved application — including products under the OTC Drug Monograph Review process or marketed outside the monograph system — are required to submit adverse event reports in electronic format under section 760 and related regulations (Sec. 329.100).
5-Day Notice Rule for Combination Products
For combination products that include a drug, if an event involves death, serious injury, or an adverse event and the product sponsor receives the information, the sponsor must provide that information to the other constituent part applicant(s) no later than 5 calendar days after receipt (21 CFR 4.103).
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-20709, Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 11.15 (Clearly Erroneous Executions)
Cboe EDGX Exchange is updating its rule about fixing trading mistakes to match new overnight trading hours. This change affects traders using the Exchange by clarifying how errors during extended hours are handled. The update is effective immediately, helping keep trading fair and smooth without extra costs or delays.
2026-20708, Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Pursuant to IEX Rule 15.110(a) and (c) To Amend the IEX Equities Fee Schedule
IEX is shaking up its fee schedule starting November 1, 2026, by tweaking who gets rebates for adding displayed liquidity and changing rebate amounts. This affects IEX members who trade stocks, giving them new ways to save or earn more on fees. The changes kick in right away after filing, so traders should get ready to adjust their strategies and cash flow.
2026-20702, Notice of Public Meetings of the Virginia Advisory Committee to the U.S. Commission on Civil Rights
The Virginia Advisory Committee to the U.S. Commission on Civil Rights is holding virtual public meetings to discuss how Virginia public universities are following rules about fair student admissions. Anyone interested can join these Zoom meetings on October 27, November 10, and December 15, 2026, to listen and share their thoughts. These meetings don’t cost money to attend, but phone users might pay regular call fees.
2026-20706, Self-Regulatory Organizations; MEMX LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Exchange's Fee Schedule
MEMX is updating its fee schedule to change the rules for a special discount called Tape B Volume Tier 2. This affects members who trade a lot on the exchange and could change how much they pay in fees. The new rules kick in right away, so members should check how this might impact their costs now.
2026-20707, Self-Regulatory Organizations; MEMX LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Exchange's Fee Schedule
MEMX is updating its options trading fees starting October 1, 2026. They’re renaming a volume discount tier and tweaking which trades count for discounts. This change mainly affects traders using MEMX’s options platform and could impact how much they pay in fees.
2026-20705, Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Antibody Specifically Binding to Severe Fever With Thrombocytopenia Syndrome Virus Antigen and Use Thereof
The National Institute of Allergy and Infectious Diseases plans to give Korea National Institute of Health an exclusive license to develop and sell a special antibody that targets a dangerous virus causing severe fever and low platelets. This deal helps speed up turning the invention into real-world treatments. Comments or license requests must be sent by October 26, 2026.
Previous / Next Documents
Previous: 2025-01150, Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal and Child Health Jurisdictional Survey Instrument for the Title V MCH Block Grant Program
HRSA is asking for public feedback on a survey tool used by states to report how they’re helping moms and kids stay healthy through the Title V MCH Block Grant program. This update aims to keep the survey clear and useful, making sure states can track their progress well. Comments are open until February 18, 2025, and this process helps keep the program effective without adding extra costs.
Next: 2025-01152, Agency Information Collection Activities; Proposed Collection; Improving the Quality and Representativeness of the Treatment Center Program Data-Data Modifications to the Current Survey Instrument Format to Minimize Misclassification; Withdrawal of Notice
The FDA has decided to cancel a planned update to how they collect data from treatment centers, which was meant to reduce mistakes in surveys. This change affects treatment centers and anyone involved in reporting data, but now there won’t be any new forms or costs. The cancellation was announced on January 17, 2025, so no changes will happen anytime soon.