CDC Seeks Comments on Tracking Deadly Toxins and Agents
Published Date: 9/8/2026
Notice
Summary
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73). This data collection allows CDC and APHIS have to collect information on the possession, use, and transfer of select agents and toxins.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 5 costs, 0 mixed.
Unregistered Possession Can Trigger Penalties
Possessing a regulated select agent or toxin without proper registration is a regulatory violation that could result in civil, criminal, and/or administrative penalties. The notice reiterates that unless an exclusion or exemption applies, individuals and entities must register to possess select agents and toxins under 42 CFR part 73.
Must Immediately Report Discovered Agents
If you find a select agent or toxin that is not covered by an exclusion and is not listed on your certificate of registration, you must immediately report that discovery to the HHS Secretary or USDA Administrator under the proposed amendment to 42 CFR 73.2. Registered entities that obtain material before amending registration would also use the new reporting requirement.
Total Reporting Burden Increased
CDC estimates the total annualized burden for all data collection under the select agent rules is 8,919 hours, which is an increase of 5,416 hours from the prior approval. CDC attributes the increase to changes in respondent numbers, shifts in average burden per response, the introduction of Form 6, and corrections to prior burden estimates.
Ongoing Documentation and Plan Requirements
Entities required to register must develop and implement written security plans, biosafety plans, and incident response plans; maintain records and training documentation; and document annual self-inspections. The notice lists these requirements (e.g., 42 CFR 73.11(a), 73.12(a), 73.14(a), 73.15(d), 73.17(a)), and includes estimated burden hours for items such as training (230 respondents × 8 hours = 1,840 hours).
New Form 6 for Discovery Reports
CDC and APHIS propose a new APHIS/CDC Form 6 titled 'Report of Discovery of Select Agent or Toxin' (42 CFR 73.19(c)) to be used whenever an entity discovers possession of a select agent or toxin. The table shows Form 6 is estimated at 20 respondents and 10/60 hours (ten minutes) per response, totaling 3 annual burden hours.
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