Department of Health and Human Services July 19, 2021 – Federal Register Recent Federal Regulation Documents

The HHS/CDC's Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture/Animal and Plant Health Inspection Service (APHIS)'s Division of Agricultural Select Agents and Toxins (DASAT) are jointly charged with the regulation of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. Due to the continuing pandemic and concerns for the safety of our workshop attendees and employees, DSAT replaced in-person workshops with webinars. The purpose of the webinars is to provide guidance on completing APHIS/CDC Form 2 (Request to Transfer Select Agents and Toxins), APHIS/CDC Form 3 (Report of a Release/Loss/Theft), and APHIS/ CDC Form 4 (Reporting the Identification of a Select Agent or Toxin) (APHIS/CDC Forms 2-4) for interested individuals. Two sessions covering the same agenda will be held to provide two opportunities for interested individuals to participate.

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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an Extension of a previously approved information collection project titled Assessment of Occupational Injury among Fire Fighters Using a Follow-back Survey. The purpose of this project is to collect follow-back telephone interview data from injured and exposed firefighters treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures.

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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluating the use of EHMRs in health settings to improve organizational implementation and worker adoption during and after the COVID-19 pandemic. NIOSH proposes using surveys and interviews to understand how elastomeric half mask respirators (EHMRs) are being perceived and used by healthcare and first responder settings during the COVID-19 pandemic.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cilastatin sodium; imipenem; relebactam for injection.