E8-25883. Possession, Use, and Transfer of Select Agents and Toxins

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Final rule; technical correction.

SUMMARY:

This document contains a technical correction to the list of select agents and toxins regulated by the U.S. Department of Health and Human Services (HHS), as well as those biological agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) published on October 16, 2008, in the Federal Register (73 FR 61363). This correction inserts “Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight segments (Reconstructed 1918 Influenza virus)” that was inadvertently omitted from the list of agents and toxins regulated by only HHS.

DATES:

This correction is effective on November 17, 2008.

FOR FURTHER INFORMATION CONTACT:

Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS A-46, Atlanta, GA 30333. Telephone: [phone].

SUPPLEMENTARY INFORMATION:

On October 17, 2008, the Centers for Disease Control and Prevention (CDC), HHS published in the Federal Register (73 FR 61363) “Possession, Use, and Transfer of Select Agents and Toxins” which completed the biennial review and republication of the lists of biological agents and toxins regulated by the HHS, as well as those biological agents and toxins regulated by USDA. Reconstructed 1918 Influenza virus (Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight segments) was inadvertently omitted from the list of agents regulated by HHS. The amendment in this document corrects that omission and does not have a substantive change to the list made final in the October 17, 2008 rule.

List of Subjects in 42 CFR Part 73

• Biologics
• Incorporation by reference
• Packaging and containers
• Penalties
• Reporting and recordkeeping requirements
• Transportation

Dated: October 24, 2008.

Michael O. Leavitt,

Secretary.

For the reasons stated in the preamble, we have amended 42 CFR part 73 as follows:

PART 73—SELECT AGENTS AND TOXINS

1. The authority citation for part 73 continues to read as follows:

Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of Title II of Public Law No. 107-188, 116 Stat. 637 (42 U.S.C. 262a).

2. In § 73.3(b), add “Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 Influenza virus)” after “Monkeypox virus”.