82 FR 54314 - Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 221 (November 17, 2017)

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 NPRM proposed to add certain influenza virus strains to the list of HHS select agents and toxins.

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Proposed Rules]
[Pages 54314-54315]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24952]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73

[Docket No. CDC-2015-0050]
RIN 0920-AA58


Possession, Use, and Transfer of Select Agents and Toxins; 
Addition of Certain Influenza Virus Strains to the List of Select 
Agents and Toxins

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

ACTION: Notice of proposed rulemaking; withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS) announces the 
withdrawal of its 2015 notice of proposed rulemaking (NPRM). The 2015 
NPRM proposed to add certain influenza virus strains to the list of HHS 
select agents and toxins.

DATES: The proposed rule published on July 16, 2015 (80 FR 42079), is 
withdrawn as of November 17, 2017.

FOR FURTHER INFORMATION CONTACT: Samuel S. Edwin, Director, Division of 
Select Agents and Toxins, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-A46, Atlanta, GA 30329. Telephone: (404) 718-
2000.

SUPPLEMENTARY INFORMATION: On July 16, 2015, HHS/CDC published a 
proposed rule (80 FR 42079) to add certain influenza virus strains to 
the list of HHS select agents and toxins. Specifically, HHS/CDC 
proposed to add the influenza viruses that contain the hemagglutinin 
(HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that 
contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), 
including wild-type viruses as a non-Tier 1 select agent. HHS/CDC also 
proposed to add any influenza viruses that contain the HA from the A/
Gs/Gd/1/96 lineage that were made transmissible among mammals by 
respiratory droplets in a laboratory as a Tier 1 select agent.
    In response to the NPRM, HHS/CDC received 24 comments from 
industry, academic institutions, professional organizations, and the 
public. Commenters expressed concern about balancing the risk of 
impeding research against the risk of an accidental laboratory incident 
or act of terrorism. Other commenters were concerned that regulation 
might further limit the ability of veterinarians, researchers, and 
farmers to identify and respond to influenza outbreaks. Finally, some 
commenters pointed out that highly pathogenic avian influenza viruses 
are already regulated as a Department of Agriculture/Animal and Plant 
Health Inspection Service (USDA/APHIS) select agent. HHS/CDC agreed 
with the commenters. Since the publication of the NPRM, the U.S. 
Government has put in place additional controls regarding the funding 
and approval of dual use research. In addition, HHS/CDC has worked with 
USDA/APHIS to ensure that biosafety and biosecurity protocols/measures 
are in place for regulated entities working with highly pathogenic

[[Page 54315]]

avian influenza viruses to mitigate the risk to public health and 
safety. Thus, HHS/CDC believes the public interest is best served by 
the withdrawal of the NPRM identified in this document. The withdrawal 
of the proposed rule identified in this document does not preclude HHS/
CDC from initiating future rulemaking concerning the influenza viruses 
that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 
lineage (the influenza viruses that contain the hemagglutinin (HA) from 
the A/Gs/Gd/1/96 lineage), including wild-type viruses or influenza 
viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were 
made transmissible among mammals by respiratory droplets.
    The NPRM published on July 16, 2015 (82 FR 42079), is hereby 
withdrawn.

    Dated: November 13, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-24952 Filed 11-16-17; 8:45 am]
 BILLING CODE 4163-18-P