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Home » 2017 Issues » 82 FR (11/17/2017) » 2017-24952. Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins

  2017-24952. Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins  

  • Start Preamble

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    The proposed rule published on July 16, 2015 (80 FR 42079), is withdrawn as of November 17, 2017.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    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 Start Printed Page 54315avian 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.

    Start Signature

    Dated: November 13, 2017.

    Eric D. Hargan,

    Acting Secretary, Department of Health and Human Services.

    End Signature End Supplemental Information

    [FR Doc. 2017-24952 Filed 11-16-17; 8:45 am]

    BILLING CODE 4163-18-P

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Document Information

Published:
11/17/2017
Department:
Health and Human Services Department
Entry Type:
Proposed Rule
Action:
Notice of proposed rulemaking; withdrawal.
Document Number:
2017-24952
Dates:
The proposed rule published on July 16, 2015 (80 FR 42079), is withdrawn as of November 17, 2017.
Pages:
54314-54315 (2 pages)
Docket Numbers:
Docket No. CDC-2015-0050
RINs:
0920-AA58: Possession, Use, and Transfer of Select Agents and Toxins: Addition of HPAI H5N1 Influenza Strains to the List of HHS Select Agents
RIN Links:
https://www.federalregister.gov/regulations/0920-AA58/possession-use-and-transfer-of-select-agents-and-toxins-addition-of-hpai-h5n1-influenza-strains-to-t
PDF File:
2017-24952.pdf
Supporting Documents:
» Select Agent: Determination that Vaccine Strain, TC-83(A3G) of Venezuelan Equine Encephalitis Virus is a Regulated Strain of VEEV
» Order Suspending Introduction of Persons from a Country Where a Communicable Disease Exists
» World Trade Center Health Program: Petition 025-Parkinson's Disease and Parkinsonism, Including Heavy Metal-Induced Parkinsonism; Finding of Insufficient Evidence
» Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act
» World Trade Center Health Program: Petition 021-Deep Vein Thrombosis and Pulmonary Embolism; Finding of Insufficient Evidence
» World Trade Center Health Program: Petition 018-Hypertension; Finding of Insufficient Evidence
» Possession, Use, and Transfer of Select Agents and Toxins: Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins
» Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations
» Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to HHS List of Select Agents and Toxins
» Control of Communicable Diseases; Delay of Effective Date
CFR: (1)
42 CFR 73