Possession, Use, and Transfer of Select Agents and Toxins; Addition of Certain Influenza Virus Strains to the List of Select Agents and Toxins, 54314-54315 [2017-24952]

Download as PDF 54314 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Proposed Rules application of those requirements would be inconsistent with the CAA. K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Population The EPA lacks the discretionary authority to address environmental justice in this rulemaking. List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Authority: 42 U.S.C. 7401 et seq. Dated: November 6, 2017. Alexis Strauss, Acting Regional Administrator, Region IX. [FR Doc. 2017–25017 Filed 11–16–17; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 71 RIN 0920–AA14 Foreign Quarantine Regulations, Proposed Revision of HHS/CDC Animal Importation Regulations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Advance notice of proposed rulemaking; withdrawal. AGENCY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2007 advance notice of proposed rulemaking (ANPRM). The 2007 ANPRM was issued to begin the process of revising the regulations concerning importation of animals and animal products. DATES: As of November 17, 2017, the ANPRM published on July 31, 2007, at 72 FR 41676, is withdrawn. FOR FURTHER INFORMATION CONTACT: Anne E. O’Connor, M.S., MT(ASCP), Office of the Chief of Staff, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–A14, Atlanta, GA 30329; email: cdcregulations@cdc.gov. SUPPLEMENTARY INFORMATION: On July 31, 2007, HHS/CDC published an advance notice of proposed rulemaking (72 FR 41679) requesting input and background information from the public on revisions to HHS/CDC’s animal rmajette on DSKBCKNHB2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 13:57 Nov 16, 2017 Jkt 244001 importation regulations found at 42 CFR part 71. The ANPRM had a 60-day comment period. On October 1, 2007, HHS/CDC published another notice (72 FR 55729) that extended the public comment period to December 1, 2007. In response to the ANPRM, HHS/CDC received 20 public comments including from individuals, organizations, three animal-rescue advocacy groups, one private pet business, and one state government entity. Some commenters asserted that the current regulations fail to take into account the increasing volume of animal imports and new threats to human health and safety posed by these imports. Other commenters asserted that the same rules and fees applicable to commercial importers should be extended to nonprofit animal shelters, rescue groups, and animal sanctuaries that effectively function as pet stores. The topics that received the most comments were changing the rabies regimen and requiring health certificate and unique identifiers for dogs, cats, and ferrets; and other strategies for preventing the introduction, spread, and transmission of zoonotic disease in the United States. HHS/CDC believes the public interest is best served by withdrawing the ANPRM identified in this document from rulemaking. The withdrawal of the ANPRM identified in this document does not preclude HHS/CDC from initiating future rulemaking to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The ANPRM published on July 31, 2007 (72 FR 41676), is hereby withdrawn. Dated: November 13, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services. [FR Doc. 2017–24951 Filed 11–16–17; 8:45 am] BILLING CODE 4163–18–P 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 Notice of proposed rulemaking; withdrawal. ACTION: 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 nonTier 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 SUMMARY: E:\FR\FM\17NOP1.SGM 17NOP1 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Proposed Rules 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket No. HHS–OS–2009–0019; NIOSH– 0137] RIN 0920–AA33 Total Inward Leakage Requirements for Respirators Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking; withdrawal. rmajette on DSKBCKNHB2PROD with PROPOSALS AGENCY: VerDate Sep<11>2014 13:57 Nov 16, 2017 Jkt 244001 The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the withdrawal of its 2009 notice of proposed rulemaking (NPRM). The 2009 NPRM proposed to establish total inward leakage requirements for halfmask, air-purifying particulate respirators approved by NIOSH. DATES: As of November 17, 2017, the proposed rule published on October 30, 2009, at 74 FR 56141, is withdrawn. FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Office of the Director, National Institute for Occupational Safety and Health, 1090 Tusculum Avenue, MS–C46, Cincinnati, OH 45226. Telephone: (855) 818–1629 (this is a toll-free number); email: NIOSHregs@cdc.gov. SUPPLEMENTARY INFORMATION: On October 30, 2009, HHS published an NPRM (74 FR 56141) that proposed to establish total inward leakage requirements for half-mask, airpurifying particulate respirators approved by NIOSH under regulations found in 42 CFR part 84. The NPRM included a 60-day comment period closing on December 29, 2009, which was eventually extended to September 30, 2010 (April 20, 2010, 75 FR 20546). In response to the proposed rule, HHS received comments from five respirator manufacturers, one manufacturer of laboratory test equipment, two labor unions, one trade organization, one state’s departments of public health and occupational safety and health, three consulting firms, and three private individuals in the field of respiratory protection. Stakeholders presented SUMMARY: PO 00000 Frm 00014 Fmt 4702 Sfmt 9990 54315 evidence that the approval decision outcomes could vary significantly between human subject panels that would be constituted according to the proposed test protocol, and expressed concern that the proposed approval requirements would not improve the performance of NIOSH-approved respirators on the market and might eliminate good-performing respirators from the market. Stakeholders also expressed concern that the cost of conducting inward leakage testing using the protocol proposed by NIOSH would be prohibitive and that costs would likely outweigh benefits. As a result of the stakeholder input submitted to the docket and during public meetings, NIOSH decided instead to pursue improved inward leakage performance of this class of respirators through participation in national and international consensus standard development efforts, rather than rulemaking. Thus, HHS finds that the public interest is best served by withdrawing the 2009 total inward leakage NPRM. The withdrawal of the 2009 total inward leakage NPRM does not preclude HHS from initiating future rulemaking concerning total inward leakage requirements for half-mask, airpurifying particulate respirators. The NPRM published on October 30, 2009 (74 FR 56141) is hereby withdrawn. Dated: November 13, 2017. Eric D. Hargan, Acting Secretary, Department of Health and Human Services. [FR Doc. 2017–24950 Filed 11–16–17; 8:45 am] BILLING CODE 4163–18–P E:\FR\FM\17NOP1.SGM 17NOP1

Agencies

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Proposed Rules]
[Pages 54314-54315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24952]


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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