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)

Page Range		54314-54315
FR Document		2017-24952

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 Issue 221 (Friday, November 17, 2017)

[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]


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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.

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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withdrawn as of November 17, 2017.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

54314 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Proposed Rules

application of those requirements would importation regulations found at 42 CFR ACTION:Notice of proposed rulemaking;
be inconsistent with the CAA. part 71. The ANPRM had a 60-day withdrawal.
comment period. On October 1, 2007,
K. Executive Order 12898: Federal SUMMARY: The Centers for Disease
HHS/CDC published another notice (72
Actions To Address Environmental Control and Prevention (CDC), located
FR 55729) that extended the public
Justice in Minority Populations and within the Department of Health and
comment period to December 1, 2007.
Low-Income Population In response to the ANPRM, HHS/CDC Human Services (HHS) announces the
The EPA lacks the discretionary received 20 public comments including withdrawal of its 2015 notice of
authority to address environmental from individuals, organizations, three proposed rulemaking (NPRM). The 2015
justice in this rulemaking. animal-rescue advocacy groups, one NPRM proposed to add certain
private pet business, and one state influenza virus strains to the list of HHS
List of Subjects in 40 CFR Part 52 select agents and toxins.
government entity. Some commenters
Environmental protection, Air asserted that the current regulations fail DATES: The proposed rule published on
pollution control, Incorporation by to take into account the increasing July 16, 2015 (80 FR 42079), is
reference, Intergovernmental relations, volume of animal imports and new withdrawn as of November 17, 2017.
Nitrogen dioxide, Ozone, Reporting and threats to human health and safety FOR FURTHER INFORMATION CONTACT:
recordkeeping requirements, Volatile posed by these imports. Other Samuel S. Edwin, Director, Division of
organic compounds. commenters asserted that the same rules Select Agents and Toxins, Centers for
Authority: 42 U.S.C. 7401 et seq. and fees applicable to commercial Disease Control and Prevention, 1600
importers should be extended to non- Clifton Road NE., MS–A46, Atlanta, GA
Dated: November 6, 2017.
profit animal shelters, rescue groups, 30329. Telephone: (404) 718–2000.
Alexis Strauss,
and animal sanctuaries that effectively SUPPLEMENTARY INFORMATION: On July
Acting Regional Administrator, Region IX. function as pet stores. The topics that 16, 2015, HHS/CDC published a
[FR Doc. 2017–25017 Filed 11–16–17; 8:45 am] received the most comments were proposed rule (80 FR 42079) to add
BILLING CODE 6560–50–P changing the rabies regimen and certain influenza virus strains to the list
requiring health certificate and unique of HHS select agents and toxins.
identifiers for dogs, cats, and ferrets; Specifically, HHS/CDC proposed to add
DEPARTMENT OF HEALTH AND and other strategies for preventing the the influenza viruses that contain the
HUMAN SERVICES introduction, spread, and transmission hemagglutinin (HA) from the Goose
of zoonotic disease in the United States. Guangdong/1/96 lineage (the influenza
42 CFR Part 71 HHS/CDC believes the public interest viruses that contain the hemagglutinin
RIN 0920–AA14
is best served by withdrawing the (HA) from the A/Gs/Gd/1/96 lineage),
ANPRM identified in this document including wild-type viruses as a non-
Foreign Quarantine Regulations, from rulemaking. The withdrawal of the Tier 1 select agent. HHS/CDC also
Proposed Revision of HHS/CDC ANPRM identified in this document proposed to add any influenza viruses
Animal Importation Regulations does not preclude HHS/CDC from that contain the HA from the A/Gs/Gd/
initiating future rulemaking to prevent 1/96 lineage that were made
AGENCY: Centers for Disease Control and the introduction, transmission, or transmissible among mammals by
Prevention (CDC), Department of Health spread of communicable diseases from respiratory droplets in a laboratory as a
and Human Services (HHS). foreign countries into the United States Tier 1 select agent.
ACTION: Advance notice of proposed and from one State or possession into In response to the NPRM, HHS/CDC
rulemaking; withdrawal. another. received 24 comments from industry,
The ANPRM published on July 31, academic institutions, professional
SUMMARY: The Centers for Disease 2007 (72 FR 41676), is hereby
Control and Prevention (CDC), located organizations, and the public.
withdrawn. Commenters expressed concern about
within the Department of Health and
Dated: November 13, 2017. balancing the risk of impeding research
Human Services (HHS) announces the
withdrawal of its 2007 advance notice of Eric D. Hargan, against the risk of an accidental
proposed rulemaking (ANPRM). The Acting Secretary, Department of Health and laboratory incident or act of terrorism.
2007 ANPRM was issued to begin the Human Services. Other commenters were concerned that
process of revising the regulations [FR Doc. 2017–24951 Filed 11–16–17; 8:45 am] regulation might further limit the ability
concerning importation of animals and BILLING CODE 4163–18–P of veterinarians, researchers, and
animal products. farmers to identify and respond to
influenza outbreaks. Finally, some
DATES: As of November 17, 2017, the
DEPARTMENT OF HEALTH AND commenters pointed out that highly
ANPRM published on July 31, 2007, at HUMAN SERVICES pathogenic avian influenza viruses are
72 FR 41676, is withdrawn. already regulated as a Department of
FOR FURTHER INFORMATION CONTACT: 42 CFR Part 73 Agriculture/Animal and Plant Health
Anne E. O’Connor, M.S., MT(ASCP), [Docket No. CDC–2015–0050] Inspection Service (USDA/APHIS)
Office of the Chief of Staff, Centers for select agent. HHS/CDC agreed with the
Disease Control and Prevention, 1600 RIN 0920–AA58 commenters. Since the publication of
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Clifton Road NE., MS–A14, Atlanta, GA the NPRM, the U.S. Government has put
30329; email: cdcregulations@cdc.gov. Possession, Use, and Transfer of
in place additional controls regarding
Select Agents and Toxins; Addition of
SUPPLEMENTARY INFORMATION: On July the funding and approval of dual use
Certain Influenza Virus Strains to the
31, 2007, HHS/CDC published an research. In addition, HHS/CDC has
List of Select Agents and Toxins
advance notice of proposed rulemaking worked with USDA/APHIS to ensure
(72 FR 41679) requesting input and AGENCY: Centers for Disease Control and that biosafety and biosecurity protocols/
background information from the public Prevention (CDC), Department of Health measures are in place for regulated
on revisions to HHS/CDC’s animal and Human Services (HHS). entities working with highly pathogenic

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Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Proposed Rules 54315

avian influenza viruses to mitigate the SUMMARY: The National Institute for evidence that the approval decision
risk to public health and safety. Thus, Occupational Safety and Health outcomes could vary significantly
HHS/CDC believes the public interest is (NIOSH), Centers for Disease Control between human subject panels that
best served by the withdrawal of the and Prevention (CDC), located within would be constituted according to the
NPRM identified in this document. The the Department of Health and Human proposed test protocol, and expressed
withdrawal of the proposed rule Services (HHS) announces the concern that the proposed approval
identified in this document does not withdrawal of its 2009 notice of requirements would not improve the
preclude HHS/CDC from initiating proposed rulemaking (NPRM). The 2009 performance of NIOSH-approved
future rulemaking concerning the NPRM proposed to establish total respirators on the market and might
influenza viruses that contain the inward leakage requirements for half- eliminate good-performing respirators
hemagglutinin (HA) from the Goose mask, air-purifying particulate from the market. Stakeholders also
Guangdong/1/96 lineage (the influenza respirators approved by NIOSH.
viruses that contain the hemagglutinin expressed concern that the cost of
DATES: As of November 17, 2017, the conducting inward leakage testing using
(HA) from the A/Gs/Gd/1/96 lineage), proposed rule published on October 30,
including wild-type viruses or influenza the protocol proposed by NIOSH would
2009, at 74 FR 56141, is withdrawn. be prohibitive and that costs would
viruses that contain the HA from the A/
FOR FURTHER INFORMATION CONTACT: likely outweigh benefits.
Gs/Gd/1/96 lineage that were made
Rachel Weiss, Office of the Director,
transmissible among mammals by As a result of the stakeholder input
National Institute for Occupational
respiratory droplets. submitted to the docket and during
The NPRM published on July 16, 2015 Safety and Health, 1090 Tusculum
Avenue, MS–C46, Cincinnati, OH public meetings, NIOSH decided
(82 FR 42079), is hereby withdrawn. instead to pursue improved inward
45226. Telephone: (855) 818–1629 (this
Dated: November 13, 2017. is a toll-free number); email: leakage performance of this class of
Eric D. Hargan, NIOSHregs@cdc.gov. respirators through participation in
Acting Secretary, Department of Health and SUPPLEMENTARY INFORMATION: On national and international consensus
Human Services. standard development efforts, rather
October 30, 2009, HHS published an
[FR Doc. 2017–24952 Filed 11–16–17; 8:45 am] NPRM (74 FR 56141) that proposed to than rulemaking. Thus, HHS finds that
BILLING CODE 4163–18–P establish total inward leakage the public interest is best served by
requirements for half-mask, air- withdrawing the 2009 total inward
purifying particulate respirators leakage NPRM. The withdrawal of the
DEPARTMENT OF HEALTH AND 2009 total inward leakage NPRM does
approved by NIOSH under regulations
HUMAN SERVICES not preclude HHS from initiating future
found in 42 CFR part 84. The NPRM
42 CFR Part 84 included a 60-day comment period rulemaking concerning total inward
closing on December 29, 2009, which leakage requirements for half-mask, air-
[Docket No. HHS–OS–2009–0019; NIOSH– was eventually extended to September purifying particulate respirators.
0137] 30, 2010 (April 20, 2010, 75 FR 20546). The NPRM published on October 30,
RIN 0920–AA33 In response to the proposed rule, HHS
2009 (74 FR 56141) is hereby
received comments from five respirator
Total Inward Leakage Requirements withdrawn.
manufacturers, one manufacturer of
for Respirators laboratory test equipment, two labor Dated: November 13, 2017.
AGENCY: Centers for Disease Control and unions, one trade organization, one Eric D. Hargan,
Prevention (CDC), Department of Health state’s departments of public health and Acting Secretary, Department of Health and
and Human Services (HHS). occupational safety and health, three Human Services.
consulting firms, and three private [FR Doc. 2017–24950 Filed 11–16–17; 8:45 am]
ACTION: Notice of proposed rulemaking;
individuals in the field of respiratory
withdrawal. BILLING CODE 4163–18–P
protection. Stakeholders presented
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Document Created: 2017-11-17 05:15:16
Document Modified: 2017-11-17 05:15:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of proposed rulemaking; withdrawal.
Dates		The proposed rule published on July 16, 2015 (80 FR 42079), is withdrawn as of November 17, 2017.
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.
FR Citation		82 FR 54314
RIN Number		0920-AA58