Possession, Use, and Transfer of Select Agents and Toxins-Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins, 64075-64081 [2021-25204]
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Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Rules and Regulations
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[FR Doc. 2021–24942 Filed 11–16–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 73
[Docket No. CDC–2021–0119]
RIN 0920–AA79
Possession, Use, and Transfer of
Select Agents and Toxins—Addition of
SARS–CoV/SARS–CoV–2 Chimeric
Viruses Resulting From Any Deliberate
Manipulation of SARS–CoV–2 To
Incorporate Nucleic Acids Coding for
SARS–CoV Virulence Factors to the
HHS List of Select Agents and Toxins
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Interim final rule.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) located
within the Department of Health and
Human Services (HHS) is amending its
select agents and toxins regulations to
add SARS–CoV/SARS–CoV–2 chimeric
viruses resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors to the list
of HHS select agents and toxins. HHS/
CDC intends to regulate this agent and
to require the regulated entity to obtain
prior approval from CDC to conduct
SUMMARY:
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deliberate manipulation of SARS–CoV–
2 to incorporate nucleic acids coding for
SARS–CoV virulence factors because
these chimeric viruses have the
potential to pose a severe threat to
public health and safety.
DATES: Effective date: The interim final
rule is effective on November 17, 2021.
Comments due date: Written
comments must be submitted on or
before January 18, 2022.
Applicability dates: By December 17,
2021, all entities that possess SARS–
CoV/SARS–CoV–2 chimeric viruses
resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors must
provide notice to the Federal Select
Agent Program regarding their
possession of this agent. By February 15,
2022, all entities that possess, use, or
transfer this agent must register (or
amend an existing registration) and
obtain a certificate of registration (or an
amended certificate of registration) that
includes this agent, in accordance with
42 CFR 73.7 and 73.7(i), respectively,
and must meet all of the requirements
of select agent regulations.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0119 or Regulation Identifier Number
(RIN) 0920–AA79, by either of the
methods listed below. Do not submit
comments by email. CDC does not
accept comments by email.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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• Mail: Division of Select Agents and
Toxins, Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop H21–7, Atlanta, Georgia 30329,
ATTN: RIN 0920–AA79.
Instructions: All submissions received
must include the agency name and RIN
for this rulemaking. All relevant
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Samuel S. Edwin, Ph.D., Director,
Division of Select Agents and Toxins,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop H21–7, Atlanta, Georgia 30329.
Telephone: (404) 718–2000. Email:
lrsat@cdc.gov.
SUPPLEMENTARY INFORMATION: The
interim final rule is organized as
follows:
I. Public Participation
II. Background
A. Legal Authority
B. Historical Background to This
Rulemaking
III. Rationale for an Interim Final Rule
IV. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. Paperwork Reduction Act of 1995
D. E.O. 12988: Civil Justice Reform
E. E.O. 13132: Federalism
F. Plain Language Act of 2010
SUPPLEMENTARY INFORMATION:
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64076
Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Rules and Regulations
I. Public Participation
Interested persons or organizations
are invited to participate in this
rulemaking by submitting written views,
recommendations, and data. Using the
criteria enumerated below, HHS/CDC
invites comments specifically, based on
the following criteria, as to whether
SARS–CoV/SARS–CoV–2 chimeric
viruses resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors should be
regulated as a select agent:
(1) The effect on human health of
exposure to the agent;
(2) The degree of contagiousness of
the agent and the methods by which the
agent is transferred to humans;
(3) The availability and effectiveness
of pharmacotherapies and
immunizations to treat and prevent any
illness resulting from infection by the
agent; and
(4) Any other criteria, including the
needs of children and other vulnerable
populations that the commenter
considers appropriate.
In addition, HHS/CDC invites
comments specifically on any virulence
factors found in SARS–CoV that would
increase virulence in SARS–CoV–2.
Comments received, including
attachments and other supporting
materials, are part of the public record
and subject to public disclosure. Do not
include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure.
HHS/CDC will carefully consider all
comments submitted in preparation of a
final rule.
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II. Background
A. Legal Authority
HHS/CDC is promulgating this rule
under the authority of sections 201–204
and 221 of Title II of Public Law 107–
188(42 U.S.C. 262a).
Title II, Subtitle A, of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002,
(42 U.S.C. 262a), requires HHS to
regulate the possession, use, and
transfer of biological agents or toxins
that have the potential to pose a severe
threat to public health and safety (select
agents and toxins). Accordingly, HHS
has promulgated regulations requiring
individuals or entities that possess, use,
or transfer select agents and toxins to
register with CDC. See 42 CFR part 73.
B. Background
Coronavirus disease 2019 is a highly
contagious disease caused by severe
acute respiratory syndrome coronavirus
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2 (SARS–CoV–2). As of October 18,
2021, SARS–CoV–2 has infected
approximately 44,857,861 individuals
and resulted in at least 723,205 deaths
in the United States. It should be noted
that SARS–CoV–2 is not currently a
select agent. However, SARS
coronavirus (SARS–CoV), a related
virus, is a select agent.
HHS/CDC is regulating, as a non-Tier
1 select agent SARS–CoV/SARS–CoV–2
chimeric viruses resulting from any
deliberate manipulation of SARS–CoV–
2 to incorporate nucleic acids coding for
SARS–CoV virulence factors. SARS–
CoV virulence factors include but are
not limited to those involved in
inflammasome activation during
infection, which could be introduced
into SARS–CoV–2 and create a chimeric
virus with increased virulence. HHS/
CDC is also requiring prior approval
from the HHS Secretary to conduct this
type of work because these viruses have
the potential to pose a severe threat to
public health and safety. HHS/CDC
believes that regulatory oversight of
these experiments and the resulting
chimeric viruses is essential to
protecting the public from the potential
consequences of a release of these
viruses. The SARS–CoV/SARS–CoV–2
chimeric viruses that result from
deliberate manipulation of SARS–CoV–
2 to incorporate SARS–CoV virulence
factors will be designated as a select
agent and subject to strict regulatory
controls on the possession, use, and
transfer of these viruses.
HHS/CDC has determined that SARS–
CoV/SARS–CoV–2 chimeric viruses
resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors are being
listed as an HHS select agent because:
• Virulence factors from SARS–CoV
including, but not limited to, those
involved in inflammasome activation
during infection, could be introduced
into SARS–CoV–2 and create a chimeric
virus with increased virulence.
• There is significant potential risk of
merging a select agent virus and
pandemic virus and creating a chimeric
virus with the transmissibility of SARS–
CoV–2 and the pathogenicity of SARS–
CoV.
III. Rationale for an Interim Final Rule
The Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (42 U.S.C. 262a)
requires the regulation of biological
agents that have the potential to pose a
severe threat to public health and safety.
5 U.S.C. 553 (Rulemaking) waives the
requirement to publish a notice of
proposed rulemaking ‘‘when the agency
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for good cause finds (and incorporates
the finding and a brief statement of
reasons therefor in the rules issued) that
notice and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest’’ (5 U.S.C. 553(b)
(B)). HHS/CDC believes that advance
public notice and the opportunity to
comment are impracticable [and
contrary to the public interest] and there
is good cause to issue an interim final
rule with comment because there is no
current regulatory oversight involving
these experiments. As a result, HHS/
CDC is unable to predict the potential
infectiousness or virulence of the
SARS–CoV/SARS–CoV–2 chimeric
viruses and believes the resulting
chimeric viruses have the potential to
pose a severe threat to public health and
safety. In addition, a release of this
modification of a non-select agent with
nucleic acids from a select agent would
require a complicated and expensive
emergency response effort. This effort
could include extensive public health
measures, such as quarantine,
preventative treatment, and diagnostic
testing for large numbers of potentially
exposed persons, and extensive
decontamination. Substantial costs
could be incurred by hospitals and other
medical facilities and institutions of
government at all levels. A release, or
widespread fear of one, also would
create significant secondary effects. It
could disrupt business, transportation,
and many other aspects of normal
behavior, on both a short-term and
potentially a long-term basis. As a
result, the regulation is needed to
protect the American public from the
potential consequences of a release of
these viruses.
IV. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts
of the interim final rule (IFR) under
Executive Order 12866, Regulatory
Planning and Review (58 FR 51735,
October 4, 1993) and Executive Order
13563, Improving Regulation and
Regulatory Review, (76 FR 3821,
January 21, 2011). Both Executive
Orders direct agencies to evaluate any
rule prior to promulgation to determine
the regulatory impact in terms of costs
and benefits to United States
populations and businesses. Further,
together, the two Executive Orders set
the following requirements: Quantify
costs and benefits where the new
regulation creates a change in current
practice; qualitatively describe costs and
benefits; choose approaches that
maximize net benefits; and support
regulations that protect public health
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Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Rules and Regulations
and safety. HHS/CDC has analyzed the
IFR as required by these Executive
Orders and has determined that it is
consistent with the principles set forth
in the Executive Orders and the
Regulatory Flexibility Act, as amended
by the Small Business Regulatory
Enforcement Fairness Act (SBREFA).
We anticipate that the rule will create
minimal cost impact, but that it could
potentially result in benefits to the
extent that it could reduce the
probability of an accidental or
intentional release of the SARS–CoV/
SARS–CoV–2 chimeric viruses resulting
from any deliberate manipulation of
SARS–CoV–2 to incorporate nucleic
acids coding for SARS–CoV virulence
factors. Such an event is a low
probability, but potentially extremely
high-cost outcome. This rule has been
determined to be a ‘‘significant
regulatory action’’ as defined by
Executive Order 12866, section 3(f).
However, this rule is not an
economically significant regulatory
action, as it will not have an annual
effect on the economy of $100 million
or more or adversely affect in a material
way the economy, a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities. This rule
has been reviewed by the Office of
Management and Budget (OMB)
pursuant to Executive Orders 12866 and
13563.
This regulatory impact section
presents the anticipated costs and
benefits that are quantified where
possible. Where quantification is not
possible, a qualitative discussion is
provided of the costs and/or benefits
that HHS/CDC anticipates from issuing
this regulation.
Need for the Regulation
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There is no current regulatory
oversight involving SARS–CoV/SARS–
CoV–2 chimeric viruses resulting from
any deliberate manipulation of SARS–
CoV–2 to incorporate nucleic acids
coding for SARS–CoV virulence factors.
Under the current regulatory baseline,
the SARS–CoV/SARS–CoV–2 chimeric
viruses resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors would not
be regulated as a select agent. As a
result, existing entities that are already
registered to handle select agents and
toxins would not need to amend their
registrations. In addition, other entities
that are not currently registered to
handle select agents and toxins would
not need to invest in upgrading their
facilities to qualify to handle select
agents or toxins or to go through the
process to register with HHS/CDC.
However, in the absence of such
activities, the risk of release of the
SARS–CoV/SARS–CoV–2 chimeric
viruses resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors would be
increased. An intentional or accidental
release of this agent could impose
significant costs on entities other than
those directly working with the
chimeric viruses. Thus, HHS/CDC is
regulating this agent as a select agent
because of its potential to pose a threat
to public health and safety.
HHS/CDC analyzed the expected costs
and benefits of this IFR by comparing
the pre-IFR baseline to the provisions of
this IFR.
Analysis of Costs and Benefits
Costs
In the following analysis, HHS/CDC
looked at two different types of entities
that may incur additional costs as a
result of this rulemaking. They are
described below: (1) A registered entity
who wishes to amend their registration
to add the agent; or (2) A new
unregistered entity who will register in
order to work with the agent. HHS/CDC
also estimated the costs for HHS/CDC to
work with entities to amend their
registration or to be registered as a result
of this IFR. All costs and benefits for
this analysis are reported in 2020 U.S.
dollars. Further, HHS/CDC assumed that
all costs would be incurred within a
one-year time period corresponding to
the expected period of time in which
experiments with these chimeric viruses
would be performed.
(1) An entity is already registered and
will amend the registration for the
agent.
This IFR will require such an entity
to amend its registration using relevant
64077
portions of APHIS/CDC Form 1
(Registration for Possession, Use, and
Transfer of Select Agents and Toxins).
The estimated time to amend this form
is one hour for one select agent (Table
1). To account for uncertainty in the
estimate, a range of 75% to 125% of this
estimate is used as the lower bound and
the upper bound estimates, respectively.
HHS/CDC used a median hourly
respondent labor rate of $49.83 for
managerial staff (occupation code 11–
1021 general and operations manager) as
the upper bound estimate and $16.98 for
clerical staff (occupation code 43–9061
office clerks, general) as the lower
bound estimate. These rates were
obtained from the Bureau of Labor
Statistics, from the 2020 Occupational
Employment Statistics Survey by
Occupation (https://www.bls.gov/oes/).
HHS/CDC assumed that the hourly
burden would be evenly split between
managerial staff and clerical staff as a
base case. The hourly respondent labor
rate for the base case was the average of
these two figures ($33.41 per hour). The
base salary is multiplied by an overhead
multiplier of 100% to account for nonwage benefits and other overhead costs
for supporting each employee. The
estimated cost per already registered
entity to amend their registration for
this agent was $66.81 (range: $25.47 to
$124.58).
The additional time for HHS/CDC’s
review of the amended registration for
the already registered entities will also
generate additional costs. HHS/CDC
estimated that one staff at the GS–13
(step 5) level is required to review the
amended registration application. The
hourly wage of a Federal Employee at
GS–13 (step 5) from the 2020 General
Schedule (GS) locality pay table for
Atlanta (where CDC has its
headquarters), $52.20 per hour, was
used to estimate the hourly base salary
(Table 1). The base salary is multiplied
by an overhead multiplier of 100% to
account for non-wage benefits and other
overhead costs for supporting each
employee. HHS/CDC estimated that the
review of the amendment application
takes two hours (range: 1.5 hours to 2.5
hours) for HHS/CDC. The estimated
HHS/CDC’s cost per entity to amend
their registration for the agent was $209
(range: $157 to $261).
TABLE 1—ESTIMATED COSTS PER ALREADY REGISTERED ENTITY TO AMEND THEIR REGISTRATION FOR THE AGENT
[2020 U.S. Dollars]
Base case
Entity:
Number of employees working on the amendment (A) .......................................................
Hourly wage (B) ....................................................................................................................
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1
$33.41
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Lower bound
1
$16.98
Upper bound
1
$49.83
64078
Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Rules and Regulations
TABLE 1—ESTIMATED COSTS PER ALREADY REGISTERED ENTITY TO AMEND THEIR REGISTRATION FOR THE AGENT—
Continued
[2020 U.S. Dollars]
Base case
Overhead multiplier (C) ........................................................................................................
Time required per staff (hours) (D) ......................................................................................
Estimated costs per entity (E) = (A) × (B) × ((C) + 1) × (D) ................................................
HHS/CDC:
Number of staff required for the review of the amendment application (F) ........................
Hourly wage (G) ...................................................................................................................
Overhead multiplier (H) ........................................................................................................
Time required for the amendment per staff (hour) (I) ..........................................................
Estimated costs per entity (J) = (F) × (G) × ((H) + 1) × (I) ..................................................
(2) A new entity will register in order
to work with the select agent (The entity
is NOT currently registered).
For new entities, which will register
for working with the agent, HHS/CDC
expects per facility costs to vary based
on the entity type, laboratory size, and
biosafety level (BSL). The first-year cost
per facility for a medium-size BSL–2/3
research institute to register to work
with the select agent is estimated at
$59,600. This estimate from the
Regulatory Impact Analysis for the 2005
Select Agent Regulations Final Rule 1
was adjusted to 2020 U.S. dollars value
using the Consumer Price Index (CPI)
Inflation Calculator.2 This results in an
adjusted value of $78,994 for each
additional registered, medium-size
BSL–2/3 research institute laboratory
(range: $41,087 to $936,528) (Table 2).
The provisions of this IFR will reduce
the risk of human exposure to the
chimeric viruses by ensuring that
laboratory facilities employ adequate
security and safety measures including:
(1) Develop and implement a written
biosafety plan and measures in place
that is commensurate with the risk of
the select agent given its intended use,
(2) Develop and implement a written
security plan and measures in place that
is sufficient to safeguard the select agent
against unauthorized access, theft, loss,
or release,
(3) Develop and implement a written
incident response plan based upon a
site-specific risk assessment,
(4) Have an adequate training program
for handling select agents, and
(5) Maintain an inventory of select
agents.
Two HHS/CDC staff, GS–12 (step 5)
would perform the initial review of the
application with the final review
conducted by GS–13 (step 5). HHS/CDC
estimated the upper bound hourly wage
for a Federal Employee at the GS–13
(step 5) from the 2020 General Schedule
(GS) locality pay table for Atlanta,
$52.20 per hour. The lower bound was
estimated using the hourly wage for a
GS–12 (step 5) employee, $43.90 per
hour (Table 2). The mean of these two
wage rates was used as the base case.
The base salary is multiplied by an
overhead multiplier of 100% to account
for non-wage benefits and other
overhead costs for supporting each
employee. HHS/CDC estimated that the
review of a new application would take
two hours (range: 1.5 hours to 2.5
hours). The estimated HHS/CDC cost
per entity to review a new application
was $384 (range: $263 to $522).
Lower bound
Upper bound
100%
1
$66.81
100%
0.75
$25.47
100%
1.25
$124.58
1
$52.20
100%
2
$209
1
$52.20
100%
1.5
$157
1
$52.20
100%
2.5
$261
The new registration also will require
a site visit by CDC to investigate the
adequacy of the laboratory to handle
select agents and toxins. HHS/CDC
assumed that two CDC investigators,
GS–12 (step 5) or GS–13 (step 5) would
travel to the laboratory and that the visit
would require 3 days (1 day for
outbound trip to the laboratory, 1 day
for the investigation, and 1 day for the
return trip) and 8 work hours per day
inclusive of report writing. The
estimated travel costs were $1,200 per
trip for two CDC investigators. The total
estimated costs associated with
laboratory investigation per entity are
$5,183 (range: $5,414 to $6,211). The
estimated total costs for CDC per new
registered entity are $6,197 (range:
$5,678 to $6,733) for application review
and laboratory investigation.
HHS/CDC assumed that all costs
associated with the IFR will occur
during the first year after the IFR is
published and that the IFR will not
affect costs for registered entities in
following years. This may result in an
over-estimate of the costs to register a
new entity if that entity were to decide
to continue to work with select agents
and toxins in future years.
TABLE 2—ESTIMATED COSTS PER NEW ENTITY, WHICH WILL REGISTER IN ORDER TO WORK WITH THE AGENT
[2020 U.S. dollars]
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Base case
Entity:
Estimated costs for new registration per entity (A) 3 ............................................................
HHS/CDC:
New application review (time) costs per entity:
Number of staff required for the review of the new application (B) .....................................
Hourly wage (C) ...................................................................................................................
Overhead multiplier (D) ........................................................................................................
Time required for the new application per staff (hour) (E) ..................................................
Estimated costs associated with a new registration application review (F) = (B) × (C) ×
((D) + 1) × (E) ...................................................................................................................
Lab investigation costs per entity:
Number of staff required for the lab investigation (G) .........................................................
1 Regulatory Impact Analysis, 42 CFR parts 73:
Possession, Use, and Transfer of Select Agents and
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Toxins Final Rule, Centers for Disease Control and
Prevention, February 3, 2005.
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Lower bound
Upper bound
$78,994
$41,087
$936,528
2
$48.05
100%
2
2
$43.90
100%
1.5
2
$52.20
100%
2.5
$384
$263
$522
2
2
2
2 https://www.bls.gov/data/inflation_
calculator.htm.
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64079
TABLE 2—ESTIMATED COSTS PER NEW ENTITY, WHICH WILL REGISTER IN ORDER TO WORK WITH THE AGENT—
Continued
[2020 U.S. dollars]
Base case
Hourly wage (H) ...................................................................................................................
Overhead multiplier (I) ..........................................................................................................
Time required for the amendment per staff (hour) (J) .........................................................
Estimated time costs for lab investigation per entity (K) = (F) × (G) × ((H) + 1) × (I) .........
Number of trips required per lab investigation (L) ...............................................................
Travel associated costs per trip (M) .....................................................................................
Travel associated costs per lab investigation (N) = (L) × (M) .............................................
Estimated costs associated with lab investigation (O) = (K) + (N) ......................................
Estimated total costs for HHS/CDC per entity (P) = (F) + (O) ...................................................
HHS/CDC is only aware of one
registered entity that is interested in
generating this agent and would likely
amend their registration to work with
this agent. The base case is that only one
registered entity would amend their
registration for the agent and no
unregistered entities would undergo the
registration process in order to work
with this agent. The lower bound is the
same as the base case. For the upper
bound, HHS/CDC assumed that two
Lower bound
$48.05
100%
24
$4,613
1
$1,200
$1,200
$5,813
$6,197
$43.90
100%
24
$4,214
1
$1,200
$1,200
$5,414
$5,678
Upper bound
$52.20
100%
24
$5,011
1
$1,200
$1,200
$6,211
$6,733
registered entities would amend their
registration to work with this agent and
one unregistered entity would undergo
the registration process to work with
this agent (Table 3).
TABLE 3—NUMBERS OF ENTITIES THAT WILL BE AFFECTED BY THE IFR
Base case
Registered entities, which want to amend the registration for the agent ...................................
Unregistered entities, which want to be registered for the agent ...............................................
The total costs associated with the IFR
for the entities working with this agent
Lower bound
1
0
1
0
Upper bound
2
1
are estimated at $67 (range: $25 to
$936,777) (Table 4).
TABLE 4—TOTAL ESTIMATED COSTS FOR ENTITIES TO WORK WITH THE SARS–COV/SARS–COV–2 CHIMERIC VIRUSES
ASSOCIATED WITH THE IFR
[2020 U.S. dollars]
Base case
Registered entities, which want to amend their registrations to work with the agent:
Number of entities (A) ..........................................................................................................
Estimated costs per entity (B) ..............................................................................................
Estimated costs (C) = (A) × (B) ............................................................................................
Unregistered entities, which would pursue registration to work with this agent:
Number of entities (D) ..........................................................................................................
Estimated costs per entity (E) ..............................................................................................
Estimated costs (F) = (D) × (E) ............................................................................................
Total estimated costs for entities to comply with HHS/CDC requirements to work with this
agent (G) = (C) + (F) ...............................................................................................................
The total estimated costs for HHS/
CDC to review applications to amend
registrations or to register new entities
to work with this agent, which are
Lower bound
Upper bound
1
$67
$67
1
$25
$25
2
$125
$249
0
$78,994
$0
0
$41,087
$0
1
$936,528
$936,528
$67
$25
$936,777
associated with the IFR are $209 (range:
$156 to $7,255) (Table 5).
TABLE 5—TOTAL ESTIMATED COSTS FOR HHS/CDC TO REVIEW ENTITIES’ APPLICATIONS TO AMEND THEIR REGISTRATIONS OR TO REGISTER NEW ENTITIES TO WORK WITH THE SARS–COV/SARS–COV–2 CHIMERIC VIRUSES ASSOCIATED WITH THE IFR
[2020 U.S. dollars]
khammond on DSKJM1Z7X2PROD with RULES
Base case
Registered entities, which want to amend the registration for the agent:
Number of entities (A) ..........................................................................................................
Estimated costs per entity (B) ..............................................................................................
3 The estimates from the Regulatory Impact
Analysis for the 2005 Select Agent Regulations
Final Rule (Regulatory Impact Analysis, 42 CFR
Parts 73: Possession, Use, and Transfer of Select
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Control and Prevention, February 3, 2005) was
adjusted to 2020 US dollars value using the
Consumer Price Index (CPI) Inflation Calculator
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1
$209
Lower bound
1
$157
(https://www.bls.gov/data/inflation_
calculator.htm).
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Upper bound
2
$261
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Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Rules and Regulations
TABLE 5—TOTAL ESTIMATED COSTS FOR HHS/CDC TO REVIEW ENTITIES’ APPLICATIONS TO AMEND THEIR REGISTRATIONS OR TO REGISTER NEW ENTITIES TO WORK WITH THE SARS–COV/SARS–COV–2 CHIMERIC VIRUSES ASSOCIATED WITH THE IFR—Continued
[2020 U.S. dollars]
Base case
Estimated costs (C) = (A) × (B) ............................................................................................
Unregistered entities, which want to be registered for the agent:
Number of entities (D) ..........................................................................................................
Estimated costs per entity (E) ..............................................................................................
Estimated costs (F) = (D) × (E) ............................................................................................
Total estimated costs for HHS/CDC (G) = (C) + (F) ...................................................................
Summary of Costs
In summary, the total estimated costs
associated with the IFR are $276 (range:
$182 to $944,032) (Table 6). All costs
are one-time costs, and the follow-up
costs are assumed to be minimal. The
upper bound cost estimate includes the
Lower bound
Upper bound
$209
$157
$522
0
$6,197
$0
$209
0
$5,678
$0
$156
1
$6,733
$6,733
$7,255
cost to register a new entity to work
with select agents and toxins, which
may not be pursued. Even this upper
bound estimate is less than $1 million.
TABLE 6—SUMMARY OF TOTAL ESTIMATED COSTS ASSOCIATED WITH THE IFR TO ADD THE SARS–COV/SARS–COV–2
CHIMERIC VIRUSES RESULTING FROM ANY DELIBERATE MANIPULATION OF SARS–COV–2 TO INCORPORATE NUCLEIC
ACIDS CODING FOR SARS–COV VIRULENCE FACTORS TO HHS/CDC’S LIST OF SELECT AGENTS AND TOXINS
[2020 U.S. dollars]
Base case
Upper bound
Total estimated costs to entities working with the agent (A) ......................................................
Total estimated costs to HHS/CDC (B) .......................................................................................
$67
209
$25
157
$936,777
7,255
Total estimated costs (C) = (A) + (B) ...................................................................................
276
182
944,032
Benefits
khammond on DSKJM1Z7X2PROD with RULES
Lower bound
The agents and toxins placed on the
HHS/CDC select list have the potential
to pose severe threats to public health
and safety. The benefits of the HHS/CDC
interim final rule derive from the
strengthened prevention against the
accidental or intentional release of
SARS–CoV/SARS–CoV–2 chimeric
viruses resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors. The
provisions of this IFR will reduce the
risk of human exposure to the chimeric
viruses by ensuring that laboratory
facilities employ adequate security and
safety measures including:
(1) Develop and implement a written
biosafety plan and measures in place
that is commensurate with the risk of
the select agent given its intended use,
(2) Develop and implement a written
security plan and measures in place that
is sufficient to safeguard the select agent
against unauthorized access, theft, loss,
or release,
(3) Develop and implement a written
incident response plan based upon a
site-specific risk assessment,
(4) Have an adequate training program
for handling select agents, and
(5) Maintain an inventory of select
agents.
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The benefits to public health and
safety from the implementation of the
rule result from the strengthened
prevention that the rules provide against
the either accidental or intentional
release of the modification of a nonselect agent with nucleic acids from a
select agent but are difficult to quantify.
The cost of such an event in morbidity
and mortality could be very high. In
addition, a release of this modification
of a non-select agent with nucleic acids
from a select agent would require a
complicated and expensive emergency
response effort. This effort could
include extensive public health
measures, such as quarantine,
preventative treatment, and diagnostic
testing for large numbers of potentially
exposed persons, and extensive
decontamination. Substantial costs
could be incurred by hospitals and other
medical facilities and institutions of
government at all levels. A release, or
widespread fear of one, also would
create significant secondary effects. It
could disrupt business, transportation,
and many other aspects of normal
behavior, on both a short-term and
potentially a long-term basis.
HHS/CDC is unable to predict the
potential infectiousness or virulence of
the SARS–CoV/SARS–CoV–2 chimeric
viruses that are regulated according to
the provisions of this IFR. However,
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Fmt 4700
Sfmt 4700
implementation of the IFR will provide
a means of determining where the
modification of a non-select agent with
nucleic acids from a select agent is
located; ensure that transfer, storage,
and use of the agent can be tracked;
provide for the screening of personnel
with access to such agent; and require
that entities in possession of such agent
develop and implement effective means
of biosafety and physical security. The
benefit of these provisions is a reduced
likelihood of either an accidental or
intentional release of the select agent
and the consequent avoidance of costs
associated with such a release.
This IFR addresses a risk associated
with substantial economic
consequences. The likelihood of these
negative outcomes under a baseline
scenario of no further regulatory action
are low, but also highly uncertain and
difficult to characterize. Based on this
analysis, HHS/CDC believes the
expected benefits of this IFR are likely
to exceed the estimated costs associated
with this IFR.
B. The Regulatory Flexibility Act (RFA),
as Amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA)
We have examined the impacts of the
interim final rule under the Regulatory
Flexibility Act (5 U.S.C. 601–612). The
Regulatory Flexibility Act (RFA), as
E:\FR\FM\17NOR1.SGM
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Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Rules and Regulations
amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA), requires agencies to analyze
regulatory options that would minimize
any significant economic impact of a
rule on small entities. Based on our
current knowledge of who may possess
this agent, we certify that this interim
final rule will not have a significant
economic impact on a substantial
number of small entities within the
meaning of the RFA.
C. Paperwork Reduction Act of 1995
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or recordkeeping
requirements included in the current
regulations are approved by the Office
of Management and Budget (OMB)
under OMB control number 0920–0576,
expiration date 1/31/2024. This
rulemaking includes a request for a
nonmaterial/non-substantive change to
account for small, potential increases in
burden for a limited number of entities
to submit amendments to their
registrations.
We expect that the entities who will
register for possession, use, or transfer
of the select agent will already be
registered with the Federal Select Agent
Program because the entity would be
registered to possess, use, or transfer
SARS–CoV. This rulemaking will
require such an entity to amend its
registration with the Federal Select
Agent Program using relevant portions
of APHIS/CDC Form 1 (Registration for
Possessing, Use, and Transfer of Select
This regulatory action is not a major
rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996. This interim final
rule will not result in an annual effect
on the economy of $100,000,000 or
more; a major increase in cost or prices;
or significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
Form name
Section 7 ........................
Section 7 ........................
Application for Registration .................................
Amendment to a Certificate of Registration ........
D. E.O. 12988: Civil Justice Reform
This rule has been reviewed under
E.O. 12988, Civil Justice Reform. Once
the interim final rule is in effect, HHS/
CDC notes that: (1) All State and local
laws and regulations that are
inconsistent with this rule will be
preempted; (2) No retroactive effect will
be given to this rule; and (3)
Administrative proceedings will not be
required before parties may file suit in
court challenging this rule.
E. E.O. 13132: Federalism
khammond on DSKJM1Z7X2PROD with RULES
Number of
respondents
Section
HHS/CDC has reviewed this interim
final rule in accordance with Executive
Order 13132 regarding Federalism and
has determined that it does not have
‘‘federalism implications.’’ The rule
does not ‘‘have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
F. Plain Language Act of 2010
Under the Plain Language Act of 2010
(Pub. L. 111–274, October 13, 2010),
executive Departments and Agencies are
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64081
Agents and Toxins). Estimated time to
amend this form is one hour for one
select agent. Additionally, any
registered entity that wishes to transfer
the select agent will be required to
submit information using APHIS/CDC
Form 2 (Request to Transfer of Select
Agent and Toxins). Estimated average
time to complete this form is one hour.
Based upon the limited publications on
this agent at this time, we estimate that
only one to five registered entities may
add the select agent to their registration
or transfer the select agent to another
registered entity. Therefore, we
calculate that there is no increase in the
number of respondents that need to
submit an application for registration,
we estimate the total number of
responses for entities to submit an
amendment to their registration may
increase by five, and the total burden
hours may increase to five hours. This
represents a nonmaterial/nonsubstantive change in burden for
respondents to this approved
information collection. The burden is
outlined in the table below.
Average
burden per
response
(in hours)
Number of
responses per
respondent
3
254
1
5
Total burden
hours
5
1
15
1,270
required to use plain language in
documents that explain to the public
how to comply with a requirement the
Federal Government administers or
enforces. HHS/CDC has attempted to
use plain language in announcing this
rule consistent with the Federal Plain
Writing Act guidelines.
SARS–CoV/SARS–CoV–2 chimeric
viruses resulting from any deliberate
manipulation of SARS–CoV–2 to
incorporate nucleic acids coding for
SARS–CoV virulence factors.
*
*
*
*
*
List of Subjects in 42 CFR Part 73
■
Biologics, Incorporation by reference,
Packaging and containers, Penalties,
Reporting and Recordkeeping
requirements, Transportation.
For the reasons stated in the
preamble, we are amending 42 CFR part
73 as follows:
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
107–188 (42 U.S.C. 262a)
2. In § 73.3 amend paragraph (b) by
adding in alphabetical order an entry for
‘‘SARS–CoV/SARS–CoV–2 chimeric
viruses’’ to read as follows:
■
§ 73.3
*
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HHS select agents and toxins.
*
*
Frm 00019
*
Fmt 4700
*
Sfmt 4700
(b) * * *
3. Amend § 73.13 by adding paragraph
(a)(3) to read as follows:
§ 73.13
*
*
Restricted experiments.
*
*
*
(a) * * *
(3) Experiments that involve the
creation of SARS–CoV/SARS–CoV–2
chimeric viruses resulting from any
deliberate manipulation of SARS–CoV–
2 to incorporate nucleic acids coding for
SARS–CoV virulence factors or vice
versa.
*
*
*
*
*
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–25204 Filed 11–15–21; 4:15 pm]
BILLING CODE 4163–18–P
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]]>Agencies
[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Rules and Regulations]
[Pages 64075-64081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25204]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
[Docket No. CDC-2021-0119]
RIN 0920-AA79
Possession, Use, and Transfer of Select Agents and Toxins--
Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting From Any
Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids
Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents
and Toxins
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) located
within the Department of Health and Human Services (HHS) is amending
its select agents and toxins regulations to add SARS-CoV/SARS-CoV-2
chimeric viruses resulting from any deliberate manipulation of SARS-
CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors to the list of HHS select agents and toxins. HHS/CDC intends to
regulate this agent and to require the regulated entity to obtain prior
approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to
incorporate nucleic acids coding for SARS-CoV virulence factors because
these chimeric viruses have the potential to pose a severe threat to
public health and safety.
DATES: Effective date: The interim final rule is effective on November
17, 2021.
Comments due date: Written comments must be submitted on or before
January 18, 2022.
Applicability dates: By December 17, 2021, all entities that
possess SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any
deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids
coding for SARS-CoV virulence factors must provide notice to the
Federal Select Agent Program regarding their possession of this agent.
By February 15, 2022, all entities that possess, use, or transfer this
agent must register (or amend an existing registration) and obtain a
certificate of registration (or an amended certificate of registration)
that includes this agent, in accordance with 42 CFR 73.7 and 73.7(i),
respectively, and must meet all of the requirements of select agent
regulations.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0119 or Regulation Identifier Number (RIN) 0920-AA79, by either of the
methods listed below. Do not submit comments by email. CDC does not
accept comments by email.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Division of Select Agents and Toxins, Centers for
Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21-7,
Atlanta, Georgia 30329, ATTN: RIN 0920-AA79.
Instructions: All submissions received must include the agency name
and RIN for this rulemaking. All relevant comments received will be
posted without change to https://www.regulations.gov, including any
personal information provided. For access to the docket to read
background documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Samuel S. Edwin, Ph.D., Director,
Division of Select Agents and Toxins, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mailstop H21-7, Atlanta, Georgia
30329. Telephone: (404) 718-2000. Email: [email protected].
SUPPLEMENTARY INFORMATION: The interim final rule is organized as
follows:
I. Public Participation
II. Background
A. Legal Authority
B. Historical Background to This Rulemaking
III. Rationale for an Interim Final Rule
IV. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. Paperwork Reduction Act of 1995
D. E.O. 12988: Civil Justice Reform
E. E.O. 13132: Federalism
F. Plain Language Act of 2010
SUPPLEMENTARY INFORMATION:
[[Page 64076]]
I. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, recommendations, and data.
Using the criteria enumerated below, HHS/CDC invites comments
specifically, based on the following criteria, as to whether SARS-CoV/
SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation
of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV
virulence factors should be regulated as a select agent:
(1) The effect on human health of exposure to the agent;
(2) The degree of contagiousness of the agent and the methods by
which the agent is transferred to humans;
(3) The availability and effectiveness of pharmacotherapies and
immunizations to treat and prevent any illness resulting from infection
by the agent; and
(4) Any other criteria, including the needs of children and other
vulnerable populations that the commenter considers appropriate.
In addition, HHS/CDC invites comments specifically on any virulence
factors found in SARS-CoV that would increase virulence in SARS-CoV-2.
Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Do not include any information in your comment or
supporting materials that you consider confidential or inappropriate
for public disclosure. HHS/CDC will carefully consider all comments
submitted in preparation of a final rule.
II. Background
A. Legal Authority
HHS/CDC is promulgating this rule under the authority of sections
201-204 and 221 of Title II of Public Law 107-188(42 U.S.C. 262a).
Title II, Subtitle A, of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a),
requires HHS to regulate the possession, use, and transfer of
biological agents or toxins that have the potential to pose a severe
threat to public health and safety (select agents and toxins).
Accordingly, HHS has promulgated regulations requiring individuals or
entities that possess, use, or transfer select agents and toxins to
register with CDC. See 42 CFR part 73.
B. Background
Coronavirus disease 2019 is a highly contagious disease caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As of
October 18, 2021, SARS-CoV-2 has infected approximately 44,857,861
individuals and resulted in at least 723,205 deaths in the United
States. It should be noted that SARS-CoV-2 is not currently a select
agent. However, SARS coronavirus (SARS-CoV), a related virus, is a
select agent.
HHS/CDC is regulating, as a non-Tier 1 select agent SARS-CoV/SARS-
CoV-2 chimeric viruses resulting from any deliberate manipulation of
SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors. SARS-CoV virulence factors include but are not limited to
those involved in inflammasome activation during infection, which could
be introduced into SARS-CoV-2 and create a chimeric virus with
increased virulence. HHS/CDC is also requiring prior approval from the
HHS Secretary to conduct this type of work because these viruses have
the potential to pose a severe threat to public health and safety. HHS/
CDC believes that regulatory oversight of these experiments and the
resulting chimeric viruses is essential to protecting the public from
the potential consequences of a release of these viruses. The SARS-CoV/
SARS-CoV-2 chimeric viruses that result from deliberate manipulation of
SARS-CoV-2 to incorporate SARS-CoV virulence factors will be designated
as a select agent and subject to strict regulatory controls on the
possession, use, and transfer of these viruses.
HHS/CDC has determined that SARS-CoV/SARS-CoV-2 chimeric viruses
resulting from any deliberate manipulation of SARS-CoV-2 to incorporate
nucleic acids coding for SARS-CoV virulence factors are being listed as
an HHS select agent because:
Virulence factors from SARS-CoV including, but not limited
to, those involved in inflammasome activation during infection, could
be introduced into SARS-CoV-2 and create a chimeric virus with
increased virulence.
There is significant potential risk of merging a select
agent virus and pandemic virus and creating a chimeric virus with the
transmissibility of SARS-CoV-2 and the pathogenicity of SARS-CoV.
III. Rationale for an Interim Final Rule
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (42 U.S.C. 262a) requires the regulation of
biological agents that have the potential to pose a severe threat to
public health and safety. 5 U.S.C. 553 (Rulemaking) waives the
requirement to publish a notice of proposed rulemaking ``when the
agency for good cause finds (and incorporates the finding and a brief
statement of reasons therefor in the rules issued) that notice and
public procedure thereon are impracticable, unnecessary, or contrary to
the public interest'' (5 U.S.C. 553(b) (B)). HHS/CDC believes that
advance public notice and the opportunity to comment are impracticable
[and contrary to the public interest] and there is good cause to issue
an interim final rule with comment because there is no current
regulatory oversight involving these experiments. As a result, HHS/CDC
is unable to predict the potential infectiousness or virulence of the
SARS-CoV/SARS-CoV-2 chimeric viruses and believes the resulting
chimeric viruses have the potential to pose a severe threat to public
health and safety. In addition, a release of this modification of a
non-select agent with nucleic acids from a select agent would require a
complicated and expensive emergency response effort. This effort could
include extensive public health measures, such as quarantine,
preventative treatment, and diagnostic testing for large numbers of
potentially exposed persons, and extensive decontamination. Substantial
costs could be incurred by hospitals and other medical facilities and
institutions of government at all levels. A release, or widespread fear
of one, also would create significant secondary effects. It could
disrupt business, transportation, and many other aspects of normal
behavior, on both a short-term and potentially a long-term basis. As a
result, the regulation is needed to protect the American public from
the potential consequences of a release of these viruses.
IV. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts of the interim final rule (IFR)
under Executive Order 12866, Regulatory Planning and Review (58 FR
51735, October 4, 1993) and Executive Order 13563, Improving Regulation
and Regulatory Review, (76 FR 3821, January 21, 2011). Both Executive
Orders direct agencies to evaluate any rule prior to promulgation to
determine the regulatory impact in terms of costs and benefits to
United States populations and businesses. Further, together, the two
Executive Orders set the following requirements: Quantify costs and
benefits where the new regulation creates a change in current practice;
qualitatively describe costs and benefits; choose approaches that
maximize net benefits; and support regulations that protect public
health
[[Page 64077]]
and safety. HHS/CDC has analyzed the IFR as required by these Executive
Orders and has determined that it is consistent with the principles set
forth in the Executive Orders and the Regulatory Flexibility Act, as
amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA). We anticipate that the rule will create minimal cost impact,
but that it could potentially result in benefits to the extent that it
could reduce the probability of an accidental or intentional release of
the SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate
manipulation of SARS-CoV-2 to incorporate nucleic acids coding for
SARS-CoV virulence factors. Such an event is a low probability, but
potentially extremely high-cost outcome. This rule has been determined
to be a ``significant regulatory action'' as defined by Executive Order
12866, section 3(f). However, this rule is not an economically
significant regulatory action, as it will not have an annual effect on
the economy of $100 million or more or adversely affect in a material
way the economy, a sector of the economy, productivity, competition,
jobs, the environment, public health or safety, or State, local, or
tribal governments or communities. This rule has been reviewed by the
Office of Management and Budget (OMB) pursuant to Executive Orders
12866 and 13563.
This regulatory impact section presents the anticipated costs and
benefits that are quantified where possible. Where quantification is
not possible, a qualitative discussion is provided of the costs and/or
benefits that HHS/CDC anticipates from issuing this regulation.
Need for the Regulation
There is no current regulatory oversight involving SARS-CoV/SARS-
CoV-2 chimeric viruses resulting from any deliberate manipulation of
SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors. Under the current regulatory baseline, the SARS-CoV/SARS-CoV-2
chimeric viruses resulting from any deliberate manipulation of SARS-
CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors would not be regulated as a select agent. As a result, existing
entities that are already registered to handle select agents and toxins
would not need to amend their registrations. In addition, other
entities that are not currently registered to handle select agents and
toxins would not need to invest in upgrading their facilities to
qualify to handle select agents or toxins or to go through the process
to register with HHS/CDC. However, in the absence of such activities,
the risk of release of the SARS-CoV/SARS-CoV-2 chimeric viruses
resulting from any deliberate manipulation of SARS-CoV-2 to incorporate
nucleic acids coding for SARS-CoV virulence factors would be increased.
An intentional or accidental release of this agent could impose
significant costs on entities other than those directly working with
the chimeric viruses. Thus, HHS/CDC is regulating this agent as a
select agent because of its potential to pose a threat to public health
and safety.
HHS/CDC analyzed the expected costs and benefits of this IFR by
comparing the pre-IFR baseline to the provisions of this IFR.
Analysis of Costs and Benefits
Costs
In the following analysis, HHS/CDC looked at two different types of
entities that may incur additional costs as a result of this
rulemaking. They are described below: (1) A registered entity who
wishes to amend their registration to add the agent; or (2) A new
unregistered entity who will register in order to work with the agent.
HHS/CDC also estimated the costs for HHS/CDC to work with entities to
amend their registration or to be registered as a result of this IFR.
All costs and benefits for this analysis are reported in 2020 U.S.
dollars. Further, HHS/CDC assumed that all costs would be incurred
within a one-year time period corresponding to the expected period of
time in which experiments with these chimeric viruses would be
performed.
(1) An entity is already registered and will amend the registration
for the agent.
This IFR will require such an entity to amend its registration
using relevant portions of APHIS/CDC Form 1 (Registration for
Possession, Use, and Transfer of Select Agents and Toxins). The
estimated time to amend this form is one hour for one select agent
(Table 1). To account for uncertainty in the estimate, a range of 75%
to 125% of this estimate is used as the lower bound and the upper bound
estimates, respectively. HHS/CDC used a median hourly respondent labor
rate of $49.83 for managerial staff (occupation code 11-1021 general
and operations manager) as the upper bound estimate and $16.98 for
clerical staff (occupation code 43-9061 office clerks, general) as the
lower bound estimate. These rates were obtained from the Bureau of
Labor Statistics, from the 2020 Occupational Employment Statistics
Survey by Occupation (https://www.bls.gov/oes/). HHS/CDC assumed that
the hourly burden would be evenly split between managerial staff and
clerical staff as a base case. The hourly respondent labor rate for the
base case was the average of these two figures ($33.41 per hour). The
base salary is multiplied by an overhead multiplier of 100% to account
for non-wage benefits and other overhead costs for supporting each
employee. The estimated cost per already registered entity to amend
their registration for this agent was $66.81 (range: $25.47 to
$124.58).
The additional time for HHS/CDC's review of the amended
registration for the already registered entities will also generate
additional costs. HHS/CDC estimated that one staff at the GS-13 (step
5) level is required to review the amended registration application.
The hourly wage of a Federal Employee at GS-13 (step 5) from the 2020
General Schedule (GS) locality pay table for Atlanta (where CDC has its
headquarters), $52.20 per hour, was used to estimate the hourly base
salary (Table 1). The base salary is multiplied by an overhead
multiplier of 100% to account for non-wage benefits and other overhead
costs for supporting each employee. HHS/CDC estimated that the review
of the amendment application takes two hours (range: 1.5 hours to 2.5
hours) for HHS/CDC. The estimated HHS/CDC's cost per entity to amend
their registration for the agent was $209 (range: $157 to $261).
Table 1--Estimated Costs per Already Registered Entity To Amend Their Registration for the Agent
[2020 U.S. Dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Entity:
Number of employees working on the amendment (A)............ 1 1 1
Hourly wage (B)............................................. $33.41 $16.98 $49.83
[[Page 64078]]
Overhead multiplier (C)..................................... 100% 100% 100%
Time required per staff (hours) (D)......................... 1 0.75 1.25
Estimated costs per entity (E) = (A) x (B) x ((C) + 1) x (D) $66.81 $25.47 $124.58
HHS/CDC:
Number of staff required for the review of the amendment 1 1 1
application (F)............................................
Hourly wage (G)............................................. $52.20 $52.20 $52.20
Overhead multiplier (H)..................................... 100% 100% 100%
Time required for the amendment per staff (hour) (I)........ 2 1.5 2.5
Estimated costs per entity (J) = (F) x (G) x ((H) + 1) x (I) $209 $157 $261
----------------------------------------------------------------------------------------------------------------
(2) A new entity will register in order to work with the select
agent (The entity is NOT currently registered).
For new entities, which will register for working with the agent,
HHS/CDC expects per facility costs to vary based on the entity type,
laboratory size, and biosafety level (BSL). The first-year cost per
facility for a medium-size BSL-2/3 research institute to register to
work with the select agent is estimated at $59,600. This estimate from
the Regulatory Impact Analysis for the 2005 Select Agent Regulations
Final Rule \1\ was adjusted to 2020 U.S. dollars value using the
Consumer Price Index (CPI) Inflation Calculator.\2\ This results in an
adjusted value of $78,994 for each additional registered, medium-size
BSL-2/3 research institute laboratory (range: $41,087 to $936,528)
(Table 2). The provisions of this IFR will reduce the risk of human
exposure to the chimeric viruses by ensuring that laboratory facilities
employ adequate security and safety measures including:
---------------------------------------------------------------------------
\1\ Regulatory Impact Analysis, 42 CFR parts 73: Possession,
Use, and Transfer of Select Agents and Toxins Final Rule, Centers
for Disease Control and Prevention, February 3, 2005.
\2\ https://www.bls.gov/data/inflation_calculator.htm.
---------------------------------------------------------------------------
(1) Develop and implement a written biosafety plan and measures in
place that is commensurate with the risk of the select agent given its
intended use,
(2) Develop and implement a written security plan and measures in
place that is sufficient to safeguard the select agent against
unauthorized access, theft, loss, or release,
(3) Develop and implement a written incident response plan based
upon a site-specific risk assessment,
(4) Have an adequate training program for handling select agents,
and
(5) Maintain an inventory of select agents.
Two HHS/CDC staff, GS-12 (step 5) would perform the initial review
of the application with the final review conducted by GS-13 (step 5).
HHS/CDC estimated the upper bound hourly wage for a Federal Employee at
the GS-13 (step 5) from the 2020 General Schedule (GS) locality pay
table for Atlanta, $52.20 per hour. The lower bound was estimated using
the hourly wage for a GS-12 (step 5) employee, $43.90 per hour (Table
2). The mean of these two wage rates was used as the base case. The
base salary is multiplied by an overhead multiplier of 100% to account
for non-wage benefits and other overhead costs for supporting each
employee. HHS/CDC estimated that the review of a new application would
take two hours (range: 1.5 hours to 2.5 hours). The estimated HHS/CDC
cost per entity to review a new application was $384 (range: $263 to
$522).
The new registration also will require a site visit by CDC to
investigate the adequacy of the laboratory to handle select agents and
toxins. HHS/CDC assumed that two CDC investigators, GS-12 (step 5) or
GS-13 (step 5) would travel to the laboratory and that the visit would
require 3 days (1 day for outbound trip to the laboratory, 1 day for
the investigation, and 1 day for the return trip) and 8 work hours per
day inclusive of report writing. The estimated travel costs were $1,200
per trip for two CDC investigators. The total estimated costs
associated with laboratory investigation per entity are $5,183 (range:
$5,414 to $6,211). The estimated total costs for CDC per new registered
entity are $6,197 (range: $5,678 to $6,733) for application review and
laboratory investigation.
HHS/CDC assumed that all costs associated with the IFR will occur
during the first year after the IFR is published and that the IFR will
not affect costs for registered entities in following years. This may
result in an over-estimate of the costs to register a new entity if
that entity were to decide to continue to work with select agents and
toxins in future years.
Table 2--Estimated Costs per New Entity, Which Will Register in Order To Work With the Agent
[2020 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Entity:
Estimated costs for new registration per entity (A) \3\..... $78,994 $41,087 $936,528
HHS/CDC:
New application review (time) costs per entity:
Number of staff required for the review of the new 2 2 2
application (B)............................................
Hourly wage (C)............................................. $48.05 $43.90 $52.20
Overhead multiplier (D)..................................... 100% 100% 100%
Time required for the new application per staff (hour) (E).. 2 1.5 2.5
Estimated costs associated with a new registration $384 $263 $522
application review (F) = (B) x (C) x ((D) + 1) x (E).......
Lab investigation costs per entity:
Number of staff required for the lab investigation (G)...... 2 2 2
[[Page 64079]]
Hourly wage (H)............................................. $48.05 $43.90 $52.20
Overhead multiplier (I)..................................... 100% 100% 100%
Time required for the amendment per staff (hour) (J)........ 24 24 24
Estimated time costs for lab investigation per entity (K) = $4,613 $4,214 $5,011
(F) x (G) x ((H) + 1) x (I)................................
Number of trips required per lab investigation (L).......... 1 1 1
Travel associated costs per trip (M)........................ $1,200 $1,200 $1,200
Travel associated costs per lab investigation (N) = (L) x $1,200 $1,200 $1,200
(M)........................................................
Estimated costs associated with lab investigation (O) = (K) $5,813 $5,414 $6,211
+ (N)......................................................
Estimated total costs for HHS/CDC per entity (P) = (F) + (O).... $6,197 $5,678 $6,733
----------------------------------------------------------------------------------------------------------------
HHS/CDC is only aware of one registered entity that is interested
in generating this agent and would likely amend their registration to
work with this agent. The base case is that only one registered entity
would amend their registration for the agent and no unregistered
entities would undergo the registration process in order to work with
this agent. The lower bound is the same as the base case. For the upper
bound, HHS/CDC assumed that two registered entities would amend their
registration to work with this agent and one unregistered entity would
undergo the registration process to work with this agent (Table 3).
---------------------------------------------------------------------------
\3\ The estimates from the Regulatory Impact Analysis for the
2005 Select Agent Regulations Final Rule (Regulatory Impact
Analysis, 42 CFR Parts 73: Possession, Use, and Transfer of Select
Agents and Toxins Final Rule, Centers for Disease Control and
Prevention, February 3, 2005) was adjusted to 2020 US dollars value
using the Consumer Price Index (CPI) Inflation Calculator (https://www.bls.gov/data/inflation_calculator.htm).
Table 3--Numbers of Entities That Will Be Affected by the IFR
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Registered entities, which want to amend the registration for 1 1 2
the agent......................................................
Unregistered entities, which want to be registered for the agent 0 0 1
----------------------------------------------------------------------------------------------------------------
The total costs associated with the IFR for the entities working
with this agent are estimated at $67 (range: $25 to $936,777) (Table
4).
Table 4--Total Estimated Costs for Entities To Work With the SARS-CoV/SARS-CoV-2 Chimeric Viruses Associated
With the IFR
[2020 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Registered entities, which want to amend their registrations to
work with the agent:
Number of entities (A)...................................... 1 1 2
Estimated costs per entity (B).............................. $67 $25 $125
Estimated costs (C) = (A) x (B)............................. $67 $25 $249
Unregistered entities, which would pursue registration to work
with this agent:
Number of entities (D)...................................... 0 0 1
Estimated costs per entity (E).............................. $78,994 $41,087 $936,528
Estimated costs (F) = (D) x (E)............................. $0 $0 $936,528
Total estimated costs for entities to comply with HHS/CDC $67 $25 $936,777
requirements to work with this agent (G) = (C) + (F)...........
----------------------------------------------------------------------------------------------------------------
The total estimated costs for HHS/CDC to review applications to
amend registrations or to register new entities to work with this
agent, which are associated with the IFR are $209 (range: $156 to
$7,255) (Table 5).
Table 5--Total Estimated Costs for HHS/CDC To Review Entities' Applications To Amend Their Registrations or To
Register New Entities To Work With the SARS-CoV/SARS-CoV-2 Chimeric Viruses Associated With the IFR
[2020 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Registered entities, which want to amend the registration for
the agent:
Number of entities (A)...................................... 1 1 2
Estimated costs per entity (B).............................. $209 $157 $261
[[Page 64080]]
Estimated costs (C) = (A) x (B)............................. $209 $157 $522
Unregistered entities, which want to be registered for the
agent:
Number of entities (D)...................................... 0 0 1
Estimated costs per entity (E).............................. $6,197 $5,678 $6,733
Estimated costs (F) = (D) x (E)............................. $0 $0 $6,733
Total estimated costs for HHS/CDC (G) = (C) + (F)............... $209 $156 $7,255
----------------------------------------------------------------------------------------------------------------
Summary of Costs
In summary, the total estimated costs associated with the IFR are
$276 (range: $182 to $944,032) (Table 6). All costs are one-time costs,
and the follow-up costs are assumed to be minimal. The upper bound cost
estimate includes the cost to register a new entity to work with select
agents and toxins, which may not be pursued. Even this upper bound
estimate is less than $1 million.
Table 6--Summary of Total Estimated Costs Associated With the IFR To Add the SARS-CoV/SARS-CoV-2 Chimeric
Viruses Resulting From Any Deliberate Manipulation of SARS-CoV-2 To Incorporate Nucleic Acids Coding for SARS-
CoV Virulence Factors to HHS/CDC's List of Select Agents and Toxins
[2020 U.S. dollars]
----------------------------------------------------------------------------------------------------------------
Base case Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Total estimated costs to entities working with the agent (A).... $67 $25 $936,777
Total estimated costs to HHS/CDC (B)............................ 209 157 7,255
-----------------------------------------------
Total estimated costs (C) = (A) + (B)....................... 276 182 944,032
----------------------------------------------------------------------------------------------------------------
Benefits
The agents and toxins placed on the HHS/CDC select list have the
potential to pose severe threats to public health and safety. The
benefits of the HHS/CDC interim final rule derive from the strengthened
prevention against the accidental or intentional release of SARS-CoV/
SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation
of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV
virulence factors. The provisions of this IFR will reduce the risk of
human exposure to the chimeric viruses by ensuring that laboratory
facilities employ adequate security and safety measures including:
(1) Develop and implement a written biosafety plan and measures in
place that is commensurate with the risk of the select agent given its
intended use,
(2) Develop and implement a written security plan and measures in
place that is sufficient to safeguard the select agent against
unauthorized access, theft, loss, or release,
(3) Develop and implement a written incident response plan based
upon a site-specific risk assessment,
(4) Have an adequate training program for handling select agents,
and
(5) Maintain an inventory of select agents.
The benefits to public health and safety from the implementation of
the rule result from the strengthened prevention that the rules provide
against the either accidental or intentional release of the
modification of a non-select agent with nucleic acids from a select
agent but are difficult to quantify. The cost of such an event in
morbidity and mortality could be very high. In addition, a release of
this modification of a non-select agent with nucleic acids from a
select agent would require a complicated and expensive emergency
response effort. This effort could include extensive public health
measures, such as quarantine, preventative treatment, and diagnostic
testing for large numbers of potentially exposed persons, and extensive
decontamination. Substantial costs could be incurred by hospitals and
other medical facilities and institutions of government at all levels.
A release, or widespread fear of one, also would create significant
secondary effects. It could disrupt business, transportation, and many
other aspects of normal behavior, on both a short-term and potentially
a long-term basis.
HHS/CDC is unable to predict the potential infectiousness or
virulence of the SARS-CoV/SARS-CoV-2 chimeric viruses that are
regulated according to the provisions of this IFR. However,
implementation of the IFR will provide a means of determining where the
modification of a non-select agent with nucleic acids from a select
agent is located; ensure that transfer, storage, and use of the agent
can be tracked; provide for the screening of personnel with access to
such agent; and require that entities in possession of such agent
develop and implement effective means of biosafety and physical
security. The benefit of these provisions is a reduced likelihood of
either an accidental or intentional release of the select agent and the
consequent avoidance of costs associated with such a release.
This IFR addresses a risk associated with substantial economic
consequences. The likelihood of these negative outcomes under a
baseline scenario of no further regulatory action are low, but also
highly uncertain and difficult to characterize. Based on this analysis,
HHS/CDC believes the expected benefits of this IFR are likely to exceed
the estimated costs associated with this IFR.
B. The Regulatory Flexibility Act (RFA), as Amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA)
We have examined the impacts of the interim final rule under the
Regulatory Flexibility Act (5 U.S.C. 601-612). The Regulatory
Flexibility Act (RFA), as
[[Page 64081]]
amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA), requires agencies to analyze regulatory options that would
minimize any significant economic impact of a rule on small entities.
Based on our current knowledge of who may possess this agent, we
certify that this interim final rule will not have a significant
economic impact on a substantial number of small entities within the
meaning of the RFA.
This regulatory action is not a major rule as defined by Sec. 804
of the Small Business Regulatory Enforcement Fairness Act of 1996. This
interim final rule will not result in an annual effect on the economy
of $100,000,000 or more; a major increase in cost or prices; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
companies to compete with foreign-based companies in domestic and
export markets.
C. Paperwork Reduction Act of 1995
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in the current regulations are
approved by the Office of Management and Budget (OMB) under OMB control
number 0920-0576, expiration date 1/31/2024. This rulemaking includes a
request for a nonmaterial/non-substantive change to account for small,
potential increases in burden for a limited number of entities to
submit amendments to their registrations.
We expect that the entities who will register for possession, use,
or transfer of the select agent will already be registered with the
Federal Select Agent Program because the entity would be registered to
possess, use, or transfer SARS-CoV. This rulemaking will require such
an entity to amend its registration with the Federal Select Agent
Program using relevant portions of APHIS/CDC Form 1 (Registration for
Possessing, Use, and Transfer of Select Agents and Toxins). Estimated
time to amend this form is one hour for one select agent. Additionally,
any registered entity that wishes to transfer the select agent will be
required to submit information using APHIS/CDC Form 2 (Request to
Transfer of Select Agent and Toxins). Estimated average time to
complete this form is one hour. Based upon the limited publications on
this agent at this time, we estimate that only one to five registered
entities may add the select agent to their registration or transfer the
select agent to another registered entity. Therefore, we calculate that
there is no increase in the number of respondents that need to submit
an application for registration, we estimate the total number of
responses for entities to submit an amendment to their registration may
increase by five, and the total burden hours may increase to five
hours. This represents a nonmaterial/non-substantive change in burden
for respondents to this approved information collection. The burden is
outlined in the table below.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Section Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 7...................................... Application for Registration........... 3 1 5 15
Section 7...................................... Amendment to a Certificate of 254 5 1 1,270
Registration.
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. E.O. 12988: Civil Justice Reform
This rule has been reviewed under E.O. 12988, Civil Justice Reform.
Once the interim final rule is in effect, HHS/CDC notes that: (1) All
State and local laws and regulations that are inconsistent with this
rule will be preempted; (2) No retroactive effect will be given to this
rule; and (3) Administrative proceedings will not be required before
parties may file suit in court challenging this rule.
E. E.O. 13132: Federalism
HHS/CDC has reviewed this interim final rule in accordance with
Executive Order 13132 regarding Federalism and has determined that it
does not have ``federalism implications.'' The rule does not ``have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.''
F. Plain Language Act of 2010
Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13,
2010), executive Departments and Agencies are required to use plain
language in documents that explain to the public how to comply with a
requirement the Federal Government administers or enforces. HHS/CDC has
attempted to use plain language in announcing this rule consistent with
the Federal Plain Writing Act guidelines.
List of Subjects in 42 CFR Part 73
Biologics, Incorporation by reference, Packaging and containers,
Penalties, Reporting and Recordkeeping requirements, Transportation.
For the reasons stated in the preamble, we are amending 42 CFR part
73 as follows:
0
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 107-188 (42 U.S.C. 262a)
0
2. In Sec. 73.3 amend paragraph (b) by adding in alphabetical order an
entry for ``SARS-CoV/SARS-CoV-2 chimeric viruses'' to read as follows:
Sec. 73.3 HHS select agents and toxins.
* * * * *
(b) * * *
SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate
manipulation of SARS-CoV-2 to incorporate nucleic acids coding for
SARS-CoV virulence factors.
* * * * *
0
3. Amend Sec. 73.13 by adding paragraph (a)(3) to read as follows:
Sec. 73.13 Restricted experiments.
* * * * *
(a) * * *
(3) Experiments that involve the creation of SARS-CoV/SARS-CoV-2
chimeric viruses resulting from any deliberate manipulation of SARS-
CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence
factors or vice versa.
* * * * *
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-25204 Filed 11-15-21; 4:15 pm]
BILLING CODE 4163-18-P
