[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]


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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.

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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: http://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 http://www.regulations.gov, including any 
personal information provided. For access to the docket to read 
background documents or comments received, go to http://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 (http://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]
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                                                                     Base case      Lower bound     Upper bound
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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:
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    \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]
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                                                                     Base case      Lower bound     Upper bound
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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
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    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).
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    \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