Select Agent: Determination That Vaccine Strain, TC-83(A3G) of Venezuelan Equine Encephalitis Virus (VEEV) Is a Regulated Strain of VEEV, 53679-53680 [2022-18973]

Download as PDF 53679 Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Rules and Regulations TABLE 4 TO PARAGRAPH (c)—APPROVED MARICOPA COUNTY AIR POLLUTION CONTROL REGULATIONS—Continued County citation * Title/subject State effective date * * EPA approval date * Additional explanation * * * Regulation III—Control of Air Contaminants * Rule 34 (paragraphs F, G, H, I, J and K only). * Organic Solvents— Volatile Organic Compounds (VOC). * * * * * * * * * June 23, 1980 ............ May 5, 1982, 47 FR 19326. * * * * Submitted on June 23, 1980. EPA approved the rescission of paragraphs A, D.1, E.1, E.3 and L. Paragraphs B and C were superseded by approval of Maricopa Rule 331; paragraph D.2 was superseded by approval of Maricopa Rule 333; paragraph E.2 was superseded by approval Maricopa Rule 335; and paragraph E.4 was superseded by approval of Maricopa Rule 336. * * * * TABLE 7—EPA-APPROVED PIMA COUNTY AIR POLLUTION CONTROL REGULATIONS County citation * Title/subject State effective date * * EPA approval date * Additional explanation * * * * * * * * 1976–1978 Rule Codification * * * * Regulation II—Fuel Burning Equipment * * Rule 7A (Paragraphs 1 and 6). Rule 7B (Paragraphs 1–4). Emission Limitation, Fuel Burning Equipment—Sulfur Dioxide. Emission Limitation, Fuel Burning Equipment—Nitrogen Oxides. * * * * * * * * June 21, 1976 ............ July 19, 1977, 42 FR 36998. Submitted on September 30, 1976. Paragraphs 2 to 5 were disapproved. See 42 FR 36998 (July 19, 1977). June 21, 1976 ............ July 19, 1977, 42 FR 36998. Submitted on September 30, 1976. * * * * ACTION: * Regulatory determination. [FR Doc. 2022–18723 Filed 8–31–22; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES jspears on DSK121TN23PROD with RULES 42 CFR Part 73 Select Agent: Determination That Vaccine Strain, TC–83(A3G) of Venezuelan Equine Encephalitis Virus (VEEV) Is a Regulated Strain of VEEV Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: VerDate Sep<11>2014 16:19 Aug 31, 2022 The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), has determined that a modification to the attenuated, excluded strain Venezuelan Equine Encephalitis Virus (VEEV) TC–83 has been shown to increase its virulence. The modified VEEV strain TC–83(A3G) demonstrated increased pathogenicity and lethality. Therefore, the modified VEEV strain TC–83(A3G) is not an excluded strain but is a select agent and is subject to regulation. SUMMARY: BILLING CODE 6560–50–P Jkt 256001 This action is effective September 1, 2022. DATES: PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 * * 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 H21–4, Atlanta, Georgia 30329, Telephone: (404) 718–2000. VEEV is a member of the genus Alphavirus in the family Togaviridae, and is a small, enveloped virus with a genome consisting of a single strand of positivesense RNA. VEEV is a mosquito-borne virus that causes encephalitis or encephalomyelitis in all equine species and humans. The select agent regulations (42 CFR part 73) established a process by which SUPPLEMENTARY INFORMATION: E:\FR\FM\01SER1.SGM 01SER1 53680 Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Rules and Regulations an attenuated strain of a select biological agent or toxin that does not pose a severe threat to public health and safety may be excluded from the requirements of the select agent regulations. On February 7, 2003, VEEV strain TC–83 was excluded from select agent regulations because mice vaccinated subcutaneously with the VEEV strain TC–83 rapidly developed immunity to subcutaneous or airborne challenge with virulent VEEV (https:// www.selectagents.gov/sat/exclusions/ overlap.htm). As such, CDC determined that the attenuated strain did not have the potential to pose a severe threat to public health and safety. As set forth under 42 CFR 73.4(e)(2), if an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, the resulting select agent will be subject to the requirements of the regulations. Based on review by subject matter experts, CDC has determined that a modification to the excluded attenuated VEEV vaccine strain TC–83 has been shown to increase its virulence and pathogenicity. An adenine (A) at position 3 in TC–83 has been shown to contribute to the attenuation of VEEV. In TC–83(A3G), the A has been changed to a guanine (G), which is found in all wild-type isolates of VEEV. The reversion of this nucleotide mutation to the wildtype nucleotide resulted in increased lethality in mice when compared to mice inoculated with the vaccine strain TC–83. Additional data determined that the pathogenic effects of TC–83(A3G) are more pronounced in young mice. As such, the modification of the excluded, attenuated VEEV vaccine strain TC–83 to create VEEV strain TC–83(A3G) restores the virus’s virulence and therefore, VEEV strain TC–83(A3G) is subject to 42 CFR part 73. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2022–18973 Filed 8–30–22; 4:15 pm] jspears on DSK121TN23PROD with RULES BILLING CODE 4163–18–P VerDate Sep<11>2014 16:19 Aug 31, 2022 Jkt 256001 DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 367 [Docket No. FMCSA–2022–0001] RIN 2126–AC51 Fees for the Unified Carrier Registration Plan and Agreement Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT). ACTION: Final rule. AGENCY: FMCSA amends the regulations for the annual registration fees States collect from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies for the Unified Carrier Registration (UCR) Plan and Agreement for the 2023 registration year and subsequent registration years. The fees for the 2023 registration year would be reduced below the fees for 2022. The reduction in annual registration fees would be between $18 and $17,688 per entity, depending on the applicable fee bracket that is based on the number of vehicles owned or operated by the affected entity. DATES: Effective September 1, 2022. Petitions for Reconsideration of this final rule must be submitted to the FMCSA Administrator no later than October 3, 2022. FOR FURTHER INFORMATION CONTACT: Mr. Kenneth Riddle, Director, Office of Registration and Safety Information, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590–0001, FMCSAMCRS@dot.gov. If you have questions on viewing or submitting material to the docket, call Dockets Operations at (202) 366–9826. SUPPLEMENTARY INFORMATION: FMCSA organizes this final rule as follows: SUMMARY: I. Availability of Rulemaking Documents II. Executive Summary A. Purpose and Summary of the Regulatory Action B. Costs and Benefits III. Abbreviations IV. Legal Basis for Rulemaking V. Discussion of Proposed Rulemaking and Comments A. The Proposed Rulemaking B. Comments Received C. Reopening of Comment Period VI. Changes From the NPRM VII. International Impacts VIII. Final 2023 State UCR Revenue Entitlements and Revenue Targets IX. Section-by-Section Analysis X. Regulatory Analyses PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 A. E.O. 12866 (Regulatory Planning and Review), E.O. 13563 (Improving Regulation and Regulatory Review), and DOT Regulatory Policies and Procedures B. Congressional Review Act C. Regulatory Flexibility Act (Small Entities) D. Assistance for Small Entities E. Unfunded Mandates Reform Act of 1995 F. Paperwork Reduction Act (Collection of Information) G. E.O. 13132 (Federalism) H. Privacy I. E.O. 13175 (Indian Tribal Governments) J. National Environmental Policy Act of 1969 I. Availability of Rulemaking Documents To view any documents mentioned as being available in the docket, go to https://www.regulations.gov/docket/ FMCSA-2022-0001/document and choose the document to review. To view comments, click this final rule, then click ‘‘Browse Comments.’’ If you do not have access to the internet, you may view the docket online by visiting Dockets Operations at U.S. Department of Transportation, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590–0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366–9317 or (202) 366–9826 before visiting Dockets Operations. II. Executive Summary A. Purpose and Summary of the Regulatory Action Under the UCR Statute, the UCR Plan and the 41 States participating in the UCR Agreement collect fees from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies. The UCR Plan and Agreement are administered by a 15-member board of directors: 14 appointed from the participating States and the industry, plus the Deputy Administrator of FMCSA. Revenues collected are allocated to the participating States and the UCR Plan. In accordance with 49 U.S.C. 14504a(d)(7) and (f)(1)(E)(ii), fee adjustments must be requested by the UCR Plan when annual revenues exceed the maximum allowed. Also, if there are excess funds after payments to the States and for administrative costs, they are retained in the UCR Plan’s depository, and fees in subsequent fee years must be reduced as required by 49 U.S.C. 14504a(h)(4). These two distinct provisions each contribute to the fee adjustment in this final rule, which reduces the annual registration fees established pursuant to the UCR E:\FR\FM\01SER1.SGM 01SER1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53679-53680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73


Select Agent: Determination That Vaccine Strain, TC-83(A3G) of 
Venezuelan Equine Encephalitis Virus (VEEV) Is a Regulated Strain of 
VEEV

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Regulatory determination.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), has 
determined that a modification to the attenuated, excluded strain 
Venezuelan Equine Encephalitis Virus (VEEV) TC-83 has been shown to 
increase its virulence. The modified VEEV strain TC-83(A3G) 
demonstrated increased pathogenicity and lethality. Therefore, the 
modified VEEV strain TC-83(A3G) is not an excluded strain but is a 
select agent and is subject to regulation.

DATES: This action is effective September 1, 2022.

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 H21-4, Atlanta, Georgia 
30329, Telephone: (404) 718-2000.

SUPPLEMENTARY INFORMATION: VEEV is a member of the genus Alphavirus in 
the family Togaviridae, and is a small, enveloped virus with a genome 
consisting of a single strand of positive-sense RNA. VEEV is a 
mosquito-borne virus that causes encephalitis or encephalomyelitis in 
all equine species and humans.
    The select agent regulations (42 CFR part 73) established a process 
by which

[[Page 53680]]

an attenuated strain of a select biological agent or toxin that does 
not pose a severe threat to public health and safety may be excluded 
from the requirements of the select agent regulations. On February 7, 
2003, VEEV strain TC-83 was excluded from select agent regulations 
because mice vaccinated subcutaneously with the VEEV strain TC-83 
rapidly developed immunity to subcutaneous or airborne challenge with 
virulent VEEV (https://www.selectagents.gov/sat/exclusions/overlap.htm). As such, CDC determined that the attenuated strain did 
not have the potential to pose a severe threat to public health and 
safety.
    As set forth under 42 CFR 73.4(e)(2), if an excluded attenuated 
strain is subjected to any manipulation that restores or enhances its 
virulence, the resulting select agent will be subject to the 
requirements of the regulations. Based on review by subject matter 
experts, CDC has determined that a modification to the excluded 
attenuated VEEV vaccine strain TC-83 has been shown to increase its 
virulence and pathogenicity. An adenine (A) at position 3 in TC-83 has 
been shown to contribute to the attenuation of VEEV. In TC-83(A3G), the 
A has been changed to a guanine (G), which is found in all wild-type 
isolates of VEEV. The reversion of this nucleotide mutation to the 
wildtype nucleotide resulted in increased lethality in mice when 
compared to mice inoculated with the vaccine strain TC-83. Additional 
data determined that the pathogenic effects of TC-83(A3G) are more 
pronounced in young mice. As such, the modification of the excluded, 
attenuated VEEV vaccine strain TC-83 to create VEEV strain TC-83(A3G) 
restores the virus's virulence and therefore, VEEV strain TC-83(A3G) is 
subject to 42 CFR part 73.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-18973 Filed 8-30-22; 4:15 pm]
BILLING CODE 4163-18-P

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