Select Agent: Modified Junín Virus Vaccine Strain, 104888-104889 [2024-30568]

Download as PDF ddrumheller on DSK120RN23PROD with RULES1 104888 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Rules and Regulations • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it proposes to approve a State program; • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act. In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address ‘‘disproportionately high and adverse human health or environmental effects’’ of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order 14096 (Revitalizing Our Nation’s Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements Executive Order 12898 and defines EJ as, among other things, ‘‘the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, Tribal affiliation, or disability, in agency decision-making and other Federal activities that affect human health and the environment.’’ The State did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of Executive Order VerDate Sep<11>2014 16:29 Dec 23, 2024 Jkt 265001 12898 of achieving EJ for communities with EJ concerns. This action is subject to the Congressional Review Act (CRA), and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this action as discussed in section II of this preamble, including the basis for that finding. Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 24, 2025. Filing a petition for reconsideration by the EPA Administrator of this action does not affect the finality of this action for the purpose of judicial review, nor does it extend the time within which petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see CAA section 307(b)(2)). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements. Dated: December 13, 2024. Martha Guzman Aceves, Regional Administrator, Region IX. [FR Doc. 2024–30409 Filed 12–23–24; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 73 Select Agent: Modified Junı́n Virus Vaccine Strain Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notification of determination. AGENCY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), has determined that a previously excluded attenuated SUMMARY: PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 strain, Junı́n virus vaccine strain Candid No.1, has key attenuating mutations in the glycoprotein envelope at GP1 T168A and GP2 F427I. Revertants at either of these positions have increased pathogenicity and virulence. Therefore, Junı́n virus vaccine strain Candid No. 1 containing GP1 168T and/or GP2 427F is a select agent and is subject to the select agent and toxin regulations. DATES: This determination is applicable as of May 3, 2024. FOR FURTHER INFORMATION CONTACT: Daniel A. Singer, MD, MPH, FACP, Acting Director, Division of Regulatory Science and Compliance, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21–4, Atlanta, Georgia 30329, Telephone: (404) 718–2000. SUPPLEMENTARY INFORMATION: Junı́n virus is a negative sense, double stranded RNA virus and is the causative agent of Argentine hemorrhagic fever. Junı́n virus causes chronic infection in Calomys musculinus, the Drylands vesper mouse. Humans can become infected upon exposure to infected animals or infected animals’ waste. Human-to-human spread is rare but can occur upon contact with an infected person’s bodily fluids. In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Response Act), HHS regulates biological agents and toxins that have the potential to pose a severe threat to public health and safety (42 U.S.C. 262a(a)(1)). The list of HHS select agents and toxins is provided in the HHS select agent and toxin regulations (42 CFR part 73) and Junı́n virus, a South American hemorrhagic fever virus, is included as a select agent (42 CFR 73.3(b)). The HHS select agent and toxin regulations established a process by which an attenuated strain of a select biological agent that does not have the potential to pose a severe threat to public health and safety may be excluded from the requirements of the select agent and toxin regulations (42 CFR 73.3(e)). On February 7, 2003, Junı́n virus vaccine strain Candid No.1 was excluded from the regulations as it does not pose a significant threat to public health and safety (McKee KT Jr, Oro JG, Kuehne AI, Spisso JA, Mahlandt BG. ‘‘Candid No. 1 Argentine hemorrhagic fever vaccine protects against lethal Junı́n virus challenge in rhesus macaques’’ Intervirology. 1992: 34(3):154–63). This exclusion was granted based on the historically safe use of this strain as a vaccine against Argentine hemorrhagic fever for E:\FR\FM\26DER1.SGM 26DER1 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Rules and Regulations agricultural workers at risk of occupational exposure in Argentina. As set forth under 42 CFR 73.3(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. CDC’s Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC), which comprises federal government subjectmatter experts from HHS, the U.S. Department Agriculture, the Department of Homeland Security, the Environmental Protection Agency, and the Department of Defense, reviewed the data published in the study, ‘‘Restoration of virulence in the attenuated Candid No.1 vaccine virus requires reversion at both positions 168 and 427 in the envelope glycoprotein GPC’’ (published in the Journal of Virology [https://doi.org/10.1128/ jvi.00112-24] on March 20, 2024). The ISATTAC concluded that the modified strains (Candid No.1 containing GP1 168T and/or GP2 427F) showed an increased virulence compared to the parental excluded Candid No.1 strain when injected into guinea pigs and huTfR1 mice. CDC concurred with the ISATTAC’s assessment and, on May 3, 2024, CDC determined that given the restoration of virulence, Junı́n virus vaccine strain Candid No.1 containing GP1 168T and/or GP2 427F is a select agent and is subject to the select agent and toxin regulations in accordance with 42 CFR 73.3(e)(2). Dated: December 18, 2024. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2024–30568 Filed 12–23–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF THE INTERIOR Bureau of Land Management 43 CFR Part 2800 [PO #4820000251] ddrumheller on DSK120RN23PROD with RULES1 RIN 1004–AE78 Rights-of-Way, Leasing, and Operations for Renewable Energy; Technical Corrections AGENCY: Bureau of Land Management, Interior. Final rule; technical corrections. ACTION: The Bureau of Land Management (BLM) is making technical corrections to regulations that published SUMMARY: VerDate Sep<11>2014 16:29 Dec 23, 2024 Jkt 265001 in the Federal Register on May 1, 2024 (final rule). DATES: Effective on December 26, 2024. FOR FURTHER INFORMATION CONTACT: Jayme Lopez, Interagency Coordination Liaison, by phone at (520) 235–4581, or by email at energy@blm.gov for information relating to the BLM Renewable Energy programs and information about the final rule. Please use ‘‘RIN 1004–AE78’’ in the subject line. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-ofcontact in the United States. SUPPLEMENTARY INFORMATION: BLM published FR Doc. 2024–08099, beginning on page 35634 in the Federal Register of May 1, 2024. Subsequently, BLM published a correction to the final rule on June 28, 2024 (89 FR 53869), correcting its instructions for 43 CFRs 2801.5 to clarify the addition of the term ‘‘Megawatt hour (MWh) rate’’ instead of revising the term ‘‘Megawatt hour (MWh) rate.’’ However, the instructions were not updated to remove the conflicting term ‘‘Megawatt rate,’’ which is no longer necessary with the changes in the final rule. This correcting amendment removes the term ‘‘Megawatt rate’’ from § 2801.5(b). Section 2803.10 of the final rule did not include the change to the title adding the words ‘‘or lease’’ as intended with the publication of the final rule. This correcting amendment revises the section title to read as, ‘‘Who may hold a grant or lease?’’ Section 2804.12 in the final rule did not include the title to paragraph (j) intended for reader clarity. This correcting amendment revises paragraph (j) adding the intended title, ‘‘Complete applications:’’ to the paragraph. In the final rule, § 2806.51(a) was not updated consistent with the changes of the final rule and incorrectly left regulatory text that directed readers to sections of the rule that are specific to the 2016 rule and are now incorrect and inaccurate and no longer able to be implemented. This correcting amendment revises paragraph (a) to retain the first sentence of paragraph (a) with slight revisions using the terminology of the final rule. The second and third sentences of paragraph (a) direct readers to the standard rate adjustment method and the scheduled PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 104889 rate adjustment method which are no longer available and were removed with the final rule. In the final rule, instruction 28 specified § 2806.52(a) through (c) were being revised without correctly identifying the removal of § 2806.52(d). Section 2806.52(d) includes regulatory citations specific to the 2016 final rule that are now incorrect and inaccurate and no longer able to be implemented. This correcting amendment removes § 2806.52(d). BLM also corrects § 2809.15(d)(2) by removing the colon at the end of the paragraph and adding a semicolon in its place. Sections 2807.17 and 2807.20 of the final rule did not include the intended addition ‘‘or lease’’ in the titles. These section titles are revised to include the missing text to now read as, ‘‘§ 2807.17 Under what conditions may BLM suspend or terminate my grant or lease?’’ and ‘‘§ 2807.20 When must I amend my application, seek an amendment of my grant or lease, or obtain a new grant or lease?’’ Sections 2809.13 and 2809.17 of the final rule did not include the intended section title revisions to change ‘‘offers’’ to read as ‘‘processes,’’ consistent with the changes in the regulatory text. These correcting amendments change the titles to read as ‘‘§ 2809.13 How will the BLM conduct competitive processes?’’ and ‘‘§ 2809.17 Will the BLM ever reject bids or re-conduct a competitive process?’’ In the final rule, the title to § 2809.18 was intended to include the addition to the section title ‘‘solar and wind energy development,’’ consistent with the new definition of ‘‘solar and wind energy development’’ added to the final rule. The section now reads as, ‘‘What terms and conditions apply to a solar and wind energy development lease?’’ Additionally, the regulatory reference in paragraph (a) should direct readers to § 2805.11(c), not 2805.11(b), for the term of a solar and wind energy development lease. Paragraph (a) is revised, correcting the regulatory reference to read as § 2805.11(c). List of Subjects in 43 CFR Part 2800 Electric power, Highways and roads, Penalties, Public lands and rights-ofway, Reporting and recordkeeping requirements. Accordingly, for the reasons stated in the preamble, the BLM corrects 43 CFR part 2800 by making the following technical corrections: E:\FR\FM\26DER1.SGM 26DER1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Rules and Regulations]
[Pages 104888-104889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73


Select Agent: Modified Jun[iacute]n Virus Vaccine Strain

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

ACTION: Notification of determination.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), has 
determined that a previously excluded attenuated strain, Jun[iacute]n 
virus vaccine strain Candid No.1, has key attenuating mutations in the 
glycoprotein envelope at GP1 T168A and GP2 F427I. Revertants at either 
of these positions have increased pathogenicity and virulence. 
Therefore, Jun[iacute]n virus vaccine strain Candid No. 1 containing 
GP1 168T and/or GP2 427F is a select agent and is subject to the select 
agent and toxin regulations.

DATES: This determination is applicable as of May 3, 2024.

FOR FURTHER INFORMATION CONTACT: Daniel A. Singer, MD, MPH, FACP, 
Acting Director, Division of Regulatory Science and Compliance, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21-
4, Atlanta, Georgia 30329, Telephone: (404) 718-2000.

SUPPLEMENTARY INFORMATION: Jun[iacute]n virus is a negative sense, 
double stranded RNA virus and is the causative agent of Argentine 
hemorrhagic fever. Jun[iacute]n virus causes chronic infection in 
Calomys musculinus, the Drylands vesper mouse. Humans can become 
infected upon exposure to infected animals or infected animals' waste. 
Human-to-human spread is rare but can occur upon contact with an 
infected person's bodily fluids.
    In accordance with the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Bioterrorism Response Act), HHS 
regulates biological agents and toxins that have the potential to pose 
a severe threat to public health and safety (42 U.S.C. 262a(a)(1)). The 
list of HHS select agents and toxins is provided in the HHS select 
agent and toxin regulations (42 CFR part 73) and Jun[iacute]n virus, a 
South American hemorrhagic fever virus, is included as a select agent 
(42 CFR 73.3(b)).
    The HHS select agent and toxin regulations established a process by 
which an attenuated strain of a select biological agent that does not 
have the potential to pose a severe threat to public health and safety 
may be excluded from the requirements of the select agent and toxin 
regulations (42 CFR 73.3(e)). On February 7, 2003, Jun[iacute]n virus 
vaccine strain Candid No.1 was excluded from the regulations as it does 
not pose a significant threat to public health and safety (McKee KT Jr, 
Oro JG, Kuehne AI, Spisso JA, Mahlandt BG. ``Candid No. 1 Argentine 
hemorrhagic fever vaccine protects against lethal Jun[iacute]n virus 
challenge in rhesus macaques'' Intervirology. 1992: 34(3):154-63). This 
exclusion was granted based on the historically safe use of this strain 
as a vaccine against Argentine hemorrhagic fever for

[[Page 104889]]

agricultural workers at risk of occupational exposure in Argentina.
    As set forth under 42 CFR 73.3(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. CDC's Intragovernmental Select Agents 
and Toxins Technical Advisory Committee (ISATTAC), which comprises 
federal government subject-matter experts from HHS, the U.S. Department 
Agriculture, the Department of Homeland Security, the Environmental 
Protection Agency, and the Department of Defense, reviewed the data 
published in the study, ``Restoration of virulence in the attenuated 
Candid No.1 vaccine virus requires reversion at both positions 168 and 
427 in the envelope glycoprotein GPC'' (published in the Journal of 
Virology [https://doi.org/10.1128/jvi.00112-24] on March 20, 2024). The 
ISATTAC concluded that the modified strains (Candid No.1 containing GP1 
168T and/or GP2 427F) showed an increased virulence compared to the 
parental excluded Candid No.1 strain when injected into guinea pigs and 
huTfR1 mice. CDC concurred with the ISATTAC's assessment and, on May 3, 
2024, CDC determined that given the restoration of virulence, 
Jun[iacute]n virus vaccine strain Candid No.1 containing GP1 168T and/
or GP2 427F is a select agent and is subject to the select agent and 
toxin regulations in accordance with 42 CFR 73.3(e)(2).

    Dated: December 18, 2024.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-30568 Filed 12-23-24; 8:45 am]
BILLING CODE 4163-18-P

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