Draft Policy Statement for Biosafety Level 4 (BSL-4) and Animal BSL-4 (ABSL-4) Laboratory Verification; Notice of Availability, 2791-2792 [2022-00928]

Download as PDF Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices Dated: January 12, 2022. Marquita Cullom, Associate Director. [FR Doc. 2022–00906 Filed 1–18–22; 8:45 am] BILLING CODE 4160–90–P Prevention and the Agency for Toxic Substances and Disease Registry. Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2022–00868 Filed 1–18–22; 8:45 am] [FR Doc. 2022–00867 Filed 1–18–22; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P BILLING CODE 4163–18–P Centers for Disease Control and Prevention DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of Closed Meeting Centers for Disease Control and Prevention [Docket No. CDC–2022–0003] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92–463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)— DP22–001, Real-World Effectiveness of Structured Lifestyle Interventions in Preventing Type 2 Diabetes. Date: March 23, 2022. Time: 10:30 a.m.–6:00 p.m., EDT. Place: Teleconference. Agenda: To review and evaluate grant applications. Jaya Raman Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop S107–8, Atlanta, Georgia 30341–3717, Telephone: (770) 488–6511; Email: JRaman@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: jspears on DSK121TN23PROD with NOTICES1 2791 VerDate Sep<11>2014 17:56 Jan 18, 2022 Jkt 256001 Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92–463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)— DP22–002, Epidemiology of Lupus: Longitudinal Studies in PopulationBased Cohorts. Date: March 17, 2022. Time: 11:00 a.m.–6:00 p.m., EDT. Place: Teleconference. Agenda: To review and evaluate grant applications. For Further Information Contact: Jaya Raman, Ph.D., Scientific Review Officer, National Center for Chronic Disease and Health Promotion, CDC, 4770 Buford Highway, Mailstop S107–8, Atlanta, Georgia 30341–3717, Telephone: (770) 488–6511, Email: JRaman@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Draft Policy Statement for Biosafety Level 4 (BSL–4) and Animal BSL–4 (ABSL–4) Laboratory Verification; Notice of Availability Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of availability and comment. AGENCY: The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on a draft policy statement regarding Biosafety Level 4 (BSL–4)/Animal Biosafety Level 4 (ABSL–4) verification requirements. The policy statement, once finalized, will assist individuals and entities in verifying that the facility design parameters and operational procedures, including heating, ventilation, and air conditioning (HVAC) systems, in BSL– 4 and/or ABLS–4 laboratories are functioning as intended to meet the biosafety sufficiency requirement in the HHS/CDC select agent regulations. DATES: Submit written or electronic comments by March 21, 2022. ADDRESSES: You may submit comments, identified by Docket No. CDC–2022– 0003, by either of the following methods. • 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. Instructions: All submissions received must include the Agency name and Docket No. CDC–2022–0003. All relevant comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. Do not send comments by email. CDC does not accept comments by email. Docket Access: For access to the docket to read background documents or comments received, or to download SUMMARY: E:\FR\FM\19JAN1.SGM 19JAN1 2792 Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices an electronic version of the draft policy statement, go to https:// www.regulations.gov. Please be aware that comments and other submissions from members of the public are made available for public viewing without changes. 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. SUPPLEMENTARY INFORMATION: A. Legal Authority HHS/CDC is issuing this draft policy under the authority of sections 201–204 and 221 of Title II of Public Law 107– 188, (42 U.S.C. 262a). jspears on DSK121TN23PROD with NOTICES1 B. Background For entities that possess select agents and toxins, the HHS select agent and toxin regulations (42 CFR part 73) require that ‘‘biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards)’’ (42 CFR 73.12(b)). BSL–4 and ABSL–4 laboratory facility specifications and operational procedures are used for work with dangerous and exotic biological agents that could easily be aerosol transmitted within the laboratory, cause severe to fatal disease in humans, and typically do not have available vaccines or treatments. Therefore, these laboratories must implement and maintain the highest level of biosafety precautions for containment. HHS/CDC reviews how entities that maintain BSL–4 and/or ABSL–4 laboratories have verified that the design and operational parameters, including HVAC, are functioning properly when determining if entities have met the sufficiency requirement in section 12(b) of the HHS select agent and toxin regulations. In developing a biosafety plan, an individual or entity should consider requirements found in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) (42 CFR 73.12(c)). HHS/CDC has developed a draft policy statement for BSL–4 and ABSL–4 laboratory verification based on the standards found in the 6th edition of the BMBL: • BSL–4 D16(a): The ventilation system is designed to maintain the laboratory at negative pressure to surrounding areas and to provide differential pressure or directional VerDate Sep<11>2014 16:58 Jan 18, 2022 Jkt 256001 airflow as appropriate between adjacent areas within the laboratory. • ABSL–4 D16(a): The supply and exhaust components of the ventilation system are designed to maintain the ABSL–4 facility at negative pressure to surrounding areas and to provide differential pressure or directional airflow as appropriate between adjacent areas within the facility. • BSL–4 D20: The facility design parameters and operational procedures are documented. The facility is tested to verify that the design and operational parameters have been met prior to operation. Facilities are also re-tested annually or after significant modification to ensure operational parameters are maintained. Verification criteria are modified, as necessary, by operational experience. • ABSL–4 D21: The ABSL–4 facility design parameters and operational procedures are documented. The facility is tested to verify that the design and operational parameters have been met prior to operation. Facilities are also retested annually or after significant modification to ensure operational parameters are maintained. Verification criteria are modified, as necessary, by operational experience. HHS/CDC is requesting public comment on a draft policy statement on BSL–4/ABSL–4 laboratory verifications standards, including HVAC, to aid individuals and entities in verifying that these laboratories are properly functioning. We are making this policy document available to the public in the Supplementary Materials tab of the docket at www.regulations.gov for review and comment. All comments, such as items related to the appropriate acceptance criteria used to ensure systems are functioning as intended and documentation to demonstrate the sufficiency requirement has been met, that we receive on or before March 21, 2022 will be carefully reviewed and considered. Dated: January 13, 2022. Angela K. Oliver, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2022–00928 Filed 1–18–22; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–22–1255] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled ‘‘Emergency Cruise Ship Outbreak Investigations (CSOIs)’’ to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on 10/13/ 2021 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/ do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2791-2792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00928]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2022-0003]


Draft Policy Statement for Biosafety Level 4 (BSL-4) and Animal 
BSL-4 (ABSL-4) Laboratory Verification; Notice of Availability

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

ACTION: Notice of availability and comment.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) announces the opening of 
a docket to obtain comment on a draft policy statement regarding 
Biosafety Level 4 (BSL-4)/Animal Biosafety Level 4 (ABSL-4) 
verification requirements. The policy statement, once finalized, will 
assist individuals and entities in verifying that the facility design 
parameters and operational procedures, including heating, ventilation, 
and air conditioning (HVAC) systems, in BSL-4 and/or ABLS-4 
laboratories are functioning as intended to meet the biosafety 
sufficiency requirement in the HHS/CDC select agent regulations.

DATES: Submit written or electronic comments by March 21, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0003, by either of the following methods.
     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.
    Instructions: All submissions received must include the Agency name 
and Docket No. CDC-2022-0003. All relevant comments received will be 
posted without change to https://www.regulations.gov, including any 
personal information provided. Do not send comments by email. CDC does 
not accept comments by email.
    Docket Access: For access to the docket to read background 
documents or comments received, or to download

[[Page 2792]]

an electronic version of the draft policy statement, go to https://www.regulations.gov. Please be aware that comments and other 
submissions from members of the public are made available for public 
viewing without changes.

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.

SUPPLEMENTARY INFORMATION:

A. Legal Authority

    HHS/CDC is issuing this draft policy under the authority of 
sections 201-204 and 221 of Title II of Public Law 107-188, (42 U.S.C. 
262a).

B. Background

    For entities that possess select agents and toxins, the HHS select 
agent and toxin regulations (42 CFR part 73) require that ``biosafety 
and containment procedures must be sufficient to contain the select 
agent or toxin (e.g., physical structure and features of the entity, 
and operational and procedural safeguards)'' (42 CFR 73.12(b)). BSL-4 
and ABSL-4 laboratory facility specifications and operational 
procedures are used for work with dangerous and exotic biological 
agents that could easily be aerosol transmitted within the laboratory, 
cause severe to fatal disease in humans, and typically do not have 
available vaccines or treatments. Therefore, these laboratories must 
implement and maintain the highest level of biosafety precautions for 
containment.
    HHS/CDC reviews how entities that maintain BSL-4 and/or ABSL-4 
laboratories have verified that the design and operational parameters, 
including HVAC, are functioning properly when determining if entities 
have met the sufficiency requirement in section 12(b) of the HHS select 
agent and toxin regulations. In developing a biosafety plan, an 
individual or entity should consider requirements found in the 
Biosafety in Microbiological and Biomedical Laboratories (BMBL) (42 CFR 
73.12(c)). HHS/CDC has developed a draft policy statement for BSL-4 and 
ABSL-4 laboratory verification based on the standards found in the 6th 
edition of the BMBL:
     BSL-4 D16(a): The ventilation system is designed to 
maintain the laboratory at negative pressure to surrounding areas and 
to provide differential pressure or directional airflow as appropriate 
between adjacent areas within the laboratory.
     ABSL-4 D16(a): The supply and exhaust components of the 
ventilation system are designed to maintain the ABSL-4 facility at 
negative pressure to surrounding areas and to provide differential 
pressure or directional airflow as appropriate between adjacent areas 
within the facility.
     BSL-4 D20: The facility design parameters and operational 
procedures are documented. The facility is tested to verify that the 
design and operational parameters have been met prior to operation. 
Facilities are also re-tested annually or after significant 
modification to ensure operational parameters are maintained. 
Verification criteria are modified, as necessary, by operational 
experience.
     ABSL-4 D21: The ABSL-4 facility design parameters and 
operational procedures are documented. The facility is tested to verify 
that the design and operational parameters have been met prior to 
operation. Facilities are also re-tested annually or after significant 
modification to ensure operational parameters are maintained. 
Verification criteria are modified, as necessary, by operational 
experience.
    HHS/CDC is requesting public comment on a draft policy statement on 
BSL-4/ABSL-4 laboratory verifications standards, including HVAC, to aid 
individuals and entities in verifying that these laboratories are 
properly functioning. We are making this policy document available to 
the public in the Supplementary Materials tab of the docket at 
www.regulations.gov for review and comment. All comments, such as items 
related to the appropriate acceptance criteria used to ensure systems 
are functioning as intended and documentation to demonstrate the 
sufficiency requirement has been met, that we receive on or before 
March 21, 2022 will be carefully reviewed and considered.

    Dated: January 13, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-00928 Filed 1-18-22; 8:45 am]
BILLING CODE 4163-18-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.