2792 Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices 

an electronic version of the draft policy 

statement, go to http://

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 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 

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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices 2793 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Emergency Cruise Ship Outbreak 

Investigations (CSOIs) (OMB Control 

No. 0920–1255, Exp. 03/30/2022)— 

Revision—National Center for 

Environmental Health (NCEH), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

Established in 1975 as a cooperative 

activity with the cruise ship industry, 

the Centers for Disease Control and 

Prevention (CDC) Vessel Sanitation 

Program (VSP) develops and 

implements comprehensive sanitation 

programs to minimize the risk of 

gastrointestinal diseases, by 

coordinating and conducting 

operational inspections, ongoing 

surveillance of gastrointestinal illness, 

and outbreak investigations on vessels. 

Under the authority of the Public 

Health Service Act (42 U.S.C. Sections 

264 and 269), the VSP is requesting a 

three-year Paperwork Reduction Act 

(PRA) clearance for a revision of an 

existing generic clearance information 

collection request (Generic ICR), titled 

‘‘Emergency Cruise Ship Outbreak 

Investigations (CSOIs)’’ (OMB Control 

Number 0020–1255, expiration date 03/ 

30/2022). This Generic ICR provides the 

quick turn-around necessary to conduct 

emergency CSOIs in response to acute 

gastroenteritis (AGE) outbreaks. CSOIs 

are used to determine the causative 

agents and their sources, modes of 

transmission, or risk factors. The VSP’s 

jurisdiction includes passenger vessels 

carrying 13 or more people sailing from 

foreign ports and within 15 days of 

arriving at a U.S. port. 

VSP uses its syndromic surveillance 

system called the ‘‘Maritime Illness and 

Death Reporting System (MIDRS)’’ 

(OMB Control No. 0920–1260, 

expiration date 04/30/2022) to collect 

aggregate data about the number of 

people onboard ships in VSP’s 

jurisdiction who are experiencing AGE 

symptoms. When the levels of illness 

meet VSP’s alert threshold (i.e., at least 

2% in either the passenger or crew 

populations), a special report is made to 

VSP via MIDRS, and remote 

environmental health and 

epidemiologic assistance is provided. 

VSP considers an outbreak to be 

greater than or equal to 3% of reportable 

AGE cases in either guest or crew 

populations. When outbreaks occur, 

cruise ships submit daily reports of 

cases in the form of AGE logs to VSP. 

When assistance is needed due to AGE 

outbreaks on cruise ships, this often 

requires VSP to deploy a response team 

to meet the ship in port within 24 hours 

of reaching the outbreak threshold, and 

in some cases deploying the response 

team to board the ship before its U.S. 

arrival and sail back to the U.S. port of 

disembarkation to conduct a more 

detailed and comprehensive 

epidemiologic and environmental 

health evaluation of the outbreak. 

Causative agent, sources of exposure, 

modes of transmission, and risk factors 

can be ascertained by gathering the 

following types of information from 

both the affected and (seemingly) 

unaffected populations: 

• Demographic information, 

• Pre-embarkation travel information, 

• Symptoms, including type, onset, 

duration, 

• Contact with people who were sick 

or their body fluids, 

• Participation in ship and shore 

activities, 

• Locations of eating and drinking, 

and 

• Foods and beverages consumed 

both on the ship and on shore. 

Rapid and flexible data collection is 

imperative given the mobile 

environment, the remaining duration of 

the voyage left for investigation, and the 

loss to follow-up if delays allow 

passengers to disembark and leave the 

ship, including those returning to 

locations outside of the U.S. 

This Generic ICR will cover 

investigations that meet all of the 

following criteria: 

• The investigation is urgent in 

nature (i.e., timely data are needed to 

inform rapid public health action to 

prevent or reduce morbidity or 

mortality). 

• The investigation is characterized 

by undetermined agents, undetermined 

sources, undetermined modes of 

transmission, or undetermined risk 

factors. 

• One or more CDC staff (including 

trainees and fellows) will be deployed 

to the field. 

• Most CSOIs involve 2 to 5 days of 

data collection; data collection is 

completed in 30 days or less. 

This Generic ICR excludes each of the 

following: 

• Investigations related to non-urgent 

outbreaks or events. 

• Investigations conducted for the 

primary purpose of program evaluation, 

needs assessment, or research (e.g., to 

contribute to generalizable knowledge). 

• Investigations with data collection 

expected for greater than 30 days. 

The cruise ship industry experience 

in 2020 and 2021 was largely not 

considered in this revision due to the 

disruption caused by the COVID–19 

pandemic. Since the first quarter of 

2020, the COVID–19 pandemic 

disrupted the number of cruise ship 

voyages operating to U.S. ports of call. 

Between March 2020 and October 2021, 

cruise industry operations were 

suspended under a federally issued No 

Sail Order, and then subsequently under 

a Conditional Sailing Order to prevent 

the risk of introducing, transmitting, 

and spreading COVID–19 by cruise ship 

travelers. The VSP conducted the 

following number of remote 

environmental health and 

epidemiologic consultations for 

outbreaks, greater than or equal to 3% 

of reportable AGE cases, by reviewing 

existing MIDRS records: 10 in 2019, 

none in 2020, and one in 2021. No new 

information was collected. Additionally, 

the VSP conducted no CSOIs in the past 

three years. 

Under the most recent MIDRS 

revision, cruise ships report an 

estimated 3,370 AGE cases (575 crew 

and 2,795 passenger) per voyage; 

therefore, VSP uses this same increase 

of 870 over the previously approved 

2,500 AGE cases per voyage for each 

CSOI. Previously, respondents were 

counted as either taking the selfadministered questionnaire or the 

interview. Currently, all AGE cases are 

requested to complete a selfadministered questionnaire. Then a 

15% subset of these AGE cases may be 

interviewed for additional information 

about their illness. Furthermore, a 40% 

subset of AGE cases may be asked for 

biospecimens for laboratory 

confirmation of the causative agent. The 

VSP uses existing laboratory 

biospecimen collection forms approved 

under other CDC ICRs (OMB Control 

No. 0920–0004, exp. date 10/31/2020; 

OMB Control No. 0920–1309, exp. date 

11/30/2023). 

As previously approved, up to 10 

CSOIs may be conducted annually in 

response to cruise ship AGE outbreaks. 

This results in a revised total of 52,234 

responses for 10 CSOIs per year; this is 

an increase of 27,232 responses over the 

previously approved 25,000. The total 

annualized time burden has increased to 

13,060 hours. There is no cost to 

respondents other than their time. 


jspears on DSK121TN23PROD with NOTICES1
2794 Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Cruise ship crew ............................................. Self-administered Questionnaire .................... 5,750 1 15/60 

Interview ......................................................... 862 1 15/60 

Biospecimen Collection .................................. 2,300 1 15/60 

Cruise ship passengers .................................. Self-administered Questionnaire .................... 27,950 1 15/60 

Interview ......................................................... 4,192 1 15/60 

Biospecimen Collection .................................. 11,180 1 15/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–00856 Filed 1–18–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–22–0607] 

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 ‘‘The National 

Violent Death Reporting System 

(NVDRS)’’ 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 August 6, 

2021, to obtain comments from the 

public and affected agencies. CDC 

received one non-substantive comment 

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 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

The National Violent Death Reporting 

System (NVDRS) (OMB Control No. 

0920–0607, Exp. 7/31/2023)— 

Revision—National Center for Injury 

Prevention and Control (NCIPC), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Violence is a public health problem. 

The World Health Organization has 

estimated that 804,000 suicides and 

475,000 homicides occurred in the year 

2012 worldwide. Violence in the United 

States is a particular problem for the 

young; suicide and homicide were 

among the top four leading causes of 

death for Americans 10–34 and 1–34 

years of age in 2015, respectively. In 

2002 Congress approved the first 

appropriation to start the National 

Violent Death Reporting System 

(NVDRS). NVDRS is coordinated and 

funded at the federal level but is 

dependent on separate data collection 

efforts managed by the state health 

department (or their bona fide agent) in 

each state. 

NVDRS, implemented by the Centers 

for Disease Control and Prevention 

(CDC), is a state-based surveillance 

system developed to monitor the 

occurrence of violent deaths (i.e., 

homicide, suicide, undetermined 

deaths, and unintentional firearm 

deaths) in the United States (U.S.) by 

collecting comprehensive, detailed, 

useful, and timely data from multiple 

sources (e.g., death certificates, coroner/ 

medical examiner reports, law 

enforcement reports) into a useable, 

anonymous database. NVDRS is an 

ongoing surveillance system that 

captures annual violent death counts 

and circumstances that precipitate each 

violent incident. Violent deaths are 

defined as any death resulting from the 

intentional use of physical force or 

power (e.g., threats or intimidation) 

against oneself, another person, or 

against a group or community. CDC 

aggregates de-identified data from each 

state into one large national database 

that is analyzed and released in annual 

reports and publications. Descriptive 

analyses such as frequencies and rates 

are employed. A restricted access 

database is available for researchers to 

request access to NVDRS data for 

analysis and a web-based query system 

is open for public use that allows for 

electronic querying of data. NVDRS 

generates public health surveillance 

information at the national, state, and 

local levels that is more detailed, useful, 

and timely. Government, state and local 

communities have used NVDRS data to 

develop and evaluate prevention 

programs and strategies. NVDRS is also 

used to understand magnitude, trends, 

and characteristics of violent death and 

what factors protect people or put them 

at risk for experiencing violence. 

CDC has received OMB approval for 

NVDRS since 2004. In this revision 

request CDC describes plans to (1) 

implement updates to the web-based 

system to improve performance, 

functionality, and accessibility, (2) add 


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