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 Department of Health and Human Services Centers for Disease Control and Prevention [60Day-25-1255; Docket No. CDC-2024-0096]
 AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
 ACTION: Notice with comment period.
 SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Emergency Cruise Ship Outbreak Investigations (CSOIs). The Vessel Sanitation Program (VSP) conducts CSOIs in response to acute gastroenteritis (AGE) outbreaks on cruise ships within the VSP's jurisdiction.
 DATES: CDC must receive written comments on or before January 24, 2025.
 ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-0096 by either of the following methods: *Federal eRulemaking Portal:**www.regulations.gov.*
                         Follow the instructions for submitting comments.
                    *Mail:*
                         Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329. *Instructions:*
                         All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to 
                        *www.regulations.gov.* *Please note:*
                         Submit all comments through the Federal eRulemaking portal (
                        *www.regulations.gov*) or by U.S. mail to the address listed above.
 FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; telephone: 404-639-7570; email: 
                        *omb@cdc.gov.*


SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the 
                    **Federal Register**
                     concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. 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; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; 4. 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 submissions of responses; and 5. Assess information collection costs. Proposed Project Emergency Cruise Ship Outbreak Investigations (CSOIs (OMB Control No. 0920-1255, Exp. 3/31/2025)—Extension—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 operational public health programs to minimize the risk of gastrointestinal illness. VSP coordinates and conducts public health inspections, ongoing surveillance of gastrointestinal illness, and outbreak investigations on cruise ships. Under the authority of the Public Health Service Act (42 U.S.C. 264 and 269), VSP is requesting a three-year Extension Information Collection Request (ICR) for an existing Generic Clearance. This ICR will provide for the quick turnaround necessary to conduct emergency Cruise Ship Outbreak Investigations (CSOIs) in response to acute gastroenteritis (AGE) outbreaks. CSOIs are used to determine causative agents and their sources, modes of transmission, or risk factors. 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 03/31/2026) 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 VSP provides environmental health and epidemiologic assistance. VSP considers an outbreak to be ≥3% of reportable AGE cases in either passenger or crew populations. When a cruise ship has an AGE outbreak, VSP often must deploy a response team to meet the ship in port within 24 hours of reaching the outbreak threshold. In some cases, the response team must 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. VSP can ascertain a causative agent, sources of exposure, modes of transmission, and risk factors 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,( print page 92938)
                Participation in ship and onshore 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 United States. This Generic Clearance will cover investigations that meet all 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.
                Data collection is completed in 30 days or less (most CSOIs involve two to five days of data collection). This Generic Clearance excludes each of the following: Investigations related to non-urgent outbreaks or events.
                Investigations conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research (*e.g.,*
                     to contribute to generalizable knowledge).
                Investigations with data collection expected for greater than 30 days. VSP estimates 10 CSOIs annually in response to cruise ship AGE outbreaks. The estimated number of respondents is 1,300 per CSOI, for a total of 13,000 respondents per year. The average time burden is 15 minutes for each respondent. Therefore, the total estimated annual burden in hours is 4,063. There is no cost to respondents other than their time. Estimated Annualized Burden Hours Type of respondents
Form name
Number of
                             respondents
Number of
                             responses per  
                             respondent
Average
                             burden per 
                             response 
                             (in hours)
Total burden
                             (in hours)Cruise ship crew
Self-administered questionnaire
3,000
1
15/60
750Cruise ship crew
Interview
450
1
15/60
113Cruise ship crew
Biospecimen collection
300
1
15/60
75Cruise ship passenger
Self-administered questionnaire
10,000
1
15/60
2,500Cruise ship passenger
Interview
1,500
1
15/60
375Cruise ship passenger
Biospecimen collection
1,000
1
15/60
250Total




4,063
 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.


[FR Doc. 2024-27467 Filed 11-22-24; 8:45 am] BILLING CODE 4163-18-P