Agency Forms Undergoing Paperwork Reduction Act Review

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Disease Control and Prevention</SUBAGY> <DEPDOC>[30Day-25-1255]</DEPDOC> <SUBJECT>Agency Forms Undergoing Paperwork Reduction Act Review</SUBJECT> 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 November 25, 2024, 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 T="03">e.g.,</E> 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 <E T="03">www.reginfo.gov/public/do/PRAMain.</E> 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. <HD SOURCE="HD1">Proposed Project</HD> Emergency Cruise Ship Outbreak Investigations (CSOIs) (OMB Control No. 0920-1255 Exp. 3/31/2025)— Reinstatement—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). <HD SOURCE="HD2">Background and Brief Description</HD> 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 for an existing Generic Clearance Information Collection Request (ICR). 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, Exp. 3/31/2026) 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 ( <E T="03">i.e.,</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 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, • 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 ( <E T="03">i.e.,</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 T="03">e.g.,</E> 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. <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s50,r50,12,12,13"> <TTITLE>Estimated Annualized Burden Hours</TTITLE> <CHED H="1">Type of respondents</CHED> <CHED H="1">Form name</CHED> <ENT>Self-administered questionnaire</ENT> <ENT>3,000</ENT> <ENT>1</ENT> <ENT>15/60</ENT> </ROW> <ROW> <ENT I="01">Cruise ship crew</ENT> <ENT>Interview</ENT> <ENT>Self-administered questionnaire</ENT> <ENT>10,000</ENT> <ENT>1</ENT> <ENT>15/60</ENT> </ROW> <ROW> <ENT I="01">Cruise ship passenger</ENT> <ENT>Interview</ENT> <ENT>1,500</ENT> <ENT>1</ENT> <ENT>15/60</ENT> <NAME>Jeffrey M. Zirger,</NAME> Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. </SIG> <FRDOC>[FR Doc. 2025-10516 Filed 6-10-25; 8:45 am]</FRDOC> </NOTICE>