87 FR 12 pgs. 2792-2794 - Agency Forms Undergoing Paperwork Reduction Act Review
Type: NOTICEVolume: 87Number: 12Pages: 2792 - 2794
Pages: 2792, 2793, 2794Docket number: [30Day-22-1255]
FR document: [FR Doc. 2022-00856 Filed 1-18-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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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.
[top] 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
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 self-administered questionnaire or the interview. Currently, all AGE cases are requested to complete a self-administered 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).
[top] 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.
| 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