E9-1225. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Quarantine Station Illness Response Forms: Airline, Maritime, and Land/Border Crossing—New—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC).

CDC proposes to collect patient-level clinical, epidemiologic, and demographic data from ill travelers and their possible contacts in order to fulfill its regulatory responsibility to prevent the importation of communicable diseases from foreign countries (42 CFR Part 71) and interstate control of communicable diseases in humans (42 CFR Part 70).

Background and Brief Description

Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the United States. The regulations that implement this law, 42 CFR Parts 70 and 71, authorize quarantine officers and other personnel to inspect and undertake necessary control measures with respect to conveyances (e.g., airplanes, cruise ships, trucks, etc.), persons, and shipments of animals and etiologic agents in order to protect the public health. The regulations also require conveyances to immediately report an “ill person” or any death on board to the Quarantine Station prior to arrival in the United States. An “ill person” is defined in statute by:

—Fever (≥100 °F or 38 °C) persisting ≥48 hours

—Fever (≥100 °F or 38 °C) AND rash, glandular swelling, or jaundice

—Diarrhea (≥3 stools in 24 hours or greater than normal amount)

The Severe Acute Respiratory Syndrome (SARS) situation and concern about pandemic influenza and other communicable diseases have prompted CDC Quarantine Stations to recommend that all illnesses be reported prior to arrival.

CDC Quarantine Stations are currently located at 20 international U.S. Ports of Entry. When a suspected illness is reported to the Quarantine Station, officers promptly respond to this report by meeting the incoming conveyance (when possible), collecting information and evaluating the patient(s), and determining whether an ill person can safely be admitted into the U.S. If Quarantine Station staff are unable to meet the conveyance, the crew or medical staff of the conveyance are trained to complete the required documentation and forward it (using a secure system) to the Quarantine Station for review and follow-up.

To perform these tasks in a streamlined manner and ensure that all relevant information is collected in the most efficient and timely manner possible, Quarantine Stations use a number of forms—the Airline Screening and Illness Response Form, the Ship Illness/Death Reporting Form, and the Land/Border Crossing Form—to collect data on passengers with suspected illness and other travelers/crew who may have been exposed to an illness. These forms are also used to respond to a report of a death aboard a conveyance.

The purpose of all of the forms is the same: to collect information that helps quarantine officials detect and respond to potential public health communicable disease threats. All forms collect the following categories of information: demographics and mode of transportation, clinical and medical history, and any other relevant facts (e.g., travel history, traveling companions, etc.). As part of this documentation, quarantine public health officers look for specific signs and symptoms common to the nine quarantinable diseases (Pandemic influenza; SARS; Cholera; Plague; Diphtheria; Infectious Tuberculosis; Smallpox; Yellow fever; and Viral Hemorrhagic Fevers), as well as most communicable diseases in general. These signs and symptoms include fever, difficulty breathing, shortness of breath, cough, diarrhea, jaundice, or signs of a neurological infection. The forms also collect data specific to the traveler's conveyance.

These data are used by Quarantine Stations to make decisions about a passenger's suspected illness as well as its communicability. This in turn enables Quarantine Station staff to assist conveyances in the public health management of passengers and crew.

The estimated total burden on the public, included in the chart below, can vary a great deal depending on the severity of the illness being reported, the number of contacts, the number of follow-up inquiries required, and who is recording the information (e.g., Quarantine Station staff versus the conveyance medical authority). In all cases, Quarantine Stations have implemented practices and procedures that balance the health and safety of the American public against the public's desire for minimal interference with their travel and trade. Whenever possible, Quarantine Station staff obtain information from other documentation (e.g., manifest order, other airline documents) to reduce the amount of the public burden.

There is no cost to respondents other than their time to complete the survey. The total estimated annualized burden for this data collection is 172 hours.

Estimate of Annualized Burden

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Airline Illness or Death Investigation Form	1320	1	6/60
International Maritime Illness or Death Report	200	1	3/60
International Maritime Illness or Death Investigation Form	200	1	7/60
Land Border Illness or Death Investigation Form	60	1	6/60

Dated: January 12, 2009.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.