2018-19381. Proposed Data Collection Submitted for Public Comment and Recommendations

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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Foreign Quarantine Regulations, an information collection related to illness and death reports from airplanes and maritime vessels coming to the United States, illness and death investigations of travelers, and information from importers of certain items specified under 42 CFR 71 subpart F.

DATES:

CDC must receive written comments on or before November 6, 2018.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2018-0078 by any of the following methods:

• Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (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-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

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; and

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.

5. Assess information collection costs.

Proposed Project

Foreign Quarantine Regulations (42 CFR 71) (OMB Control No. 0920-0134) (Exp 5/31/2019)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Section 361 of the Public Health Service Act (PHSA) (42 U.S.C. 264) (Attachment A1) 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. Statute and the existing regulations governing foreign quarantine activities (42 CFR 71) authorize quarantine officers and other personnel to inspect and undertake necessary control measures with respect to conveyances, persons, and shipments of animals and etiologic agents in order to protect the public's health. Other inspection agencies, such as Customs and Border Protection (CBP), assist quarantine officers in public health screening of persons, pets, and other importations of public health importance and make referrals to quarantine station staff when indicated. These practices and procedures ensure protection against the introduction and spread of communicable diseases into and within the United States with a minimum of recordkeeping and reporting procedures, as well as a minimum of interference with trade and travel.

U.S. Quarantine Stations are located at 20 ports of entry and land-border crossings where international travelers arrive. The jurisdiction of each station includes air, maritime, and/or land-border ports of entry. Quarantine Station staff work in partnership with international, federal, state, and local agencies and organizations to fulfill their mission to reduce morbidity and mortality among globally mobile populations. This work is performed to prevent the introduction, transmission, and spread of communicable diseases from foreign countries into the United States or from one State or possession to another State or possession. When an illness suggestive of a communicable disease is reported by conveyance operators or port partners (e.g., Customs and Border Protection), Quarantine Officers respond to carry out an onsite public health assessment and collect data from the individual. This response may occur jointly with port partners. The collection of comprehensive, pertinent public health information during these responses enables Quarantine Officers to make an accurate public health assessment and identify appropriate next steps. For this reason, quarantine station staff need to systematically interview ill travelers and collect relevant health and epidemiologic information.

CDC is making a number of changes and adjustments to this information collection. The changes are as follows:

• CDC is merging this information collection with another, 0920-0821 Illness Response Forms: Airline, Maritime, and Land/Border Crossing.
• CDC is disaggregating the information collection 42 CFR 71.21(a) report of illness or death from ships so that the influenza like illness (ILI) report, which is voluntary, is separate from the required report of ill person or death.
• CDC is removing the information collection pertaining to Partner Government Agency Message Sets, because CDC will not collect information using these tools.
• CDC is removing the acute gastroenteritis reports from ships and removal of medical logs information collection from this information collection request, because CDC's Vessel Sanitation Program will submit a separate information collection request for these tools.

CDC is requesting the following adjustments

• As described above, CDC is requesting a separation of the maritime (ILI) and other maritime illness or death reports. CDC is also requesting an increase in the total number of maritime reports of illness of each type, ILI and others.
• For fall 2018, CDC is considering a policy change related to requirements for rabies vaccination documentation for dogs coming from certain countries; therefore, CDC is providing estimates of burden and respondents related to importation of dogs into the United States.
• Revised estimates under 42 CFR 71.55, 42 CFR 71.32 Dead Bodies—Death certificates.
• Revised estimate of the number of requests for exemptions for importation of African rodents.

Respondents for this information collection request are any pilot in command of an aircraft or maritime vessel operator. With an ill person meeting certain criteria, or death aboard; any individual who is subject to federal quarantine or isolation; any ill traveler who is reported by the airlines, Customs and Border Protection, or EMS to CDC or the local public health authority that meets the definition of ill person; and any importer or filer who seeks to bring certain animals, animal products, or other CDC-regulated item into the United States.

For most of these collections, there are no costs to respondents other than their time. Examinations of imported animals is only required if the pet is ill on arrival or if it has died during transport. These exams are not routine. Depending on the time of arrival, the initial exam fee may be between $100 and $200. Rabies testing on a dog that dies may be between $50 and $100. The expected number of ill or dead dogs arriving into the United States for which CDC may require an examination is estimated at less than 30 per year. CDC is requesting a three-year approval.

Estimated Annualized Burden Hours

Type of respondent	Regulatory provision or form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
Maritime Vessel Operator	42 CFR 71.21(a) report of illness or death from ships—Maritime Conveyance Illness or Death Investigation Form sections 1-4	500	1	5/60	42
Maritime Vessel Operator	42 CFR 71.21(a) report of illness or death from ships—Maritime Conveyance Illness or Death Investigation Form section 5	100	1	2/60	3
Maritime Vessel Operator	Cumulative Influenza/Influenza-Like Illness (ILI)	3,000	1	2/60	100
Pilot in command	42 CFR 71.21(b) Death/Illness reports from aircrafts	1,700	1	2/60	57
Traveler	Airline Travel Illness or Death Investigation Form	1,700	1	5/60	142
Traveler	Land Travel Illness or Death Investigation Form	100	1	5/60	8
Isolated or Quarantined individuals	42 CFR 71.33 Report by persons in isolation or surveillance	11	1	3/60	1
Maritime Vessel Operator	42 CFR 71.35 Report of death/illness during stay in port	5	1	30/60	3
Importer	42 CFR 71.51(c)(1), (d)—Valid Rabies Vaccination Certificates	113,500	1	15/60	28,375
Importer	CDC Form 75.37 Notice To Owners And Importers Of Dogs: Requirement for Dog Confinement	14	1	10/60	2
Importer	42 CFR 71.51(c)(i), (ii), and (iii) exemption criteria for the importation of a dog without a rabies vaccination certificate	958,000	1	15/60	239,500
Importer	42 CFR 71.51(c)(2), (d) Application For Permission To Import A Dog Inadequately Against Rabies	50	1	45/60	38
Importer	42 CFR 71.51(b)(3) Dogs/cats: Record of sickness or deaths	20	1	15/60	5
Importer	42 CFR 71.52(d) Turtle Importation Permits	5	1	30/60	3
Importers	42 CFR 71.55 Dead Bodies, 42 CFR 71.32—Death certificates	20	1	1	20
Importer	42 CFR 71.56 (a)(2) African Rodents—Request for exemption	25	1	1	25
Importer	42 CFR 71.56(a)(iii) Appeal	2	1	1	2
Importer	42 CFR 71.32 Statements or documentation of non-infectiousness	2,000	1	5/60	167
Total					268,493

Jeffrey M. Zirger,

Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.