0920-0488_2012__Supporting_Statement 121412

Restrictions on Interstate Travel of Persons

(42 CFR Part 70)

(OMB Control No. 0920-0488)

Request for Revision

December 12, 2012

Contact:

Amy McMillen

Office of Policy and Planning

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E., MS C12

Atlanta, Georgia 30333

Phone: (404) 639-1045

Email: [email protected]

1. Justification………………………………………………………………………1

A.1. Circumstances Making the Collection of Information Necessary……………….1

A.2. Purpose and Use of Information Collection……………………………………...5

A.3. Use of Improved Information Technology and Burden Reduction……………...7

A.4. Efforts to Identify Duplication and Use of Similar Information…………………7

A.5. Impact on Small Businesses or Other Entities…………………………………...7

A.6. Consequences of Collecting the Information Less Frequently…………………..7

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5……………7

A.8. Comments in Response to the Federal Register Notice and Efforts to

Consult Outside the Agency……………………………………………………..7

A.9. Explanation of Any Payment or Gift to Respondents……………………………8

A.10. Assurance of Confidentiality Provided to Respondents………………………..8

A.11. Justification for Sensitive Questions……………………………………………9

A.12. Estimates of Annualized Burden Hours and Costs……………………………..9

A.13. Estimates of Other Total Annual Cost Burden to Respondents

or Record Keepers……………………………………………………………..13

A.14. Annualized Cost to the Government…………………………………………..13

A.15. Explanation for Program Changes or Adjustments……………………………13

A.16. Plans for Tabulation and Publication and Project Time Schedule…………….14

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate………………...14

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions……...14

Restriction on Travel of Persons

(42 CFR Part 70)

(OMB Control No. 0920-0488)

A. Justification

1. Circumstances Making the Collection of Information Necessary

This is a request for a revision of the currently approved Information Collection Request (ICR), OMB0920-0488, expiring March 31, 2013. This ICR includes a program change that involves splitting the current form into two separate forms based on the type of respondent; an ill traveler, or the master of a vessel or conveyance engaged in interstate travel. The method of reporting from masters of vessels is also modified to include radio or other telecommunications for routine reporting of illness during domestic travel, and paper-based reporting when requested by CDC during a public health emergency. An additional 100 hours is requested due to the separation of routine from emergency reporting on the part of the masters of vessels or conveyances.

This ICR also includes an update to wages based on 2011 data from the Bureau of Labor Statistics for respondent burden.

Section 361 of the Public Health Service Act (42 USC 264) (Attachment 1a) authorizes the Secretary of the Department 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, or from one State or possession into any other State or possession. Regulations pertaining to preventing the importation and spread of communicable diseases from foreign countries (42 CFR Part 71) are administered by the Centers for Disease Control and Prevention (CDC). Regulations pertaining to interstate control of communicable diseases (42 CFR Part 70) (Attachment 1b) are also administered by CDC.

Regulations found at 42 CFR Part 70 require that a person who is in the communicable period of cholera, plague, smallpox, typhus, or yellow fever or who, having been exposed to any such disease, is in the incubation period thereof, request a permit from the Surgeon General or his/her designated representative to travel from one State to another, if that State has a requirement for such a permit. The regulations further require that the master of a vessel or a person in charge of a conveyance engaged in interstate traffic, on which a suspected case of communicable disease develops shall notify the local health authority at the next port of call, station, or stop, and take such measures to prevent the spread of the disease as the local health authority directs.

1.1 Privacy Impact Assessment

Overview of the Data Collection System: The data collection system for this information collection request consists of two separate forms: one for requirements under 42 CFR 70.3, and 42 CFR 70.5 (Ill Person Travel Permit, Attachment 3), and one for requirements 42 CFR 70.4 (Master of Vessel or Conveyance Illness Report, Attachment 4). The forms will be completed by either the traveler or applicant (requesting a permit to travel) or master of a vessel or person in charge of a conveyance (reporting an ill passenger). The Ill Person Travel Permit form should include the accompanying physician’s diagnosis. Both forms will be sent to CDC in the most expeditious manner possible.

Items of Information to be Collected

This information collection involves requesting information in identifiable form, including name, date of birth, Social Security Number (SSN), mailing address, phone numbers, medical information, and email address. CDC is also requesting from masters of vessels or operators of conveyances the location to which reports of illness are made, conveyance identification information, the origin and destination of a conveyance’s travel, observed symptoms during travel, and the number of individuals with observed symptoms.

2. Purpose and Use of Information Collection

Control of disease transmission within the United States is largely considered to be the province of State and local health authorities, with Federal assistance being sought by those authorities on a cooperative basis, without application of Federal regulations. The regulations at 42 CFR Part 70 were developed to facilitate Federal action in the event of large outbreaks requiring a coordinated effort involving several States, or in the event in inadequate local control. While it is not known whether, or to what extent, situations may arise in which these regulations would be invoked, contingency planning for domestic emergency preparedness is not uncommon. If a domestic emergency occurs, the reporting and record keeping requirements contained in the regulations will be used by CDC to carry out quarantine responsibilities as required by law, specifically, to prevent the spread of communicable diseases from one State or possession into any other State or possession.

The data collected under 70.4 is also a critical part of routine CDC operations involving the collection of reports of illnesses that occur aboard domestic flights or maritime voyages within the U.S. However, CDC will only require use of the paper form for reports under 70.4 (Attachment 4) in emergency circumstances as a directed by CDC. For routine reports of illness aboard domestic voyages, masters of vessels or airplane captains will continue to report electronically, by phone, or radio. The burden hours for routine reporting are accounted for separately from those hours requested for public health emergencies.

The information outlined on the two forms will only be collected when it is required by CDC, and is the minimum necessary to meet statutory obligations. Two forms are proposed for use in collecting essential information (Attachments 3 and 4).

42 CFR Part 70 has 3 sections with reporting requirements:

• 42 CFR 70.3: Personal identifying information and medical information pertinent to obtaining a permit to travel between States and/or possessions. This information would be submitted to the Health Officer of the State, possession, or locality of destination (if such permit is required under the law applicable to the place of destination) and to CDC. (Attachment 3)

• 42 CFR 70.4: Personal identifying information and information about symptoms exhibited by a person who becomes ill while engaged in travel between states and/or possessions. This information would be submitted to the health authority at the next port of call, station, or stop and to CDC. (Attachment 4)

• 42 CFR 70.5: Personal identifying information and medical information pertinent to obtaining a permit for travel between States and/or possessions of any person who is the communicable period of cholera, plague, smallpox, typhus, or yellow fever, or who, having been exposed to any such disease, is in the incubation period thereof. This information would be submitted to the Surgeon General or the Surgeon General’s designated representative. (Attachment 3)

This information is not being collected for research purposes.

2.1 Privacy Impact Assessment Information

This data is being collected to fulfill regulatory requirements under 42 CFR Part 70. The data will be used by CDC to prevent the spread of communicable disease from one State or possession to another State or possession. Use of the information collection is described on the form. Data will become part of CDC Privacy Act System 09-20-0171, “Quarantine and Traveler-Related Activities, Including Records for Contact Tracing, Investigation, and Notification under 42 CFR Parts 70 and 71”, and may be disclosed to appropriate State or local public health departments and cooperating medical authorities to deal with conditions of public health significance; to private contractors assisting CDC in analyzing and reviewing records; to investigators under certain limited circumstances to conduct further investigations; to organizations to carry out audits and reviews on behalf of HHS; to the Department of Justice for litigation purposes; and to a congressional office assisting individuals in obtaining their records. An accounting of the disclosures that have been made by CDC will be made available to the subject individual upon request. Except for these and other permissible disclosures expressly authorized by the Privacy Act, no other disclosure may be made without the subject individual’s written consent.

Highly sensitive information is being collected and would affect a respondent’s privacy if there were a breach of confidentiality. However, stringent safeguards are in place to ensure a respondent’s privacy including authorized users, physical safeguards, and procedural safeguards.

Authorized users: A database security package is implemented on CDC’s computer systems to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of CDC or its contractors as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected.

Physical safeguards: Access to the CDC facility where the mainframe computer is located is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric code) system. Access to the data entry area is also controlled by a cardkey system. Guard service in buildings provides personnel screening of visitors. The computer room is protected by an automatic sprinkler system, numerous automatic sensors are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. Computer files are backed up on a routine basis. Hard copy records are stored in locked cabinets at CDC headquarters and CDC Quarantine Stations which are located in a secure area of the airport.

Procedural safeguards: Protections for computerized records includes programmed verification of valid user identification code and password prior to logging on to the system, mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily back-up procedures, and secure off-site storage is available. To avoid inadvertent data disclosure, measures are taken to ensure that all data are removed from electronic medical containing Privacy Act information. Finally, CDC and contractor employees who maintain records are instructed to check with the system manager prior to making disclosures of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel. Privacy Act provisions are included in contracts and the CDC Project Director, contract officers and project officers oversee compliance with these requirements.

3. Use of Improved Information Technology and Burden Reduction

Reporting requirements imposed by the regulations have been reduced and streamlined by reliance upon State and local health departments to manage most situations occurring within their jurisdictions. If submission of information under these regulations becomes necessary, all information may be submitted in the most expeditious manner practical. At this time, there are no plans for electronic data submission.

4. Efforts to Identify Duplication and Use of Similar Information

These regulations have been in existence for many years, either under the administration of the Food and Drug Administration or the Centers for Disease Control and Prevention (since 2000). There is no duplication of data.

5. Impact on Small Businesses or Other Small Entities

Small transportation businesses (e.g., independent bus lines, limousine, and taxicab companies, ferry lines, tour operators, air taxi operators, etc.) may be affected by this data collection. The information requested has been kept to the absolute minimum in order to minimize the public burden.

6. Consequences of Collecting the Information Less Frequently

Information will only be collected when it is essential to protect the public’s health. Further reduction of required reporting would prevent CDC from meeting its legislative mandate, thereby endangering the public’s health.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. A 60 day Federal Register Notice (Attachment 2) was published in the Federal Register on Wednesday, October 31, 2012; Vol. 77, No. 211. No public comments were received.

B. There have been no consultations with persons outside of CDC on the information collection tool itself. However, CDC regularly discusses procedures with airlines for reporting illness and death on board flights that operate within the United States. Recently, CDC has been in discussions with air industry regarding the alignment of illness and death reporting for both domestic and international flights. Airlines will soon have the same protocols for reporting illness and death aboard both domestic and international flights. This includes guidance as to the types of physical conditions CDC requires and recommends be reported to public health authorities. CDC’s goal is to ensure that illness and death is reported to public health authorities as soon as is practicable without unduly affecting airline operations.

9. Explanation of Any Payment or Gift to Respondents

No payment is made to any respondent.

10. Assurance of Confidentiality Provided to Respondents

This information collection request has been reviewed by the National Center for Emerging and Zoonotic Diseases (NCEZID). NCEZID has determined that the Privacy Act does apply to this information collection request. The applicable System of Records Notice is 09-20-0171.

Information submitted will be entered into a computer system for analysis and later retrieval if necessary. Data containing personal identifiers and source documents will be retained until the event prompting the collection of data has concluded. Data not containing personal identifiers will be retained indefinitely for statistical and historical documentation purposes. Electronic media will be protected by adequate physical, administrative, and procedural safeguards to ensure the security of the data. Access will be restricted to agency employees with a bona fide “need to know” in order to carry out the duties of their positions or to accomplish the purposes for which the data were collected. When information is deleted, a special “certified” process will be used to completely overwrite tapes on the mainframe or overwriting (not merely deleting) microcomputer files. Source documents, printouts and thumb drives will be safeguarded by storing them in locked cabinets in locked offices when not in use.

10.1 Privacy Impact Assessment Information

A. This data collection is subject to the Privacy Act. The applicable Systems of Records Notice is 09-20-0171.

B. Electronic media will be protected by adequate physical, administrative, and procedural safeguards to ensure the security of the data. Access will be restricted to agency employees with a bona fide “need to know” in order to carry out the duties of their positions or to accomplish the purposes for which the data were collected. When information is deleted, a special “certified” process will be used to completely overwrite tapes on the mainframe or overwriting (not merely deleting) microcomputer files. Source documents, printouts and thumb drives will be safeguarded by storing them in locked cabinets in locked offices when not in use.

C. Respondent’s indicate their consent by their signature on the form. Use of the information collection is described on the form. The data will be used to track disease patterns. Data will become part of CDC Privacy Act System 09-20-0171, “Quarantine and Traveler-Related Activities, Including Records for Contact Tracing, Investigation, and Notification under 42 CFR Parts 70 and 71”, and may be disclosed to appropriate State or local public health departments and cooperating medical authorities to deal with conditions of public health significance; to private contractors assisting CDC in analyzing and reviewing records; to investigators under certain limited circumstances to conduct further investigations; to organizations to carry out audits and reviews on behalf of HHS; to the Department of Justice for litigation purposes; and to a congressional office assisting individuals in obtaining their records. An accounting of the disclosures that have been made by CDC will be made available to the subject individual upon request. Except for these and other permissible disclosures expressly authorized by the Privacy Act, no other disclosure may be made without the subject individual’s written consent.

D. The response to the data collection is mandatory if the traveler wishes to obtain a special permit to travel. The permit will not be issued without a completed form. The master of a vessel/conveyance is required by regulation to inform the local health authority.

11. Justification for Sensitive Questions

The form used in these data collections requests the traveler’s social security number (SSN), date of birth, mailing address, phone number, and email address. If a domestic emergency occurs, the reporting and record keeping requirements contained in the regulations will be used by CDC to carry out quarantine responsibilities as required by law, specifically, to prevent the spread of communicable diseases from one State or possession into any other State or possession. The purpose of obtaining this unique identifier is to enable CDC to accurately identify and track the traveler in the event of a public health emergency. The information would only be collected when it is required, and is the minimum necessary to meet statutory obligations. Completion of these fields is mandatory on the form.

12. Estimates of Annualized Burden Hours and Costs

A. Because of the uncertainty about whether a situation will ever arise precipitating CDC’s enforcement of these regulations, the following data collection burden estimate was prepared using the article Smallpox: An Attack Scenario, Tara O’Toole; Emerging Infectious Diseases, Vol. 5, No. 4, Jul-Aug 1999 (Attachment 5). This article describes the aftermath of a hypothetical bioterrorist attach using smallpox virus. Of the potentially 15,000 persons infected with smallpox, the data collection assumes that one-fourth of these would apply for a permit to move from one State to another while in the communicable period of or having been exposed to smallpox, under the requirements set forth in 42 CFR 70.5. During such an event, it is assumed that an additional 2,000 persons not infected with smallpox may, as a precautionary measure, be required to obtain a State permit in order to move from one State to another, and that 8 States would be involved, under the requirements set forth in 42 CFR 70.3. Further, it is assumed that during such an event, the master of a vessel or person in charge of a conveyance may be required to notify a local health authority of as many as 1,500 suspected cases of communicable disease developed and/or observed during transit, involving as many as 20 State or local jurisdictions, under the requirements set forth in 42 CFR 70.4.

In such a scenario, it would be likely that CDC would obtain for follow-up and analysis any information it requires to be delivered to a State or local health authority. Accordingly, an additional burden may be imposed upon this authority to copy and transmit that information. We assume that the burden would apply to 100% of the information submitted under both 42 CFR 70.3 and 42 CFR 70.4.

For non-emergency reports of illness aboard domestic flights, the burden outlined below under 42 CFR 70.4 for illness reports by masters of a vessel of person in charge of a conveyance are accounted for separately from those hours requested for public health emergencies. CDC requests sufficient hours to cover an estimated 200 domestic reports of illness a year, totaling 50 hours. CDC also assumes that the same amount of time will be required for state health authorities to copy and transmit this information, but does not limit this to a specific number of jurisdictions.

Estimated Annualized Burden Hours

Type of Respondent	Form Name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Traveler	42 CFR 70.3 Application to the State of destination for a permit	2,000	1	15/60	500
Attending physician	42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority	2,000	1	15/60	500
State health authority	42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority	8	250	6/60	200
Master of a vessel or person in charge of a conveyance	42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel (Paper Form if requested by CDC during public health emergency)	1,500	1	15/60	375
State health authority	42 CFR 70.4 Copy of material submitted to state or local health authority under this provision (Paper Form if requested by CDC during public health emergency)	20	75	6/60	150
Master of a vessel or person in charge of a conveyance	42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel (Radio or other telecommunication for routine reporting)	200	1	15/60	50
State health authority	42 CFR 70.4 Copy of material submitted to state or local health authority under this provision (Radio or other telecommunication for routine reporting)	200	1	15/60	50
Traveler	42 CFR 70.5 Application for a permit to move from State to State while in the communicable period	3,750	1	15/60	938
Attending physician	42 CFR 70.5 Application for a permit to move from State to State while in the communicable period	3,750	1	15/60	938
Total					3,701

B. The cost to respondents was calculated using the May 2011 National Occupational Employment and Wage Estimates United States data from the Bureau of Labor Statistics (http://www.bls.gov/oes/current/oes_nat.htm).

Estimated Annualized Burden Costs

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
Traveler	42 CFR 70.3 Application to the State of destination for a permit	500	$21.74	$10,870
Attending physician	42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority	500	$90.97	$45,485
State/local health authority	42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority	200	$48.09	$9,618
Master of vessel or person in charge of conveyance	42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel (Paper Form)	375	$40.15	$15,056
State/local health authority	42 CFR 70.4 Copy of material submitted to state or local health authority under this provision (Paper Form)	150	$48.09	$7,214
Master of vessel or person in charge of conveyance	42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel (Electronic)	50	$40.15	$2,008
State/local health authority	42 CFR 70.4 Copy of material submitted to state or local health authority under this provision (Electronic)	50	$48.09	$2,405
Traveler	42 CFR 70.5 Application for a permit to move from State to State while in the communicable period	938	$21.74	$20,392
Attending physician	42 CFR 70.5 Application for a permit to move from State to State while in the communicable period	938	$90.97	$85,330
	Total			$198,378

• For Master in change of a vessel, we constructed a weighted average estimating that 50% of travelers will use air transportation (53-2011 Airline Pilots, Copilots, and Flight Engineers = $56.76, estimated by dividing BLS yearly salary by 2080 hrs); 10% will use a water vessel (53-5021 Captains, Mates, and Pilots of Water Vessels = $34.50); 10% will use rail transportation (53-4011 Locomotive Engineers = $25.45); 20% will use bus transportation (53-3021 Bus Drivers, Transit and Intercity = $18.00); and 10% will use private transportation (00-0000 All Occupations = $21.74)

• State/local health authority, 19-1041 Epidemiologists at the 90% is used to account for the likely high rank of the health authority used. Epidemiologist is a likely category of public health professional to use form (attachment 4). This hour wage is $32.83. (19-1041 Epidemiologists: http://www.bls.gov/oes/current/oes191041.htm)

• For the general public, 00-0000 All Occupations is used. The hourly wage for this occupational category is $21.74. (00-0000 All Occupations: http://www.bls.gov/oes/current/oes_nat.htm#00-0000)

• For the Attending Physician, we used 29-1063 Internists, General, average wage = $90.97

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

None

14. Annualized Cost to the Government

Each report results in action taken by CDC Quarantine Station staff to respond to the report. Their action is determined by the statutory and regulatory requirements for each report. The action taken varies, depending on the specifics of the report, from filing and/or data entry to conducting an investigation involving multiple staff. CDC estimates the yearly cost for this information collection request to be $100,000.

15. Explanation of Program Changes or Adjustments

This ICR is a request for a revision that involves splitting the current form into two separate forms based on the type of respondent: an ill traveler, or the master of a vessel or conveyance engaged in interstate travel. This was done to avoid confusion on the part of the respondents as to which section of the form requires completion. An additional 100 hours is requested due to the separation of routine from emergency reporting on the part of the masters of vessels or conveyances.

For ill travelers, the form will include those data elements required to fulfill regulatory requirements under 70.3 All Communicable Diseases and 70.5 Certain Communicable Diseases; special requirements. The information requested for these sections is not changing.

For masters of vessels or persons in charge of conveyances, the report form makes the following changes:

• Removes the fields at the top of the form for Date of Birth, Social Security number, Phone number, Address, Physician’s Name, Physician’s Address.

• Adds two additional destinations for reports of illness, CDC Quarantine Stations and CDC’s Emergency Operations Center. The form includes a check box to indicate how the report was made.

• Modifies “Vessel or Conveyance” field to “Vessel or Conveyance Identification”.

• Adds fields for traveler name (passenger or crew), seat number or work area, and approximate age. This is to facilitate potential public health measures when the flight arrives.

• Includes fields for “Departure from” and “Arrival at”, as well as a “Date” field.

• Includes a field for “Persons on board observed to be suffering from physical conditions other than airsickness/motion sickness or the effects of accidents, as well as those cases of illness disembarked during the travel period”.

• Replace “Suspected case of a communicable disease: observed symptoms” to “Any physical condition on board which may lead to the spread of disease”

The changes to the master of vessel/person in charge of a conveyance form were made to allow the form to stand alone as a reporting tool for illnesses occurring during travel. Data fields for PII are no longer needed. The terminology is also more reflective of verbiage used by the program in recording this data.

CDC is also changing how these domestic reports of illness can be submitted. For routine reporting, the use of radio or telecommunications to transmit the required information will suffice for domestic reports of illness. Paper-based submissions may be requested from masters of vessels or conveyance operators by CDC during a public health emergency.

This ICR also includes an update to wages based on 2011 data from the Bureau of Labor Statistics for respondent burden.

16. Plans for Tabulation and Publication and Project Time Schedule

Data are not collected for statistical purposes, but only to meet the legislative mandate as implemented in 42 CFR Part 70.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

Not applicable

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

Attachment 1a: Section 361 of the Public Health Service Act (42 USC 264)

Attachment 1b: 42 CFR Part 70

Attachment 2: 60 day Federal Register Notice

Attachment 3: Ill Person Travel Permit

Attachment 4: Master of Vessel or Conveyance Illness Report

Attachment 5: Smallpox: An Attack Scenario, Tara O’Toole; Emerging Infectious

Diseases, Vol. 5, No. 4, Jul-Aug 1999

Attachment 6: IRB Determination Letter

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