Justification for Change

Foreign Quarantine Regulations (42 CFR 71)

(OMB Control No. 0920-0134) Expiration date 7/31/2015

Program 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]

Submission Date: March 1, 2013

Circumstances of Change Request for OMB 0920-0134

CDC requests approval for a nonmaterial/non-substantive change to the approved OMB information collection number 0920-0134: Foreign Quarantine Regulations (expiring 7/31/2015). These changes could affect how some ships arriving into the United States will report illnesses or deaths to CDC that occur during a voyage. CDC also requests to add a voluntary aggregate report of cumulative influenza-like illness (ILI) (Attachment A), which is an abbreviated version of the Maritime Illness or Death Form that approved that is approved under OMB 0920-0821(Expiring 8/31/2015) (Attachment B)). All other parts of the information collection approved in 0920-0134 Foreign Quarantine Regulations remain unchanged. No additional burden is expected.

Description of Changes

CDC requests two minor changes:

1) All illnesses and deaths occurring on board cruise ships arriving into the United States are currently reported using an online portal, the Maritime Illness and Death Reporting System (MIDRS), by telephone, or email containing the same data that are emailed or faxed directly to CDC. The MIDRS portal contains a web-form to report non-gastrointestinal disease (GI) and deaths to CDC (Attachment C). The URL for the MIDRS site is: https://wwwn.cdc.gov/midrs/GILogin.aspx.

Cargo ships do not have access to the MIDRS portal. Illnesses (including GI illnesses) and deaths occurring onboard cargo ships are currently reported by telephone, email or fax

Due to operational program changes, technical difficulties with the MIDRS portal, and redundant data entry resulting in increased burden to the public, CDC will no longer accept the initial reporting of non-GI illnesses and deaths via MIDRS. This change will allow CDC to harmonize data collection from all maritime partners, i.e. both cruise and cargo ships, for better analysis and response to public health risks.

Non-GI illnesses and deaths occurring aboard cruise ships will be reported using sections 1-3 of the fillable pdf titled “Maritime Illness and Death Investigation Form,” that was previously approved under OMB 0920-0821: Quarantine Station Illness Response Forms: Airline, Maritime, and Land/Border Crossing (Expiring 8/31/2015) (Attachment B). Sections 1-3 of this form are almost identical to the non-GI illness web-form (Attachment C) currently available in MIDRS. This change will result in a reduction of duplicative forms, thereby reducing the burden on the public.

The primary website where cruise and cargo ships can download the fillable pdf is: http://www.cdc.gov/quarantine/maritime-activity.html. The form will also be available here: http://wwwnc.cdc.gov/travel/page/travel-industry-cruise.htm

Cargo ships will have the option of reporting to CDC using the electronic fillable pdf form, as well as phone, fax, or email.

In summation, the proposed change will no longer allow cruise ships to report non-GI illness or death to CDC via the web-form available in MIDRS. Cruise and cargo ships will instead provide information to CDC on sections 1-3 of the Maritime Illness and Death Investigation Form that is available as a fillable pdf.

2) CDC requests the addition of a Cumulative ILI reporting form (Attachment B), which contains the same data fields as sections 1-2 of the Maritime Illness and Death Investigation Form, with the exception of:

• the addition of two data fields that request the total number of passengers and crew onboard and total ILI cases among passengers and crew during the voyage, and

• the removal of data fields requesting the type of notification, type of traveler and conveyance type.

This form is voluntary and does not include personally identifiable information. CDC proposes the use of this form to reduce the reporting burden to ships and streamline information collection. Instead of submitting several individual reports for each case of influenza-like illness using the Maritime Illness and Death Investigation form, respondents will be able to send one Cumulative ILI report containing multiple cases of ILI. Cumulative case numbers and denominator data (total number of persons onboard) will allow calculation of illness rates to identify possible outbreaks and guide recommendations to the ship. No additional burden is anticipated.

Burden

The annualized burden hours and cost to reporting jurisdictions to submit this data to CDC will not change significantly, if at all, from the original estimates in the “Estimates of Annualized Burden Hours and Costs” section in A.12 of the supporting documentation for OMB 0920-0134. The change to the annualized burden hours and cost is minimal because the reporting methods used for collecting these data elements will be the same.

Estimates of Annualized Burden Hours 0920-0134 Foreign Quarantine (no change)

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in hours)	Total Burden hours
Maritime conveyance operators	71.21(a) Radio Report of death/illness - illness reports from ships (fillable PDF (individual case and cumulative report), phone, transcribed email)	2000	1	2/60	67
Aircraft commander or operators	71.21 (b) Death/Illness reports from aircrafts (verbal, no form)	1700	1	2/60	57
Maritime conveyance operators	71.21 (c ) Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS)	17000	1	3/60	850
Maritime conveyance operators	71.21 (c) Recordkeeping -Medical logs (no form, captains provide logs)	17000	1	3/60	850
Isolated or Quarantined individuals	71.33(c) Report by persons in isolation or surveillance (verbal, no form)	11	1	3/60	1
Maritime conveyance operators	71.35 Report of death/illness during stay in port (verbal, no form)	5	1	30/60	3
Aircraft commander or operators	Locator Form used in an outbreak of public health significance	2,700,000	1	5/60	225,000
Aircraft commander or operators	Locator Form used for reporting of an ill passenger(s)	800	1	5/60	67
Importer	71.51(b)(2) Dogs/cats: Certification of Confinement, Vaccination (CDC form 75.37)	2000	1	10/60	333
Importer	71.51(b) (3) Dogs/cats: Record of sickness or deaths (no form, record review)	20	1	15/60	5
Importer	71.52(d) Turtle Importation Permits (no form, just written request)	5	1	30/60	3
Importers	71.55 Dead bodies (death certificates submitted)	5	1	1	5
Importer	71.56 (a)(2) African Rodents -Request for exemption ( no form, written request only)	20	1	1	20
Importer	71.56(a)(iii) Appeal (no form, written request only)	2	1	1	2
	Total	2,740,568			227,263

Estimates of Annualized Cost Burden 0920-0134 Foreign Quarantine (no change)

Types of Respondents	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Maritime conveyance operators	71.21(a) Radio Report of death/illness - illness reports from ships	67	$44.56	$2,986
Aircraft commander or operators	71.21 (b) Death/Illness reports from aircrafts	57	$44.56	$2,540
Maritime conveyance operators	71.21 (c ) Gastrointestinal Illnesses reports 24 and 4 hours before arrival (VSP)	850	$44.56	$37,876
Maritime conveyance operators	71.21 (c) Recordkeeping - Medical logs	850	$44.56	$37,876
Isolated or Quarantined individuals	71.33(c) Report by persons in isolation or surveillance	1	$21.35	$21
Maritime conveyance operators	71.35 Report of death/illness during stay in port	3	$44.56	$134
Aircraft commander or operators	Locator Form used in an outbreak of public health significance	225,000	$32.83	$7,386,750
Aircraft commander or operators	Locator Form used for reporting of an ill passenger(s)	67	$32.83	$2,200
Importer	71.51(b)(2) Dogs/cats: Certification of Confinement, Vaccination	333	$21.35	$7,110
Importer	71.51(b) (3) Dogs/cats: Record of sickness or deaths	5	$21.35	$107
Importer	71.52(d) Turtle Importation Permits	3	$21.35	$64
Importers	71.55 Dead bodies	5	$21.35	$107
Importer	71.56 (a)(2) African Rodents -Request for exemption	20	$21.35	$427
Importer	71.56(a)(iii) and (c) Appeal	2	$21.35	$43
	Total : with a disease outbreak, extensive use of PLF	227,263		$7,478,241

Privacy Impact Assessment

This change in how ships report non-GI illnesses to CDC has no effect on the Privacy Impact Assessment provided in the supporting statement for the information collection approved under OMB 0920-0134. All of the procedural and physical safeguards and access requirements remain the same.

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