[NCEZID] Adverse Health Outcomes Associated with Medical Tourism Surveillance System

Forms and Documents

Document Name	Status
Ill Persons Adverse Outcome Form 2 Form and Instruction	New
Ill Persons Adverse Outcome Form 1 part A Form and Instruction	New
State and Local HD Staff Form 1 part B Form and Instruction	New
Att. G- Privacy Impact Assessment.pdf Supplementary Document	2025-07-23
Att. F - Human Subjects Determination Medical Tourism Surveillance Forms.pdf Supplementary Document	2025-07-23
Att. E - Public Health Department Consent Script.docx Supplementary Document	2025-07-23
Att. B1 - Published 60-Day FRN.pdf Supplementary Document	2025-07-23
Att. A5 - Section 311.pdf Supplementary Document	2025-07-23
Att. A4 - Section 301.pdf Supplementary Document	2025-07-23
Att. A3 - 42 CFR Part 71.pdf Supplementary Document	2025-07-23
Att. A2 - 42 CFR Part 70.pdf Supplementary Document	2025-07-23
Att. A1 - Section 361 of the Public Health Service Act (42 USC 264).pdf Supplementary Document	2025-07-23
Supporting Statement B_Medical Tourism_062325_FINAL.docx Supporting Statement B	2025-07-23
Supporting Statement A_Medical Tourism_070225_final.docx Supporting Statement A	2025-07-23

IC Document Collections

IC ID	Document Title	Status
276634	Ill Persons Adverse Outcome Form 2 Form and Instruction	New
276633	Ill Persons Adverse Outcome Form 1 part A Form and Instruction	New
276632	State and Local HD Staff Form 1 part B Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202507-0920-014
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-24HD
Title: [NCEZID] Adverse Health Outcomes Associated with Medical Tourism Surveillance System
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/23/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,000	0
Time Burden (Hours)	438	0
Cost Burden (Dollars)	0	0

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Abstract: Medical tourism has been associated with adverse health outcomes including infection and death. Tracking these adverse health outcomes have been challenging for numerous reasons. The first step the prevention of medical tourism-related adverse health events is to establish a concise form and eventually a surveillance system that will be used to identify trends and outbreaks with the goal of identifying prevention measures and improving awareness.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 65358	08/09/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 33958	07/18/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Ill Persons Adverse Outcome Form 1 part A	n/a	Form 1 Medical Tourism Case Intake Form
Ill Persons Adverse Outcome Form 2	n/a	Form 2 Medical Tourism Enhanced Form
State and Local HD Staff Form 1 part B	n/a	Form 1 Medical Tourism Case Intake Form

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,000	0	0	2,000	0	0
Annual Time Burden (Hours)	438	0	0	438	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a New Collection.

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Annual Cost to Federal Government: $8,980

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/23/2025

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