[NCEZID] DFWED National Hypothesis Generation and Investigation Module

Forms and Documents

Document Name	Status
Form Form 9 NARMS SIRI Questionnaire Module 5 Form and Instruction	New
Form Form 8 NARMS SIRI Questionnaire Module 4 Form and Instruction	New
Form Form 7 NARMS SIRI Questionnaire Module 3 Form and Instruction	New
Form Form 6 NARMS SIRI Questionnaire Module 2 Form and Instruction	New
Form Form 5 NARMS SIRI Questionnaire Module 1 Form and Instruction	New
Form Form 4 Shigella Hypothesis Generating Questionnaire Form and Instruction	New
Form Form 3 Animal Contact Focus Questionnaire Form and Instruction	New
Form Form 2 Foodborne Focus Questionnaire Form and Instruction	New
Form Form 1 National Hypothesis Generating Questionnaire Form and Instruction	New
Attachment 15-Non-research determination forms 5-9.pdf Supplementary Document	2025-01-28
Attachment 14- Non-research determination forms 1-4.pdf Supplementary Document	2025-01-28
Attachment 13-20240625_DCIPHER_SAAS_PIA.pdf Supplementary Document	2025-01-28
Attachment 13a-DCIPHER PIA.pdf Supplementary Document	2025-01-28
Attachment 2-60-DAY FRN Publication.pdf Supplementary Document	2025-01-28
Attachment 1- Authorizing Legislation 42 USC 241.pdf Supplementary Document	2025-01-28
Supporting Statement B DFWED_Clean.docx Supporting Statement B	2025-04-28
Supporting Statement A DFWED_Tracked Clean.docx Supporting Statement A	2025-04-28

IC Document Collections

IC ID	Document Title	Status
273887	NARMS SIRI Questionnaire Module 5 Form and Instruction	New
273886	NARMS SIRI Questionnaire Module 4 Form and Instruction	New
273885	NARMS SIRI Questionnaire Module 3 Form and Instruction	New
273884	NARMS SIRI Questionnaire Module 2 Form and Instruction	New
273883	NARMS SIRI Questionnaire Module 1 Form and Instruction	New
273881	Shigella Hypothesis Generating Questionnaire Form and Instruction	New
273880	Animal Contact Focus Questionnaire Form and Instruction	New
273879	Foodborne Focus Questionnaire Form and Instruction	New
273878	National Hypothesis Generating Questionnaire Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202501-0920-007
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-24EE
Title: [NCEZID] DFWED National Hypothesis Generation and Investigation Module
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: 06/26/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	10,610	0
Time Burden (Hours)	5,850	0
Cost Burden (Dollars)	0	0

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Abstract: The goal of this package is to define a core set of data elements to be used for hypothesis generation as part of investigations of clusters or outbreaks of foodborne, waterborne, and other enteric diseases. These instruments will be used by federal, state, and local public health officials responsible for conducting interviews with reported cases in their jurisdiction in order to systematically assess core exposure elements and risk factors among cases.

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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 24004	04/05/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 24798	06/12/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Animal Contact Focus Questionnaire	Form 3	Animal Contact Focus Questionnaire
Foodborne Focus Questionnaire	Form 2	Foodborne Focus Questionnaire
NARMS SIRI Questionnaire Module 1	Form 5	NARMS SIRI Module 1
NARMS SIRI Questionnaire Module 2	Form 6	NARMS SIRI Module 2
NARMS SIRI Questionnaire Module 3	Form 7	NARMS SIRI Module 3
NARMS SIRI Questionnaire Module 4	Form 8	NARMS SIRI Module 4
NARMS SIRI Questionnaire Module 5	Form 9	NARMS SIRI Module 5
National Hypothesis Generating Questionnaire	Form 1	NHGQ
Shigella Hypothesis Generating Questionnaire	Form 4	Shigella Hypothesis Generating Questionnaire

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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	10,610	0	0	10,610	0	0
Annual Time Burden (Hours)	5,850	0	0	5,850	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: $161,061

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 06/26/2025

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