Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) during Investigations of Foodborne Disease Clusters and Outbreaks

Forms and Documents

Document Name	Status
Cyclosporiasis National Hypothesis Generating Questionnaire Form and Instruction	Modified
CNHGQ_OMB Change Request--3.27.18.docx Justification for No Material/Nonsubstantive Change	2018-03-27
Attachment F. Determination of Non-Applicability of Human Subjects Regulations.docx Supplementary Document	2017-04-11
AttachmentB_60-day Federal Register Notice.pdf Supplementary Document	2017-04-10
AttachmentA_CNHGQ_PHSA.PDF Supplementary Document	2017-04-10
Supporting Statement B CNHGQ (002).docx Supporting Statement B	2017-04-10
Supporting Statement A CNHGQ_FINAL 01SEP2017.docx Supporting Statement A	2017-09-13

IC Document Collections

IC ID	Document Title	Status
226341	Cyclosporiasis National Hypothesis Generating Questionnaire Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1198	ICR Reference No: 201803-0920-019
Status: Historical Active	Previous ICR Reference No: 201703-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18XJ
Title: Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) during Investigations of Foodborne Disease Clusters and Outbreaks
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/10/2018
	Date Received in OIRA: 03/28/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	09/30/2020	09/30/2020
Responses	1,000	0	1,000
Time Burden (Hours)	767	0	750
Cost Burden (Dollars)	0	0	0

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Abstract: Foodborne outbreaks of cyclosporiasis have been reported in the United States since the mid-1990s and have been linked to various types of fresh produce. It is likely that more cases (and outbreaks) occurred than were reported; in addition, because of insufficient data, many of the reported cases could not be directly linked to an outbreak or to a particular food vehicle. The Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) was developed to capture information from case-patients that is pertinent to Cyclospora and fresh produce vehicles of infection to aid in the investigation and detection of outbreaks.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	81 FR 93937	12/22/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 16842	04/06/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Cyclosporiasis National Hypothesis Generating Questionnaire	n/a	Cyclosporiasis National Hypothesis Generating Questionnaire - FAX version - rev. Spring 2018

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ICR Summary of Burden

	Total Approved	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	1,000	1,000	0	0	0	0
Annual Time Burden (Hours)	767	750	0	17	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 request is for the addition of 6 new disease-specific data elements and 1 new optional data element, modifications of 23 data elements, and deletion of 7 data elements. The questionnaire was revised to improve clarity, ease of use, and data quality. The changes result in an increase of 1 minute to the interview portion of the instrument (total of 17 annualized burden hours). There is no change to the estimated number of respondents.

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Annual Cost to Federal Government: $7,137

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.     No

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)? Yes

Is this ICR related to the Pandemic Response? Uncollected

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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: 03/28/2018

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