Enhanced surveillance for cases linked to a multistate outbreak of multidrug-resistant Campylobacter infections linked to contact with pet store puppies

Forms and Documents

Document Name	Status
Form 0920-XXXX DOG EXPOSURE QUESTIONNAIRE - State and Local Health Department Staff Form and Instruction	New
Form 0920-XXXX DOG EXPOSURE QUESTIONNAIRE - General Public Form and Instruction	New
Authorizing Legislation.pdf Supplementary Document	2019-04-18
4. Non-research determination.pdf Supplementary Document	2019-04-18
5. Canine Exposure Supplemental Questionnaire.pdf Supplementary Document	2019-04-18
Emergency Review Request Memo - signed.pdf Supplementary Document	2019-04-18
SUPP~0GR.DOC Supporting Statement B	2019-04-18
SUPP~IPY.DOC Supporting Statement A	2019-04-18

IC Document Collections

IC ID	Document Title	Status
235774	DOG EXPOSURE QUESTIONNAIRE - State and Local Health Department Staff Form and Instruction	New
235768	DOG EXPOSURE QUESTIONNAIRE - General Public Form and Instruction	New

ICR Details

OMB Control No: 0920-1261	ICR Reference No: 201904-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19APK
Title: Enhanced surveillance for cases linked to a multistate outbreak of multidrug-resistant Campylobacter infections linked to contact with pet store puppies
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/22/2019
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/18/2019
	Date Received in OIRA: 04/18/2019
Terms of Clearance: OMB is approving this information collection request for a period of 6 months during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	6 Months From Approved
Responses	100	0	0
Time Burden (Hours)	38	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: During 2016 – 2018 CDC, several states, and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service investigated a multistate outbreak of multidrug-resistant Campylobacter infections. Epidemic and laboratory evidence indicated that contact with puppies sold through Petland stores was the major source of this outbreak. A total of 113 people with laboratory-confirmed infections or symptoms consistent with Campylobacter infection were linked to this outbreak. Illnesses were reported from 17 states. CDC proposes an enhanced surveillance project, screening available Campylobacter isolates for the unique multidrug resistance pattern using predictive resistance software. Epidemiologic information would then be collected from newly identified cases to determine if cases were associated with the outbreak.

Emergency Justfication: During 2016–2018 CDC, several states, and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service investigated a multistate outbreak of multidrug-resistant Campylobacter infections. Epidemic and laboratory evidence indicated that contact with puppies sold through Petland stores was the major source of this outbreak. Due to the high numbers of the general public exposed to dogs potentially shedding the multidrug-resistant outbreak strain, development of interventions and disease prevention programs is critical to fully understand the scope of the outbreak associated cases. Given, the extremely multidrug-resistant nature of the outbreak strain and the potentially large number of people exposed to dogs shedding the outbreak strain, CDC requests an emergency clearance.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
DOG EXPOSURE QUESTIONNAIRE - General Public	0920-XXXX	Dog Exposure Questionnaire
DOG EXPOSURE QUESTIONNAIRE - State and Local Health Department Staff	0920-XXXX	Dog Exposure Questionnaire

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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	100	0	0	100	0	0
Annual Time Burden (Hours)	38	0	0	38	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: Submission of 0920-19APK - Enhanced surveillance for cases linked to a multistate outbreak of multidrug-resistant Campylobacter infections linked to contact with pet store puppies is a New Emergency Clearance Request

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Annual Cost to Federal Government: $26,329

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)? No

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: 04/18/2019

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