Canine Leptospirosis Surveillance in Puerto Rico

Forms and Documents

Document Name	Status
Form 0920-1170 Case Questionnaire - Dog Owner Form and Instruction	Modified
Form 0920-1170 Case Questionnaire - Veterinarian Form and Instruction	Modified
Form 0920-1170 Log Sheet Form and Instruction	Modified
Form 0920-1170 Enrollment Questionnaire for Clinics and Shelter Form and Instruction	Modified
Att I - PIA.pdf Supplementary Document	2019-04-23
Att H - Consent form (Kidney) - Spanish.doc Supplementary Document	2019-04-23
Att H - Consent form (Kidney) - English.doc Supplementary Document	2019-04-23
Att G - IACUC Exemption.pdf Supplementary Document	2019-04-23
Att F - Consent Form SPANISH.doc Supplementary Document	2019-04-23
Att F - Consent Form ENGLISH.doc Supplementary Document	2019-04-23
Att B - 60-Day FRN.pdf Supplementary Document	2019-04-23
Att A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2019-04-23
Supporting Statement B final.docx Supporting Statement B	2019-04-23
Supporting Statement A final.docx Supporting Statement A	2019-04-23

IC Document Collections

IC ID	Document Title	Status
225039	Case Questionnaire - Dog Owner Form and Instruction	Modified
225038	Case Questionnaire - Veterinarian Form and Instruction	Modified
225036	Log Sheet Form and Instruction	Modified
225035	Enrollment Questionnaire for Clinics and Shelter Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1170	ICR Reference No: 201903-0920-008
Status: Active	Previous ICR Reference No: 201701-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 16BGH
Title: Canine Leptospirosis Surveillance in Puerto Rico
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/28/2019
	Date Received in OIRA: 04/24/2019
Terms of Clearance: Approved for a period of three years 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	05/31/2022	36 Months From Approved
Responses	1,898	0	0
Time Burden (Hours)	168	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goals of the data collection are to characterize the epidemiology of canine leptospirosis in Puerto Rico, assess the applicability of canine Leptospira vaccines used in the island, and determine potential rodent, livestock, and wildlife reservoirs for leptospirosis. Findings will be used to develop recommendations for the prevention of leptospirosis in dogs, focus human surveillance efforts, and guide further investigations on leptospirosis in Puerto Rico. In the next two years, several leptospirosis surveillance and research activities in humans, animals and the environment will be developed in Puerto Rico by the CDC and other federal and non-government agencies. The approval of this reinstatement and continuation of information collection for canine leptospirosis will contribute to this One Health understanding of leptospirosis in Puerto Rico.

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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:
	84 FR 457	01/29/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 16861	04/23/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Case Questionnaire - Veterinarian	0920-1170, 0920-1170	Case Questionnaire ,   Case Questionnaire Spanish
Case Questionnaire - Dog Owner	0920-1170, 0920-1170	Case Questionnaire ,   Case Questionnaire Spanish
Enrollment Questionnaire for Clinics and Shelter	0920-1170, 0920-1170	Site Enrollment Questionnaire ,   Site Enrollment Quesionnaire Spanish
Log Sheet	0920-1170, 0920-1170	Study Log Sheet ,   Study Log Sheet Spanish

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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	1,898	0	0	0	0	1,898
Annual Time Burden (Hours)	168	0	0	0	0	168
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $75,105

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? 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: 04/24/2019

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