[Federal Register Volume 84, Number 19 (Tuesday, January 29, 2019)]
[Notices]
[Pages 457-458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-1170; Docket No. CDC-2018-0113]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the data 
collection project titled ``Canine leptospirosis surveillance in Puerto 
Rico.'' This surveillance project aims to characterize the epidemiology 
of canine leptospirosis, assess the applicability of canine Leptospira 
vaccines used in Puerto Rico, and determine potential rodent, 
livestock, and wildlife reservoirs for leptospirosis. Findings from the 
study 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.

DATES: CDC must receive written comments on or before April 1, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0113 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
<a href="/cdn-cgi/l/email-protection#a3cccec1e3c0c7c08dc4ccd5"><span class="__cf_email__" data-cfemail="b3dcded1f3d0d7d09dd4dcc5">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Canine Leptospirosis Surveillance in Puerto Rico (OMB Control No. 
0920-1170 Exp. Date 03/31/2019)--Revision--National Center for Emerging 
and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) Bacterial 
Special Pathogens Branch (BSPB) requests for approval of revisions to 
existing data collection tools used in active surveillance for canine 
leptospirosis in Puerto Rico. The methods for data collection have not 
changed.
    Active surveillance allows for the collection of prospective data 
on acute cases to determine the incidence and distribution of 
leptospirosis in dogs, assess risk factors for infection, characterize 
circulating Leptospira serovars and species, assess applicability of 
vaccines currently in use based on serovar determination, and assess 
rodent, livestock, and wildlife reservoirs of leptospirosis based on 
infecting serovars found in dogs. Findings from this study will aid in 
the development of evidence-based, targeted interventions for the 
prevention of canine leptospirosis, be used to focus human 
leptospirosis surveillance efforts, and guide future investigations on 
leptospirosis in humans and animals in Puerto Rico.
    The information collection for which approval sought is in 
accordance with BSPB's mission to prevent illness, disability, or death 
caused by bacterial zoonotic diseases through surveillance, epidemic 
investigations, epidemiologic and laboratory research, training and

[[Page 458]]

public education. Authorizing Legislation comes from Section 301 of the 
Public Health Service Act (42 U.S.C. 241). Successful execution of 
BSPB's public health mission requires data collection activities in 
collaboration with the state health department in Puerto Rico and with 
local veterinary clinics and animal shelters participating in the 
study.
    These activities include collecting information about dogs that 
meet the study case definition for a suspect case of leptospirosis seen 
at participating veterinary clinics and shelters. Participating 
veterinarians and their veterinary staff collect information by 
interviewing the dog owner (shelters are an exception as dog will not 
have an owner) and reviewing medical and administrative records, as 
necessary. Basic information about the participating sites will also be 
collected for study management and to enhance data analysis.
    Information will be collected using paper forms and provided in 
Spanish. Staff at participating sites find it easier to complete a 
paper copy when abstracting medical record information and interviewing 
owners for information about their dog's risk factors and symptoms. 
Study coordinators will enter collected data into an electronic 
database.
    The types of information collected include information about the 
dog's signalment, location of residence, environmental risk factors, 
vaccination history, clinical signs and symptoms, laboratory results, 
and clinical outcome. Approval of this revision ICR will allow BSPB to 
continue to collect information which can help inform animal public 
health and will help contribute to a One Health understanding of 
leptospirosis in Puerto Rico.
    BSPB estimates involvement of at least 411 respondents (a minimum 
385 from the general public and 26 veterinarians and their veterinary 
staff) and estimates a total of 168 hours of burden for research 
activities each year. The collected information will not impose a cost 
burden on the respondents beyond that associated with their time to 
provide the required data.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Veterinarians or veterinary     Enrollment                    26               1            5/60               2
 staff.                          Questionnaire
                                 (Attachment C).
Veterinarians or veterinary     Log Sheet                     26              24            1/60              10
 staff.                          (Attachment D).
Veterinarians or veterinary     Case                          26              24           10/60             104
 staff.                          Questionnaire
                                 (Attachment E).
Dog owners (general public)...  Case                         624               1            5/60              52
                                 Questionnaire
                                 (Attachment E).
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             168
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-00276 Filed 1-28-19; 8:45 am]
 BILLING CODE 4163-18-P


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