82 FR 4339 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 9 (January 13, 2017)

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4339-4341]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-16BGH]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the

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following: (a) 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; (b) 
Evaluate the accuracy of the agencies estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) Enhance the quality, utility, and 
clarity of the information to be collected; (d) 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 submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Canine Leptospirosis Surveillance in Puerto Rico--Existing 
Collection in use without an OMB Control Number--National Center for 
Emerging and Zoonotic 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 a two-year approval of data 
collection tools used for active surveillance of canine leptospirosis 
in Puerto Rico. Active surveillance will allow 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 is 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 
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.
    Researchers will collect information on dogs that meet the study 
case definition for a suspect case of canine leptospirosis seen at 
participating veterinary clinics and shelters (sites) throughout Puerto 
Rico. Examples of information collected about the dog include the dog's 
signalment, risk factors, clinical signs and symptoms, laboratory 
results, treatment, and clinical outcome. In addition, basic 
information about participating clinics and shelters such as site 
capacity, available resources, vaccination practices, and origin of 
dogs will also be collected to enhance data analysis and aid in study 
management.
    BSPB will not directly collect the information. Veterinary staff 
including veterinarians, assistants, and administrative staff will 
record the information onsite using paper forms by interviewing dog 
owners, and reviewing medical and administrative records, as necessary. 
BSPB and Puerto Rico Department of Health study coordinators will 
maintain the collected information in an electronic database.
    BSPB estimates involvement of 26 veterinarians and their staff, and 
a maximum of 624 responses from owners of enrolled dogs. The enrollment 
questionnaire is completed once in the beginning of the study while the 
log sheet and case questionnaires will be completed for each enrolled 
suspect case. The number of suspect leptospirosis cases can vary from 0 
to 2 cases per month per location based on anecdotal reports from local 
veterinarians. Taking the highest possible response per month, the 
number of responses per form for the log sheet and case questionnaire 
is calculated by multiplying 2 cases/month with 12 months giving a 
total of 24 responses per form for each veterinarian. The total number 
of veterinarians is not expected to exceed 26 (the maximum number of 
participating sites).
    A minimum of 385 responses from dog owners is needed based on 
sample size calculation. However, extra clinics were enrolled to ensure 
that the sample size is met in the event that some clinics withdraw 
from the study or if fewer numbers of suspect leptospirosis cases are 
enrolled at the clinics. Given this, a maximum of 624 responses (26 
clinics x 24 responses/clinic) are calculated for the burden to the 
general public (dog owners). Although it is unlikely the maximum number 
of responses will be reached, the total number of dog owners will not 
exceed 624.
    This information collection will not impose a cost burden on the 
respondents beyond that associated with their time to provide the 
required data.
    The total annualized burden for this information collection is 
estimated to be 168 hours.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Veterinarian..........................  Enrollment Questionnaire              26               1            5/60
                                        Log Sheet...............              26              24            1/60
                                        Case Questionnaire......              26              24           10/60
General Public (Dog owner)............  Case Questionnaire......             624               1            5/60
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-00590 Filed 1-12-17; 8:45 am]
 BILLING CODE 4163-18-P