[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Notices]
[Pages 16861-16862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08145]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-19-1170]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Canine Leptospirosis Surveillance in Puerto 
Rico to the Office of Management and Budget (OMB) for review and 
approval. CDC previously published a ``Proposed Data Collection 
Submitted for Public Comment and Recommendations'' notice on January 
29, 2019 to obtain comments from the public and affected agencies. CDC 
did not receive comments related to the previous notice. This notice 
serves to allow an additional 30 days for public and affected agency 
comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Canine Leptospirosis Surveillance in Puerto Rico (OMB Control No. 
0920-1170, Exp. Date 03/31/2019)--Reinstatement with Change--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), National 
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division 
of High-Consequence Pathogens and Pathology (DHCPP), Bacterial Special 
Pathogens Branch (BSPB), requests three years of OMB approval for a 
reinstatement to the approved ICR ``Canine Leptospirosis Surveillance 
in Puerto Rico.'' Approved methods of information collection will not 
change.
    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 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.
    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 being collected include information about 
the dog's signalment, location of residence, environmental risk 
factors, vaccination history, clinical signs and symptoms,

[[Page 16862]]

laboratory results, and clinical outcome. Approval of this 
reinstatement ICR will allow BSPB to continue to collect these 
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 (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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Veterinarian..........................  Enrollment Questionnaire              26               1            5/60
                                        Log Sheet...............              26              24            1/60
                                        Case Questionnaire......              26              24           10/60
General public........................  Case Questionnaire......             624               1            5/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-08145 Filed 4-22-19; 8:45 am]
BILLING CODE 4163-18-P