81 FR 70684 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 198 (October 13, 2016)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on data collection project entitled ``Data Collection for Canine Leptospirosis Surveillance in Puerto Rico.'' The goals of the project are 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.

[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70684-70685]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24667]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-16BGH; Docket No. CDC-2016-0097]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on data collection 
project entitled ``Data Collection for Canine Leptospirosis 
Surveillance in Puerto Rico.'' The goals of the project are 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: Written comments must be received on or before December 12, 
2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0097 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted 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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    ``Data Collection for 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 approval of data collection 
tools to be 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

[[Page 70685]]

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. The information is 
collected by veterinarians or their veterinary technical staff by 
interviewing the dog owner and reviewing medical and administrative 
records, as necessary. Basic information about the participating sites 
will also be collected for study management, as well as to augment data 
analysis.
    Approval of this data collection tool will allow BSPB to collect 
information from veterinarians, vet staff and dog owners about the 
dog's signalment, risk factors, clinical signs and symptoms, laboratory 
results, treatment, and outcome. The study will also collect basic site 
information from participating clinics and shelters, including 
information about site capacity, vaccination practices, origin of dogs, 
and resources available at the sites.
    Data collection tools will be completed onsite. For dogs that have 
an owner, information about the dog may be collected by veterinarians 
and their vet staff by interviewing the dog owner. Otherwise, data 
collection tools may be completed by reviewing administrative and 
medical records, as necessary. Data will be recorded on paper forms. 
Study coordinators will enter collected data into an electronic 
database.
    BSPB estimates involvement of at least 411 respondents (385 from 
the general public and 26 veterinarians and their veterinary technical 
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)
----------------------------------------------------------------------------------------------------------------
Veterinarians or vet technical  Enrollment                    26               1            5/60               2
 staff.                          Questionnaire.
Veterinarians or vet technical  Log Sheet.......              26              24            1/60              10
 staff.
Veterinarians or vet technical  Case                          26              24           15/60             156
 staff.                          Questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             168
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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. 2016-24667 Filed 10-12-16; 8:45 am]
 BILLING CODE 4163-18-P