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)

Page Range		70684-70685
FR Document		2016-24667

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 Issue 198 (Thursday, October 13, 2016)

[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]


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

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.

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

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


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

Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices 70685

use based on serovar determination, and with the state health department in clinics and shelters, including
assess rodent, livestock, and wildlife Puerto Rico and with local veterinary information about site capacity,
reservoirs of leptospirosis based on clinics and animal shelters participating vaccination practices, origin of dogs,
infecting serovars found in dogs. in the study. and resources available at the sites.
Findings from this study will aid in the These activities include collecting Data collection tools will be
development of evidence-based, information about dogs that meet the completed onsite. For dogs that have an
targeted interventions for the prevention study case definition for a suspect case owner, information about the dog may
of canine leptospirosis, be used to focus of leptospirosis seen at participating be collected by veterinarians and their
human leptospirosis surveillance veterinary clinics and shelters. The vet staff by interviewing the dog owner.
efforts, and guide future investigations information is collected by veterinarians Otherwise, data collection tools may be
on leptospirosis in humans and animals or their veterinary technical staff by completed by reviewing administrative
in Puerto Rico. interviewing the dog owner and and medical records, as necessary. Data
The information collection for which reviewing medical and administrative will be recorded on paper forms. Study
approval is sought is in accordance with records, as necessary. Basic information coordinators will enter collected data
BSPB’s mission to prevent illness, about the participating sites will also be into an electronic database.
disability, or death caused by bacterial collected for study management, as well BSPB estimates involvement of at
zoonotic diseases through surveillance, as to augment data analysis. least 411 respondents (385 from the
epidemic investigations, epidemiologic Approval of this data collection tool general public and 26 veterinarians and
and laboratory research, training and will allow BSPB to collect information their veterinary technical staff) and
public education. Authorizing from veterinarians, vet staff and dog estimates a total of 168 hours of burden
Legislation comes from Section 301 of owners about the dog’s signalment, risk for research activities each year. The
the Public Health Service Act (42 U.S.C. factors, clinical signs and symptoms, collected information will not impose a
241). Successful execution of BSPB’s laboratory results, treatment, and cost burden on the respondents beyond
public health mission requires data outcome. The study will also collect that associated with their time to
collection activities in collaboration basic site information from participating provide the required data.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)

Veterinarians or vet technical staff ... Enrollment Questionnaire ................. 26 1 5/60 2
Veterinarians or vet technical staff ... Log Sheet ......................................... 26 24 1/60 10
Veterinarians or vet technical staff ... Case Questionnaire ......................... 26 24 15/60 156

Total ........................................... ........................................................... ........................ ........................ ........................ 168

Leroy A. Richardson, Place: CDC, 1600 Clifton Road NE., timeliness, equity, and patient-
Chief, Information Collection Review Office, Tom Harkin Global Communications centeredness of laboratory services;
Office of Scientific Integrity, Office of the Center, Building 19, Auditorium B, revisions to the standards under which
Associate Director for Science, Office of the Atlanta, Georgia 30329. clinical laboratories are regulated; the
Director, Centers for Disease Control and impact of proposed revisions to the
Prevention. Status: Open to the public, limited
only by the space available. The meeting standards on medical and laboratory
[FR Doc. 2016–24667 Filed 10–12–16; 8:45 am] practice; and the modification of the
room accommodates approximately 100
BILLING CODE 4163–18–P
people. This meeting will also be standards and provision of non-
webcast, please see information below. regulatory guidelines to accommodate
technological advances, such as new
DEPARTMENT OF HEALTH AND Purpose: This Committee is charged test methods, the electronic
HUMAN SERVICES with providing scientific and technical transmission of laboratory information,
advice and guidance to the Secretary of and mechanisms to improve the
Centers for Disease Control and Health and Human Services (HHS); the integration of public health and clinical
Prevention Assistant Secretary for Health; the laboratory practices.
Director, Centers for Disease Control Matters for Discussion: The agenda
Clinical Laboratory Improvement and Prevention; the Commissioner, will include agency updates from CDC,
Advisory Committee Meeting Food and Drug Administration (FDA); CMS, and FDA. Presentations and
and the Administrator, Centers for discussions will include a report on the
In accordance with section 10(a)(2) of
Medicare and Medicaid Services (CMS). cytology workload assessment and time
the Federal Advisory Committee Act
The advice and guidance pertain to measure study; an update on CLIAC
(Pub. L. 92–463), the Centers for Disease
general issues related to improvement in recommendations for laboratory
Control and Prevention (CDC)
clinical laboratory quality and biosafety; laboratory preparedness and
announces the following committee
Lhorne on DSK30JT082PROD with NOTICES

laboratory medicine practice and response: The case of Zika; a report from
meeting.
specific questions related to possible the Institute of Medicine (IOM) CLIAC
Times and Dates: revision of the Clinical Laboratory workgroup; and future CLIAC topics.
8:30 a.m.–5 p.m., EDT, November 2, Improvement Amendment (CLIA) Agenda items are subject to change as
2016. standards. Examples include providing priorities dictate.
8:30 a.m.–12 p.m., EDT, November 3, guidance on studies designed to Webcast: The meeting will also be
2016. improve safety, effectiveness, efficiency, webcast. Persons interested in viewing

VerDate Sep<11>2014 14:07 Oct 12, 2016 Jkt 241001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

Document Created: 2016-10-13 00:53:30
Document Modified: 2016-10-13 00:53:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before December 12, 2016.
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]
FR Citation		81 FR 70684

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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