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70684

Federal Register / Vol. 81, No. 198 / Thursday, October 13, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents

Form name

Individuals ...............................

Standardized National Hypothesis Generating Questionnaire
(Core Elements).

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. 2016–24668 Filed 10–12–16; 8:45 am]
BILLING CODE 4163–18–P

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

AGENCY:

ACTION:

Notice with comment period.

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.

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SUMMARY:

Written comments must be
received on or before December 12,
2016.

DATES:

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Number of
respondents

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.

ADDRESSES:

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.

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
FOR FURTHER INFORMATION CONTACT:

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Number of
responses per
respondent

4,000

Average
burden per
response
(in hours)

1

45/60

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

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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Veterinarians or vet technical staff ...
Veterinarians or vet technical staff ...
Veterinarians or vet technical staff ...

Enrollment Questionnaire .................
Log Sheet .........................................
Case Questionnaire .........................

26
26
26

1
24
24

5/60
1/60
15/60

2
10
156

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee Meeting

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Number of
responses per
respondent

Number of
respondents

Type of respondents

In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following committee
meeting.
Times and Dates:
8:30 a.m.–5 p.m., EDT, November 2,
2016.
8:30 a.m.–12 p.m., EDT, November 3,
2016.

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Place: CDC, 1600 Clifton Road NE.,
Tom Harkin Global Communications
Center, Building 19, Auditorium B,
Atlanta, Georgia 30329.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 100
people. This meeting will also be
webcast, please see information below.
Purpose: This Committee is charged
with providing scientific and technical
advice and guidance to the Secretary of
Health and Human Services (HHS); the
Assistant Secretary for Health; the
Director, Centers for Disease Control
and Prevention; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare and Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and
laboratory medicine practice and
specific questions related to possible
revision of the Clinical Laboratory
Improvement Amendment (CLIA)
standards. Examples include providing
guidance on studies designed to
improve safety, effectiveness, efficiency,

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timeliness, equity, and patientcenteredness of laboratory services;
revisions to the standards under which
clinical laboratories are regulated; the
impact of proposed revisions to the
standards on medical and laboratory
practice; and the modification of the
standards and provision of nonregulatory guidelines to accommodate
technological advances, such as new
test methods, the electronic
transmission of laboratory information,
and mechanisms to improve the
integration of public health and clinical
laboratory practices.
Matters for Discussion: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
discussions will include a report on the
cytology workload assessment and time
measure study; an update on CLIAC
recommendations for laboratory
biosafety; laboratory preparedness and
response: The case of Zika; a report from
the Institute of Medicine (IOM) CLIAC
workgroup; and future CLIAC topics.
Agenda items are subject to change as
priorities dictate.
Webcast: The meeting will also be
webcast. Persons interested in viewing

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