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blood biweekly at the clinic or hospital
until there are 2 consecutive negative
blood tests for ZIKV. Fetal tissue will be
collected for pregnancy losses to assess
fetal ZIKV infection. All pregnancy
outcomes and any additional testing
during pregnancy or in the immediate
neonatal period as part of clinical care
will be abstracted from medical records.
Male partners will be recruited via
their pregnant partners around the time
of their pregnant partners’ enrollment
into the study. At enrollment, men will
complete a baseline questionnaire and
ZIKV symptom questionnaire and
provide a blood sample. Urine samples
in men will be collected at home every
2 weeks through the second trimester of
pregnancy to monitor for incident ZIKV

3 days after delivery. Urine samples and
information on infant’s symptoms will
be collected every 2 weeks at home
visits to monitor for ZIKV infection in
infancy. Additionally, any infant health
conditions or results from medical
testing during this 6-month period
conducted as part of routine clinical
care will be abstracted from medical
records.
INS and CDC will use the study
results to guide their recommendations
to prevent ZIKV infection; to improve
counseling of patients about risks to
themselves, their pregnancies, their
partners, and their infants; and to help
agencies prepare to provide services to
affected children and families.

infection. Men will complete a ZIKV
symptom questionnaire at the time of
each specimen collection. If a man
becomes symptomatic, he will be asked
to provide a blood sample at the clinic
for ZIKV testing. If ZIKV is detected,
semen collection at home will be
scheduled every two weeks until there
are 2 consecutive negative tests, or the
end of pregnancy. In addition, if a man’s
at-home urine sample is positive, he
will again be asked to participate in
semen collection at home every two
weeks until there are 2 consecutive
negative tests, or the end of pregnancy.
All newborns of mothers participating
in the study will be followed from birth
to 6 months of age. A blood sample will
be collected at delivery or no later than

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Total burden
hours

Form name

Pregnant women ...............................

Pregnant women eligibility questionnaire.
Pregnant women enrollment questionnaire.
Adult symptom questionnaire ...........
Pregnant women follow-up questionnaire.
Infant symptoms questionnaire ........
Male partner eligibility questionnaire
Male enrollment questionnaire .........
Adult symptom questionnaire ...........

6,250

1

5/60

520

5,000

1

20/60

1,666

5,000
5,000

12
12

5/60
15/60

5,000
15,000

4,500
5,000
1,250
1,250

4
1
1
12

5/60
5/60
15/60
5/60

1,500
417
312
1,250

...........................................................

........................

........................

........................

25,665

Male partners ....................................

Total ...........................................

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. 2016–27691 Filed 11–16–16; 8:45 am]
BILLING CODE 4163–18–P

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

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 Calls for the
Laboratory Response Network’’
collected from its members concerning
their capacity to respond to public
health threat emergencies.
Written comments must be
received on or before January 17, 2017.

DATES:

[60Day–17–0881; Docket No. CDC–2016–
0109]

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Respondents

Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of

SUMMARY:

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Jkt 241001

You may submit comments,
identified by Docket No. CDC–2017–
0109 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.

ADDRESSES:

Proposed Data Collection Submitted
for Public Comment and
Recommendations

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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

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Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Notices
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

information as well as staff and
equipment inventories. However,
semiannually or during emergency
response the LRN Program Office may
conduct a Special Data Call to obtain
additional information from LRN
Member Laboratories in regards to
biological or chemical terrorism
preparedness.
LRN has used the currently approved
generic information collection plan
twice during the last three years. Once
in 2014, LRN surveyed its members to
ascertain which, if any, labs would be
willing to test clinical specimens for
Ebola virus.
The information gathered led to an
emergency deployment of a new Ebola
assay for LRN members. It is critical for
the LRN to know which labs have
equipment to support an agent specific
assay during an emergency. In 2015,
LRN surveyed members via broadcast
email asking how many facilities had a
specific version of an instrument. The
information was used to help the LRN
program office determine if new
procedures should be written and made
available to members to support the
instrument in question.
Special Data calls may be conducted
via queries that are distributed by
broadcast emails or by survey tools (i.e.
Survey Monkey).
This is a request for a three year
extension to this generic clearance.
The only cost to respondents is their
time to respond to the data call.
Authorizing legislation comes from
Section 301 of the Public Health Service
Act.

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 Calls for the Laboratory
Response Network, (OMB Control No.
0920–0881 exp. 4/30/2017)—
Extension—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Laboratory Response Network
(LRN) was established by the
Department of Health and Human
Services, Centers for Disease Control
and Prevention (CDC) in accordance
with Presidential Decision Directive 39,
which outlined national anti-terrorism
policies and assigned specific missions
to Federal departments and agencies.
The LRN’s mission is to maintain an
integrated national and international
network of laboratories that can respond
to acts of biological, chemical, or
radiological terrorism and other public
health emergencies. Federal, state and
local public health laboratories
voluntarily join the LRN.
The LRN Program Office maintains a
database of information for each
member laboratory that includes contact

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

Number of
responses per
respondent

Total burden
(in hours)

Form name

Public Health Laboratorians ..............

Special Data Call .............................

136

1

30/60

68

Total ...........................................

...........................................................

........................

........................

........................

68

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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

[FR Doc. 2016–27693 Filed 11–16–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10169]

Agency Information Collection
Activities: Proposed Collection;
Comment Request; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction of notice.
AGENCY:

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This document corrects the
information provided for [Document
Identifier: CMS–10169] titled ‘‘Durable
Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)
Competitive Bidding Program; Change
of Ownership Forms.’’
FOR FURTHER INFORMATION CONTACT:
William N. Parham, III, (410) 786–4669.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Background
In the October 14, 2016, issue of the
Federal Register (81 FR 71100), we

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