Proposed Data Collection Submitted for Public Comment and Recommendations, 26231-26234 [2016-10113]
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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices
FEDERAL RESERVE SYSTEM
Beach, Missouri; Central Bank of
Moberly, Moberly, Missouri; Central
Bank of Oklahoma, Tulsa, Oklahoma;
Central Bank of Sedalia, Sedalia,
Missouri; Central Bank of St. Louis,
Clayton, Missouri; Central Bank of The
Midwest, Lee’s Summit, Missouri;
Central Bank of The Ozarks, Springfield,
Missouri; Central Bank of Warrensburg,
Warrensburg, Missouri; The Central
Trust Bank, Jefferson City, Missouri; and
Jefferson Bank of Missouri, Jefferson
City, Missouri.
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
Board of Governors of the Federal Reserve
System, April 27, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
percent of the voting shares of Keystone
Investment, Inc., and thereby indirectly
acquire voting shares of Bank of
Keystone, both in Keystone, Nebraska.
Board of Governors of the Federal Reserve
System, April 27, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2016–10238 Filed 4–29–16; 8:45 am]
srobinson on DSK5SPTVN1PROD with NOTICES
BILLING CODE 6210–01–P
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than May 17,
2016.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. William C. Wetzeler, individually
and acting in concert with Carol L.
Schultz, Judith K. Nece, and Andrew J.
Schultz, all of Spirit Lake, Iowa, to join
the Wetzeler Family Control Group; to
retain voting shares of State Banco, LTD,
and thereby indirectly retain voting
shares of The State Bank, both in Spirit
Lake, Iowa.
B. Federal Reserve Bank of St. Louis
(David L. Hubbard, Senior Manager)
P.O. Box 442, St. Louis, Missouri
63166–2034. Comments can also be sent
electronically to
Comments.applications@stls.frb.org:
1. Robert R. Hermann, Jr., Palm
Beach, Florida; as co-trustee of the
Central Bancompany Voting Trust; to
acquire voting shares of Central
Bancompany, Inc., Jefferson City,
Missouri, and thereby indirectly acquire
voting shares of Central Bank of
Audrain County, Mexico, Missouri;
Central Bank of Boone County,
Columbia, Missouri; Central Bank of
Branson, Branson, Missouri; Central
Bank of Lake of The Ozarks, Osage
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[FR Doc. 2016–10239 Filed 4–29–16; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than May 26, 2016.
A. Federal Reserve Bank of Cleveland
(Nadine Wallman, Vice President) 1455
East Sixth Street, Cleveland, Ohio
44101–2566. Comments can also be sent
electronically to
Comments.applications@clev.frb.org:
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26231
1. Ohio Valley Banc Corp, Gallipolis,
Ohio; to acquire Milton Bancorp, Inc.,
and thereby indirectly acquire Milton
Banking Company, both in Wellston,
Ohio.
B. Federal Reserve Bank of
Minneapolis (Jacquelyn K. Brunmeier,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. The First National Bank of Bemidji
ESOP & Trust, Bemidji, Minnesota; to
acquire additional voting shares, for a
total of 36.63 percent, of First Bemidji
Holding Company, and thereby
indirectly acquire additional voting
shares of The First National Bank of
Bemidji, both in Bemidji, Minnesota.
Board of Governors of the Federal Reserve
System, April 26, 2016.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2016–10102 Filed 4–29–16; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–16AFR; Docket No. CDC–2016–
0040]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
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
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 an information collection
request proposal entitled ‘‘Continuing
International and Domestic Information
Collections from the 2016 Zika Virus
Emergency Response.’’ These
collections will allow CDC to continue
its ongoing response to the Zika virus
outbreak.
SUMMARY:
Written comments must be
received on or before July 1, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0040 by any of the following methods:
DATES:
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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Notices
• Federal eRulemaking Portal:
Regulation.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.
srobinson on DSK5SPTVN1PROD with NOTICES
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: omb@cdc.gov.
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,
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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
Continuing International and
Domestic Information Collections from
the 2016 Zika Virus Emergency
Response—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
In May 2015, the Pan American
Health Organization (PAHO) issued an
alert regarding the first confirmed Zika
virus infections in Brazil. Since then,
CDC has been responding to increased
reports of Zika and has assisted in
investigations with PAHO and the
Brazil Ministry of Health. The first
regional travel notices for Zika in South
America and Mexico were posted in
December 2015. In December 2015, the
Commonwealth of Puerto Rico, a United
States territory, reported its first
confirmed locally transmitted Zika virus
case. Cases of local transmission have
recently been confirmed in two other
US territories, the United States Virgin
Islands and American Samoa. As of
April 6, 2016, US territories had
reported 351 locally acquired Zika cases
and 3 travel-associated Zika cases to
CDC. Of the 354 cases reported, 37 were
in pregnant women. Zika has not been
spread by mosquitoes in the continental
United States. However, lab tests have
confirmed Zika virus in travelers
returning to the United States. These
travelers have gotten the virus from
mosquito bites and a few non-travelers
got Zika through sex. With the recent
outbreaks in the Americas, the number
of Zika cases among travelers visiting or
returning to the United States is
increasing. CDC monitors and reports to
the public cases of Zika, which will
help improve our understanding of how
and where Zika is spreading.
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Zika virus is spread to people
primarily through the bite of an infected
Aedes species mosquito (A. aegypti and
A. albopictus). Mosquitoes that spread
Zika virus are aggressive daytime biters,
but they can also bite at night. A
pregnant woman can pass Zika virus to
her fetus during pregnancy. CDC is
studying how Zika affects pregnancies.
Zika is linked to microcephaly, a severe
birth defect that is a sign of incomplete
brain development. Microcephaly is a
condition where a baby’s head is much
smaller than expected. During
pregnancy, a baby’s head grows because
the baby’s brain grows. Microcephaly
can occur because a baby’s brain has not
developed properly during pregnancy or
has stopped growing after birth.
In February and March 2016, CDC
used OMB emergency clearance
procedures to initiate and expedite
multiple urgently needed information
collections in American Samoa, Puerto
Rico, Brazil, and domestically within
state, tribal, local, and territorial (STLT)
jurisdictions. These procedures have
allowed the agency to target and refine
public health interventions to arrest
ongoing spread of infection.
With this notice, the CDC is
announcing its intention to seek OMB
clearances to continue four Zika-related
information collections beyond their
current emergency expiration dates.
These four projects will be submitted to
OMB as standalone ICRs:
1. A call center in CDC’s Emergency
Operations Center (EOC) to respond to
inquiries on clinical care of persons
potentially of interest for Zika virus
infection [OMB Control No. 0920–1101,
expiration date 8/31/16]. Respondents
to this information collection include
the general public, clinicians, and
employees at STLT health departments.
The purpose of this information
collection is to document and track
clinical inquiries made to the CDC EOC
call center and to systematically collect
standardized clinical/demographic/
epidemiological information about
suspected cases. The emergency
clearance for this information collection
dealt specifically with Zika-related
clinical inquiries. However, the new ICR
will cover this project for any EOC
activation. Regardless of the disease or
hazard being responded to, the EOC
operates this call center to answer and
respond to clinical inquiries. This
information collection is a necessary
part of operating this call center and
responding to emergency situations.
2. A study, in Puerto Rico, on the
persistence of Zika virus in bodily fluids
[OMB Control No. 0920–1106,
expiration date 9/30/16]. Since getting
OMB approval in March 2016, CDC has
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investigated the persistence of Zika
virus in different body fluids (shedding)
and its relation to immune response to
provide a basis for development of nonblood-based diagnostic tools, and target
and refine public health interventions to
arrest ongoing spread of infection. CDC
has begun a prospective cohort study of
symptomatic individuals with reverse
transcription-polymerase chain reaction
(RT–PCR) positive Zika virus infection
and a cross-sectional study of their
household contacts. Information
collection is expected to conclude
within one year. Results and analyses
will be used to update relevant
counseling messages and
recommendations from the CDC.
Participants for the shedding study are
patients with laboratory-confirmed Zika
virus infection and their household
contacts.
3. A study, carried out in the United
States, on the persistence of Zika virus
in the semen and urine of men with
laboratory-confirmed Zika virus
infection [OMB Control No. 0920–1109,
expiration date 9/30/2016]. Since
getting emergency OMB approval in
March, 2016, specimens have been
tested for Zika RNA by reverse
0920–1101, expiration date 8/31/16]. As
part of the public health response to the
Zika virus disease outbreak, CDC has
been collecting information from
clinicians in the U.S. about pregnant
women they treat who are diagnosed
with Zika virus infection. CDC also
plans to collect information from
clinicians about their patients’ infants in
order to better understand the clinical
consequences of Zika virus infection in
pregnancy and its impact on newborn
infants. Information gathered directs
public health messages provided by
CDC on reducing the risk of adverse
outcomes for pregnant women and their
infants.
These information collections will
align with their legislative authority,
Section 301 of the Public Health Service
Act (42 U.S.C. 241).
There are no costs to the respondents
other than their time. The total
annualized burden requested is 1,146
hours. This number represents the
number of burden hours yet to be
imposed. It does not include the burden
hours sustained during the initial sixmonth emergency clearance period.
transcriptase polymerase chain reaction
assay (RT–PCR) at CDC; those testing
positive may be further evaluated by
virus isolation techniques. Zika virus
disease is a nationally notifiable
condition, and participants are recruited
through contact with CDC personnel.
Urine and semen specimens are selfcollected using home collection kits, a
short questionnaire is self-administered,
and participants receive a token of
appreciation. Results of testing will be
provided to participants at the
conclusion of testing. The results of this
study are expected to have immediate
implications for public health
recommendations and disease
prevention. The results of this study
will be of great relevance to provide
evidence-based information to
circumvent Zika virus transmission.
They will inform the development of
recommendations used in the current
epidemic setting, as well as in future
Zika virus situations. Results and
analysis will be used to update and
refine relevant counseling messages and
recommendations.
4. Registry of pregnant women with
laboratory-confirmed Zika virus
infections in the U.S. [OMB Control No.
ESTIMATED ANNUALIZED BURDEN HOURS
1—CLINICAL INQUIRIES DATABASE
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
Type of respondents
Form name
Local health departments .................
Clinicians and other providers ..........
Clinical inquiries database ...............
Clinical inquiries database ...............
420
800
1
1
15/60
15/60
105
200
Total ...........................................
...........................................................
........................
........................
........................
305
2—PERSISTENCE OF ZIKA VIRUS IN BODILY FLUIDS STUDY, PUERTO RICO
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
Type of respondents
Form name
Public health personnel .....................
200
600
8
1
10/60
10/60
267
100
General public ...................................
Questionnaire (Symptomatics) ..........
Questionnaire
(Cross-Sectional
household contacts).
Eligibility Form ...................................
1,000
1
2/60
33
Total ............................................
............................................................
........................
........................
........................
400
3—PERSISTENCE OF ZIKA VIRUS IN BODILY FLUIDS STUDY, UNITED STATES
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
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Type of respondents
Form name
General public ...................................
Introductory survey ............................
Follow-Up survey ...............................
175
175
1
12
2/60
1/60
6
35
Total ............................................
............................................................
........................
........................
........................
41
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4—PREGNANCY REGISTRY
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs.)
Total burden
(in hrs.)
Type of respondents
Form name
State and Local Health Departments
Maternal Health History Form ...........
Specimen Collection Form ................
Assessment at Delivery Form ...........
Infant Health Follow-Up Form ...........
100
100
100
100
5
1
1
1
30/60
15/60
30/60
30/60
250
25
50
50
............................................................
........................
........................
........................
400
Clinicians and other providers ...........
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. 2016–10113 Filed 4–29–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–131 and
CMS–R–244]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by June 1, 2016.
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SUMMARY:
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When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
ADDRESSES:
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1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Advance
Beneficiary Notice of Noncoverage
(ABN); Use: The Advance Beneficiary
Notice (ABN) is delivered by Part B paid
physicians, providers (including
institutional providers like outpatient
hospitals), practitioners (such as
chiropractors), and suppliers, as well as
hospice providers and Religious Nonmedical Health Care Institutions paid
under Part A. Home health agencies
providing items and services under Part
A or Part B also use the ABN. Other
Medicare institutional providers paid
under Part A use other approved notices
for this purpose. With this PRA
submission, minimal formatting changes
have been made to the ABN form,
including the addition of language
informing beneficiaries of their rights
under Section 504 of the Rehabilitation
Act of 1973 (Section 504) by alerting the
beneficiary to CMS’s nondiscrimination
practices and the availability of
alternate forms of this notice, if needed.
Additionally, minor language and
grammatical changes have been made to
the form’s instructions to improve
provider/supplier comprehension and
decrease the probability of errors in
completing the ABN. There are no
substantive changes to the form or to the
instructions. Form Number: CMS–R–
131 (OMB control number: 0938–0566);
Frequency: Occasionally; Affected
Public: Private sector (Business or other
for-profits and Not-for-profit
institutions); Number of Respondents:
1,540,850; Total Annual Responses:
63,601,300; Total Annual Hours:
7,420,364. (For policy questions
regarding this collection contact Evelyn
Blaemire at 410–786–1803.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: The PACE
Organization (PO) Application Process
in 42 CFR part 460; Use: In general,
Programs of All-Inclusive Care for the
Elderly (PACE) services are provided
through a PO. An entity wishing to
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]]>Agencies
[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26231-26234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10113]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-16AFR; Docket No. CDC-2016-0040]
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 an information
collection request proposal entitled ``Continuing International and
Domestic Information Collections from the 2016 Zika Virus Emergency
Response.'' These collections will allow CDC to continue its ongoing
response to the Zika virus outbreak.
DATES: Written comments must be received on or before July 1, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0040 by any of the following methods:
[[Page 26232]]
Federal eRulemaking Portal: Regulation.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: omb@cdc.gov.
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
Continuing International and Domestic Information Collections from
the 2016 Zika Virus Emergency Response--New--National Center for
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
In May 2015, the Pan American Health Organization (PAHO) issued an
alert regarding the first confirmed Zika virus infections in Brazil.
Since then, CDC has been responding to increased reports of Zika and
has assisted in investigations with PAHO and the Brazil Ministry of
Health. The first regional travel notices for Zika in South America and
Mexico were posted in December 2015. In December 2015, the Commonwealth
of Puerto Rico, a United States territory, reported its first confirmed
locally transmitted Zika virus case. Cases of local transmission have
recently been confirmed in two other US territories, the United States
Virgin Islands and American Samoa. As of April 6, 2016, US territories
had reported 351 locally acquired Zika cases and 3 travel-associated
Zika cases to CDC. Of the 354 cases reported, 37 were in pregnant
women. Zika has not been spread by mosquitoes in the continental United
States. However, lab tests have confirmed Zika virus in travelers
returning to the United States. These travelers have gotten the virus
from mosquito bites and a few non-travelers got Zika through sex. With
the recent outbreaks in the Americas, the number of Zika cases among
travelers visiting or returning to the United States is increasing. CDC
monitors and reports to the public cases of Zika, which will help
improve our understanding of how and where Zika is spreading.
Zika virus is spread to people primarily through the bite of an
infected Aedes species mosquito (A. aegypti and A. albopictus).
Mosquitoes that spread Zika virus are aggressive daytime biters, but
they can also bite at night. A pregnant woman can pass Zika virus to
her fetus during pregnancy. CDC is studying how Zika affects
pregnancies. Zika is linked to microcephaly, a severe birth defect that
is a sign of incomplete brain development. Microcephaly is a condition
where a baby's head is much smaller than expected. During pregnancy, a
baby's head grows because the baby's brain grows. Microcephaly can
occur because a baby's brain has not developed properly during
pregnancy or has stopped growing after birth.
In February and March 2016, CDC used OMB emergency clearance
procedures to initiate and expedite multiple urgently needed
information collections in American Samoa, Puerto Rico, Brazil, and
domestically within state, tribal, local, and territorial (STLT)
jurisdictions. These procedures have allowed the agency to target and
refine public health interventions to arrest ongoing spread of
infection.
With this notice, the CDC is announcing its intention to seek OMB
clearances to continue four Zika-related information collections beyond
their current emergency expiration dates. These four projects will be
submitted to OMB as standalone ICRs:
1. A call center in CDC's Emergency Operations Center (EOC) to
respond to inquiries on clinical care of persons potentially of
interest for Zika virus infection [OMB Control No. 0920-1101,
expiration date 8/31/16]. Respondents to this information collection
include the general public, clinicians, and employees at STLT health
departments. The purpose of this information collection is to document
and track clinical inquiries made to the CDC EOC call center and to
systematically collect standardized clinical/demographic/
epidemiological information about suspected cases. The emergency
clearance for this information collection dealt specifically with Zika-
related clinical inquiries. However, the new ICR will cover this
project for any EOC activation. Regardless of the disease or hazard
being responded to, the EOC operates this call center to answer and
respond to clinical inquiries. This information collection is a
necessary part of operating this call center and responding to
emergency situations.
2. A study, in Puerto Rico, on the persistence of Zika virus in
bodily fluids [OMB Control No. 0920-1106, expiration date 9/30/16].
Since getting OMB approval in March 2016, CDC has
[[Page 26233]]
investigated the persistence of Zika virus in different body fluids
(shedding) and its relation to immune response to provide a basis for
development of non-blood-based diagnostic tools, and target and refine
public health interventions to arrest ongoing spread of infection. CDC
has begun a prospective cohort study of symptomatic individuals with
reverse transcription-polymerase chain reaction (RT-PCR) positive Zika
virus infection and a cross-sectional study of their household
contacts. Information collection is expected to conclude within one
year. Results and analyses will be used to update relevant counseling
messages and recommendations from the CDC. Participants for the
shedding study are patients with laboratory-confirmed Zika virus
infection and their household contacts.
3. A study, carried out in the United States, on the persistence of
Zika virus in the semen and urine of men with laboratory-confirmed Zika
virus infection [OMB Control No. 0920-1109, expiration date 9/30/2016].
Since getting emergency OMB approval in March, 2016, specimens have
been tested for Zika RNA by reverse transcriptase polymerase chain
reaction assay (RT-PCR) at CDC; those testing positive may be further
evaluated by virus isolation techniques. Zika virus disease is a
nationally notifiable condition, and participants are recruited through
contact with CDC personnel. Urine and semen specimens are self-
collected using home collection kits, a short questionnaire is self-
administered, and participants receive a token of appreciation. Results
of testing will be provided to participants at the conclusion of
testing. The results of this study are expected to have immediate
implications for public health recommendations and disease prevention.
The results of this study will be of great relevance to provide
evidence-based information to circumvent Zika virus transmission. They
will inform the development of recommendations used in the current
epidemic setting, as well as in future Zika virus situations. Results
and analysis will be used to update and refine relevant counseling
messages and recommendations.
4. Registry of pregnant women with laboratory-confirmed Zika virus
infections in the U.S. [OMB Control No. 0920-1101, expiration date 8/
31/16]. As part of the public health response to the Zika virus disease
outbreak, CDC has been collecting information from clinicians in the
U.S. about pregnant women they treat who are diagnosed with Zika virus
infection. CDC also plans to collect information from clinicians about
their patients' infants in order to better understand the clinical
consequences of Zika virus infection in pregnancy and its impact on
newborn infants. Information gathered directs public health messages
provided by CDC on reducing the risk of adverse outcomes for pregnant
women and their infants.
These information collections will align with their legislative
authority, Section 301 of the Public Health Service Act (42 U.S.C.
241).
There are no costs to the respondents other than their time. The
total annualized burden requested is 1,146 hours. This number
represents the number of burden hours yet to be imposed. It does not
include the burden hours sustained during the initial six-month
emergency clearance period.
Estimated Annualized Burden Hours
1--Clinical Inquiries Database
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
Local health departments...... Clinical 420 1 15/60 105
inquiries
database.
Clinicians and other providers Clinical 800 1 15/60 200
inquiries
database.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 305
----------------------------------------------------------------------------------------------------------------
2--Persistence of Zika Virus in Bodily Fluids Study, Puerto Rico
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
Public health personnel........ Questionnaire 200 8 10/60 267
(Symptomatics).
Questionnaire 600 1 10/60 100
(Cross-Sectional
household
contacts).
General public................. Eligibility Form. 1,000 1 2/60 33
-------------------------------------------------------------
Total...................... ................. .............. .............. .............. 400
----------------------------------------------------------------------------------------------------------------
3--Persistence of Zika Virus in Bodily Fluids Study, United States
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
General public................. Introductory 175 1 2/60 6
survey.
Follow-Up survey. 175 12 1/60 35
-------------------------------------------------------------
Total...................... ................. .............. .............. .............. 41
----------------------------------------------------------------------------------------------------------------
[[Page 26234]]
4--Pregnancy Registry
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
----------------------------------------------------------------------------------------------------------------
State and Local Health Maternal Health 100 5 30/60 250
Departments. History Form.
Specimen 100 1 15/60 25
Collection Form.
Clinicians and other providers. Assessment at 100 1 30/60 50
Delivery Form.
Infant Health 100 1 30/60 50
Follow-Up Form.
-------------------------------------------------------------
Total...................... ................. .............. .............. .............. 400
----------------------------------------------------------------------------------------------------------------
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. 2016-10113 Filed 4-29-16; 8:45 am]
BILLING CODE 4163-18-P
