Att B - 60 day FRN

Att B_published 60d FRN.pdf

Emergency Epidemic Investigation Data Collections - Expedited Reviews (Y3Q4)

Att B - 60 day FRN

OMB: 0920-1011

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Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices

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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:

Users interacting with third-party
applications, such as those developed
by government agencies, may be asked
to authorize the third-party application
to access their system resources, such as
their personal profile information. If a
user authorizes use of his or her
information, the third-party application
will be given programmatic access to the
user’s account resources. All
interactions with a user’s account, such
as reading personal profile information,
are logged and are auditable by the user.
Users can revoke a third-party
application’s authorization to access
their account resources at any time.
System information may be accessed by
system managers, technical support and
designated analysts in the course of
their official duties. Information from
this system also may be disclosed as a
routine use:
a. In any legal proceeding, where
pertinent, to which GSA, a GSA
employee, or the United States is a party
before a court or administrative body.
b. To a Federal, State, local, or foreign
agency responsible for investigating,
prosecuting, enforcing, or carrying out a
statute, rule, regulation, or order when
GSA becomes aware of a violation or
potential violation of civil or criminal
law or regulation.
c. To a Member of Congress or his or
her staff on behalf of, and at the request
of, the individual who is the subject of
the record.
d. To the Office of Personnel
Management (OPM), the Office of
Management and Budget (OMB), and
the Government Accountability Office
(GAO) in accordance with their
responsibilities for evaluating Federal
programs.
e. To an expert, consultant, or
contractor of GSA in the performance of
a Federal duty to which the information
is relevant.
f. To the National Archives and
Records Administration (NARA) for
records management purposes.
g. To a Federal agency in connection
with the hiring or retention of an
employee; the issuance of a security
clearance; the reporting of an
investigation; the letting of a contract; or
the issuance of a grant, license, or other
benefit to the extent that the information
is relevant and necessary to a decision.
h. To appropriate agencies, entities,
and persons when (1) the Agency
suspects or has confirmed that the
security or confidentiality of
information in the system of records has
been compromised; (2) The Agency has
determined that as a result of the

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suspected or confirmed compromise
there is a risk of harm to economic or
property interests, identity theft or
fraud, or harm to the security or
integrity of this system or other systems
or programs (whether maintained by
GSA or another agency or entity) that
rely upon the compromised
information; and (3) the disclosure
made to such agencies, entities, and
persons is reasonably necessary to assist
in connection with GSA’s efforts to
respond to the suspected or confirmed
compromise and prevent, minimize, or
remedy such harm.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING AND
DISPOSING OF RECORDS IN THE SYTEM:
STORAGE:

All records are stored electronically in
a database. Personally identifiable
information is encrypted.
RETRIEVABILITY:

Records are retrieved using an
authorization protocol. A user of the
system grants explicit authorization to
an application or government agency to
access his or her profile. The system
generates a unique token that authorizes
only that application or agency to access
the user’s account. The system
correlates the unique token, ensures that
both the agency and the user involved
are correct, and returns the information
to the agency.
SAFEGUARDS:

System records are safeguarded in
accordance with the requirements of the
Privacy Act. Access to physical
infrastructure is limited to authorized
individuals with passwords; the
database is maintained behind a firewall
certified in accordance with National
Institute of Standards and Technology
standards and information in the
database is encrypted.
SAFEGUARDS AGAINIST UNAUTHORIZED ACCESS:

Records are safeguarded in
accordance with Privacy Act
requirements. Access is limited to
authorized individuals and protected
with two-factor authentication,
databases are behind a firewall.
Personally Identifiable Information is
encrypted at rest, and all transmissions
of any information over external
networks are encrypted. All passwords,
encryption algorithms and firewalls are
compliant with National Institute of
Standards and Technology standards.
RETENTION AND DISPOSAL:

System records are retained and
disposed of according to GSA records
maintenance and disposition schedules

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and the requirements of the National
Archives and Records Administration.
Users may delete their own information
from the system at any time.
SYSTEM MANAGER AND ADDRESS:

Director, USA.gov, General Services
Administration, 1800 F Street NW.,
Washington, DC 20405.
NOTIFICATION PROCEDURE:

Individuals or users maintain their
own information. Inquires can be made
via the Web site at https://www.usa.gov,
or at the above address under ‘System
Manager and Address’.
RECORD ACCESS PROCEDURES:

Individuals or users wishing to access
their own records may do so by
password.
CONTESTING RECORD PROCEDURES:

Individuals or users of the system
may amend or delete their own records
online.
RECORD SOURCE CATEGORIES:

The sources for information in the
system are the individuals (or system
users) for whom the records are
maintained and third-party applications
which the user has authorized to
contribute information to his or her
account.
[FR Doc. 2016–16868 Filed 7–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–1011; Docket No. CDC–2016–
0061]

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 a request for extension of
an approved information collection
entitled Emergency Epidemic

SUMMARY:

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Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices

Investigation Data Collections (OMB
Control No. 0920–1011). CDC will use
the information collected to identify
prevention and control measures in
response to outbreaks and other public
health events.
DATES: Written comments must be
received on or before September 16,
2016.
You may submit comments,
identified by Docket No. CDC–2016–
0061 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.

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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

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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
Emergency Epidemic Investigation
Data Collections (OMB control number
0920–1011), Expiration 03–31–2017–
Extension—Division of Scientific
Education and Professional
Development, Center for Surveillance,
Education, and Laboratory Services,
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC previously conducted Emergency
Epidemic Investigations (EEIs) under
Office of Management and Budget
(OMB) control number 0920–0008. In
2013, CDC received OMB approval
(OMB control number 0920–1011) for a
new OMB generic clearance for a 3-year
period to collect vital information
during EEIs in response to urgent
outbreaks or events (i.e., natural,
biological, chemical, nuclear,
radiological) characterized by
undetermined agents, undetermined
sources, undetermined transmission, or
undetermined risk factors. CDC seeks
OMB approval for an extension of this
generic clearance (OMB control number
0920–1011) for a 3-year period.
Supporting effective emergency
epidemic investigations is one of the
most important ways that CDC protects
the health of the public. CDC is
frequently called upon to conduct EEIs

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at the request of local, state, or
international health authorities seeking
support to respond to urgent outbreaks
or urgent public health-related events.
In response to external partner requests,
CDC provides necessary epidemiologic
support to identify the agents, sources,
modes of transmission, or risk factors to
effectively implement rapid prevention
and control measures to protect the
public’s health. Data collection is a
critical component of the epidemiologic
support provided by CDC; data are
analyzed to determine the agents,
sources, modes of transmission, or risk
factors so that effective prevention and
control measures can be implemented.
During an unanticipated outbreak or
event, immediate action by CDC is
necessary to minimize or prevent public
harm. The legal justification for EEIs are
found in the Public Health Service Act
(42 U.S.C. Sec. 301[241](a).
Successful investigations are
dependent on rapid and flexible data
collection that evolves during the
investigation and is customized to the
unique circumstances of each outbreak
or event. Data collection elements will
be those necessary to identify the
agents, sources, mode of transmission,
or risk factors. Examples of potential
data collection methods include
telephone or face-to-face interview;
email, web or other type of electronic
questionnaire; paper-and-pencil
questionnaire; focus groups; medical
record review; laboratory record review;
collection of clinical samples; and
environmental assessment. Respondents
will vary depending on the nature of the
outbreak or event; examples of potential
respondents include health care
professionals, patients, laboratorians,
and the general public. Participation in
EEIs is voluntary and there are no
anticipated costs to respondents other
than their time. CDC will use the
information gathered during EEIs to
rapidly identify and effectively
implement measures to minimize or
prevent public harm.
CDC projects 60 EEIs in response to
outbreaks or events characterized by
undetermined agents, undetermined
sources, undetermined transmission, or
undetermined risk factors annually. The
projected average number of
respondents is 200 per EEI, for a total
of 12,000 respondents. CDC estimates
the average burden per response is 0.5
hours and each respondent will be
asked to respond once. Therefore, the
total estimated annual burden hours are
6,000. These estimates are based on the
reported burden for EEIs that have been
performed during the previous two
years.

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Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices
OMB approval is requested for three
years. Participation is based on previous

Emergency Epidemic Investigations.
There are no costs to respondents.

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

Total burden
hours
(in hours)

Form name

Emergency Epidemic Investigation
Participants.

Emergency Epidemic Investigation
Data Collection Instruments.

12,000

1

30/60

6,000

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

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

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

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

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

6,000

Jeffrey M. Zirger,
Acting 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. 2016–16882 Filed 7–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority

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Total
number of
responses per
respondent

Number of
respondents

Type of respondent

Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 81 FR 30307–30308,
dated May 16, 2016) is amended to
reflect the reorganization of the Office of
the Director, Centers for Disease Control
and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
After the title and the mission and
function statements for the Office of the
Associate Director for Laboratory
Science and Safety (CAC) insert the
following:
Office of the Director (CAC1). (1)
Provides scientific, technical, and
managerial expertise and leadership in
the development and enhancement of
laboratory science and safety programs;
(2) oversees and monitors the
development, implementation, and
evaluation of the laboratory safety and
quality management programs across
CDC; (3) advises on policy,
partnerships, and issues management
matters; (4) advises on matters related to
internal and external public health
communications; (5) provides oversight
to ensure CDC compliance with

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regulations for select agents and toxins,
and the safe possession, use and transfer
of select agents and toxins; and (6) leads
responses to laboratory incidents and
emergencies.
Office of Laboratory Science (CACB).
(1) Provides high-level oversight and
coordination of laboratory quality and
safety training programs at all CDC
campuses; (2) develops agency-level
plans, policies, procedures and
guidelines for implementation of quality
management programs within Centers,
Institute, and Offices (CIOs); (3) assures
regulatory compliance and tracking for
CDC’s portfolio of laboratory developed
tests; and (4) provides oversight of the
catalog of laboratory safety training
activities and tracking agency-wide
progress and compliance with
laboratory safety training requirements.
Office of Laboratory Safety (CACC).
(1) Provides high-level oversight and
coordination of laboratory safety at all
CDC campuses; (2) develops and assures
effectiveness of agency-level plans,
policies, manuals and tools for
implementation of laboratory safety
standards; (3) assures regulatory
compliance for biological safety,
chemical safety, radiation safety and the
possession, use and transport of select
agents and toxins; and (4) provides
expertise and consultation for biological
safety, chemical safety and radiation
safety.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2016–16884 Filed 7–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–16–16AVB]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to [email protected]. Written
comments and/or suggestions regarding
the items contained in this notice

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