80 FR 67759 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 212 (November 3, 2015)

Page Range		67759-67760
FR Document		2015-27890

Federal Register, Volume 80 Issue 212 (Tuesday, November 3, 2015)

[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67759-67760]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27890]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0824]


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 should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    BioSense (OMB Control No. 0920-0824, Expiration 11/30/2015)--
Revision--Center for Surveillance, Epidemiology and Laboratory Services 
(CSELS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The BioSense Program was created by congressional mandate as part 
of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 and was launched by the CDC in 2003. The original 
BioSense Program (BioSense 1.0) was intended to serve as a national 
level public health syndromic surveillance system for early detection 
and rapid assessment of potential bioterrorism-related illness and 
injury. In 2009, CDC began planning and developing the computing cloud-
based BioSense 2.0 Platform. This cloud-based system would offer secure 
storage space for data and data sharing capacity for each state and 
local health department. Since August 2012, when CDC submitted a 
request to OMB for approval of a revision to the BioSense information 
collection request, HHS published new guidance on Meaningful Use of 
Electronic Health Records for syndromic surveillance. During this time, 
CDC also initiated its new CDC Surveillance Strategy. These actions 
provided new guidance for improvements to the BioSense Program, which 
resulted in new requirements for data submission to the BioSense 
Platform and new requests specified below.
    CDC requests a three-year Revision approval for BioSense. This 
Revision includes new requests for approval to: (1) Change the title of 
the information collection request from BioSense to the National 
Syndromic Surveillance Program (NSSP); (2) receive data from additional 
state, local, and territorial health departments; (3) receive from 
state, local, and territorial health departments syndromic surveillance 
data submitted to those health departments from urgent care, ambulatory 
care and hospital inpatient settings (in addition to data from hospital 
emergency departments, included in the previously approved information 
collection request); and (4) receive from state, local, and territorial 
health departments additional syndromic surveillance data elements.
    The total estimated number of burden hours has decreased since the 
previously approved information collection request because we 
inadvertently included estimates for the Department of Defense, 
Department of Veterans Affairs, and the two organizations that provide 
pharmacy data. We only included estimates for state, local, and 
territorial public health jurisdictions and the private sector 
laboratory company that provides laboratory data free of charge to CDC 
in this information collection request. There is no burden for the 
private sector laboratory company for recruitment, registration, and 
healthcare data collection. The private sector laboratory company chose 
their sharing permissions when they registered to use the system. The 
estimated annual burden is 39 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
State, Local and Territorial Public     Recruitment Information               20               1               1
 Health Departments.                     Collection.
State, Local and Territorial Public     Registration Information             200               1            5/60
 Health Departments.                     Collection.
State, Local, and Territorial Public    Healthcare Information                20               1            5/60
 Health Departments.                     Collection:
                                         Administrator Data
                                         Sharing Agreements/
                                         Permissions.
----------------------------------------------------------------------------------------------------------------



[[Page 67760]]

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. 2015-27890 Filed 11-2-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices 67759

Leroy A. Richardson, technological collection techniques or time, CDC also initiated its new CDC
Chief, Information Collection Review Office, other forms of information technology, Surveillance Strategy. These actions
Office of Scientific Integrity, Office of the e.g., permitting electronic submission of provided new guidance for
Associate Director for Science, Office of the responses; and (e) Assess information improvements to the BioSense Program,
Director, Centers for Disease Control and collection costs. which resulted in new requirements for
Prevention. To request additional information on data submission to the BioSense
[FR Doc. 2015–27888 Filed 11–2–15; 8:45 am] the proposed project or to obtain a copy Platform and new requests specified
BILLING CODE 4163–18–P of the information collection plan and below.
instruments, call (404) 639–7570 or CDC requests a three-year Revision
send an email to omb@cdc.gov. Written approval for BioSense. This Revision
DEPARTMENT OF HEALTH AND comments and/or suggestions regarding
HUMAN SERVICES includes new requests for approval to:
the items contained in this notice (1) Change the title of the information
should be directed to the Attention: collection request from BioSense to the
Centers for Disease Control and CDC Desk Officer, Office of Management
Prevention National Syndromic Surveillance
and Budget, Washington, DC 20503 or Program (NSSP); (2) receive data from
[30Day–16–0824] by fax to (202) 395–5806. Written additional state, local, and territorial
comments should be received within 30 health departments; (3) receive from
Agency Forms Undergoing Paperwork days of this notice. state, local, and territorial health
Reduction Act Review departments syndromic surveillance
Proposed Project
The Centers for Disease Control and BioSense (OMB Control No. 0920– data submitted to those health
Prevention (CDC) has submitted the 0824, Expiration 11/30/2015)— departments from urgent care,
following information collection request Revision—Center for Surveillance, ambulatory care and hospital inpatient
to the Office of Management and Budget Epidemiology and Laboratory Services settings (in addition to data from
(OMB) for review and approval in (CSELS), Centers for Disease Control hospital emergency departments,
accordance with the Paperwork and Prevention (CDC). included in the previously approved
Reduction Act of 1995. The notice for information collection request); and (4)
the proposed information collection is Background and Brief Description receive from state, local, and territorial
published to obtain comments from the The BioSense Program was created by health departments additional
public and affected agencies. congressional mandate as part of the syndromic surveillance data elements.
Written comments and suggestions Public Health Security and Bioterrorism The total estimated number of burden
from the public and affected agencies Preparedness and Response Act of 2002 hours has decreased since the
concerning the proposed collection of and was launched by the CDC in 2003. previously approved information
information are encouraged. Your The original BioSense Program collection request because we
comments should address any of the (BioSense 1.0) was intended to serve as inadvertently included estimates for the
following: (a) Evaluate whether the a national level public health syndromic Department of Defense, Department of
proposed collection of information is surveillance system for early detection Veterans Affairs, and the two
necessary for the proper performance of and rapid assessment of potential organizations that provide pharmacy
the functions of the agency, including bioterrorism-related illness and injury. data. We only included estimates for
whether the information will have In 2009, CDC began planning and state, local, and territorial public health
practical utility; (b) Evaluate the developing the computing cloud-based jurisdictions and the private sector
accuracy of the agencies estimate of the BioSense 2.0 Platform. This cloud-based laboratory company that provides
burden of the proposed collection of system would offer secure storage space laboratory data free of charge to CDC in
information, including the validity of for data and data sharing capacity for this information collection request.
the methodology and assumptions used; each state and local health department. There is no burden for the private sector
(c) Enhance the quality, utility, and Since August 2012, when CDC laboratory company for recruitment,
clarity of the information to be submitted a request to OMB for registration, and healthcare data
collected; (d) Minimize the burden of approval of a revision to the BioSense collection. The private sector laboratory
the collection of information on those information collection request, HHS company chose their sharing
who are to respond, including through published new guidance on Meaningful permissions when they registered to use
the use of appropriate automated, Use of Electronic Health Records for the system. The estimated annual
electronic, mechanical, or other syndromic surveillance. During this burden is 39 hours.

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

State, Local and Territorial Public Health Departments Recruitment Information Collection 20 1 1
State, Local and Territorial Public Health Departments Registration Information Collection 200 1 5/60
State, Local, and Territorial Public Health Departments Healthcare Information Collection: 20 1 5/60
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Administrator Data Sharing
Agreements/Permissions.

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67760 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices

Leroy A. Richardson, comments and/or suggestions regarding be, to our knowledge, the first U.S.
Chief, Information Collection Review Office, the items contained in this notice study to systematically examine the
Office of Scientific Integrity, Office of the should be directed to the Attention: association between low pressure events
Associate Director for Science, Office of the CDC Desk Officer, Office of Management and acute gastrointestinal and
Director, Centers for Disease Control and and Budget, Washington, DC 20503 or respiratory illnesses. Study findings will
Prevention.
by fax to (202) 395–5806. Written inform the Environmental Protection
[FR Doc. 2015–27890 Filed 11–2–15; 8:45 am]
comments should be received within 30 Agency (EPA), CDC, and other drinking
BILLING CODE 4163–18–P days of this notice. water stakeholders of the potential
health risks associated with low
Proposed Project
pressure events in drinking water
DEPARTMENT OF HEALTH AND Epidemiologic Study of Health Effects distribution systems and whether
HUMAN SERVICES Associated With Low Pressure Events in additional measures (e.g., new
Centers for Disease Control and Drinking Water Distribution Systems standards, additional research, or policy
Prevention (OMB Control No. 0920–0960, development) are needed to reduce the
expiration 3/31/2016)—Extension— risk for health effects associated with
[30Day–15–0960] National Center for Emerging and low pressure events in the drinking
Zoonotic Infectious Diseases (NCEZID), water distribution system.
Agency Forms Undergoing Paperwork Centers for Disease Control and
Reduction Act Review We will conduct a cohort study
Prevention (CDC). among households that receive water
The Centers for Disease Control and Background and Brief Description from six water utilities across the U.S.
Prevention (CDC) has submitted the The water systems will be
following information collection request In the United States (U.S.), drinking
geographically diverse and will include
to the Office of Management and Budget water distribution systems are designed
both chlorinated and chloraminated
(OMB) for review and approval in to deliver safe, pressurized drinking
systems. These water utilities will
accordance with the Paperwork water to our homes, hospitals, schools
provide information about low pressure
Reduction Act of 1995. The notice for and businesses. However, the water
events that occur during the study
the proposed information collection is distribution infrastructure is 50–100
period using a standardized form
published to obtain comments from the years old in much of the U.S. and an
(approximately 11 events per utility).
public and affected agencies. estimated 240,000 water main breaks
Utilities will provide address listings of
Written comments and suggestions occur each year. Failures in the
households in areas exposed to the low
from the public and affected agencies distribution system such as water main
pressure event and comparable
concerning the proposed collection of breaks, cross-connections, back-flow,
households in an unexposed area to
information are encouraged. Your and pressure fluctuations can result in
CDC staff, who will randomly select
comments should address any of the potential intrusion of microbes and
participants and send them an
following: (a) Evaluate whether the other contaminants that can cause
introductory letter and questionnaire.
proposed collection of information is health effects, including acute
Consenting household respondents will
necessary for the proper performance of gastrointestinal and respiratory illness.
be asked about symptoms and duration
the functions of the agency, including Approximately 200 million cases of
of any recent gastrointestinal or
whether the information will have acute gastrointestinal illness occur in
respiratory illness, tap water
practical utility; (b) Evaluate the the U.S. each year, but we lack reliable
consumption, and other exposures
accuracy of the agencies estimate of the data to assess how many of these cases
including international travel, daycare
burden of the proposed collection of are associated with drinking water.
attendance or employment, animal
information, including the validity of Further, data are even more limited on
contacts, and recreational water
the methodology and assumptions used; the human health risks associated with
exposures. Study participants may
(c) Enhance the quality, utility, and exposure to drinking water during and
choose between two methods of survey
clarity of the information to be after the occurrence of low pressure
response: A mail-in paper survey and a
collected; (d) Minimize the burden of events (such as water main breaks) in
Web-based survey.
the collection of information on those drinking water distribution systems. A
who are to respond, including through study conducted in Norway from 2003– Participation in this study will be
the use of appropriate automated, 2004 found that people exposed to low voluntary. No financial compensation
electronic, mechanical, or other pressure events in the water distribution will be provided to study participants.
technological collection techniques or system had a higher risk for The study duration is anticipated to last
other forms of information technology, gastrointestinal illness. A similar study 30 months. An estimated 6,750
e.g., permitting electronic submission of is needed in the United States. individuals will be contacted and we
responses; and (e) Assess information The purpose of this data collection is anticipate 4,050 utility customers (18
collection costs. to conduct an epidemiologic study in years of age or older) will consent to
To request additional information on the U.S. to assess whether individuals participate in this study. The total
the proposed project or to obtain a copy exposed to low pressure events in the estimated annualized hours associated
of the information collection plan and water distribution system are at an with this study is expected to be 548.
instruments, call (404) 639–7570 or increased risk for acute gastrointestinal There are no costs to respondents
send an email to omb@cdc.gov. Written or respiratory illness. This study would other than their time.
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Document Created: 2018-03-01 11:32:23
Document Modified: 2018-03-01 11:32:23

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
FR Citation		80 FR 67759

80 FR 67759 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 212 (November 3, 2015)

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