80 FR 42500 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 137 (July 17, 2015)

Page Range		42500-42501
FR Document		2015-17554
Federal Register, Volume 80 Issue 137 (Friday, July 17, 2015)
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42500-42501]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17554]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-15-15VA]


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

[[Page 42501]]

comments should be received within 30 days of this notice.

Proposed Project

    National Disease Surveillance Program III--CDC Support for Case 
Investigation, Contact Tracing, and Case Reports--New--National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The international outbreak of Ebola virus disease (EVD) in West 
Africa began March 10, 2014. The initial cases were from southern 
Guinea, near its rural border with Liberia and Sierra Leone. Highly 
mobile populations contributed to increasing waves of person-to-person 
transmission of EVD that occurred in multiple countries in West Africa. 
The CDC activated its Emergency Operations Center on July 9, 2014 to 
help coordinate technical assistance and control activities with 
international partners and to deploy teams of public health experts to 
the affected countries.
    The operations turned to the United States (U.S.) when the first 
imported case of EVD was diagnosed in Texas on September 30, 2014. In 
response, on October 11, 2014, the CDC Quarantine Stations and the 
Department of Homeland Security Customs and Border Patrol mobilized to 
screen, detect, and refer arriving travelers who were potential persons 
at risk for EVD to appropriate state, territorial, and local (STL) 
authorities. The CDC also increased its commitment to support STL 
public health authorities to combat and control the spread of EVD 
within their jurisdictions.
    Thus in 2014, the CDC requested and received an expedited emergency 
review and approval from OMB of an information collection request to 
initiate multiple urgently needed information collections in West 
Africa, at U.S. ports of entry, and within STL jurisdictions. These 
information collections allowed the agency to accomplish its primary 
mission on many fronts to quickly prevent public harm, illness, and 
death from the uncontrolled spread of EVD.
    This new collection of information is designed to allow CDC to 
conduct active disease surveillance in support of and at the request of 
STL authorities among respondents that may include the general public, 
workers, and STL authorities. This should cut down on the need for 
multiple steps in emergency requests that were experienced in the first 
year of the 2014 Ebola virus response.
    There are no costs to the respondents other than their time. The 
total annualized burden requested is 14,702 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of      Avg. burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
General Public--Case...............  Ebola Virus Disease Case                 15               1           30/60
                                      Investigation Form--United
                                      States.
General Public--Case...............  Symptom Monitoring Form....              15              42            5/60
General Public--Person Under         Ebola Virus Disease Person              300               1           10/60
 Investigation (PUI).                 Under Investigation (PUI)
                                      Form.
General Public--Person Under         Symptom Monitoring Form....             300              42            5/60
 Investigation (PUI).
General Public--Contact............  Ebola Virus Disease Contact             105               1           10/60
                                      Tracing Form--United
                                      States.
General Public--Contact............  Symptom Monitoring Form....             105              42            5/60
Healthcare Workers.................  Ebola Virus Disease                     600              15           10/60
                                      Tracking Form for
                                      Healthcare Workers with
                                      Direct Patient Contact.
Healthcare Workers.................  Symptom Monitoring Form....             600              57            5/60
Laboratory Personnel...............  Ebola Tracking Form for                 600              15           10/60
                                      Laboratory Personnel.
Laboratory Personnel...............  Symptom Monitoring Form....             600              57            5/60
Environmental Services Personnel...  Ebola Tracking Form for                 600              15           10/60
                                      Environmental Services
                                      Personnel.
Environmental Services Personnel...  Symptom Monitoring Form....             600              57            5/60
State, Territorial, and Local        White House Evening Report.              15              42           10/60
 Public Health Authorities and
 Their Delegates.
                                                                 -----------------------------------------------
    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. 2015-17554 Filed 7-16-15; 8:45 am]
BILLING CODE 4163-18-P
42500 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices

techniques, and approaches dealing fostering H&S knowledge, motivation, personal characteristics have the biggest
with occupational safety and health proactive behaviors, and safety impact on proactive and compliant
problems. outcomes. Because these emergent, health and safety behaviors. Dominance
This research relates to the interplay worker perception-based constructs and relative weights analysis will be
of personal, organizational, and cultural have a theoretical and empirical history, used as the data analysis method to
influences on risk-taking and proactive psychometrically tested items exist for statistically rank order the importance
decision-making behaviors among mine each of them. of predictors in numerous regression
workers. The antecedents, or NIOSH researchers will administer contexts. Safety proactive and safety
characteristics, that impact these this survey at mine sites to as many
compliance will serve as the dependent
behaviors are not well understood in participating mine workers as possible
variables in these regression analyses,
mining. Understanding the degree to to answer the research questions. Upon
which antecedents influence decisions data collection and analysis NIOSH with the organizational and personal
can inform the focus of future health researchers will revalidate each scale to characteristics as independent variables.
and safety management interventions. ensure that measurement is valid. A Findings will be used to improve the
NIOSH proposes a project that seeks quantitative approach, via a short safety and health organizational values
to empirically understand the following: survey, allows for prioritization, based and focus of mine organizations, as
What are the most important on statistical significance, of the executed through their health and safety
organizational antecedent antecedents that have the most critical management system for mitigating
characteristics needed to support influence on proactive behaviors. Data health and safety risks at their mine site.
worker health and safety (H&S) collection will take place with Specifically, if organizations are lacking
performance behaviors in the mining approximately 1,200 mine workers over in values that are of high importance
industry? three years. The respondents targeted among employees, site leadership
What are the most important personal for this study include any active mine knows where to focus new, innovative
antecedent characteristics needed to worker at a mine site, both surface and
methods, techniques, and approaches to
support worker health and safety (H&S) underground. All participants will be
performance behaviors in the mining dealing with their occupational safety
between the ages of 18 and 75, currently
industry? employed, and living in the United and health problems. Finally, the data
To answer the above questions, States. Participation will require no can be directly compared to data from
NIOSH researchers developed a more than 20 minutes of workers’ time other mine organizations that
psychometrically supported survey. (5 minutes for consent and 15 minutes administered the same standardized
Researchers identified seven worker for the survey). There is no cost to methods to provide broader context for
perception-based ‘organizational values’ respondents other than their time. areas in which the mining industry can
and four ‘personal characteristics’ that Upon collection of the data, it will be focus more attention if trying to
are presumed to be important in used to answer what organizational/ encourage safer work behavior.

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

Safety/health Mine Operator ........................... Mine Recruitment Script ................................. 10 1 5/60
Mine Worker .................................................... Individual Miner Recruitment Script ............... 400 1 5/60
Mine Worker .................................................... Survey ............................................................ 400 1 15/60

Leroy A. Richardson, to the Office of Management and Budget clarity of the information to be
Chief, Information Collection Review Office, (OMB) for review and approval in collected; (d) Minimize the burden of
Office of Scientific Integrity, Office of the accordance with the Paperwork the collection of information on those
Associate Director for Science, Office of the Reduction Act of 1995. The notice for who are to respond, including through
Director, Centers for Disease Control and the proposed information collection is the use of appropriate automated,
Prevention. published to obtain comments from the electronic, mechanical, or other
[FR Doc. 2015–17553 Filed 7–16–15; 8:45 am] public and affected agencies. technological collection techniques or
BILLING CODE 4163–18–P Written comments and suggestions other forms of information technology,
from the public and affected agencies e.g., permitting electronic submission of
concerning the proposed collection of responses; and (e) Assess information
DEPARTMENT OF HEALTH AND information are encouraged. Your
HUMAN SERVICES collection costs.
comments should address any of the
following: (a) Evaluate whether the To request additional information on
Centers for Disease Control and proposed collection of information is the proposed project or to obtain a copy
Prevention necessary for the proper performance of of the information collection plan and
the functions of the agency, including instruments, call (404) 639–7570 or
srobinson on DSK5SPTVN1PROD with NOTICES

[30 Day–15–15VA] send an email to omb@cdc.gov. Written
whether the information will have
practical utility; (b) Evaluate the comments and/or suggestions regarding
Agency Forms Undergoing Paperwork
accuracy of the agencies estimate of the the items contained in this notice
Reduction Act Review
burden of the proposed collection of should be directed to the Attention:
The Centers for Disease Control and information, including the validity of CDC Desk Officer, Office of Management
Prevention (CDC) has submitted the the methodology and assumptions used; and Budget, Washington, DC 20503 or
following information collection request (c) Enhance the quality, utility, and by fax to (202) 395–5806. Written

VerDate Sep<11>2014 20:59 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices 42501

comments should be received within 30 2014 to help coordinate technical information collection request to initiate
days of this notice. assistance and control activities with multiple urgently needed information
international partners and to deploy collections in West Africa, at U.S. ports
Proposed Project
teams of public health experts to the of entry, and within STL jurisdictions.
National Disease Surveillance affected countries. These information collections allowed
Program III—CDC Support for Case The operations turned to the United the agency to accomplish its primary
Investigation, Contact Tracing, and Case States (U.S.) when the first imported mission on many fronts to quickly
Reports—New—National Center for case of EVD was diagnosed in Texas on prevent public harm, illness, and death
Emerging and Zoonotic Infectious September 30, 2014. In response, on from the uncontrolled spread of EVD.
Diseases (NCEZID), Centers for Disease October 11, 2014, the CDC Quarantine This new collection of information is
Control and Prevention (CDC). Stations and the Department of designed to allow CDC to conduct active
Homeland Security Customs and Border disease surveillance in support of and at
Background and Brief Description
Patrol mobilized to screen, detect, and the request of STL authorities among
The international outbreak of Ebola refer arriving travelers who were respondents that may include the
virus disease (EVD) in West Africa potential persons at risk for EVD to general public, workers, and STL
began March 10, 2014. The initial cases appropriate state, territorial, and local authorities. This should cut down on
were from southern Guinea, near its (STL) authorities. The CDC also the need for multiple steps in
rural border with Liberia and Sierra increased its commitment to support emergency requests that were
Leone. Highly mobile populations STL public health authorities to combat experienced in the first year of the 2014
contributed to increasing waves of and control the spread of EVD within Ebola virus response.
person-to-person transmission of EVD their jurisdictions. There are no costs to the respondents
that occurred in multiple countries in Thus in 2014, the CDC requested and other than their time. The total
West Africa. The CDC activated its received an expedited emergency annualized burden requested is 14,702
Emergency Operations Center on July 9, review and approval from OMB of an hours.

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

General Public—Case .................................... Ebola Virus Disease Case Investigation 15 1 30/60
Form—United States.
General Public—Case .................................... Symptom Monitoring Form ............................. 15 42 5/60
General Public—Person Under Investigation Ebola Virus Disease Person Under Inves- 300 1 10/60
(PUI). tigation (PUI) Form.
General Public—Person Under Investigation Symptom Monitoring Form ............................. 300 42 5/60
(PUI).
General Public—Contact ................................ Ebola Virus Disease Contact Tracing Form— 105 1 10/60
United States.
General Public—Contact ................................ Symptom Monitoring Form ............................. 105 42 5/60
Healthcare Workers ........................................ Ebola Virus Disease Tracking Form for 600 15 10/60
Healthcare Workers with Direct Patient
Contact.
Healthcare Workers ........................................ Symptom Monitoring Form ............................. 600 57 5/60
Laboratory Personnel ...................................... Ebola Tracking Form for Laboratory Per- 600 15 10/60
sonnel.
Laboratory Personnel ...................................... Symptom Monitoring Form ............................. 600 57 5/60
Environmental Services Personnel ................. Ebola Tracking Form for Environmental 600 15 10/60
Services Personnel.
Environmental Services Personnel ................. Symptom Monitoring Form ............................. 600 57 5/60
State, Territorial, and Local Public Health Au- White House Evening Report ........................ 15 42 10/60
thorities and Their Delegates.

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

Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Chief, Information Collection Review Office, HUMAN SERVICES Administration (FDA or Agency) is
Office of Scientific Integrity, Office of the announcing the availability of a draft
Associate Director for Science, Office of the Food and Drug Administration guidance for industry entitled
Director, Centers for Disease Control and ‘‘Testicular Toxicity: Evaluation During
Prevention. [Docket No. FDA–2015–D–2306] Drug Development.’’ The draft guidance
[FR Doc. 2015–17554 Filed 7–16–15; 8:45 am] addresses nonclinical findings that may
srobinson on DSK5SPTVN1PROD with NOTICES

BILLING CODE 4163–18–P Testicular Toxicity: Evaluation During raise concerns of a drug-related adverse
Drug Development; Draft Guidance for effect on the testes, clinical monitoring
Industry; Availability of adverse testicular effects early in
AGENCY: Food and Drug Administration, clinical development, and the design
HHS. and conduct of a safety clinical trial
assessing drug-related testicular
ACTION: Notice.
toxicity. The draft guidance is intended

VerDate Sep<11>2014 20:59 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\17JYN1.SGM 17JYN1
Document Created: 2018-02-23 09:21:27
Document Modified: 2018-02-23 09:21:27
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 42500
80 FR 42500 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 137 (July 17, 2015)

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