80_FR_42637 80 FR 42500 - Agency Forms Undergoing Paperwork Reduction Act Review

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 Range42500-42501
FR Document2015-17554

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]


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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 omb@cdc.gov. 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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 42500 
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