[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16405-16408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15UX: Docket No. CDC-2015-0011]


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.

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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 ``Continuing and 
New International and U.S. Data Collections from the 2014 CDC Ebola 
Virus Disease Emergency Response''. Under the current 60-day Federal 
Register Notice, the CDC is announcing its intention to seek three-year 
OMB approval to continue several Ebola-related information collections 
beyond their current emergency expiration dates and to conduct newly 
proposed information collections within international borders of Ebola-
affected West African countries and within the domestic borders of 
State, Territorial and Local (STL) public health authorities in the 
U.S. These existing ``source'' information collections and new 
information collection requests (ICRs) will be submitted under four 
``destination'' ICRs for Office of Management and Budget (OMB) 
approval.

DATES: Written comments must be received on or before May 26, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0011, by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#214e4c43614245420f464e57"><span class="__cf_email__" data-cfemail="4b2426290b282f28652c243d">[email protected]</span></a>.

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 and New International and U.S. Data Collections from the 
2014 CDC Ebola Virus Disease Emergency Response--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 Centers for Disease Control and Prevention (CDC) Emergency 
Operations Center (EOC) was activated 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 (DHS) Customs and Border Patrol (CBP) 
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 used OMB emergency clearance procedures to 
initiate and expedite multiple urgently needed information collections 
in West Africa, at U.S. ports of entry, and within STL jurisdictions. 
These procedures allowed the agency to accomplish its primary mission 
on many fronts to quickly prevent public harm, illness,

[[Page 16406]]

and death from the uncontrolled spread of EVD.
    With this notice, the CDC is announcing its intention to seek 
three-year OMB clearances to continue several Ebola-related information 
collections beyond their current emergency expiration dates and to 
conduct newly proposed information collections within international 
borders of Ebola-affected West African countries and within the 
domestic borders of STL public health authorities in the U.S. These 
existing ``source'' information collections and new ICRs will be 
submitted under four ``destination'' ICRs for OMB approval.
    On the international front, CDC seeks to continue to address key 
public health surveillance and medical treatment objectives in 
collaboration with West African ministries of health (MoHs), the World 
Health Organization (WHO), and other key partners. Examples of 
``source'' information collections include: (1) ``2014 Emergency 
Response to Ebola in West Africa'' (OMB Control No. 0920-1033, 
expiration date 4/30/2015) which helped to establish country EVD 
surveillance systems for case investigations and contact tracing; and 
(2) the emergency clearance for ``Household Transmission Survey--a 
Public Health Response Evaluation in Western Area, Sierra Leone'' (OMB 
Control No. 0920-1043, expiration date 07/31/2015). This was a one-time 
investigation that will be the first of a new ``destination'' generic 
clearance ICR that will identify ways to improve established 
surveillance systems in other West African countries and settings.
    On the domestic front, CDC's information collections will focus on 
continued support of STL public health authorities and healthcare 
providers in EVD infection control and notifiable disease reporting to 
the CDC. CDC wishes to extend OMB clearance for the ``source'' 
emergency information collection, ``Ebola Virus Disease in the United 
States: CDC Support for Case and Contact Investigation'' (OMB Control 
Number 0920-1045, expiration date: 07/31/2015). For this, the CDC 
proposes a new ``destination'' ICR titled ``National Disease 
Surveillance Program III--CDC Support for Case Investigations, Contact 
Tracing, and Case Reports.'' This new mechanism will be 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.
    The CDC will seek OMB approval for another new domestic ICR titled 
``CDC Emergency Operations Center Clinical Inquiries'' an Ebola-related 
information collection currently in use without an OMB control number. 
Early in the response, a call center was quickly set up to support 
urgent inquiries about active monitoring, diagnosis, and clinical 
treatment of EVD. The clinical inquirers were STL authorities and 
health facilities that were notified by U.S. Quarantine Stations that 
persons requiring investigation and possible treatment for EVD were 
arriving in their respective jurisdictions and facilities.
    Although initiated by EOC Task Forces, the lead CDC center for the 
emergency response (based on subject matter, mission, and program 
areas) will sponsor these information collections. These information 
collections will align with their legislative authority, which is 
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 378,695 hours.

Estimated Annualized Burden Hours

                                      A--CDC International Emergency Response Case and Contact Surveillance Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Public.................................  A1--Viral Hemorrhagic Fever Case                 13,650               1           20/60           4,550
                                                  Investigation Form (English).
General Public.................................  A2--Viral Hemorrhagic Fever Case                  7,350               1           20/60           2,450
                                                  Investigation Form (French).
General Public.................................  A3--Viral Hemorrhagic Fever Case                  5,850               1           10/60             975
                                                  Investigation Short Form (English).
General Public.................................  A4--Viral Hemorrhagic Fever Case                  3,150               1           10/60             525
                                                  Investigation Short Form (French).
General Public.................................  A5--Viral Hemorrhagic Fever Contact              19,500               1           15/60           4,875
                                                  Listing Form (English).
General Public.................................  A6--Viral Hemorrhagic Fever Contact              10,500               1           15/60           2,625
                                                  Listing Form (French).
General Public.................................  A7--Viral Hemorrhagic Fever Contact             195,000               1           63/60         204,750
                                                  Tracing Follow-Up Form (English).
General Public.................................  A8--Viral Hemorrhagic Fever Contact             105,000               1           63/60         110,250
                                                  Tracing Follow-Up Form (French).
General Public.................................  A9--Ebola Virus Disease Case Contact            195,000               1            5/60          16,250
                                                  Questionnaire (English).
General Public.................................  A10--Ebola Virus Disease Case Contact           105,000               1            5/60           8,750
                                                  Questionnaire (French).
General Public.................................  A11--Ebola Outbreak Response Sexual                 500               1           30/60             250
                                                  Transmission Adult Case Investigation
                                                  Form (English).
General Public.................................  A12--Ebola Outbreak Response Sexual                 300               1           30/60             150
                                                  Transmission Adult Case Investigation
                                                  Form (French).
Healthcare Workers or Proxy....................  A13--Healthcare Worker Ebola Virus                1,950               1           30/60             975
                                                  Disease Exposure Report--West Africa
                                                  (CDC-WHO) (English).
Healthcare Workers or Proxy....................  A14--Healthcare Worker Ebola Virus                1,050               1           30/60             525
                                                  Disease Exposure Report--West Africa
                                                  (CDC-WHO) (French).

[[Page 16407]]

 
Healthcare Workers or Proxy....................  A15--Healthcare Worker Ebola Virus                  400               1           30/60             200
                                                  Investigation Questionnaire (Liberia).
Healthcare Workers or Proxy....................  A16--Healthcare Worker Ebola Virus                  400               1           30/60             200
                                                  Disease Exposure Report (Sierra Leone).
Healthcare Workers or Proxy....................  A17--Health Facility Assessment and               3,900               1           30/60           1,950
                                                  Case Finding Survey (English).
Healthcare Workers or Proxy....................  A18--Health Facility Assessment and               2,100               1           30/60           1,050
                                                  Case Finding Survey (French).
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............         361,300
--------------------------------------------------------------------------------------------------------------------------------------------------------


                     B--Generic Clearance for ``Household Transmission Surveys in West Africa: Public Health Response Evaluations''
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Case-patients or caregiver (as proxy)..........  B1--Initial Questionnaire for Case-                 357               1           20/60             119
                                                  Patients--SAMPLE FORM.
Heads of household.............................  B2--Questionnaire for Ebola-affected                357               1           20/60             119
                                                  Households--SAMPLE FORM.
Household contacts of case-patient.............  B3--Questionnaire for Investigation of            3,570               1           30/60           1,785
                                                  Household Contacts of Ebola-infected
                                                  Case-patients--SAMPLE FORM.
Household contacts of case-patient.............  B4--Contact Exit Questionnaire--SAMPLE            3,570               1            5/60             298
                                                  FORM.
Laboratory analyst and project staff...........  B5--Patient Laboratory Record--SAMPLE               573               1            5/60              48
                                                  FORM.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           2,369
--------------------------------------------------------------------------------------------------------------------------------------------------------


                 C--``National Disease Surveillance Program III--CDC Support for Case Investigation, Contact Tracing, and Case Reports''
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Public--Case...........................  C1--Ebola Virus Disease Case                         15               1           30/60               8
                                                  Investigation Form--United States.
General Public--Case...........................  C2--Symptom Monitoring Form............              15              57            5/60              72
General Public--Person Under Investigation       C3--Ebola Virus Disease Person Under                300               1           10/60              50
 (PUI).                                           Investigation (PUI) Form.
General Public--Person Under Investigation       C2--Symptom Monitoring Form............             300              42            5/60           1,050
 (PUI).
General Public--Contact........................  C4--Ebola Virus Disease Contact Tracing             105               1           10/60              18
                                                  Form--United States.
General Public--Contact........................  C2--Symptom Monitoring Form............             105              42            5/60             368
Healthcare Workers.............................  C5--Ebola Virus Disease Tracking Form               600              15           10/60           1,500
                                                  for Healthcare Workers with Direct
                                                  Patient Contact.
Healthcare Workers.............................  C2--Symptom Monitoring Form............             600              57            5/60           2,850
Laboratory Personnel...........................  C6--Ebola Tracking Form for Laboratory              600              15           10/60           1,500
                                                  Personnel.
Laboratory Personnel...........................  C2--Symptom Monitoring Form............             600              57            5/60           2,850
Environmental Services Personnel...............  C7--Ebola Tracking Form for                         600              15           10/60           1,500
                                                  Environmental Services Personnel.
Environmental Services Personnel...............  C2--Symptom Monitoring Form............             600              57            5/60           2,850

[[Page 16408]]

 
State, Territorial, and Local Public Health      C8--Daily and Weekly Report............              15              42           10/60             105
 Authorities and Their Delegates.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............          14,721
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                                                D--``CDC Emergency Operations Center Clinical Inquiries''
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
State and Local Health Departments.............  D1--Clinical Inquiries Database........             420               1           15/60             105
Clinicians and Other Providers.................  D1--Clinical Inquiries Database........             800               1           15/60             200
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             305
--------------------------------------------------------------------------------------------------------------------------------------------------------


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. 2015-07037 Filed 3-26-15; 8:45 am]
 BILLING CODE 4163-18-P


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