[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Notices]
[Pages 81143-81144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27692]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17ZQ; Docket No. CDC-2016-0107]


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.

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

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 Zika Virus 
Associated Neurologic Illness Case Control Study. This collection 
intends to identify potential risk factors for the development of 
severe neurologic illnesses using a case-control investigation.

DATES: Written comments must be received on or before January 17, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0107 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.
    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: [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 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

    Zika Virus Associated Neurologic Illness Case Control Study--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    There is an urgent public health need to understand the potential 
association between neurological illness and Zika Virus (ZIKV) 
infection. Currently, increased numbers of neurologic illness cases 
have been reported in ZIKV-affected contexts, but it is not known if 
this is due to ZIKV, another etiologic agent, or some combination/
interaction thereof. The Puerto Rico Department of Health (PRDH) is 
establishing neurologic illness surveillance and defining baseline 
incidence toward investigating the association between neurologic 
illness and ZIKV infection in Puerto Rico. More broadly, the results of 
this investigation would be relevant to other ZIKV-affected contexts, 
serving toward enabling clinical and/or public health action to manage 
and prevent additional cases.
    A case-control investigation will be conducted to identify 
potential risk factors for the development of neurological illness. As 
part of the investigation, blood specimens will be collected from cases 
and matched controls to evaluate for antibodies against several 
pathogens known to cause neurological illness (e.g., influenza) or 
pathogens hypothesized to contribute to this illness cluster (e.g., 
ZIKV, dengue virus, chikungunya virus, HIV, Campylobacter jejuni, 
Leptospira species bacteria).
    This information collection request is a continuation on the work 
begun under the following Emergency Clearance: OMB 0920-1106 
(Expiration date 9/30/16). Specifically, beginning in March 2016, CDC 
collaborated with the PRDH on the collection of very similar data for a 
Guillain-Barre syndrome case-control

[[Page 81144]]

investigation. After clinical reports and field observation of a 
broader range of health endpoints, this larger investigation is now 
being undertaken to expand the exploration of the association of Zika 
virus infection with not only Guillain-Barre syndrome but also other 
severe neurologic illnesses.
    Under this request, case and control interviews similar to those 
conducted under the previously approved information collection will be 
conducted using the questionnaire developed by the investigation team. 
All cases and controls will be asked questions about activities, 
antecedent signs and symptoms of illness, and exposures in the two 
months prior to onset of neurologic illness for cases and the same time 
period for their matched controls. A calendar will be used to orient 
cases and controls to the time period of interest.
    As in the previously approved information collection activities, 
sera, urine, and saliva will be collected from cases and controls at 
the time of interview using standard techniques. The sera will be 
tested for antibodies against suspected infectious pathogens, such as 
ZIKV, dengue virus, chikungunya virus, influenza virus, human 
immunodeficiency virus, and Leptospira species bacteria. Urine 
specimens will be tested by rRT-PCR to identify ZIKV, dengue virus, or 
chikungunya virus.
    If any residual specimens are available from cases, those will also 
be obtained and undergo testing for infectious pathogens. It is not 
expected that matched controls will have any previously collected 
clinical specimens; however, in cases where controls had specimens 
collected while seeking medical care for an acute illness experienced 
within two months of GBS symptom onset of the matching case, these 
specimens will also be collected and tested for evidence of infection 
with the aforementioned pathogens.
    Residual samples will be stored after infectious testing is 
complete at the U.S. CDC with an identification number for possible 
additional testing for GBS-associated biological markers or other 
infectious pathogens as clinically indicated. If a participant does not 
provide consent to store the specimens, all specimens for that 
participant will be destroyed once testing for infectious disease 
pathogens has been completed. As with cases, written consent will also 
be obtained to review controls' medical records, where applicable and 
available, using a standardized chart abstraction form. Diagnostic test 
results will be securely transmitted from CDC to PRDH, which will then 
transmit diagnostic test results to participants by telephone or mail, 
as they prefer.
    Data analysis will focus on potential demographic, environmental, 
and/or medical risk factors for developing neurologic illness, as well 
as laboratory evidence for infection with the aforementioned pathogens.
    The total number of estimated annualized burden hours for this 
project is 90. There are no other costs to respondents other than their 
time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Public Health Personnel.......  Severe                        10               6               1              60
                                 Neurologic
                                 Illness Chart
                                 Abstraction
                                 Questionnaire.
General Public................  Severe                       120               1           15/60              30
                                 Neurologic
                                 Illness
                                 Questionnaire
                                 for Cases and
                                 Controls.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              90
----------------------------------------------------------------------------------------------------------------


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. 2016-27692 Filed 11-16-16; 8:45 am]
 BILLING CODE 4163-18-P