82 FR 24709 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 102 (May 30, 2017)

Page Range		24709-24710
FR Document		2017-11019

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 an information collection titled ``Zika Virus Enhanced Surveillance of Selected Populations.'' This information collection will help state health departments better define the public health burden and clinical characteristics of Zika virus disease.

Federal Register, Volume 82 Issue 102 (Tuesday, May 30, 2017)

[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24709-24710]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17AHW; Docket No. CDC-2017-0052]


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 an information 
collection titled ``Zika Virus Enhanced Surveillance of Selected 
Populations.'' This information collection will help state health 
departments better define the public health burden and clinical 
characteristics of Zika virus disease.

DATES: Written comments must be received on or before July 31, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0052 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 Leroy A. Richardson, 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 Enhanced Surveillance of Selected Populations--Emergency 
ICR--National Center for Emerging and Zoonotic Infectious Diseases 
(NCEZID), Centers for Disease Control and Prevention (CDC)

Background and Brief Description
    Zika virus is a mosquito-borne flavivirus primarily transmitted to 
humans by Aedes mosquitoes. Zika virus infections can also be 
transmitted congenitally, at the time of birth from a viremic mother to 
her newborn, sexually, through blood transfusion, and through 
inadvertent laboratory exposure. Most Zika virus infections are 
asymptomatic. Clinical illness, when it occurs, is generally mild and 
characterized by acute onset of fever, maculopapular rash, arthralgia, 
and/or nonpurulent conjunctivitis. As routine surveillance data have 
been reported to CDC, it has become apparent that the

[[Page 24710]]

full spectrum of Zika virus disease may have been underestimated. In 
addition, there has been recent recognition that some non-congenital 
infections are quite severe. Guillain-Barre syndrome, other neurologic 
manifestations, and thrombocytopenia have been reported following Zika 
virus infections, but specific clinical findings and outcomes are not 
well described. Additionally, there are few published reports 
describing postnatally-acquired Zika virus disease among children, but 
there is some indication that the disease presentation in children may 
differ from that seen in adults. Identifying risk factors for 
developing more severe disease with Zika virus infections and better 
describing the full spectrum of Zika virus disease is important to 
obtain prior to the next transmission season in order develop or revise 
existing guidance used by clinicians and public health officials.
    This information is essential to the CDC's ongoing Zika response in 
order to be able to develop more specific guidance and other 
informational tools for clinicians who care for patients and assist 
public health officials in targeting prevention messages towards high 
risk groups. This information will help healthcare providers recognize 
Zika virus disease among their patients and allow them to alert their 
state or local health department of suspect cases to facilitate 
diagnosis and mitigate the risk for local transmission.
    CDC cannot reasonably comply with the normal OMB clearance 
procedures given the need for these data to evaluate and revise 
existing guidance documents and informational products prior to the 
summer months when we anticipate that Zika virus transmission in the 
Americas will substantially increase.
    CDC will request an accelerated OMB review to give CDC the ability 
to rapidly answer urgent remaining questions that will shape the course 
of this public health emergency response.
    The specific goals and objectives are:
    1. Describe the clinical manifestations and outcomes among:
    a. Patients hospitalized for Zika virus disease.
    b. Children <18 years of age with postnatally acquired Zika virus 
disease.
    c. Children of different age groups.
    d. Persons with neurologic symptoms associated with Zika virus 
disease.
    2. Assess for unique clinical feature of Zika virus disease in 
children <18 years of age.
    3. Compare demographics, underlying medical conditions, and acute 
symptoms among cases hospitalized and not hospitalized for Zika virus 
disease.
    Basic demographic information, clinical, and laboratory data will 
be collected by participating health departments from patients/
guardians, providers, or medical records as appropriate. Many of the 
data elements included in the Enhanced Surveillance Forms are standard 
ArboNET variables covered by OMB Control No. 0920-0728.
    Additional data elements requested for this enhanced surveillance 
project are sometimes already routinely collected by health departments 
but are not reported to CDC.
    Once eligible cases are identified by participating health 
departments, staff will extract data already collected using pre-
existing case report forms and available medical records.
    If data are missing in existing records, patients/caregivers or 
healthcare providers will be contacted telephonically using a standard 
script and the case investigation form to collect any additional data 
elements needed.
    Once data are collected, participating sites will submit data to 
CDC through secure means. Data will be coded prior to submission to CDC 
for analysis purposes.
    There is no cost to respondents other than the time to participate.
    Authorizing legislation comes from Section 301 of the Public Health 
Service Act (42 U.S.C. 241).

                                        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)
----------------------------------------------------------------------------------------------------------------
Health Departments............  Zika Virus                    11               3               4             132
                                 Disease
                                 Enhanced
                                 Surveillance--N
                                 eurologic
                                 symptoms
                                 associated with
                                 Zika virus
                                 disease.
                                Zika Virus                    12              10               1             120
                                 Disease
                                 Enhanced
                                 Surveillance--P
                                 ostnatally
                                 acquired Zika
                                 virus disease
                                 among children
                                 aged <18 years.
                                Zika Virus                    12               5               2             120
                                 Disease
                                 Enhanced
                                 Surveillance--H
                                 ospitalization
                                 associated with
                                 Zika virus
                                 disease.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             372
----------------------------------------------------------------------------------------------------------------


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. 2017-11019 Filed 5-26-17; 8:45 am]
 BILLING CODE 4163-18-P

24710 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices

full spectrum of Zika virus disease may health department of suspect cases to departments from patients/guardians,
have been underestimated. In addition, facilitate diagnosis and mitigate the risk providers, or medical records as
there has been recent recognition that for local transmission. appropriate. Many of the data elements
some non-congenital infections are quite CDC cannot reasonably comply with included in the Enhanced Surveillance
severe. Guillain-Barre syndrome, other the normal OMB clearance procedures Forms are standard ArboNET variables
neurologic manifestations, and given the need for these data to evaluate covered by OMB Control No. 0920–
thrombocytopenia have been reported and revise existing guidance documents 0728.
following Zika virus infections, but and informational products prior to the Additional data elements requested
specific clinical findings and outcomes summer months when we anticipate for this enhanced surveillance project
are not well described. Additionally, that Zika virus transmission in the are sometimes already routinely
there are few published reports Americas will substantially increase. collected by health departments but are
describing postnatally-acquired Zika CDC will request an accelerated OMB not reported to CDC.
virus disease among children, but there review to give CDC the ability to rapidly
answer urgent remaining questions that Once eligible cases are identified by
is some indication that the disease participating health departments, staff
presentation in children may differ from will shape the course of this public
health emergency response. will extract data already collected using
that seen in adults. Identifying risk pre-existing case report forms and
factors for developing more severe The specific goals and objectives are:
1. Describe the clinical manifestations available medical records.
disease with Zika virus infections and
and outcomes among: If data are missing in existing records,
better describing the full spectrum of
a. Patients hospitalized for Zika virus patients/caregivers or healthcare
Zika virus disease is important to obtain
disease. providers will be contacted
prior to the next transmission season in b. Children <18 years of age with telephonically using a standard script
order develop or revise existing postnatally acquired Zika virus disease. and the case investigation form to
guidance used by clinicians and public c. Children of different age groups. collect any additional data elements
health officials. d. Persons with neurologic symptoms needed.
This information is essential to the associated with Zika virus disease.
CDC’s ongoing Zika response in order to Once data are collected, participating
2. Assess for unique clinical feature of
be able to develop more specific sites will submit data to CDC through
Zika virus disease in children <18 years
guidance and other informational tools secure means. Data will be coded prior
of age.
for clinicians who care for patients and 3. Compare demographics, underlying to submission to CDC for analysis
assist public health officials in targeting medical conditions, and acute purposes.
prevention messages towards high risk symptoms among cases hospitalized and There is no cost to respondents other
groups. This information will help not hospitalized for Zika virus disease. than the time to participate.
healthcare providers recognize Zika Basic demographic information, Authorizing legislation comes from
virus disease among their patients and clinical, and laboratory data will be Section 301 of the Public Health Service
allow them to alert their state or local collected by participating health Act (42 U.S.C. 241).

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

Health Departments .......................... Zika Virus Disease Enhanced Sur- 11 3 4 132
veillance—Neurologic symptoms
associated with Zika virus disease.
Zika Virus Disease Enhanced Sur- 12 10 1 120
veillance—Postnatally acquired
Zika virus disease among children
aged <18 years.
Zika Virus Disease Enhanced Sur- 12 5 2 120
veillance—Hospitalization associ-
ated with Zika virus disease.

Total ........................................... ........................................................... ........................ ........................ ........................ 372

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.
sradovich on DSK3GMQ082PROD with NOTICES

[FR Doc. 2017–11019 Filed 5–26–17; 8:45 am]
BILLING CODE 4163–18–P

VerDate Sep<11>2014 19:59 May 26, 2017 Jkt 241001 PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 E:\FR\FM\30MYN1.SGM 30MYN1

Document Created: 2018-11-08 08:55:30
Document Modified: 2018-11-08 08:55:30

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
Action		Notice with comment period.
Dates		Written comments must be received on or before July 31, 2017.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, 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]
FR Citation		82 FR 24709

82 FR 24709 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 82, Issue 102 (May 30, 2017)

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