[Federal Register Volume 81, Number 84 (Monday, May 2, 2016)]
[Notices]
[Pages 26231-26234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AFR; Docket No. CDC-2016-0040]


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 an information 
collection request proposal entitled ``Continuing International and 
Domestic Information Collections from the 2016 Zika Virus Emergency 
Response.'' These collections will allow CDC to continue its ongoing 
response to the Zika virus outbreak.

DATES: Written comments must be received on or before July 1, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0040 by any of the following methods:

[[Page 26232]]

     Federal eRulemaking Portal: Regulation.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

    Continuing International and Domestic Information Collections from 
the 2016 Zika Virus Emergency Response--New--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    In May 2015, the Pan American Health Organization (PAHO) issued an 
alert regarding the first confirmed Zika virus infections in Brazil. 
Since then, CDC has been responding to increased reports of Zika and 
has assisted in investigations with PAHO and the Brazil Ministry of 
Health. The first regional travel notices for Zika in South America and 
Mexico were posted in December 2015. In December 2015, the Commonwealth 
of Puerto Rico, a United States territory, reported its first confirmed 
locally transmitted Zika virus case. Cases of local transmission have 
recently been confirmed in two other US territories, the United States 
Virgin Islands and American Samoa. As of April 6, 2016, US territories 
had reported 351 locally acquired Zika cases and 3 travel-associated 
Zika cases to CDC. Of the 354 cases reported, 37 were in pregnant 
women. Zika has not been spread by mosquitoes in the continental United 
States. However, lab tests have confirmed Zika virus in travelers 
returning to the United States. These travelers have gotten the virus 
from mosquito bites and a few non-travelers got Zika through sex. With 
the recent outbreaks in the Americas, the number of Zika cases among 
travelers visiting or returning to the United States is increasing. CDC 
monitors and reports to the public cases of Zika, which will help 
improve our understanding of how and where Zika is spreading.
    Zika virus is spread to people primarily through the bite of an 
infected Aedes species mosquito (A. aegypti and A. albopictus). 
Mosquitoes that spread Zika virus are aggressive daytime biters, but 
they can also bite at night. A pregnant woman can pass Zika virus to 
her fetus during pregnancy. CDC is studying how Zika affects 
pregnancies. Zika is linked to microcephaly, a severe birth defect that 
is a sign of incomplete brain development. Microcephaly is a condition 
where a baby's head is much smaller than expected. During pregnancy, a 
baby's head grows because the baby's brain grows. Microcephaly can 
occur because a baby's brain has not developed properly during 
pregnancy or has stopped growing after birth.
    In February and March 2016, CDC used OMB emergency clearance 
procedures to initiate and expedite multiple urgently needed 
information collections in American Samoa, Puerto Rico, Brazil, and 
domestically within state, tribal, local, and territorial (STLT) 
jurisdictions. These procedures have allowed the agency to target and 
refine public health interventions to arrest ongoing spread of 
infection.
    With this notice, the CDC is announcing its intention to seek OMB 
clearances to continue four Zika-related information collections beyond 
their current emergency expiration dates. These four projects will be 
submitted to OMB as standalone ICRs:
    1. A call center in CDC's Emergency Operations Center (EOC) to 
respond to inquiries on clinical care of persons potentially of 
interest for Zika virus infection [OMB Control No. 0920-1101, 
expiration date 8/31/16]. Respondents to this information collection 
include the general public, clinicians, and employees at STLT health 
departments. The purpose of this information collection is to document 
and track clinical inquiries made to the CDC EOC call center and to 
systematically collect standardized clinical/demographic/
epidemiological information about suspected cases. The emergency 
clearance for this information collection dealt specifically with Zika-
related clinical inquiries. However, the new ICR will cover this 
project for any EOC activation. Regardless of the disease or hazard 
being responded to, the EOC operates this call center to answer and 
respond to clinical inquiries. This information collection is a 
necessary part of operating this call center and responding to 
emergency situations.
    2. A study, in Puerto Rico, on the persistence of Zika virus in 
bodily fluids [OMB Control No. 0920-1106, expiration date 9/30/16]. 
Since getting OMB approval in March 2016, CDC has

[[Page 26233]]

investigated the persistence of Zika virus in different body fluids 
(shedding) and its relation to immune response to provide a basis for 
development of non-blood-based diagnostic tools, and target and refine 
public health interventions to arrest ongoing spread of infection. CDC 
has begun a prospective cohort study of symptomatic individuals with 
reverse transcription-polymerase chain reaction (RT-PCR) positive Zika 
virus infection and a cross-sectional study of their household 
contacts. Information collection is expected to conclude within one 
year. Results and analyses will be used to update relevant counseling 
messages and recommendations from the CDC. Participants for the 
shedding study are patients with laboratory-confirmed Zika virus 
infection and their household contacts.
    3. A study, carried out in the United States, on the persistence of 
Zika virus in the semen and urine of men with laboratory-confirmed Zika 
virus infection [OMB Control No. 0920-1109, expiration date 9/30/2016]. 
Since getting emergency OMB approval in March, 2016, specimens have 
been tested for Zika RNA by reverse transcriptase polymerase chain 
reaction assay (RT-PCR) at CDC; those testing positive may be further 
evaluated by virus isolation techniques. Zika virus disease is a 
nationally notifiable condition, and participants are recruited through 
contact with CDC personnel. Urine and semen specimens are self-
collected using home collection kits, a short questionnaire is self-
administered, and participants receive a token of appreciation. Results 
of testing will be provided to participants at the conclusion of 
testing. The results of this study are expected to have immediate 
implications for public health recommendations and disease prevention. 
The results of this study will be of great relevance to provide 
evidence-based information to circumvent Zika virus transmission. They 
will inform the development of recommendations used in the current 
epidemic setting, as well as in future Zika virus situations. Results 
and analysis will be used to update and refine relevant counseling 
messages and recommendations.
    4. Registry of pregnant women with laboratory-confirmed Zika virus 
infections in the U.S. [OMB Control No. 0920-1101, expiration date 8/
31/16]. As part of the public health response to the Zika virus disease 
outbreak, CDC has been collecting information from clinicians in the 
U.S. about pregnant women they treat who are diagnosed with Zika virus 
infection. CDC also plans to collect information from clinicians about 
their patients' infants in order to better understand the clinical 
consequences of Zika virus infection in pregnancy and its impact on 
newborn infants. Information gathered directs public health messages 
provided by CDC on reducing the risk of adverse outcomes for pregnant 
women and their infants.
    These information collections will align with their legislative 
authority, 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 1,146 hours. This number 
represents the number of burden hours yet to be imposed. It does not 
include the burden hours sustained during the initial six-month 
emergency clearance period.

                                        Estimated Annualized Burden Hours
                                         1--Clinical Inquiries Database
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                                                                     Number of      Avg. burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Local health departments......  Clinical                     420               1           15/60             105
                                 inquiries
                                 database.
Clinicians and other providers  Clinical                     800               1           15/60             200
                                 inquiries
                                 database.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             305
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                        2--Persistence of Zika Virus in Bodily Fluids Study, Puerto Rico
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                                                                       Number of      Avg. burden
      Type of respondents            Form name         Number of     responses per   per response   Total burden
                                                      respondents     respondent       (in hrs.)      (in hrs.)
----------------------------------------------------------------------------------------------------------------
Public health personnel........  Questionnaire                 200               8           10/60           267
                                  (Symptomatics).
                                 Questionnaire                 600               1           10/60           100
                                  (Cross-Sectional
                                  household
                                  contacts).
General public.................  Eligibility Form.           1,000               1            2/60            33
                                                   -------------------------------------------------------------
    Total......................  .................  ..............  ..............  ..............           400
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                       3--Persistence of Zika Virus in Bodily Fluids Study, United States
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                                                                       Number of      Avg. burden
      Type of respondents            Form name         Number of     responses per   per response   Total burden
                                                      respondents     respondent       (in hrs.)      (in hrs.)
----------------------------------------------------------------------------------------------------------------
General public.................  Introductory                  175               1            2/60             6
                                  survey.
                                 Follow-Up survey.             175              12            1/60            35
                                                   -------------------------------------------------------------
    Total......................  .................  ..............  ..............  ..............            41
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[[Page 26234]]


                                              4--Pregnancy Registry
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                                                                       Number of      Avg. burden
      Type of respondents            Form name         Number of     responses per   per response   Total burden
                                                      respondents     respondent       (in hrs.)      (in hrs.)
----------------------------------------------------------------------------------------------------------------
State and Local Health           Maternal Health               100               5           30/60           250
 Departments.                     History Form.
                                 Specimen                      100               1           15/60            25
                                  Collection Form.
Clinicians and other providers.  Assessment at                 100               1           30/60            50
                                  Delivery Form.
                                 Infant Health                 100               1           30/60            50
                                  Follow-Up Form.
                                                   -------------------------------------------------------------
    Total......................  .................  ..............  ..............  ..............           400
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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. 2016-10113 Filed 4-29-16; 8:45 am]
 BILLING CODE 4163-18-P