82_FR_16902 82 FR 16837 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 16837 - 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 65 (April 6, 2017)

Page Range16837-16839
FR Document2017-06864

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 persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study) to fill gaps in the scientific knowledge base for ZIKV regarding the persistence and transmissibility of ZIKV in body fluids. This information assist ongoing public health response activities, as well as advance the scientific understanding of ZIKV illness and transmission.

Federal Register, Volume 82 Issue 65 (Thursday, April 6, 2017)
[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Notices]
[Pages 16837-16839]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06864]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-1140; Docket No. CDC-2017-0030]


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 
persistence in body fluids of patients with Zika virus infection in 
Puerto Rico (ZIPER Study) to fill gaps in the scientific knowledge base 
for ZIKV regarding the persistence and transmissibility of ZIKV in body 
fluids. This information assist ongoing public health response 
activities, as well as advance the scientific understanding of ZIKV 
illness and transmission.

DATES: Written comments must be received on or before June 5, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0030 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

[[Page 16838]]

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 persistence in body fluids of patients with Zika virus 
infection in Puerto Rico (ZIPER Study)--Revision--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    CDC plans to seek a one-year OMB approval to extend information 
collection covered under OMB Control Number 0920-1140, expiration date 
10/31/2017.
    The Zika PERsistence (ZIPER) study will help inform the presence 
and duration of Zika virus (ZIKV) shedding in several body fluids among 
RT-PCR-positive ZIKV cases from Puerto Rico. It will also provide 
information regarding the duration of detection of anti-ZIKV 
Immunoglobulin M (IgM) antibodies and the time for development of 
Immunoglobulin G (IgG) antibodies among the same population. In 
addition, this study will determine the prevalence of anti-ZIKV IgM and 
IgG, and virus shedding in body fluids among household contacts of ZIKV 
cases.
    We propose to investigate the persistence (shedding) of ZIKV in 
different body fluids 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. To do so, we will conduct a prospective cohort study of 
individuals with reverse transcription-polymerase chain reaction (RT-
PCR) positive ZIKV infection and a cross-sectional study of their 
household contacts. Results and analyses will be used to update 
relevant counseling messages and recommendations from the CDC.
    The study will include baseline and follow-up questionnaires and 
the collection of the following specimens: blood, saliva, urine from 
participants of all ages, and semen/vaginal secretions from adults 
(ages 21 years or older) and legally emancipated minors (support 
themselves financially, live independent of their parents, are 
pregnant, or have children). Individuals with RT-PCR positive ZIKV 
infection will be recruited through the Sentinel Enhanced Dengue 
Surveillance System (SEDSS) at Saint Luke's Episcopal Hospital in 
Ponce, Puerto Rico and through passive surveillance in selected 
municipalities in Puerto Rico. SEDSS was established in 2012 through a 
cooperative agreement between the hospital in Consortium with the Ponce 
School of Medicine and Ponce Research Institute from the Ponce Health 
Sciences University and the CDC (Protocol #6214). Specimens will be 
tested for the presence of ZIKV ribonucleic acid (RNA) by RT-PCR at the 
CDC Dengue Branch Laboratory in San Juan, and positive specimens will 
be further tested for virus isolation to evaluate infectivity. Each 
body fluid will be collected on a weekly basis for 4 weeks and biweekly 
thereafter until two consecutive negative RT-PCR results are obtained 
from all specimens. Irrespective of RNA detection, body fluids will 
also be collected for RT-PCT at 2, 4, and 6 months to investigate 
intermittent shedding. Analyses of antibody response through titers of 
IgM and IgG will be performed at baseline and repeated at 2, 4, and 6 
months. Among symptomatic participants seven milliliters (ml) of blood 
will be drawn at each study visit split into a tiger top tube (5ml) and 
a purple top tube (2ml) for a total not to exceed 50 ml during any 
given 8-week period. At enrollment healthy non-pregnant adults will 
have 20 ml of blood collected following standard procedures. Two tiger 
top tubes of 8.5 ml and one 3ml purple top tubes will be collected. 
These procedures will be repeated at each follow-up visit, see below. 
RT-PCR-positive participants will be asked to refer up to 5 household 
members to establish the percentage of household members with 
detectable and potentially infectious Zika virus RNA in body fluids. 
Household members who are found to be ZIKV RT-PCR-positive in any body 
fluid will be invited to participate in the cohort study. A second 
study visit will be scheduled with household contact at 2 or 4 months, 
to detect new infections and estimate incidence. Because the original 
study consent forms do not include this visit, household contacts will 
be contacted by study staff and will be consented again using the same 
consent form.
    Since receipt of the initial OMB information collection approval in 
October 2016, the project has enrolled 295 Zika virus-infected 
individuals into the Zika virus Persistence study, which are 55 
individuals below the target enrollment of 350 individuals. 
Nonetheless, preliminary findings have been published in New England 
Journal of Medicine, where we also expect that the final report that 
includes the full sample size will be published.
    This is a request to continue information collection with minor 
modifications. Modifications have been made to reflect the developing 
nature of the science surrounding Zika virus infection and potential 
outcomes associated with infection, as well as additional questions 
that were best answered by taking advantage of the existing study 
platform. Specifically, CDC proposes the addition of two components to 
the collection of data under this study, one of which has already 
begun:

    1. A follow-up household visit has been added to determine how many 
household members of Zika virus-infected participants become infected 
during the 4 months following initial screening. For any household 
members that had no evidence of Zika virus infection at the initial 
visit, the same questionnaires used at the initial household visit will 
again be completed ~4 months later. Such information will provide 
additional information regarding the incidence of Zika virus infections 
among households with a Zika-positive household member.
    2. Additionally, CDC proposes following up with men with Zika 
virus-positive semen specimens to better understand the effect of Zika 
virus infection on sperm. To do this, 8-14 semen ejaculates from 10-20 
men participating in the ZIPER study will be used to determine the 
presence and/or detection of the Zika virus in different fractions of 
the semen ejaculate (i.e., seminal plasma, cellular debris, including 
White Blood Cells [WBCs] and spermatozoa). CDC's Institutional Review 
Board (IRB) has approved this modification, but information collection 
has not begun.

    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).

[[Page 16839]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
      Type of respondents           Form name        Number of     responses per    burden per     Total burden
                                                    respondents     respondent    response (hrs)       (hrs)
----------------------------------------------------------------------------------------------------------------
Public health personnel.......  Shedding                      55               8           10/60              74
                                 Questionnaire
                                 (Symptomatics).
                                Shedding                     100               1           10/60              17
                                 Questionnaire
                                 (Cross-
                                 Sectional
                                 Asymptomatics).
                                Questionnaire                 30               1           20/60              10
                                 for men semen
                                 sub-study.
General public................  Shedding                     160               1            2/60               6
                                 Eligibility
                                 Form.
                                Contact                       32               1            2/60               1
                                 Information
                                 Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             108
----------------------------------------------------------------------------------------------------------------


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. 2017-06864 Filed 4-5-17; 8:45 am]
 BILLING CODE 4163-18-P



                                                                                      Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices                                                         16837

                                                  who drive a company vehicle will also                           additional minutes to complete for those                          Comments submitted in response to
                                                  be asked to complete ‘‘Module 4: Motor                          using the tablet (approximately 168                             this notice will be reviewed and
                                                  Vehicle.’’ An estimated 75% of the                              workers per year) as well as 5 minutes                          addressed prior to OMB application
                                                  workers will complete the driving                               for those completing the hardcopy                               submission. The total estimated burden
                                                  portion of the survey (187 workers).                            version (19 workers per year).                                  hours are 151.
                                                  This module will take approximately 5

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

                                                  Screening of Workers ........................................   Module 1: Screening .........................................             313               1   5/60
                                                  O&G Extraction Workers ...................................      Non Respondent Questionnaire .......................                       63               1   5/60
                                                  O&G Extraction Workers ...................................      Tablet Version, Modules 2: General, Module 3:                             225               1   25/60
                                                                                                                    Well Site Work, and, Module 5: Closing
                                                                                                                    Questions.
                                                  O&G Extraction Workers ...................................      Hardcopy, Version, Modules 2: General, Mod-                                25               1   25/60
                                                                                                                    ule 3: Well Site Work, and, Module 5: Clos-
                                                                                                                    ing Questions.
                                                  O&G Extraction Workers who drive at work .....                  Tablet Version, Module 4: Motor Vehicle .........                         168               1   5/60
                                                  O&G Extraction Workers who drive at work .....                  Hardcopy Version, Module 4: Motor Vehicle ....                             19               1   5/60


                                                  Leroy A. Richardson,                                            public health response activities, as well                      Management and Budget (OMB) for each
                                                  Chief, Information Collection Review Office,                    as advance the scientific understanding                         collection of information they conduct
                                                  Office of Scientific Integrity, Office of the                   of ZIKV illness and transmission.                               or sponsor. In addition, the PRA also
                                                  Associate Director for Science, Office of the                   DATES: Written comments must be                                 requires Federal agencies to provide a
                                                  Director, Centers for Disease Control and                       received on or before June 5, 2017.                             60-day notice in the Federal Register
                                                  Prevention.                                                                                                                     concerning each proposed collection of
                                                                                                                  ADDRESSES: You may submit comments,
                                                  [FR Doc. 2017–06874 Filed 4–5–17; 8:45 am]                                                                                      information, including each new
                                                                                                                  identified by Docket No. CDC–2017–
                                                  BILLING CODE 4163–18–P
                                                                                                                  0030 by any of the following methods:                           proposed collection, each proposed
                                                                                                                    • Federal eRulemaking Portal:                                 extension of existing collection of
                                                                                                                  Regulations.gov. Follow the instructions                        information, and each reinstatement of
                                                  DEPARTMENT OF HEALTH AND                                                                                                        previously approved information
                                                                                                                  for submitting comments.
                                                  HUMAN SERVICES                                                    • Mail: Leroy A. Richardson,                                  collection before submitting the
                                                  Centers for Disease Control and                                 Information Collection Review Office,                           collection to OMB for approval. To
                                                  Prevention                                                      Centers for Disease Control and                                 comply with this requirement, we are
                                                                                                                  Prevention, 1600 Clifton Road NE., MS–                          publishing this notice of a proposed
                                                  [60Day–17–1140; Docket No. CDC–2017–                            D74, Atlanta, Georgia 30329.                                    data collection as described below.
                                                  0030]                                                             Instructions: All submissions received                           Comments are invited on: (a) Whether
                                                                                                                  must include the agency name and                                the proposed collection of information
                                                  Proposed Data Collection Submitted                              Docket Number. All relevant comments                            is necessary for the proper performance
                                                  for Public Comment and                                          received will be posted without change                          of the functions of the agency, including
                                                  Recommendations                                                 to Regulations.gov, including any                               whether the information shall have
                                                  AGENCY: Centers for Disease Control and                         personal information provided. For                              practical utility; (b) the accuracy of the
                                                  Prevention (CDC), Department of Health                          access to the docket to read background                         agency’s estimate of the burden of the
                                                  and Human Services (HHS).                                       documents or comments received, go to                           proposed collection of information; (c)
                                                                                                                  Regulations.gov.                                                ways to enhance the quality, utility, and
                                                  ACTION: Notice with comment period.
                                                                                                                    Please note: All public comment                               clarity of the information to be
                                                  SUMMARY:    The Centers for Disease                             should be submitted through the                                 collected; (d) ways to minimize the
                                                  Control and Prevention (CDC), as part of                        Federal eRulemaking portal                                      burden of the collection of information
                                                  its continuing efforts to reduce public                         (Regulations.gov) or by U.S. mail to the                        on respondents, including through the
                                                  burden and maximize the utility of                              address listed above.                                           use of automated collection techniques
                                                  government information, invites the                             FOR FURTHER INFORMATION CONTACT: To                             or other forms of information
                                                  general public and other Federal                                request more information on the                                 technology; and (e) estimates of capital
                                                  agencies to take this opportunity to                            proposed project or to obtain a copy of                         or start-up costs and costs of operation,
                                                  comment on proposed and/or                                      the information collection plan and                             maintenance, and purchase of services
                                                  continuing information collections, as                          instruments, contact the Information                            to provide information. Burden means
                                                  required by the Paperwork Reduction                             Collection Review Office, Centers for                           the total time, effort, or financial
                                                  Act of 1995. This notice invites                                Disease Control and Prevention, 1600                            resources expended by persons to
mstockstill on DSK3G9T082PROD with NOTICES




                                                  comment on Zika virus persistence in                            Clifton Road NE., MS–D74, Atlanta,                              generate, maintain, retain, disclose or
                                                  body fluids of patients with Zika virus                         Georgia 30329; phone: 404–639–7570;                             provide information to or for a Federal
                                                  infection in Puerto Rico (ZIPER Study)                          Email: omb@cdc.gov.                                             agency. This includes the time needed
                                                  to fill gaps in the scientific knowledge                        SUPPLEMENTARY INFORMATION: Under the                            to review instructions; to develop,
                                                  base for ZIKV regarding the persistence                         Paperwork Reduction Act of 1995 (PRA)                           acquire, install and utilize technology
                                                  and transmissibility of ZIKV in body                            (44 U.S.C. 3501–3520), Federal agencies                         and systems for the purpose of
                                                  fluids. This information assist ongoing                         must obtain approval from the Office of                         collecting, validating and verifying


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                                                  16838                          Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices

                                                  information, processing and                             independent of their parents, are                       Since receipt of the initial OMB
                                                  maintaining information, and disclosing                 pregnant, or have children). Individuals              information collection approval in
                                                  and providing information; to train                     with RT–PCR positive ZIKV infection                   October 2016, the project has enrolled
                                                  personnel and to be able to respond to                  will be recruited through the Sentinel                295 Zika virus-infected individuals into
                                                  a collection of information, to search                  Enhanced Dengue Surveillance System                   the Zika virus Persistence study, which
                                                  data sources, to complete and review                    (SEDSS) at Saint Luke’s Episcopal                     are 55 individuals below the target
                                                  the collection of information; and to                   Hospital in Ponce, Puerto Rico and                    enrollment of 350 individuals.
                                                  transmit or otherwise disclose the                      through passive surveillance in selected              Nonetheless, preliminary findings have
                                                  information.                                            municipalities in Puerto Rico. SEDSS                  been published in New England Journal
                                                                                                          was established in 2012 through a                     of Medicine, where we also expect that
                                                  Proposed Project
                                                                                                          cooperative agreement between the                     the final report that includes the full
                                                    Zika virus persistence in body fluids                 hospital in Consortium with the Ponce                 sample size will be published.
                                                  of patients with Zika virus infection in                School of Medicine and Ponce Research
                                                  Puerto Rico (ZIPER Study)—Revision—                                                                             This is a request to continue
                                                                                                          Institute from the Ponce Health Sciences              information collection with minor
                                                  National Center for Emerging and                        University and the CDC (Protocol
                                                  Zoonotic Infectious Diseases (NCEZID),                                                                        modifications. Modifications have been
                                                                                                          #6214). Specimens will be tested for the              made to reflect the developing nature of
                                                  Centers for Disease Control and                         presence of ZIKV ribonucleic acid
                                                  Prevention (CDC).                                                                                             the science surrounding Zika virus
                                                                                                          (RNA) by RT–PCR at the CDC Dengue
                                                                                                                                                                infection and potential outcomes
                                                  Background and Brief Description                        Branch Laboratory in San Juan, and
                                                                                                                                                                associated with infection, as well as
                                                                                                          positive specimens will be further tested
                                                     CDC plans to seek a one-year OMB                                                                           additional questions that were best
                                                                                                          for virus isolation to evaluate
                                                  approval to extend information                                                                                answered by taking advantage of the
                                                                                                          infectivity. Each body fluid will be
                                                  collection covered under OMB Control                                                                          existing study platform. Specifically,
                                                                                                          collected on a weekly basis for 4 weeks
                                                  Number 0920–1140, expiration date 10/                                                                         CDC proposes the addition of two
                                                                                                          and biweekly thereafter until two
                                                  31/2017.                                                                                                      components to the collection of data
                                                                                                          consecutive negative RT–PCR results are
                                                     The Zika PERsistence (ZIPER) study                                                                         under this study, one of which has
                                                                                                          obtained from all specimens.
                                                  will help inform the presence and                                                                             already begun:
                                                                                                          Irrespective of RNA detection, body
                                                  duration of Zika virus (ZIKV) shedding
                                                                                                          fluids will also be collected for RT–PCT                 1. A follow-up household visit has
                                                  in several body fluids among RT–PCR–
                                                                                                          at 2, 4, and 6 months to investigate                  been added to determine how many
                                                  positive ZIKV cases from Puerto Rico. It
                                                                                                          intermittent shedding. Analyses of                    household members of Zika virus-
                                                  will also provide information regarding
                                                                                                          antibody response through titers of IgM               infected participants become infected
                                                  the duration of detection of anti-ZIKV
                                                                                                          and IgG will be performed at baseline                 during the 4 months following initial
                                                  Immunoglobulin M (IgM) antibodies
                                                                                                          and repeated at 2, 4, and 6 months.                   screening. For any household members
                                                  and the time for development of
                                                                                                          Among symptomatic participants seven                  that had no evidence of Zika virus
                                                  Immunoglobulin G (IgG) antibodies
                                                                                                          milliliters (ml) of blood will be drawn               infection at the initial visit, the same
                                                  among the same population. In addition,
                                                                                                          at each study visit split into a tiger top            questionnaires used at the initial
                                                  this study will determine the prevalence
                                                  of anti-ZIKV IgM and IgG, and virus                     tube (5ml) and a purple top tube (2ml)                household visit will again be completed
                                                  shedding in body fluids among                           for a total not to exceed 50 ml during                ∼4 months later. Such information will
                                                  household contacts of ZIKV cases.                       any given 8-week period. At enrollment                provide additional information
                                                     We propose to investigate the                        healthy non-pregnant adults will have                 regarding the incidence of Zika virus
                                                  persistence (shedding) of ZIKV in                       20 ml of blood collected following                    infections among households with a
                                                  different body fluids and its relation to               standard procedures. Two tiger top                    Zika-positive household member.
                                                  immune response to provide a basis for                  tubes of 8.5 ml and one 3ml purple top                   2. Additionally, CDC proposes
                                                  development of non-blood-based                          tubes will be collected. These                        following up with men with Zika virus-
                                                  diagnostic tools, and target and refine                 procedures will be repeated at each                   positive semen specimens to better
                                                  public health interventions to arrest                   follow-up visit, see below. RT–PCR-                   understand the effect of Zika virus
                                                  ongoing spread of infection. To do so,                  positive participants will be asked to                infection on sperm. To do this, 8–14
                                                  we will conduct a prospective cohort                    refer up to 5 household members to                    semen ejaculates from 10–20 men
                                                  study of individuals with reverse                       establish the percentage of household                 participating in the ZIPER study will be
                                                  transcription-polymerase chain reaction                 members with detectable and                           used to determine the presence and/or
                                                  (RT–PCR) positive ZIKV infection and a                  potentially infectious Zika virus RNA in              detection of the Zika virus in different
                                                  cross-sectional study of their household                body fluids. Household members who                    fractions of the semen ejaculate (i.e.,
                                                  contacts. Results and analyses will be                  are found to be ZIKV RT–PCR-positive                  seminal plasma, cellular debris,
                                                  used to update relevant counseling                      in any body fluid will be invited to                  including White Blood Cells [WBCs]
                                                  messages and recommendations from                       participate in the cohort study. A                    and spermatozoa). CDC’s Institutional
                                                  the CDC.                                                second study visit will be scheduled                  Review Board (IRB) has approved this
                                                     The study will include baseline and                  with household contact at 2 or 4                      modification, but information collection
                                                  follow-up questionnaires and the                        months, to detect new infections and                  has not begun.
                                                  collection of the following specimens:                  estimate incidence. Because the original
                                                  blood, saliva, urine from participants of               study consent forms do not include this                 There is no cost to respondents other
                                                  all ages, and semen/vaginal secretions                  visit, household contacts will be                     than the time to participate.
mstockstill on DSK3G9T082PROD with NOTICES




                                                  from adults (ages 21 years or older) and                contacted by study staff and will be                    Authorizing legislation comes from
                                                  legally emancipated minors (support                     consented again using the same consent                Section 301 of the Public Health Service
                                                  themselves financially, live                            form.                                                 Act (42 U.S.C. 241).




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                                                                                        Federal Register / Vol. 82, No. 65 / Thursday, April 6, 2017 / Notices                                                                                                16839

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

                                                  Public health personnel              Shedding Questionnaire (Symptomatics) ............                                                  55                           8                    10/60                 74
                                                                                       Shedding      Questionnaire         (Cross-Sectional                                               100                           1                    10/60                 17
                                                                                         Asymptomatics).
                                                                                       Questionnaire for men semen sub-study ............                                                  30                           1                    20/60                 10
                                                  General public ...............       Shedding Eligibility Form .....................................                                    160                           1                     2/60                  6
                                                                                       Contact Information Form ....................................                                       32                           1                     2/60                  1

                                                       Total .......................   ..............................................................................   ........................   ........................   ........................            108



                                                  Leroy A. Richardson,                                                   DATES:  Written comments must be                                              collection before submitting the
                                                  Chief, Information Collection Review Office,                           received on or before June 5, 2017.                                           collection to OMB for approval. To
                                                  Office of Scientific Integrity, Office of the                          ADDRESSES: You may submit comments,                                           comply with this requirement, we are
                                                  Associate Director for Science, Office of the                          identified by Docket No. CDC–2017–                                            publishing this notice of a proposed
                                                  Director, Centers for Disease Control and                                                                                                            data collection as described below.
                                                  Prevention.
                                                                                                                         0032 by any of the following methods:
                                                                                                                           • Federal eRulemaking Portal:                                                  Comments are invited on: (a) Whether
                                                  [FR Doc. 2017–06864 Filed 4–5–17; 8:45 am]
                                                                                                                         Regulations.gov. Follow the instructions                                      the proposed collection of information
                                                  BILLING CODE 4163–18–P
                                                                                                                         for submitting comments.                                                      is necessary for the proper performance
                                                                                                                           • Mail: Leroy A. Richardson,                                                of the functions of the agency, including
                                                                                                                         Information Collection Review Office,                                         whether the information shall have
                                                  DEPARTMENT OF HEALTH AND
                                                                                                                         Centers for Disease Control and                                               practical utility; (b) the accuracy of the
                                                  HUMAN SERVICES
                                                                                                                         Prevention, 1600 Clifton Road NE., MS–                                        agency’s estimate of the burden of the
                                                  Centers for Disease Control and                                        D74, Atlanta, Georgia 30329.                                                  proposed collection of information; (c)
                                                  Prevention                                                               Instructions: All submissions received                                      ways to enhance the quality, utility, and
                                                                                                                         must include the agency name and                                              clarity of the information to be
                                                  [60Day–17–17ZX; Docket No. CDC–2017–                                   Docket Number. All relevant comments                                          collected; (d) ways to minimize the
                                                  0032]                                                                  received will be posted without change
                                                                                                                                                                                                       burden of the collection of information
                                                                                                                         to Regulations.gov, including any
                                                  Proposed Data Collection Submitted                                                                                                                   on respondents, including through the
                                                                                                                         personal information provided. For
                                                  for Public Comment and                                                                                                                               use of automated collection techniques
                                                                                                                         access to the docket to read background
                                                  Recommendations                                                                                                                                      or other forms of information
                                                                                                                         documents or comments received, go to
                                                                                                                                                                                                       technology; and (e) estimates of capital
                                                                                                                         Regulations.gov.
                                                  AGENCY: Centers for Disease Control and                                                                                                              or start-up costs and costs of operation,
                                                                                                                           Please note: All public comment
                                                  Prevention (CDC), Department of Health                                                                                                               maintenance, and purchase of services
                                                                                                                         should be submitted through the
                                                  and Human Services (HHS).                                                                                                                            to provide information. Burden means
                                                                                                                         Federal eRulemaking portal
                                                  ACTION: Notice with comment period.                                    (Regulations.gov) or by U.S. mail to the                                      the total time, effort, or financial
                                                                                                                         address listed above.                                                         resources expended by persons to
                                                  SUMMARY:   The Centers for Disease                                                                                                                   generate, maintain, retain, disclose or
                                                  Control and Prevention (CDC), as part of                               FOR FURTHER INFORMATION CONTACT: To
                                                                                                                                                                                                       provide information to or for a Federal
                                                  its continuing efforts to reduce public                                request more information on the
                                                                                                                                                                                                       agency. This includes the time needed
                                                  burden and maximize the utility of                                     proposed project or to obtain a copy of
                                                                                                                                                                                                       to review instructions; to develop,
                                                  government information, invites the                                    the information collection plan and
                                                                                                                         instruments, contact the Information                                          acquire, install and utilize technology
                                                  general public and other Federal                                                                                                                     and systems for the purpose of
                                                  agencies to take this opportunity to                                   Collection Review Office, Centers for
                                                                                                                         Disease Control and Prevention, 1600                                          collecting, validating and verifying
                                                  comment on proposed and/or                                                                                                                           information, processing and
                                                  continuing information collections, as                                 Clifton Road NE., MS–D74, Atlanta,
                                                                                                                         Georgia 30329; phone: 404–639–7570;                                           maintaining information, and disclosing
                                                  required by the Paperwork Reduction                                                                                                                  and providing information; to train
                                                  Act of 1995. This notice invites                                       Email: omb@cdc.gov.
                                                                                                                                                                                                       personnel and to be able to respond to
                                                  comment on ‘‘Childhood Blood Lead                                      SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                                                                       a collection of information, to search
                                                  Surveillance (CBLS) and Adult Blood                                    Paperwork Reduction Act of 1995 (PRA)
                                                                                                                                                                                                       data sources, to complete and review
                                                  Lead Epidemiology and Surveillance                                     (44 U.S.C. 3501–3520), Federal agencies
                                                                                                                                                                                                       the collection of information; and to
                                                  (ABLES).’’ The National Center for                                     must obtain approval from the Office of
                                                                                                                                                                                                       transmit or otherwise disclose the
                                                  Environmental Health (NCEH) is leading                                 Management and Budget (OMB) for each
                                                  a new three-year information collection                                collection of information they conduct                                        information.
                                                  request (ICR) that covers two CDC                                      or sponsor. In addition, the PRA also                                         Proposed Project
                                                  information collections, one for                                       requires Federal agencies to provide a
mstockstill on DSK3G9T082PROD with NOTICES




                                                  childhood blood lead surveillance by                                   60-day notice in the Federal Register                                           Childhood Blood Lead Surveillance
                                                  NCEH and another for adult blood lead                                  concerning each proposed collection of                                        (CBLS) and Adult Blood Lead
                                                  surveillance by the National Institute for                             information, including each new                                               Epidemiology and Surveillance
                                                  Occupational Safety and Health                                         proposed collection, each proposed                                            (ABLES)—New—National Center for
                                                  (NIOSH). CDC requests an annual time                                   extension of existing collection of                                           Environmental Health (NCEH), Centers
                                                  burden of 1,120 burden hours for both                                  information, and each reinstatement of                                        for Disease Control and Prevention
                                                  collections.                                                           previously approved information                                               (CDC).


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Document Created: 2017-04-06 01:46:36
Document Modified: 2017-04-06 01:46:36
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
ActionNotice with comment period.
DatesWritten comments must be received on or before June 5, 2017.
ContactTo 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]
FR Citation82 FR 16837 

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