82_FR_56254 82 FR 56028 - Agency Forms Undergoing Paperwork Reduction Act Review

82 FR 56028 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 82, Issue 226 (November 27, 2017)

Page Range56028-56030
FR Document2017-25495

Federal Register, Volume 82 Issue 226 (Monday, November 27, 2017)
[Federal Register Volume 82, Number 226 (Monday, November 27, 2017)]
[Notices]
[Pages 56028-56030]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25495]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-1190]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ZEN Colombia Study: Zika in Pregnant Women 
and Children in Colombia to the Office of Management and Budget (OMB) 
for review and approval. CDC previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
August 30, 2017 to obtain comments from the public and affected 
agencies. CDC did not receive comments related to the previous notice. 
This notice serves to allow an additional 30 days for public and 
affected agency comments.

[[Page 56029]]

    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW., Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia 
(OMB Control Number 0920-1190, expires 07/31/2019)--Revision--National 
Center on Birth Defects and Developmental Disabilities, Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    Zika virus (ZIKV) infection is a mosquito-borne flavivirus 
transmitted by Aedes species mosquitoes, and also through sexual and 
mother-to-child transmission; laboratory-acquired infections have also 
been reported. Health officials observed sporadic evidence of human 
ZIKV infection in Africa and Asia prior to 2007, when an outbreak of 
ZIKV caused an estimated 5,000 infections in the State of Yap, 
Federated States of Micronesia. Since then, health officials have found 
evidence of ZIKV in 65 countries and territories, mostly in Central and 
South America. Common symptoms of ZIKV in humans include rash, fever, 
arthralgia, and nonpurulent conjunctivitis. The illness is usually mild 
and self-limited, with symptoms lasting for several days to a week; 
however, based on previous outbreaks, some infections are asymptomatic. 
The prevalence of asymptomatic infection in the current Central and 
South American epidemic is unknown.
    Although the clinical presentation of ZIKV infection is typically 
mild, ZIKV infection in pregnancy can cause microcephaly and related 
brain abnormalities when fetuses are exposed in utero. Other adverse 
pregnancy outcomes related to ZIKV infection remain under study, and 
include pregnancy loss, other major birth defects, arthrogryposis, eye 
abnormalities, and neurologic abnormalities.
    As the spectrum of adverse health outcomes potentially related to 
ZIKV infection continues to grow, large gaps remain in our 
understanding of ZIKV infection in pregnancy. These include the full 
spectrum of adverse health outcomes in pregnant women, fetuses, and 
infants associated with ZIKV infection; the relative contributions of 
sexual transmission and mosquito-borne transmission to occurrence of 
infections in pregnancy; and variability in the risk of adverse fetal 
outcomes by gestational week of maternal infection or symptoms of 
infection. There is an urgency to fill these large gaps in our 
understanding given the rapidity of the epidemic's spread and the 
severe health outcomes associated with ZIKV to date.
    Colombia's Instituto Nacional de Salud (INS) began surveillance for 
ZIKV in 2015, reporting the first autochthonous transmission in October 
2015 in the north of the country. As of December 2016, Colombia has 
reported over 106,000-suspected ZIKV cases, with over 19,000 of them 
among pregnant women. With a causal link established between ZIKV 
infection in pregnancy and microcephaly, there is an urgent need to 
understand: How to prevent ZIKV transmission; the full spectrum of 
adverse maternal, fetal, and infant health outcomes associated with 
ZIKV infection; and risk factors for occurrence of these outcomes. To 
answer these questions, INS and the CDC will follow 5,000 women 
enrolled in the first trimester of pregnancy, their male partners, and 
their infants, in various cities in Colombia where ZIKV transmission is 
currently ongoing.
    The primary study objectives are to: (1) Describe the 
sociodemographic and clinical characteristics of the study population; 
(2) Identify risk factors for ZIKV infection in pregnant women and 
their infants. These include behaviors such as use of mosquito-bite 
prevention measures or condoms, and factors associated with maternal-
to-child transmission; (3) Assess the risk for adverse maternal, fetal, 
and infant outcomes associated with ZIKV infection; (4) Assess 
modifiers of the risk for adverse outcomes among pregnant women and 
their infants following ZIKV infection. This includes investigating 
associations with gestational age at infection, presence of ZIKV 
symptoms, extended viremia, mode of transmission, prior infections or 
immunizations, and co-infections.
    The project aims to enroll approximately 5,000 women, 1,250 male 
partners, 4,500 newborns, and a subset of 900 infants/children. 
Pregnant women will be recruited in the first trimester of pregnancy 
for study enrollment, followed by assessments during pregnancy (every 
other week until 32 weeks gestation and monthly thereafter), and within 
10 days postpartum. At all visits, participants will complete visit-
specific questionnaires. In addition to the questionnaires, at all 
pregnancy and delivery visits, participants will receive Colombian 
national recommended clinical care and provide samples for laboratory 
testing.
    Researchers will recruit male partners around the time of the 
pregnant partners' study enrollment, followed by monthly visits until 
his pregnant partner reaches the third trimester (approximately 27 
weeks gestation). If the male partner contracts ZIKV during this time, 
visits will occur every other week until the partner has two negative 
consecutive tests for ZIKV or the pregnancy ends. At all study visits, 
male partners will complete visit-specific questionnaires and provide 
samples for laboratory testing.
    Researchers will follow all newborns of mothers participating in 
the study every other week from birth to 6 months of age. At all 
visits, infants will receive national recommended clinical care (at 
birth and follow-up visits at 1, 2, 3, and 6 months), provide samples 
for laboratory testing, and mothers will complete study-specific 
questionnaires about infant ZIKV symptoms and developmental milestones. 
During follow-up, infants will also have cranial ultrasounds, their 
head circumference measured, and hearing and vision tests. For mothers 
and their infants and as part of clinical care, researchers will 
abstract relevant information from medical records.
    The revised information collection package includes the following 
changes.

[[Page 56030]]

During the data collection period, researchers will follow a subset of 
900 infants until 2-years of age. A parent of each of these infants 
will answer a questionnaire at 6, 9, 12, 18, and 24 months, as well as 
have other clinical assessments performed to examine developmental 
delays.
    CDC will use study results to guide recommendations made by both 
INS and CDC to prevent ZIKV infection; to improve counseling of 
patients about risks to themselves, their pregnancies, their partners, 
and their infants; and to help agencies prepare to provide services to 
affected children and families. Participation in this study is 
voluntary and there are no costs to participants other than their time.
    The total burden hours are 14,210.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Pregnant Women........................  Pregnant Women                       600               1            5/60
                                         Eligibility
                                         Questionnaire.
                                        Pregnant Women                       500               1           35/60
                                         Enrollment
                                         Questionnaire.
                                        Adult Symptoms                       500              15           10/60
                                         Questionnaire.
                                        Pregnant Women Follow-up             500               8           15/60
                                         Questionnaire.
                                        Infant Symptoms                    2,250              14           10/60
                                         Questionnaire.
                                        Parent-Child Eligibility           1,000               1            5/60
                                         Questionnaire.
                                        Parent-Child Enrollment              900               1           20/60
                                         Questionnaire.
                                        Parent-Child Follow-up               900               4           15/60
                                         Questionnaire.
                                        Ages and Stages                    2,250               2           15/60
                                         Questionnaire: 2 and 6
                                         Month Visits.
                                        Ages and Stages                      900               2           15/60
                                         Questionnaire: 12 and
                                         24 Month Visits.
                                        Bayley Scales of Infant              900               3           30/60
                                         and Toddler Development.
                                        Strengths and                        900               1            5/60
                                         Difficulties
                                         Questionnaire.
                                        Peabody Developmental                900               1           30/60
                                         Motor Scales.
                                        Parenting Stress Index               900               5           10/60
                                         IV.
                                        Center for Epidemiologic             900               5            5/60
                                         Studies Depression
                                         Scale.
                                        Test of Nonverbal                    900               1           20/60
                                         Intelligence.
Male partners.........................  Male Partner Eligibility             150               1            5/60
                                         Questionnaire.
                                        Male Enrollment                      125               1           25/60
                                         Questionnaire.
                                        Adult Symptoms                       125               7           10/60
                                         Questionnaire.
----------------------------------------------------------------------------------------------------------------


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. 2017-25495 Filed 11-24-17; 8:45 am]
 BILLING CODE 4163-18-P



                                                    56028                             Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices

                                                      4. Minimize the burden of the                                         OMB approval to extend this survey for                                        determining health care work force
                                                    collection of information on those who                                  an additional three years.                                                    needs, and assessing the health status of
                                                    are to respond, including through the                                      The target universe of the NHAMCS is                                       the population.
                                                    use of appropriate automated,                                           in-person visits made to emergency                                               Starting 2018, CDC will implement
                                                    electronic, mechanical, or other                                        departments (EDs) of non-Federal, short-                                      the ED component of NHAMCS.
                                                    technological collection techniques or                                  stay hospitals (hospitals with an average                                     However, between December 2017 and
                                                    other forms of information technology,                                  length of stay of less than 30 days) that                                     May 2018, the 2017 survey will run
                                                    e.g., permitting electronic submissions                                 have at least six beds for inpatient use,                                     concurrently with the 2018 survey. This
                                                    of responses.                                                           and with a specialty of general (medical                                      is typical with any data collection cycle:
                                                      5. Assess information collection costs.                               or surgical) or children’s general.                                           It begin in the last month of the
                                                                                                                               NHAMCS was initiated to                                                    preceding year and ends around the
                                                    Proposed Project                                                        complement the National Ambulatory                                            middle of the following year. For the
                                                                                                                            Medical Care Survey (NAMCS, OMB                                               2017 data collection, CDC will collect
                                                      National Hospital Ambulatory                                          Control Number 0920–0234, Expiration
                                                    Medical Care Survey (NHAMCS) (OMB                                                                                                                     information on all three settings (ED,
                                                                                                                            Date 03/31/2019), which provides                                              OPD, and ASL). For this three-year
                                                    Control Number 0920–0278, Expiration                                    similar data concerning patient visits to
                                                    Date 02/28/2018)—Revision—National                                                                                                                    request, CDC does not expect
                                                                                                                            physicians’ offices. NAMCS and
                                                    Center for Health Statistics (NCHS),                                                                                                                  substantive changes or supplements for
                                                                                                                            NHAMCS are the principal sources of
                                                    Centers for Disease Control and                                                                                                                       the survey.
                                                                                                                            data on ambulatory care provided in the
                                                    Prevention (CDC).                                                       United States.                                                                   Users of NHAMCS data include, but
                                                                                                                               NHAMCS provides a range of baseline                                        are not limited to, congressional offices,
                                                    Background and Brief Description
                                                                                                                            data on the characteristics of the users                                      Federal agencies, state and local
                                                      Section 306 of the Public Health                                      and providers of hospital ambulatory                                          governments, schools of public health,
                                                    Service (PHS) Act (42 U.S.C. 242k), as                                  medical care. Data collected include                                          colleges and Universities, private
                                                    amended, authorizes that the Secretary                                  patients’ demographic characteristics,                                        industry, nonprofit foundations,
                                                    of Health and Human Services (DHHS),                                    reason(s) for visit, providers’ diagnoses,                                    professional associations, clinicians,
                                                    acting through NCHS, shall collect                                      diagnostic services, medications, and                                         researchers, administrators, and health
                                                    statistics on ‘‘utilization of health care’’                            disposition. These data, together with                                        planners.
                                                    in the United States. The National                                      trend data, may be used to monitor the                                           There are no costs to the respondents
                                                    Hospital Ambulatory Medical Care                                        effects of change in the health care                                          other than their time. The total
                                                    Survey (NHAMCS) has conducted                                           system, for the planning of health                                            estimated annualized burden hours are
                                                    annually since 1992. NCHS is seeking                                    services, improving medical education,                                        1,806.

                                                                                                                           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)

                                                    Hospital Chief Executive Officer .......                 Hospital Induction 2017 Data Col-                                                60                            1                   75/60                 75
                                                                                                               lection.
                                                    Hospital Chief Executive Officer .......                 Hospital Induction 2018+ Data Col-                                              340                            1                   75/60                425
                                                                                                               lection.
                                                    Ancillary Service Executive ...............              Ambulatory Unit Induction (ED, OPD                                              810                           1                    15/60                203
                                                                                                               and ASL).
                                                    Ancillary Service Executive ...............              Ambulatory Unit Induction (ED only)                                            583                           1                     15/60                146
                                                    Medical Record Clerk .......................             Retrieving Patient Records (ED,                                                396                         144                      1/60                950
                                                                                                               OPD and ASL).
                                                    Ancillary Service Executive—Re-                          Reabstraction Telephone Call (ED,                                                29                           1                      5/60                 2
                                                      abstraction.                                             OPD and ASL).
                                                    Medical Record Clerk—Reabstrac-                          Pulling and re-filing Patient Records                                            29                          10                      1/60                 5
                                                      tion.                                                    (ED, OPD and ASL).

                                                         Total ...........................................   ...........................................................   ........................   ........................   ........................          1,806



                                                    Leroy A. Richardson,                                                    DEPARTMENT OF HEALTH AND                                                      collection request titled ZEN Colombia
                                                    Chief, Information Collection Review Office,                            HUMAN SERVICES                                                                Study: Zika in Pregnant Women and
                                                    Office of Scientific Integrity, Office of the                                                                                                         Children in Colombia to the Office of
                                                    Associate Director for Science, Office of the                           Centers for Disease Control and                                               Management and Budget (OMB) for
                                                    Director, Centers for Disease Control and                               Prevention                                                                    review and approval. CDC previously
                                                    Prevention.
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                                                                                                                                                                                                          published a ‘‘Proposed Data Collection
                                                    [FR Doc. 2017–25496 Filed 11–24–17; 8:45 am]                            [30Day–18–1190]                                                               Submitted for Public Comment and
                                                    BILLING CODE 4163–18–P
                                                                                                                            Agency Forms Undergoing Paperwork                                             Recommendations’’ notice on August
                                                                                                                            Reduction Act Review                                                          30, 2017 to obtain comments from the
                                                                                                                                                                                                          public and affected agencies. CDC did
                                                                                                                              In accordance with the Paperwork                                            not receive comments related to the
                                                                                                                            Reduction Act of 1995, the Centers for                                        previous notice. This notice serves to
                                                                                                                            Disease Control and Prevention (CDC)                                          allow an additional 30 days for public
                                                                                                                            has submitted the information                                                 and affected agency comments.


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                                                                               Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices                                             56029

                                                       CDC will accept all comments for this                America. Common symptoms of ZIKV                      ZIKV infection in pregnant women and
                                                    proposed information collection project.                in humans include rash, fever,                        their infants. These include behaviors
                                                    The Office of Management and Budget                     arthralgia, and nonpurulent                           such as use of mosquito-bite prevention
                                                    is particularly interested in comments                  conjunctivitis. The illness is usually                measures or condoms, and factors
                                                    that:                                                   mild and self-limited, with symptoms                  associated with maternal-to-child
                                                       (a) Evaluate whether the proposed                    lasting for several days to a week;                   transmission; (3) Assess the risk for
                                                    collection of information is necessary                  however, based on previous outbreaks,                 adverse maternal, fetal, and infant
                                                    for the proper performance of the                       some infections are asymptomatic. The                 outcomes associated with ZIKV
                                                    functions of the agency, including                      prevalence of asymptomatic infection in               infection; (4) Assess modifiers of the
                                                    whether the information will have                       the current Central and South American                risk for adverse outcomes among
                                                    practical utility;                                      epidemic is unknown.                                  pregnant women and their infants
                                                       (b) Evaluate the accuracy of the                        Although the clinical presentation of              following ZIKV infection. This includes
                                                    agencies estimate of the burden of the                  ZIKV infection is typically mild, ZIKV                investigating associations with
                                                    proposed collection of information,                     infection in pregnancy can cause                      gestational age at infection, presence of
                                                    including the validity of the                           microcephaly and related brain                        ZIKV symptoms, extended viremia,
                                                    methodology and assumptions used;                       abnormalities when fetuses are exposed                mode of transmission, prior infections
                                                       (c) Enhance the quality, utility, and                in utero. Other adverse pregnancy                     or immunizations, and co-infections.
                                                    clarity of the information to be                        outcomes related to ZIKV infection                       The project aims to enroll
                                                    collected;                                              remain under study, and include                       approximately 5,000 women, 1,250 male
                                                       (d) Minimize the burden of the                       pregnancy loss, other major birth                     partners, 4,500 newborns, and a subset
                                                    collection of information on those who                  defects, arthrogryposis, eye                          of 900 infants/children. Pregnant
                                                    are to respond, including, through the                  abnormalities, and neurologic                         women will be recruited in the first
                                                    use of appropriate automated,                           abnormalities.                                        trimester of pregnancy for study
                                                    electronic, mechanical, or other                           As the spectrum of adverse health                  enrollment, followed by assessments
                                                    technological collection techniques or                  outcomes potentially related to ZIKV                  during pregnancy (every other week
                                                    other forms of information technology,                  infection continues to grow, large gaps               until 32 weeks gestation and monthly
                                                    e.g., permitting electronic submission of               remain in our understanding of ZIKV                   thereafter), and within 10 days
                                                    responses; and                                          infection in pregnancy. These include                 postpartum. At all visits, participants
                                                       (e) Assess information collection                    the full spectrum of adverse health                   will complete visit-specific
                                                    costs.                                                  outcomes in pregnant women, fetuses,                  questionnaires. In addition to the
                                                       To request additional information on                 and infants associated with ZIKV                      questionnaires, at all pregnancy and
                                                    the proposed project or to obtain a copy                infection; the relative contributions of              delivery visits, participants will receive
                                                    of the information collection plan and                  sexual transmission and mosquito-borne                Colombian national recommended
                                                    instruments, call (404) 639–7570 or                     transmission to occurrence of infections              clinical care and provide samples for
                                                    send an email to omb@cdc.gov. Direct                    in pregnancy; and variability in the risk             laboratory testing.
                                                    written comments and/or suggestions                     of adverse fetal outcomes by gestational                 Researchers will recruit male partners
                                                    regarding the items contained in this                   week of maternal infection or symptoms                around the time of the pregnant
                                                    notice to the Attention: CDC Desk                       of infection. There is an urgency to fill             partners’ study enrollment, followed by
                                                    Officer, Office of Management and                       these large gaps in our understanding                 monthly visits until his pregnant
                                                    Budget, 725 17th Street NW.,                            given the rapidity of the epidemic’s                  partner reaches the third trimester
                                                    Washington, DC 20503 or by fax to (202)                 spread and the severe health outcomes                 (approximately 27 weeks gestation). If
                                                    395–5806. Provide written comments                      associated with ZIKV to date.                         the male partner contracts ZIKV during
                                                    within 30 days of notice publication.                      Colombia’s Instituto Nacional de                   this time, visits will occur every other
                                                                                                            Salud (INS) began surveillance for ZIKV               week until the partner has two negative
                                                    Proposed Project                                        in 2015, reporting the first                          consecutive tests for ZIKV or the
                                                      ZEN Colombia Study: Zika in                           autochthonous transmission in October                 pregnancy ends. At all study visits, male
                                                    Pregnant Women and Children in                          2015 in the north of the country. As of               partners will complete visit-specific
                                                    Colombia (OMB Control Number 0920–                      December 2016, Colombia has reported                  questionnaires and provide samples for
                                                    1190, expires 07/31/2019)—Revision—                     over 106,000-suspected ZIKV cases,                    laboratory testing.
                                                    National Center on Birth Defects and                    with over 19,000 of them among                           Researchers will follow all newborns
                                                    Developmental Disabilities, Centers for                 pregnant women. With a causal link                    of mothers participating in the study
                                                    Disease Control and Prevention (CDC).                   established between ZIKV infection in                 every other week from birth to 6 months
                                                                                                            pregnancy and microcephaly, there is an               of age. At all visits, infants will receive
                                                    Background and Brief Description                        urgent need to understand: How to                     national recommended clinical care (at
                                                       Zika virus (ZIKV) infection is a                     prevent ZIKV transmission; the full                   birth and follow-up visits at 1, 2, 3, and
                                                    mosquito-borne flavivirus transmitted                   spectrum of adverse maternal, fetal, and              6 months), provide samples for
                                                    by Aedes species mosquitoes, and also                   infant health outcomes associated with                laboratory testing, and mothers will
                                                    through sexual and mother-to-child                      ZIKV infection; and risk factors for                  complete study-specific questionnaires
                                                    transmission; laboratory-acquired                       occurrence of these outcomes. To                      about infant ZIKV symptoms and
                                                    infections have also been reported.                     answer these questions, INS and the                   developmental milestones. During
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                                                    Health officials observed sporadic                      CDC will follow 5,000 women enrolled                  follow-up, infants will also have cranial
                                                    evidence of human ZIKV infection in                     in the first trimester of pregnancy, their            ultrasounds, their head circumference
                                                    Africa and Asia prior to 2007, when an                  male partners, and their infants, in                  measured, and hearing and vision tests.
                                                    outbreak of ZIKV caused an estimated                    various cities in Colombia where ZIKV                 For mothers and their infants and as
                                                    5,000 infections in the State of Yap,                   transmission is currently ongoing.                    part of clinical care, researchers will
                                                    Federated States of Micronesia. Since                      The primary study objectives are to:               abstract relevant information from
                                                    then, health officials have found                       (1) Describe the sociodemographic and                 medical records.
                                                    evidence of ZIKV in 65 countries and                    clinical characteristics of the study                    The revised information collection
                                                    territories, mostly in Central and South                population; (2) Identify risk factors for             package includes the following changes.


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                                                    56030                            Federal Register / Vol. 82, No. 226 / Monday, November 27, 2017 / Notices

                                                    During the data collection period,                                  assessments performed to examine                            their partners, and their infants; and to
                                                    researchers will follow a subset of 900                             developmental delays.                                       help agencies prepare to provide
                                                    infants until 2-years of age. A parent of                              CDC will use study results to guide                      services to affected children and
                                                    each of these infants will answer a                                 recommendations made by both INS                            families. Participation in this study is
                                                    questionnaire at 6, 9, 12, 18, and 24                               and CDC to prevent ZIKV infection; to                       voluntary and there are no costs to
                                                    months, as well as have other clinical                              improve counseling of patients about                        participants other than their time.
                                                                                                                        risks to themselves, their pregnancies,                       The total burden hours are 14,210.
                                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                        Average
                                                                                                                                                                                                      Number of
                                                                                                                                                                                   Number of                          burden per
                                                                     Type of respondents                                                     Form name                                              responses per
                                                                                                                                                                                  respondents                          response
                                                                                                                                                                                                      respondent       (in hours)

                                                    Pregnant Women ............................................        Pregnant Women Eligibility Questionnaire ....                          600                1              5/60
                                                                                                                       Pregnant Women Enrollment Questionnaire                                500                1             35/60
                                                                                                                       Adult Symptoms Questionnaire .....................                     500               15             10/60
                                                                                                                       Pregnant Women Follow-up Questionnaire ...                             500                8             15/60
                                                                                                                       Infant Symptoms Questionnaire .....................                  2,250               14             10/60
                                                                                                                       Parent-Child Eligibility Questionnaire .............                 1,000                1              5/60
                                                                                                                       Parent-Child Enrollment Questionnaire .........                        900                1             20/60
                                                                                                                       Parent-Child Follow-up Questionnaire ...........                       900                4             15/60
                                                                                                                       Ages and Stages Questionnaire: 2 and 6                               2,250                2             15/60
                                                                                                                          Month Visits.
                                                                                                                       Ages and Stages Questionnaire: 12 and 24                              900                 2             15/60
                                                                                                                          Month Visits.
                                                                                                                       Bayley Scales of Infant and Toddler Devel-                            900                 3             30/60
                                                                                                                          opment.
                                                                                                                       Strengths and Difficulties Questionnaire ........                     900                 1              5/60
                                                                                                                       Peabody Developmental Motor Scales ..........                         900                 1             30/60
                                                                                                                       Parenting Stress Index IV ..............................              900                 5             10/60
                                                                                                                       Center for Epidemiologic Studies Depression                           900                 5              5/60
                                                                                                                          Scale.
                                                                                                                       Test of Nonverbal Intelligence .......................                900                 1             20/60
                                                    Male partners ..................................................   Male Partner Eligibility Questionnaire ............                   150                 1              5/60
                                                                                                                       Male Enrollment Questionnaire ......................                  125                 1             25/60
                                                                                                                       Adult Symptoms Questionnaire .....................                    125                 7             10/60



                                                    Leroy A. Richardson,                                                  Description: The Family and Youth                         Performance Analysis Study, and an
                                                    Chief, Information Collection Review Office,                        Services Bureau (FYSB) and the Office                       Impact and In-Depth Implementation
                                                    Office of Scientific Integrity, Office of the                       of Planning, Research, Evaluation                           Study. Data collection related to the
                                                    Associate Director for Science, Office of the                       (OPRE) in the Administration for                            Design and Implementation Study is
                                                    Director, Centers for Disease Control and                           Children and Families (ACF) are                             complete; data collection related to the
                                                    Prevention.                                                         requesting an extension without change                      Performance Analysis Study will be
                                                    [FR Doc. 2017–25495 Filed 11–24–17; 8:45 am]                        of a currently approved information                         complete in late summer 2017. This
                                                    BILLING CODE 4163–18–P                                              collection (OMB No. 0970–0398). The                         notice is specific to data collection
                                                                                                                        purpose of the extension is to complete                     activities for the Impact and In-Depth
                                                                                                                        the ongoing follow-up data collection                       Implementation Study, which is being
                                                    DEPARTMENT OF HEALTH AND                                            for the Personal Responsibility                             conducted in four sites. The proposed
                                                    HUMAN SERVICES                                                      Education Program (PREP) Multi-                             extension is necessary to complete
                                                    Administration for Children and                                     Component Evaluation, which was                             ongoing follow-up data collection. The
                                                    Families                                                            designed to document how PREP                               resulting data will be used in a rigorous
                                                                                                                        programs are designed and                                   program impact analysis to assess the
                                                    Submission for OMB Review;                                          implemented in the field, collect                           effectiveness of each program in
                                                    Comment Request                                                     performance measure data for PREP                           reducing teen sexual activity and
                                                                                                                        programs, and assess the effectiveness of                   associated risk behaviors.
                                                      Title: Personal Responsibility                                    selected PREP-funded programs.                                 Respondents: Youth participants who
                                                    Education Program (PREP) Multi-                                       The PREP Multi-Component                                  agreed to participate in the study upon
                                                    Component Evaluation Extension.                                     Evaluation contains three components:                       enrollment in the four impact study
                                                      OMB No.: 0970–0398.                                               A Design and Implementation Study, a                        sites.
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                                                                                                ANNUAL BURDEN ESTIMATES
                                                                                                                                                                Total/annual        Number of           Average      Total/annual
                                                                                                 Instrument                                                      number of        responses per       burden hours   burden hours
                                                                                                                                                                respondents        respondents        per response

                                                    Second follow-up survey .................................................................................         325              1                  .75            244




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Document Created: 2017-11-25 01:08:41
Document Modified: 2017-11-25 01:08:41
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
FR Citation82 FR 56028 

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