82 FR 51839 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 215 (November 8, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 215 (November 8, 2017)
| Page Range | 51839-51841 | |
| FR Document | 2017-24314 |
[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)] [Notices] [Pages 51839-51841] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24314] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-17AZX] 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 Zika Puerto Rico Study: Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico 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 April 19, 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. 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 [[Page 51840]] 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 Zika Puerto Rico Study: Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico--New--National Center of Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention (CDC). Background and Brief Description The Puerto Rico Department of Health (PRDH) reported the first case of autochthonous transmission of Zika virus (ZIKV) in December 2015. As of December 16, 2016, Puerto Rico reported 35,648 ZIKV cases, more than any other location in the U.S., and health officials expect the number of cases to continue to rise. Among the cases, 2,864 have been among pregnant women, and the PRDH announced the first case of microcephaly in a fetus with confirmed ZIKV infection on May 13, 2016. Currently, testing for ZIKV infection can be done by either using rRT-PCR to detect the presence of ZIKV RNA or by serologic testing to detect IgM and neutralizing antibodies. rRT-PCR testing is the preferred and suggested method for diagnosing ZIKV infection because it provides a definitive diagnosis and is not subject to the limitations (e.g., cross-reactivity) associated with serology testing. However because level of viremia is generally low and RNA concentrations decline over time, ZIKV rRT-PCR has generally only been considered for a short testing window (2 weeks). Currently, the CDC and the PRDH recommend ZIKV testing of all pregnant women living in areas with active ZIKV transmission, such as Puerto Rico. Symptomatic pregnant women should have serum and urine tested for the presence of ZIKV RNA by rRT-PCR within two weeks of symptom onset. Symptomatic pregnant women tested more than two weeks after symptom onset and symptomatic women with negative rRT-PCR test results should have serologic testing. CDC recommends serologic testing of asymptomatic pregnant women at the initiation of prenatal care and again during their second and third trimesters as a part of routine care; CDC recommends serum and urine rRT-PCR testing after a positive or equivocal serological test result to identify persistent RNA and to provide a definitive diagnosis. For infants, CDC currently recommends ZIKV testing within two days of life for infants born to women with laboratory evidence of possible ZIKV and for infants who have abnormal clinical or neuroimaging findings suggestive of congenital ZIKV syndrome, regardless of maternal ZIKV test results. Limited data suggest that ZIKV RNA might be detectable for a much longer period in whole blood than in serum or urine; however, researchers have primarily seen these results in non-pregnant adults. While ZIKV RNA typically only persists in serum for 3-7 days and is thought to clear by 10 days, animal data suggest that pregnancy may be associated with prolonged detection of ZIKV RNA. An ongoing study of pregnant Rhesus macaques found ZIKV RNA in plasma up to 36 and 71 days post first trimester infection, and up to 9 and 36 days after third trimester infection. Preliminary results from a first trimester- infected macaque with detectable virus for 71 days indicate that the fetus had no clinical signs of microcephaly but fetal necropsy showed ZIKV RNA in the axillary lymph nodes, bone marrow, and optic nerve (although not in brain tissue). By comparison, two non-pregnant female animals no longer had detectable RNA at 17 days post-infection. Limited data from human studies also suggest that pregnant women have persistent detection of ZIKV RNA in serum. Symptomatic women had detectable virus at 17, 23, 44, and 46 days post symptom onset and one asymptomatic woman was still rRT-PCR positive 53 days after returning from travel. In one symptomatic pregnant woman with prolonged detection of ZIKV RNA, the pregnancy ended as a fetal loss and researchers found ZIKV RNA in the fetus. Findings from these case reports and series led to the hypothesis that persistent detection of RNA in pregnant women may be a marker of fetal infection and thus, potentially a marker of adverse fetal outcomes including microcephaly and brain abnormalities. However, researchers need more data including whether the detection of IgM influences the risk of adverse infant outcomes. Researchers know even less about persistent detection of ZIKV RNA and IgM in infants. One case study reported persistent ZIKV RNA detection in a male child born in Brazil at 40 weeks gestation with brain abnormalities. Fifty-four days after birth, the infant's serum, saliva, and urine all tested positive for ZIKV RNA; the detection of ZIKV RNA continued in the infant's serum on day 67 and had cleared by day 216. The infant exhibited no obvious illness or evidence of being immunocompromised when examined on day 54. However, he demonstrated neuropsychomotor developmental delay, with global hypertonia and spastic hemiplegia, by 6 months of age. The duration of IgM detection in infants is also important to determine the window of diagnostic utility of this test for infants not tested at birth. Due to the short window of time during which ZIKV RNA is typically detectable in serum, expanding rRT-PCR testing to asymptomatic women and women outside of the two-week window may provide more information than serologic testing alone. This is because positive serology does not allow for definitive diagnosis of infection as false positives and cross-reactivity with other flaviviruses complicates diagnosis. The rRT-PCR, per standard, requires a blood sample obtained by venipuncture for ZIKV RNA detection. However, recent unpublished data from the Institute Pasteur have demonstrated that in 57% of patients there was a significantly longer ZIKV RNA detection in capillary blood samples collected from Zika positive pregnant women tested with rRT-PCR than in venous samples. Similar findings from a study conducted during the Ebola outbreak showed that capillary blood samples can be used as an alternative to venous blood samples, and may be a more accurate method for monitoring viral load. If prolonged ZIKV RNA persistence is, in fact, a marker of fetal infection and [[Page 51841]] adverse outcomes, determining the prevalence of prolonged detection of ZIKV RNA is essential for clinical management of pregnant women with ZIKV infection and public health planning for the outbreak. Further, understanding persistent ZIKV RNA in congenitally-exposed infants is also important for clinical management of infants and identifying adverse outcomes that may present several months after birth. Finally, understanding the relationship between persistence and viral load may inform clinical guidance and management of pregnant women and their families. In this study, we will estimate the prevalence and duration of persistent ZIKV RNA in pregnant women and congenitally exposed infants. We will also evaluate the diagnostic utility of PCR testing for ZIKV RNA on capillary blood and determine if persistent ZIKV RNA in pregnant women is associated with adverse outcomes or infection in infants. Finally, we will examine the association of different factors that are associated with persistent detection of ZIKV RNA in pregnant women and congenitally exposed infants. This study will provide critical data in establishing guidance for testing in pregnant women and congenitally exposed infants. There are no costs to the respondents other than their time. The total estimated annual burden hours are 785. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondents Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- ZIKV positive Pregnant women.......... Pregnant women screening 150 1 2/60 form. ZIKV positive Pregnant women.......... Pregnant women 150 1 8/60 enrollment questionnaire. ZIKV positive Pregnant women.......... Pregnant women symptom 150 1 8/60 questionnaire. ZIKV positive Pregnant women.......... Pregnant women follow-up 150 30 8/60 questionnaire. ZIKV positive Pregnant women.......... Infant enrollment and 150 1 8/60 delivery questionnaire. ZIKV positive Pregnant women.......... Infant follow-up 150 6 8/60 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. 2017-24314 Filed 11-7-17; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51839
populations, and to prevent the in a school district in Wisconsin. CDC influenza. It was demonstrated that
introduction, transmission, or spread of will collect reports of individual student absenteeism due to ILI in school
communicable diseases within the symptoms, vaccination status, recent children was highly correlated with
United States. Insights gained from this travel, recent exposure to people with PCR-confirmed influenza in enrolled
information collection will assist in influenza symptoms, and duration of school children (r = 0.73; P < 0.001) and
pandemic preparedness planning and illness. In accordance with the revised with medically-attended influenza in
implementation of CDC Pre-Pandemic proposal, CDC will also collect reports the surrounding community (r = 0.72; P
Guidance on the use of school related on household composition, and < 0.001) suggesting that ILI-specific
measures, including school closures, to influenza vaccination status; symptoms school absenteeism can be considered a
slow transmission during an influenza and severity of illness; related useful tool for predicting influenza
pandemic. healthcare visits; and missed work or outbreaks in the surrounding
School closures were considered an school of the participating students’
community. However, researchers
important measure during the earliest household members. This information
stage of the 2009 H1N1 pandemic, require more observations during
accomplished through telephone and in-
because a pandemic vaccine was not influenza seasons caused by other
person interviews.
available until October (six months CDC will use findings obtained from influenza strains to make these findings
later), and sufficient stocks to immunize this information to inform and update more robust.
all school-age children were not CDC’s Pre-pandemic Guidance on the This revision adds a household
available until December. However, implementation of school related transmission component to the ongoing
retrospective review of the U.S. measures to prevent the spread of approved information collection. In
government response to the pandemic influenza, especially school closures. addition to collecting data and
identified a limited evidence-base Both state and local health departments biospecimens from students who were
regarding the effectiveness, in the United States use this guidance absent from school because of the ILI,
acceptability, and feasibility of various as an important planning and reference information and biospecimens will also
school related measures during mild or tool. be collected from household members of
moderately severe pandemics. Guidance CDC has enrolled in the study 651 these students. This revision aims to
updates will require an evidence-based students absent from school due to ILI
enhance current knowledge and
rationale for determining the since gaining OMB approval in
understanding of introduction of
appropriate triggers, timing, and December 2014, 651 students absent
influenza infection to households that
duration of school related measures, from school due to ILI. Of them, 58%
were positive for at least one respiratory have school-age children as well as
including school closures, during a
pathogen included in the PCR panel that within-household transmission.
pandemic.
CDC staff proposes that the tests for the presence of 17 common There are no costs to the respondents
information collection for this project respiratory viruses, and 27% of the other than their time. The total
will target adult and child populations students were found to be positive for estimated annual burden hours are 419.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Parents of children/adolescents or adult stu- Screening Form .............................................. 345 1 5/60
dents (≥18 yo) attending schools. Acute Respiratory Infection and Influenza 300 1 15/60
Surveillance Form.
Household Study Form .................................. 300 1 5/60
Student ............................................................ Biospecimen collection ................................... 300 2 5/60
Household members ....................................... Household Study Form .................................. 720 2 10/60
Leroy A. Richardson, DEPARTMENT OF HEALTH AND (OMB) for review and approval. CDC
Chief, Information Collection Review Office, HUMAN SERVICES previously published a ‘‘Proposed Data
Office of Scientific Integrity, Office of the Collection Submitted for Public
Associate Director for Science, Office of the Centers for Disease Control and Comment and Recommendations’’
Director, Centers for Disease Control and Prevention notice on April 19, 2017 to obtain
Prevention. comments from the public and affected
[FR Doc. 2017–24315 Filed 11–7–17; 8:45 am] [30Day–18–17AZX] agencies. CDC did not receive comments
BILLING CODE 4163–18–P Agency Forms Undergoing Paperwork related to the previous notice. This
Reduction Act Review notice serves to allow an additional 30
days for public and affected agency
In accordance with the Paperwork comments.
Reduction Act of 1995, the Centers for CDC will accept all comments for this
ethrower on DSK3G9T082PROD with NOTICES
Disease Control and Prevention (CDC) proposed information collection project.
has submitted the information The Office of Management and Budget
collection request titled Zika Puerto is particularly interested in comments
Rico Study: Zika Virus RNA Persistence that:
in Pregnant Women and Congenitally (a) Evaluate whether the proposed
Exposed Infants in Puerto Rico to the collection of information is necessary
Office of Management and Budget for the proper performance of the
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![Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51841
adverse outcomes, determining the persistence and viral load may inform association of different factors that are
prevalence of prolonged detection of clinical guidance and management of associated with persistent detection of
ZIKV RNA is essential for clinical pregnant women and their families. ZIKV RNA in pregnant women and
management of pregnant women with In this study, we will estimate the congenitally exposed infants.
ZIKV infection and public health prevalence and duration of persistent
This study will provide critical data
planning for the outbreak. Further, ZIKV RNA in pregnant women and
congenitally exposed infants. We will in establishing guidance for testing in
understanding persistent ZIKV RNA in
congenitally-exposed infants is also also evaluate the diagnostic utility of pregnant women and congenitally
important for clinical management of PCR testing for ZIKV RNA on capillary exposed infants. There are no costs to
infants and identifying adverse blood and determine if persistent ZIKV the respondents other than their time.
outcomes that may present several RNA in pregnant women is associated The total estimated annual burden
months after birth. Finally, with adverse outcomes or infection in hours are 785.
understanding the relationship between infants. Finally, we will examine the
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of re-
Number of burden per
Type of respondents Form name sponses per
respondents response
respondent (in hours)
ZIKV positive Pregnant women ...................... Pregnant women screening form ................... 150 1 2/60
ZIKV positive Pregnant women ...................... Pregnant women enrollment questionnaire ... 150 1 8/60
ZIKV positive Pregnant women ...................... Pregnant women symptom questionnaire ..... 150 1 8/60
ZIKV positive Pregnant women ...................... Pregnant women follow-up questionnaire ...... 150 30 8/60
ZIKV positive Pregnant women ...................... Infant enrollment and delivery questionnaire 150 1 8/60
ZIKV positive Pregnant women ...................... Infant follow-up questionnaire ........................ 150 6 8/60
Leroy A. Richardson, Healthy Homes and Lead Poisoning must obtain approval from the Office of
Chief, Information Collection Review Office, Surveillance System (HHLPSS) is to Management and Budget (OMB) for each
Office of Scientific Integrity, Office of the support healthy homes surveillance collection of information they conduct
Associate Director for Science, Office of the activities at the state and national levels. or sponsor. In addition, the PRA also
Director, Centers for Disease Control and requires Federal agencies to provide a
DATES: CDC must receive written
Prevention.
comments on or before January 8, 2018. 60-day notice in the Federal Register
[FR Doc. 2017–24314 Filed 11–7–17; 8:45 am]
ADDRESSES: You may submit comments, concerning each proposed collection of
BILLING CODE 4163–18–P information, including each new
identified by Docket No. CDC–2017–
0096 by any of the following methods: proposed collection, each proposed
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: extension of existing collection of
Regulations.gov. Follow the instructions information, and each reinstatement of
HUMAN SERVICES
for submitting comments. previously approved information
Centers for Disease Control and • Mail: Leroy A. Richardson, collection before submitting the
Prevention Information Collection Review Office, collection to the OMB for approval. To
Centers for Disease Control and comply with this requirement, we are
[60Day–18–0931; Docket No. CDC–2017– Prevention, 1600 Clifton Road NE., MS– publishing this notice of a proposed
0096] data collection as described below.
D74, Atlanta, Georgia 30329.
Proposed Data Collection Submitted Instructions: All submissions received The OMB is particularly interested in
for Public Comment and must include the agency name and comments that will help:
Recommendations Docket Number. CDC will post, without 1. Evaluate whether the proposed
change, all relevant comments to collection of information is necessary
AGENCY: Centers for Disease Control and Regulations.gov. for the proper performance of the
Prevention (CDC), Department of Health Please note: Submit all Federal comments functions of the agency, including
and Human Services (HHS). through the Federal eRulemaking portal whether the information will have
ACTION: Notice with comment period. (regulations.gov) or by U.S. mail to the practical utility;
address listed above. 2. Evaluate the accuracy of the
SUMMARY: The Centers for Disease
Control and Prevention (CDC), as part of FOR FURTHER INFORMATION CONTACT: To agency’s estimate of the burden of the
its continuing effort to reduce public request more information on the proposed collection of information,
burden and maximize the utility of proposed project or to obtain a copy of including the validity of the
government information, invites the the information collection plan and methodology and assumptions used;
general public and other Federal instruments, contact Leroy A. 3. Enhance the quality, utility, and
agencies the opportunity to comment on Richardson, Information Collection clarity of the information to be
a proposed and/or continuing Review Office, Centers for Disease collected; and
ethrower on DSK3G9T082PROD with NOTICES
information collection, as required by Control and Prevention, 1600 Clifton 4. Minimize the burden of the
the Paperwork Reduction Act of 1995. Road NE., MS–D74, Atlanta, Georgia collection of information on those who
This notice invites comment on a 30329; phone: 404–639–7570; Email: are to respond, including through the
proposed information collection project omb@cdc.gov. use of appropriate automated,
titled ‘‘Healthy Homes and Lead SUPPLEMENTARY INFORMATION: Under the electronic, mechanical, or other
Poisoning Surveillance System Paperwork Reduction Act of 1995 (PRA) technological collection techniques or
(HHLPSS)’’. The overarching goal of the (44 U.S.C. 3501–3520), Federal agencies other forms of information technology,
VerDate Sep<11>2014 17:26 Nov 07, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1](https://thefederalregister.org/doc/82_FR_52054/page/3.svg)
Document Created: 2017-11-08 01:21:03
Document Modified: 2017-11-08 01:21:03
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| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| FR Citation | 82 FR 51839 |
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