This PDF is the current document as it appeared on Public Inspection on 04/18/2017 at 08:45 am.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
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 a proposed information collection project titled “ZIRP Puerto Rico Study: Zika Virus RNA Persistence in Pregnant Women and Congenitally-Infected Infants in Puerto Rico.”
Written comments must be received on or before June 19, 2017.
You may submit comments, identified by Docket No. CDC-2017-0006 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.
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.Start Further Info
FOR FURTHER INFORMATION CONTACT:
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: email@example.com.End Further Info End Preamble Start Supplemental Information
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
ZIRP Puerto Rico Study: Zika Virus RNA Persistence in Pregnant Women and Congenitally-Infected Infants in Puerto Rico—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 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. Evidence of human ZIKV infection was observed sporadically 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.Start Printed Page 18463
In addition to mosquito-to-human transmission, ZIKV infections have been documented through sexual transmission, blood transfusion, laboratory exposure, intrauterine transmission resulting in congenital infection, and intrapartum transmission from a viremic mother to her newborn. Along with serum, ZIKV RNA has been detected in semen, urine, breast milk, and amniotic fluid. ZIKV IgM antibodies are generally first detectable at 4 to 8 days after onset of illness and likely persist for weeks to months; however, the duration of persistence of anti ZIKV IgM antibodies is unknown as well as the timing form infection to the development of IgG antibodies. The prevalence of ZIKV RNA in various body fluids among patients with acute ZIKV infection and the length of time that ZIKV RNA might persist in these body fluids is not well understood, nor the frequency with which it is infectious.
A few small studies have suggested that testing pregnant women for Zika virus (ZIKV) more than seven days from symptom onset might detect women with persistence of ZIKV RNA. Less is known about persistent ZIKV RNA in congenitally-infected infants.
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, 35,648 confirmed ZIKV cases had been reported in Puerto Rico, more than any other location in the U.S., and the number is expected to rise. Among the confirmed cases, 2,864 have been among pregnant women, and the first case of microcephaly in a fetus with confirmed ZIKV infection was announced by the PRDH 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 has been the preferred and suggested method for diagnosing ZIKV infection, but has a shorter testing window.
ZIKV RNA typically only persists in serum for 3-7 days and is thought to be cleared by 10 days. Currently, CDC recommends that all pregnant women living in areas with active ZIKV transmission such as Puerto Rico be tested. 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 being tested more than two weeks after symptom onset and symptomatic women with negative rRT-PCR test results should have serologic testing. Asymptomatic pregnant women are recommended to have serologic testing at the initiation of prenatal care and again during their first and second trimesters as a part of routine care; serum and urine rRT-PCR testing should be done after a positive or equivocal serological test result.
Limited data from human studies suggest that pregnant women have persistent detection of ZIKV RNA. In one case report, a pregnant woman became symptomatic at 11 weeks gestation and was rRT-PCR-positive at 16 weeks gestation. In another case report, a pregnant woman tested positive by rRT-PCR 107 days after symptom onset. A recent case series found persistent detection of ZIKV RNA in five pregnant women. 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. This pattern has led to the hypothesis that persistent detection of ZIKV RNA in pregnant women may be a marker of fetal infection and thus potentially a marker of adverse fetal outcomes including microcephaly.
Additionally, researchers have speculated that fetal infection might be influenced by viral load as well as persistence. The increasing number of cases and stage of the outbreak in Puerto Rico provide an opportunity to collect actionable information on a shorter timeframe than is possible elsewhere.
The ZIRP Puerto Rico study aims to determine the prevalence and duration of ZIKV RNA persistence in pregnant women and congenitally infected infants. This information will be essential for establishing guidance for testing and clinical management of pregnant women and congenitally infected infants with exposure to ZIKV. Moreover, this study is expected to provide critical scientific information to help the United States prepare for the unprecedented challenges posed by Zika and possible clinical guidelines related to ZIKV RNA testing.
CDC is requesting emergency OMB review for six months of clearance. However, because information collection is expected to take two years, CDC will submit a non-emergency information collection request to OMB for an additional two years of clearance.
Authorizing Legislation for this information collection comes from Section 301 of the Public Health Service Act (42 U.S.C. 241)
There is no cost to respondents other than their time to participate.
|Respondents||Form name||Number of respondents||Number of responses per respondent||Average burden per response (in hours)||Total burden hours|
|ZIKV positive Pregnant women||Pregnant women screening form||150||1||2/60||5|
|Pregnant women enrollment questionnaire||150||1||8/60||20|
|Pregnant women symptom questionnaire||150||1||8/60||20|
|Pregnant women follow-up questionnaire||150||48||8/60||960|
|Parents of ZIKV positive Infants||Infant enrollment questionnaire||150||1||8/60||20|
|Infant sample collection questionnaire||150||1||8/60||20|
|Infant follow-up questionnaire||150||6||8/60||120|
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. 2017-07881 Filed 4-18-17; 8:45 am]
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