[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53731-53732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Inventory for Poliovirus Containment: Minimizing Risk of 
Poliovirus Release From Laboratories in the United States; Availability

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The United States National Authority for Containment of 
Poliovirus (NAC), Centers for Disease Control and Prevention (CDC), 
Department of Health and Human Services (HHS), announces the 
availability of the National Inventory for Poliovirus Containment 
survey. This survey is designed to collect relevant laboratory 
inventory data to ensure facilities throughout the United States are in 
compliance with requirements established in the World Health 
Organization (WHO) Global Action Plan (GAPIII), as adapted for the WHO 
Region of the Americas. Per GAPIII, each country is required to 
complete a national inventory of poliovirus-containing materials, 
including poliovirus potentially infectious materials (PIM).

DATES: The deadline for completion of the survey is December 31, 2019.

FOR FURTHER INFORMATION CONTACT: Lia Haynes Smith, Director, National 
Authority for Containment of Poliovirus, Centers for Disease Control 
and Prevention, 1600 Clifton Road, NE, MS H21-6, Atlanta, GA 30329. 
Telephone: (404)718-5160.

SUPPLEMENTARY INFORMATION:  The survey should be completed by 
laboratories, storage sites, or other facilities that test, extract, 
handle, or store biological samples from humans, experimentally 
infected animals, sewage, or environmental waters. The survey questions 
are intended to identify facilities that possess any materials that may 
contain poliovirus. The questions seek to distinguish between 
potentially infectious materials (PIM) containing wild poliovirus 
(WPV), circulating vaccine-derived poliovirus (cVDPV), and oral 
poliovirus vaccine (OPV). PIM includes historical domestic and 
international specimens, human respiratory secretions, fecal specimens 
and environmental samples collected for non-polio related work in a 
time and place where wild poliovirus (WPV) or vaccine-derived 
poliovirus (cVDPV) was circulating or where oral polio vaccine (OPV) 
was in use. A table of country-specific poliovirus data can be found at 
http://polioeradication.org/wp-content/uploads/2018/11/PIM-Annex-2-16-Nov-18.pdf. Additionally, PIM cultured in some common cell lines in 
order to isolate other viruses of interest may have unintentionally 
amplified poliovirus, so respiratory or enteric viral isolates obtained 
from PIM specimens using these cell lines are also considered PIM. With 
the release of the WHO PIM guidance in April 2018, nucleic acid 
extracted using a validated method and specimens that potentially 
contain only OPV (OPV PIM), are no longer subject to containment under 
WHO GAP III. However, they are still considered part of the U.S. 
inventory and should be reported.
    For the purpose of this survey, PIM should be identified based on 
where and when the specimens were collected, not based on any test 
results.
    If a facility intends to destroy any of the potentially infectious 
poliovirus material or infectious material it possesses, it must submit 
material destruction attestation to the NAC. The NAC will send this 
attestation form to the facility once the completed survey is received.
    Although the U.S. no longer immunizes with OPV, poliovirus 
materials are still present within a limited number of U.S. facilities 
for public health and virologic research, as well as diagnostic and 
manufacturing-related purposes. In these essential facilities 
[poliovirus-essential facilities; PEFs], poliovirus materials will 
continue to be retained, post-eradication, to serve critical national 
and international functions. It is crucial that poliovirus materials 
are appropriately contained under strict biosafety and biosecurity 
handling and storage conditions to ensure that the virus is not 
released into the environment, either accidentally or intentionally, to 
cause outbreaks of the disease in susceptible populations. The risk 
from a poliovirus reintroduction can be minimized, in part, by ensuring 
that facilities retaining poliovirus are located in areas with high 
levels of vaccination coverage. The data collected from this survey 
will be used to identify facilities with poliovirus materials, to 
inform poliovirus immunization activities at PEFs including the 
potential need to immunize particular facility staff, and to identify 
vaccination coverage estimates for communities surrounding these 
facilities.

Survey Overview

    An overview of the survey questions can be found at https://www.cdc.gov/cpr/polioviruscontainment/00_docs/SurveyGuidance.pdf. This 
overview document is provided to help facilities prepare their survey 
responses and is not intended to be completed as a paper-based format. 
The survey must be completed online.
    Access to the survey, including appendices and other references, 
can be found at https://www.cdc.gov/cpr/polioviruscontainment/NIPC.htm 
The time needed to complete the online survey will vary depending on 
the complexity of a facility and the availability of needed 
information.

Paperwork Reduction Act

    CDC has determined that the information collection activities 
conducted under this project are exempt from the requirements of the 
Paperwork Reduction Act (PRA) as they fall under the activities 
authorized under the National Childhood Vaccine Injury Act (NCVIA) at 
section 2102(a)(6)-(a)(7) of the Public Health Service Act (42 U.S.C. 
300aa-2(a)(6)-(a)(7).


[[Page 53732]]


    Dated: October 2, 2019.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2019-21864 Filed 10-7-19; 8:45 am]
BILLING CODE 4163-18-P