[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