National Inventory for Poliovirus Containment: Minimizing Risk of Poliovirus Release From Laboratories in the United States; Availability, 53731-53732 [2019-21864]
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Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Notices
Authorized contractors shall submit
requests for IFMS vehicles and related
services in writing to the appropriate
GSA point of contact in accordance with
the FAR. Contractors’ requests must
include: (1) Two copies of the agency
authorization; (2) The number of
vehicles and related services required
and period of use; (3) A list of
employees who are authorized to
request the vehicles or related services;
(4) A listing of equipment authorized to
be serviced; and (5) Billing instructions
and address.
C. Annual Burden
Respondents: 132.
Total Annual Responses: 132.
Total Burden Hours: 132.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the General
Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F
Street NW, Washington, DC 20405,
telephone 202–501–4755. Please cite
OMB Control No. 9000–0032, Contractor
Use of Interagency Fleet Management
System Vehicles, in all correspondence.
Dated: October 2, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–21886 Filed 10–7–19; 8:45 am]
BILLING CODE 6820–EP–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
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
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SUMMARY:
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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 countryspecific poliovirus data can be found at
https://polioeradication.org/wp-content/
uploads/2018/11/PIM-Annex-2-16-Nov18.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
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Sfmt 4703
53731
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 manufacturingrelated purposes. In these essential
facilities [poliovirus-essential facilities;
PEFs], poliovirus materials will
continue to be retained, posteradication, 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).
E:\FR\FM\08OCN1.SGM
08OCN1
53732
Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1722–N]
Medicare Program; Town Hall Meeting
on the FY 2021 Applications for New
Medical Services and Technologies
Add-On Payments
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a
Town Hall meeting in accordance with
section 1886(d)(5)(K)(viii) of the Social
Security Act (the Act) to discuss fiscal
year (FY) 2021 applications for add-on
payments for new medical services and
technologies under the hospital
inpatient prospective payment system
(IPPS). Interested parties are invited to
this meeting to present their comments,
recommendations, and data regarding
whether the FY 2021 new medical
services and technologies applications
meet the substantial clinical
improvement criterion.
DATES: Meeting Date: The Town Hall
Meeting announced in this notice will
be held on Monday, December 16, 2019
and Tuesday December 17, 2019 (the
number of new technology applications
submitted will determine if a second
day for the meeting is necessary; see the
SUPPLEMENTARY INFORMATION section for
details regarding the second day of the
meeting and the posting of the
preliminary meeting agenda). The Town
Hall Meeting will begin each day at 9:00
a.m. Eastern Standard Time (e.s.t.) and
check-in will begin at 8:30 a.m. e.s.t.
Deadline for Registration for
Participants (not Presenting) at the
Town Hall Meeting: The deadline to
register to attend the Town Hall Meeting
is 5:00 p.m. e.s.t. on Monday, December
9, 2019.
Deadline for Requesting Special
Accommodations: The deadline to
submit requests for special
accommodations is 5 p.m. e.s.t. on
Monday, November 25, 2019.
Deadline for Registration of Presenters
at the Town Hall Meeting: The deadline
to register to present at the Town Hall
Meeting is 5 p.m. e.s.t. on Monday,
November 18, 2019.
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SUMMARY:
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Deadline for Submission of Agenda
Item(s) or Written Comments for the
Town Hall Meeting: Written comments
and agenda items for discussion at the
Town Hall Meeting, including agenda
items by presenters, must be received by
5 p.m. e.s.t. on Monday, November 25,
2019.
Deadline for Submission of Written
Comments after the Town Hall Meeting
for consideration in the FY 2021 IPPS
proposed rule: Individuals may submit
written comments after the Town Hall
Meeting, as specified in the ADDRESSES
section of this notice, on whether the
service or technology represents a
substantial clinical improvement. These
comments must be received by 5:00
p.m. e.s.t. on Friday, January 3, 2020, for
consideration in the FY 2021 IPPS
proposed rule.
ADDRESSES: Meeting Location: The
Town Hall Meeting will be held in the
main Auditorium in the central building
of the Centers for Medicare & Medicaid
Services located at 7500 Security
Boulevard, Baltimore, MD 21244–1850.
In addition, we are providing two
alternatives to attending the meeting in
person—(1) there will be an open tollfree phone line to call into the Town
Hall Meeting; or (2) participants may
view and participate in the Town Hall
Meeting via live stream technology or
webinar. These options are discussed in
section II.B. of this notice.
Registration and Special
Accommodations: Individuals wishing
to participate in the meeting must
register by following the on-line
registration instructions located in
section III of this notice or by contacting
staff listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice. Individuals who need special
accommodations should contact staff
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
Submission of Agenda Item(s) or
Written Comments for the Town Hall
Meeting: Each presenter must submit an
agenda item(s) regarding whether a FY
2021 application meets the substantial
clinical improvement criterion. Agenda
items, written comments, questions or
other statements must not exceed three
single-spaced typed pages and may be
sent via email to newtech@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Michelle Joshua, (410) 786–6050,
michelle.joshua@cms.hhs.gov; or
Michael Treitel, (410) 786–4552,
michael.treitel@cms.hhs.gov.
Alternatively, you may forward your
requests via email to newtech@
cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
I. Background on the Add-On Payments
for New Medical Services and
Technologies Under the IPPS
Sections 1886(d)(5)(K) and (L) of the
Social Security Act (the Act) require the
Secretary to establish a process of
identifying and ensuring adequate
payments to acute care hospitals for
new medical services and technologies
under Medicare. Effective for discharges
beginning on or after October 1, 2001,
section 1886(d)(5)(K)(i) of the Act
requires the Secretary to establish (after
notice and opportunity for public
comment) a mechanism to recognize the
costs of new services and technologies
under the hospital inpatient prospective
payment system (IPPS). In addition,
section 1886(d)(5)(K)(vi) of the Act
specifies that a medical service or
technology will be considered ‘‘new’’ if
it meets criteria established by the
Secretary (after notice and opportunity
for public comment). (See the fiscal year
(FY) 2002 IPPS proposed rule (66 FR
22693, May 4, 2001) and final rule (66
FR 46912, September 7, 2001) for a more
detailed discussion.) As finalized in the
FY 2020 IPPS/LTCH PPS final rule,
technologies which are eligible for the
alternative new technology pathway for
transformative new devices or the
alternative new technology pathway for
Qualified Infectious Disease Products do
not need to meet the requirement under
42 CFR 412.87(b)(1) that the technology
represent an advance that substantially
improves, relative to technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.
These medical devices or products will
also be considered new and not
substantially similar to an existing
technology for purposes of new
technology add-on payment under the
IPPS. (See the FY 2020 IPPS/LTCH PPS
final rule (84 FR 42292 through 42297)
for additional information.)
In the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42289 through 42292), we
codified in our regulations at § 412.87
the following aspects of how we
evaluate substantial clinical
improvement for purposes of new
technology add-on payments under the
IPPS in order to determine if a new
technology meets the substantial
clinical improvement requirement:
• The totality of the circumstances is
considered when making a
determination that a new medical
service or technology represents an
advance that substantially improves,
relative to services or technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.
• A determination that a new medical
service or technology represents an
E:\FR\FM\08OCN1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
https://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
