National Institute for Occupational Safety and Health Partnership Opportunity on a Research Project To Evaluate the Performance of Isolation Gowns, 21607-21608 [2013-08461]
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Federal Register / Vol. 78, No. 70 / Thursday, April 11, 2013 / Notices
attendance must be completed before
close of business on April 30, 2013.
Dated: March 28, 2013.
Shellie Y. Pfohl,
Executive Director, President’s Council on
Fitness, Sports, and Nutrition.
[FR Doc. 2013–08494 Filed 4–10–13; 8:45 am]
BILLING CODE 4150–35–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Stakeholder Listening Session in
Preparation for the 66th World Health
Assembly
Time and date: May 6, 2013, 3 p.m.–
4:30 p.m. EST.
Place: Great Hall of the Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
Status: Open, but requiring RSVP to
OGA.RSVP@hhs.govmailto:Rebecca.
Powell@hhs.gov.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Purpose
The U.S. Department of Health and
Human Services (HHS)—charged with
leading the U.S. delegation to the 66th
World Health Assembly—will hold an
informal Stakeholder Listening Session
on Monday, May 6, 3–4:30 p.m., in the
Great Hall of the HHS Hubert H.
Humphrey Building, 200 Independence
Avenue SW., Washington, DC 20201.
The Stakeholder Listening Session
will help the HHS’s Office of Global
Affairs prepare for the World Health
Assembly by taking full advantage of the
knowledge, ideas, feedback, and
suggestions from all communities
interested in and affected by agenda
items to be discussed at the 66th World
Health Assembly. Your input will
contribute to US positions as we
negotiate these important health topics
with our international colleagues.
The listening session will be
organized around the interests and
perspectives of stakeholder
communities, including, but not limited
to:
• Public health and advocacy groups;
• State, local, and Tribal groups;
• Private industry;
• Minority health organizations; and
• Academic and scientific
organizations.
It will allow public comment on all
agenda items to be discussed at the 66th
World Health Assembly https://apps.
who.int/gb/ebwha/pdf_files/WHA66/
A66_1-en.pdf.
RSVP
Due to security restrictions for entry
into the HHS Hubert H. Humphrey
Building, we will need to receive RSVPs
VerDate Mar<15>2010
17:37 Apr 10, 2013
Jkt 229001
for this event. Please include your first
and last name as well as organization
and send it to OGA.RSVP@hhs.gov. If
you are not a US citizen please note this
in the subject line of your RSVP, and
our office will contact you to gain
additional biographical information for
your clearance. Please RSVP no later
than Monday, April 29th.
Written comments are welcome and
encouraged, even if you are planning on
attending in person. Please send these to
the same email address OGA.RSVP@
hhs.gov.
We look forward to hearing your
comments relative to the 66th World
Health Assembly agenda items.
Dated: April 4, 2013.
Nils Daulaire,
Assistant Secretary for Global Affairs.
[FR Doc. 2013–08513 Filed 4–10–13; 8:45 am]
BILLING CODE 4150–38–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institute for Occupational
Safety and Health Partnership
Opportunity on a Research Project To
Evaluate the Performance of Isolation
Gowns
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of opportunity to support
research.
AGENCY:
The NIOSH National Personal
Protective Technology Laboratory is
initiating a research study in support of
American Society for Testing and
Materials (ASTM) International
standards development to establish
minimum performance requirements for
isolation gowns for health care workers.
NIOSH is seeking to identify currently
marketed isolation gown products. All
manufacturers are requested to submit
samples to NIOSH free of charge for
testing. There will be no cost to the
manufacturers for testing. Not all
submitted products may be tested,
depending on the response to this
announcement and the results of
screening tests. Each manufacturer that
submits gowns that are tested will
receive the test results from their gowns.
Through submission of the gown
samples, manufacturers will be making
an important contribution to ASTM,
International’s process to establish an
SUMMARY:
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
21607
important standard for evaluating the
protection provided for health care
workers by isolation gowns.
Participating manufacturers will be
recognized as contributing to the
establishment of the performance
standard. Manufacturers whose
products are tested will also receive the
results of all gowns tested in a blinded
format.
Gown Criteria: Candidate gowns for
inclusion in the research program must
meet the following criteria: (1) The
gowns must be identified (labeled) as
‘‘isolation gowns’’ and have full
coverage in the back to provide
protection for the health care worker
and the patient; (2) A minimum of 100
units for each code (model) of
disposable (single use) gown submitted;
(3) A minimum of 200 ‘‘new’’
(unprocessed, unused, unwashed)
reusable gowns for each model
submitted. Reusable gown submissions
must include a labeling
recommendation for the maximum
number of laundering cycles to be
included in this study. Half of the gown
samples will be tested after one
laundering and drying cycle and half of
the gown samples will be tested as
laundered for the maximum number of
cycles claimed by the manufacturer;
and, (4) Samples should be provided in
finished package format, with any
claims that may not be noted on the
packaging or labels provided by the
manufacturer. NIOSH will not return
any gowns submitted for this testing.
DATES: Submit letters of interest to
provide gowns and participate in this
research program prior to May 13, 2013.
ADDRESSES: Interested manufacturers
should submit a letter of interest with
information about their isolation gowns’
capabilities to: NIOSH, National
Personal Protective Technology
Laboratory, Attn: Selcen Kilinc, PO Box
18070, Pittsburgh, PA 15236, Email
address: jcq8@cdc.gov
Background: It has been reported by
user groups (e.g. Association of
Perioperative Registered Nurses and
Association for Professionals in
Infection Control and Epidemiology) as
well as U.S. Food and Drug
Administration (FDA), that performance
properties and levels of protection for
isolation gowns are poorly understood
and defined. NIOSH and FDA are
currently working with the ASTM
International Committee on Personal
Protective Clothing and Equipment—
Biological Subcommittee, to establish a
standard that defines criteria for
measurement and minimum levels of
performance for isolation gowns.
Development of a standard is expected
E:\FR\FM\11APN1.SGM
11APN1
21608
Federal Register / Vol. 78, No. 70 / Thursday, April 11, 2013 / Notices
TKELLEY on DSK3SPTVN1PROD with NOTICES
to improve users’ understanding of
levels of protection to be provided.
Product testing results will be
provided to the ASTM Committee on
Personal Protective Clothing and
Equipment—Biological Subcommittee
(a.k.a. ASTM Task Force), which will
utilize the data as the scientific basis to
develop a standard establishing
minimum performance criteria for
single-use and reusable isolation gowns.
The research objective is to evaluate
performance properties, such as strength
and barrier properties, of isolation
gowns to be provided to the ASTM Task
Force as scientific input for establishing
minimum performances for
conformance to this standard.
In this study, all testing will be
conducted blind. Results will be shared
with the ASTM Task Force only in a
blinded format. Results will be shared
with the individual manufacturers for
their gowns only. The final summary of
the testing will be shared in a blinded
format only with all manufacturers that
participated.
Randomized samples will be tested by
both NIOSH and Nelson Labs. The
ASTM Task Force will review and
analyze all test results. Establishment of
the minimum requirement for each
property will be the responsibility of the
ASTM Task Force. NIOSH plans to
conduct testing to measure the
following properties: Fabric weight,
breaking strength, tear strength, seam
strength, water resistance (impact
penetration and hydrostatic pressure),
microbial/viral penetration resistance,
air permeability, evaporative resistance,
and thermal insulation.
Neither this announcement, nor
product submittals in response to this
announcement, obligates NIOSH to
enter into a contractual agreement with
any respondent. Inquiries should be
sent to Selcen Kilinc at jcq8@cdc.gov.
NIOSH reserves the right to establish a
partnership based on scientific analysis
and capabilities found by way of this
announcement or other searches, if
determined to be in the best interest of
the government.
Dated: April 5, 2013.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08461 Filed 4–10–13; 8:45 am]
BILLING CODE 4163–19–P
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17:37 Apr 10, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Notice of Hearing: Reconsideration of
Disapproval of Maine State Plan
Amendments (SPA) 12–010
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of hearing.
AGENCY:
This notice announces an
administrative hearing to be held on
May 23, 2013, at the CMS Boston
Regional Office, JFK Federal Building,
15 N. Sudbury Street, Room 2050,
Boston, Massachusetts 02203–0003 to
reconsider CMS’ decision to disapprove
Maine SPA 12–010.
DATES: Closing Date: Requests to
participate in the hearing as a party
must be received by the presiding
officer by (15 days after publication).
FOR FURTHER INFORMATION CONTACT:
Benjamin Cohen, Presiding Officer,
CMS, 2520 Lord Baltimore Drive, Suite
L, Baltimore, Maryland 21244,
Telephone: (410) 786–3169.
SUPPLEMENTARY INFORMATION: This
notice announces an administrative
hearing to reconsider CMS’ decision to
disapprove Maine SPA 12–010 which
was submitted on August 1, 2012, and
disapproved on January 7, 2013. The
SPA proposed changes to eligibility for
parents, caretaker relatives, and
children whose income is at or below
133 percent of the federal poverty level
(FPL). The proposal would make
eligibility standards, methods, and
procedures more restrictive than those
in effect on March 23, 2010.
CMS disapproved this SPA after
consulting with the Secretary as
required by 42 CFR 430.15(c)(2) because
it appeared the proposal would have
eliminated Medicaid eligibility for
parents and caretaker relatives eligible
under sections 1902(a)(10)(A)(i)(I) and
1931 whose incomes are between 100
percent and 133 percent of the FPL, and
Medicaid eligibility of certain
individuals considered ‘‘children’’
under Maine’s state Medicaid plan. Both
proposals constituted more restrictive
eligibility standards than those in effect
in Maine as of March 23, 2010, that
could not be excepted from the
maintenance-of-effort (MOE) mandate
that Maine is subject to under section
1902(a)(74) and (gg) of the Social
Security Act (hereafter ‘‘the Act’’). At
issue in this appeal are the following
issues.
While states generally have authority
to modify Medicaid eligibility rules,
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
sections 1902(a)(74) and (gg) of the Act
require that states maintain eligibility
standards, methodologies, and
procedures that are no more restrictive
than those in effect under a state’s plan
as of the date of enactment of the Patient
Protection and Affordable Care Act
(March 23, 2010). This MOE
requirement applies to adults until a
state’s health insurance exchange is
operational (January 1, 2014) and to
children until October 1, 2019.
Section 1902(gg)(3) of the Act offers a
partial non-application of the MOE
requirement during the period between
January 1, 2011, and December 31, 2013,
when a state certifies to the Secretary
that it has a budget deficit during the
fiscal year for which it is seeking a nonapplication, or projects a budget deficit
during the succeeding fiscal year. This
provision limits the non-application to
‘‘nonpregnant, nondisabled adults who
are eligible for medical assistance under
the state plan or under a waiver of the
plan at the option of the state and whose
income exceeds 133 percent of the
poverty line.’’
Maine certified a projected budget
deficit for state fiscal year 2013 in
December 2011 and requested a nonapplication of the MOE requirement for
the period of July 1, 2012, through June
30, 2013. On February 10, 2012, CMS
notified Maine that it qualified for the
non-application for the requested
period.
Maine submitted SPA #12–010 on
August 1, 2012, which proposed
changes to its Medicaid eligibility rules
for parents, caretaker relatives, children,
and to Medicare savings programs
(MSPs). Specifically, Maine proposed:
Reducing the income eligibility limit
from 150 percent of the FPL to 100
percent for parents and caretaker
relatives who may qualify under section
1902(a)(10)(A)(i)(I) and 1931 of the Act;
lowering the age limit of eligibility from
20 to 18 for children who meet the
eligibility requirements for the aid to
families with dependent children
(AFDC) state plan but who would not
have received AFDC based on age; and
reducing income eligibility for the MSPs
through the elimination of certain
income disregards. Maine eventually
split the SPA into two, with the
proposal relating to families, caretaker
relatives, and children identified as SPA
#12–010, and the proposal relating to
MSPs identified as SPA #12–010A.
On January 7, 2013, CMS approved
SPA #12–010A, but disapproved SPA
#12–010. CMS determined that Maine’s
SPAs proposed eligibility rules more
restrictive than Maine’s rules in effect
on March 23, 2010. However, due to
Maine’s FY 2013 budget deficit
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21607-21608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health Partnership
Opportunity on a Research Project To Evaluate the Performance of
Isolation Gowns
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of opportunity to support research.
-----------------------------------------------------------------------
SUMMARY: The NIOSH National Personal Protective Technology Laboratory
is initiating a research study in support of American Society for
Testing and Materials (ASTM) International standards development to
establish minimum performance requirements for isolation gowns for
health care workers. NIOSH is seeking to identify currently marketed
isolation gown products. All manufacturers are requested to submit
samples to NIOSH free of charge for testing. There will be no cost to
the manufacturers for testing. Not all submitted products may be
tested, depending on the response to this announcement and the results
of screening tests. Each manufacturer that submits gowns that are
tested will receive the test results from their gowns. Through
submission of the gown samples, manufacturers will be making an
important contribution to ASTM, International's process to establish an
important standard for evaluating the protection provided for health
care workers by isolation gowns. Participating manufacturers will be
recognized as contributing to the establishment of the performance
standard. Manufacturers whose products are tested will also receive the
results of all gowns tested in a blinded format.
Gown Criteria: Candidate gowns for inclusion in the research
program must meet the following criteria: (1) The gowns must be
identified (labeled) as ``isolation gowns'' and have full coverage in
the back to provide protection for the health care worker and the
patient; (2) A minimum of 100 units for each code (model) of disposable
(single use) gown submitted; (3) A minimum of 200 ``new'' (unprocessed,
unused, unwashed) reusable gowns for each model submitted. Reusable
gown submissions must include a labeling recommendation for the maximum
number of laundering cycles to be included in this study. Half of the
gown samples will be tested after one laundering and drying cycle and
half of the gown samples will be tested as laundered for the maximum
number of cycles claimed by the manufacturer; and, (4) Samples should
be provided in finished package format, with any claims that may not be
noted on the packaging or labels provided by the manufacturer. NIOSH
will not return any gowns submitted for this testing.
DATES: Submit letters of interest to provide gowns and participate in
this research program prior to May 13, 2013.
ADDRESSES: Interested manufacturers should submit a letter of interest
with information about their isolation gowns' capabilities to: NIOSH,
National Personal Protective Technology Laboratory, Attn: Selcen
Kilinc, PO Box 18070, Pittsburgh, PA 15236, Email address: jcq8@cdc.gov
Background: It has been reported by user groups (e.g. Association
of Perioperative Registered Nurses and Association for Professionals in
Infection Control and Epidemiology) as well as U.S. Food and Drug
Administration (FDA), that performance properties and levels of
protection for isolation gowns are poorly understood and defined. NIOSH
and FDA are currently working with the ASTM International Committee on
Personal Protective Clothing and Equipment--Biological Subcommittee, to
establish a standard that defines criteria for measurement and minimum
levels of performance for isolation gowns. Development of a standard is
expected
[[Page 21608]]
to improve users' understanding of levels of protection to be provided.
Product testing results will be provided to the ASTM Committee on
Personal Protective Clothing and Equipment--Biological Subcommittee
(a.k.a. ASTM Task Force), which will utilize the data as the scientific
basis to develop a standard establishing minimum performance criteria
for single-use and reusable isolation gowns. The research objective is
to evaluate performance properties, such as strength and barrier
properties, of isolation gowns to be provided to the ASTM Task Force as
scientific input for establishing minimum performances for conformance
to this standard.
In this study, all testing will be conducted blind. Results will be
shared with the ASTM Task Force only in a blinded format. Results will
be shared with the individual manufacturers for their gowns only. The
final summary of the testing will be shared in a blinded format only
with all manufacturers that participated.
Randomized samples will be tested by both NIOSH and Nelson Labs.
The ASTM Task Force will review and analyze all test results.
Establishment of the minimum requirement for each property will be the
responsibility of the ASTM Task Force. NIOSH plans to conduct testing
to measure the following properties: Fabric weight, breaking strength,
tear strength, seam strength, water resistance (impact penetration and
hydrostatic pressure), microbial/viral penetration resistance, air
permeability, evaporative resistance, and thermal insulation.
Neither this announcement, nor product submittals in response to
this announcement, obligates NIOSH to enter into a contractual
agreement with any respondent. Inquiries should be sent to Selcen
Kilinc at jcq8@cdc.gov. NIOSH reserves the right to establish a
partnership based on scientific analysis and capabilities found by way
of this announcement or other searches, if determined to be in the best
interest of the government.
Dated: April 5, 2013.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2013-08461 Filed 4-10-13; 8:45 am]
BILLING CODE 4163-19-P
