Standard Test Procedures Approval Process for Respirators To Be Used in Wildland Fire-Fighting Operations; Standard Test Procedures for Composite Multi-Gas and Particulate Protection and Approval Process for Respirators To Be Used in Wildland Fire-Fighting Operations, 68784-68785 [2012-27898]
Download as PDF
68784
Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
042,987, filed 4/7/2008, entitled
‘‘Recombinant Rift Valley Fever (RVF)
Viruses and Method of Use,’’ PCT
Application PCT/US2008/087023, filed 12/
16/2008, entitled ‘‘Recombinant Rift Valley
Fever (RVF) Viruses and Method of Use,’’ US
National Stage Application 12/809,561, filed
6/18/2010, entitled ‘‘Recombinant Rift Valley
Fever (RVF) Viruses and Methods of Use,’’
and all related continuing and foreign
patents/patent applications for the
technology family. CDC Technology ID No. I–
008–08.
Status: Pending.
Priority Date(s):
61/042,987 4/7/2008.
61/016,065 12/21/2007.
The planned co-exclusive license and
exclusive license will be royalty-bearing
and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR
404.7.
Technology: The technology allows
for the generation of precisely defined
attenuated vaccine constructs that
contain complete deletions of critical
virulence factors of Rift Valley Fever
(RVF) virus. These attenuated vaccines
constructs still have the ability to
induce robust protective immunity
following the administration of a single
vaccine dose in a rat model of lethal
disease. The vaccines can protect
immunized animals against virulent
virus challenge. The vaccine candidates
also allow for the differentiation of
naturally infected and vaccinated
animals—a feature that is critical in
agricultural settings. This approach will
allow for the rapid generation of
effective, safe RVF vaccine candidates to
control and prevent the spread of wildtype RVF virus in a variety of settings,
including preventing the infection of
humans or animals during endemic,
epidemic or epizootic situations in
affected countries, or for prophylactic
use among humans in high risk
occupational settings, or following
intentional release of RVF virus during
bioterrorism.
DATES: Only written comments and/or
applications for a license which are
received by CDC on or before December
17, 2012 will be considered.
ADDRESSES: Requests for a copy of these
patent applications, inquiries,
comments, and other materials relating
to the planned license should be
directed to Donald Prather, J.D., Ph.D.,
Technology Licensing and Marketing
Specialist, Technology Transfer Office,
Centers for Disease Control and
Prevention (CDC), 4770 Buford
Highway, Mailstop K–79, Atlanta, GA
30341, Telephone: (770) 488–8612;
Facsimile: (770) 488–8615; Email:
dmprather@cdc.gov.
VerDate Mar<15>2010
15:43 Nov 15, 2012
Jkt 229001
SUPPLEMENTARY INFORMATION:
Applications for a license filed in
response to this notice will be treated as
objections to giving the planned license.
Comments and objections submitted
in response to this notice will not be
made available for public inspection,
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: November 8, 2012.
J. Ronald Campbell,
Director, Division of Executive Secretariat,
Centers for Disease Control and Prevention.
[FR Doc. 2012–27897 Filed 11–15–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Prospective Grant of Exclusive
License: Multiple-Valent
Opsonophagocytic Assay Selection
Panel Arrays
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
This is a notice in accordance
with 35 U.S.C. 209(e) and 37 CFR
404.7(a)(1)(i) that the Technology
Transfer Office, Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS), is thinking about giving
a worldwide, exclusive license to
practice the inventions listed in the
patent referred to below to Flow
Applications, Inc., having a place of
business in Okawville, Illinois. The
patent rights in these inventions have
been assigned to the government of the
United States of America. The patent to
be licensed is:
SUMMARY:
US Patent 7,642,068, entitled, ‘‘MultipleValent Opsonophagocytic Assay Selection
Panel Arrays and Uses Therefor’’, issued 1/
5/2010. CDC Technology ID No. I–035–04.
Status: Patent Issued.
Priority Date: 4/22/2005.
Issue Date: 1/5/2010.
The planned exclusive license will be
royalty-bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7.
Technology: This technology utilizes
a specific medium for the selection of
up to 90 different Streptococcus
pneumoniae serotypes following a
viability opsonophagocytosis assay.
This medium includes different
antibiotics, growth factors for
pneumococcus, and a colorimetric
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
detection agent. These specific
antibiotic panels can be preserved for
later use in conjunction with a panel of
selected pneumococcal strains that will
allow for the measurement of functional
antibodies elicited by pneumococcal
vaccines.
DATES: Only written comments and/or
applications for a license which are
received by CDC on or before December
3, 2012 will be considered.
ADDRESSES: Requests for a copy of this
patent, inquiries, comments, and other
materials relating to the contemplated
license should be directed to Donald
Prather, J.D., Ph.D., Technology
Licensing and Marketing Specialist,
Technology Transfer Office, Centers for
Disease Control and Prevention (CDC),
4770 Buford Highway, Mailstop K–79,
Atlanta, GA 30341, Telephone: (770)
488–8612; Facsimile: (770) 488–8615:
Email: dwj5@cdc.gov.
SUPPLEMENTARY INFORMATION:
Applications for a license filed in
response to this notice will be treated as
objections to giving the planned license.
Comments and objections submitted
in response to this notice will not be
made available for public inspection,
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: November 8, 2012.
J. Ronald Campbell,
Director, Division of Executive Secretariat
Centers for Disease Control and Prevention.
[FR Doc. 2012–27895 Filed 11–15–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Standard Test Procedures Approval
Process for Respirators To Be Used in
Wildland Fire-Fighting Operations;
Standard Test Procedures for
Composite Multi-Gas and Particulate
Protection and Approval Process for
Respirators To Be Used in Wildland
Fire-Fighting Operations
The 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: Respirators with Composite
Protection for Wildland Fire-Fighting
Operations; Notice of Testing and
Evaluation.
AGENCY:
The Centers for Disease
Control and Prevention’s (CDC) National
SUMMARY:
E:\FR\FM\16NON1.SGM
16NON1
Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Institute for Occupational Safety and
Health (NIOSH) intends to employ
existing provisions in 42 CFR Part 84 to
test and approve air-purifying
respirators (APRs) and powered airpurifying respirators (PAPRs) that
provide composite multi-gas and
particulate protection for inhalation
hazards associated with wildland firefighting. NIOSH will evaluate candidate
respirators for inhalation protections
tailored against exposures identified in
the National Fire Protection Association
(NFPA) 1984 standard on respirators for
wildland fire-fighting (WFF) operations.
Under 42 CFR Part 84 requirements,
NIOSH approval is necessary for the
complete evaluation of WFF respirators
pursuant to NFPA 1984 (2011).
SUPPLEMENTARY INFORMATION:
Background
Wildland firefighting presents many
hazards to firefighters, including
inhalation exposure to smoke and other
combustion (fire) byproducts. Studies
indicate that most wildland firefighters
work in smoke levels that are not
expected to cause health problems or
exceed legal and recommended limits.1
However, wildland firefighters
occasionally experience smoke levels
that exceed guidelines recommended by
occupational health experts, and are
higher than Federal occupational safety
and health regulations allow. Because
manufacturers have not yet developed
respiratory protection for this
occupational setting, firefighters battling
wild fires often resort to using devices
not approved by NIOSH, or NIOSHapproved filtering facepiece respirators
which are not designed for this use, or
no respiratory protection at all. Without
a NIOSH-approved respirator designed
to protect against the combination of
particulates, gases and vapors generally
produced by wildfires, firefighters
cannot be sure that they are receiving
adequate or any protection at all.
Filtering facepiece respirators approved
under the current NIOSH standards
provide no protection against fire gases
or vapors and may structurally fail at
the elevated temperatures encountered
in wildland firefighting environments.
NIOSH is now accepting applications
for respiratory protective devices
designed for the inhalation hazards of
this occupational setting.
On July 10, 2012 NIOSH issued a
letter to manufacturers 2 announcing
that NIOSH was prepared to evaluate
respirators used for protection against
1 See: Reinhardt,TE, Ottmar, RD. 2000. Smoke
exposure at western wildfires. Res. Pap. PNW–RP–
525. Portland, OR: U.S. Department of Agriculture,
Forest Service, Pacific Northwest Research Station.
VerDate Mar<15>2010
15:43 Nov 15, 2012
Jkt 229001
the inhalation hazards identified in the
National Fire Protection Association
(NFPA) standard 1984 (2011 Edition).3
This new evaluation will be conducted
in accordance with a Memorandum of
Understanding between the NIOSH
National Personal Protective
Technology Laboratory (NPPTL) and the
Safety Equipment Institute (SEI), a nongovernmental non-profit organization
that administers third-party certification
programs to certify a broad range of
safety and protective products. Under
this MOU, NIOSH/NPPTL and SEI will
coordinate their certification programs.
SEI will evaluate candidate respirators
for compliance with NFPA 1984–2011,
Standard on Respirators for Wildland
Fire-Fighting Operations, which
includes Tentative Interim Amendment
(TIA) No. 11–1.
Under NFPA 1984, the wildland
firefighter respirator must be approved
by NIOSH as an APR or a PAPR. NIOSH
has developed test procedures for a
composite particulate and multi-gas
protection for APR and PAPR approvals
in accordance with 42 CFR 84.60(b);
84.63(a), (b), (c), and (d); 84.110(c); and
84.190(b). The standard test procedures
are available upon request and will be
available on the NIOSH NPPTL Web site
at: https://www.cdc.gov/niosh/npptl/
stps/APresp.html.
FOR FURTHER INFORMATION CONTACT: Tim
Rehak, NIOSH National Personal
Protective Technology Laboratory
(NPPTL), P.O. Box 18070, 626 Cochrans
Mill Road, Pittsburgh, PA 15236; (412)
386–5200 (this is not a toll-free
number).
Dated: November 8, 2012.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2012–27898 Filed 11–15–12; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10028, CMS–
10180, CMS–R–199 and CMS–10443]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
AGENCY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
68785
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Children’s
Health Insurance Program (CHIP) Report
on Payables and Receivables; Use:
Collection of CHIP data and the
calculation of the CHIP Incurred But
Not Reported (IBNR) estimate are
pertinent to CMS’ financial audit. The
CFO auditors have reported the lack of
an estimate for CHIP IBNR payables and
receivables as a reportable condition in
the FY 2005 audit of CMS’s financial
statements. It is essential that CMS
collect the necessary data from State
agencies in FY 2006, so that CMS
continues to receive an unqualified
audit opinion on its financial
statements. Program expenditures for
the CHIP have increased since its
inception; as such, CHIP receivables and
payables may materially impact the
financial statements. The CHIP Report
on Payables and Receivables will
provide the information needed to
calculate the CHIP IBNR.; Form
Number: CMS–10180 (OMB#: 0938–
0988); Frequency: Reporting—Annually;
Affected Public: State, Local or Tribal
governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 392. (For policy
questions regarding this collection
contact Michele Myers at 410–786–
7911. For all other issues call 410–786–
1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid Report
on Payables and Receivables; Use: The
Chief Financial Officers (CFO) Act of
1990, as amended by the Government
Management Reform Act (GMRA) of
1994, requires government agencies to
produce auditable financial statements.
Because the Centers for Medicare &
Medicaid Services (CMS) fulfills its
E:\FR\FM\16NON1.SGM
16NON1
Agencies
[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68784-68785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Standard Test Procedures Approval Process for Respirators To Be
Used in Wildland Fire-Fighting Operations; Standard Test Procedures for
Composite Multi-Gas and Particulate Protection and Approval Process for
Respirators To Be Used in Wildland Fire-Fighting Operations
AGENCY: The 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: Respirators with Composite Protection for Wildland Fire-
Fighting Operations; Notice of Testing and Evaluation.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention's (CDC)
National
[[Page 68785]]
Institute for Occupational Safety and Health (NIOSH) intends to employ
existing provisions in 42 CFR Part 84 to test and approve air-purifying
respirators (APRs) and powered air-purifying respirators (PAPRs) that
provide composite multi-gas and particulate protection for inhalation
hazards associated with wildland fire-fighting. NIOSH will evaluate
candidate respirators for inhalation protections tailored against
exposures identified in the National Fire Protection Association (NFPA)
1984 standard on respirators for wildland fire-fighting (WFF)
operations. Under 42 CFR Part 84 requirements, NIOSH approval is
necessary for the complete evaluation of WFF respirators pursuant to
NFPA 1984 (2011).
SUPPLEMENTARY INFORMATION:
Background
Wildland firefighting presents many hazards to firefighters,
including inhalation exposure to smoke and other combustion (fire)
byproducts. Studies indicate that most wildland firefighters work in
smoke levels that are not expected to cause health problems or exceed
legal and recommended limits.\1\ However, wildland firefighters
occasionally experience smoke levels that exceed guidelines recommended
by occupational health experts, and are higher than Federal
occupational safety and health regulations allow. Because manufacturers
have not yet developed respiratory protection for this occupational
setting, firefighters battling wild fires often resort to using devices
not approved by NIOSH, or NIOSH-approved filtering facepiece
respirators which are not designed for this use, or no respiratory
protection at all. Without a NIOSH-approved respirator designed to
protect against the combination of particulates, gases and vapors
generally produced by wildfires, firefighters cannot be sure that they
are receiving adequate or any protection at all. Filtering facepiece
respirators approved under the current NIOSH standards provide no
protection against fire gases or vapors and may structurally fail at
the elevated temperatures encountered in wildland firefighting
environments.
---------------------------------------------------------------------------
\1\ See: Reinhardt,TE, Ottmar, RD. 2000. Smoke exposure at
western wildfires. Res. Pap. PNW-RP-525. Portland, OR: U.S.
Department of Agriculture, Forest Service, Pacific Northwest
Research Station.
---------------------------------------------------------------------------
NIOSH is now accepting applications for respiratory protective
devices designed for the inhalation hazards of this occupational
setting.
On July 10, 2012 NIOSH issued a letter to manufacturers \2\
announcing that NIOSH was prepared to evaluate respirators used for
protection against the inhalation hazards identified in the National
Fire Protection Association (NFPA) standard 1984 (2011 Edition).\3\
This new evaluation will be conducted in accordance with a Memorandum
of Understanding between the NIOSH National Personal Protective
Technology Laboratory (NPPTL) and the Safety Equipment Institute (SEI),
a non-governmental non-profit organization that administers third-party
certification programs to certify a broad range of safety and
protective products. Under this MOU, NIOSH/NPPTL and SEI will
coordinate their certification programs. SEI will evaluate candidate
respirators for compliance with NFPA 1984-2011, Standard on Respirators
for Wildland Fire-Fighting Operations, which includes Tentative Interim
Amendment (TIA) No. 11-1.
Under NFPA 1984, the wildland firefighter respirator must be
approved by NIOSH as an APR or a PAPR. NIOSH has developed test
procedures for a composite particulate and multi-gas protection for APR
and PAPR approvals in accordance with 42 CFR 84.60(b); 84.63(a), (b),
(c), and (d); 84.110(c); and 84.190(b). The standard test procedures
are available upon request and will be available on the NIOSH NPPTL Web
site at: https://www.cdc.gov/niosh/npptl/stps/APresp.html.
FOR FURTHER INFORMATION CONTACT: Tim Rehak, NIOSH National Personal
Protective Technology Laboratory (NPPTL), P.O. Box 18070, 626 Cochrans
Mill Road, Pittsburgh, PA 15236; (412) 386-5200 (this is not a toll-
free number).
Dated: November 8, 2012.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2012-27898 Filed 11-15-12; 8:45 am]
BILLING CODE 4163-19-P