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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.