83 FR 49388 - Self-Contained Breathing Apparatus Compressed Breathing Gas Containers; Request for Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 190 (October 1, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 190 (October 1, 2018)
| Page Range | 49388-49389 | |
| FR Document | 2018-21256 |
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)] [Notices] [Pages 49388-49389] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21256] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2018-0093; NIOSH-320] Self-Contained Breathing Apparatus Compressed Breathing Gas Containers; Request for Information AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Request for information. ----------------------------------------------------------------------- SUMMARY: In October 2017, the Department of Transportation (DOT) issued a special permit to the Digital Wave Corporation, allowing the company to extend the service life of certain carbon-fiber reinforced aluminum- lined cylinders. Some stakeholders, including respirator and cylinder manufacturers, have expressed concern to the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention, about the safety of cylinders extended beyond the manufacturers' stated service life. NIOSH is seeking information about the potential effect of the special permit, as it may relate to the safety of self-contained breathing apparatus respirators approved by NIOSH for use in U.S. workplaces. DATES: Comments must be received by November 30, 2018. ADDRESSES: Written comments: You may submit comments by any of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments to the docket. Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226. Instructions: All submissions received must include the agency name (Centers for Disease Control and Prevention, HHS) and docket number (CDC-2018-0093; NIOSH-320) for this action. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Jeffrey Peterson, NIOSH National Personal Protective Technology Laboratory, 626 Cochrans Mill Road, Pittsburgh, PA 15236; 1-888-654-2294 (this is a toll-free number); [email protected]. SUPPLEMENTARY INFORMATION: The Department of Transportation approves certain carbon-fiber reinforced aluminum-lined cylinders (hereinafter ``DOT-CFFC''), which are commonly used to provide breathing air in the self-contained breathing apparatus (SCBA) respirators typically carried by firefighters and other industrial workers to protect them in atmospheres immediately dangerous to life and health. Currently, all DOT-CFFC approved cylinders that are a sub-component of NIOSH-approved SCBA have a service life of 15 years; DOT regulations require ``requalification'' every 5 years to ensure that each cylinder can hold its rated pressure for the duration of the 15-year service life. In October 2017, the DOT Pipeline and Hazardous Materials Safety Administration issued special permit, DOT-SP 16320 (Third Revision), to Digital Wave Corporation of Centennial, CO.\1\ Digital Wave Corporation manufactures ultrasonic examination cylinder testing equipment, modal acoustic emission testing equipment, and provides associated inspection services, including the requalification of carbon-fiber reinforced aluminum-lined cylinders. Pursuant to DOT-SP 16320, modal acoustic emission requalification testing allows DOT-CFFC cylinders to be authorized for use for 5 years after the original 15-year service life; cylinders could be requalified three times beyond the original 15-year service life, for a total service life of 30 years. --------------------------------------------------------------------------- \1\ DOT Pipeline and Hazardous Materials Safety Administration, DOT-SP 16320, https://www.phmsa.dot.gov/approvals-and-permits/hazmat/file-serve/offer/SP16320.pdf/offerserver/SP16320. --------------------------------------------------------------------------- Modal acoustic emission testing is an advanced, non-destructive evaluation of carbon-fiber reinforced aluminum-lined cylinders that detects structural damage which can compromise burst pressure strength in a composite overwrapped pressure vessel. The modal acoustic emission waveforms can be used to identify damage such as fiber breakage and delamination. Some stakeholders have expressed concerns regarding potential cylinder failure when the service life is extended past the service life identified on the original special permit. Since DOT-SP 16320 was issued, more than 3,500 carbon-fiber reinforced aluminum- lined cylinders have been requalified beyond their original 15-year service life using the modal acoustic emission method. NIOSH has published guidance advising SCBA users who may be concerned about using modal acoustic emission-requalified cylinders as part of their NIOSH-approved SCBA configuration to review the user instructions, supplemental informational inserts, safety precautions, and SCBA warranty information provided by the NIOSH approval holder.\2\ The guidance further encourages approval holders to provide respiratory protection program administrators and SCBA users with current recommendations regarding the DOT-SP 16320 requalification method with regard to service life limitations or other relevant matters. --------------------------------------------------------------------------- \2\ https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/respprotect/CA-2018-1006.html. --------------------------------------------------------------------------- NIOSH seeks to better understand the use of modal acoustic emission testing to requalify DOT-CFFC cylinders beyond the original 15-year service life, as permitted by DOT-SP 16320, as well as the safety and health concerns of users in industrial settings, including the fire service and first responders. [[Page 49389]] Accordingly, NIOSH is seeking data and information from all interested stakeholders in response to the following questions: 1. Are users of DOT-CFFC cylinders that have been requalified for service life beyond 15 years, pursuant to the provisions of DOT-SP 16320, exposed to any elevated safety or health risk as a result of either the modal acoustic emission requalification testing itself or the service life extension? If so, identify the concern or concerns and provide substantive data, studies, references, and information to further characterize and/or quantify the concern. 2. Does the service-life extension offered by DOT-SP 16320 or the modal acoustic emission testing itself provide a benefit to either end users or institutional users (e.g., fire departments)? If so, please provide any relevant data, studies, references, or other corroborating information. 3. What factors do respiratory protection program managers consider in determining whether to replace an expiring cylinder with a new replacement cylinder or requalify the expiring cylinder using modal acoustic emission testing? 4. In which industries and operations are modal acoustic emission- requalified cylinders currently being used? John J. Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2018-21256 Filed 9-28-18; 8:45 am] BILLING CODE 4163-19-P
![49388 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
instructions) Occupational Safety and Health CO.1 Digital Wave Corporation
D. Long-term cognitive impairment (NIOSH), within the Centers for Disease manufactures ultrasonic examination
(Change in cognition after delirium Control and Prevention, about the safety cylinder testing equipment, modal
that has a long-term duration or is of cylinders extended beyond the acoustic emission testing equipment,
possibly permanent) manufacturers’ stated service life. and provides associated inspection
E. Institutionalization (living in an NIOSH is seeking information about the services, including the requalification of
assisted living facility or nursing potential effect of the special permit, as carbon-fiber reinforced aluminum-lined
home) it may relate to the safety of self- cylinders. Pursuant to DOT–SP 16320,
F. Caregiver burden/strain contained breathing apparatus modal acoustic emission requalification
G. Falls respirators approved by NIOSH for use testing allows DOT–CFFC cylinders to
H. Memory of patient distress in U.S. workplaces. be authorized for use for 5 years after
III. Resource utilization the original 15-year service life;
Comments must be received by
DATES:
A. Re-admissions to hospital or ICU cylinders could be requalified three
November 30, 2018. times beyond the original 15-year
B. Length of stay in ICU
C. Length of stay in hospital ADDRESSES: service life, for a total service life of 30
D. Length of stay in skilled nursing Written comments: You may submit years.
facility comments by any of the following Modal acoustic emission testing is an
E. Sitter use methods: advanced, non-destructive evaluation of
F. Hospice enrollment carbon-fiber reinforced aluminum-lined
• Federal eRulemaking Portal: http:// cylinders that detects structural damage
IV. Adverse effects of intervention(s) www.regulations.gov. Follow the
A. Sedation which can compromise burst pressure
instructions for submitting comments to strength in a composite overwrapped
B. Weight gain the docket.
C. Changes in appetite pressure vessel. The modal acoustic
• Mail: NIOSH Docket Office, Robert emission waveforms can be used to
D. Cardiac effects
A. Taft Laboratories, MS–C34, 1090 identify damage such as fiber breakage
E. Neurologic effects
Tusculum Avenue, Cincinnati, OH and delamination. Some stakeholders
F. Paradoxical reactions
45226. have expressed concerns regarding
G. Hypersensitivity reactions
H. Inappropriate continuation of Instructions: All submissions received potential cylinder failure when the
antipsychotic medication must include the agency name (Centers service life is extended past the service
I. Swallowing difficulties for Disease Control and Prevention, life identified on the original special
J. Aspiration pneumonia HHS) and docket number (CDC–2018– permit. Since DOT–SP 16320 was
III. Timing 0093; NIOSH–320) for this action. All issued, more than 3,500 carbon-fiber
A. Any duration of follow-up relevant comments, including any reinforced aluminum-lined cylinders
IV. Settings personal information provided, will be have been requalified beyond their
A. Hospital setting posted without change to http:// original 15-year service life using the
B. Post-acute care setting www.regulations.gov. modal acoustic emission method.
NIOSH has published guidance
C. Palliative care setting FOR FURTHER INFORMATION CONTACT: advising SCBA users who may be
Francis D. Chesley, Jr., Jeffrey Peterson, NIOSH National concerned about using modal acoustic
Deputy Director. Personal Protective Technology emission-requalified cylinders as part of
[FR Doc. 2018–21242 Filed 9–28–18; 8:45 am] Laboratory, 626 Cochrans Mill Road, their NIOSH-approved SCBA
BILLING CODE 4160–90–P
Pittsburgh, PA 15236; 1–888–654–2294 configuration to review the user
(this is a toll-free number); instructions, supplemental
PPEconcerns@cdc.gov. informational inserts, safety
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: The precautions, and SCBA warranty
HUMAN SERVICES Department of Transportation approves information provided by the NIOSH
certain carbon-fiber reinforced approval holder.2 The guidance further
Centers for Disease Control and aluminum-lined cylinders (hereinafter encourages approval holders to provide
Prevention ‘‘DOT–CFFC’’), which are commonly respiratory protection program
[Docket No. CDC–2018–0093; NIOSH–320] used to provide breathing air in the self- administrators and SCBA users with
contained breathing apparatus (SCBA) current recommendations regarding the
Self-Contained Breathing Apparatus respirators typically carried by DOT–SP 16320 requalification method
Compressed Breathing Gas firefighters and other industrial workers with regard to service life limitations or
Containers; Request for Information to protect them in atmospheres other relevant matters.
immediately dangerous to life and NIOSH seeks to better understand the
AGENCY: Centers for Disease Control and use of modal acoustic emission testing
health. Currently, all DOT–CFFC
Prevention, HHS. to requalify DOT–CFFC cylinders
approved cylinders that are a sub-
ACTION: Request for information. component of NIOSH-approved SCBA beyond the original 15-year service life,
have a service life of 15 years; DOT as permitted by DOT–SP 16320, as well
SUMMARY: In October 2017, the as the safety and health concerns of
Department of Transportation (DOT) regulations require ‘‘requalification’’
every 5 years to ensure that each users in industrial settings, including
issued a special permit to the Digital the fire service and first responders.
cylinder can hold its rated pressure for
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Wave Corporation, allowing the
company to extend the service life of the duration of the 15-year service life. 1 DOT Pipeline and Hazardous Materials Safety
certain carbon-fiber reinforced In October 2017, the DOT Pipeline Administration, DOT–SP 16320, https://
aluminum-lined cylinders. Some and Hazardous Materials Safety www.phmsa.dot.gov/approvals-and-permits/
Administration issued special permit, hazmat/file-serve/offer/SP16320.pdf/offerserver/
stakeholders, including respirator and SP16320.
cylinder manufacturers, have expressed DOT–SP 16320 (Third Revision), to 2 https://www.cdc.gov/niosh/npptl/resources/
concern to the National Institute for Digital Wave Corporation of Centennial, pressrel/letters/respprotect/CA-2018-1006.html.
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![Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices 49389
Accordingly, NIOSH is seeking data and collection of information) and to allow CMS–10142 Bid Pricing Tool (BPT) for
information from all interested 60 days for public comment on the Medicare Advantage (MA) Plans and
stakeholders in response to the proposed action. Interested persons are Prescription Drug Plans (PDP)
following questions: invited to send comments regarding our CMS–R–262 Contract Year 2020 Plan
1. Are users of DOT–CFFC cylinders burden estimates or any other aspect of Benefit Package (PBP) Software and
that have been requalified for service this collection of information, including Formulary Submission
life beyond 15 years, pursuant to the the necessity and utility of the proposed CMS–179 Medicaid State Plan Base
provisions of DOT–SP 16320, exposed information collection for the proper Plan Pages
to any elevated safety or health risk as performance of the agency’s functions, Under the PRA (44 U.S.C. 3501–
a result of either the modal acoustic the accuracy of the estimated burden, 3520), federal agencies must obtain
emission requalification testing itself or ways to enhance the quality, utility, and approval from the Office of Management
the service life extension? If so, identify clarity of the information to be and Budget (OMB) for each collection of
the concern or concerns and provide collected, and the use of automated information they conduct or sponsor.
substantive data, studies, references, collection techniques or other forms of The term ‘‘collection of information’’ is
and information to further characterize information technology to minimize the defined in 44 U.S.C. 3502(3) and 5 CFR
and/or quantify the concern. information collection burden. 1320.3(c) and includes agency requests
2. Does the service-life extension DATES: Comments must be received by or requirements that members of the
offered by DOT–SP 16320 or the modal November 30, 2018. public submit reports, keep records, or
acoustic emission testing itself provide provide information to a third party.
ADDRESSES: When commenting, please
a benefit to either end users or Section 3506(c)(2)(A) of the PRA
reference the document identifier or
institutional users (e.g., fire requires federal agencies to publish a
OMB control number. To be assured
departments)? If so, please provide any 60-day notice in the Federal Register
consideration, comments and
relevant data, studies, references, or concerning each proposed collection of
recommendations must be submitted in
other corroborating information. information, including each proposed
any one of the following ways: extension or reinstatement of an existing
3. What factors do respiratory
1. Electronically. You may send your
protection program managers consider collection of information, before
comments electronically to http://
in determining whether to replace an submitting the collection to OMB for
www.regulations.gov. Follow the
expiring cylinder with a new approval. To comply with this
instructions for ‘‘Comment or
replacement cylinder or requalify the requirement, CMS is publishing this
Submission’’ or ‘‘More Search Options’’ notice.
expiring cylinder using modal acoustic
to find the information collection
emission testing? Information Collection
4. In which industries and operations document(s) that are accepting
are modal acoustic emission-requalified comments. 1. Type of Information Collection
2. By regular mail. You may mail Request: Revision of a currently
cylinders currently being used?
written comments to the following approved collection; Title of
John J. Howard, address: CMS, Office of Strategic Information Collection: Bid Pricing Tool
Director, National Institute for Occupational Operations and Regulatory Affairs, (BPT) for Medicare Advantage (MA)
Safety and Health, Centers for Disease Control Division of Regulations Development, Plans and Prescription Drug Plans
and Prevention. Attention: Document Identifier/OMB (PDP); Use: The competitive bidding
[FR Doc. 2018–21256 Filed 9–28–18; 8:45 am] Control Number ll, Room C4–26–05, process defined by the ‘‘The Medicare
BILLING CODE 4163–19–P 7500 Security Boulevard, Baltimore, Prescription Drug, Improvement, and
Maryland 21244–1850. Modernization Act’’ (MMA) applies to
To obtain copies of a supporting both the MA and Part D programs. It
DEPARTMENT OF HEALTH AND statement and any related forms for the was first used for Contract Year 2006. It
HUMAN SERVICES proposed collection(s) summarized in is an annual process that encompasses
this notice, you may make your request the release of the MA rate book in April,
Centers for Medicare & Medicaid using one of the following: the bid’s that plans submit to CMS in
Services 1. Access CMS’ website address at June, and the release of the Part D and
[Document Identifiers: CMS–10142, CMS– https://www.cms.gov/Regulations-and- RPPO benchmarks, which typically
R–262, and CMS–179] Guidance/Legislation/PaperworkReduct occurs in August.
ionActof1995/PRA-Listing.html. CMS requires that Medicare
Agency Information Collection 2. Email your request, including your Advantage Organizations (MAOs) and
Activities: Proposed Collection; address, phone number, OMB number, Prescription Drug Plans (PDPs)
Comment Request and CMS document identifier, to complete the BPT as part of the annual
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. bidding process. During this process,
Medicaid Services, HHS. 3. Call the Reports Clearance Office at organizations prepare their proposed
(410) 786–1326. actuarial bid pricing for the upcoming
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: contract year and submit them to CMS
SUMMARY: The Centers for Medicare & William Parham at (410) 786–1326. for review and approval. The purpose of
Medicaid Services (CMS) is announcing SUPPLEMENTARY INFORMATION: the BPT is to collect the actuarial
an opportunity for the public to pricing information for each plan. It is
comment on CMS’ intention to collect Contents an Excel workbook with multiple
amozie on DSK3GDR082PROD with NOTICES
information from the public. Under the This notice sets out a summary of the worksheets and special functions
Paperwork Reduction Act of 1995 (the use and burden associated with the through which bidders present to CMS
PRA), federal agencies are required to following information collections. More their plan pricing information. Bidders
publish notice in the Federal Register detailed information can be found in enter information, such as plan
concerning each proposed collection of each collection’s supporting statement experience, projected enrollment, and
information (including each proposed and associated materials (see risk profile, and the BPT calculates the
extension or reinstatement of an existing ADDRESSES). plan premiums and other values that
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Document Created: 2018-09-29 04:26:31
Document Modified: 2018-09-29 04:26:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for information. | |
| Dates | Comments must be received by November 30, 2018. | |
| Contact | Jeffrey Peterson, NIOSH National Personal Protective Technology Laboratory, 626 Cochrans Mill Road, Pittsburgh, PA 15236; 1-888-654-2294 (this is a toll-free number); [email protected] | |
| FR Citation | 83 FR 49388 |
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