Draft-Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report, 36748-36749 [2021-14801]
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
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Draft—Approaches to Developing
Occupational Exposure Limits or
Bands for Engineered Nanomaterials:
User Guide and Technical Report
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Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2021–14852 Filed 7–12–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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: Request for comment.
AGENCY:
NIOSH announces the
availability of a draft technical report
entitled Approaches to Developing
Occupational Exposure Limits or Bands
for Engineered Nanomaterials: User
Guide and Technical Report now
available for public comment. To view
the notice and related materials, visit
https://www.regulations.gov and enter
CDC–2021–0067 in the search field and
click ‘‘Search.’’
DATES: Electronic or written comments
must be received by September 13,
2021.
ADDRESSES: You may submit comments,
identified by CDC–2021–0067 and
docket number NIOSH–342, by any of
the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
[CDC–2021–0067; NIOSH–342]. All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. All
electronic comments should be
formatted as Microsoft Word. For access
to the docket to read background
SUMMARY:
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documents or comments received, go to
https://www.regulations.gov. All
information received in response to this
notice will also be available for public
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue,
Room 155, Cincinnati, OH 45226–1998.
FOR FURTHER INFORMATION CONTACT:
Nathan Drew, National Institute for
Occupational Safety and Health,
Emerging Technologies Branch, 1090
Tusculum Avenue, MS C–14,
Cincinnati, OH 45226, telephone (513)
533–8352 (not a toll free number).
SUPPLEMENTARY INFORMATION: On
December 17, 2019, the National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention announced in the Federal
Register [84 FR 68935] plans to evaluate
the scientific data on engineered
nanomaterials for the development of
categorical occupational exposure
limits. The draft NIOSH technical report
describing approaches to evaluating
these scientific data is now available for
public comment, Approaches to
Developing Occupational Exposure
Limits or Bands for Engineered
Nanomaterials: User Guide and
Technical Report.
Background: Most chemical
substances, including engineered
nanomaterials, do not have specific
occupational exposure limits.
Alternative methods are needed to
assess the potential occupational safety
and health hazards of engineered
nanomaterials. Categorical occupational
exposure limits are one approach to
estimating exposure concentrations for
groups of materials with similar
toxicological effects and/or
physicochemical properties.
Occupational exposure banding is
another approach to protect worker
health by assigning chemical substances
into specific categories or ‘‘bands’’
based on their associated health
outcomes and on potency
considerations. These bands correspond
to a range of airborne exposure
concentrations to inform risk
management decisions for substances
that do not have occupational exposure
limits. NIOSH has proposed an
evidence-based approach to evaluate the
scientific information available in order
to derive occupational exposure limits,
or bands, for engineered nanomaterials.
This proposed approach is described in
the draft NIOSH technical report
available for public comment,
Approaches to Developing Occupational
Exposure Limits or Bands for
Engineered Nanomaterials: User Guide
and Technical Report. This draft report
contains two main parts: (I) User Guide
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
and (II) full Technical Report and
Appendixes.
The purpose of the public comment
period is to obtain comments on the
draft report. Comments are being sought
from individuals including scientists
and representatives from various
government agencies, industry, labor,
and other stakeholders, and also the
public. If there are errors of fact,
unsubstantiated claims, evidence of
careless experimental work, inclusion of
too much information already in the
literature, or statements that are
inaccurate, please note such in your
review comments.
The authors ask that special emphasis
be placed on technical review of the
following issues:
1. Does the draft document adequately
describe the process for gathering and
evaluating the information available on
occupational exposure limits or bands
for engineered nanomaterials?
2. Does the draft document adequately
describe the development of a
framework for categorizing engineered
nanomaterials by potential occupational
health hazard from inhalation exposure?
3. Are the clustering and classification
modeling methodologies reasonable for
these data?
4. Is a revision to current occupational
exposure banding guidance needed to
incorporate a band F?
5. How useful and practical is the
approach described in both the user
guide and full technical report for
deriving categorical occupational
exposure limits, and what are the
opportunities for improvement?
6. Are the current searches and
collection of scientific data sufficient,
and are there additional opportunities
for obtaining data that were not
included?
7. Would the methods used in the
report also be appropriate for a future
comprehensive dataset of experimental,
toxicological, and physicochemical
information for engineered
nanomaterials?
8. Are there additional comments that
you would like to provide?
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2021–14801 Filed 7–12–21; 8:45 am]
BILLING CODE 4163–18–P
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17:47 Jul 12, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7063–N]
Announcement of the Advisory Panel
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July 28, 2021 Virtual Meeting
Centers for Medicare &
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Human Services (HHS).
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AGENCY:
This notice announces the
next meeting of the APOE (the Panel) in
accordance with the Federal Advisory
Committee Act. The Panel advises and
makes recommendations to the
Secretary of the U.S. Department of
Health and Human Services (HHS) (the
Secretary) and the Administrator of the
Centers for Medicare & Medicaid
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Meeting Date: Wednesday, July 28,
2021 from 12:00 p.m. to 5:00 p.m.
eastern daylight time (e.d.t).
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Presentations, Special
Accommodations, and Comments:
Wednesday, July 14, 2021, 5:00 p.m.
(e.d.t).
SUMMARY:
ADDRESSES:
Meeting Location: Virtual. All those
who RSVP will receive the link to
attend.
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Presentations and written comments
should be submitted to: Lisa Carr,
Designated Federal Official (DFO),
Office of Communications, Centers for
Medicare & Medicaid Services, 200
Independence Avenue SW, Mailstop
325G HHH, Washington, DC 20201,
202–690–5742, or via email at APOE@
cms.hhs.gov.
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the space available. Persons wishing to
attend this meeting must register at the
website https://www.eventbrite.com/e/
apoe-july-28-2021-virtual-meetingtickets-151112584809 or by contacting
the DFO listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice, by the date listed in the DATES
section of this notice. Individuals
requiring sign language interpretation or
other special accommodations should
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contact the DFO at the address listed in
the ADDRESSES section of this notice by
the date listed in the DATES section of
this notice.
FOR FURTHER INFORMATION CONTACT: Lisa
Carr, Designated Federal Official, Office
of Communications, 200 Independence
Avenue SW, Mailstop 325G HHH,
Washington, DC 20201, 202–690–5742,
or via email at APOE@cms.hhs.gov.
Additional information about the
APOE is available at: https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/APOE. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145.
SUPPLEMENTARY INFORMATION:
I. Background and Charter Renewal
Information
A. Background
The Advisory Panel for Outreach and
Education (APOE) (the Panel) is
governed by the provisions of the
Federal Advisory Committee Act
(FACA) (Pub. L. 92–463), as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
federal advisory committees. The Panel
is authorized by section 1114(f) of the
Social Security Act (the Act) (42 U.S.C.
1314(f)) and section 222 of the Public
Health Service Act (42 U.S.C. 217a).
The Secretary of the U.S. Department
of Health and Human Services (HHS)
(the Secretary) signed the charter
establishing the Citizen’s Advisory
Panel on Medicare Education 1 (the
predecessor to the APOE) on January 21,
1999 (64 FR 7899) to advise and make
recommendations to the Secretary and
the Administrator of the Centers for
Medicare & Medicaid Services (CMS) on
the effective implementation of national
Medicare education programs, including
with respect to the Medicare+Choice
(M+C) program added by the Balanced
Budget Act of 1997 (Pub. L. 105–33).
The Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173)
expanded the existing health plan
options and benefits available under the
M+C program and renamed it the
Medicare Advantage (MA) program.
CMS has had substantial responsibilities
to provide information to Medicare
beneficiaries about the range of health
plan options available and better tools
to evaluate these options. The
successful MA program implementation
required CMS to consider the views and
policy input from a variety of private
1 We note that the Citizen’s Advisory Panel on
Medicare Education is also referred to as the
Advisory Panel on Medicare Education (65 FR
4617). The name was updated in the Second
Amended Charter approved on July 24, 2000.
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Agencies
[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36748-36749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14801]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number CDC-2021-0067, NIOSH-342]
Draft--Approaches to Developing Occupational Exposure Limits or
Bands for Engineered Nanomaterials: User Guide and Technical Report
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: Request for comment.
-----------------------------------------------------------------------
SUMMARY: NIOSH announces the availability of a draft technical report
entitled Approaches to Developing Occupational Exposure Limits or Bands
for Engineered Nanomaterials: User Guide and Technical Report now
available for public comment. To view the notice and related materials,
visit https://www.regulations.gov and enter CDC-2021-0067 in the search
field and click ``Search.''
DATES: Electronic or written comments must be received by September 13,
2021.
ADDRESSES: You may submit comments, identified by CDC-2021-0067 and
docket number NIOSH-342, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov
Follow the instructions for submitting comments.
Mail: National Institute for Occupational Safety and
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati,
Ohio 45226-1998.
Instructions: All information received in response to this notice
must include the agency name and docket number [CDC-2021-0067; NIOSH-
342]. All relevant comments received will be posted without change to
https://www.regulations.gov, including any personal information
provided. All electronic comments should be formatted as Microsoft
Word. For access to the docket to read background documents or comments
received, go to https://www.regulations.gov. All information received
in response to this notice will also be available for public
examination and copying at the NIOSH Docket Office, 1150 Tusculum
Avenue, Room 155, Cincinnati, OH 45226-1998.
FOR FURTHER INFORMATION CONTACT: Nathan Drew, National Institute for
Occupational Safety and Health, Emerging Technologies Branch, 1090
Tusculum Avenue, MS C-14, Cincinnati, OH 45226, telephone (513) 533-
8352 (not a toll free number).
SUPPLEMENTARY INFORMATION: On December 17, 2019, the National Institute
for Occupational Safety and Health, Centers for Disease Control and
Prevention announced in the Federal Register [84 FR 68935] plans to
evaluate the scientific data on engineered nanomaterials for the
development of categorical occupational exposure limits. The draft
NIOSH technical report describing approaches to evaluating these
scientific data is now available for public comment, Approaches to
Developing Occupational Exposure Limits or Bands for Engineered
Nanomaterials: User Guide and Technical Report.
Background: Most chemical substances, including engineered
nanomaterials, do not have specific occupational exposure limits.
Alternative methods are needed to assess the potential occupational
safety and health hazards of engineered nanomaterials. Categorical
occupational exposure limits are one approach to estimating exposure
concentrations for groups of materials with similar toxicological
effects and/or physicochemical properties. Occupational exposure
banding is another approach to protect worker health by assigning
chemical substances into specific categories or ``bands'' based on
their associated health outcomes and on potency considerations. These
bands correspond to a range of airborne exposure concentrations to
inform risk management decisions for substances that do not have
occupational exposure limits. NIOSH has proposed an evidence-based
approach to evaluate the scientific information available in order to
derive occupational exposure limits, or bands, for engineered
nanomaterials. This proposed approach is described in the draft NIOSH
technical report available for public comment, Approaches to Developing
Occupational Exposure Limits or Bands for Engineered Nanomaterials:
User Guide and Technical Report. This draft report contains two main
parts: (I) User Guide
[[Page 36749]]
and (II) full Technical Report and Appendixes.
The purpose of the public comment period is to obtain comments on
the draft report. Comments are being sought from individuals including
scientists and representatives from various government agencies,
industry, labor, and other stakeholders, and also the public. If there
are errors of fact, unsubstantiated claims, evidence of careless
experimental work, inclusion of too much information already in the
literature, or statements that are inaccurate, please note such in your
review comments.
The authors ask that special emphasis be placed on technical review
of the following issues:
1. Does the draft document adequately describe the process for
gathering and evaluating the information available on occupational
exposure limits or bands for engineered nanomaterials?
2. Does the draft document adequately describe the development of a
framework for categorizing engineered nanomaterials by potential
occupational health hazard from inhalation exposure?
3. Are the clustering and classification modeling methodologies
reasonable for these data?
4. Is a revision to current occupational exposure banding guidance
needed to incorporate a band F?
5. How useful and practical is the approach described in both the
user guide and full technical report for deriving categorical
occupational exposure limits, and what are the opportunities for
improvement?
6. Are the current searches and collection of scientific data
sufficient, and are there additional opportunities for obtaining data
that were not included?
7. Would the methods used in the report also be appropriate for a
future comprehensive dataset of experimental, toxicological, and
physicochemical information for engineered nanomaterials?
8. Are there additional comments that you would like to provide?
John J. Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2021-14801 Filed 7-12-21; 8:45 am]
BILLING CODE 4163-18-P