Research Plan, Continuing To Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025, 17824-17825 [2018-08472]
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Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices
The
National Occupational Research Agenda
(NORA) is a partnership program
created to stimulate innovative research
and improved workplace practices. The
national agenda is developed and
implemented through the NORA sector
and cross-sector councils. Each council
develops and maintains an agenda for
its sector or cross-sector.
Background: The National
Occupational Research Agenda for
Wholesale and Retail Trade (WRT) is
intended to identify the research,
information, and actions most urgently
needed to prevent occupational
illnesses and injuries in the WRT sector.
The National Occupational Research
Agenda for WRT provides a vehicle for
stakeholders to describe the most
relevant issues, gaps, and safety and
health needs for the sector. Each NORA
research agenda is meant to guide or
promote high priority research efforts on
a national level, conducted by various
entities, including: Government, higher
education, and the private sector.
The first National Occupational
Research Agenda for WRT was
published in 2009 for the second decade
of NORA (2006–2016). This draft is an
updated agenda for the third decade of
NORA (2016–2026). The revised agenda
was developed considering new
information about injuries and illnesses,
the state of the science, and the
probability that new information and
approaches will make a difference. As
the steward of the NORA process,
NIOSH invites comments on the draft
National Occupational Research
Agenda for Wholesale and Retail Trade.
Comments expressing support or with
specific recommendations to improve
the Agenda are requested. A copy of the
draft Agenda is available at https://
www.regulations.gov (see Docket
Number CDC–2018–0028).
SUPPLEMENTARY INFORMATION:
Dated: April 19, 2018.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2018–08473 Filed 4–23–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2018–0038, NIOSH–
312]
Research Plan, Continuing To Protect
the Nanotechnology Workforce: NIOSH
Nanotechnology Research Plan for
2018–2025
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:
The National Institute for
Occupational Safety and Health of the
Centers for Disease Control and
Prevention announces the availability of
a draft research plan entitled Continuing
To Protect the Nanotechnology
Workforce: NIOSH Nanotechnology
Research Plan for 2018–2025 for public
comment. To view the notice and
related materials, visit https://
www.regulations.gov and enter CDC–
2018–0038 in the search field and click
‘‘Search.’’
DATES: Electronic or written comments
must be received by June 25, 2018.
ADDRESSES: You may submit comments,
identified by CDC–2018–0038 and
docket number NIOSH–312, 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 submissions received
in response to this notice must include
the agency name and docket number
[CDC–2018–0038; NIOSH–312]. All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. 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:
Charles L. Geraci (CGeraci@cdc.gov),
National Institute for Occupational
Safety and Health, Centers for Disease
Control and Prevention, 1090 Tusculum
SUMMARY:
PO 00000
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Avenue, MS C–14, Cincinnati, OH
45226, phone (513) 533–8339 (not a toll
free number).
SUPPLEMENTARY INFORMATION: NIOSH is
seeking stakeholder input on the draft
document Continuing To Protect the
Nanotechnology Workforce: NIOSH
Nanotechnology Research Plan for
2018–2025, to ensure that the program
is meeting the needs of the stakeholders,
and to identify ways in which the
program can be improved to increase its
impact on the safety and health of
nanomaterial workers across the United
States.
Background: Since 2004, NIOSH has
pioneered research on the toxicological
properties and characteristics of
nanoparticles. This research has
involved characterizing occupationally
relevant nanoparticles for predicting
whether these particles pose a risk of
adverse health effects and for providing
guidance on controlling workplace
exposures. In September 2005, NIOSH
developed its first nanotechnology
strategic plan to further guide the
Institute in identifying and prioritizing
nanotechnology research. This strategic
plan was updated in 2009 [https://
www.cdc.gov/niosh/docs/2010-105/
pdfs/2010-105.pdf] and again in 2013
[https://www.cdc.gov/niosh/docs/2014106/pdfs/2014-106.pdf]. NIOSH would
like to build on the accomplishments of
ongoing research to develop the next
strategic research goals and objectives
for 2018–2025. NIOSH has identified 10
critical research areas for
nanotechnology research and
communication. These 10 critical
research areas are: (1) Toxicity and
internal dose, (2) measurement
methods, (3) exposure assessment, (4)
epidemiology and surveillance, (5) risk
assessment, (6) engineering controls and
personal protective equipment (PPE), (7)
fire and explosion safety, (8)
recommendations and guidance, (9)
global collaborations, and (10)
applications and informatics.
NIOSH is considering focusing the
overarching strategic research goals for
these critical areas on 5 key goals: (1)
Increase understanding of new hazards
and related health risks to nanomaterial
workers, (2) expand understanding of
the initial hazard findings of engineered
nanomaterials, (3) support the creation
of guidance materials to inform
nanomaterial workers, employers,
health professionals, regulatory
agencies, and decision makers about
hazards, risks and risk management
approaches, (4)support epidemiologic
studies for nanomaterial workers
including medical and exposure studies,
and (5) assess and promote national
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Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices
adherence with risk management
guidance.
Public comments are requested,
including those expressing support or
with specific suggestions to improve the
Research plan. A copy of the draft
Research plan is available at https://
www.regulations.gov (see Docket
Number CDC–2018–0038).
Dated: April 19, 2018.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2018–08472 Filed 4–23–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1328]
Severely Debilitating or LifeThreatening Hematologic Disorders:
Nonclinical Development of
Pharmaceuticals; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Severely
Debilitating or Life-Threatening
Hematologic Disorders: Nonclinical
Development of Pharmaceuticals.’’ The
purpose of this guidance is to provide
information to assist sponsors in the
design of an appropriate program of
nonclinical studies for the development
of pharmaceuticals used to treat patients
with severely debilitating or lifethreatening hematologic disorders
(SDLTHDs). While FDA has guidance
for oncology indications (most of which
are considered severely debilitating or
life-threatening diseases) and for rare
diseases (which include some SDLTHD
conditions), FDA has no guidance to
facilitate nonclinical development
specifically for pharmaceuticals used to
treat nononcology patients with
SDLTHDs. A streamlined approach to
drug development is necessary to allow
patients with SDLTHDs earlier and
continued access to new and potentially
effective therapies.
DATES: Submit either electronic or
written comments on the draft guidance
by June 25, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
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You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1328 for ‘‘Severely Debilitating
or Life-Threatening Hematologic
Disorders: Nonclinical Development of
Pharmaceuticals; Draft Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions–To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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17825
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: John
Leighton, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2204, Silver Spring,
MD 20993–0002, 301–796–0750; or
Haleh Saber, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2117, Silver Spring,
MD 20993–0002, 301–796–0750.
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]]>Agencies
[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)]
[Notices]
[Pages 17824-17825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number CDC-2018-0038, NIOSH-312]
Research Plan, Continuing To Protect the Nanotechnology
Workforce: NIOSH Nanotechnology Research Plan for 2018-2025
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: The National Institute for Occupational Safety and Health of
the Centers for Disease Control and Prevention announces the
availability of a draft research plan entitled Continuing To Protect
the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for
2018-2025 for public comment. To view the notice and related materials,
visit https://www.regulations.gov and enter CDC-2018-0038 in the search
field and click ``Search.''
DATES: Electronic or written comments must be received by June 25,
2018.
ADDRESSES: You may submit comments, identified by CDC-2018-0038 and
docket number NIOSH-312, 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 submissions received in response to this notice
must include the agency name and docket number [CDC-2018-0038; NIOSH-
312]. All relevant comments received will be posted without change to
https://www.regulations.gov, including any personal information
provided. 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: Charles L. Geraci ([email protected]),
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, 1090 Tusculum Avenue, MS C-14,
Cincinnati, OH 45226, phone (513) 533-8339 (not a toll free number).
SUPPLEMENTARY INFORMATION: NIOSH is seeking stakeholder input on the
draft document Continuing To Protect the Nanotechnology Workforce:
NIOSH Nanotechnology Research Plan for 2018-2025, to ensure that the
program is meeting the needs of the stakeholders, and to identify ways
in which the program can be improved to increase its impact on the
safety and health of nanomaterial workers across the United States.
Background: Since 2004, NIOSH has pioneered research on the
toxicological properties and characteristics of nanoparticles. This
research has involved characterizing occupationally relevant
nanoparticles for predicting whether these particles pose a risk of
adverse health effects and for providing guidance on controlling
workplace exposures. In September 2005, NIOSH developed its first
nanotechnology strategic plan to further guide the Institute in
identifying and prioritizing nanotechnology research. This strategic
plan was updated in 2009 [https://www.cdc.gov/niosh/docs/2010-105/pdfs/2010-105.pdf] and again in 2013 [https://www.cdc.gov/niosh/docs/2014-106/pdfs/2014-106.pdf]. NIOSH would like to build on the
accomplishments of ongoing research to develop the next strategic
research goals and objectives for 2018-2025. NIOSH has identified 10
critical research areas for nanotechnology research and communication.
These 10 critical research areas are: (1) Toxicity and internal dose,
(2) measurement methods, (3) exposure assessment, (4) epidemiology and
surveillance, (5) risk assessment, (6) engineering controls and
personal protective equipment (PPE), (7) fire and explosion safety, (8)
recommendations and guidance, (9) global collaborations, and (10)
applications and informatics.
NIOSH is considering focusing the overarching strategic research
goals for these critical areas on 5 key goals: (1) Increase
understanding of new hazards and related health risks to nanomaterial
workers, (2) expand understanding of the initial hazard findings of
engineered nanomaterials, (3) support the creation of guidance
materials to inform nanomaterial workers, employers, health
professionals, regulatory agencies, and decision makers about hazards,
risks and risk management approaches, (4)support epidemiologic studies
for nanomaterial workers including medical and exposure studies, and
(5) assess and promote national
[[Page 17825]]
adherence with risk management guidance.
Public comments are requested, including those expressing support
or with specific suggestions to improve the Research plan. A copy of
the draft Research plan is available at https://www.regulations.gov
(see Docket Number CDC-2018-0038).
Dated: April 19, 2018.
John J. Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2018-08472 Filed 4-23-18; 8:45 am]
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