83 FR 17824 - Research Plan, Continuing To Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 79 (April 24, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 79 (April 24, 2018)
| Page Range | 17824-17825 | |
| FR Document | 2018-08472 |
[Federal Register Volume 83, Number 79 (Tuesday, April 24, 2018)] [Notices] [Pages 17824-17825] From the Federal Register Online [www.thefederalregister.org] [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] BILLING CODE 4163-19-P
![17824 Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices
SUPPLEMENTARY INFORMATION: The DEPARTMENT OF HEALTH AND Avenue, MS C–14, Cincinnati, OH
National Occupational Research Agenda HUMAN SERVICES 45226, phone (513) 533–8339 (not a toll
(NORA) is a partnership program free number).
created to stimulate innovative research Centers for Disease Control and SUPPLEMENTARY INFORMATION: NIOSH is
and improved workplace practices. The Prevention seeking stakeholder input on the draft
national agenda is developed and [Docket Number CDC–2018–0038, NIOSH– document Continuing To Protect the
implemented through the NORA sector 312] Nanotechnology Workforce: NIOSH
and cross-sector councils. Each council Nanotechnology Research Plan for
develops and maintains an agenda for Research Plan, Continuing To Protect 2018–2025, to ensure that the program
its sector or cross-sector. the Nanotechnology Workforce: NIOSH is meeting the needs of the stakeholders,
Nanotechnology Research Plan for and to identify ways in which the
Background: The National 2018–2025 program can be improved to increase its
Occupational Research Agenda for
impact on the safety and health of
Wholesale and Retail Trade (WRT) is AGENCY: National Institute for
nanomaterial workers across the United
intended to identify the research, Occupational Safety and Health
States.
information, and actions most urgently (NIOSH) of the Centers for Disease
Background: Since 2004, NIOSH has
needed to prevent occupational Control and Prevention (CDC),
pioneered research on the toxicological
illnesses and injuries in the WRT sector. Department of Health and Human
properties and characteristics of
The National Occupational Research Services (HHS).
nanoparticles. This research has
Agenda for WRT provides a vehicle for ACTION: Request for comment. involved characterizing occupationally
stakeholders to describe the most relevant nanoparticles for predicting
SUMMARY: The National Institute for
relevant issues, gaps, and safety and whether these particles pose a risk of
Occupational Safety and Health of the
health needs for the sector. Each NORA adverse health effects and for providing
Centers for Disease Control and
research agenda is meant to guide or Prevention announces the availability of guidance on controlling workplace
promote high priority research efforts on a draft research plan entitled Continuing exposures. In September 2005, NIOSH
a national level, conducted by various To Protect the Nanotechnology developed its first nanotechnology
entities, including: Government, higher Workforce: NIOSH Nanotechnology strategic plan to further guide the
education, and the private sector. Research Plan for 2018–2025 for public Institute in identifying and prioritizing
comment. To view the notice and nanotechnology research. This strategic
The first National Occupational
related materials, visit https:// plan was updated in 2009 [https://
Research Agenda for WRT was
www.regulations.gov and enter CDC– www.cdc.gov/niosh/docs/2010-105/
published in 2009 for the second decade
2018–0038 in the search field and click pdfs/2010-105.pdf] and again in 2013
of NORA (2006–2016). This draft is an [https://www.cdc.gov/niosh/docs/2014-
updated agenda for the third decade of ‘‘Search.’’
106/pdfs/2014-106.pdf]. NIOSH would
NORA (2016–2026). The revised agenda DATES: Electronic or written comments
like to build on the accomplishments of
was developed considering new must be received by June 25, 2018. ongoing research to develop the next
information about injuries and illnesses, ADDRESSES: You may submit comments, strategic research goals and objectives
the state of the science, and the identified by CDC–2018–0038 and for 2018–2025. NIOSH has identified 10
probability that new information and docket number NIOSH–312, by any of critical research areas for
approaches will make a difference. As the following methods: nanotechnology research and
the steward of the NORA process, • Federal eRulemaking Portal: communication. These 10 critical
NIOSH invites comments on the draft https://www.regulations.gov. Follow the research areas are: (1) Toxicity and
National Occupational Research instructions for submitting comments. internal dose, (2) measurement
Agenda for Wholesale and Retail Trade. • Mail: National Institute for methods, (3) exposure assessment, (4)
Comments expressing support or with Occupational Safety and Health, NIOSH epidemiology and surveillance, (5) risk
specific recommendations to improve Docket Office, 1090 Tusculum Avenue, assessment, (6) engineering controls and
the Agenda are requested. A copy of the MS C–34, Cincinnati, Ohio 45226–1998. personal protective equipment (PPE), (7)
draft Agenda is available at https:// Instructions: All submissions received fire and explosion safety, (8)
www.regulations.gov (see Docket in response to this notice must include recommendations and guidance, (9)
the agency name and docket number global collaborations, and (10)
Number CDC–2018–0028).
[CDC–2018–0038; NIOSH–312]. All applications and informatics.
Dated: April 19, 2018. relevant comments received will be NIOSH is considering focusing the
John J. Howard, posted without change to https:// overarching strategic research goals for
Director, National Institute for Occupational www.regulations.gov, including any these critical areas on 5 key goals: (1)
Safety and Health, Centers for Disease Control personal information provided. For Increase understanding of new hazards
and Prevention. access to the docket to read background and related health risks to nanomaterial
[FR Doc. 2018–08473 Filed 4–23–18; 8:45 am] documents or comments received, go to workers, (2) expand understanding of
BILLING CODE 4163–19–P
https://www.regulations.gov. All the initial hazard findings of engineered
information received in response to this nanomaterials, (3) support the creation
notice will also be available for public of guidance materials to inform
examination and copying at the NIOSH nanomaterial workers, employers,
daltland on DSKBBV9HB2PROD with NOTICES
Docket Office, 1150 Tusculum Avenue, health professionals, regulatory
Room 155, Cincinnati, OH 45226–1998. agencies, and decision makers about
FOR FURTHER INFORMATION CONTACT: hazards, risks and risk management
Charles L. Geraci (CGeraci@cdc.gov), approaches, (4)support epidemiologic
National Institute for Occupational studies for nanomaterial workers
Safety and Health, Centers for Disease including medical and exposure studies,
Control and Prevention, 1090 Tusculum and (5) assess and promote national
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![Federal Register / Vol. 83, No. 79 / Tuesday, April 24, 2018 / Notices 17825
adherence with risk management ADDRESSES: You may submit comments submission. You should submit two
guidance. on any guidance at any time as follows: copies total. One copy will include the
Public comments are requested, information you claim to be confidential
Electronic Submissions
including those expressing support or with a heading or cover note that states
with specific suggestions to improve the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Research plan. A copy of the draft following way: CONFIDENTIAL INFORMATION.’’ The
Research plan is available at https:// • Federal eRulemaking Portal: Agency will review this copy, including
www.regulations.gov (see Docket https://www.regulations.gov. Follow the the claimed confidential information, in
Number CDC–2018–0038). instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
Dated: April 19, 2018.
including attachments, to https:// claimed confidential information
John J. Howard, www.regulations.gov will be posted to redacted/blacked out, will be available
Director, National Institute for Occupational the docket unchanged. Because your
Safety and Health, Centers for Disease Control
for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
and Prevention.
solely responsible for ensuring that your both copies to the Dockets Management
[FR Doc. 2018–08472 Filed 4–23–18; 8:45 am] comment does not include any Staff. If you do not wish your name and
BILLING CODE 4163–19–P confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
HUMAN SERVICES in the body of your comments and you
confidential business information, such must identify this information as
Food and Drug Administration as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
[Docket No. FDA–2018–D–1328] information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
Severely Debilitating or Life- comments, that information will be more information about FDA’s posting
Threatening Hematologic Disorders: posted on https://www.regulations.gov. of comments to public dockets, see 80
Nonclinical Development of • If you want to submit a comment FR 56469, September 18, 2015, or access
Pharmaceuticals; Draft Guidance for with confidential information that you the information at: https://www.gpo.gov/
Industry; Availability do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
AGENCY: Food and Drug Administration, public, submit the comment as a 23389.pdf.
HHS. written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
SUMMARY: The Food and Drug Written/Paper Submissions received, go to https://
Administration (FDA or Agency) is www.regulations.gov and insert the
Submit written/paper submissions as
announcing the availability of a draft docket number, found in brackets in the
follows:
guidance for industry entitled ‘‘Severely • Mail/Hand delivery/Courier (for heading of this document, into the
Debilitating or Life-Threatening written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Hematologic Disorders: Nonclinical Management Staff (HFA–305), Food and and/or go to the Dockets Management
Development of Pharmaceuticals.’’ The Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
purpose of this guidance is to provide Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
information to assist sponsors in the • For written/paper comments You may submit comments on any
design of an appropriate program of submitted to the Dockets Management guidance at any time (see 21 CFR
nonclinical studies for the development Staff, FDA will post your comment, as 10.115(g)(5)).
of pharmaceuticals used to treat patients well as any attachments, except for Submit written requests for single
with severely debilitating or life- information submitted, marked and copies of the draft guidance to the
threatening hematologic disorders identified, as confidential, if submitted Division of Drug Information, Center for
(SDLTHDs). While FDA has guidance as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food
for oncology indications (most of which Instructions: All submissions received and Drug Administration, 10001 New
are considered severely debilitating or must include the Docket No. FDA– Hampshire Ave., Hillandale Building,
life-threatening diseases) and for rare 2018–D–1328 for ‘‘Severely Debilitating 4th Floor, Silver Spring, MD 20993–
diseases (which include some SDLTHD or Life-Threatening Hematologic 0002. Send one self-addressed adhesive
conditions), FDA has no guidance to Disorders: Nonclinical Development of label to assist that office in processing
facilitate nonclinical development Pharmaceuticals; Draft Guidance for your requests. See the SUPPLEMENTARY
specifically for pharmaceuticals used to Industry; Availability.’’ Received INFORMATION section for electronic
treat nononcology patients with comments will be placed in the docket access to the draft guidance document.
SDLTHDs. A streamlined approach to and, except for those submitted as FOR FURTHER INFORMATION CONTACT: John
drug development is necessary to allow ‘‘Confidential Submissions,’’ publicly Leighton, Center for Drug Evaluation
patients with SDLTHDs earlier and viewable at https://www.regulations.gov and Research, Food and Drug
continued access to new and potentially or at the Dockets Management Staff Administration, 10903 New Hampshire
daltland on DSKBBV9HB2PROD with NOTICES
effective therapies. between 9 a.m. and 4 p.m., Monday Ave., Bldg. 22, Rm. 2204, Silver Spring,
DATES: Submit either electronic or through Friday. MD 20993–0002, 301–796–0750; or
written comments on the draft guidance • Confidential Submissions–To Haleh Saber, Center for Drug Evaluation
by June 25, 2018 to ensure that the submit a comment with confidential and Research, Food and Drug
Agency considers your comment on this information that you do not wish to be Administration, 10903 New Hampshire
draft guidance before it begins work on made publicly available, submit your Ave., Bldg. 22, Rm. 2117, Silver Spring,
the final version of the guidance. comments only as a written/paper MD 20993–0002, 301–796–0750.
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Document Created: 2018-04-24 00:38:54
Document Modified: 2018-04-24 00:38:54
| 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 comment. | |
| Dates | Electronic or written comments must be received by June 25, 2018. | |
| 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). | |
| FR Citation | 83 FR 17824 |
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