82 FR 13122 - Proposed Revised Definitions for the Levels of Evidence for NIOSH Skin Notation Profiles; Request for Comment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 45 (March 9, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 45 (March 9, 2017)
| Page Range | 13122-13123 | |
| FR Document | 2017-04628 |
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)] [Notices] [Pages 13122-13123] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04628] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number CDC-2017-0017, NIOSH 153-D] Proposed Revised Definitions for the Levels of Evidence for NIOSH Skin Notation Profiles; Request for Comment 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 comments. ----------------------------------------------------------------------- SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) proposes to clarify the definitions for `sufficient', `limited', and `insufficient' levels of evidence for the designation of NIOSH skin notations. In NIOSH Current Intelligence Bulletin (CIB) 61--A Strategy for Assigning New NIOSH Skin Notations, Appendix E.2, Evaluation of data, pp. 41-42 [http://www.cdc.gov/niosh/docs/2009-147/pdfs/2009-147.pdf] these levels of evidence are defined as the following: ``Data sets classified as sufficient are those that include human and/or animal toxicity studies conducted according to standardized protocols and that provide in-depth descriptions of the exposure conditions and study findings. Data sets classified as limited via the qualitative ranking scheme contain either human and/or animal studies conducted by non-standardized protocols or contain incomplete descriptions of the exposure conditions and study findings. Data sets classified as insufficient include studies that primarily either did not apply standard protocols or did not provide an in-depth description of the exposure conditions or study findings. Data sets that receive the insufficient ranking will not be used as the basis for the NIOSH skin notation.'' NIOSH proposes to clarify the definitions for the sufficient, limited, [[Page 13123]] and insufficient levels of evidence to the following: ``Data sets classified as sufficient are those that include human and/or animal studies conducted using standardized protocols and that provide complete descriptions of the exposure conditions and study findings. Data sets classified as limited are those that include human and/or animal studies conducted using non-standardized protocols or that provide incomplete descriptions of the exposure conditions or study findings. Data sets classified as insufficient are those that include human and/or animal studies conducted using non-standardized protocols and that provide incomplete descriptions of the exposure conditions and study findings. Data sets that receive the insufficient ranking will not be used as the basis for the NIOSH skin notation.'' Evaluation of dose-related effects in studies with limited or insufficient evidence, mechanistic data, and analogous chemical properties may be factored into the classification scheme for determining the level of evidence for identified studies. Data sets that provide insufficient evidence will not be used as the basis for the NIOSH skin notation but, in some cases, may provide information to support or contradict evidence for the skin notation. For data sets with conflicting findings, an overall determination based on the body of evidence will be developed by evaluating data adequacy, reliability and relevance, and assessing each study's quality of evidence. The studies with the best quality and validity to support the notation are identified and cited in the individual Skin Notation Profile documents. NIOSH seeks comments on proposed changes as described above. DATES: Comments must be submitted on or before April 10, 2017. ADDRESSES: You may submit comments, identified by CDC-2017-0017 and docket number NIOSH 153-D, by any of the following methods:Federal eRulemaking Portal: http://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-2017-0017; NIOSH 153-D]. All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to www.regulations.gov. For access to the original docket [NIOSH- 153] to view background documents or comments received, go to https://www.cdc.gov/niosh/docket/archive/docket153.html. All information received in response to this notice will 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: Naomi Hudson or G. Scott Dotson, NIOSH, Education and Information Division, Robert A. Taft Laboratories, 1190 Tusculum Ave, MS C-32, Cincinnati, OH 45226, email: [email protected] or [email protected]. SUPPLEMENTARY INFORMATION: In 2009, NIOSH published Current Intelligence Bulletin 61--A Strategy for assigning New NIOSH Skin Notations [NIOSH 2009-147; http://www.cdc.gov/niosh/docs/2009-147/pdfs/2009-147.pdf]. The CIB presents a strategic framework that is a form of hazard identification that ensures that the assigned skin notations reflect the contemporary state of scientific knowledge, provides transparency behind the assignment process, communicates the hazards of chemical exposures of the skin, and meets the needs of health professionals, employers, and others interested in protecting workers from chemical contact with the skin. Published Skin Notation Profile documents are available at https://www.cdc.gov/niosh/topics/skin/skin-notation_profiles.html. Frank Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2017-04628 Filed 3-8-17; 8:45 am] BILLING CODE 4163-18-P
![13122 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
(404) 498–2741; or via email at bsc/) or call (404–498–2539) at least five Prevention and the Agency for Toxic
NAnderson@cdc.gov. business days in advance of the Substances and Disease Registry.
The Director, Management Analysis meeting. Teleconference is available
Elaine L. Baker,
and Services Office, has been delegated toll-free; please dial (888) 397–9578,
the authority to sign Federal Register Director, Management Analysis and Services
Participant Pass Code 63257516. Adobe
Office, Centers for Disease Control and
Notices pertaining to announcements of Connect webcast will be available at Prevention (CDC).
meetings and other committee https://odniosh.adobeconnect.com/ [FR Doc. 2017–04620 Filed 3–8–17; 8:45 am]
management activities, for the Centers nioshbsc/ for participants wanting to
BILLING CODE 4163–18–P
for Disease Control and Prevention and connect remotely.
the Agency for Toxic Substances and
Purpose: The Secretary, the Assistant
Disease Registry.
Secretary for Health, and by delegation DEPARTMENT OF HEALTH AND
Elaine L. Baker, the Director, Centers for Disease Control HUMAN SERVICES
Director, Management Analysis and Services and Prevention, are authorized under
Office, Centers for Disease Control and Sections 301 and 308 of the Public Centers for Disease Control and
Prevention. Health Service Act to conduct directly Prevention
[FR Doc. 2017–04621 Filed 3–8–17; 8:45 am] or by grants or contracts, research,
[Docket Number CDC–2017–0017, NIOSH
BILLING CODE 4163–18–P experiments, and demonstrations 153–D]
relating to occupational safety and
health and to mine health. The Board of Proposed Revised Definitions for the
DEPARTMENT OF HEALTH AND Scientific Counselors provides guidance Levels of Evidence for NIOSH Skin
HUMAN SERVICES to the Director, National Institute for Notation Profiles; Request for
Occupational Safety and Health on Comment
Centers for Disease Control and research and prevention programs.
Prevention Specifically, the Board provides AGENCY: National Institute for
guidance on the Institute’s research Occupational Safety and Health
Board of Scientific Counselors, (NIOSH) of the Centers for Disease
National Institute for Occupational activities related to developing and
evaluating hypotheses, systematically Control and Prevention (CDC),
Safety and Health (BSC, NIOSH) Department of Health and Human
documenting findings and
In accordance with section 10(a)(2) of disseminating results. The Board Services (HHS).
the Federal Advisory Committee Act evaluates the degree to which the ACTION: Request for comments.
(Pub. L. 92–463), the Centers for Disease activities of the National Institute for
Control and Prevention (CDC) Occupational Safety and Health: (1) SUMMARY: The National Institute for
announces the following meeting for the Conform to appropriate scientific Occupational Safety and Health
aforementioned committee: standards, (2) address current, relevant (NIOSH) of the Centers for Disease
Time and Date: 8:30 a.m.–12:45 p.m., needs, and (3) produce intended results. Control and Prevention (CDC) proposes
EDT, April 12, 2017. to clarify the definitions for ‘sufficient’,
Place: 1095 Willowdale Road, Matters for Discussion: NIOSH ‘limited’, and ‘insufficient’ levels of
Morgantown, WV 26505. The meeting is Director’s update; occupational motor evidence for the designation of NIOSH
also available via webcast. vehicle safety, the nanotoxicolgy skin notations. In NIOSH Current
Status: This meeting is open to the program, flu-related research, and mold Intelligence Bulletin (CIB) 61—A
public, limited only by the space investigations. Strategy for Assigning New NIOSH Skin
available. The meeting room Agenda items are subject to change as Notations, Appendix E.2, Evaluation of
accommodates approximately 50 priorities dictate. data, pp. 41–42 [http://www.cdc.gov/
people. The public is welcome to An agenda is also posted on the niosh/docs/2009-147/pdfs/2009-
participate during the public comment NIOSH Web site (http://www.cdc.gov/ 147.pdf] these levels of evidence are
period, 9:20 a.m.–9:30 a.m. EDT, April niosh/bsc/). Members of the public who defined as the following:
12, 2017. Please note that the public wish to address the NIOSH BSC are ‘‘Data sets classified as sufficient are
comment period ends at the time requested to contact the Executive those that include human and/or animal
indicated above or following the last Secretary for scheduling purposes (see toxicity studies conducted according to
call for comments, whichever is earlier. contact information below). standardized protocols and that provide
Members of the public who want to Alternatively, written comments to the in-depth descriptions of the exposure
comment must sign up by providing BSC may be submitted via an on-line conditions and study findings. Data sets
their name by mail, email, or telephone, form at the following Web site: http:// classified as limited via the qualitative
at the addresses provided below by www.cdc.gov/niosh/bsc/contact.html. ranking scheme contain either human
April 7, 2017. Each commenter will be and/or animal studies conducted by
provided up to five minutes for Contact Person for More Information: non-standardized protocols or contain
comment. A limited number of time Paul J. Middendorf, Ph.D., Executive incomplete descriptions of the exposure
slots are available and will be assigned Secretary, BSC, NIOSH, CDC, 1600 conditions and study findings. Data sets
on a first come-first served basis. Clifton Road NE., MS–E20, Atlanta, GA classified as insufficient include studies
Written comments will also be accepted 30329–4018, telephone (404) 498–2500, that primarily either did not apply
asabaliauskas on DSK3SPTVN1PROD with NOTICES
from those unable to attend the public fax (404) 498–2526. standard protocols or did not provide an
session via an on-line form at the The Director, Management Analysis in-depth description of the exposure
following Web site: http://www.cdc.gov/ and Services Office has been delegated conditions or study findings. Data sets
niosh/bsc/contact.html. The meeting is the authority to sign Federal Register that receive the insufficient ranking will
also open to the public via webcast. If notices pertaining to announcements of not be used as the basis for the NIOSH
you wish to attend in person or by meetings and other committee skin notation.’’
webcast, please see the NIOSH Web site management activities, for both the NIOSH proposes to clarify the
to register (http://www.cdc.gov/niosh/ Centers for Disease Control and definitions for the sufficient, limited,
VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/82_FR_13167/page/1.svg)
![Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 13123
and insufficient levels of evidence to the documents or comments received, go to TIME AND DATE: 1:00 p.m.–5:00 p.m.,
following: www.regulations.gov. For access to the EDT, April 11, 2017 (Closed).
‘‘Data sets classified as sufficient are original docket [NIOSH–153] to view PLACE: Teleconference.
those that include human and/or animal background documents or comments STATUS: The meeting will be closed to
studies conducted using standardized received, go to https://www.cdc.gov/ the public in accordance with
protocols and that provide complete niosh/docket/archive/docket153.html. provisions set forth in Section 552b(c)
descriptions of the exposure conditions All information received in response to (4) and (6), Title 5 U.S.C., and the
and study findings. Data sets classified this notice will be available for public Determination of the Director,
as limited are those that include human examination and copying at the NIOSH Management Analysis and Services
and/or animal studies conducted using Docket Office, 1150 Tusculum Avenue, Office, CDC, pursuant to Public Law 92–
non-standardized protocols or that Room 155, Cincinnati, OH 45226–1998. 463.
provide incomplete descriptions of the
FOR FURTHER INFORMATION CONTACT: MATTERS FOR DISCUSSION: The meeting
exposure conditions or study findings.
Naomi Hudson or G. Scott Dotson, will include the initial review,
Data sets classified as insufficient are
NIOSH, Education and Information discussion, and evaluation of
those that include human and/or animal
Division, Robert A. Taft Laboratories, applications received in response to
studies conducted using non-
1190 Tusculum Ave, MS C–32, ‘‘Cooperative Agreement on Global
standardized protocols and that provide
Cincinnati, OH 45226, email: iuz8@ Occupational Health with the World
incomplete descriptions of the exposure
cdc.gov or fya8@cdc.gov. Health Organization (WHO)’’, RFA–
conditions and study findings. Data sets
OH17–1701.
that receive the insufficient ranking will SUPPLEMENTARY INFORMATION: In 2009,
not be used as the basis for the NIOSH NIOSH published Current Intelligence CONTACT PERSON FOR MORE INFORMATION:
skin notation.’’ Bulletin 61—A Strategy for assigning Nina Turner, Ph.D., Scientific Review
Evaluation of dose-related effects in New NIOSH Skin Notations [NIOSH Officer, NIOSH, CDC, 1095 Willowdale
studies with limited or insufficient 2009–147; http://www.cdc.gov/niosh/ Road, Mailstop G905, Morgantown,
evidence, mechanistic data, and docs/2009-147/pdfs/2009-147.pdf]. The West Virginia 26506, Telephone: (304)
analogous chemical properties may be CIB presents a strategic framework that 285–5976.
factored into the classification scheme is a form of hazard identification that The Director, Management Analysis
for determining the level of evidence for ensures that the assigned skin notations and Services Office, has been delegated
identified studies. Data sets that provide reflect the contemporary state of the authority to sign Federal Register
insufficient evidence will not be used as scientific knowledge, provides notices pertaining to announcements of
the basis for the NIOSH skin notation transparency behind the assignment meetings and other committee
but, in some cases, may provide process, communicates the hazards of management activities, for both the
information to support or contradict chemical exposures of the skin, and Centers for Disease Control and
evidence for the skin notation. meets the needs of health professionals, Prevention and the Agency for Toxic
For data sets with conflicting employers, and others interested in Substances and Disease Registry.
findings, an overall determination based protecting workers from chemical Elaine L. Baker,
on the body of evidence will be contact with the skin. Published Skin Director, Management Analysis and Services
developed by evaluating data adequacy, Notation Profile documents are Office, Centers for Disease Control and
reliability and relevance, and assessing available at https://www.cdc.gov/niosh/ Prevention.
each study’s quality of evidence. The topics/skin/skin-notation_profiles.html. [FR Doc. 2017–04626 Filed 3–8–17; 8:45 am]
studies with the best quality and BILLING CODE 4163–18–P
validity to support the notation are Frank Hearl,
identified and cited in the individual Chief of Staff, National Institute for
Skin Notation Profile documents. Occupational Safety and Health, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
NIOSH seeks comments on proposed HUMAN SERVICES
changes as described above. [FR Doc. 2017–04628 Filed 3–8–17; 8:45 am]
DATES: Comments must be submitted on BILLING CODE 4163–18–P Centers for Disease Control and
or before April 10, 2017. Prevention
ADDRESSES: You may submit comments, DEPARTMENT OF HEALTH AND Advisory Committee to the Director
identified by CDC–2017–0017 and HUMAN SERVICES (ACD), Centers for Disease Control and
docket number NIOSH 153–D, by any of Prevention (CDC)
the following methods: Centers for Disease Control and
• Federal eRulemaking Portal: http:// Prevention In accordance with section 10(a)(2) of
www.regulations.gov. Follow the the Federal Advisory Committee Act
instructions for submitting comments. Disease, Disability, and Injury (Pub. L. 92–463), the Centers for Disease
• Mail: National Institute for Prevention and Control Special Control and Prevention (CDC)
Occupational Safety and Health, NIOSH Emphasis Panel (SEP): Initial Review announces the following meeting of the
Docket Office, 1090 Tusculum Avenue, aforementioned committee:
MS C–34, Cincinnati, Ohio 45226–1998. In accordance with Section 10(a)(2) of Time and Date: 8:30 a.m.–3:00 p.m.,
Instructions: All information received the Federal Advisory Committee Act EDT, April 20, 2017.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
in response to this notice must include (Pub. L. 92–463), the Centers for Disease Place: CDC, Building 19, Auditorium
the agency name and docket number Control and Prevention (CDC) B3, 1600 Clifton Road NE., Atlanta,
[CDC–2017–0017; NIOSH 153–D]. All announces a meeting for the initial Georgia 30329.
relevant comments received will be review of applications in response to Status: Open to the public, limited
posted without change to RFA–OH17–1701, Cooperative only by the seating and phone lines
www.regulations.gov, including any Agreement on Global Occupational available. The meeting room
personal information provided. For Health with the World Health accommodates approximately 60
access to the docket to read background Organization (WHO). people. Advance registration for in-
VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/82_FR_13167/page/2.svg)
Document Created: 2017-03-09 04:58:30
Document Modified: 2017-03-09 04:58:30
| 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 comments. | |
| Dates | Comments must be submitted on or before April 10, 2017. | |
| Contact | Naomi Hudson or G. Scott Dotson, NIOSH, Education and Information Division, Robert A. Taft Laboratories, 1190 Tusculum Ave, MS C-32, Cincinnati, OH 45226, email: [email protected] or [email protected] | |
| FR Citation | 82 FR 13122 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR