Proposed Revised Definitions for the Levels of Evidence for NIOSH Skin Notation Profiles; Request for Comment, 13122-13123 [2017-04628]

Download as PDF 13122 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices (404) 498–2741; or via email at NAnderson@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2017–04621 Filed 3–8–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention asabaliauskas on DSK3SPTVN1PROD with NOTICES Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting for the aforementioned committee: Time and Date: 8:30 a.m.–12:45 p.m., EDT, April 12, 2017. Place: 1095 Willowdale Road, Morgantown, WV 26505. The meeting is also available via webcast. Status: This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 50 people. The public is welcome to participate during the public comment period, 9:20 a.m.–9:30 a.m. EDT, April 12, 2017. Please note that the public comment period ends at the time indicated above or following the last call for comments, whichever is earlier. Members of the public who want to comment must sign up by providing their name by mail, email, or telephone, at the addresses provided below by April 7, 2017. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following Web site: http://www.cdc.gov/ niosh/bsc/contact.html. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH Web site to register (http://www.cdc.gov/niosh/ VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 bsc/) or call (404–498–2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397–9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https://odniosh.adobeconnect.com/ nioshbsc/ for participants wanting to connect remotely. Purpose: The Secretary, the Assistant Secretary for Health, and by delegation the Director, Centers for Disease Control and Prevention, are authorized under Sections 301 and 308 of the Public Health Service Act to conduct directly or by grants or contracts, research, experiments, and demonstrations relating to occupational safety and health and to mine health. The Board of Scientific Counselors provides guidance to the Director, National Institute for Occupational Safety and Health on research and prevention programs. Specifically, the Board provides guidance on the Institute’s research activities related to developing and evaluating hypotheses, systematically documenting findings and disseminating results. The Board evaluates the degree to which the activities of the National Institute for Occupational Safety and Health: (1) Conform to appropriate scientific standards, (2) address current, relevant needs, and (3) produce intended results. Matters for Discussion: NIOSH Director’s update; occupational motor vehicle safety, the nanotoxicolgy program, flu-related research, and mold investigations. Agenda items are subject to change as priorities dictate. An agenda is also posted on the NIOSH Web site (http://www.cdc.gov/ niosh/bsc/). Members of the public who wish to address the NIOSH BSC are requested to contact the Executive Secretary for scheduling purposes (see contact information below). Alternatively, written comments to the BSC may be submitted via an on-line form at the following Web site: http:// www.cdc.gov/niosh/bsc/contact.html. Contact Person for More Information: Paul J. Middendorf, Ph.D., Executive Secretary, BSC, NIOSH, CDC, 1600 Clifton Road NE., MS–E20, Atlanta, GA 30329–4018, telephone (404) 498–2500, fax (404) 498–2526. The Director, Management Analysis and Services Office has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 2017–04620 Filed 3–8–17; 8:45 am] BILLING CODE 4163–18–P 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 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. AGENCY: 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/2009147.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, SUMMARY: E:\FR\FM\09MRN1.SGM 09MRN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 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 nonstandardized 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 VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 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: iuz8@ cdc.gov or fya8@cdc.gov. 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. SUPPLEMENTARY INFORMATION: 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] 13123 1:00 p.m.–5:00 p.m., EDT, April 11, 2017 (Closed). PLACE: Teleconference. STATUS: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92– 463. MATTERS FOR DISCUSSION: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Cooperative Agreement on Global Occupational Health with the World Health Organization (WHO)’’, RFA– OH17–1701. CONTACT PERSON FOR MORE INFORMATION: Nina Turner, Ph.D., Scientific Review Officer, NIOSH, CDC, 1095 Willowdale Road, Mailstop G905, Morgantown, West Virginia 26506, Telephone: (304) 285–5976. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. TIME AND DATE: Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2017–04626 Filed 3–8–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P Centers for Disease Control and Prevention DEPARTMENT OF HEALTH AND HUMAN SERVICES Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to RFA–OH17–1701, Cooperative Agreement on Global Occupational Health with the World Health Organization (WHO). PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Time and Date: 8:30 a.m.–3:00 p.m., EDT, April 20, 2017. Place: CDC, Building 19, Auditorium B3, 1600 Clifton Road NE., Atlanta, Georgia 30329. Status: Open to the public, limited only by the seating and phone lines available. The meeting room accommodates approximately 60 people. Advance registration for in- E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13122-13123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04628]


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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: iuz8@cdc.gov 
or fya8@cdc.gov.

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