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)

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, 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.

[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]


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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.

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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