Department of Health and Human Services March 9, 2017 – Federal Register Recent Federal Regulation Documents

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) 61A Strategy for Assigning New NIOSH Skin Notations, Appendix E.2, Evaluation of data, pp. 41-42 [https://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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.