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

Proposed Revised Definitions for the Levels of Evidence for NIOSH Skin Notation Profiles; Request for Comment
Document Number: 2017-04628
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 [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.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04626
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04625
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04624
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04623
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04622
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee
Document Number: 2017-04621
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2017-04620
Type: Notice
Date: 2017-03-09
Agency: 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)-Health Disparities Subcommittee (HDS)
Document Number: 2017-04619
Type: Notice
Date: 2017-03-09
Agency: 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)
Document Number: 2017-04618
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Council for the Elimination of Tuberculosis: Notice of Charter Renewal
Document Number: 2017-04616
Type: Notice
Date: 2017-03-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Document Number: 2017-04614
Type: Notice
Date: 2017-03-09
Agency: Department of Health and Human Services, Office of the Secretary
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.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2017-04613
Type: Notice
Date: 2017-03-09
Agency: Department of Health and Human Services, Office of the Secretary
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 renewal of the approved information collection assigned OMB control number 0990-0416, scheduled to expire on March 31, 201. 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-04581
Type: Notice
Date: 2017-03-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-04580
Type: Notice
Date: 2017-03-09
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-04577
Type: Notice
Date: 2017-03-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Proposed Collection; 60-Day Comment Request; Application Process for Clinical Research Training and Medical Education at the NIH Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center)
Document Number: 2017-04573
Type: Notice
Date: 2017-03-09
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Clinical Center (CC) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.