Department of Health and Human Services December 16, 2015 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2015-31642
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Proposed Collection; 60-Day Comment Request; CareerTrac
Document Number: 2015-31632
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), including the Intramural Research and Training Award (IRTA) and Superfund Research Program (SRP) within NIEHS, National Institute of General Medical Science (NIGMS), and National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Rachel Sturke, Evaluation Officer, Division of Science Policy, Planning, and Evaluation, FIC, NIH, 16 Center Drive, Bethesda, MD 20892 or call non-toll-free number (301)-480-6025 or Email your request, including your address to: rachel.sturke@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: CareerTrac, 0925-0568, Expiration Date: 02/29/ 2016REVISION, Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), National Institute of General Medical Science (NIGMS), National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This data collection system is being developed to track, evaluate and report short and long-term outputs, outcomes and impacts of trainees involved in health research training programsspecifically tracking this for at least ten years following training by having Principal Investigators enter data after trainees have completed the program. The data collection system provides a streamlined, web-based application permitting principal investigators to record career achievement progress by trainee on a voluntary basis. FIC, NLM, NIEHS, NCI and NIGMS management will use this data to monitor, evaluate and adjust grants to ensure desired outcomes are achieved, comply with OMB Part requirements, respond to congressional inquiries, and as a guide to inform future strategic and management decisions regarding the grant program. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 8,714.
National Institute of Mental Health; Notice of Meeting
Document Number: 2015-31621
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions and Delegations of Authority
Document Number: 2015-31594
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
Minutes of Institutional Review Board Meetings: Guidance for Institutions and Institutional Review Boards; Draft Guidance; Extension of the Comment Period
Document Number: 2015-31593
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are extending the comment period for the draft guidance entitled ``Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.'' A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of November 5, 2015. The Agencies are taking the initiative to extend the comment period for an additional 30 days because the timing of the due date for comments intersects with comment periods on other Federal Register documents requiring review by the same group of stakeholders. This extension will allow interested persons additional time to submit comments.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-31581
Type: Notice
Date: 2015-12-16
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services, Centers for Disease Control and Prevention
Waivers for State Innovation
Document Number: 2015-31563
Type: Rule
Date: 2015-12-16
Agency: Department of Health and Human Services, Department of the Treasury
This guidance relates to Section 1332 of the Patient Protection and Affordable Care Act (ACA) and its implementing regulations. Section 1332 provides the Secretary of Health and Human Services and the Secretary of the Treasury with the discretion to approve a state's proposal to waive specific provisions of the ACA (a State Innovation Waiver), provided the proposal meets certain requirements. In particular, the Secretaries can only exercise their discretion to approve a waiver if they find that the waiver would provide coverage to a comparable number of residents of the state as would be provided coverage absent the waiver, would provide coverage that is at least as comprehensive and affordable as would be provided absent the waiver, and would not increase the Federal deficit. If the waiver is approved, the state may receive funding equal to the amount of forgone Federal financial assistance that would have been provided to its residents pursuant to specified ACA programs, known as pass- through funding. State Innovation Waivers are available for effective dates beginning on or after January 1, 2017. They may be approved for periods up to 5 years and can be renewed. The Departments promulgated implementing regulations in 2012. This document provides additional information about the requirements that must be met, the Secretaries' application review procedures, the amount of pass-through funding, certain analytical requirements, and operational considerations.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2015-31556
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-31555
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2015-31554
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2015-31553
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2015-31552
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-31550
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-31549
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2015-31548
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2015-31547
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2015-31546
Type: Notice
Date: 2015-12-16
Agency: Department of Health and Human Services, National Institutes of Health
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