Department of Health and Human Services October 24, 2016 – Federal Register Recent Federal Regulation Documents

Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-25671
Type: Notice
Date: 2016-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection project entitled ``Assessment of Targeted Training and Technical Assistance (TTA) Efforts on the Implementation of Comprehensive Cancer Control''. CDC is requesting to collect information about TTA offered under two different cooperative agreements using case studies, a web-based survey, and in-depth interviews in order to document how TTA was provided and identify elements of TTA administered across both cooperative agreements that could inform the development of a viable TTA model for enhancing future tobacco and cancer prevention and control efforts.
Program for Parallel Review of Medical Devices
Document Number: 2016-25659
Type: Notice
Date: 2016-10-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Food and Drug Administration
The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) (the Agencies) are informing the public that the Parallel Review of medical devices pilot program will be fully implemented and extended indefinitely. The Agencies are soliciting nominations from manufacturers of innovative medical devices to participate in the ``Program for Parallel Review of Medical Devices.'' The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA's granting of a de novo request and Medicare coverage decisions through CMS's National Coverage Determination (NCD) process. This program is intended to ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2016-25650
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Evaluation of the Maternal and Child Health Bureau's Autism CARES Act Initiative
Document Number: 2016-25618
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects pursuant to the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Document Number: 2016-25606
Type: Notice
Date: 2016-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Generic Drug User Fees; Notice of Public Meeting; Request for Comments; Extension of Comment Period; Correction
Document Number: 2016-25603
Type: Notice
Date: 2016-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the extension of the comment period and correcting a notice that appeared in the Federal Register of Monday, September 26, 2016 (81 FR 66035). The document announced a public meeting entitled ``Generic Drug User Fees; Public Meeting; Request for Comments.'' In that Federal Register notice, FDA requested comments on the draft recommendations related to the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The Agency is taking this action to allow interested persons the statutorily required 30 days to submit comments. Also, the document was published with an error in the SUPPLEMENTARY INFORMATION section. This document corrects that error.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
Document Number: 2016-25602
Type: Rule
Date: 2016-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the Eustachian tube balloon dilation system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-25601
Type: Notice
Date: 2016-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2016-25588
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25587
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25586
Type: Notice
Date: 2016-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-25579
Type: Notice
Date: 2016-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision to the ``World Trade Center Health Program Enrollment, Treatment, Appeals & Reimbursement'' information collection approved under OMB Control Number 0920-0891, which allows the collection of information from Program members and affiliated medical providers for the purpose of determining eligibility and providing treatment services in accordance with the James Zadroga 9/11 Health and Compensation Act of 2010.
Specifications for Medical Examinations of Coal Miners
Document Number: 2016-24405
Type: Rule
Date: 2016-10-24
Agency: Department of Health and Human Services
With this action, the Department of Health and Human Services (HHS), in accordance with recent rulemaking by the Department of Labor's Mine Safety and Health Administration (MSHA), finalizes amendments to Coal Workers' Health Surveillance Program regulations to establish standards for the approval of facilities to conduct spirometry and requires that all coal mine operators submit a plan for the provision of spirometry testing and X-ray examinations to all surface and underground coal miners.