Department of Health and Human Services December 17, 2019 – Federal Register Recent Federal Regulation Documents

Request for Information on Toxicological and Physicochemical Data of Engineered Nanomaterials To Evaluate in Developing Categorical Occupational Exposure Limits (OELs)
Document Number: 2019-27169
Type: Notice
Date: 2019-12-17
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) intends to evaluate the scientific data on engineered nanomaterials (ENMs) to develop categorical occupational exposure limits (OELs) based on the available scientific evidence regarding the hazard or safety of these materials. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible adverse health risks of occupational exposure to ENMs.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-27139
Type: Notice
Date: 2019-12-17
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Request for Public Comment: 60-Day Information Collection: Application for Participation in the IHS Scholarship Program
Document Number: 2019-27121
Type: Notice
Date: 2019-12-17
Agency: Department of Health and Human Services, Indian Health Service
In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Application for Participation in the IHS Scholarship Program,'' Office of Management and Budget (OMB) Control No. 0917-0006. IHS is requesting OMB to approve an extension for this collection, which expires on March 31, 2020.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-27102
Type: Notice
Date: 2019-12-17
Agency: Department of Health and Human Services, National Institutes of Health
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
Document Number: 2019-27045
Type: Proposed Rule
Date: 2019-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). We are proposing to discontinue publishing in the Federal Register after each quarter a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is proposing to take this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also proposing to update Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.
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