Department of Health and Human Services October 4, 2018 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21618
Type: Notice
Date: 2018-10-04
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Database.'' This proposed information collection was previously published in the Federal Register on July 16th, 2018 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications
Document Number: 2018-21610
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.
Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
Document Number: 2018-21597
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 17, 2018. FDA requested comments on the draft guidance for industry and FDA staff entitled ``Process To Request a Review of FDA's Decision Not To Issue Certain Export Certificates for Devices.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2019 Proposed Guidance Development
Document Number: 2018-21596
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2019. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.
United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments
Document Number: 2018-21594
Type: Notice
Date: 2018-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Charlotte, NC, scheduled for November 11 through 15, 2018. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Charlotte, NC.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-21590
Type: Notice
Date: 2018-10-04
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21587
Type: Notice
Date: 2018-10-04
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21576
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Dental & Craniofacial Research: Notice of Closed Meeting
Document Number: 2018-21575
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21574
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21573
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-21572
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-21571
Type: Notice
Date: 2018-10-04
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of information collection project titled Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program (National DPP) in Underserved Areas. This revision is to allow CDC to continue collecting the information needed to assess the effectiveness of its program, ``Scaling the National DPP in Underserved Areas'', and to collect more targeted information on CDC grantees' success in reaching both general and priority populations in underserved areas.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-21570
Type: Notice
Date: 2018-10-04
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Laboratory Response Network to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-21569
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-21568
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-21567
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
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