Department of Health and Human Services February 7, 2019 – Federal Register Recent Federal Regulation Documents

Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment; Guidance for Industry; Availability
Document Number: 2019-01517
Type: Notice
Date: 2019-02-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.'' This guidance reflects the Agency's current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder. Passive- compliance formulations such as sustained-release injectable depots and implants can provide effective treatment of opioid use disorder in a treatment paradigm that may be less subject to misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films. This guidance finalizes the draft guidance entitled ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment'' issued in April 2018.
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-01496
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-01481
Type: Notice
Date: 2019-02-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Cover Sheet
Document Number: 2019-01477
Type: Notice
Date: 2019-02-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01464
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01463
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01462
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01461
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01460
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01459
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01457
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2019-01456
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-01455
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-01454
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-01453
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-01452
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-01451
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-01450
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-01449
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01448
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-01447
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-01446
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01445
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01444
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01443
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01442
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01441
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01440
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Children's Graduate Medical Education Quality Bonus System (QBS) Initiative Response Form, OMB No. 0906-xxxx-New
Document Number: 2019-01434
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, 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.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2019-01431
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Ziopharm Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.
Prospective Grant of an Exclusive Patent License: Virus-Like Particles Vaccines Against Human Polyomaviruses, BK Virus (BKV) and JC Virus (JCV)
Document Number: 2019-01430
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to BioE Holdings Inc. (parent company, Biological E Ltd.) located in Los Altos, California.
Proposed Information Collection Activity; Survey of Head Start Grantees on Training and Technical Assistance (New Collection)
Document Number: 2019-01428
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct a statistically representative survey of directors and managers/ coordinators from Head Start grantee organizations regarding their access to and use of training and technical assistance (T/TA) from multiple sources, including ACF's Early Childhood Training and Technical Assistance system. The purpose of the data collection is to inform ACF on three aspects of grantee directors and managers/ coordinators T/TA experience: (1) Search and selection of T/TA; (2) receipt of T/TA; (3) and potential relationships between T/TA received and perceived change in practice.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01418
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01417
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01416
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2019-01415
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2019-01414
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-01413
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-01412
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-01411
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-01410
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01409
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01408
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01407
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01406
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01405
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01404
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01403
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01402
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01401
Type: Notice
Date: 2019-02-07
Agency: Department of Health and Human Services, National Institutes of Health