Department of Health and Human Services January 16, 2020 – Federal Register Recent Federal Regulation Documents

Privacy Act of 1974; System of Records Notice
Document Number: 2020-00633
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH) is modifying system of records 09-90-0067 to reflect that the records are now maintained by NIH, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) and to rename the system of records ``Invention, Patent, and Licensing Documents Related to Inventions By Public Health Service Employees, Grantees, Fellowship Recipients, and Contractors.'' In addition, HHS/NIH is rescinding a related NIH system of records, 09- 25-0168.
Submission for OMB Review; Building Capacity To Evaluate Child Welfare Community Collaborations To Strengthen and Preserve Families (CWCC) Cross-Site Process Evaluation (New Collection)
Document Number: 2020-00594
Type: Notice
Date: 2020-01-16
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) intends to collect data for an evaluation of the initiative, Community Collaborations to Strengthen and Preserve Families (also referred to as Child Welfare Community Collaborations [CWCC]). The cross-site process evaluation will provide insight to ACF about the various factors that promote or impede the implementation of child welfare community collaborations.
Submission for OMB Review; Tribal Maternal, Infant, and Early Childhood Home Visiting Program Form 2: Grantee Performance Measures (OMB #0970-0500)
Document Number: 2020-00593
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACFTribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program Form 2: Grantee Performance Measures (OMB #0970-0500; Expiration date 8/31/2020). There are no changes requested to the form.
Pediatric Study Plans for Oncology Drugs: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2020-00592
Type: Notice
Date: 2020-01-16
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 draft guidance for industry entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers.'' This draft guidance provides information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, when finalized, this draft guidance will provide FDA's current thinking regarding iPSPs for oncology drugs in light of the amendments to the FD&C Act made by the FDA Reauthorization Act of 2017 (FDARA). FDA has received a number of questions on this topic and, as a result, is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council
Document Number: 2020-00584
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on February 20, 2020 of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and can be accessed remotely. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory- councils/meetings. The meeting will include consideration of the minutes from the August 21, 2019, SAMHSA, CMHS NAC meeting; updates from the CMHS Director and SAMHSA Policy Lab Director; presentation from the National Academies of Sciences, Engineering, and Medicine; and discussions on Trauma Informed Care and Certified Community Behavioral Health Clinics.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2020-00579
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00578
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-00577
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-00576
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-00575
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
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