Department of Health and Human Services February 1, 2018 – Federal Register Recent Federal Regulation Documents

National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-02052
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (the Secretary) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2018-02038
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-02037
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2018-02036
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2018-02035
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-02034
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-02033
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-02032
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-02031
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee for Women's Services (ACWS); Notice of Meeting
Document Number: 2018-02010
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Evidence-Based Falls Prevention Program; OMB Control Number, 0985-0039
Document Number: 2018-02000
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to ACL's Evidence-Based Falls Prevention Program's Proposed Extension with Changes of a Currently Approved Collection.
Best Practices in Modeling and Simulation for Oncology Products; Public Workshop
Document Number: 2018-01992
Type: Notice
Date: 2018-02-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA, the Agency, or we) Center for Drug Evaluation and Research (CDER), in co-sponsorship with the International Society of Pharmacometrics (ISoP), is announcing a public workshop entitled ``Best Practices in Modeling and Simulation for Oncology Products.'' The purpose of the meeting is to discuss ``best practices'' in integrating pharmacokinetic, pharmacodynamic, efficacy, and safety data into models to best inform oncology drug development, evaluate disease- and mechanism-specific early endpoints to predict long-term efficacy, and discuss potential regulatory implications of model-informed decisions in drug development. This workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).
Proposed Information Collection Activity; Comment Request
Document Number: 2018-01987
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-01985
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, Administration for Children and Families
Determination of Regulatory Review Period for Purposes of Patent Extension; CORLANOR
Document Number: 2018-01979
Type: Notice
Date: 2018-02-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CORLANOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Advisory Committee on Immunization Practices (ACIP); Notice of Charter Amendment; Correction
Document Number: 2018-01969
Type: Notice
Date: 2018-02-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-01954
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, National Institutes of Health
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2018-01931
Type: Notice
Date: 2018-02-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.
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