Department of Health and Human Services December 18, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Health Insurance MarketplaceSM
This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance MarketplaceSM,\1\ Medicare, Medicaid, and Children's Health Insurance Program (CHIP) consumer education strategies. This meeting is open to the public.
Announcement of Intent To Establish the 2018 Physical Activity Guidelines Advisory Committee and Solicitation of Nominations for Appointment to the Committee Membership
The U.S. Department of Health and Human Services (HHS) announces the intent to establish a Physical Activity Guidelines Advisory Committee (Committee). It is planned for the Committee to be established in calendar year 2016. This notice also serves to announce that an invitation is being extended for nominations of qualified candidates to be considered for appointment as a member of the Committee.
Workshop on Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety; Notice of Public Meeting; Registration Information
The National Toxicology Program (NTP) announces the public workshop, ``Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety.'' Presenters from academia, government, and industry will introduce the challenges in assessing botanical dietary supplement safety and present various approaches that could facilitate progress in three focus areas. The workshop will consist of plenary presentations and panel discussions. Information about the meeting and registration is available at (https://ntp.niehs.nih.gov/go/ workshop_botanicals).
Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Fundamentals of Using Quantitative Structure-Activity Relationship Models and Read-across Techniques in Predictive Toxicology; Notice of Public Webinar; Registration Information
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Fundamentals of Using Quantitative StructureActivity Relationship Models and Read- Across Techniques in Predictive Toxicology.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation Alternative Toxicological Methods (NICEATM) and hosted by the U.S. Environmental Protection Agency's (EPA's) National Center for Computational Toxicology (NCCT). Interested persons may participate via Adobe[supreg] ConnectTM. Time is allotted for questions from the audience.
Prospective Grant of Exclusive License: Development of a Small Molecule Farnesoid X Receptor Inhibitor
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute (NCI), 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 following U.S. Patents and Patent Applications to Heliome Biotech, Inc. (``Heliome'') located in New York, NY, USA. Intellectual Property:
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) providing for the use of nitarsone in medicated feed for chickens and turkeys. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) providing for the use of nitarsone in medicated feed for chickens and turkeys. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
Determination of Regulatory Review Period for Purposes of Patent Extension; XTANDI
The Food and Drug Administration (FDA) has determined the regulatory review period for XTANDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.
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