Department of Health and Human Services September 13, 2013 – Federal Register Recent Federal Regulation Documents
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HHS Retrospective Review 2013 Request for Information
The Department of Health and Human Services (HHS) seeks comment from interested parties on existing regulations HHS should consider reviewing in order to streamline or eliminate unnecessary, obsolete, or burdensome regulations or to modify others to increase their effectiveness, efficiency, and flexibility.
Health Insurance Exchanges; Application by the Accreditation Association for Ambulatory Health Care To Be a Recognized Accrediting Entity for the Accreditation of Qualified Health Plans
This notice announces the receipt of an application from the Accreditation Association for Ambulatory Health Care (AAAHC) to be a recognized accrediting entity for the purposes of fulfilling the accreditation requirement as part of qualified health plan (QHP) certification. Regulations require HHS to publish a notice identifying the accrediting entity, summarizing its analysis of whether the accrediting entity meets certain criteria, and providing no less than a 30-day public comment period.
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.
Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry entitled ``Arsenic in Apple Juice: Action Level'' that appeared in the Federal Register of July 15, 2013 (78 FR 42086). The draft guidance identifies for the industry an action level for inorganic arsenic in apple juice that FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes FDA's intended sampling and enforcement approach. In the notice, we requested comments on the draft guidance. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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.
Draft Guidance for Industry on Bioanalytical Method Validation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioanalytical Method Validation.'' The draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) for therapeutic biologics regulated by the Center for Drug Evaluation and Research. This draft guidance may apply to some studies related to the veterinary drug approval process (Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and Abbreviated New Animal Drug Applications (ANADAs)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is revising the guidance to reflect advancements in the science and technology of bioanalytical method validation.
Announcement of Requirements and Registration for Game On!: HIV/STD Prevention Mobile Application (App) Video Game Challenge
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Game On!: HIV/STD Prevention Mobile Application (App) Video Game Challenge. We invite video game developers to create an original, innovative, and highly entertaining game for smartphones that educates either adolescents (13 to 17 years of age) or young adults (18 to 24 years of age) about HIV infection and sexually transmitted diseases (STDs). Developers are encouraged to treat youth and young adults as distinct audience/player segments in the design of the game. The game should deliver health information that provides information on key HIV/STD prevention topics such as condom use, testing, and treatment. Specifically, the game should emphasize one or more of the following prevention messages``Get the Facts'', ``Speak Up'', ``Use Condoms'', ``Get Tested'', and ``Get Treated''. More information on these prevention messages is found in SUPPLEMENTARY INFORMATION.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Decision to Evaluate a Petition to Designate a Class of Employees from the Sandia National Laboratory-Livermore in Livermore, California To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by Department of Health and Human Services regulations of a decision to evaluate a petition to designate a class of employees from the Sandia National Laboratory- Livermore in Livermore, California to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
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