Department of Health and Human Services February 9, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Mobile Medical Applications: Guidances for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of two guidance documents. FDA is issuing ``Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices'' to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with regulatory requirements for Medical Device Data Systems (MDDS) and two similar radiology device types due to the low risk they pose to patients and the importance they play in advancing digital health. FDA is also issuing an updated version of the guidance document ``Mobile Medical Applications,'' originally issued on September 25, 2013, that has been edited to be consistent with the MDDS guidance document.
Availability of Final Toxicological Profiles
This notice announces the availability of the final Toxicological Profiles Toxaphene and Trichlorobenzenes prepared by ATSDR.
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.'' This revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs and biologics with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers. FDA is also announcing the withdrawal of the draft guidance for industry entitled ``Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.''
Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws; Withdrawal of Guidance
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws,'' dated August 2010. We are taking this action because the policies stated in the guidance have been superseded by our issuance of final rules on menu and vending machine labeling.
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of three Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended after initial issuance, for three in vitro diagnostic devices for detection of the Ebola virus in response to the 2014 Ebola virus outbreak in West Africa. FDA is issuing these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by BioFire Defense, LLC (BioFire Defense) and altona Diagnostics GmbH (altona). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Adoption and Foster Care Analysis and Reporting System
The Administration for Children and Families (ACF) proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations. This notice of proposed rulemaking (NPRM) builds on an earlier proposed rule, published January 11, 2008 that addressed the requirements for State title IV-E agencies to collect and report data to ACF on children who are in out-of-home care and in subsidized adoption or guardianship arrangements with the State and AFCARS penalty requirements of the Adoption Promotion Act of 2003. This NPRM proposes many of the same changes and additions as the earlier NPRM and includes several new modifications to address changes made by the Fostering Connections to Success and Increasing Adoptions Act of 2008, such as collecting and reporting data related to the title IV-E guardianship assistance program, sibling placement, the extension of title IV-E assistance to children age 18 or older, educational stability plans and transition plans for children in foster care and the inclusion of Tribal title IV-E agencies. Additionally, modifications were made to address new requirements in the Preventing Sex Trafficking and Strengthening Families Act, which was enacted on September 29, 2014 to include information on: Victims of sex trafficking, children in foster care who are pregnant or parenting, and children in non-foster family settings.
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