Department of Health and Human Services April 25, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 27 of 27
AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355. AstraZeneca has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for OFORTA (fludarabine phosphate) Tablets held by sanofi-aventis, U.S., LLC (sanofi-aventis), 55 Corporate Dr., Bridgewater, NJ 08807-0977. Sanofi-aventis has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives.'' The draft guidance, when finalized, will explain FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affects the safety and regulatory status of the food substance, and whether a new regulatory submission to FDA is warranted.
Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them.
Meeting of the National Toxicology Program (NTP) Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
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.
Solicitation of Written Comments on Draft: National Action Plan To Prevent Healthcare-Associated Infections: Roadmap to Elimination
The Office of Healthcare Quality is soliciting public comment on the revised draft National Action Plan to Prevent Healthcare- Associated Infections: Roadmap to Elimination.
Scientific Information Request on Chronic Venous Ulcers Treatments
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of chronic venous ulcer treatment medical devices. Scientific information is being solicited to inform our Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities report, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Scientific Information Request on Medical Devices To Treat Otitis Media With Effusion
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of otitis media with effusion medical devices, such as tympanostomy tubes and autoinflation devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Otitis Media with Effusion (OME) Treatments, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Scientific Information Request on Local Therapies for the Treatment of Stage I Non-Small Cell Lung Cancer and Endobronchial Obstruction Due to Advanced Lung Tumors
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of Conventional Two-Dimensional External Beam Radiotherapy (2D-EBRT), 3- dimensional conformal radiation therapy (3D-CRT), Intensity-modulated radiation therapy (IMRT), Stereotactic body radiation therapy (SBRT), Proton beam radiotherapy (PBR), Brachytherapy, Radiofrequency ablation, Endobronchial debridement and stents, and Nd-YAG Laser Therapy medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Local Therapies for the Treatment of Stage I Non-Small Cell Lung Cancer and Endobronchial Obstruction Due to Advanced Lung Tumors, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
World Trade Center Health Program Requirements for the Addition of New WTC-Related Health Conditions
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. This final rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking, including a process for considering petitions by interested parties to add a new condition.
TANF Assistance and Electronic Benefit Transfer Transactions; Request for Public Comment
The Office of Family Assistance (OFA) is interested in learning about how States deliver Temporary Assistance to Needy Families (TANF) assistance to beneficiaries, whether States have implemented policies and practices to prevent electronic benefit transfer transactions involving TANF assistance in liquor stores, casinos, gambling casinos, or other gaming establishments, and retail establishments which provide adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment; what the States' experiences have been in implementing such policies and practices; and whether States place other similar types of restrictions on assistance usage. OFA also is interested in learning about States' current approaches to ensuring that recipients have adequate access to their cash assistance, including policies that provide access to assistance with no fees or charges or current approaches to imposing fees or charges in connection with receipt of assistance, along with other information relevant to considering what might be minimal fees or charges. Additionally, OFA is interested in hearing the perspectives of vendors, consumer advocates, and any other individuals or entities that have information that could be relevant to the development and implementation of policies and procedures to prevent electronic benefit transfer transactions in certain establishments, and to ensuring access to cash assistance with minimal fees or charges, including opportunities to access assistance without fees or charges. The information provided will be used to inform OFA as it develops regulations to implement Section 4004 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96), which, among other things, requires States to prevent the use of TANF assistance in electronic benefit transfer transactions at specified locations.
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