Department of Health and Human Services October 23, 2013 – Federal Register Recent Federal Regulation Documents
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UPDATE-Meeting of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces an update to the meeting of the Community Preventive Services Task Force (Task Force). The in-person Task Force meeting is being replaced by an abbreviated conference call as a result of the lapse in the FY 2014 appropriation, which limited CDC's ability to complete the necessary scientific and logistical support for the meeting. The Task Force is an independent, nonfederal, and uncompensated panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. These recommendations provide evidence-based options from which decision makers in communities, companies, health departments, health plans and healthcare systems, non-governmental organizations, and at all levels of government can choose what best meets the needs, preferences, available resources, and constraints of their constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Announcing the Award of Four Single-Source Expansion Supplement Grants Under the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV), Tribal Early Learning Initiative Program
This announces the award of single-source program expansion supplement grants to the following Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) grantees to support their ongoing participation in the Tribal Early Learning Initiative, by the Office of Child Care, a program of the Administration for Children and Families.
Privacy Act of 1974; Report of an Altered CMS System of Records Notice
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS proposes several alterations to the existing system of records titled, ``Health Insurance Exchanges (HIX) Program'' (No. 09-70-0560), published at 78 FR 8538 (February 6, 2013) and amended and published at 78 FR 32256 (May 29, 2013). The alterations affect the ``Purposes of the System'', ``Categories of Individuals Covered by the System'', ``Categories of Records in the System'', ``Authority for Maintenance of the System'', ``System Location'', ``Retention and Disposal'', ``System Manager and Address'', ``Routine Uses of Records Maintained in the System'', and ``Record Source Categories'' sections of the accompanying System of Records Notice, as more fully explained in the Supplementary Information section.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With Relapsed or Refractory, Low Grade, Follicular, or Transformed CD20 Positive Non-Hodgkin's Lymphoma Who Have Not Received Prior Rituximab; BEXXAR
The Food and Drug Administration (FDA) is withdrawing approval of the indication for treatment of patients with relapsed or refractory, low grade, follicular, or transformed CD20 positive non- Hodgkin's lymphoma who have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held by GlaxoSmithKline LLP, P.O. Box 5089, 1250 South Collegeville Rd., Collegeville, PA 19426 (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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.
Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or non-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,'' in both paper and electronic format, as required by FDA regulations.
Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the development of new antibacterial drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes the revised draft guidance of the same name issued on August 27, 2010.
International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Elemental Impurities.'' Prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), this guidance is intended to develop a harmonized approach for the control of elemental impurities that helps industry avoid the uncertainty and duplication of work resulting from differing requirements across ICH regions. It includes the specific elements to be limited and the appropriate limits for impurities, and emphasizes control of supply chains and risk assessments. It is expected to provide appropriate safety-based limits for the control of elemental impurities, consistent expectations for test requirements and regulatory filings, and a global policy for limiting elemental impurities, both qualitatively and quantitatively, in drug products and ingredients.
Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a previous draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment'' issued on September 14, 2010.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins Test General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14: Bacterial Endotoxins Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).
Determination That INTAL (cromolyn sodium) Inhalation Capsule, 20 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that INTAL (cromolyn sodium) Inhalation Capsule, 20 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cromolyn sodium inhalation capsule, 20 mg, if all other legal and regulatory requirements are met.
Fibromyalgia Public Meeting on Patient-Focused Drug Development; Correction
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of September 23, 2013 (78 FR 58313). The document announced a public meeting entitled ``Fibromyalgia Public Meeting on Patient-Focused Drug Development'' and opportunity for public comment. The document published with an incorrect date for submission of electronic and written comments. This document corrects that error.
Determination That PARAFLEX (Chlorzoxazone) Tablets, 250 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PARAFLEX (Chlorzoxazone) Tablets, 250 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PARAFLEX (Chlorzoxazone) Tablets, 250 mg, if all other legal and regulatory requirements are met.
Determination That Potassium Citrate, 10 Milliequivalents/Packet and 20 Milliequivalents/Packet, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that Potassium Citrate, 10 milliequivalents/packet (mEq/packet) and 20 mEq/ packet, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Potassium Citrate, 10 mEq/packet and 20 mEq/packet, if all other legal and regulatory requirements are met.
Special Emphasis Panel; Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS-13-010, Closing the Gap in Healthcare Disparities through Dissemination and Implementation of Patient Centered Outcomes Research (U18)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
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