Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents
Results 301 - 350 of 3,583
Partnerships to Advance the National Occupational Research Agenda (NORA)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''.
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same dose levels approved for single-ingredient Type C medicated feeds containing melengestrol acetate, monensin, or tylosin phosphate for heifers fed in confinement for slaughter in three-way, combination drug Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate.
New Animal Drugs for Use in Animal Feeds; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 10 new animal drug applications (NADAs) from Merial Ltd. to Huvepharma AD.
Animal Food Labeling; Declaration of Certifiable Color Additives
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods. FDA is proposing this amendment in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the act) by requiring, among other things, the listing on food labels of the common or usual names of all color additives required to be certified by FDA. An additional purpose of this amendment is to make these regulations consistent with the regulations regarding the declaration of certified color additives on the labels of human food. The proposed rule also suggests appropriate terminology for the declaration of certification-exempt color additives on the labels of animal food.
Medicaid Program; Coverage for Rehabilitative Services; Withdrawal
This document withdraws a proposed rule that was published in the Federal Register on August 13, 2007. The proposed rule discussed our proposal to amend the definition of Medicaid ``rehabilitative services.'' It also clarified the broad general language of the current regulation to ensure that rehabilitative services are provided in a coordinated manner, are limited to rehabilitative purposes, and are furnished by qualified providers.
Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs; Proposed New Data Elements for Adverse Event Reports on Revised Forms FDA 1932 and 1932a
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 and to allow for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.
Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 191 entitled ``Changes to Approved NADAsNew NADAs vs. Category II Supplemental NADAs.'' This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).
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. 207 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.
Oral Dosage Form New Animal Drugs; Sulfadimethoxine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of Sulfadimethoxine Soluble Powder in medicated drinking water of cattle, chickens, and turkeys for the treatment of various bacterial infections.
Request for Public Comment: 30-Day Notice; Proposed Information Collection: Indian Health Service Forms
The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the PRA95, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval.
Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2010.
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same increased dose levels approved for single-ingredient Type C medicated feeds for heifers fed in confinement for slaughter containing melengestrol acetate or monensin in two-way, combination drug Type C medicated feeds containing melengestrol acetate and monensin.
Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus''. This draft guidance provides recommendations for assessing blood donor suitability and blood product safety and maintaining blood and blood product availability in response to pandemic (H1N1) 2009 virus. It is intended for establishments that manufacture Whole Blood and blood components intended for use in transfusion and blood components intended for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts Label Formats
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of Nutrition Facts label formats.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397
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.
Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting
The Food and Drug Administration (FDA) is announcing a meeting with sponsors of certain opioid drug products regarding the development of Risk Evaluation and Mitigation Strategies (REMS) for these products. Other members of the public are invited to attend and observe. The REMS is intended to ensure that the benefits of these drugs continue to outweigh certain risks. FDA has encouraged affected sponsors to work collectively to develop a proposed REMS. The purpose of this meeting is to hear from sponsors about the status of the development of a proposed REMS and their views regarding the specific features of the REMS for these products. To promote transparency of the REMS development process, other members of the public are invited to attend the meeting as observers. Additional opportunities for public input will be provided before FDA finalizes the elements of the REMS.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the reporting of biological product deviations (BPDs) and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Form FDA 3486 and Addendum 3486A.
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