Department of Health and Human Services September 2010 – Federal Register Recent Federal Regulation Documents
Results 301 - 350 of 364
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRYAN CERVICAL DISC SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for BRYAN CERVICAL DISC SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12 Update); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers (Question 12 Update)'' dated August 2010. This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the ``Bar Code Label Requirements Questions and Answers'' guidance dated October 2006 (Bar Code Guidance), to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. When this guidance is finalized, we intend to incorporate the revised response to Q12 into the Bar Code Guidance, but otherwise continue with our recommendations for bar code label requirements as currently provided in the Bar Code Guidance.
Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Blood Establishments That Collect Whole Blood and Blood Components
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Whole Blood and blood components. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Whole Blood and blood components to submit a request to CBER if they are interested in participating in this pilot program.
Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs
In this rule, we are proposing to withdraw two provisions from the ``Medicaid Program; Prescription Drugs'' final rule (referred to hereafter as ``AMP final rule'') published in the July 17, 2007 Federal Register. The provisions we are proposing to withdraw are as follows: The determination of average manufacturer price (AMP), and the Federal upper limits (FULs) for multiple source drugs. We are also proposing to withdraw the definition of ``multiple source drug'' as it was revised in the ``Medicaid Program; Multiple Source Drug Definition'' final rule published in the October 7, 2008 Federal Register. The provisions of the AMP final rule and the definition of multiple source drug that we are proposing to withdraw were challenged in a lawsuit that was filed in November 2007. The challenged regulations have been superseded in significant part by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, and the FAA Air Transportation Modernization and Safety Improvement Act. This document would withdraw the regulatory provisions challenged in the aforementioned litigation.
Privacy Act of 1974
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Health Administration Center (HAC) of the Department of Veteran Affairs. We have provided background information about the proposed matching program in the ``Supplementary Information'' section below. The Privacy Act provides an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Determination of Regulatory Review Period for Purposes of Patent Extension; NEURX DIAPHRAGM PACING SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for NEURX DIAPHRAGM PACING SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
New Animal Drugs for Use in Animal Feed; Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADAs provide for administering a Type C medicated feed containing ractopamine hydrochloride as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter.
New Animal Drugs; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Alpharma, Inc., to Alpharma LLC. The sponsor's mailing address will also be changed.
Oral Dosage Form New Animal Drugs; Praziquantel and Pyrantel
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 Bayer HealthCare LLC. The supplement provides for two new sizes of praziquantel and pyrantel pamoate tablets used in cats and kittens for the removal of various internal parasites and for a revised kitten age and weight restriction.
New Animal Drugs; Change of Sponsor; Penicillin G Benzathine and Penicillin G Procaine Suspension; Penicillin G Procaine Aqueous Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from G. C. Hanford Manufacturing Co. to Norbrook Laboratories, Ltd.
Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin
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 Intervet, Inc. The supplemental NADA adds Mycoplasma bovis to the bovine respiratory disease (BRD) pathogens for which use of an injectable solution containing florfenicol and flunixin meglumine is an approved treatment.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 11 on Capillary Electrophoresis 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 ICH Regions; Annex 11: Capillary Electrophoresis 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 Capillary Electrophoresis 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. This 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'' (the core ICH Q4B guidance).
Office of Community Services: Notice To Award an Expansion Supplement
The Administration for Children and Families (ACF), Office of Community Services (OCS) has awarded an expansion supplement to Community Action Partnership (CAP), located in Washington, DC. The project is designed to support Training and Technical Assistance (T/TA) by strengthening the ability of the Community Action Network to comply with and carry out the programs funded by the American Recovery and Reinvestment Act of 2009 (ARRA). The project objective is to strengthen CSBG-eligible entity administrative governance and financial management efforts related to job creation and new initiatives that target careers in energy efficiency and other environmentally beneficial fields. It will do so by implementing a coordinated strategy that: (1) Promotes exemplary practices applicable to ARRA and ``regular'' CSBG funds; (2)
Office of Community Services; Expansion Supplements Under 2009 American Recovery and Reinvestment Act
The Administration for Children and Families (ACF), Office of Community Services (OCS) has awarded an expansion supplement to National Association for State Community Services Programs (NASCSP), located in Washington, DC. The project is designed to support T/TA that strengthens the ability of the Community Action Network to comply with and carry out the programs funded by the American Recovery and Reinvestment Act of 2009 (ARRA). The project objective is to strengthen CSBG-eligible entity efforts related to benefits enrollment and coordination activities and asset development activities. It will do so by: (1) Assessing the CSBG Network's current benefits enrollment and coordination activities; (2) assessing the CSBG Network's asset development activities; and (3) identifying and promulgating exemplary practices in benefits enrollment and coordination activities and asset development activities. The project resources will promote accountability and help CSBG-eligible entities and States enhance the overall administration of ARRA-funded programs. These resources include issue briefs; congressional reports; a catalog of exemplary practices; webinars and/or conference calls; conference workshops focused on resources related to benefits enrollment and coordination activities and asset development activities; and online toolkit(s). The T/TA NASCSP will provide under this award is particularly critical at this time due to the large temporary increase in CSBG funding to CSBG- eligible entities and the need to ensure adherence to high standards of accountability and tracking of the funds and results. The activities funded by this expansion supplement expand upon prior activities provided by NASCSP under their cooperative agreement. A new grant award number will be issued to allow NASCSP to track and report separately on expenditures from funds made available by ARRA.
Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Availability
The Food and Drug Administration (FDA) is announcing the availability of a Level 2 guidance for industry 201 entitled ``Small Entities Compliance GuideThe Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This small entities compliance guide aids industry in complying with the requirements of the final rule that published in the Federal Register of December 6, 2007. This regulation establishes administrative procedures and criteria for index listing a new animal drug for use in a minor species as provided by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS).
Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor Uses or Minor Species; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 200 entitled ``Small Entities Compliance GuideDesignation of New Animal Drugs for Minor Uses or Minor Species.'' This small entities compliance guide (SECG) aids industry in complying with the requirements of the final rule that published in the Federal Register of July 26, 2007. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving 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 ICH Regions; Annex 12: Analytical Sieving 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 Analytical Sieving 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. This 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'' (the core ICH Q4B guidance).
Notice To Award an Expansion Supplement
The Administration for Children and Families (ACF), Office of Community Services (OCS) has awarded a single source expansion supplement to Community Action Program Legal Services, Inc. (CAPLAW), located in Boston, MA. The project is designed to support T/TA that strengthens the ability of the Community Action Network to comply with and carry out the programs funded by ARRA. The objectives of the project are to: (1) clarify CSBG policy issues, and (2) strengthen CSBG-eligible entity governance and accountability. It will do so by analyzing CSBG policy issues needing clarification, as identified by
Administration for Native Americans; Notice of Meeting
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a tribal consultation to solicit input on the agency's draft tribal consultation policy.
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