Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents
Results 1,401 - 1,600 of 3,583
Kim C. Hendrick: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Kim C. Hendrick, M.D., from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Hendrick was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Hendrick failed to request a hearing. Dr. Hendrick's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Paul H. Kornak: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Paul H. Kornak from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Paul H. Kornak was convicted of three felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Kornak failed to request a hearing. Mr. Kornak's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Renewal of Charter for the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the U.S. Department of Health and Human Services is hereby announcing renewal of the charter for the Presidential Advisory Council on HIV/AIDS (PACHA).
Authorization of Emergency Use of Certain Personal Respiratory Protection Devices; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization), as amended, for certain personal respiratory protection devices.\1\ FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized personal respiratory protection devices. The Authorization follows the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain disposable National Institute for Occupational Safety and Health (NIOSH) certified N95 respirators, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorization, as amended, which includes an explanation of the reasons for its issuance, is reprinted in this document. Elsewhere in this issue of the Federal Register, FDA is announcing the issuance of EUAs for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate and the issuance of EUAs for certain in vitro diagnostic devices.
Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations), one of which was amended, for certain in vitro diagnostic devices. FDA is issuing the Authorizations under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document. Elsewhere in this issue of the Federal Register, FDA is announcing the issuance of EUAs for certain antiviral drug products and the issuance of an EUA for certain personal respiratory protection devices.
Authorizations of Emergency Use of Certain Antiviral Drugs-Zanamivir and Oseltamivir Phosphate; Availability
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antiviralsZanamivir and oseltamivir phosphate. FDA is issuing the Authorizations under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized zanamivir and oseltamivir phosphate products. The Authorizations follow the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain products from the neuraminidase class of antiviralsZanamivir and oseltamivir phosphate, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document. Elsewhere in this issue of the Federal Register, FDA is announcing the issuance of EUAs for certain in vitro diagnostic devices and the issuance of an EUA for certain personal respiratory protection devices.
Implementation of Section 5001 of the American Recovery and Reinvestment Act of 2009 (ARRA) for Adjustments to the Third Quarter of Fiscal Year 2009 Federal Medical Assistance Percentage (FMAP) Rates for Federal Matching Shares for Medicaid and Foster Care and Adoption Assistance
This notice with comment period describes the methodology for calculating the higher federal matching funding that is made available under Section 5001 of the American Recovery and Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for temporary increases in the Federal Medical Assistance Percentage (FMAP) rates to provide fiscal relief to States and to protect and maintain State Medicaid programs in a period of economic downturn. The increased FMAP rates apply during a recession adjustment period that is defined as the period beginning on October 1, 2008 and ending on December 31, 2010.
Cooperative Agreement Between the Food and Drug Administration and the Dauphin Island Sea Lab
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy and educating the general public.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
The Food and Drug Administration (FDA) is announcing that a collection of information entitled Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; XIENCE V EECSS
The Food and Drug Administration (FDA) has determined the regulatory review period for XIENCE V EECSS 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; RECOTHROM
The Food and Drug Administration (FDA) has determined the regulatory review period for RECOTHROM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; EOVIST
The Food and Drug Administration (FDA) has determined the regulatory review period for EOVIST 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 human drug product.
Administration for Children and Families; Office of Refugee Resettlement
The Office of Refugee Resettlement (ORR) announces the award of program expansion supplements to five Wilson-Fish Program grantees. The Wilson-Fish Program is an alternative to traditional State- administered refugee assistance programs and provides integrated assistance and services to refugees, asylees, Amerasian Immigrants, Cuban and Haitian Entrants, Trafficking Victims and Iraqi/Afghani Special Immigrant Visas (SIVs). The five supplemental awards will allow the grantees to provide cash and medical assistance to arriving refugees and to others who are also eligible for refugee benefits through the remainder of Fiscal Year (FY) 2009. The expansion supplement awards will enable the grantees to provide services needed to a higher number of arrivals than originally planned. The Refugee Act of 1980 mandates that the ORR reimburse State agencies and Wilson-Fish projects for the costs of cash and medical assistance for newly arriving refugees. Since 1991, ORR has reimbursed State agencies and Wilson-Fish agencies for providing cash and medical assistance to eligible individuals during their first eight months in the United States. The following Wilson-Fish Program grantees are awarded program expansion supplemental funding:
Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy
The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, ``Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the devices.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This guidance document describes a means by which manufacturers of dental amalgam, mercury, and amalgam alloy may comply with special controls that apply to these class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify dental amalgam into class II (special controls), reclassify dental mercury from class I (general controls) to class II (special controls), and designate a special controls guidance document to support the class II classification of these two devices, as well as the current class II classification of amalgam alloy.
Determination and Declarations Regarding Emergency Use of Certain In vitro Diagnostic, Antiviral, and Personal Respiratory Products Accompanied by Emergency Use Information
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb-3(b)(4). On April 26, 2009, the Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009-H1N1 Influenza A, or 2009-H1N1 influenza) that affects or has significant potential to affect national security. On the basis of this determination, on April 26 and April 27, 2009, the Acting Secretary declared emergencies justifying the authorization of emergency use of certain in vitro diagnostic, antiviral, and personal respiratory protection products accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb-3(a). The Acting Secretary also specified that these declarations are declarations of emergency as defined by former Secretary Michael O. Leavitt in the October 10, 2008 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Influenza Antivirals Oseltamivir Phosphate and Zanamavir, as amended, and the December 17, 2008 Declaration under the PREP Act for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices.
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.
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.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications and supplements, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2010.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2010
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2010.
Prescription Drug User Fee Rates for Fiscal Year 2010
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720). These fees are effective on October 1, 2009, and will remain in effect through September 30, 2010. For applications and supplements that are submitted on or after October 1, 2009, the new fee schedule must be used. Invoices for establishment and product fees for FY 2010 will be issued in August 2009, using the new fee schedule.
Medical Device User Fee Rates for Fiscal Year 2010
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2010 fee rates are provided in this document. These fees apply from October 1, 2009, through September 30, 2010. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2010 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes.'' This guidance is intended to cover the entire tomato supply chain, both domestic firms and foreign firms exporting tomatoes into the United States, to enhance the safety of tomatoes by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh- cut produce.
Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons.'' This draft guidance is intended to cover the entire melon supply chain, both domestic firms and foreign firms exporting melons into the United States, to enhance the safety of melons by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh-cut produce.
Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens.'' This draft guidance is intended to cover the entire leafy greens supply chain, both domestic firms and foreign firms exporting leafy greens products into the United States, to enhance the safety of leafy greens by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh-cut produce.
Privacy Act of 1974; Report of Altered Systems of Records
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to alter four existing systems of records (SORs) for the reasons indicated below:
Seafood Hazard Analysis and Critical Control Points Alliance for Education and Training (U18)
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the University of Florida for the support of the Seafood Hazard Analysis and Critical Control Points (HACCP) Alliance for Education and Training. The goal of the Seafood HACCP Alliance for Education and Training is to provide partial support, periodic clerical assistance, and personnel travel to national and international events and committee meetings.
New Animal Drugs; Nitrofurazone Ointment
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 nitrofurazone ointment on horses for prevention or treatment of superficial bacterial infections.
National Biodefense Science Board; Notification of Charter Renewal
The Secretary of Health and Human Services has renewed the National Biodefense Science Board (NBSB) charter for an additional two- year period through July 3, 2011.
Meeting of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.
National Biodefense Science Board: Notification of a Public Teleconference
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Biodefense Science Board (NBSB) will hold three teleconference meetings. The meetings are open to the public. Pre- registration is NOT required, however, individuals who wish to participate in the public comment session should e-mail NBSB@HHS.GOV to RSVP.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
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.
Preparation for International Cooperation on Cosmetics Regulations Meetings in Tokyo, Japan; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR3 Meetings in Tokyo, Japan'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Tokyo, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICCR steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Tokyo, Japan, scheduled for the week of September 7, 2009.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at Area IV of the Santa Susana Field Laboratory, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
International Conference on Harmonisation; Draft Guidance on E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. The draft guidance is intended to foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities.
Fiscal Year (FY) 2009 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $30,000 (total costs) for one year to the Community Anti- Drug Coalitions of America (CADCA). This is not a formal request for applications. Assistance will be provided only to the Community Anti- Drug Coalitions of America (CADCA) based on the receipt of a satisfactory application that is approved by an independent review group.
Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.
Family-To-Family Health Information Center Program
The Health Resources and Services Administration (HRSA) will be transferring Family Voices Colorado Family-To-Family Health Information Center (F2F HIC) grant (H84 MC 09577) from Cerebral Palsy of Colorado to the Colorado Non-Profit Development Center in Denver in order to ensure the continued provision of health resources, financing, related services and parent-to-parent support for families with children and youth with special health care needs in the State of Colorado.
Part C Early Intervention Services Grant
HRSA will be awarding noncompetitively Part C Ryan White HIV/ AIDS program funds to support comprehensive primary care services for persons living with HIV/AIDS including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services, and adherence monitoring/education services to the Wyoming Department of Health in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care to clients in the State of Wyoming.
Proposed Collection; Comment Request; Parental Knowledge, Attitudes, and Behaviors Related to Pediatric Cardiovascular Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Determination of Regulatory Review Period for Purposes of Patent Extension; DUREZOL
The Food and Drug Administration (FDA) has determined the regulatory review period for DUREZOL 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 human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; RAPAFLO
The Food and Drug Administration (FDA) has determined the regulatory review period for RAPAFLO 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 human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
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: Nucleic Acid Testing To Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products,'' dated July 2009. The guidance document provides to manufacturers of plasma-derived products recommendations for performing parvovirus B19 NAT as an in-process test for Source Plasma and recovered plasma to identify and help to prevent the use of plasma units containing high levels of parvovirus B19. The guidance also recommends how to report to FDA implementation of parvovirus B19 NAT. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2008.
Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Standard Oil Development Company in Linden, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Standard Oil Development Company in Linden, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the national health promotion and disease prevention objectives for 2020. This meeting will be open to the public and will be held online via WebEx software. The Secretary's Advisory Committee on National Health
Office of Community Services; Notice To Award a Single Source Program Expansion Supplement Under the American Recovery and Reinvestment Act (ARRA) to Technical Assistance by Community Action Program Legal Services, Inc.
The Office of Community Services (OCS) announces the awarding of a $96,952 single source program expansion supplement to the Community Action Legal Services, Inc. (CAPLAW), located in Boston, MA, to support training and technical assistance on legal issues faced by Community Action Agencies (CAAs) related to the American Recovery and Reinvestment Act of 2009 (ARRA). The project activities are designed to support and strengthen the ability of the CAA network to comply with, and carry out, Community Services Block Grant (CSBG) activities funded by ARRA. The training projects and resources developed under the award will include analysis and explanation of the practical impact of ARRA for States and CSBG-eligible entities so that they can work more effectively to reach the ARRA goals and document how they have in fact reached those goals and used the ARRA funds. The project's overall approach is based on the following five key elements: (1) Technical assistance and issue-specific consultation; (2) Publications, including online postings on the CAPLAW Web site, e-Bulletins, and a print newsletter, which is also available on CAPLAW's Web site; (3) Online toolkit; (4) Presentations at CAA conferences, including CAPLAW's 2009 national training conference, and CAPLAW audio conferences.
Notice of Withdrawal: Second Publication of Reconsideration of Disapproval of Washington State Plan Amendment (SPA) 08-019
This document withdraws the notice published on July 13, 2009 (74 FR 33449), which announced a hearing scheduled on August 4, 2009, to reconsider disapproval of Washington SPA 08-019. The July 13 notice is being withdrawn because it was an inadvertent republication of the same notice published on June 23, 2009 (74 FR 29703). This notice of withdrawal eliminates the duplication, by withdrawing the July 13 notice.
Submission for OMB Review; Comment Request; NHLBI Health Information Center's Revolving Customer Satisfaction Survey
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 7, 2009, page 21372, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA)
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare and Medicaid Programs; Application of the Accreditation Commission for Health Care for Deeming Authority for Hospices
This proposed notice acknowledges the receipt of a deeming application from the Accreditation Commission for Health Care (ACHC) for recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Announcement of Five New Members to the Advisory Panel on Ambulatory Payment Classification Groups
This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of DHHS (the Secretary) and the Administrator of CMS (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Medicare and Medicaid Programs; Resolicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE) and Announcement of Closing Date
This notice resolicits proposals for the private, for-profit demonstration project for the Program of All-Inclusive Care for the Elderly (PACE) and announces a closing date for the solicitation. We previously solicited proposals from private, for-profit organizations for a fully capitated joint Medicare and Medicaid demonstration.
Medicare Program; Request for Nominations and Meeting of the Practicing Physicians Advisory Council, August 31, 2009
This notice invites all organizations representing physicians to submit nominations for consideration to fill four seats on the Practicing Physicians Advisory Council (the Council) that will be vacated by current Council members in 2010. This notice also announces a quarterly meeting of the Council. The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Request for Public Comment: 60-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires to provide a 60-days advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
Request of Public Comment: 60-Day Proposed Information Collection; Indian Health Service Forms To Implement the Privacy Rule (45 CFR Parts 160 and 164); Correction
The Indian Health Service published a document in the Federal Register (FR) on June 24, 2009. The document contained two errors.
Acquisition Regulations in Fiscal Year 2009
The Department of Health and Human Services (HHS) is interested in encouraging HHS prime contractors to assist small businesses, small disadvantaged businesses, HUBZone businesses, veteran-owned businesses, service-disabled veteran-owned businesses, and woman-owned businesses, in enhancing their capabilities to perform contracts and subcontracts for HHS and other Federal agencies. The program seeks to provide a Mentor-Prot[eacute]g[eacute] Program that assists qualified small businesses to receive development assistance from HHS prime contractors in order to increase the base of small business eligible to perform HHS contracts and subcontracts.
Availability of Draft Toxicological Profile for Perfluoroalkyls
This notice announces the availability of the draft toxicological profile for perfluoroalkyls, prepared by ATSDR, for review and comment.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; SMP (Formerly Senior Medicare Patrol) Program Outcome Measurement
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Notice of Development of Set 23 Toxicological Profiles
This notice announces the development of Set 23 Toxicological Profiles. Set 23 Toxicological Profiles consists of three new drafts and two updated drafts. These profiles will be available to the public on or about October 17, 2009. Electronic access to these documents will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/ toxpro2.html.
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.
Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA) listed in table 1 of this document. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs and ANADA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987
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 (the PRA).
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Contact Substances Notification System
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Contact Substances Notification System'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export of Food and Drug Administration Regulated Products: Export Certificates
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export of Food and Drug Administration Regulated Products: Export Certificates'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Notice of Participation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Study of Factors Influencing Consumer Choices Among Health Plans and Clinicians.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on September 3rd, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. This notice differs from the 60 day notice in the following ways: (1) The number of responses has been decreased from 6,000 to 4,950, (2) the burden hours are decreased from 838 to 709, and (3) the descriptions of each experimental arm in the sections: Clinician Choice Experimental Design and Health Plan Choice Experimental Design were removed.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health Literacy Item Set Supplemental to CAHPS Hospital SurveyPretest of Proposed Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
National Health and Nutrition Examination Survey (NHANES) Stored Biologic Specimens: Guidelines for Proposals to Use Samples and Proposed Cost Schedule
The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS, have provided national estimates of health and nutritional status of the United States civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population in the most recent survey, serum, urine and limited plasma samples were collected and stored for future research projects. Specimens are currently available from NHANES III (conducted from 1988-1994) and from NHANES 1999-2008. In 1999, NHANES became a continuous survey with data release every two years. Specimens are available from two year survey cycles after the demographic file has been released to the public. Participants in the survey that began in 1999 signed a separate consent document agreeing to specimen storage allowing their biologic specimens to be used for approved research projects.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL45); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (198) entitled ``Draft Guidance for Industry on Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products,'' VICH GL45. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance is an annex to a VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' VICH GL3(R), that published in the Federal Register of November 23, 2007 (72 FR 65751). This draft VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).
Ajinomoto Co., Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Ajinomoto Co., Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of N-[N-[3- (3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1- methyl ester, monohydrate (CAS Reg. No. 714229-20-6) for use as a non- nutritive sweetener in tabletop applications and powdered beverage mixes. Ajinomoto Co., Inc., also proposes that this additive be identified as advantame.
Advisory Committee; Risk Communication Advisory Committee; Termination and Recharter
The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency's regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.
Submission for OMB Review; Comment Request; CareerTrac
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Fogarty International Center (FIC) and National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 12, 2009, page 22172, and allowed 60-days for public comment. No comments were received from this notification regarding the cost and hour burden estimates. The purpose of this announcement is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Coronary Heart Disease Health Claim
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Record Retention Requirements for the Soy Protein and Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates
This proposed rule would revise 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 proposed rule, we describe the proposed 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 would be applicable to services furnished on or after January 1, 2010.
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