Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents
Results 1,001 - 1,200 of 3,583
Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products'' dated September 2009. The guidance document provides recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus. The guidance identifies the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title, dated May 2008.
New Animal Drugs; Fomepizole
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.
Draft Guidance for Industry on Microbiological Data for Systemic Antibacterial Drug Products-Development, Analysis, and Presentation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. Recommendations in this guidance cover microbiological considerations in the three major areas of conducting general nonclinical studies; conducting animal and human studies and clinical trials; and establishing and updating in vitro susceptibility test methods, quality control (QC) parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.
Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Extension of Deadlines to Request Participation in Pilot Program and to Submit Applications; and Notice of Increase in the Number of Original Applications in Pilot Program
The Food and Drug Administration (FDA) is announcing an extension of the deadline for submitting requests to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls (CMC)) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. Because the deadline for requests to participate in the pilot is being extended, FDA is also extending the application submission deadlines. FDA is also announcing an increase in the number of original applications being accepted into the pilot program.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Contract Health Services Report
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 60-day advance opportunity for public comment on the proposed information collection project, 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 for Information on Glutaraldehyde
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on glutaraldehyde, and develop appropriate communication documents, such as a Criteria Document, which will convey the potential health risks, recommended measures for safe handling, and establish an updated Recommended Exposure Limit (REL) for glutaraldehyde. The current NIOSH REL for glutaraldehyde is 0.2 ppm as a ceiling limit.
Request for Information on 1-Bromopropane
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on the brominated organic solvent, 1- Bromopropane (1-BP, CAS 106-94-5, also known as n-propyl bromide), and develop appropriate communication documents, such as a Current Intelligence Bulletin, Criteria Document and/or other informational products, and establish a Recommended Exposure Limit (REL) for 1-BP. NIOSH is requesting information on the following: (1) published and unpublished reports and findings from in vitro and in vivo toxicity studies with 1-BP, (2) information on possible health effects observed in workers exposed to 1-BP, (3) information on workplaces and products in which 1-BP can be found, (4) description of work tasks and scenarios with a potential for exposure to 1-BP, (5) workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to 1-BP occur.
Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac
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 Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for a revised human food safety warning for use of diclofenac sodium topical cream in horses.
Request for Information on Alternative Duty: Temporary Reassignment for Health Care Workers Who Work With Hazardous Drugs
NIOSH intends to publish a Current Intelligence Bulletin (CIB) on alternative duty and other forms of administrative controls for health care workers who work with hazardous drugs and are trying to conceive, are pregnant, and/or are breast feeding. Alternative duty involves transferring the worker to a similar position, but one in which they would not be required to handle hazardous drugs.
Medicare Program; Limitation on Recoupment of Provider and Supplier Overpayments
This final rule implements a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) which prohibits recouping Medicare overpayments from a provider or supplier that seeks a reconsideration from a Qualified Independent Contractor (QIC). This provision changes how interest is to be paid to a provider or supplier whose overpayment is reversed at subsequent administrative or judicial levels of appeal. This final rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in our obligation to pay interest to a provider or supplier whose appeal is successful at levels above the QIC.
Children's Health Insurance Program (CHIP); Allotment Methodology and States' Fiscal Year 2009 CHIP Allotments
This proposed rule describes the implementation of certain funding provisions under title XXI of the Social Security Act (the Act), the Children's Health Insurance Program (CHIP), as amended by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), and by other related CHIP legislation. Specifically, this
National Fisheries Institute; Filing of Food Additive Petition; Amendment
The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by the National Fisheries Institute, to provide for the safe use of ionizing radiation for control of foodborne pathogens in crustaceans and processed crustaceans.
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; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey
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.
Agency Emergency Processing Under the Office of Management and Budget Review; Tobacco Product Establishment Registration and Submission of Certain Health Information; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by the Family Smoking Prevention and Tobacco Control Act. The document was published with an incorrect date for submitting written or electronic comments on the proposed collection. This document corrects that error.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Office of the National Coordinator for Health Information Technology; HIT Standards Committee; Notice and Publication of Committee Recommendations to the National Coordinator for Health Information Technology
This notice publishes recommendations made by the HIT Standards Committee (Committee) at its public meeting on August 20, 2009, and invites public input on the recommendations at the Committee's next meeting on September 15, 2009. The Committee is a Federal advisory committee to the Office of the National Coordinator for Health Information Technology (ONC).
Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' This draft guidance provides FDA's proposed recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation. This draft guidance is not final nor is it in effect at this time.
Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes.'' The purpose of the public workshop is to solicit information from primary and secondary health care providers, academia, industry, and professional societies on various aspects of device clinical trials involving pediatric diseases and patients. Information from this public workshop will help stimulate interest in pediatric device clinical trial research methods, and develop topics for further discussion regarding the safety of pediatric device clinical trials. The information gathered in this and future workshops will help to develop future guidance for developing safe clinical trials for devices intended for pediatric patients. We encourage participation and comments from workshop attendees on the topics and questions discussed. Please see instructions for registration and for providing comments in the sections of this document entitled ``Registration'' and ``Comments.''
Memorandum of Understanding With Duke University
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and Duke University. The purpose of this MOU is to establish a framework for collaboration between the Parties and for pursuing specific collaborative projects. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium.
Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket
The Food and Drug Administration (FDA) is announcing the opening of a public docket to receive information and comments regarding the current classification process related to electroconvulsive therapy devices (ECT). The current classification process for this device pertains to the ``Order for Certain Class III Devices; Submission of Safety and Effectiveness,'' published in the Federal Register of April 9, 2009 (74 FR 16214). Under the Order, FDA required manufacturers of certain Class III devices, including ECT, to submit a summary of, and citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information which has not been submitted under the Federal Food, Drug, and Cosmetic Act (the act). For each device subject to the Order, FDA is reviewing the submitted information to determine whether FDA should maintain the device as class III and require the submission of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP), or whether FDA should reclassify the device into class II or class I. FDA is now inviting interested persons to submit comments that relate to the safety and effectiveness of ECT.
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.
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Department of Health and Human Services' (HHS) receipt and review of the annual report submitted to the Secretary and Congress by the contracted consensus-based entity regarding performance measurement as mandated by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The statute requires HHS to publish not later than six months after receiving the annual report to Congress in the Federal Register together with any Secretarial comments.
Meeting of the National Vaccine Advisory Committee
A notice was published in the Federal Register on Wednesday, August 26, 2009, Vol. 74, No. 164, to announce that a meeting of the National Vaccine Advisory Committee will be held on September 15 and 16, 2009. The meeting is open to the public. The meeting proceedings also will be Webcast; the Webcast can be viewed at https:// videocast.nih.gov.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of human papillomaviruses.
Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
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 contained in FDA regulations entitled ``Environmental Impact Considerations.''
Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.'' The document provides guidance to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels
The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH).
Request for Notification from Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives on Medical Device Advisory Committee Panels and Request for Nonvoting Industry Representatives on Medical Device Advisory Committee Panels
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Pool of Nonvoting Industry Representatives for the Risk Communication Advisory Committee and Request for Nominations for Nonvoting Industry Representatives for the Risk Communication Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a pool of nonvoting industry representative candidates available to serve as temporary nonvoting members on its Risk Communication Advisory Committee (the Committee) for the Office of the Commissioner notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations for the pool will be accepted effective with this notice.
Privacy Act of 1974; Report of an Altered System of Records Medical Staff Credentials and Privileges Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes several administrative revisions which includes the deletion of the Social Security Numbers (SSNs) language to comply with the Office of Management and Budget (OMB) Memorandum (M)07- 16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eliminate the unnecessary collection and use of SSNs; and the inclusion of a new routine use to comply with OMB (M)07-16 and the HHS Memorandum dated September 19, 2007 to incorporate Notification of Breach Routine Use language; and the update of the Appendix 1 of the SOR.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 022
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 022'' (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
2009 Parenteral Drug Association and Food and Drug Administration Joint Regulatory Conference
The Food and Drug Administration (FDA) in co-sponsorship with the Parenteral Drug Association (PDA), is announcing a conference entitled ``Securing the Future of Medical Product Quality: A 2020 Vision.'' The workshop helps to achieve objectives set forth in the FDA Modernization Act of 1997, which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Customer Satisfaction Survey
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60-day 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.
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.
Proposed Collection; Comment Request; NCCAM Customer Service Data Collection
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), will submit to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. A notice of this proposed information collection was previously published in the Federal Register on June 26, 2009 (Volume 74, Number 122, page 30577). To date, no public comments have been received. The purpose of this notice is to announce a final 30 days for public comment. NIH 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BANZEL
The Food and Drug Administration (FDA) has determined the regulatory review period for BANZEL 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; TALENT ABDOMINAL STENT GRAFT SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for TALENT ABDOMINAL STENT GRAFT 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; DORIBAX
The Food and Drug Administration (FDA) has determined the regulatory review period for DORIBAX 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; Evaluation of Potential Data Sources for the Sentinel Initiative
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.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon, by holders of approved drug and biological products. This is the agency's report on the status of the studies and clinical trials that applicants have agreed to or are required to conduct.
National Health and Nutrition Examination Survey (NHANES) DNA Samples: Guidelines for Proposals To Use Samples and 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 the health and nutritional status of the U.S. civilian non-institutionalized population. To add to the extensive amount of information collected for the purpose of describing the health of the population, DNA specimens were collected during three NHANES surveys. DNA is available in the form of crude lysates of cell lines derived from approximately 7,157 participants enrolled in Phase II of NHANES III (1991-1994). In addition, DNA purified from whole blood is also available from approximately 7,900 participants enrolled in the NHANES 1999-2002 and 4,621 participants enrolled in NHANES 2007- 2008. All specimens (NHANES III, NHANES 1999-2002 and NHANES 2007-2008) were sent to the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH) for processing. DNA samples from these specimens are being made available to the research community for genetic analyses.
Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App.), the U.S. Department of Health and Human Services is hereby giving notice that the Secretary's Committee on National Health Promotion and Disease Prevention Objectives for 2020 will hold a meeting. The meeting will be open to the public.
Common Formats for Patient Safety Data Collection and Event Reporting
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26 (Patient Safety Act), provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The initial release of the formats, Version 0.1 Beta, was announced in the Federal Register on August 29, 2008: 73 FR 50974-50976. The purpose of this notice is to announce the availability of the expanded and enhanced Common Formats Version 1.0 and the process for their continued development and refinement.
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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Notice Regarding 340B Drug Pricing Program-Children's Hospitals
Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (section 6004) added certain qualifying children's hospitals to the list of covered entities eligible to access 340B discounted drugs. The purpose of this notice is to inform interested parties of final guidelines regarding the addition of children's hospitals that meet certain requirements, specifically: (1) The process for the registration of children's hospitals to the 340B Program; and (2) the obligation of manufacturers to provide the statutorily mandated discount to those children's hospitals.
Determination of Regulatory Review Period for Purposes of Patent Extension; TAPENTADOL HYDROCHLORIDE
The Food and Drug Administration (FDA) has determined the regulatory review period for TAPENTADOL HYDROCHLORIDE 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 Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration and Submission of Certain Health Information
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Importer's Entry Notice
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The document provides guidance to the dietary supplement industry for complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance on labeling requirements for nonprescription (over- the-counter) human drugs marketed without an approved application, issued by FDA's Center for Drug Evaluation and Research, is announced elsewhere in this issue of the Federal Register.
Guidance for Industry on Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.'' This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.
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.
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 IT Community Tracking Study 2009.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
Decision To Evaluate a Petition To Designate a Class of Employees for the Metals and Controls Corporation in Attleboro, MA, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Metals and Controls Corporation in Attleboro, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Office of Research Integrity; Privacy Act of 1974; Report of an Altered System of Records
HHS proposes to revise the Privacy Act exempt system of records 09-37-0021, entitled ``Public Health Service Records Related to Inquiries and Investigations of Scientific Misconduct, HHS/OASH/ORI.'' This system became effective on August 29, 1994 (59 FR 36717, July 19, 1994). Changes were made in response to comments received, and the revised systems notice was published on January 6, 1995 (60 FR 2140). The proposed revisions include changing the routine uses and changing the title of the system to ``HHS Records Related to Research Misconduct Proceedings, HHS/OS/ORI.'' The revisions are necessary to reflect the changes made by the Public Health Service Policies on Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 (``Part 93''), and to update the system to reflect current practices and procedures under that regulation.
Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative
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 Institute of Allergy and Infectious Diseases (NIAID), 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.
Prospective Grant of Exclusive License: Development of Anti-Angiogenesis Cancer Therapeutics Targeting Adrenomedullin or Proadrenomedullin N-Terminal 20 Peptide (PAMP)
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/002,514, filed on August 18, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/0-US-01); U.S. Patent Application No. 60/002,936, filed on August 30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/1-US-01); U.S. Patent Application No. 60/ 013,172, filed on March 12, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/2-US-01); PCT Application No. PCT/US96/13286, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-PCT-01); Australian Patent No. 710662, issued on October 5, 2000, entitled ``Functional Role of Adrenomedullin (AM) and the Gene- Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-AU-02); Canadian Patent Application No. 2229741, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-CA-03); U.S. Patent No. 6,320,022, issued on November 20, 2001, entitled ``Adrenomedullin Peptides'' (HHS Reference No. E-206-1995/3-US-04); European Patent No. 0845036, issued on June 2, 1999, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-EP-07), and validated in France, Germany, and the United Kingdom; Japanese Patent Application No. 509499/97, filed on August 16, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the Gene- Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-JP-09); U.S. Patent No. 7,101,548, issued on September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-10); U.S. Patent Application No. 11/ 517,599, filed on September 5, 2006, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206-1995/3-US-11); Japanese Patent No. 4077861, issued on February 8, 2008, entitled ``Functional Role of Adrenomedullin (AM) and the Gene-Related Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E-206- 1995/3-JP-12); U.S. Patent Application No. 60/153,397, filed on September 10, 1999, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-01); PCT Application No. PCT/US00/24722, filed on September 8, 2000, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-PCT-02); Australian Patent No. 774725, issued on May 25, 2004, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E- 256-1999/0-AU-03); Canadian Patent Application No. 2383419, filed on September 8, 2000, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-CA-04); European Patent No. 1214600, issued on December 21, 2005, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E- 256-1999/0-EP-05), and validated in France, Germany, the United Kingdom, Italy, Spain, and Portugal; U.S. Patent Application No. 10/ 070,853, filed on March 8, 2002, entitled ``Determination of AM-Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256 091999/0-US-06); U.S. Patent Application No. 11/ 530,411, filed on September 8, 2006, entitled ``Determination of AM- Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-13); U.S. Patent Application No. 12/ 236,418, filed on September 23, 2008, entitled ``Determination of AM- Binding Proteins and the Association of Adrenomedullin (AM) Therewith'' (HHS Reference No. E-256-1999/0-US-14); U.S. Patent Application No. 60/ 425,018, filed on November 7, 2002, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294- 2002/0-US-01); PCT Application No. PCT/US03/35633, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-PCT-02); U.S. Patent No. 7,462,593, issued on December 9, 2008, entitled ``Compositions and Methods for Promoting Angiogenesis'' (HHS Reference No. E-294-2002/0- US-03); European Patent Application No. 03786608.4, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-EP-04); Australian Patent Application No. 2003295422, filed on April 18, 2005, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-AU-05); Canadian Patent Application No. 2504953, filed on November 7, 2003, entitled ``A New Target for Angiogenesis and Anti- Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-CA-06); Japanese Patent Application No. 2004-551922, filed on May 9, 2005, entitled ``A New Target for Angiogenesis and Anti-Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-JP-07); U.S. Patent Application No. 12/ 240,656, filed on September 29, 2008, entitled ``Target for Anti- Angiogenesis Therapy'' (HHS Reference No. E-294-2002/0-US-08); U.S. Patent Application No. 60/500,650, filed on September 8, 2003, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/0-US-01); PCT Application No. PCT/US04/29293, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-PCT-01); European Patent Application No. 04783513.7, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-EP-03); Canadian Patent Application No. 2539467, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1-CA-04); Australian Patent Application No. 2004273057, filed on September 8, 2004, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1- AU-05); and U.S. Patent Application No. 10/571,012, filed on March 8, 2006, entitled ``Non-Peptide Agonists and Antagonists of Adrenomedullin (AM) And Gastrin Releasing Peptide'' (HHS Reference No. E-246-2003/1- US-06) to Arana Therapeutics (VIC) Pty. Ltd., having a place of business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 3052, Australia, a wholly-owned subsidiary of Arana Therapeutics Limited, having a place of business at Level 2, 37 Epping Road, Macquarie Park, NSW 2113, Australia, a wholly-owned subsidiary of Cephalon, Inc., having a place of business at 41 Moores Road, Frazer, PA 19355, USA. The patent rights in this invention have been assigned to the United States of America.
National Toxicology Program (NTP): Report on Carcinogens (RoC); Availability of the Draft Background Document for Formaldehyde; Request for Comments on the Draft Background Document; Announcement of the Formaldehyde Expert Panel Meeting
The NTP announces the availability of the draft background document for formaldehyde by September 3, 2009, on the RoC Web site (https://ntp.niehs.nih.gov/go/29679) or in printed text from the RoC
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-October 21, 2009
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, October 21, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of catheter ablation for the treatment of atrial fibrillation. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Notice of Availability of Draft Policy Document for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.
Medicare and Medicaid Programs; Application of the American Osteopathic Association for Continued Deeming Authority for Hospitals
This notice announces our decision to approve the American Osteopathic Association (AOA) for continued recognition as a national accreditation program for hospitals seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education
This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel) to fill current vacancies and vacancies that will become available in 2009. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program.
Interagency Risk Assessment of the Public Health Impact From Foodborne Listeria monocytogenes in Some Ready-to-Eat Foods Sliced, Prepared, and/or Packaged in Retail Facilities; Request for Comments and for Scientific Data and Information; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until September 29, 2009, the comment period for the notice published in the Federal Register of January 21, 2009 (74 FR 3617). In that document, FDA requested comments and scientific data and information that would assist in the conduct of a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods sliced, prepared, and/or packaged in retail facilities. The risk assessment is being conducted by FDA in collaboration with the Food Safety and Inspection Service (FSIS). The agency is reopening the comment period because FDA and FSIS held a public meeting on June 23, 2009, to present the background, approach, scope, and data needs for the recently initiated interagency risk assessment (74 FR 27276; June 9, 2009) and this additional time will allow for public comment after this meeting.
Memorandum of Understanding Between the Food and Drug Administration, National Center for Toxicological Research, and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, for Toxicity of Nanomaterials
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Air Force Research Laboratory. This Memorandum of Understanding (MOU) between the Food and Drug Administration, National Center for Toxicological Research (NCTR), and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, Applied Biotechnology Branch (711 HPW/RHPB) (hereinafter referred to as ``the Parties''), sets forth the agreement of the Parties to facilitate information sharing in the area of toxicogenomic and computational toxicology research. Through the exchange of information, the Parties intend to coordinate research efforts so as to identify and expedite research and development of new tools and technologies that can be implemented that promote new understanding of the mechanisms of biological responses to environmental stressors, including toxic injury, and to identify biomarkers of exposure and disease that can be used to improve and protect human health.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates; and Changes to the Long-Term Care Hospital Prospective Payment System and Rate Years 2010 and 2009 Rates
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the TMA, Abstinence Education, and QI Program Extension Act of 2007, the Medicare Improvements for Patients and Providers Act of 2008, and the American Recovery and Reinvestment Act of 2009. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 2009. We also are setting forth the update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of- increase limits are effective for cost reporting periods beginning on or after October 1, 2009.
Electronic Public Comment Transmission Error for Two Medicare Program Rules
This document requests that the public resubmit their comments on the CY 2010 Physician Fee Schedule or CY 2010 Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center Payment System proposed rule before the close of the comment period for these rules (that is, August 31, 2009) if their comments were originally submitted via www.regulations.gov during the period from July 26, 2009 through July 30, 2009.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov, call 202-690-5566, or complete the on-line form on the NVAC Web site (https:// www.hhs.gov/nvpo/nvac/.) to register.
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